Head, Solid Tumors Cell Therapy, Cellular Therapeutics Center (CTC)
My research focuses on tumor immunology, chimeric antigen receptor (CAR) T-cell therapy, and combination immunotherapy for thoracic cancers. Over the years, we have developed clinically-relevant mouse models and modeled biological therapies in these models. This research has yielded mechanistic data that has been translated and is now in CAR T-cell and combination immunotherapy clinical trials for patients with lung cancer, pleural mesothelioma, and breast cancer. Our ongoing research focuses on investigating immunotherapy efficacy in human ex vivo translational models.
Our laboratory research has been funded by federal agencies and foundations resulting in >60 grant awards. My research has progressed to clinical trials and >180 publications including in Cancer Discov, FASEB, J Clin Invest, J Clin Oncol, J Natl Cancer Inst, Nat Med, and Sci Transl Med. In addition to serving on medical journal editorial boards, I am the Deputy Editor for Molecular Therapy Oncolytics. I serve as a member of national peer-review committees including NCI, DoD, PCORI, National health institutions of Austria, Belgium, Ireland, Italy, Poland, Netherlands, Switzerland, and the United Kingdom. I am a member of the Fleischner Society and American Society of Clinical Investigation. I serve on international committees including the American Society of Cell and Gene Therapy, NCI thoracic cancers steering committee, International Association for the Study of Lung Cancer, and the American Association for Thoracic Surgery. In my laboratory, I mentor MDs, MD/PhDs, and PhDs in thoracic oncology research, including visiting scholars from international institutions.

Senior Application Scientist
Jeffrey Ahlgren obtained a BS degree in Biological Sciences from the University of Wisconsin-Milwaukee, and a PhD in Biology from the University of Illinois Urbana-Champaign. He was a Research Chemist for the US Department of Agriculture. His research interests include using Light Scattering for the characterization of proteins and polysaccharides by Size Exclusion Chromatography and Field Flow Fractionation. Joining Wyatt Technology in 2002, he is a Senior Field Applications Scientist in the Southwestern Region.

Scientist, Protein Technologies
Rich Altman has 30 years of experience working in the pharmaceutical industry. In early 2016, he joined the Protein Technologies Mammalian Expression group at Amgen San Francisco, supporting biologics drug development. Prior to Amgen, he worked for several pharmaceutical companies on the cloning, expression, purification and characterization of recombinant proteins. This work supported both small-molecule high-throughput screening and protein therapeutic efforts. He received his MS degree from the University of Pittsburgh School of Medicine in the Department of Molecular Biology and Biochemistry.

Senior Staff Scientist, Oncology and Angiogenesis
Julian is an accomplished Scientist / Manager with 10+ years of experience in Biotech and the Pharmaceutical Industry (5+ years of experience managing PhD and non-PhD direct reports). He possesses proven expertise in drug discovery of small molecules, antibodies, bi-specifics and antibody-drug conjugates, as well as in signal transduction by oncogenes, and translational research. Julian is also a Cell Biologist focusing on building microscopy-based platforms to support targeted therapeutics and personalized medicine. He received his PhD from NYU School of Medicine in 2000.

Senior Scientist, Downstream Processing
Senior Scientist (Technical Lead Scientist) at the Centre for Process Innovation’s (CPI’s) National Biologics Manufacturing Centre (NBMC) based in Darlington, County Durham, United Kingdom. Michael holds a PhD in Food Biochemistry from the University of Leeds and has extensive experience in the biochemical separation and characterisation of proteins, process development and scale up for the production of novel therapeutic products under current Good Manufacturing Practice (cGMP) guidelines. His roles in Industry have included Technical Project Lead with responsibility for the Technology Transfer, Downstream Process Development and contract manufacturing of Active Pharmaceutical Ingredients (APIs, including domain antibodies) expressed in microbial (E.coli) and yeast (Pichia pastoris) culture at 100L, 750L and 3000L scale for toxicology and early phase clinical trials. Michael currently manages an Advanced Manufacturing Supply Chain Initiative (AMSCI) work package centered on the production and purification of 50 monoclonal antibody variants derived for mammalian (CHO) cells at 10L bioreactor scale. Michael is also involved in various collaborative and commercial development projects at the CPI NBMC.

Engineer I, Department of Cell Culture
Tia Arena is an Engineer in the Department of Cell Culture at Genentech where she has worked in the field of transient transfections for over five years. She is part of a team that generates protein for research and preclinical studies by way of high-throughput transient and stable transfections in mammalian cells. Tia’s work focuses on the development of high-titer HEK293 transient transfection systems including automating small-scale transfections and scaling up the transfection process. Tia obtained her MSc from San Francisco State University and her BSc from the University of Calgary.

Program Manager & Scientific Liaison
Dr. Arias Rivas is Program Manager & Scientific Liaison at Batavia Biosciences, where she is responsible for the portfolio of innovation projects. She has hold positions at HZI and worked on a collaborative project between Crucell and Leiden University. She has been involved in the development of several vaccines and production of proteins, antibodies and biopolymers. Dr. Arias Rivas has a PhD in Molecular Biology and is co-author of 5 patents and 17 scientific publications.

Associate Professor, Medicine, Lineberger Comprehensive Cancer Center
Paul Armistead is an associate professor of Medicine in the Lineberger Comprehensive Cancer Center the University of North Carolina, Chapel Hill. He is a member of the Bone Marrow Transplant Program at UNC and has research interests in the development of immunotherapeutics against hematologic malignancies. His primary laboratory interests are cancer antigen discovery and the characterization of T-cell mediated anti-cancer immune responses.

Director, Oncology Research
Tara Arvedson is a researcher and team leader in the Oncology Research department at Amgen. She received her Ph.D. at Caltech and was later a Damon Runyon Cancer Research Fellow at UC San Diego. Since being at Amgen she has led multiple programs targeting benign and malignant hematology and solid tumors using both large and small molecules. These programs have progressed from discovery stage to the clinic.

Vice President, Scientific Affairs
Dr. George Badescu is Vice President Scientific Affairs at Heidelberg Pharma and has over 15 years of experience in the biotechnology sector. He most recently served as Vice President Scientific Affairs at Abzena Plc where he led the scientific promotion and commercialization of Abzena’s Technologies and Chemistry Research and Manufacturing Services. Prior to this, he led PolyTherics’ Antibody Drug Conjugates (ADCs) program since its inception and is co-inventor on several patents in the field of bioconjugation and ADCs. Prior to this, George has worked on lead identification by viral display technologies, antibody engineering and characterisation of antibody-hapten interactions. George received his PhD from the University of Warwick.

Senior Director, Research & Development
Sven Bahrke is a leading scientist at Glycotope GmbH since 2007. As a specialist in glycobiology he was responsible for the establishment of the glyco-analytic department at where he implemented all necessary technologies for high standard glycan profiling as well as for MS based protein analysis. In addition, Sven Bahrke manages the bioanalytical service department of Glycotope and the development of biopharmaceutical products with focus on antibody-drug conjugates. Before the appointment at Glycotope he studied Chemistry at the University of Potsdam and gained experience in the fields of glycobiology and instrumental analytics during his PhD and Postdoctoral fellowship in the departments of Chemistry and Biochemistry as well as the Interdisciplinary Center for Mass Spectrometry / Berlin.

Professor, Computer Science
Chris Bailey-Kellogg is Professor of Computer Science at Dartmouth. His lab develops and applies computational methods for experiment optimization and analysis in studies of protein sequence-structure-function relationships. He is currently pursuing computationally-driven development of both protein therapeutics, redesigning non-human proteins so as to render them acceptable to the immune system, as well as vaccines, modeling and predicting immune responses to infection and vaccination.
Chris earned a BS/MS with Sandy Pentland at MIT and a PhD with Feng Zhao at Ohio State and Xerox PARC, conducted postdoctoral research with Bruce Donald at Dartmouth, and started his faculty career at Purdue. His work has been recognized with an NSF Career award and an Alfred P. Sloan Foundation fellowship.

Scientist, Pharmaceutical Research and Development
Bryan Balthazor is a currently a Scientist at Pfizer Inc. with a Bachelor of Science in Biochemistry from the University of Illinois in Urbana, IL and a Master of Arts in Biophysics from Washington University in Saint Louis, MO. Bryan’s role at Pfizer is a drug product development scientist responsible for leading drug product development of early and late stage biologics. His development activities include drug substance and drug product formulation development, commercial dosage form selection, lyophilization cycle development, drug product process development, drug substance and drug product technology transfer to clinical and commercial manufacture sites, and authoring regulatory submissions. Bryan’s has also researched formulation development techniques to reduce viscosity of high concentration monoclonal antibody solutions and investigated foam drying to stabilize biologics in the dried state with focus on understanding the impact of formulation and drying process parameters on foaming process and product stabilization.

Director, Bioprocess Development and Automation, Protein Therapeutics Program
PhD from the University of Washington - School of Medicine

• High-throughput production of Optides (cystine knot proteins) as novel therapeutics
• Optimization of Optide production at scale
• Development of an automated platform for high throughput mammalian protein production:
  • capable of producing up to 500 targets/week at small scale
  • successfully used for removing product liabilities, mutagenesis and SAR

Please visit: www.projectviolet.org

Senior Director, Late Stage Research
Alex Bankovich, Ph.D. joined Stemcentrx in December 2009 and took on many roles during the growth of the company from startup through integration after acquisition by AbbVie in June 2016 and beyond. He co-leads efforts in target validation for pipeline oncology ADCs. He is a founding member of the joint research committee for the Stemcentrx collaboration efforts with Pfizer, which resulted in clinical programs targeting PTK7 and EFNA4. Alex previously worked in academia studying immune homing to lymph nodes during post-doctoral studies at UCSF and structural biology of adaptive immune and cytokine receptors during doctoral studies at Stanford University.

Product Specialist, Chromatography
William Barrett, Ph.D is a Product Specialist with Gore. He has over 20 years combined experience in biotechnology, chromatography and the medical device industries. Most recently, Bill’s focused on affinity purification chromatography. Previously, Bill worked at Agilent on affinity depletion devices used in biomarker discovery and proteomics. He received a Ph.D in Biochemistry from the University of Illinois and completed his fellowship in the Laboratory of Biochemistry at the NHLB Institute at the NIH.

COO, R&D
Anton Bauer has served since 2015 as COO of The Antibody Lab, a privately held Austrian Biotech company, where he is co-founder. He developed together with Emilio Casanova BAC expression vectors for rapid generation of stable production cell lines, now called “BESTcell”. He has a strong background in antibody engineering and protein expression. Before joining The Antibody Lab, from 2006 on he was part of the founding team of f-star, where he established with his colleagues a novel antibody platform and identified the first clinical candidate. Anton studied biochemistry and immunology at the University of Vienna, and expanded his knowledge in cell biology and protein expression at the Research Institute of Molecular Pathology of Boehringer Ingelheim in Vienna and the German Cancer Research Center in Heidelberg. He previously contributed to several successful Biotech companies founded in Austria like f-star, Intercell/Valneva and Axon Neurosciences.

Associate Director, Protein Engineering
Matthew Bernett is an Associate Director in the Protein and Antibody Engineering group at Xencor, Inc. Since joining Xencor in 2005, he has been involved in all aspects of the company’s discovery and engineering efforts. Seven antibodies (four of which are bispecifics) engineered by Dr. Bernett and the team at Xencor are currently in clinical development, with many more in the pre-clinical stage. Presently, his work focuses on the design of novel antibody and cytokine-based bispecifics.

Assistant Professor & Director, Carleton Functional Proteomics Facility, Biochemistry
Dr. Biggar’s research is primarily focused in functional proteomics. This includes how proteins dynamically interact with each other, how enzymes select substrates, as well as working to define the changes in protein signaling, or regulatory networks, that accompany disease progression or resistance to treatment. He is also the founder and director of the Carleton Functional Proteomics Facility, and a member of the advisory board for NuvoBio Pharmaceutics (a Canadian company interested in developing peptide-based protein inhibitor using peptide array technology).

Associate Professor, Chemical and Biomolecular Engineering, Mike and Josie Harper Cancer Research Institute, NDnano Center for Nano Science and Technology
Basar Bilgicer joined the University of Notre Dame in 2008. In addition to his appointment in chemical and biomolecular engineering, he serves as a concurrent associate professor in chemistry and biochemistry. His research focuses on understanding the basic principles of antigen-binding biomolecular interactions, as well as the design of multivalent therapeutic and diagnostic molecules with which to deliver novel solutions to complex diseases, such as cancer, autoimmune diseases, and allergies. He received his bachelor’s in chemistry from Boğaziçi University in Turkey in 1998 and his doctorate in chemistry from Tufts University in 2005. Prior to joining the Notre Dame faculty, he served as a postdoctoral fellow in the George M. Whitesides research group at Harvard University from 2005 to 2008.

Professor, Biochemistry, University of Paris-Sud; Co-Founder, Acticor Biotec
Philippe Billiald (PharmD, PhD) is currently Professor of Biochemistry at the University of Paris-Sud (France) and co-founder of Acticor Biotech, a spinoff dedicated to the development of innovative, efficient and safe treatments of arterial thrombosis. Before completing postdoctoral training in antibody engineering at the University of Oxford, he received a PhD from the University of Paris VI in the field of immunoelectron microscopic observations and structural analysis of complex macromolecules. He was appointed at the University of Tours (F) where he served as a full Professor of Biochemistry and Biotherapy until 2008. His research is focused on the design of novel therapeutic antibody-based agents. With his co-workers he engineered recombinant antibodies neutralizing animal toxins and designed new antibody formats that protects animals against experimental scorpion envenomings. He is presently contributing to the development of new IgG-based antithrombotic molecules, ACT017 being the lead for the treatment of acute ischemic stroke without bleeding risks.

CTO
Uli Binder studied Molecular Biotechnology and Business Administration. He accomplished his Ph.D. studies at the Technical University of Munich and has extensive experience in protein engineering.

Section Head, High Throughput Biologics, R&D Biologics Research/Protein Therapeutics
2015- Sanofi – Biologics Research_Protein Therapeutics ◊ Section head HT-biologics 2008-2014 Bayer Healthcare – Global Biologics_Antibody Lead Discovery ◊ Lab head Molecular Biology and Antibody Informatics; Scientific lead for antibody optimization 2007-2008 Direvo Biotech AG ◊ Senior scientist protein engineering 2006-2007 University of Duesseldorf, Germany - Group Leader Biochemistry 2002-2006 The Scripps Research Institute, La Jolla, US ◊ Postdoc Immunology Education: Ph.D. Biochemistry, University of Frankfurt and Max-Planck Institute for Brain Research, Germany

Director, Scientific Operations, Research and Manufacturing
Catherine has more than 15 years’ experience in biochemistry research (specifically protein identification, purification and characterization). Prior to joining Absolute Antibody, she studied proteins related to cancer pathways, DNA repair and Duchenne muscular dystrophy, in research roles at the Medical College of Georgia (USA), Leeds University and Newcastle University.

Senior Investigator, Antibody Discovery
John is a protein and antibody engineer with 12+ years of experience at drug discovery and development. He led antibody discovery campaigns against multiple classes of antigens, and developed and implemented novel bispecific antibody technologies for the treatment of oncology and autoimmune disease. John successfully led bispecific antibody projects (MOR209/ES414) from discovery to IND, and also led additional bispecific antibody projects from discovery to preclinical proof-of-concept or non-clinical testing. He is familiar with pre-clinical, non-clinical, CMC, and regulatory challenges specific to bispecific antibody development, and is experienced working across functions and with external collaborators.

Vice President, Research & Development/Co-Founder
Dr. Boado co-founded ArmaGen in 2004, following more than 25 years of academic experience in fields of molecular and cell biology of the BBB, and drug delivery to the brain. His leadership and expertise have been instrumental in the development of ArmaGen’s extensive product pipeline, including potential biotherapeutic treatments for mucopolysaccharidosis, stroke, Alzheimer’s disease and Parkinson’s disease. Dr. Boado was the principal investigator in a number of Small Business Innovation Research (SBIR) programs granted by the National Institutes of Health to ArmaGen. Dr. Boado is also a co-inventor of the intellectual property that supports ArmaGen’s pipeline. He Professor Emeritus of Medicine at UCLA and has published over 200 scientific peer-reviewed publications and book chapters related to his field.

Professor, Department of Pharmaceutical Sciences, School of Pharmacy
Dr. Bogner is Professor of Pharmaceutics in the Department of Pharmaceutical Science at the University of Connecticut where she is also a member of the Institute of Materials Science. She received her BS in Pharmacy from Rutgers University, MS from the University of Iowa, and PhD from Rutgers University after which she joined the faculty of the University of Connecticut. Dr. Bogner’s research interests are focused on the characterization and dissolution of pharmaceutical solids, both freeze-dried parenterals and oral dosage forms. She teaches a course in mass transfer and a module in a freeze-drying course at the University of Connecticut. Dr. Bogner has served on several editorial boards, a USP committee, an FDA advisory committee and in various leadership roles in the American Association of Pharmaceutical Scientists (AAPS). She is a Teaching Fellow at the University of Connecticut, and Fellow of the AAPS.

Senior R&D Manager, Bioprocess R&D
Michael Collins is a Senior Research and Development Manager for Pall Biotech based in Westborough, USA. He has worked for Pall for more than 30 years and in Biotech for around 20 years, with extensive experience in the area of cell harvest/clarification including depth filtration, tangential flow filtration and novel technologies such as Acoustic Wave Separation and PallSep Vibrating Membrane Filtration. In his current role, Mike manages the Pall Biotech continuous filtration group within R&D.

Research Scientist, Biotechnology Discovery Research
Jeffrey Boyles received his M.Sc in Biochemistry/Structural Biology from Duke University in 2008. He joined the Protein Optimization Team within the Biotherapeutics Discovery Research organization at Lilly in 2010. As a member of this team, he is focused on the generation and characterization of potential therapeutic proteins and the delivery of candidate molecules. Prior to joining Lilly, he worked at KBI Biopharma and focused on antibody pre-formulation development.

CSO
Andrew Bradbury was trained in medicine at the universities of Oxford and London, and subsequently practiced medicine for five years (one full-time, and four part-time) in the UK. He received his PhD (Cambridge University) in the MRC Laboratory of Molecular Biology under the guidance of Dr. Cesar Milstein. After his PhD he spent 10 years in Italy: three years as a post doc in the CNR Institute of neurobiology, Rome, Italy; and seven years in Trieste, where he was first visiting professor, and subsequently tenured as assistant professor at the International School for Advanced Studies (SISSA, Trieste, Italy). He was a staff scientist and group leader at Los Alamos National Lab from July 1999 to June 2017, when he left to join Specifica, a startup he founded that specializes in antibody selections and selling unique antibody libraries. He has worked in the field of phage display and antibody engineering for 25 years and has helped organize over forty international congresses and practical courses in this field, both in Europe and the US. He has published over 130 peer-reviewed articles, including a number of reviews and commentaries on phage display and antibody engineering. He is one of the founding members of “The Antibody Society” and is on the editorial board of three journals.

Founder
Dr. Bramhill has over 20 year’s experience in biologics, both in large biopharma and startup biotech companies. He has experience in isolating and improving antibodies using phage display and is an inventor on library design techniques for small scaffolds. He also has experience in diverse expression systems for producing antibodies, antibody fragments and different scaffolds. He has taught numerous technical courses for over 10 years at international conferences.

Assistant Professor, Immunology and Microbiology
Bryan did his graduate work at Vanderbilt University under the mentorship of James Crowe, followed by a postdoctoral fellowship in Dennis Burton’s lab at The Scripps Research Institute. In 2018, he joined the Department of Immunology and Microbiology as an Assistant Professor. His lab studies the genetics of antibody responses to immunization and infection.

Senior Scientist III, Global Biologics
Nathan Brown received his PhD in Chemical Engineering from Northwestern University in Evanston, IL for his work on structure-activity relationships of synthetic analogues of surfactant protein C. Following his graduate work, Nathan joined the AbbVie Bioresearch Center in Worcester, MA as a senior analytical scientist originally in Operations and now within the Discovery organization. In his current role, he leads the Biologics Pharmacy and Analytics group within the Global Protein Sciences, where his group is responsible for analytical and biophysical method development and characterization in support of early and late discovery initiatives.

Associate Professor, Department of Chemical Engineering
Dr. Brad Bundy is an Associate Professor of Chemical Engineering at Brigham Young University. His research is focused in cell-free synthetic biology with five specific thrusts: (1) Optimizing PEGylated Protein Therapeutics, (2) Creating On-Demand, Just-Add-Water Protein Synthesis Systems, (3) Building Better Biocatalysts, (4) Rewriting the Genetic Code, and (5) Biosensing. He is the recipient of the NSF CAREER Award, DARPA Young Faculty Award, and BYU Young Scholar awards. He is also committed to excellence in education and received the Outstanding Faculty Teaching Award in Chemical Engineering in 2010, 2012, 2013, 2016, and 2017 as voted by the BYU chemical engineering students.

Professor and Teddy Traylor Faculty Scholar, Chemistry and Biochemistry
Michael Burkart, Ph.D., is a Professor and Vice Chair of Chemistry & Biochemistry at the University of California, San Diego. Originally from Texas, he received a BS in Chemistry from Rice University and a Ph.D. in Chemistry from The Scripps Research Institute, followed by a post-doctoral fellowship at Harvard University. The Burkart Laboratory pursues interdisciplinary research in the fields of organic and biological chemistry, with a focus on natural product synthesis and biosynthesis.

Head, Integrated Production Platforms
During his undergraduate studies at the RWTH Aachen University (Aachen Germany) Johannes Buyel started working on recombinant protein expression in the Biochemical Engineering Department (Prof. Jochen Büchs) and the Institute for Molecular Biotechnology (Prof. Rainer Fischer). As a part-time lab manager at m2p-labs (Aachen, Germany), he continued his master studies at the Lund University (Lund, Sweden; Prof. Carl Borrebaeck) and the Fraunhofer Center for Molecular Biotechnology (Newark, DE, USA, Prof. Vidadi Yusibov), where Johannes worked with microbial, mammalian and plant-based expression systems, respectively. His PhD at the RWTH Aachen University focused on modelling protein expression in plants. Between 2013 and 2014 Johannes continued this work as a Post-Doc and started a second PhD on process optimization and downstream processing at the Karlsruhe Institute of Technology (Karlsruhe, Germany; Prof. Jürgen Hubbuch) which he finished in 2017. In 2015, Johannes also joined the Fraunhofer Institute for Molecular Biology and Applied Ecology IME as a group leader to develop a high-through screening platform for protein expression and purification and was promoted to head the department of Integrated Production Platforms in the same year. Johannes is now supervising process development and scale-up especially for challenging proteins.

Senior Scientist, Process Development
Bill Callahan is a Senior Scientist at Amgen. He has been with the company for 28 years. Bill was responsible for the formulation development of Romiplostim, currently on the market. He has also worked on and supported other formulation development projects. At present, he is involved in the lifecycle management of some existing products, in addition to managing the formulation development of new products. His research interests include novel formulation development, solubility theory and the stability of proteins.

Postdoctoral Researcher, Center for Cellular Immunotherapies
Dr. Mauro Castellarin is a postdoctoral researcher in the Laboratory of Carl June at the University of Pennsylvania, where he is using synthetic biology to develop new CAR T cell technologies. During his PhD research at Canada's Michael Smith Genome Sciences Centre, he used deep sequencing to profile mutations, microbes and immune cells associated with cancer. His scientific contributions include finding a link between colon cancer and bacteria and identifying mutation-specific T cells in ovarian cancer. Dr. Castellarin’s current research interests focus on developing CAR T cell therapy for treatment of solid tumors.

Senior Research Officer, Human Health Therapeutics
I am a Senior Research Officer at the National Research Council of Canada (NRC) and CNS Pharmacology Team Lead in the Department of Translational Biosciences, Human Health and Therapeutics. I have a PhD degree in Biochemistry from Dalhousie University, NS, Canada. My expertise is in Cell signalling and Signal transduction processes, particularly involving of protein kinases. My laboratory has a long standing interest in identifying and understanding signaling pathways (protein kinases and phosphatases) and signaling complexes (protein-protein interactions) involved in neuronal cell survival and death in neurodegenerative disorders/diseases such as stroke and Alzheimer’s disease (AD) using cell culture and animal models.
In the past 10 years my research is mainly focused on understanding the molecular mechanism(s) underlying ß-amyloid (Aß) accumulation and synaptic degeneration in Alzheimer’s disease (AD). A major focus is on understanding the role of neurotrophic receptor p75NTR in ß-amyloid-induced toxicity using cell culture, animal models and post-mortem human brain tissues. We have discovered and characterized an Aß oligomer-binding peptide (ABP) that targets Aß deposits in the brain and can potentially facilitate their clearance in vivo. To enable ABP transport across blood-brain barrier (BBB) and engage Aß deposits in target regions of the brain, it has been fused with a unique BBB-carrier developed at NRC. In collaboration with a Canadian Pharmaceutical Company, KalGene, we are currently developing BBB-enabled ABP as a potential AD therapeutic. I have over 80 publications in peer-reviewed International Journals, including review articles and a book and hold a patent on ABP.

Senior Director, Protein Engineering
Javier worked for 8 years in the field of enzyme engineering and received his PhD in 2003. After his postdoctoral training he joint Pfizer, where he is leading the protein engineering department. In this role, he is responsible for leading biotherapeutic discovery work, including lead generation and optimization, structural determination, structural based design, biophysical characterization, and non-GLP biotherapeutic production. Javier is interested in understanding the underlying biology of drug design and delivery and engineering solutions for challenges associated with developing the next generation of biotherapeutics.

Senior Scientist, Research Department
Chao-Guang Chen is a Senior Scientist and Head of the Protein Engineering Group at CSL Ltd. This group performs a wide range of molecular engineering functions including antibody phage-display library generation; antibody affinity maturation; protein engineering; mammalian surface display and high throughput antibody construct generation and expression. Chao-Guang has a passion for technological innovation and his ability to simplify and streamline time-consuming and labor-intensive complex procedures has transformed many of the platform technologies employed within the Research Department at CSL.

Product Manager Marketing

Principal Investigator, Institute of Molecular and Cell Biology
Dr. Qingfeng Chen received his BS in 2003 and PhD in June 2008 from University of Science and Technology of China. In July 2008, he joined in Singapore-MIT Alliance for Research and Technology (SMART) to pursue postdoctoral research on developing humanized mouse models. He Joined in Institute of Molecular and Cell Biology, A*STAR in January 2012 to establish humanized mouse unit. He is currently a Principal Investigator in IMCB, joint Principal Investigator in National Cancer Centre Singapore and adjunct assistant professor in Yong Loo Lin School of Medicine, National University of Singapore. Dr. Chen is also an awardee of Gilead Sciences International Research Scholar 2015 and Singapore National Research Foundation Fellowship 2017. Dr. Chen’s group has shown that adoptive transfer of human stem cells into immuno-deficient mice leads to stable development of functional human blood, liver and other biological systems in mice (Humanized Mouse). His research focus is to apply humanized mouse technologies in study of hepatotropic diseases, immuneoncology, as well as the assessment of the efficacy of human specific therapeutics.

Assistant Professor
Dr. Wen-Hsiang Chen currently serves as Director of Quality Control and Analytical Development at Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine, where they study recombinant protein-based vaccines against emerging and neglected infectious diseases. He leads a team tasked to develop biophysical and biochemical assays to characterize vaccine antigens and monitor their quality and stability. The team coordinate with the Process Development and Formulation teams to design a complete process with antigen-specific technologies that are ready to be transferred to cGMP manufacturing. They also work with the Quality Assurance team to generate data for FDA regulatory submission. Dr. Chen also has experience in gene cloning and expression in E. coli, Pichia pastoris, baculovirus/Sf9 and CHO cell line, and extensive experience in upstream and downstream process development at the 5 to 10 L scale.

Assistant Professor, Chemical & Biomolecular Engineering
Dr. Yvonne Chen earned her BS in Chemical Engineering from Stanford University and her PhD in Chemical Engineering from the California Institute of Technology. She received postdoctoral training at the Center for Childhood Cancer Research within the Seattle Children’s Research Institute, and at the Department of Systems Biology at Harvard Medical School. Yvonne was a Junior Fellow in the Harvard Society of Fellows prior to joining the Department of Chemical and Biomolecular Engineering at the University of California, Los Angeles in 2013. The Chen Laboratory focuses on applying synthetic biology and biomolecular engineering techniques to the development of novel mammalian-cell systems, particularly T-cell therapy for cancer. Yvonne has been a recipient of the NIH Director’s Early Independence Award, the Hellman Fellowship, the ACGT Young Investigator Award in Cell and Gene Therapy for Cancer, and the NSF CAREER Award.

Senior Research Investigator, Discovery Pharmaceutics & Analytical Sciences
Yuan is currently a Senior Research Investigator in Department of Discovery Pharmaceutics and Analytical Sciences at Bristol-Myers Squibb. Yuan obtained his PhD from University of North Carolina at Chapel Hill. He also completed postdoctoral studies in protein biophysics and structural biology at University of Texas Southwestern Medical Center and in protein formulation and biophysical characterization at Department of Pharmaceutical Chemistry, University of Kansas.
Since joining Bristol-Myers Squibb in 2014, Yuan has worked in the field of protein preformulation and drug candidate selection. He has worked on numerous drug modalities including antibody, domain antibody, antibody-drug conjugate and fusion protein.

Senior Director, BioMedicine Design, Medicinal Sciences, Worldwide Research and Development
Dr. Gabriel WC Cheung joined Pfizer in 2015. He is a Senior Director at BioMedicine Design. He oversees the endogenous antibody discovery, high throughput screening, and technologies group supporting Biotherapeutic needs across all Pfizer Research Units. Through his interests and passion in technology development and humoral immunity, Dr. Cheung is committed to transform how Pharma industry rapidly delivers high quality and functionally relevant biotherapeutics through the use of deep repertoire discovery.
Prior to joining Pfizer, Dr. Cheung spent 14 years at Cell Signaling Technology leading the company to global leadership in rabbit monoclonal antibody development. He and his research team developed a number of industry leading and state-of-the-art antibody discovery technologies and platforms to address real world commercial needs. During his tenure at CST, he and his research team also made noticeable scientific contributions and collaborations in the field of immunology and vaccine leading to a number of patents and high profile publications in Nature Biotechnology, Nature Immunology, and Immunity. Dr. Cheung received his PhD in Biochemistry, molecular biology, and biophysics from University of Minnesota, Twin Cities.

Director, Cell Biology, Life Science Solutions
Dr. Chiou has over 15 years of experience working on development of mammalian protein expression systems and transfection reagents. For the past nine years, he has worked as a principal scientist and now in product development and portfolio management for Life Technologies, now part of Thermo Fisher Scientific. He has led the development efforts on a number of products, including the FreeStyle™ transient expression systems, Lipofectamine™ LTX and Lipofectamine™ RNAiMAX. Prior to Life Technologies, he worked for several biotech companies on biotherapeutic gene delivery systems. Dr. Chiou received his doctorate from Harvard University and completed a postdoctoral fellowship at the University of Pennsylvania.

Instructor, Neurosurgery, Brigham and Women’s Hospital
Dr. Cho is a faculty member at the Brigham and women’s medical school, and a research affiliate at MIT. Dr. Cho and colleagues have pioneered the blood-brain-barrier organoid platform as an in vitro screening model to study brain-permeable agents. The Cho laboratory at the Brigham and women’s hospital continues to employ this technology as a tool to design new therapeutics for treating diseases of the central nervous system.

Project Leader, Biomaterials Group
Marcus Cicerone received his PhD in Physical Chemistry at the University of Wisconson-Madison in 1995. After graduation he worked at Johnson & Johnson Clinical Diagnostics for three years and then as a visiting assistant professor at Brigham Young University for two years before taking a position at the National Institute of Standards and Technology where he is currently a project leader in the Biomaterials Group. He has received two NIST Bronze Medals and the Washington Academy of Science award for Physical Sciences and Biology. He and published approximately 80 peer-reviewed papers, which have received more than 4200 citations (h-index = 32).
His research has two broad focus areas. One is nonlinear spectroscopic imaging. In 2004 he and his research team introduced broadband coherent anti-Stokes Raman scattering (BCARS) microscopy. Subsequent advances by his group have led to BCARS being the fastest method of acquiring Raman spectra from delicate biological samples. Biophotonics Magazine recognized these advances as being among the top 10 advances of 2014.
Dr. Cicerone’s other research area is dynamics of amorphous and glassy systems. This area includes work in biopreservation – stabilizing proteins in dry state for therapeutic and diagnostic use. He and his colleagues were the first to show that dynamics on the ps to ns timescale ultimately control protein degradation rates in sugar-based glasses, a discovery that is expected to lead to increased efficiency in formulating freeze-dried protein drugs. This work was recognized by a 2014 Innovations in Biotechnology award from the American Association of Pharmaceutical Scientists.

Director, Research
Dr. Cizeau is the Director of Research at Viventia Bio Inc., a subsidiary of Sesen Bio. Dr. Cizeau is responsible for the design, engineering and biological characterization of Eleven’s next generation ADC Targeted Protein Therapeutics (TPT) platform including TPTs carrying the de-immunized proprietary plant toxin payload, deBouganin. Prior to joining Viventia Bio Inc., Dr. Cizeau was a post-doctoral fellow at the Manitoba Institute of Cell Biology in Winnipeg (CANADA) and received his Ph.D. in molecular biology from the University of Orleans (France).

O’Hara Professor of Chemistry & Biochemistry; Concurrent Professor of Chemical & Biomolecular Engineering
Patricia L. Clark is the O’Hara Professor of Chemistry & Biochemistry, Concurrent Professor of Chemical and Biomolecular Engineering and Director of the Biophysics Graduate Program at the University of Notre Dame. Her laboratory uses a broad range of biophysical, genetic and other tools to investigate protein folding mechanisms. She leads a multi-disciplinary, NIH-funded research network comprised of eight laboratories investigating the effects of protein synthesis rate on successful protein folding. Professor Clark has received multiple awards throughout her career, including an NSF CAREER Award, the Bárány Award from the Biophysical Society and the Notre Dame Joyce Award for Excellence in Undergraduate Teaching.

Principal Scientist, Cell Sciences
Howard Clarke is currently a Principal Scientist leading the Cell Line Development group at Seattle Genetics and has over 20 years of biotechnology and contract manufacturing experience, from expression vector design to upstream process development (UPD), in a variety of roles from researcher to UPD director. He obtained a PhD in microbiology from the University of Washington, focusing on cellular and molecular biology of transgene expression, and then transitioned to industry to pursue therapeutic biologics expression. His research and process development focus includes improving recombinant protein expression through vector, host cell and media improvements, secretory folding and posttranslational modifications, and predictive screening technologies, applied to the development of many different cell lines expressing antibodies to complex glycoproteins. Current research focuses on genetic characterization of cell lines to investigate clonality and transgene stability as cells age to understand the impact of genetic drift on production consistency and product comparability.

Senior Scientist, Physical Life Sciences
Dr. Coleman is a senior biomedical staff scientist at Lawrence Livermore National Laboratory and an adjunct professor in the department of radiation oncology at University of California Davis School of Medicine and. He received his Ph.D. in molecular biochemistry and cellular biology from Boston University. Dr. Coleman has authored over 130 publications in peer-reviewed journals, published proceedings and book chapters covering a diverse breadth of molecular and cellular biology and biochemistry. He has over 19 years experience characterizing genomic responses of genotoxic stressors such as ionizing radiation. Dr. Coleman is also very active in the development of advance biochemical techniques using nanoparticles made of apolipoproteins and phospholipids called nanolipoproitein particles (NLPs). NLPs closely mimic the cellular membrane bilayer and represent an ideal platform for characterizing membrane proteins involved in signal transduction. For example, NLPs are proving useful for the characterization of the structure and function of G-protein coupled protein receptors. NLPs are also proving useful for drug delivery, immuno-modulation and in vivo imaging in the treatment of cancer.

Research Officer, Human Health Therapeutics
Christopher received his PhD from McGill University under the supervision of Prof. Nicolas Moitessier. After his PhD, he joined the National Research Council of Canada (NRC) as a Research Associate under the supervision of Dr. Enrico Purisima investigating solvation and protein loop searching. Following his time at the NRC he joined Chemical Computing Group as a Research Scientist developing tools for biologics design. After 4 years, he decided to leave private industry and rejoin NRC as a Research Officer focusing on investigating tools for computer-aided biologics design.

Process Informatics Manager, Global Engineering
Carly Cox has a passion for finding the most efficient way to use data to make better decisions and has spent the past 12 years helping the Pfizer manufacturing sites to more easily access and analyze their process data to enable increased process understanding. For the past six years, she has worked with experts across the industry as a member of the BioPhorum Operations Group (BPOG) Continued Process Verification (CPV) and Informatics team, contributing to the publication of several guidance documents around both the CPV process and the informatics systems that support it. Ms. Cox holds a Bachelor of Science in Chemical Engineering from the Massachusetts Institute of Technology.

Co-Founder & CEO
Dr. Manon M.J. Cox, MBA, founded NextWaveBio early 2018 following her departure from Protein Sciences Corporation where she led the development of Flublok®, the only FDA approved recombinant influenza vaccine. In August 2017 Sanofi completed the acquisition of Protein Sciences Corporation where she served as President and Chief Executive Officer since April 2010 and Director since 2008. She joined Protein Sciences in 1998 as Director of Business Development and became Chief Operating Officer in 2003. She serves on the Board of Trustees of St. Joseph University, the Board of the Netherland-America Foundation and its Education Committee, and the Scientific Advisory Boards of Pall BioPharmaceuticals and Epivax Oncology. Previously she was with Gist-brocades, a large Dutch company specialized in fermentation, where she held various management positions, most recently in New Business Development and before that in Production and Research and Development. Prior to joining Gist-brocades, she worked as a Molecular Biologist on the development of a PCR screening test for cervical cancer at the University of Amsterdam. Dr. Cox has received many honors and awards recognizing her stature as a leader in innovation and influenza, including in 2014 receiving a Doctorate in Humane Letters honoris causa from St. Joseph University and the Woman of Innovation award from the Connecticut Technology Council and was elected fellow in the International Society of Vaccines in 2015. Dr. Cox holds a Doctorate from the University of Wageningen, received her MBA with distinction from the University of Nijenrode and the University of Rochester, NY and holds a Doctorandus degree in Molecular Biology, Genetics and Biochemistry from the University of Nijmegen, The Netherlands.

William Weightman Walker Professor, Isermann Department of Chemical and Biological Engineering
Steven Cramer is the William Weightman Walker Professor of Chemical and Biological Engineering at Rensselaer Polytechnic Institute, Troy, New York. Prof. Cramer is a bioprocessing downstream expert whose research focuses on applying fundamental understanding of biomolecular interactions towards the development of novel chromatographic and precipitation protein separation processes. He served as the Editor-in-Chief of the International journal Separations, Science and Technology for 20 years. Professor Cramer was the awarded the Alan S. Michaels Award for the Recovery of Biological Products (ACS Division of Biochemical Technology) and the 2016 ACS National Award in Separation Science and Technology. He was also awarded Rensselaer’s School of Engineering Outstanding Professor Award and the Research Excellence Award. Professor Cramer has been elected a fellow of the American Association for the Advancement of Science, American Institute of Chemical Engineers, the American Chemical Society and the American Institute for Medical and Biological Engineering. Prof. Cramer is a consultant for several biopharmaceutical and bioseparation companies. He is also the Chair of the Recovery of Biological Products Board. Prof. Cramer has published over 180 papers in peer-reviewed journals and has 11 patents. Importantly, he has produced 45 Ph.D. students who have gone on to leadership positions in the biotechnology industry and academia.

Director, BioProcess Development
Philippe Cronet, PhD, is Director of Global Bioprocess Development at Wacker Biotech. Philippe is trained as protein engineering and production specialist. He developed a strong experience in the CDMO industry, overseeing the development of small and large scale production processes for various biopharmaceuticals. Philippe heads the global organization who is responsible for the development of robust and cost-effective processes to deliver high quality biotherapeutic agents to Wacker´s customers.

Senior Director, Biology
Marc Damelin is Senior Director and Head of Biology at Mersana Therapeutics, where is he focused on ADC discovery and development for oncology. Prior, he spent 10 years at Pfizer, where he led ADC project teams, oversaw the ADC portfolio and mentored two postdoctoral fellows. He is the Editor of the book “Innovations for Next-Generation Antibody-Drug Conjugates” published by Springer in 2018. Marc received his Ph.D. in Biophysics from Harvard University and was a Postdoctoral Fellow of the Damon Runyon Cancer Research Foundation at Columbia University.

QA/QC and GMP Consultant
Trevor has 39 years of experience in pharmaceutical development, manufacturing, quality control and quality assurance. He is registered as an eligible QP under EC Directive and has also practiced as a registered Pharmacist in the UK. He now resides in Maryland and has his own consulting business. He has a PhD in Peptide Chemistry and has extensive expertise in aseptic processing, and in a wide range of unique and unusual biotechnology processes, including live vaccines, tissue culture products, and cell-based products. He has practiced as a QP since 1983 and his QP experience includes commercial batch release, investigational medicinal products and “Specials.” He has established and operated Quality Systems in compliance with the European Clinical Trials Directive and with global regulatory expectations (FDA, WHO, ANVISA, etc.). He has led scale-up and technology transfer projects for large and small molecules, has managed many projects with contract manufacturing organizations, has undertaken a number of evaluations of new technologies, and has performed due diligence evaluations of such products for acquisition.

Associate Professor, Department of Biochemistry and Biophysics
Jan-Willem de Gier’s laboratory at Stockholm University has been shaping E. coli for recombinant protein production using both evolutionary and engineering approaches. JWdG is co-founder of the biopharmaceutical company Xbrane Biopharma AB (www.xbrane.com) and the vaccine company Abera Bioscience AB (www.aberabio.com).

Assistant Professor, Pharmaceutical Chemistry and Chemical Engineering
Dr. Brandon DeKosky is an Assistant Professor at the University of Kansas Departments of Chemical Engineering and Pharmaceutical Chemistry, where his laboratory leverages recent advances in next-generation DNA sequencing technologies to achieve a more comprehensive understanding of immune function and to accelerate the development of new vaccines and therapeutics. During his graduate research, Dr. DeKosky invented the very first technology for sequencing the antibody proteins encoded by B cells at the single-cell level, at a massive scale (for example, over 5 million single B cells in a one-day experiment), which reduced cost and enhanced throughput for antibody sequencing by multiple orders of magnitude compared to traditional antibody discovery platforms. Dr. DeKosky also pioneered the associated bioinformatic methods for rapid statistical analysis of the very large datasets generated by this approach. These inventions have contributed to one issued patent, several pending patents, and 13 original research articles since 2013 including 7 articles in Nature publication group journals; three of these have >100 citations to date. Ongoing efforts in the DeKosky lab are expanding our ability to determine the mechanisms of protection for human vaccines and to develop novel and improved targeted human therapeutics.

William L. Lewis Professor, Chemical & Biomolecular Engineering
Matthew DeLisa received his BS in Chemical Engineering from the University of Connecticut in 1996; his PhD in Chemical Engineering from the University of Maryland in 2001; and did postdoctoral work at the University of Texas-Austin, Department of Chemical Engineering. DeLisa joined the Department of Chemical and Biomolecular Engineering at Cornell University as an assistant professor in 2003. He was promoted to associate professor in 2009 and to professor in 2013, at which time he was named the William L. Lewis Professor of Engineering. He also recently served as a Gastprofessur at the Swiss Federal Institute of Technology (ETH Zürich) in the Institut für Mikrobiologie.

Associate Director, Formulation & Drug Product Development
Roberto DePaz has extensive experience in the formulation development of biologics, encompassing a wide variety of molecule types. He was responsible for formulation development at AlphaVax, a startup vaccine company in Research Triangle Park, NC that used alphaviruses as viral vectors for vaccine applications. He was then part of the Formulation Sciences department at MedImmune, where he worked on the formulation development of fusion proteins, monoclonal antibodies, and antibody-drug conjugates. He is currently Associate Director at REGENXBIO, responsible for formulation development of AAV vectors for gene therapy. Roberto holds a BS from the University of Illinois and a PhD from the University of Colorado, both in Chemical Engineering.

Senior Director, R&D, Vaccine Product Development Center
Dr. Antu Dey is Senior Director, Research & Development, at International AIDS Vaccine Initiative (IAVI). He is responsible for managing, supporting and administering the Vaccine Product Development Center’s (VxPDC) efforts to accelerate the development of HIV vaccine candidates. Before joining IAVI, Dr. Dey worked at Novartis Vaccines/GSK Vaccines where he worked on multiple vaccine candidates and adjuvant platforms as Process and Product Development leader. Dr. Dey holds a Masters in Science from India and a DPhil. from University of Oxford, UK. Dr. Dey has over 30 peer-reviewed publications and multiple patents.

Senior Director and Head, Biologics Process and Analytical Development
Dr. Dhanasekharan is Head of Biologics Development at Amicus Therapeutics responsible for development and scale-up of biologics of early and late phase programs. Previously, he was responsible for process and analytical development at Cook Pharmica, a contract and development organization (CDMO) in Bloomington, Indiana. Prior to that, he was at Genzyme-Sanofi in various leadership roles including process development, process engineering and manufacturing sciences at Genzyme in Framingham, Massachusetts. He led Quality by Design (QbD) implementation efforts including a lifecycle approach to process validation with process monitoring and control programs. He also led efforts in viral risk mitigation and provided technical leadership for several projects related to Consent Decree remediation. Kumar has a PhD in Food Science from Rutgers University and a Bachelor's in Chemical Engineering from Indian Institute of Technology, Chennai, India. He has over 50 conference presentations and over 10 peer-reviewed publications.

Principal Scientist, Process Development & Analytics
Iskandar Dib got his education at Graz University of Technology and the Research Center Applied Biocatalysis. After obtaining his PhD he joined the team of VTU Technology where he is now heading the DSP and Analytics department. His areas of expertise include process development for up- and downstream processes applying DoE tools for process understanding.

Director, Center for Antibody Therapeutics
Dr. Dimitrov graduated and completed his PhD at the University of Sofia, Sofia, Bulgaria, and thereafter he worked in the Bulgarian Academy of Sciences where he defended his ScD and was Professor of Biophysics until he joined the National Cancer Institute (NCI) of the National Institutes of Health (NIH), USA, in 1990. There he was tenured as Senior Investigator and appointed at the Senior Biomedical Research Service. He joined the University of Pittsburgh in 2017 as the Director of the new Center for Antibody Therapeutics (CAT). He is expert in display/screening/libraries methodologies, antibody engineering, and protein biochemistry as well as in mathematical modeling, immunology, virology, physical chemistry and biophysics. His major long-term goal is the development of clinically useful therapeutics and vaccines based on human monoclonal antibodies in different formats including engineered antibody domains, chimeric antigen receptors, antibody drug conjugates, full size antibodies, bispecific antibodies and antibody-based fusion proteins. He has authored or coauthored more than 400 articles cited more than 22,000 times, several books and is inventor or coinventor of more than 100 inventions, patent applications or patents.

Senior Scientific Director, Biologics
Mario DiPaola received a PhD from New York University in Chemistry/Biochemistry and a MBA in Finance from Baruch College (City University of New York). He conducted several years of postdoctoral work first at NYU Medical School in Pharmacology and then at Columbia University Medical School in Neurology/Biochemistry, where he also held the title of Adjunct Professor. Over the past 15+ years, he has worked at Biogen in the Analytical Development/Quality Control Department and then at Antigenics (Agenus) where he led Quality Control/Manufacturing and Materials Logistics. More recently, he co-founded Blue Stream Laboratories, which was purchased by CRL in 2016. He currently holds the title of Senior Scientific Director in Biologics at Charles River. Mario has authored 40+ publications, over the years, and holds several patents on the production of natural alpha-interferon.

Vice President and Global Head, Translational Sciences-Biologics Safety Assessment
Rakesh is a Vice President, R&D and the Global Head of the Biologics Safety Assessment comprising of Toxicology, Pathology and Laboratory Animal Resources functions where he is responsible for overseeing the biologics safety assessment of the entire MedImmune biologics portfolio in all therapeutics areas (2006-todate). Prior to joining MedImmune in 2006, Rakesh served as Senior Director of Toxicology in Johnson and Johnson and Associate Director-Research Fellow in Toxicology in Merck and Co., Inc. (1992-2005). Rakesh has over 25 years of experience in developing pharmaceutical and biotechnology-derived drugs and is the author of over 60 peer-reviewed scientific publications and has been invited to deliver Rakesh is regarded as a Key Opinion Leader in Toxicology community. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and an Associate Editor of Toxicology and Applied Pharmacology and Journal of Toxicology and Environmental Health- all key major toxicology journals.

Senior Biology Director, Chief Scientist and Leidos Technical Fellow, Advanced Solutions Group
Dr. Dresios has 20 years of experience in the fields of protein synthesis and regulation of gene expression. As a Chief Scientist at Leidos (formerly SAIC), he has conceptualized, captured and directed internally- and U.S. government-funded programs for the development of advanced diagnostic and therapeutic technologies at the intersection of biology, chemistry and engineering. His accomplishments have been recognized with various awards and his elevation to the rank of Technical Fellow. At Leidos, his team developed a cell free protein synthesis platform for end-to-end production of protein biologics within 24 hrs. As a Skaggs Postdoctoral Fellow at the Scripps Research Institute, he pioneered research that unraveled fundamental mechanisms of protein synthesis and control of gene expression. As an NIH Postdoctoral Fellow at the University of Chicago, he made discoveries in the fields of RNA and protein structure and interactions as well as prokaryotic and eukaryotic ribosome function and dynamics.

Director, Bioprocess & Clinical Manufacturing
Zhimei Du earned a PhD from Cornell University Medical College, Immunology Program, studying molecular mechanisms in tumor immunology and autoimmune disease areas. After graduation, she joined Robert G. Roeder’s laboratory at Rockefeller University, studying gene expression control mechanism during B cell development. After three years, she was recruited by Regeneron’s antibody engineering group, focusing on bi-specific antibody engineering. Later, she joined Amgen’s Cell Sciences & Technology department, focusing on cell line and process development. She then joined Teva Pharmaceuticals leading Upstream development. Currently she is the director of Bioprocess at Merck. She is also the leader and core member of multiple Industrial-side Consortium teams to generate positional white paper and common practice in various biotherapeutics development areas, including ADC/Bispeicifics BPOD Consortium team, of IQ comparability consortium team, IQ sequence variant consortium team, IQ and BPOD monoclonality consortium team.

Head of Formulation, Analytical and Drug Product Development
Sachin Dubey is presently working with Glenmark Pharmaceuticals, Switzerland, where he is heading formulation, analytical and drug product development unit. His current responsibilities includes designing and executing product development and characterization strategies for both early and late stage products for Glenmark Biologics. Sachin earned his PhD from the University of Geneva, Switzerland and has previously worked with Novozymes Biopharma, Denmark. He has ~ 12 year of experience in biopharmaceutical formulation and analysis. His principal research interests are protein formulation, stabilization, combinational product development, analytical characterization, DOE and QbD. He also has a keen interest in practicing lean principles. He has received multiple research awards and has several publications and presentations to his credit.

Executive Director, Medical Affairs
Jennifer Dumont is Executive Director of Global Medical Research at Bioverativ, a Sanofi Company in Waltham, MA. Dr. Dumont has been directly involved in bringing the first extended half-life clotting factor products (ALPROLIXÒ and ELOCTATEÒ) to the market for the treatment of hemophilia. Prior to her current role at Bioverativ, Dr. Dumont was Scientific Director, Global Medical, Hematology at Biogen. Prior to that, Dr. Dumont was Senior Director of Research at Syntonix Pharmaceuticals, which was acquired by Biogen Idec in 2007 for their hemophilia products in development. Before joining Syntonix, Dr. Dumont worked at Hoechst Marion Roussel (now Sanofi) in Oncology and Parasite Biochemistry research where she led product teams in these therapeutic areas. Dr. Dumont earned her Ph.D. in Cell Biology from the University of Cincinnati, College of Medicine, a M.S in Biochemistry at the same Institution, and a B.S. in Biology from Rochester Institute of Technology and is the co-author of several scientific papers and co-inventor of several patents.

Professor, Institute for Cancer Research
Dr. Dunbrack received a PhD in Biophysics from Harvard University in 1993, studying with Martin Karplus and Jack Strominger. After a postdoc with Ken Dill and Fred Cohen at UCSF, he became a faculty member at the Fox Chase Cancer Center in Philadelphia, where he has been ever since, as an assistant professor, associate professor, and full professor. His research is in statistical studies of protein structure for the purpose of developing better structure prediction and refinement algorithms and extensive application of prediction methods to biological problems.

Principal Scientific Researcher, Protein Chemistry
Diego is the Lead scientist in the production of T-cell Dependent Bispecific (TDB) antibody program. He leads a team of three scientist to support the protein production and characterization for multiple bispecific antibody pipeline projects. Diego is currently developing novel antibody formats to bestow new functionalities. He received his Doctor of Philosophy (PhD) from the University of Buenos Aires in 2001.

Vice President, Discovery
Peter Ellmark joined Alligator Bioscience in 2008 and is VP Discovery since 2018. He holds a PhD and an associate professorship in Immunotechnology at Lund University. Peter has more than 15 years’ experience of developing antibodies for immunotherapy of cancer. Dr. Ellmark´s research interest is focused on developing mono and bispecific antibodies for tumor directed immunotherapy of cancer.

Associate Professor, Senior Scientist
Ulla Elofsson is currently Assoc. Prof. (not employed) at KTH and working as senior scientist at RISE Research Institutes of Sweden. She received her PhD in 1996 in Biophyiscal technology at Lund University after studies on interfacial and solution behaviour of self-associating proteins. She has a long experience of applying surface chemistry in the sectors of food, pharmaceuticals and for oral care applications, both from previous academic research and the last 18 years at RISE (previously YKI, Institute for Surface Chemistry). Her competence areas are biomolecules in solution and at interfaces, surface modifications, formulation, encapsulation, controlled delivery and release. Elofsson is one of the PI’s in the Research Centre NextBioForm – Centre for Formulation and development of next generation biologics, with the aim to create better products for patients. Protein stability and mechanistic understanding of drivers for aggregation and degradation in liquid and solids forms using advanced methodologies is at the heart of the center activities. Prof. Elofsson has supervised several PhD students research focus of proteins at interfaces and has more than 40 publications in peer reviewed journals.

TISenior Vice President, ResearchTLE
Daniel Emerling is Senior Vice President of Research and a founder of Atreca. He received a BA in biochemistry from the University of California, Berkeley, and a PhD in neurobiology from the Massachusetts Institute of Technology, and he performed postdoctoral research at the University of California, Berkeley.

Senior Scientist, Protein Chemistry
James Ernst received his Ph.D. in Biophysical Chemistry from Yale University and took post-Doctoral Studies in Neurobiology at the Stanford University Medical School. He is currently a Senior Scientist in the Protein Sciences division of the Genentech Research and Early Development organization. He has more than 16 years of experience supporting all stages of therapeutic development from target identification to clinical validation.

COO and Senior Vice President, Technical Operations
Dr. Ulrich Ernst is the Chief Operating Officer at Amunix. Dr. Ernst has previously held senior level positions with several global biopharmaceutical companies and brings over 25 years of experience in successfully moving products from clinical stage development to market approval. As VP/Site Head of Alexion’s commercial Rhode Island manufacturing facility, Dr. Ernst led the startup efforts to gain FDA, EMA and rest-of-world site approvals for SOLIRIS®. As Vice-President of Commercial Manufacturing at ZymoGenetics, Dr. Ernst helped create the infrastructure for the commercial manufacturing/medical device enterprise which launched the RECOTHROM® hemostasis franchise. Additionally, Dr. Ernst has held senior operations positions with JNJ and Baxter, where he contributed to the product development and global launches of NATRECOR® and ADVATE®, respectively. Dr. Ernst began his career at Regeneron and Somatogen where he contributed to development efforts on novel protein therapeutics. Dr. Ernst received a BS in Chemical Engineering from the University of Minnesota and a PhD in Chemical Engineering from Lehigh University in Pennsylvania. Dr. Ernst is broadly published and is an inventor on several patents.

Vice President, Preclinical Research
Dr. Elizabeth Evans is currently Vice President of Preclinical Research at Vaccinex, with an MS degree in Microbiology and Immunology, and a PhD in Pathology from the University of Rochester, NY. Dr. Evans is engaged in the discovery and development of therapeutic antibodies and biological drug candidates, with a primary focus in neurodegenerative diseases and oncology. Elizabeth leads a group of scientists investigating of mechanism of action and translational clinical research efforts. Vaccinex is currently evaluating VX15/2503, antibody to Semaphorin 4D, in a phase 2 clinical trial (SIGNAL) enrolling late prodromal and early manifest HD subjects. Additionally, the clinical activity of VX15/2503 is being evaluated in several Phase 1/2 immuno-oncology trials in patients with advanced solid tumors.

Assistant Professor, Radiology and Biomedical Imaging
Michael J. Evans, PhD is an Assistant Professor in the Departments of Radiology and Biomedical Imaging, and Pharmaceutical Chemistry at UCSF. His lab applies chemical biology and nuclear medicine technologies to address important unmet clinical needs for cancer detection and treatment. Dr. Evans is a co-author on over 45 manuscripts in peer reviewed journals on these topics and is the recipient of numerous awards like a Young Investigator Award from the Prostate Cancer Foundation, a Research Scholar Award from the American Cancer Society, and a Discovery Award from the American Brain Tumor Association.

Group Leader, Molecular Biology and Expression
Dr. Falconer received her PhD from the University of British Columbia in developmental genetics. During her post-doctoral studies at the BC Cancer Agency, she developed sequencing technologies to map genomic rearrangements in single cells. In 2015 she joined AbCellera Biologics as a senior scientist to optimize and automate single-cell sequencing.

Marketing Manager, Analytics Marketing

Department of Pharmaceutical Sciences, School of Pharmacy
Lauren received her Bachelor of Science degree in Chemistry, with a concentration in Biochemistry from Framingham State University. She spent 15 years in the pharmaceutical industry in areas including analytical, medical devices, and protein development. Lauren joined the graduate program in Pharmaceutical Sciences at the University of Connecticut in 2013, and is currently a doctoral candidate in her final year, advised by Dr. Robin Bogner. For her dissertation research, she is developing a Raman spectroscopic method to detect tertiary structural changes in proteins in the solid state. The goal is to characterize changes in lyophilized proteins during formulation development, process development and stability studies.

Assistant Professor, Biology
I received my PhD at EPFL, Switzerland, under the supervision of Prof. Yury Tsybin. My PhD thesis was focused on the top-down and middle-down characterization of antibodies. After my PhD, I moved to Chicago to work as a postdoc in Prof. Neil Kelleher’s group at Northwestern University. At Northwestern I developed new methods for top-down proteomics in the context of translational sciences and cancer biology, and I also worked on native mass spectrometry of multiproteoform complexes.
I have started working as an Assistant Professor at the University of Oklahoma in the fall of 2018.

Director, Antibody Discovery and Development
Before joining Northern Biologics, Johan was a Principal Scientist in the Biologics Research organization at Janssen R&D, Johnson and Johnson, based in San Diego, California.
During his time at Janssen, which he joined in 2006 (then Centocor), Johan was part of implementing the internal phage display discovery technology, including generation of new antibody libraries for both ‘de novo’ discovery and lead optimization. He was also involved in several antibody humanization programs and has published a review paper about this subject. Johan led multiple project teams across functional areas, with emphasis on immunology and oncology indications, and was part of advancing antibody programs from early target validation studies to cell line development.
Prior to joining Janssen, Johan completed his PhD in the lab of Dr. Carl A K Borrebaeck in Lund, Sweden, where he studied antibodies that bind and internalize into human tumor cells and identified several tumor associated antigens on these cells. He received his MS in Chemical Engineering in 2002 from Lund University in Sweden, which included a year of study at University of California, Los Angeles (UCLA).

Staff Fellow, Office of Biotechnology Products, Division of Biotechnology Review and Research II
Erica Fratz-Berilla, PhD, is a Staff Fellow in the Office of Biotechnology Products (OBP) within the FDA’s Center for Drug Evaluation and Research where she leads the cell culture team within the upstream bioprocessing laboratory of Cyrus Agarabi, PharmD, MBA, PhD. She began at the FDA in 2015 as an ORISE fellow in the Office of Testing and Research’s biotechnology group where she gained her first experience running bioreactors, and moved on to OBP in 2016. Erica obtained her bachelor’s degree in Biochemistry from Lehigh University and PhD in Biomedical Sciences from the University of South Florida Morsani College of Medicine.

Senior Scientist
Sara Fritzell joined Alligator Bioscience in 2013 and is a Senior Scientist developing bispecific antibodies for tumor directed immunotherapy of cancer. Her background is within tumor immunology, she holds a PhD from Lund University, where she developed strategies to combine local chemotherapy and immunotherapy against experimental malignant brain tumors. Dr Fritzell is Alligator´s Scientific Lead on ALG-APV-527, a collaboration project with Aptevo Therapeutics.

Director, Sales
Jeremy Fry gained his DPhil. from the University of Oxford developing gene therapy strategies to induce immunological tolerance in transplant recipients. Jeremy joined ProImmune to generate a new class of MHC multimer staining reagents. For the past 18 years as ProImmune's Director of Sales, he has led the sales team in a growing business, focusing on developing and implementing innovative technologies that radically improve our understanding of immune responses.

Senior Manager, Product Marketing
Peter has over 23 years of industry experience developing, commercializing and marketing products in the life science sector. Peter is currently the Senior Product Marketing Manager at NanoTemper Technologies and oversees marketing activities for the Prometheus and Tycho product lines. Peter previously worked for Biocompare, ProteinSimple, Molecular Devices and DiscoveRx. He received his PhD in molecular and cellular biology from Syracuse University and a BS in molecular biology from Iowa State University.

Centre Director, NextBioForm; Senior Scientist, Surface, Process and Formulation, RISE Research Institutes of Sweden
Dr. Millqvist Fureby has a PhD in Biotechnology from Lund University (1995). She did a post-doc at Institute of Food Research In Reading UK, focusing on enzyme catalyzed syntheses if carbohydrates. She has been a researcher at Institute for Surface Chemistry (now RISE) in Stockholm since 1997, with a focus on dry formulation and controlled release for pharmaceutics, as well as foods and nutraceuticals. Dr Millqvist Fureby is heading the Research Centre NextBioForm – Centre for Formulation and development of next generation biologics, with the aim to create better products for patients. Protein stability and mechanistic understanding of drivers for aggregation and degradation in liquid and solids forms using advanced methodologies is at the heart of the centre activities. Dr. Millqvist Fureby has supervised several PhD students, and has more than 40 publications in peer reviewed journals.

Lab Head, Bioinformatics, High Throughput Biologics
Upon finishing his studies in Pharmaceutical Sciences, Norbert pursued his PhD thesis in Computational Life Sciences at the University of Bonn focusing on computer-aided design, synthesis, and biological evaluation of protease inhibitors. After being a Principal Scientist for Analytical Development at Merck KGaA, he joined Sanofi as Lab Head for Bioinformatics working on the integration of computational methods and data workflows for high-throughput screening technologies within the Biologics Research department.

Senior Scientist
Richard Galas received his BS in Chemical Engineering from SUNY Buffalo and his PhD in Chemical Engineering from Purdue University. His dissertation was on developing vascular constructs to support tissue engineering applications of adult Mesenchmal Stem Cells. After his PhD he received a fellowship from the German Government partnering with the Specialty and Fine Chemicals Division of BASF at their flagship chemical plant in Ludwigshafen, Germany. At BSAF his research focused on using enzyme catalysis for industrial production of specialty compounds as well as industrial production techniques for enzymes as a final product. Upon returning to the USA he accepted a position in the Drug Product and Formulation group of Takeda Pharmaceuticals in Cambridge, MA. He has focused his research at Takeda on supporting both early and late stage biologics developing final formulations as well as developing manufacturing processes.

CSO
Pierre-Alain is a graduate of the University of Lausanne, where he also received his PhD. Pierre-Alain completed a postdoc at the University of Wisconsin-Madison where he studied ubiquitin-pathway-mediated protein degradation. He returned to Switzerland in 1993, where he discovered a family of genetic sequences that are involved in the epigenetic regulation of genes. This discovery has subsequently been used to express therapeutic proteins in pharma and biotech. Pierre-Alain has served Selexis as CSO since 2006.

Chief Science Officer
Glassy graduated from the University of California, Riverside and received his PhD in biochemistry in 1978. He did his post-doctoral studies in molecular immunology at the Scripps Research Institute in La Jolla. Glassy joined the faculty of the Department of Medicine and Cancer Center at UCSD in 1980 and is currently in the Translational Neuro-Oncology Laboratory at the UCSD Moores Cancer Center. In addition to UCSD, Glassy is the Founder and Chairman of Nascent Biotech, Inc. He has prepared and directed several FDA approved clinical trials involving human monoclonal antibodies to cancer. Glassy has over 170 publications in the biomedical literature, is the Editor-in-Chief of the journal, HUMAN ANTIBODIES, and the Program Chairman of the meeting series,"The International Conference on Human Antibodies and Hybridomas". Glassy is the inventor of Pritumumab, the first human antibody used to treat a cancer patient and is the recipient of the 2003 Arthur Furst Award (citation: “Outstanding research advancing science for the betterment of humanity”). He is also the author of the books,"The Biology of Science Fiction Cinema", “Movie Monsters in Scale”, and"Biology Run Amok!"

VP of Business Development
As the VP of Business Development, Divya has served in a key role overseeing platform development and licensing for Celltheon. Celltheon develops cutting-edge expression technologies such as its Celltheon SMARTTM expression platform which is comprised of novel expression vectors, proprietary CTCHOTM cells and the Celltheon SMARTTM Bioprocessing knowhow. As a bioprocess engineer by training, Divya is not only involved in external facing business opportunities, she also works with the technical staff to evaluate new bioprocessing technologies and develop efficient workflows that can be leveraged by the greater Pharmaceutical Industry. Divya holds a BS in Biology from Drexel University and a Master’s in Business and Science (MBS) from Keck Graduate Institute in Bioprocess Engineering and Business. Since joining Celltheon, many of the client molecules she has overseen have advanced into clinical trials. Divya is committed to overseeing the application of Celltheon’s novel technologies to develop high titer, high quality products and ensuring seamless tech transfer.

Principal Scientist, Large Molecule Research, Roche Pharma Research & Early Development
Dr. Goepfert received his professional training in molecular biology and biochemistry at the University of Tuebingen and the Max-Planck-Institute of Biochemistry in Munich. In 2002 he joined the Large Molecule Research group of Roche in Penzberg. As a technical expert in cell line engineering and molecular characterization he contributed to the preclinical development of numerous therapeutic proteins. In addition, he has been working on various aspects of cell line development, such as molecular mechanisms of cell line instability, cell culture automation, clonality and the detection of sequence variants.

Principal Scientist, Discovery Sciences
Shalom Goldberg is a principal scientist in the Targeted Therapeutics group, part of Discovery Sciences at Janssen R&D/Johnson & Johnson. He received his PhD from Columbia University and was a postdoctoral fellow at the University of Pennsylvania School of Medicine.

Staff Scientist & Team Leader (Structural Biology), Drug Discovery Program
Dr. Chris Gray graduated with a PhD in biochemistry from the University of Glasgow in 2000, followed by postdoctoral positions at the Institute of Cancer Research (London, UK) and the CRUK Beatson Institute (Glasgow, UK) where he developed interests in protein crystallography and biophysics. He is currently a Team Leader within the Beatson Institute Drug Discovery Program, with responsibility for biophysics and structural biology activities that include protein production. Chris and his team are actively engaged in a range of method development and process optimization projects that increase the efficiency of production of high-quality recombinant proteins.

Co-Founder, Vice President, Technology
Dr. Greving received his PhD in Biochemistry at Arizona State University. That research ultimately produced the peptide library platform behind RubrYc’s Interface Discovery Engine. Dr. Greving has spent more than 15 years developing high-throughput diagnostics and discovery technologies with several publications and innovation awards including The Society of Lab Automation and Screening (SLAS) 2012 “Innovation of the Year Award” and R&D Magazine’s “2013 R&D 100 Oscar of Innovation”.

Development Scientist, Global Analytical and Pharmaceutical Development
Currently Working as Scientist III at Alexion, responsible for developability, assay development and pre-formulation. Worked at Sanofi-Genzyme prior to Alexion, responsible for protein characterization, assay development and formulation.

Co-Founder and CCO
As ATUM’s Co-Founder and CCO, Dr. Gustafsson oversees all the company’s external communications. Prior to co-founding ATUM, Gustafsson was Scientist and Manager at Maxygen Inc., where he led, managed and collaborated with key strategic teams for more than five years. He also held a Scientist position at Kosan Biosciences, and a number of research, teaching positions at UCs Santa Cruz and San Francisco. He holds 43 issued U.S. patents and has published >40 scientific papers.

Professor
András Guttman, MTA-PE Lendulet professor of Translational Glycomics, is the head of the Horváth Csaba Memorial Institute of Bioanalytical Research in Debrecen (Hungary) and also leads the application efforts at Sciex (Brea, CA, USA). His work is focused on capillary electrophoresis and CESI-MS based glycomics and glycoproteomics analysis of biomedical and biopharmaceutical interests. Dr Guttman has close to 300 scientific publications, wrote 35 book chapters, edited 4 textbooks and holds 23 patents. He is a member of the Hungarian Academy of Sciences, on the board of several international organizations, serves as editorial board member for a dozen scientific journals and has been recognized by numerous awards including the Analytical Chemistry Award of the Hungarian Chemical Society (2000), named as Fulbright Scholar (2012), received the CASSS CE Pharm Award (2013), the Arany Janos medal of the Hungarian Academy of Sciences, the Pro Scientia award of the University of Pannonia and the Dennis Gabor Award of the Novofer Foundation in 2014. Dr Guttman is also the recipient of the 2017 Dal Nogare Award of the Delaware Valley Chromatography Forum and the Grand Prize of the Swedish Chamber of Commerce.

Senior Scientist, Pharma Technical Development Analytics Extended Characterization
Markus is experienced in the detailed characterization of therapeutic proteins, mainly monoclonal antibodies for almost all kinds of post-translational modifications by mass spectrometry. He is responsible for lab automation in our department (sample preparation, analytical methods). Markus is also an expert in glycosylation analytics of proteins (MS and fluorescence-based methods).

Principal Research Scientist, Biologics Discovery
Denise Karaoglu Hanzatian, PhD, is a Principal Research Scientist at AbbVie Bioresearch Center. She received her PhD in Biochemistry and Molecular Biology from Clark University. She joined Abbott Laboratories (now AbbVie) to lead Biologics efforts in immunogenicity assessment and bioanalytical testing of biotherapeutics in various disease indications. In addition, she has worked on several drug candidates, including the ones currently in clinical trials, from different therapeutic areas such as immunology, neuroscience, and oncology. More recently, Dr. Karaoglu has been focusing on the targeting and delivery of biotherapeutics, especially, to CNS.

CSO
2010-2015 - PhD Biomedical Sciences - The Ohio State University - Six manuscripts written (three as first author). 2015-2018 - Postdoctoral Fellow - Washington University in St. Louis - Six manuscripts written (four as first author; including first author on Nature Reviews Microbiology manuscript). 2016 - present - Co-Founder and Chief Scientific Officer VaxNewMo - biotech developing next gen conjugate vaccines - to date raised $600K in non-dilutive funding - first manuscript in preparation. Authored three Phase I SBIR/STTR applications - impact scores of 17, 26, and 35- two funded - $550K in funds for VaxNewMo

CSO
Andrea Hawe, is co-founder and Chief Scientific Officer of Coriolis Pharma, a science-driven contract research organization supporting drug product development of biopharmaceuticals, with focus on formulation development, lyophilization technologies and analytics (GMP and non-GMP) of biopharmaceuticals. Andrea Hawe received her PhD degree in Pharmaceutical Technology from the Ludwig Maximilian University of Munich, Germany in the field of protein lyophilization and formulation. Before founding Coriolis Pharma she has worked as post doctoral scientist at Leiden University, The Netherlands, on different projects related to protein characterization, innovative fluorescence based methods, development of heat-stable formulations for third world countries and immunogenicity. She is an expert for protein formulation and protein characterization, and has published more than 30 articles in peer-reviewed journals.

Senior Scientific Researcher, Biochemical & Cellular Pharmacology
Biochemical and cellular biologist with extensive industry research experience in therapeutic antibody drug development for neural degenerative diseases. I have been working on preclinical research projects using antibody drugs to treat neural degenerative diseases in Genentech. I was one of the people discovered, isolated and successfully banked human neural stem cells (HuCNS-SC) at StemCells Inc. HuCNS-SC platform technology used as a potential therapeutic to treat diseases and disorders of the central nervous system. HuCNS-SC had been used as a cell-based therapy in 5 clinical trials of diseases and disorders of the central nervous system.

Principal Scientist, R&D
Phil Hemken has worked at Abbott in the Diagnostics Division for 21.5 years. He has for the last 15 years been involved with numerous assay development projects for the automated immunoassay instrument ARCHITECT including companion diagnostics. Phil Received his BS in Microbiology from Iowa State University, MA in Biotechnology from Washington University in St. Louis and his PhD in Molecular, Cellular and Developmental Biology from Iowa State University in Ames, Iowa under the direction of Dr. Richard M Robson in the Muscle Biology Group.

Team Lead, MS & NMR Analytics
Jennifer Hill received a PhD from Harvard University in molecular signaling, prior to joining Wyeth for a postdoctoral fellowship where she applied mass spectrometry technology to identify new therapeutic targets. In 2003, Jennifer joined the National Research Council Canada where her research explores the intersection of cancer biology, biotherapeutic characterization, and mass spectrometry methods. Jennifer currently acts as Project Lead for Target Prioritization and Team Lead for Mass Spectrometry & NMR Analytics.

Senior Investigator, National Cancer Institute
Mitchell Ho is currently a Senior Investigator at the NIH and the Chief of the Antibody Therapy Section at NCI’s Laboratory of Molecular Biology. He is also the Chair of the Department of Biochemistry for the FAES Graduate School at the NIH. He received a BS from East China Normal University, a MA from San Francisco State University. After three years at DNAX Research Institute and Protein Design Labs as a research associate, he moved to the University of Illinois at Urbana-Champaign where he received a PhD as a NIH/NIDA National Research Service Award predoctoral fellow. He completed a postdoctoral fellowship with Ira Pastan at the NCI. Dr. Ho has received many honors including the APAO Scientific Achievement Award, NIH DDIR Innovation Award, NCI Director's Intramural Innovation Award for Principal Investigators, and a Zijiang Distinguished Chair Professorship from East China Normal University. He is the founding Editor-in-Chief of Antibody Therapeutics.

Senior Scientist
Isidro Hötzel received his PhD from Washington State University and joined Genentech in 2005. He is currently a Senior Scientist in the Department of Antibody Engineering. His research at Genentech has focused on novel technologies for therapeutic antibody discovery and optimization.

Senior Fellow, MedImmune, Inc.; CSO, Spirogen, Ltd.
Dr. Howard is a Founding Scientist and Chief Scientific Officer at Spirogen. He has been conducting research into the pyrrolobenzodiazepine (PBD) family of antitumor antibiotics for twenty years in both academia and industry. Philip has worked as a part of a multi-disciplinary team, supported by Cancer Research UK and Spirogen, on the synthesis, biological evaluation and development of the PBD dimers. Since 2008 he has been working on the development of the PBDs as payloads for antibody-drug conjugate therapy with a number of leading companies including, Seattle Genetics, Stemcentrx, ADC Therapeutics, Genentech, Regeneron and Tanabe Research Laboratories USA Inc. Dr Howard designed the tesirine payload (SG3249) and the warhead SG3132 released by the talirine payload. His work at MedImmune is focused on the further development of their PBD-ADC platform. At the time of writing, more than 23 PBD-ADCs, arising from Spirogen collaborations, have been submitted to clinicaltrials.gov for 11 targets.

Senior Investigator II and Technology Leader, Multispecific Modalities
Dr. Thomas Huber’s current role is technology leader and co-project team leader for bispecific modalities at NIBR biologics center Basel. In 2012-2013, he was appointed project team leader at respiratory disease in Horsham, UK. He joined Novartis Basel in 2007 and was establishing several technology platforms in the field of therapeutic antibody and protein engineering. Dr. Huber received his PhD in the group of prof. Andreas Plückthun at the Department of Biochemistry of the University of Zürich.

Director, Purification Process Sciences
Alan Hunter holds a Ph.D. in Chemical Engineering from the University of Virginia, where he studied process chromatography and protein mass transport. He has worked in the biopharmaceutical industry for over 15 years and is currently employed as a Director with MedImmune in Gaithersburg Maryland. At MedImmune he leads a group responsible for developing purification processes for cGMP manufacture novel biotherapeutics. He has extensive experience with CMC team leadership, regulatory filings, and strategy for early and late stage drug development.

Professor, Ped. Oncology/Hematology
Paul Imbach is a highly respected pediatric oncologist-hematologist who has developed worldwide clinical research on the indications for intravenous immuno- globulin. Dr. Imbach graduated in Medicine in 1972. He went on to structure the Swiss Pediatric Oncology Group (SPOG) and in 1978 performed the first autolo- gous stem cell transplantation in Switzerland. He discovered the immunomodula- tory effects of human immunoglobulin G concentrate (IVIG) in childhood immune thrombocytopenia (as reported in Lancet in 1981). In 1990, Dr. Imbach began working at the University Children’s Hospital Basel, where he started stem cell trans- plantation in children and was appointed Head of Pediatric Oncology-Hematology. He was subsequently elected as full professor and also as Dean of Education intro- ducing a thorough curriculum reform at the medical faculty of the University of Basel. In parallel to his other activities, he co-founded the International Cooperative ITP Study (ICIS) group (www.itpbasel.ch), which now has more than 90 centers worldwide. He has served as president of medical societies and foundations, is a member of medical editorial boards, and has published over 350 peer-reviewed articles, textbook chapters as well as the textbook Pediatric Oncology – A Comprehensive Guide (3rd edition 2014) in German and English. In 2015 he was awarded the Guido Fanconi Prize, the highest award of the Swiss Society of Pediatrics.

Principal Scientist, Biologics Preformulation and Drug Delivery
Peter Ihnat leads the Biologics Preformulation and Drug Delivery Group at the Abbvie Bioresearch Center in Worcester, MA. Peter’s group is responsible for profiling and risk assessment of candidate biologics and recommending molecules for CMC formulation development. The diversity of screened biomolecules includes monoclonal antibodies, bispecific antibodies and antibody drug conjugates as well as other novel formats. Additionally, the Preformulation Group develops sustained release and targeted drug delivery systems and novel excipients for improving solution properties of biologic therapeutics. Peter received his PhD in Pharmaceutical Sciences from the University of Nebraska Medical Center. He also holds degrees in Biochemistry and Pharmacy from Rutgers University and Union University respectively.

Research Assistant Professor, Molecular Biosciences, Georgiou Lab
Dr. Ippolito initially studied physics at Reed College and then completed training in B-cell immunology at The University of Alabama at Birmingham, The University of Cologne (Germany), and The University of Texas at Austin. A former Director for Research and Development at a publicly traded antibody biologics company, he has had the privilege since 2011 to launch, spearhead, and supervise antibody technology development and human immunology projects in the laboratory of Professor George Georgiou at The University of Texas at Austin.

Associate Professor, Radiology
Dr Janowski is a neurosurgeon by training and his research interest falls into real-time imaging of the process of interventional neuroradiology techniques as a route of delivery of therapeutic agents at a high-dose to the desired areas of the brain. Currently he serves as an Associate Professor in the Department of Radiology at the Johns Hopkins University, as well as he is a co-founder and first President of the Society for Image-Guided Neurointervention (SIGN).

Emeritus Professor, Institute of Immunology & Immunotherapy
Following a PhD in Chemistry I moved to the Medical School (Birmingham) to initiate research on the structure and function of antibody molecules. Studies revealed the individual functions of the four human IgG subclasses the profound impact that glycosylation has on the mechanisms of action (MoA), in vitro and in vivo. A current focus is the potential for immunogenicity of i) immune complexes/aggregates; ii) possible consequences of a mismatch of IgG polymorphisms (allotypes) between a therapeutic and a patient’s IgG haplotype. In consideration of published research, I am elected: Member of the Royal College of Physicians (MRCP) and Fellow of the Royal College of Pathologists (FRCPath).

CSO, Research & Development
Jan Jezek is the Chief Scientific Officer at Arecor Ltd. He has been trained as a biophysical chemist. He was the principal scientist at Insense Ltd, leading the development of a range of novel medical devices from the proof-of-concept all the way to market. During his time at Insense, he and his team developed a novel formulation platform to achieve superior stability of proteins and other biological molecules. His inventions related to protein stabilization led to inception of Arecor Ltd as a separate company focusing on commercialization and further development of the stabilization platform.

Product Manager, iCE Marketing
Xin Jiang received his PhD in Pharmacology from Indiana University. He is the Product Manager of the iCE systems at ProteinSimple since 2016. Prior to that, he was a Senior Fellow at University of Washington (Seattle), and held different marketing and product management positions at Molecular Devices, a Danaher company.

Senior Principal Scientist, Analytical Research and Development
Keith is a Senior Principal Scientist and group leader in the Analytical Research and Development (ARD) group at Pfizer in Andover, MA. The group is responsible for development and qualification of release and stability testing methods, biochemical characterization, and comparability assessment for therapeutic proteins in all stages of development. Keith received a Bachelor of Science degree in chemistry from the University of Colorado, and he received a Doctorate degree in analytical chemistry from the University of Georgia while studying mass spectrometry. At Pfizer, Keith has been a member of the mass spectrometry and biophysical characterization group, the project progression line (biochemistry) group, and he is currently co-leading the Multi-Attribute Method team within ARD.

CTO
Matt completed a PhD in Molecular Biology investigating novel surface proteins of the B. cereus endospore. He joined Abcam in 2005, where held several roles over his 8 years in the company, culminating in the post of Head of R&D. He built and ran a research group with interests in recombinant antibody/binder technologies, alternative detection methodologies, immunoassay development and antibody characterisation. Matt became CTO of Avacta Life Sciences in 2013.

CEO, Calviri, Inc., Director and Professor, Biodesign Center for Innovations in Medicine, Arizona State University
Stephen Albert Johnston is focused on biomedical inventions. He was co-inventor of the gene gun, DNA vaccines, organelle transformation, immunosignatures, synbodies and others. His current focus at ASU and Calviri is on cancer vaccines – both therapeutic and prophylactic. The discovery of frameshift neoantigens produced by RNA misprocessing has created new opportunities for cancer vaccines and diagnostics which are being commercialized through Calviri, Inc, an ASU startup.

Senior Product & Applications Manager, Marketing
Aled is a Senior Product & Applications Manager at ProZyme, focusing on tools for glycobiology. He received his BSc and PhD degrees in biochemistry from Cardiff University, completing graduate work in the connective tissue biology laboratories. This was followed by a postdoctoral fellowship at Wyeth Research in Cambridge MA, where he subsequently worked as a Senior Research Scientist.

Vice President, BioProcess Sciences
As the VP of BioProcess Sciences Paul oversees the global development and process validation organizations for the Biologics Drug Substance Division within Patheon, part of Thermo Fisher Scientific. Paul has held multiple leadership roles in process development, technology transfer and operations. In his career Paul has developed, transferred or manufactured over 50 biotherapeutic proteins at various clinical phases, including multiple commercial products. Experience includes purification development, technology transfer, operations management, process characterization and process validation. Prior to joining Thermo Fisher Paul worked for Bristol Myers Squibb and GE Plastics (now SABIC). Paul holds a BS in Chemical Engineering and Management from Purdue University, West Lafayette, IN and a Masters in Chemical Engineering from Cornell University, Ithaca, NY.

Professor, Department of Chemistry & Biochemistry
Simpson Joseph received a PhD from the University of Vermont. He studied the mechanism of RNA catalysis by the hairpin ribozyme for his PhD thesis in John Burke's group. He then joined Harry Noller's group at the University of California, Santa Cruz for his postdoctoral research. In the Noller lab, he carried out directed hydroxyl radical probing studies to map tRNA binding sites in the ribosome. He also became interested in the mechanism of mRNA-tRNA translocation. He continues to study the mechanism of protein synthesis and translational control as a faculty in the Department of Chemistry and Biochemistry at the University of California, San Diego.

Bioengineering
Mr. Joshi is currently a PhD candidate at McGill University, Canada. His research focuses on rAAV production process development for clinical applications. Prior to joining McGill, he was associated with Intas Biopharmaceuticals, India as an associate process engineer in upstream process development group working on rCHO cell based biotherapeutics. Mr. Joshi holds bachelor`s degree in Pharmacy and Master`s degree in bioprocess technology from India.

Distinguished Professor, Eshelman School of Pharmacy
Alexander Kabanov, PhD, DSc MAE, FNAI, FAIMBE is a Distinguished Professor, Director, Center for Nanotechnology in Drug Delivery, and Co-Director, Carolina Institute for Nanomedicine, University of North Carolina at Chapel Hill. He conducted pioneering research that introduced major concepts in the nanomedicine field including polymeric micelles, DNA/polycation complexes, block ionomer complexes, nanogels, nanoparticle-macrophage carriers and exosomes for delivery of small drugs, nucleic acids and polypeptides to treat cancers and diseases of the central nervous system. His work led to first-in-man polymeric micelle drug to treat cancer. He published over 300 scientific papers, his work was cited 29,000 times (hirsh index 90) and he was named the Thomson Reuters 2014 Highly Cited Researcher. He holds 34 Unites States patents and co-founded several companies. He has founded the first nanomedicine symposium series in the United States, NanoDDS and chaired numerous meetings including two Gordon Research Conferences. He received numerous awards and was elected a member of Academia Europaea and a fellow of NAI and AIMBE. His research is supported by grants from NIH, and other national and international sources.

Scientist, Late Stage Formulation Sciences
Cavan Kalonia received a BS Degree in Applied Mathematics from the University of Connecticut and a PhD with Honors in Pharmaceutical Chemistry from the University of Kansas. At the University of Kansas, Cavan worked in the lab of David Volkin to better understand the rates and mechanisms of protein aggregation at the air-water interface and in bulk solution. After completing his PhD, Cavan pursued a postdoctoral fellowship at the National Institute of Standards and Technology (NIST) in the Polymers and Complex Fluids Group. At NIST, Cavan worked with Steven Hudson to investigate protein adsorption and aggregation at solid-liquid interfaces. He now works at MedImmune in the Late Stage Formulation Sciences group where he maintains an interest in interfaces, surfactants, and protein aggregation.

Director, Analytical Development
Dr. Jichao Kang holds a PhD in Pharmaceutics and has over 20 years of experience in Biologics development. He is an accomplished researcher with over 20 peer-reviewed journal articles and book chapters, several patents and numerous conference presentations. He has hands-on development experience in cytokines, antibodies, enzymes, virus vaccines, and protein conjugates. He is a key contributor in over 50 IND/IMPD projects and over a dozen of late phase and BLA/MAA projects. He is currently the Director of Analytical Development at Amicus Therapeutics. Prior to Amicus, he was the Director of Analytical and Formulation Development at Patheon Biologics, part of Thermo Fisher Scientific. He also worked in Protein Design Labs, Neose Technologies, MedImmune, and Auxilium.

Director, Protein Engineering
I obtained my Bachelor’s and Master’s degrees from the Agricultural University of Athens, Department of Biotechnology, Athens, Greece in 2008 and 2010 respectively. In 2010 I moved to Goettingen, Germany where I did my PhD work at the Max Planck Institute for Biophysical Chemistry. During my PhD years I focused on Enzyme Biochemistry and Biophysics, as well as on the development of single-cell high-throughout screening platforms (Fluorescence-activated cell sorting; FACS and droplet-based microfluidic systems) for the identification of catalytically improved enzyme variants. Following my graduation in 2014, and being obliged to do so, I served for 1 year to the Greek military. Subsequently, in 2016 I joined Professor George Georgiou’s laboratory (Department of Chemical Engineering at University of Texas at Austin, USA) for my post-doctoral studies during which I got trained in enzyme engineering techniques. In parallelI I worked at Professor Kenneth Johnson’s laboratory (Department of Molecular Biosciences at University of Texas at Austin, USA) where I learned transient kinetic methods for the mechanistic characterization of enzyme reactions. Since late 2018 I have been the Protein Engineering Director of Aeglea Biotherapeutics, located in Austin, Texas, USA.

Senior Associate, Scientist
Sr Associate Scientist with 33 years of oncology research. Research scope spans from target discovery, to high throughput small molecule inhibitor screening, cellular proof of concept, lead optimization and animal modeling. Our lab is a Simple Western systems early adopter. As such, we currently have 3 Sally Sue’s and one Peggy Sue that are running daily at capacity.

Director, Biologics Optimization, Discovery Research
Ph.D., University of Illinois at Urbana-Champaign
Post-Doctoral Fellow-I, University of Chicago
Post-Doctoral Fellow-II, University of Arizona, Tucson
Visiting Research Scientist, University of Rio de Janeiro
Higher-Throughput Protein Production and Characterization

Director, Biopharmaceutical Development
Don Kerkow has over 15 years research experience with a strong emphasis on protein and nucleic acid biochemistry, protein structure and function, formulation and characterization of biopharmaceuticals, and recombinant protein expression and purification. In his role at KBI Biopharma, Don is responsible for formulation development, analytical development, characterization, comparability/biosimilarity studies, and quality control functions. In the realm of formulation development, Don and his team over the past 6 years have successfully developed liquid and lyophilized formulations for over 25 different clinical biopharmaceutical products ranging from high concentration (>200 mg/mL) mAbs to very low concentration enzymes, and including unique molecules like PEGylated growth factors and engineered peptide fusions. Because KBI Biopharma believes successful formulation development is inexorably linked to a deep understanding of the molecule’s analytical profile, Don and his team are directly involved in the biophysical, biochemical, and QC analytical characterization of the formulated products they develop. Don earned his PhD in Biochemistry from the Scripps Research Institute in La Jolla, CA.

Candidate
Woojoo Eunice Kim received her BS in Chemistry from Sogang University, Seoul, South Korea in 2014. During her time there, she worked under Professor Bongjin Moon, conducting synthesis of functional polymers. She has been in the PhD program at the University of California, San Diego in the Department of Chemistry and Biochemistry under the guidance of Professor Michael Burkart’s Laboratory since 2014. Her current work focuses on the development of new tools in studying protein-protein interactions in nonribosomal peptide synthetases.

Deputy Director, Head of Biophysics and Conformation Unit, Analytical R&D Biochemistry
Marina Kirkitadze, PhD, MBA has 16 year experience in Sanofi Pasteur, the vaccine division of Sanofi group. She is Head of Biophysics and Conformation Unit at Biochemistry Platform, Analytical R&D North America. Marina's main focus is characterization of vaccine components, specifically, protein conformation and stability in solution and in adjuvanted form, analysis of raw materials, and particle sizing technologies. Her contributions went towards CMC section in eBLA application for Adacel, new manufacturing facility submission, Pentacel, and to Module 3 CTD of Hexaxim vaccine submission. Marina has published 33 manuscripts.

Professor, Applied Biochemistry
Harald Kolmar is full professor at the Technische Universität Darmstadt, Germany where he heads the Department of Applied Biochemistry. He holds a Ph.D. and habilitation in biochemistry and molecular biology. His current scientific interests mainly focus on protein engineering and design, nanobiotechnology, antibody engineering, chemical biology and development of tailor-made peptides and proteins for applications in diagnostics and therapy.

Senior Scientific Manager, BioMolecular Resources
Dr. Edward Kraft is a Sr. Scientific Manager at Genentech and currently leads the high throughput protein expression analysis group. His group evaluates the small-scale expression of non-antibody proteins for the Genentech research organization to inform construct design and protein scalability. Dr. Kraft has been working in the field of high throughput protein expression for over 10 years in the biotech industry.

I received my PhD in physics from the University of Maryland, College Park, MD in 1987. My thesis work was performed at the NIST Center for Neutron Research (NCNR), where I studied the structure of concentrated proteins inside cells and vesicles using small-angle neutron scattering (SANS). After a two-year National Research Council postdoc at NIST, I became a staff scientist at the NCNR. My research focus has been on structural studies of biological macromolecules in solution using both SANS and neutron reflectometry. My interests include not only studies of proteins in crowded conditions, but also larger complexes consisting of multiple protein subunits, proteins and lipids, or proteins and nucleic acids, as well as membrane proteins in biomimetic environments.
I have been involved in software development throughout my career, including both instrument control and data analysis software. My latest efforts have been in the development of the SASSIE program suite, which is used to create atomistic models of biomolecular systems and to compare scattering data from these models directly to experimental neutron scattering data.

Professor, Biochemistry and Biophysics
Brian Kuhlman, PhD, is a Professor in the Department of Biochemistry and Biophysics at the University of North Carolina at Chapel Hill. Members of his laboratory are active developers of the molecular modeling software Rosetta, which they have applied to a diverse set of problems including de novo protein design, antibody engineering, optogenetics, protein interface design, and protein switch design. Dr. Kuhlman is a recipient of the AAAS Newcomb Cleveland prize, the Feynman Prize in Nanotechnology and the ASBMB DeLano Award for Computational Biosciences.

Scientific Director, Cell and Developability Sciences
Steven LaBrenz is a Scientific Director with Janssen R&D, LLC in the Cell and Developability Sciences group. He has been a member of Janssen R&D since 2002, leading the areas of formulation development, product troubleshooting, assay development and high-throughput screening. Steve’s areas of expertise include polysorbate chemistry, oxidation reactions and biophysics in protein formulations.

Researcher
After graduating with First Class Honours in Bachelor of Science from National University of Singapore, I was awarded the NGS (National Graduate School of Engineering Science and Technology) scholarship to pursue my PhD study. My PhD project focused on oncology and immunology, specifically how DNA sensors in innate immunity pathway play a role in tumorigenesis. After obtaining my PhD from the National University of Singapore, I joined Chugai Pharmabody Research as a researcher in pharmacokinetics (PK) unit. Besides developing bioanalytical assays for PK measurement and conducting PK simulation, I am also interested in establishment of novel cell-based assays for in vivo PK prediction.

Professor Emeritus, Molecular, Cellular and Biomedical Sciences
Tom Laue is the emeritus Carpenter Professor of Molecular, Cellular and Biomedical Sciences, and emeritus professor of Material Sciences at the University of New Hampshire. He is the founder of the Biomolecular Interaction Technologies Center. He received his bachelor’s degree in Natural Sciences from the Johns Hopkins University in 1971and his PhD in Biophysics and Biochemistry from the University of Connecticut in 1981. His post-doctoral studies were conducted at the University of Oklahoma. Between 1969 and 1975, he worked as a technician in the deep space program of NASA. His work has focused on developments for the analytical ultracentrifuge and analytical electrophoresis. Data from these instruments have contributed to over 3800 publications since 1980.

Senior Manager, Biologics, Marketing
Andrew LeBeau, PhD, is Senior Manager of Biologics Marketing at Dotmatics. He joined Dotmatics in 2017, bringing more than 15 years of experience in the life sciences industry. At Dotmatics, Andrew leads efforts to highlight the capabilities of Dotmatics software to support the rapidly growing field of biologics drug discovery.

Scientist
Jonas is a scientist at Amgen Department of Therapeutics Discovery purifying membrane proteins. Jonas got PhD in University of California in Berkeley under a protein X-ray crystallographer Prof. Sung-Hou Kim studying properties of bacterial chemotaxis receptors, and he completed a postdoc in California Institute of Technology under a membrane protein X-ray crystallographer Prof. Doug Rees, delineating the structure and function of a heavy metal ABC transporter.

President and CEO
Howard L. Levine, PhD, President and CEO of BioProcess Technology Consultants, Inc. (BPTC), is a pioneer and thought leader in the biopharmaceutical industry with extensive strategic and operational experience in biopharmaceutical product development and commercialization. Before founding BPTC in 1994 and building it into the leading biologics CMC consulting company worldwide, Dr. Levine was Vice President of Manufacturing Operations at Repligen Corporation where he was responsible for all process development and manufacturing activities and Director, Pilot Plant Operations at Xoma Corporation where he was responsible for the development and manufacture of monoclonal antibody products for clinical trial. He has also held positions of increasing responsibility in process development and manufacturing at Genentech and Amgen. Under Dr. Levine’s leadership, BPTC has assisted numerous companies in developing biological products, provided strategic input in the development of new manufacturing technologies, and participated in the successful commercialization of several of these products. In addition to leading BPTC, Dr. Levine is a member of the Board of Directors and co-founder of DNX Biopharmaceuticals, Inc. and is also a member of the Pall Life Sciences Scientific Advisory Board, and a member of the Editorial Advisory Board of BioPharm International Magazine. Until their acquisition by Sanofi in late 2017, Dr. Levine was a member of the Board of Directors of Protein Sciences Corporation. He is a frequently invited lecturer on manufacturing strategy, downstream processing, and commercialization of biotechnology products and an author of numerous, peer-reviewed publications. Dr. Levine holds a PhD in chemistry from the University of Chicago and completed a postdoctoral fellowship at Harvard University.

Assistant Professor, Department of Pediatrics
I am an assistant professor in the Department of Pediatrics in the UC San Diego School of Medicine. My group focuses on the integration of -omic data with in silico models of metabolism for probing into drug development in Chinese hamster ovary cells (Xu, et al. Nat Biotech, 2011), (Lewis, et al. Nat Biotech, 2013), (Kildegaard, et al., Curr Opin Biotech, 2013), and human disease (Lewis, et al., Nat Biotech, 2010). We also are interested in tool development for constraint-based modeling (Lewis, et al., Nat Rev Microb, 2012).

CEO
Dr. Lin is CEO of Biocytogen Boston Corp and Senior VP of Biocytogen. Dr. Lin has extensive expertise in multiple drug R&D and therapeutic areas, including cell biology, genetically engineered mouse tumor model, therapeutic antibody development and antibody engineering. He received Ph.D. degree from Albert-Einstein College of Medicine and completed postdoc training from Harvard Medical School. ​Prior to joining Biocytogen, he worked in Pfizer as a principal scientist and group leader of antibody engineering group.

Senior Scientist, Biochemical and Cellular Pharmacology
Kelly Loyet is currently a Senior Scientist at Genentech in the department of Biochemical and Cellular Pharmacology (BCP). She received her BS in Biochemistry from University of Illinois-Urbana-Champaign and PhD in Biochemistry from University of Wisconsin-Madison where her research concentrated on protein-phospholipid interactions in regulated exocytosis. She joined Genentech Research as a postdoctoral fellow in the Protein Chemistry Department where she characterized protein interactions and utilized proteomic mass spectrometry tools to profile Th1 and Th2 cell membrane proteins. Currently she and her team develop functional and bioanalytical assays to select and characterize biotherapeutics for investigative and preclinical studies. She is a lab head and represents BCP on various immunology, oncology, infectious disease, and ocular project teams.

Senior Research Associate, Late Stage Pharmaceutical Development
I received my Bachelor of Science degree in Biochemistry and Molecular Biology from Pennsylvania State University. I worked at Eli Lilly before joining Genentech in 2006. I am currently a Senior Research Associate in Late Stage PharmDev. Some of my past experience includes working supporting product technology transfers for commercial products. Currently, I am focused on formulation development for high protein concentration subcutaneous delivery and am an inventor on a formulation patient.

Customer Applications Director
Mats has over 25 years experience in biotechnology, holding a PhD in Immunology, Cell & Molecular Biology, Karolinska Institute, Stockholm, SE. He has held positions as scientist, team manager and VP at Pharmacia, AZ and biotech companies. Previously, managed both the Cell line & Upstream Process Development teams at a major biotech. Currently, works across different viral vector and vaccine projects and upstream topics, focusing on customer support, applicability of new technologies and manufacturing solutions.

Senior Consultant
Sheila Magil has over 20 years of experience in quality and analytical method development for biologics, peptides and small molecules. Her expertise includes quality assurance, protein and peptide biochemistry and analytical development. She was formerly Senior Manager of Analytical Development and Quality Control at Biomeasure, Inc., and previously held positions at Waratah Pharma, Alkermes, Bion and HHMI at Massachusetts General Hospital. Dr. Magil has implemented quality systems and has managed external analytical and QC activities for multiple biopharmaceutical products. Dr. Magil holds a PhD in Biochemistry from the University of Minnesota.

Scientist II
Prakash Manikwar is currently working as a scientist in the Formulation Sciences group at MedImmune. He has extensive experience in developing formulation and process for a wide variety of molecules such as monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, fusion proteins, enzymes, peptides, and vaccines. Extensive experience in developing frozen, liquid, lyophilized and inhalation products. He has served as a formulation lead on numerous early stage development projects from preclinical stage to Phase 2 clinical supply. Prior to joining MedImmune in 2013, he worked as a post-doctoral researcher at Macromolecule and Vaccine Stabilization Laboratory, University of Kansas.Prakash holds a PhD degree in Pharmaceutical Chemistry from The University of Kansas.

Chief of Staff, Chief of Performance Excellence, Zuckerberg San Francisco General Hospital and Trauma Center; Professor of Anesthesia, UCSF Department of Anesthesia and Perioperative Care
Dr. James D. Marks co-founded Hermes Biosciences, Inc. and serves as its Vice President of Antibody Discovery. Dr. Marks serves as the Chief of Anesthesia at San Francisco General Hospital, and also serves as Professor of Anesthesia and Pharmaceutical Chemistry at the University of California, San Francisco (UCSF). Dr. Marks serves as Vice-Chairman of the Department of Anesthesia and Perioperative Care at UCSF. Director of the Medical-Surgical Intensive Care Unit, San Francisco General Hospital. Dr. Marks served as Chairman of Medical Advisory Board at Symphogen A/S. Dr. Marks has been a Member of Scientific Advisory Board at Adimab, LLC since 2007. Dr. Marks serves as a Member of the Scientific Advisory Board at Quinnova Pharmaceuticals, Inc. and Merrimack Pharmaceuticals, Inc. Dr. Marks is a Program Member of UCSF Comprehensive Cancer Center at University of California, San Francisco. Dr. Mark' s research interests include the development of phage display technology for production of human antibodies and the development of techniques for increasing antibody affinity. He serves as Director of HERMES Biosciences, Inc. He serves as Member of Scientific Advisory Board of ImaginAb, Inc. He serves as Director of Silver Creek Pharmaceuticals, Inc. He has published more than 75 scientific papers and acts as a referee for top-ranking international journals including Nature Biotechnology, Nature Medicine, Journal of Molecular Biology, Gene, Blood, and Human Antibodies and Hybridomas. Dr. Marks is the co-inventor on 4 major phage display patents. He holds a PhD from the MRC Laboratory of Molecular Biology, Cambridge, UK on the making of human antibody fragments in bacteria and bacteriophage. He is board certified in Internal Medicine, Anesthesia, and Critical Care Medicine. He was an undergraduate at the University of California Berkeley majoring in biochemistry and received his medical degree from UCSF. He completed residencies in Internal Medicine and Anesthesia as well as a fellowship in Critical Care Medicine, all at UCSF.

Associate Professor, Chemical Engineering
Dr. Maynard received her undergraduate degree in Human Biology from Stanford University, followed by a PhD in Chemical Engineering from the University of Texas at Austin, and postdoctoral studies as an NIH NRSA fellow in Microbiology and Immunology at Stanford University. She returned to the University of Texas at Austin as a faculty member in the Department of Chemical Engineering in 2007.

Senior Scientist, Antibody Discovery & Protein Engineering
Yariv Mazor received his PhD in Molecular Microbiology and Biotechnology from Tel-Aviv University, Israel in 2005, where he studied and developed antibody therapeutics and antibody-drug conjugates for Cancer treatment under Prof. Itai Benhar. He then pursued postdoctoral training at the Dept. of Chemical Engineering, University of Texas at Austin, TX under Prof. George Georgiou where he developed a novel platform for the selection and screening of engineered full-length IgG antibodies from libraries expressed in E. coli. In 2009 Yariv joined the Dept. of Antibody Discovery and Protein Engineering at Medimmune, LLC where as a Senior Scientist he is managing the antibody discovery group and leading antibody bio-therapeutic programs into clinical development. Yariv is an inventor on 10 patents or patent applications related to antibody therapeutics and technologies thereof and author on 20 peer-reviewed papers.

Senior Scientific Liaison, Global Biologics
Dr. McCarthy is a Senior Scientific Liaison in USP’s Global Biologics Department. Diane works with USP Expert Committees as well as several Expert Panels to develop documentary standards (chapters and monographs) and Reference Standards that support biopharmaceutical quality assessment. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where she directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.

Research Scientist, Preclinical Research
Kim McDowell is a Research Scientist at Proclara Biosciences, where she leads a preclinical amyloidosis program based on implementation of translational models of and novel biomarkers for proteopathic amyloid seeds. Prior to joining Proclara, she led a team of scientists at UCLA devoted to translational preclinical studies utilizing Parkinson’s disease mouse models. She earned her doctorate in Neuroscience from the University of Maryland, Baltimore, where she created and studied a novel rodent model of Parkinson’s disease induced by environmental toxin exposure. Over the course of her career, Kim has received numerous awards from multiple institutions for her work in Parkinson’s disease and neurodegeneration.

Reader in Molecular Immunology, Cellular and Molecular Immunology Research Centre, London Metropolitan University; Honorary Senior Research Fellow, National Heart and Lung Institute, Imperial College London
Dr. McLean is a research scientist with over 20 years of experience in monoclonal antibody generation and recombinant antibody expression in academic settings and has developed significant ties with biotechnology and vaccine companies. His scientific training has led him to British Columbia where he produced and used monoclonal antibodies for cancer therapy; New York where he studied antibody gene diversification; and Texas where he continued studies using monoclonal antibodies as antiviral agents. He is currently based in London UK where his research now focuses on monoclonal antibody guided vaccine design for human viruses.

Postdoctoral Fellow
Shrenik Mehta obtained a masters degree in Pharmaceutical Sciences from Virginia Commonwealth University in Richmond, Virginia and a PhD in Pharmacology from Baylor College of Medicine in Houston, Texas. He is currently a postdoctoral fellow at Genentech working on technology development for ocular drug delivery using peptide and protein engineering approaches.

COO
Sebastian is Chief Operating Officer of Numab Innovation, an emerging Swiss biotech company with partnered as well as proprietary pipeline assets in the field of immuno-oncology. Prior to joining Numab, Sebastian headed the downstream processing and analytics unit of ESBATech, focusing on process development and characterization of novel scFv drug candidates in Phase I/II of clinical development, including RTH258 (brolucizumab). Prior to that, Sebastian was a group leader in bioprocess development at Cytos Biotechnology. Sebastian holds a degree in Biochemistry from the University of Hamburg and a PhD from the University of Zurich.

Professor, Digital Life Sciences
Enkelejda Miho is a Professor for Digital Life Sciences at School of Life Sciences, FHNW University of Applied Sciences and Arts Northwestern Switzerland. Prof. Enkelejda Miho holds a MS in Pharmaceutical Chemistry and Technology from the University of Bologna (2011) and a DAS in Pharmaceutical Medicine from the European Center of Pharmaceutical Medicine (ECPM), University of Basel (2016). Prof. Miho obtained her doctorate degree in Biotechnology from ETH Zurich (2017). As a Pioneer Fellow at the Innovation & Entrepreneurship Lab (ETH ieLab), she founded aiNET, the immuno-informatics ETH spin-off for therapeutic antibody and T-cell discovery.

Judy Gugenheim Research Professor, Director, Interdepartmental Immunobiology Center, Microbiology-Immunology
Dr. Stephen Miller is the Judy E. Gugenheim Research Professor of Microbiology-Immunology at Northwestern University Feinberg School of Medicine in Chicago. He received his Ph.D. in 1975 from the Pennsylvania State University and did postdoctoral training at the University of Colorado Health Sciences Center before joining the faculty at Northwestern in 1981 where he currently serves as Director of the Northwestern University Interdepartmental Immunobiology Center. Dr. Miller is internationally recognized for his research on pathogenesis and regulation of autoimmune diseases. He has published over 400 journal articles, reviews and book chapters and has trained multiple generations of scientists. His work has significantly enhanced understanding of immune inflammatory processes underlying chronic autoimmune disease employing animal models of multiple sclerosis (MS) and Type 1 diabetes (T1D). His work has focused on the study of the cellular and molecular mechanisms underlying treatment of established T cell-mediated autoimmune diseases using antigen-specific immune tolerance. His current work is geared to translating the use of antigen-linked biodegradable PLG nanoparticles for the treatment of human immune-mediated diseases including autoimmunity, allergy and tissue/organ transplantation.

Principal Scientist, Therapeutic Discovery
Marissa Mock is a Principal Scientist in Biologics Optimization within Therapeutic Discovery at Amgen. She received her PhD in Chemistry from the California Institute of Technology and completed postdoctoral studies in Molecular Biology at The Scripps Research Institute. Prior to joining Amgen in 2011, she was a research scientist at the biotechnology company Codexis. Her current research focus at Amgen is engineering and optimization of large molecule therapeutics.

Vice President, Immunology & Cell Biology
Paul has 25 years of experience working in biotech, coordinating efforts focused on the discovery and development of novel biologic based therapies. At MacroGenics, he leads a research group dedicated to the discovery, preclinical development and clinical translational biology of antibody-based therapeutics including Fc-optimized mAbs and bispecifics for cancer or autoimmune disease through harnessing of the host immune system. He began his biotechnology career at HGS, where he directed genomic-based target discovery programs and the preclinical development of various protein and mAb-based therapeutics. Notably these efforts led to the discovery of BLyS as a B-cell survival factor providing the basis for the development of Benlysta for the treatment for lupus. Paul obtained his PhD from the University of Glasgow, and performed post-doctoral work at the Roche Institute of Molecular Biology. He has co-authored over 70 peer-reviewed manuscripts and 40 issued US patents.

Senior Scientist, CMC
Alessandro Mora is the head of cell line and cell culture development group, CMC department at Jounce therapeutics, a biotech company focused on the development of immuno-oncology therapies. Prior to Jounce, Alessandro worked at AbbVie Bioresearch Center, where he held multiple positions in the Process Sciences department. Alessandro received his PhD in biomedical engineering from University of Massachusetts, Lowell and his MSc in Biotechnology from Sapienza, university of Rome, Italy.

Distinguished Research Professor, Microbiology, Immunology and Molecular Genetics
Sherie Morrison received her B.A. and Ph.D. degrees from Stanford University in 1963 and 1966. After working as a part-time postdoctoral fellow at Columbia University, University of California at Berkeley and Albert Einstein College of Medicine she joined the faculty of the Department of Microbiology at Columbia University College of Physicians and Surgeons in 1974 where she remained until 1988, rising to the rank of Professor. In 1988 she joined the faculty of the University of California at Los Angeles where, she is currently Distinguished Research Professor of Microbiology, Immunology and Molecular Genetics. She served as Department Chair from 1992 to 2002 and as Interim Department Chair 2014-2015. Her long-time research interest has been the functional properties of antibodies and novel antibody-related proteins. A current focus of her laboratory is antibody fusions with interferon for the treatment of malignancy.

Senior Scientist, Drug Product Development
Ehab Moussa is a Senior Research Scientist in New Biological Entities at AbbVie Inc. He was a visiting scholar at Manchester and Oxford Universities and completed his PhD in Pharmaceutics at Purdue University.

Research Engineer, Materials Engineering Division
Dr. Monica Moya is a biomedical engineer researcher at Lawrence Livermore National Laboratory. Currently she works as the principal investigator and as a technical lead on three bioengineering projects including 3D bioprinting of human tissues. She received her Bachelors of Science from Northwestern University and her PhD in biomedical engineering from Illinois Institute of Technology.

Research Scientist, Virginia G. Piper Center for Personalized Diagnostics
Dr. Murugan obtained his graduate degree from Tata Institute of Fundamental Research, India. He completed his postdoctoral training at The University of Texas at Austin and later at the Dana Farber Cancer Institute, Harvard Medical School. Before moving to ASU, he was the Director of assay development section at Sanaria Inc. In his role as the assay development scientist, his team developed and optimized in-vitro assays for testing the potency of candidate vaccines before they get to the clinic. His current research focus at ASU is to develop a qPCR-based radiation biodosimetry assay to detect radiation exposure in people. His main research interest is in developing biomarker-based diagnostic tests for early detection of disease(s)/pathogens. As a trained molecular biologist, Dr. Murugan also oversees the production of expression clones. He has worked both in academia and Industry and has extensive experience in assay development as well as high-throughput screens. Over the past 20 years of his scientific career he has trained and mentored several postdoctoral trainees, graduate students, research technicians and undergraduate researchers, many of whom have gone on to further training as graduate students or postdocs or are researchers in biotechnology industry.

Professor, Pharmacology, The Center for Translational Targeted Therapeutics and Nanomedicine (CT3N) and Systems Pharmacology
Vladimir Muzykantov (MD from First Moscow Medical School, 1980 and Ph.D. in Biochemistry from Russian National Cardiology Research Center, 1985), joined PENN in 1993 and in 2010 became a Professor and Vice-Chair of the Department of Systems Pharmacology and Translational Therapeutics. In 2010 he established the PENN Center for Targeted Therapeutics and Translational Nanomedicine, which he directs. He published ~250 papers and edited a book “Biomedical Aspects of Drug Targeting” (Kluwer, 2003). Honors include: AHA Established Investigator (1996), AHA Bugher Stroke Award (2000), Chair of Transatlantic Airway Conference on Targeting Molecular Signatures in Lungs (Luzerne, 2009), Gordon Conference on Drug Carriers (2012) and HLBI Division of Lung Diseases Workshop “Precision Therapeutics Delivery for Lung Diseases” (2014), Keynote Speaker Annual Italian Society of Biochemistry and Molecular Biology Conference (2015). His research focuses on drug delivery by red blood cells and endothelial targeting for treatment inflammation, thrombosis and ischemia.

President
Dr. Rajiv Nayar is Founder and President of HTD Biosystems. Previously, Dr. Nayar was at Bayer where he established the formulation and drug delivery Group in the biotechnology division and was responsible for managing the formulation and drug delivery activities within the global Bayer network on protein/peptide based drugs. He was a recipient of 3 consecutive Presidential Achievement Awards at Bayer for implementing Continuous Improvement Processes in pharmaceutical development. He is the inventor the Bayer’s albumin-free Factor VIII formulation (Kogenate® FS). Prior to Bayer, he was at the Canadian Liposome Company and involved in the development of liposomal doxorubicin and vincristine (Caelyx®, Myocet®).
He is an inventor on >20 patents and has authored >70 publications. Dr. Nayar received his PhD (Biochemistry) from University of British Columbia and was an MRC fellow at MD Anderson Tumor Institute.

Laboratory Head Formulation Development Biologics, Global Pharmaceutical Development Biologics
Reza Nejadnik is a senior scientist in the Global Pharmaceutical Development Biologics department at Sanofi. He is responsible for biologics formulation and associated developability and deviceability considerations. As a member of the drug product development teams, he is actively involved in innovation activities and investigation of the stability of various drug products.
Reza has a long track of collaborating with various partners in industry and academia for addressing the challenges concerning the formulation, characterization and delivery of biologics. He has authored several scientific articles and given numerous presentations on stability topics and has been an active member of professional associations working towards safe and efficient delivery of biopharmaceuticals to patients.

Senior Scientist, Laboratory Automation & High-Throughput Process Development
Kelcy is a resourceful, solutions-focused Senior Scientist with a 12-year portfolio of success leading cross-functional teams in delivering innovations for MedImmune, the biologics division of Astra Zeneca. In this role, I lead cross-functional matrix team of 20+ Scientists in developing automation and high-throughput process development (HTPD) tools for biopharmaceutical development. I manage HTPD labs in optimizing pipeline and building HTPD and collaborative automation tools to fully automate scale-down models and analytics. My PhD is from the University of Massachusetts Amherst.

Project Lead and Laboratory Supervisor, Human Health Therapeutics
Dr. Feng Ni received his PhD in biophysical chemistry (with Harold A. Scheraga) from Cornell University in 1988. Shortly after, Dr. Ni joined the NRC as a Research Associate in Protein Engineering at the Biotechnology Research Institute (BRI), where in 1996 he became the Group Leader of the Biomolecular NMR laboratory. In 1996-97, Dr. Ni set up Canada’s first 800 MHz NMR facility, which was the workhorse for a Genomics NMR project during 1999-2007. He also holds an adjunct professorship with Experimental Medicine, McGill University Faculty of Medicine and led an active research laboratory with over 90 peer-reviewed publications. During 2008-2013, he ventured into the drug discovery/development arena and had a number of patents in the area of novel thrombin inhibitors, locally-active anti-thrombotics and targeting molecules specific for inflamed and fibrotic tissues.

Senior Scientist
Henrike Niederholtmeyer is a postdoctoral fellow in the lab of Neal Devaraj at the University of California, San Diego, where she is working on engineering artificial cell-mimics and artificial organelles. Henrike is interested in studying the organization of living cells using artificial, biochemical systems such as cell-free expression and materials that mimic cellular structures. Before joining the Devaraj lab in 2015, Henrike earned her PhD at the Swiss Federal Institute of Technology in Lausanne (EPFL) with Sebastian Maerkl. At EPFL, she studied genetic oscillators in cell-free transcription and translation systems, how to transfer genetic networks from cell-free reactions into bacteria, and engineered microfluidic reactors.

Scientist, Protein Analytics
R. Paul Nobrega earned a PhD in biophysics form the University of Massachusetts Medical School where he studied protein folding. Currently, Paul is a Scientist at Adimab LLC and is focused on ensuring that the mAbs produced for our clients are highly developable.

Associate Professor, Synthetic Biology, Biological Physics
Vincent Noireaux got his BSc in applied physics at the University of Tours (France) in 1994. He did his PhD at the Curie Institute (Paris, 1996-2000) in biological physics in the laboratory of Jacques Prost on the motion of the bacterium Listeria. He learned the biology related to this project in the laboratory of Daniel Louvard. In 2000 he joined the laboratory of Albert Libchaber at the Rockefeller University in New York City where he spent five years as a postdoc. He used cell-free expression systems to construct elementary gene networks and synthetic cell systems. In 2005, he moved to the University of Minnesota where he is pursuing his work in synthetic biology. His research consists of constructing and characterizing biochemical systems in vitro by executing synthetic DNA programs in cell-free expression systems.

Research Associate, Pediatrics, Pediatric Tropical Medicine
In 2006, I received the UNESCO-L'Oréal for Women in Science International Fellowship that allowed me to have research placement at the University of Sheffield, UK between 2006–2008. Later, I returned to my home country Malaysia and completed my PhD in Structural Biology in 2009, gaining expertise in X-ray crystallography and NMR spectroscopy. In 2009, I began applying these techniques to the study of α1-antitrypsin deficiency when I joined the Gooptu group (Birkbeck College, London, UK) as a postdoctoral researcher. During the postdoc training, I applied wide range of structural and biophysical methods to understand the dynamic and conformational changes induced misfolding of the archetypal serpin α1-antitrypsin. In 2015 I accepted the position as postdoc associate in the Baylor College of Medicine, Houston Texas. These few years, I have expanded my technical expertise in process development of vaccine against Middle East respiratory syndrome (MERS) coronavirus and neglected tropical disease.

Scientist II, Translational Cellular Sciences
Birgit received her PhD in Neuroimmunology from the Max-Planck Institute for Neurobiology in Munich, Germany, studying the role of B cells and antibodies in multiple sclerosis. To pursue her interest around mechanisms of how immune cells infiltrate the brain, Birgit joined the lab of Dr. Ransohoff at the Cleveland Clinic for her postdoctoral training where she developed expertise in cell-based models of the BBB.
Since joining Biogen, Birgit’s research has focused on continuously advancing BBB models using microfluidic technology in combination with human stem cell derived cell sources to evaluate drug delivery of brain therapeutics and to develop a mechanistic understanding of BBB biology in the context of neurological disease. In her current role in Biogen’s Translational Biology Center of Excellence, Birgit supports groups across multiple Research Units, providing existent and innovative novel cell-based models of human disease.

Senior Director, Pharmaceutical Research and Development, Biotherapeutic Pharmaceutical Sciences
Satoshi Ohtake is the Senior Director of Pharmaceutical Research and Development at Pfizer, where he oversees all biotherapeutic drug product development activities. Prior to joining Pfizer, he’s held positions of increasing responsibility at Nektar Therapeutics and Aridis Pharmaceuticals specializing in the development of novel processing technologies and formulation of various modalities ranging from small molecules to live attenuated vaccines. He also serves as an executive board member of a non-profit organization, adjunct faculty member at University of Kansas, and Editorial Advisory Board member of peer-reviewed journals. He received his BS from Caltech and PhD from University of Wisconsin Madison, both in Chemical Engineering.

Associate General Manager, R&D, Planning Department
In 2000, the speaker began his career at Pharmaceutical Research Labs, Ajinomoto and has 15 years experiences in drug discovery. The speaker acquired a Ph.D. degree at Tokyo Institute of Technology in 2006, and worked in UC San Francisco in the field of chemical biology between 2007-2009. In 2014, the speaker moved to R&D Planning Department in Ajinomoto and now works in business development of biopharma-related platform technologies, including site-specific ADC manufacturing technologies.

Professor and Head, Bioprocesses and Bioanalytics, Institute of Bio- and Geosciences, IBG-1, Biotechnology
Marco Oldiges received a diploma in chemistry with major in technical chemistry from University of Bonn (Germany). Promotion at University Bonn / Forschungszentrum JWich (FZI) in 2004 in the field of bioprocess engineering and metabolomics for microbial L-phenylalanine production. Head of 'Bioprocesses and Bioanalytics' group at Institute of Bio- and Geosciences (IBG-1: Biotechnology) since 2005. Prize to promote up-and-coming teachers in higher education from German society for chemical technology and biotechnology (Dechema) in 2007. Associate professorship for Bioprocess Analytics at RWTH Aachen University (Germany) since 2011. Research interest comprise metabolic and bioprocess engineering with omics application, development of metabolomics and lab automation for bioprocess development.

Professor, Department of Material and Life Science, Graduate School of Engineering
Professor (PhD), Osaka University (2015-). 1992 PhD, Osaka University; Assistant Professor, Osaka University (1992-2005); Associate Professor, Osaka University (2005-2010); Professor, Tokushima University (2010-2015); Visiting Scientist, University of Rochester (NY) (1998-1999). Research Subject: Production of biologics in Chinese hamster ovary cell. Academic Activity: JAACT vice president, Chair for biochemical engineering division of SCEJ.

Senior Bioprocess Engineer, Bioprocess Engineering, Process Science
Dr. Raquel Orozco is a Senior Bioprocess Engineer in the Process Science Department at Boehringer Ingelheim Fremont, Inc. She leads a group of purification scientists focusing on tech development and potential implementation of integrated downstream processing. She received her bachelor’s degree in chemical engineering from UC Berkeley and her PhD in chemical engineering with an emphasis in biotechnology from UC Davis.

CEO
Norman Packard has over two decades of experience in chaos theory, learning algorithms, predictive modeling of complex systems, statistical analysis of evolution, artificial life and complex adaptive systems. Prior to daptics, Packard co-founded Prediction Company, where he applied learning algorithms and statistical modeling to predict financial markets. Before 1991, Packard was associate professor of Physics at the University of Illinois, Urbana-Champaign. He holds a Ph.D. in Physics from the UC Santa Cruz.

Senior Staff Scientist, Product Development
Marcin Paduch is a Senior Staff Scientist at GRAIL working on developing integrated sample processing workflows for noninvasive cfDNA-based multi-cancer detection. His expertise is focusing on an invention of high-throughput technologies in support of early discovery and product development stages. In the past, he served as Pipeline Director at Recombinant Antibody Network (RAN), tasked with the generation of therapeutic-grade recombinant antibodies at a proteome-wide scale for biology and biomedicine.

Head, Tech Ops & Andover Site
Palani has over twenty five years of pharmaceutical experience and continues to contribute to commercial registration and clinical development of numerous candidates in small molecule, biologics, ADCs and cell therapy. He currently serves as the head of Technical Operations at Sarepta Therapeutics and focuses on small molecule and antisense based RNA medicines. He is currently leading Sarepta’s gene therapy CMC and Manufacturing team and is responsible for all stages of development from research through commercial. Prior to Sarepta, he held increasing leadership positions and recently lead biologics and new modality development at Takeda Pharmaceuticals with responsibility for global development of drug candidates in variety of modalities including cell and gene therapy, microbiomes and antibody drug conjugates, etc. Before Takeda, he spent a number of years each at Millennium Pharmaceuticals, Biogen, Gilead Sciences and Par Pharmaceuticals. Palani completed executive leadership education at Oxford University and Insead, post-doctoral work at University of California Riverside and Virginia Commonwealth University Richmond. He received his PhD from Indian Institute of Technology Kanpur.

CTO
Sebastian is the CTO of Ansa Biotechnologies, a startup in the field of enzymatic DNA synthesis. Prior to working at Ansa Biotechnologies, Sebastian received a Master's degree in Biomolecular Engineering from Darmstadt University of Technology and then joined Jay Keasling’s group at Lawrence Berkeley Laboratory / the Joint BioEnergy Institute for his PhD studies. During his PhD research, Sebastian and colleague Daniel Arlow developed a novel technology for enzymatic de novo DNA synthesis that is based on polymerase-nucleotide conjugates. Sebastian and Dan then co-founded Ansa Biotechnologies to commercialize the technology.

Galletti Professor, Bioengineering; Principal Investigator, Systems Biology Research Group, Bioengineering; Professor, Pediatrics
Bernhard Palsson is the Galletti Professor of Bioengineering, the Principal Investigator of the Systems Biology Research Group in the Department of Bioengineering, and Professor of Pediatrics at the University of California, San Diego. He is also the CEO of the Novo Nordisk Center for Biosustainability in Denmark, working in this capacity since 2011. Dr. Palsson has co-authored more than 420 peer-reviewed research articles and has authored four textbooks. His research includes the development of methods to analyze metabolic dynamics (flux-balance analysis, and modal analysis), and the formulation of complete models of selected cells (the red blood cell, E. coli, CHO cells, and several human pathogens). He sits on the editorial broad of several leading peer-reviewed microbiology, bioengineering, and biotechnology journals. He previously held a faculty position at the University of Michigan for 11 years and was named the G.G. Brown Associate Professor at Michigan in 1989, a Fulbright fellow in 1995, and an Ib Henriksen Fellow in 1996. He is the author of over 40 U.S. patents, the co-founder of several biotechnology companies, and holds several major biotechnology awards. He received his PhD in Chemical Engineering from the University of Wisconsin, Madison. Dr. Palsson is a member of the National Academy of Engineering and is a Fellow of the AIMBE, AAAS, and the AAM.

CEO
Thirty years developing cutting-edge solutions for protein characterization, with 20 years in pharmaceutical bioprocessing. Patented innovator in protein aggregation and strong network in the biologics community, having trained a generation of students in biotechnology, protein spectroscopy and characterization for subsequent employment in the biopharmaceutical industry.

Specialist, Protein & Peptide Biophysics
Marie Ø. Pedersen earned her PhD from Aarhus University, Denmark in 2009 within structural biology and NMR spectroscopy and continued this research as a postdoctoral fellow at Monash University, Australia. Since 2011, Marie Ø. Pedersen has been a scientist in the Department of Protein and Peptide Biophysics at Novo Nordisk A/S, Denmark. Her work is focused on solubility and physical stability screening of novel peptides/proteins, and detailed biophysical characterization of research lead candidates; several of which are currently in phase I or II development.

Associate Dean for External Affairs, College of Engineering
Dimitrios Peroulis is Reilly Professor of Electrical and Computer Engineering and serves as Associate Dean for External Affairs in the College of Engineering at Purdue University. He received his PhD degree in Electrical Engineering from the University of Michigan at Ann Arbor in 2003. His current research interests are focused on the areas of reconfigurable electronics, cold-plasma RF electronics, and wireless sensors. He received the National Science Foundation CAREER award in 2008. He is an IEEE Fellow and has co-authored over 300 journal and conference papers. In 2014 he received the Outstanding Young Engineer Award of the IEEE Microwave Theory and Techniques Society (MTT-S). In 2012 he received the Outstanding Paper Award from the IEEE Ultrasonics, Ferroelectrics, and Frequency Control Society (Ferroelectrics section). His students have received numerous student paper awards and other student research-based scholarships. He has been a Purdue University Faculty Scholar and has also received ten teaching awards including the 2010 HKN C. Holmes MacDonald Outstanding Teaching Award and the 2010 Charles B. Murphy award, which is Purdue University's highest undergraduate teaching honor.

Executive Director, External R&D and Alliances
David is the Executive Director for External R&D and Alliances and has been at Zymeworks for 10 years. During this span, he held various positions including overseeing all wet-lab operations and made key contributions to the development of the Azymetric™ and AlbuCORE™ platforms. He is currently responsible for Zymeworks’ strategic in- and out-licensing activities and key drug development collaborations. David received his Ph.D. in Chemistry from the University of British Columbia with a focus on studying the structure-function relationship of enzymes using NMR spectroscopy.

Principal Scientist
Jinshu Qiu is a Principal Scientist at Process Development, Amgen Inc. He is responsible for testing of process related impurities and excipients. He was the first in the industry to propose the use of safety margin as a criterion to determine the need of specification testing for raw materials. He also studied targeted metabolomics using LC-MS/MS and GC-MS to support culture media and process development. He published papers on process-related impurity testing strategies and excipient analyses in biopharmaceutical products.Jinshu received a PhD degree from North Carolina State University and a BS degree from Zhejiang University, China.

Associate Professor, Immunology and Microbiology
Christoph Rader studied biochemistry in Germany and Switzerland where he received his Ph.D. from the University of Zurich in 1995. Following postdoctoral training at The Scripps Research Institute in La Jolla, CA, USA (TSRI-CA), he was appointed Assistant Professor at TSRI-CA in 1999. In 2003, he was recruited as Senior Scientist to the National Cancer Institute, National Institutes of Health in Bethesda, MD, USA (NCI, NIH). He rejoined The Scripps Research Institute in Jupiter, FL (TSRI-FL) as Associate Professor with Tenure in 2012. All three Rader laboratories have focused on antibody drug and target discovery for cancer therapy with a specific interest in the development and application of antibody engineering and conjugation technologies including phage display, mammalian cell display, homogeneous antibody-drug conjugates, chemically programmed antibodies, bispecific antibodies, and chimeric antigen receptor T-cell therapies. Several antibodies developed in the Rader laboratories have reached preclinical and clinical investigations. Christoph Rader has authored >100 peer-reviewed journal articles and is named inventor on 12 issued and twice as many pending patents. In addition to his academic activities that include his appointment as Associate Dean for Graduate Studies at TSRI-FL in 2018, he serves on the Scientific Advisory Boards of NBE-Therapeutics, Inc. (Basel, Switzerland) and BlinkBio, Inc. (Jupiter, FL, USA) and is a co-founder of T-CURX, Inc. (Würzburg, Germany).

Scientist, Antibody Discovery & Protein Engineering
Dr. Sarav Rajan received his PhD from McGill University working in functional genomics and trained in antibody phage display in the lab of Dr. Sachdev Sidhu at the University of Toronto. At MedImmune, he has led and participated in multiple antibody discovery efforts and is developing an ultrahigh-throughput method to recover and screen natively-paired antibody repertoires from millions of human B cells.

Head of Bio-Structure and Biophysics, Integrated Drug Discovery
Alexey Rak got his MSc in Biology and Genetics, and in Biochemistry. He then completed PhD in Biochemistry and Biophysics working on protein biosynthesis machinery characterization. He did his PostDoc and then held a Group Leader position at Max-Planck Institute for Molecular Physiology in Germany working in the field of vesicular membrane trafficking. For this work he was awarded several honors including European Young Investigator Award in 2004. Since 2007 Alexey joined Sanofi as head of protein crystallization in Paris where he has developed new methods to characterize biophysical properties of proteins including biologics and enabling the lead discovery of challenging protein targets. Since 2014 he is heading Bio Structure and Biophysics at Integrated Drug Discovery in Sanofi.

Senior Principal Scientist, Molecular Technology
Harun has 18 years of biotech R&D experience in cutting-edge molecular biology with expertise in recombinant protein expression and engineering, synthetic biology, genome engineering and strain development. Currently, Harun is leading the Molecular Technology Department at Ambrx, Inc. to optimize their NNAA incorporation technology for the production of protein therapeutics in bacterial (ReCODE) system. Prior to that, he had engineered protein therapeutics, and optimized expression systems for development candidates at Genencor International and at Catalyst Biosciences that had moved to clinical stages.

Associate Professor, Biosystems Science and Engineering
Sai Reddy is an Associate Professor in the Department of Biosystems Science & Engineering, ETH Zurich, Switzerland. His research group uses methods in systems and synthetic biology to study and manipulate immune responses for applications in biotechnology, vaccination, and immunotherapy.

Lead Scientist, Cell Line Development
Bernd brings over 25 years in the cell line development field within the biotech industry. Over the years, Bernd has worked on developing GMP-compliant processes for clinical grade rAAV production, heading the cell line development team at Rentschler, leading projects to generate & characterize cell line for GMP production, and most recently director of process development for gene therapy before joining the Cella team as Lead Scientist.

Principal Scientist, Downstream Process Development and Engineering
Dr. Ríos joined Merck Research Laboratories in 2006 in purification through the acquisition of GlycoFi were she joined 2002 to establishe a new purification group. Presently, Dr. Rios is a Principal Scientist in the Downstream Process Development and Engineering group. In her current role, her responsibilities include working with members of strain development, high-throughput screening and strain selection, fermentation and analytical development to develop purification processes for novel and best-in-class biologics, process scale-up, and technology transfer.

Leader, Bioprocess Measurements Group
Dean received a PhD from Cornell University in 1991. After a successful career at NIST developing methods and standards in thermometry, in 2010 he became Leader of the Bioprocess Measurements Group, which conducts research supporting biomanufacturing and health care. His own research focuses on new standards and methods for characterizing protein particulates. Dean has presented workshops on measurement issues to many industrial groups, ranging from petroleum producers to vaccination program coordinators. He is an active member of the NCSLI Healthcare Metrology subcommittee, the ASTM committee on the Manufacture of Pharmaceutical Products, and expert panels of the US Pharmacopeia. In recognition of his contributions, he has received awards from the Department of Commerce, ASME, and two ASTM committees.

Senior Consultant
Frank J Riske, PhD, Senior Consultant at BioProcess Technology Consultants has over 25 years of experience in the biopharmaceutical industry. Prior to joining BioProcess Technology Consultants, Dr. Riske was Senior Director in the Late Phase Process Development Group at Genzyme, a Sanofi company. Before Genzyme, Dr. Riske held positions at Epic Therapeutics, Repligen and Hoffmann-LaRoche. Dr. Riske has extensive experience in the development of downstream processes for cytokines, proteins and virus from plasma, E coli, Pichia and mammalian systems and in the development and manufacture of novel drug delivery systems. Dr. Riske received his BS in Biology from Fairfield University, PhD in Biochemistry and Microbiology from Rutgers University and completed a post-doctoral position at Hoffmann-LaRoche.

Professor, Chemical & Biomolecular Engineering
Dr. Roberts is a Professor in the Department of Chemical and Biomolecular Engineering at the University of Delaware (UD). He is the Associate Director for the National Institute for Innovation in Manufacturing of Biopharmaceuticals (NIIMBL), and the Director of an industry-university research consortium (the Biomolecular Interaction Technology Center, BITC). He received a Bachelors of Chemical Engineering degree from UD, and a PhD in Chemical Engineering from Princeton University. Prior to joining UD in 2002, he worked in the pharmaceutical industry as a formulation scientist for protein and small-molecule based drugs. The Roberts laboratory focuses on fundamentals and applications of protein physical and chemical stability, (mis)folding, aggregation, statistical mechanics, molecular modeling, and kinetics and thermodynamics to address questions of biopharmaceutical product design, stability, and manufacturing.

Managing Director, DNA
Dr. Robinson’s pharmaceutical career of over 20 years has included work as a physician at several companies such as Pfizer and Sankyo. His broad experience spans several positions in clinical development, marketing, and management. He has worked on many types of studies with many different products, and he has also guided several programs, including Procardia, Procardia XL, and Benicar, through the NDA approval process. Recently, Dr. Robinson’s interests have become more entrepreneurial in nature. He is one of two founders of a new company, Aerosol Therapeutics, based on a foundation of intellectual property. He is now focused on the commercialization of the Atmospheric Spray Freeze Drying process. This includes all aspects of development from equipment manufacturing to testing and from accounting to financing. Dr. Robinson is also an MBA graduate of Columbia Business School.

Professor, Chemistry
Dr. Floyd E. Romesberg, PhD is renowned scientist and professor of chemistry at The Scripps Research Institute. Dr. Romesberg is the Scientific Founder of Synthorx Inc. He was scientific co-founder of RQx Pharmaceuticals. He served as Principal Scientific Founder and Advisor of Achaogen, Inc. Dr. Romesberg is an expert on DNA replication, repair and mutation. His work examining the role of gene products in the active introduction of mutations is the basis of the Achaogen technology platform. He was Assistant Professor of Chemistry at The Scripps Research Institute. Dr. Romesberg has managed a research group at The Scripps Research Institute since 1998. He serves as a Director of RQx Pharmaceuticals, Inc. and Synthorx Inc.

Professor, Natural and Medical Sciences Institute, University of Tübingen, and Co-Founder, ChromoTek Gmb
Dr. Rothbauer has studied biology at the Ludwig-Maximilians University (LMU), Munich. He received his PhD in Biochemistry in 2003 in the group of Prof. Walter Neupert revealing the pathomechanism of a mitochondrial disease. In 2006 he became an independent group leader at the LMU-Biocenter focusing on the development of nanobody-derived tools for protein purification, proteomics and cellular diagnostics. 2008 he founded the Biotech company ChromoTek, which becomes the leading provider of innovative research reagents and technologies based on the nano-/chromobody-technology. Since 2011 he is full professor for Pharmaceutical Biotechnology at the University Tuebingen, Germany working on the development of novel nano- and chromobodies for protein analysis, immunoassays and cellular screening models.

Senior Scientist, Disease Relevant Cellular Assays
Filip Roudnicky is a senior scientist in the disease relevant cellular assay team in chemical biology at Roche. He is focusing on disease relevant cellular assays involving endothelial cells. His responsibility is also genome editing for disease modeling and CRISPR/Cas9 genetic screens. Filip started his career with a PhD in a lab of Prof. M. Detmar at ETH Zurich. He studied tumor angiogenesis of invasive bladder carcinoma and identified several biomarkers and molecular targets on tumor-associated blood vessels of bladder cancer. As a guest research scientist he has worked, in RIKEN Yokohama, Japan, under Dr. Jay W. Shin, on induced-neuronal stem cells and RNA-sequencing analysis. He has been a postdoctoral fellow in Roche and Harvard with the lab of Prof. C. Cowan developing an in vitro model of retinal endothelial cells.

Staff Scientist, Bioanalytical Method Development
Jamie received her PhD in Molecular Biosciences from the University of Kansas. After doing her Postdoctoral Studies at Washington University School of Medicine in the Pharmacology Department she went on to be an Assistant Professor of Biological Sciences at the University at Albany. She then transitioned out of academia to a small biotech company where she was the lead scientist and Head of the DNA/Genotyping facility. Jamie joined Regeneron in 2015 where she is a Staff Analytical Scientist focused on development and technology transfer of impurity and contaminant biochemical methods including those to analyze host cell DNA and proteins.

Senior Research Scientist
Dr. Sacha is a senior research scientist in the Research and Development department at Baxter Healthcare in Bloomington, IN. Greg is responsible for the formulation and process development of parenteral dosage forms that include both large and small molecules. His work resulted in several patents for formulation and process development of large molecules. His interests and expertise are in lyophilization and thermal characterization of pharmaceutical products.

President & CEO, Research & Development
Darryl Sampey co-founded BioFactura in 2004 and as President and CEO manages all strategic and scientific endeavors of the Company. He is an inventor on all BioFactura technology patents, applied the StableFast-NS0 platform to the manufacture of biosimilars and novel drug candidates and recently designed, commissioned and validated the Company’s first cGMP clinical production facility. Before BioFactura, he led both process development and manufacturing teams at Human Genome Sciences, Inc. (HGS). Prior to his work at HGS, Dr. Sampey designed and optimized fermentation and product recovery processes for novel whooping cough and meningitis vaccines at North American Vaccine, Inc. Dr. Sampey graduated first in his class with a Bachelor of Science in Chemical Engineering, magna cum laude, and subsequently earned a PhD in Bioengineering both from the University of Maryland.

Consultant Biologist, Bioprocess Research & Development
Stephanie received a BS degree in Microbiology from Purdue University, and an MS degree in Microbiology/Immunology from Vanderbilt University. She joined Eli Lilly and Company in 2000, beginning her career in the Discovery organization specifically the Department of Infection Diseases, developing a mouse model in which to evaluate anti-HCV compounds. Stephanie later transitioned to Bioprocess Research and Development in 2003 to develop microbial expression technologies for the production of therapeutic proteins. In 2007, she moved to the Molecular and Cellular Biology Group which is responsible for supporting all of Lilly’s mammalian-based manufacturing processes. Most recently, Stephanie has helped develop and establish state-of-the-art cell line engineering capabilities at Lilly.

Head of Upstream, Mammalian Development, Mammalian Cell Culture
Fay is the Head of the Mammalian Cell Culture team within Process Development at FDB UK site. She has been an integral part in the development of FDB's proprietary Apollo™ mammalian expression platform. She earned her Ph.D in Biotechnology from the Open University.

CSO
Andreas holds a PhD in plant biotechnology. Before joining Greenovation in 2009, he held positions at Universities of Muenster and Freiburg. At Greenovation, Andreas was responsible for advancing BryoTechnology to a fully viable biopharmaceutical platform and establishing the company’s product pipeline. Since 2015, Andreas is acting as Chief Scientific Officer.

Group Head, R&D IDD In vitro Biology & HT Chemistry Library, Chiral & Peptide Purification
Mathias Schaffrath studied biotechnology and made his PhD at the University of Hamburg about enantioselective separations of complex natural products.
He started his career in R&D of Intervet (today MSD) and was engaged in the isolation and purification of proteins. Then he moved to Sanofi/Aventis and started the construction and operation of a high throughput purification unit for small molecules /chemical libraries and single compounds. Later he was responsible for chiral separations and implemented the SFC technology in the research laboratories. A few years ago, he established the purification of peptides in research.

Director, Recombinant Technologies Research
Peter conducted his PhD at Bayer Healthcare in Wuppertal, Germany in the area of nitric oxide-independent blood pressure regulation. Based on this work he got awarded an Alexander-von-Humboldt Fellowship to continue his research at the department of Pharmacology at Monash University in Melbourne. He left academia to join CSIRO and, after 4 years, took over the position as Senior Scientist in CSL’s R&D department in Melbourne, Australia. After 7 years in Australia Peter has recently relocated to Germany to run the department of Recombinant Technologies. As such he is involved in all aspects of the early development of new biologics.

Head, Operations (COO)
Dr. Stefan R. Schmidt currently serves as Head of Operations at BioAtrium AG in Switzerland. Previously he held the position as CSO and other senior executive roles at Rentschler Biopharma with overall responsibilities for development and production for more than 5 years. Before that, he was CSO at ERA Biotech in Barcelona, directing the company’s R&D efforts. Prior to that, he worked for 7 years at AstraZeneca in Sweden where he led the unit of Protein Sciences as Associate Director. He started his leadership career at Biotech companies in Munich where he built up protein biochemistry teams for Connex and GPC-Biotech.

Director and Professor, Cellular & Molecular Biology
In conjunction with his M.D. and chemical engineering degrees, Dr. Schnitzer has developed extensive experience in vascular cell biology and targeting, biological interfaces and transport phenomena, drug delivery, molecular imaging, antibody and nano-engineering, proteomics and target discovery. His recent research has focused on identifying novel approaches to overcome systematically key barriers preventing specific drug delivery and full therapeutic efficacy in vivo. For instance, proteomic-imaging technologies have been developed to map the molecular and functional diversity of endothelial and epithelial cell barriers in vivo. New discoveries include not only cell-, tissue- and disease-specific proteins and targeting but perhaps more importantly, a unique transcytotic, vesicular pumping system that goes well beyond classic vascular targeting of endothelial cell surfaces to actually achieve robust tissue penetration. Characterizing specific proteins, signaling, and trafficking functions of key gateways into and across cell barriers has led to novel drug delivery platforms currently being designed at PRISM to rapidly concentrate intravenously injected imaging and/or therapeutic agents specifically inside a single diseased tissue including solid tumor cells.

Takeru Higuchi Distinguished Professor and Chair, Department of Pharmaceutical Chemistry
Dr. Schöneich is the Takeru Higuchi Distinguished Professor for Bioanalytical Chemistry and Chair of the Department of Pharmaceutical Chemistry at The University of Kansas. Between 1987 and 1991 he worked in the Department of Radiation Chemistry at the Hahn-Meitner Institut in Berlin, Germany, and he received his PhD in Chemistry in 1990 from the Technical University Berlin, Germany. He joined the Department of Pharmaceutical Chemistry at The University of Kansas as a post-doctoral fellow in 1991, and as a faculty member in 1992; in 2004, he was a Visiting Professor at the ETH Zürich, Switzerland. His research focuses on oxidation reactions of peptides and proteins in vivo and in vitro, and their potential consequences for the development of stable protein pharmaceuticals, biological aging and age-related pathologies. He has published >250 papers in the field of peptide and protein oxidation reactions

CSO
Dr. van Schooten has over 25 years of biotechnology management experience. Dr. van Schooten co-founded THP, Inc. in 2000 and served as its Chief Executive Officer until its sale to Roche Pharmaceuticals in March 2007. From 1993 to1999, he led the development of cell therapeutics at Dendreon, Inc. Dr. van Schooten studied Immunology at the University of Leiden and the Royal Tropical Institute in Amsterdam, The Netherlands.

Senior Scientist, Upstream Process Development
I obtained a BS in Biology from Pennsylvania State University, PA and a MS in Biotechnology from Kean University, NJ. I started my career at GlaxoSmithKline in 2003 and then moved to Eli Lilly (formerly ImClone Systems) in late 2004. In 2017 I moved to Celgene where I currently work as a Senior Scientist in the Biologics Upstream Process Development group. Over the course of my career, I’ve worked in upstream commercial manufacturing, clinical manufacturing, process development and have had extensive MS&T experience. In my current role I work on upstream process development related activities (e.g., process optimization, process characterization, technology transfer) as well as author and support regulatory filings and health authority information requests for current Biologics projects.

Executive Director, Pharmaceutical Development
Evgenyi Shalaev, PhD, AAPS Fellow, is an executive director in Pharmaceutical Development, Allergan plc, Irvine, California, USA, and an adjunct professor in the Department of Pharmaceutics, University of Minnesota. Dr. Shalaev held the Royal Society Fellowship in Pafra Biopreservation and the University of Cambridge, UK, post-doctoral research appointments at the University of Wisconsin-Madison and Cornell University, and worked at the Institute of Carbon (Russia), Institute of Molecular Biology (Russia), and Pfizer Inc. (USA), before taking his present position. His responsibilities in Allergan are focused on biological drug products covering both controlled release dosage forms and conventional formulations such as solutions and freeze-dried powders. Dr Shalaev’s research interests include amorphous and other disordered solids; phase transitions in aqueous systems during freezing and drying; chemical and physical stability of small molecules and biologicals; development and scale-up of freeze-drying processes. He has published over ninety peer-reviewed papers, book chapters, and patent applications.

Scientist I, High Throughput Expression
Beth Sharkey received her BS in chemical engineering from the University of New Hampshire in 2003. She worked as a process engineer at Stryker Biotech from 2003-2008 prior to joining Adimab, LLC, where she is currently employed as a scientist in the High Throughput Expression group.

Senior Scientist, Cell Culture, Pharma Technical Development
David is a Senior Scientist and Group Leader in the Cell Culture department in Pharma Technical Development at Genentech, Inc. David leads one of the groups responsible for clinical cell line development and is responsible for developing automated cell culture workflows to support the entire cell line development group. David is also a Technical Development Team Leader responsible for a cross-functional team enabling the Early Development of an antibody drug through clinical trials. Prior to Genentech, David was a Principal Research Scientist and Head of Molecular Biology and Protein Sciences at Roche Palo Alto and a Research Professor at the South Carolina Cancer Center.

John A. Biles Professor, Pharmacology and Pharmaceutical Sciences
Dr. Wei-Chiang Shen is John A. Biles Professor in Pharmaceutical Sciences at the University of Southern California School of Pharmacy. Dr. Shen's research focuses on the development of novel systems for improving peptide and protein drug delivery. Dr. Shen is Fellow of the American Association of Pharmaceutical Scientists (AAPS) and the American Association for the Advancement of Sciences (AAAS). He was the recipient of the Grand Prize of Eurand Award for Outstanding Novel Research in Oral Drug Delivery from Controlled Release Society in 2002.

Principal Scientist, Technical Department
Yuyi Shen is the principal scientist at Grifols, USA. She also served different scientist roles in process development and manufacturing science department at various biotech company including XOMA, Bayer and BioMarin. She holds a PhD degree in Chemical Engineering from University of California, Davis. Yuyi provide scientific leadership with specialty in process improvement, scale up, technical transfer to bioprocess manufacturing in cGMP environment. She is a strong subject matter expert in design robust processes for protein purification with monoclonal antibody, antigen and Viral like Particle etc, ensuring Critical Quality Attributes are achieved. She had solid trouble shooting and problem solving skills and encouraging innovation technology to achieve high efficiency and better quality.

Director, Program Design
Nigel Shipston, Director of Program Design at Fujifilm Diosynth Biotechnologies. He has 28 years’ industrial experience, including current role as Senior Technical Project Leader. He has been responsible for leading process development and manufacturing teams involved in the expression and production of numerous recombinant proteins and commercially useful enzyme products using E. coli, P. pastoris and CHO expression systems. He received his BS from Imperial College, London and PhD from the University of Kent, UK.

Head, NBE High-Throughput and Advanced Formulation Sciences, Development Sciences
Michael Siedler received his PhD in Solid State Chemistry from the University of Hamburg.
In 2007 he joined the Biologics Drug Product Development as a group leader at AbbVie (previously Abbott) in Germany till 2010 when he was appointed Head of the Preformulation and Discovery Support Group at the AbbVie Bioresearch Center in Worcester, MA, USA. In 2014 he became a Section Head in the NBE Drug Product Development at AbbVie GmbH & Co KG, Germany and in 2016 he was assigned Head of the NBE High-Throughput and Advanced Formulation Sciences function.

Postdoctoral Researcher, Protein Crystallization, Pharmaceutical Development Biologics
Hanno Sjuts is a Scientist at Sanofi in R&D Bio Research Protein Therapeutics, Frankfurt, Germany. At Sanofi, Hanno is working at the R&D interface using biophysical and biochemical approaches for the development of biotherapeutic drugs. During his postdoctoral time at the Goethe University Frankfurt, Hanno investigated inhibitor binding and optimization against multidrug antibiotic efflux pumps. In 2013 Hanno received his PhD in Structural Biology from the University of Manchester, UK, in which he elucidated reaction mechanisms of Vitamin B12 dependent enzyme systems using X-ray crystallography and biophysical approaches.

Chair, Chemical and Biomolecular Engineering, Catherine and Henry Boh Professor of Engineering, Tulane Brain Institute Faculty Member
Anne Skaja Robinson joined the faculty at Carnegie Mellon in November as Head of Chemical Engineering. She has several patents and over 85 publications in the areas of protein (re)folding and aggregation, protein biophysics, and protein expression of therapeutically relevant protein molecules, and has graduated 23 PhD students to date. Her honors include a DuPont Young Professor Award, a National Science Foundation Presidential Early Career Award for Science and Engineering (PECASE) Award, and she is a fellow of the American Institute for Medical and Biological Engineering and the American Institute of Chemical Engineers.

Scientist
Dave joined Genentech in October, 2013 and is the leader of the Pharmaceutical Development Automation Group which supports the biological formulation development process. As part of this role Dave was responsible for defining the laboratory automation strategy and is currently focused on efforts to develop actionable miniaturized stability testing workflows. Prior to working at Genentech, Dave was a Senior Scientist at OTRADI in Portland Oregon where we worked with multiple biotech startups to apply high throughput and high content screening approaches to diverse focus areas ranging from optimization of bacterial protein expression to small molecule regulation of protein folding. Dave earned his PhD in Chemical Biology from UC San Francisco and a post-Doc at St. Jude Children’s Research Hospital with Dr. Kip Guy. During his career Dave has personally conducted multiple high throughput screening campaigns in excess of 1.5 million data points in both in-vitro biochemical and whole cell assay systems. He also got to play with lots of robots and continues this activity at Genentech.

Senior Scientist, Global Protein Sciences, AbbVie Bioresearch Center
Silvino “Serry” Sousa is a Senior Scientist that heads the expression scale-up laboratory in AbbVie’s Global Protein Sciences Department in Worcester, MA and is responsible for production of antigen and therapeutic proteins to support discovery research. He has a Bachelor of Science degree in Biological Sciences (Gordon College) and a Master of Science degree in Molecular Biology (State University of NY at Albany). Serry has nearly 25 years of industry experience working very closely with discovery project teams in areas of molecular biology, protein engineering, gene expression and protein production as well as stable cell line generation.

Professor and Head, Protein Science
Professor Ståhl took a PhD in biochemistry 1992 and has since then acted as research leader at the Dept. of Protein Science, KTH, where he was appointed professor in 1999. Between April 2000 and Dec 2002 he acted as Chief Scientific Officer at Affibody AB, still retaining PhD students and research activity at KTH. Prof. Ståhl is cofounder of the biotech companies Creative Peptides AB (1996), Affibody AB (1998), Visual Bioinformatics AB (1999), Atlas Therapeutics (2010) and Amylonix AB (2018). He is the inventor of > 20 patents, has published more than 190 scientific articles in international peer-reviewed journals, has > 11,000 citations, 57 as h-index and has supervised > 25 PhD students to their dissertation.

AVP, Protein Science
Gary Starling is AVP, Protein Science, for Merck Research Labs, based in the San Francisco Bay Area. He hails from Christchurch New Zealand, where he studied NK cell and dendritic cell biology. Gary’s Biopharmaceutical career has focused on Biologics Discovery and Early Development, working for Bristol-Myers Squibb, CuraGen Corporation, PDL BioPharma (which became Facet Biotech prior to acquisition by Abbott Labs, now AbbVie). He Joined Merck in 2012 and currently has responsibilities for advancing the implementation novel therapeutic modalities across the Merck Network.

Assistant Professor, Pharmaceutical and Biomedical Sciences
Dr. Strauch recently joined the Dept. of Pharmaceutical and Biomedical Sciences at the University of Georgia as an Assistant Professor where she is working on the design of therapeutic proteins and methods to design better immunogens. She has substantial experience in protein engineering, both applying and developing directed evolution and computational protein design methodologies focusing on the generation of targeted protein-protein interactions and de novo scaffolding proteins. Her achievements have included the generation of self-assembling trimeric protein designs that efficiently neutralize the Influenza virus and the design of the first conditionally binding protein design that enables pH dependent binding to the constant region of antibodies.

Associate Professor, Bioengineering
Dr. Suh received her SB in Chemical Engineering from MIT in 1999 and a PhD in Biomedical Engineering from Johns Hopkins School of Medicine in 2004. She then completed a two-year postdoctoral fellowship in the Laboratory of Genetics at the Salk Institute for Biological Studies. She is currently the associate chair and associate professor of Bioengineering at Rice University located in Houston, Texas. Dr. Suh works at the interface of virology, synthetic biology, and protein engineering to investigate and create virus-based materials for biomedical applications. By manipulating the “inputs” and “outputs” of viruses, she endeavors to develop platform technologies that can be used as therapeutics for a broad range of human diseases. She was awarded the NSF CAREER Award and the MDACC Ovarian Cancer SPORE Career Development Program Award for her innovative work on reprogramming viruses as therapeutic platforms. Most recently, Dr. Suh was awarded the Outstanding New Investigator Award from the American Society for Gene and Cell Therapy. Her work is funded by the National Institutes of Health, National Science Foundation, and the American Heart Association.

Scientist II, Alzheimer’s Disease and Dementia Research Unit
I received my PhD in neuroscience from the University of Cincinnati where we utilized a variation of the Theiler’s virus model of multiple sclerosis to study the role of antigen-specific CD8 T cells in modulation of blood-brain barrier integrity. For my post-doctoral training I joined the laboratory of Denisa Wagner at Harvard Medical School to learn more about endothelial biology, innate immunity and hemostasis. Currently, I am at Biogen where my work is focused on understanding the underlying biology of vascular dysfunction in Alzheimer’s disease.

Life Scientist III, Advanced Solutions Group
Challise has over 18 years of hands-on laboratory experience in a wide range of applications, spanning the fields of molecular biology, protein biology, and biomedical research. Through both her bench and lab management experience in academic labs, biotechnology labs, and now in a unique sector at a government contractor, she has gained perspective on the strategies and skills required to manage an efficient laboratory. In her current role at Leidos, she has been a key team member on multiple corporate-level award-winning teams, supported research on high visibility government contracts, and co-authored multiple publications and a patent. Most recently, she was pivotal in the development of a cell free protein synthesis platform for end-to-end production of protein biologics and coordinated many members of a multi-disciplinary team for this effort.

Principal Scientist
George Svitel is a Principal Scientist at Merck in Pre-formulation Sciences, Kenilworth, NJ. George is currently working on the development of co-formulated products and his expertise is in protein biophysics and aggregate-sensitive techniques including analytical ultracentrifugation, light scattering and field flow fractionation. Before joining Merck he worked at Amgen, Thousand Oaks, CA in Process Development department and at the National Institutes of Health, Bethesda, MD. He received a PhD in bioengineering from Technical University, Bratislava, Slovakia.

Associate Professor, Department of Biochemistry and Molecular Biology
Dr. Takagi is an Associate Professor at Indiana University School of Medicine. He received a BS degree from Ibaraki University, a MS degree from The University of Tokyo, and PhD degree in biochemistry from University of Oklahoma. He conducted a postdoctoral research at the laboratory of Dr. Roger Kornberg (Nobel Laureate 2006) at Stanford University. Takagi laboratory is interested in understanding the mechanisms of assembly, structure and function of large multi-protein complexes – “molecular machines” – involved in eukaryotic gene regulation. His lab is particularly interested in development of new expression technologies, which enable productions of large and often problematic proteins and protein complexes for structural (x-ray crystallography, and cryo-EM), and functional studies.

Assistant Professor, Chemical Engineering
Phanourios Tamamis received his B.S. degree in 2006 and Ph.D. degree in 2010 from the Physics Department of the University of Cyprus, and was recognized as the top Cypriot undergraduate researcher in 2006. During his undergraduate, graduate and early-postdoctoral studies, he was supervised by Professor Georgios Archontis. After finishing his Ph.D. studies, from 2010 until 2012, Phanourios Tamamis served as a Postdoctoral Fellow at the University of Cyprus and as a Fulbright Scholar at the University of California at Riverside and Princeton University, under the co-supervision of Professors Dimitrios Morikis and Christodoulos A. Floudas. In 2013, he joined the lab of Professor Christodoulos A. Floudas at the Chemical and Biological Engineering Department of Princeton University as a Postdoctoral Research Associate. In 2015, he joined the Chemical Engineering Department of Texas A&M University as an Assistant Professor.

Head, TC Facility, Biochemistry
Dr. Rastislav Tamaskovic is head of TC facility at the Department of Biochemistry, University of Zurich. After completing PhD at the Paul Scherrer Institut (PSI), Switzerland, he joined as a postdoctoral fellow the Friedrich Miescher Institute (FMI) in Basel. Here he pioneered the work on tumor suppressor protein kinase NDR and postulated its function in cell cycle progression and mitotic exit network. He and his colleagues also unveiled ‒ based on studies with knockout animals ‒ the crucial role of PKB kinase in the maintenance of cell survival via counteracting p53-dependent apoptosis. In 2005, he joined Plückthun’s laboratory at the University of Zurich where he initiated the SCL project on next generation of tumor targeting of ErbB family receptors. Among other anti-tumor compounds, he and his coworkers invented the bispecific and biparatopic designed ankyrin repeat proteins (DARPins), a novel class of tumoricidal agents triggering a potent apoptotic response in ErbB2-overexpressing breast tumors.

Professor, Department of Chemistry & Biochemistry
Suresh Kumar studies the biomolecular interactions that make life possible. He and his research group work to decipher the underlying mechanisms involved in cell growth, cell differentiation and the onset of diseases such as Alzheimer’s, cancer and diabetes. A major project focuses on fibroblast growth factor, or FGF, a protein that plays a crucial role in wound healing. Kumar’s goal is to create new forms of FGF that will remain stable at room temperature, allowing this important protein to reach people in less developed parts of the world. He’s also working to design new anti-fungal, anticoagulant and anticancer drugs.

Principal Scientist, Biologics – Protein Technologies
Dr. Thomas has more than 12 years’ experience in biologics in the biopharma industry. She has experience in downstream purification and analytical characterization of a wide range of proteins, supporting both large and small molecule therapeutic development. Her work with bispecific modalities has included antibody-based formats as well as alternative scaffolds. Recently, she has led an initiative to couple a standardized biologics relational data model with a LIMS system to define, track and mine protein data from engineering design to final product quality.

Vice President and Head, External Research
Dr. Mei Mei Tian is a vice president and the head of external research at Bioasis Technologies, Inc. Dr. Tian has extensive experience working on brain delivery research in both academia and biotech. In the early years at University of British Columbia, she focused her work on melanoma malignancy and cellular uptake. Since joining the Bioasis team in 2012, she has been a significant contributor in the development and continued expansion of the proprietary blood-brain barrier technology, xB3. With her oncology and neurology background, she is a committed and driven individual with a passion for brain delivery research.

Vice President, Research
John Timmer is the VP of Research at Inhibrx, and leads single domain antibody discovery, protein engineering, and therapeutic strategy at Inhibrx. He has enabled many of Inhibrx’s therapeutic platforms, including the multi-valent immune agonists, the multi-specific checkpoint inversion, and tuned cytokines.

Senior Field Applications, Scientist
Hoang has over 20 years of experience working with ÄKTA™ systems and UNICORN™ software. Hoang worked for 10+ years in the biotech sector holding positions in preclinical research and process development. He has been with GE for 6 years providing customer training for the AKTA lab-scale systems and UNICORN software. Much of his work focuses on the introduction of automation, productivity and efficiency to protein purification using the AKTA systems.

CSO & CEO, R&D
Dr. Truong is a founder of Aridis and was elected CEO in 2014 after having served as the company’s Chief Scientific Officer since 2005. He has more than 20 years of experience in biopharmaceutical drug development. Having maintained a life-long interest in infectious diseases, he has focused on researching and developing innovative human monoclonal antibodies and vaccines designed to address life-threatening infections. His product development experience includes FluMist™, Synagis™ mAb and a number of other monoclonal antibody-based therapeutics. Dr. Truong is the principal architect of Aridis’ technologies, which includes a range of anti-infective products and pharmaceutical processing technologies. He received his PhD in Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine.

Associate Professor, Department of Chemical and Biological Engineering
My group is interested in controlling the movement of materials across biological membranes, with a goal of enabling and enhancing the production of pharmaceuticals, biofuels, and materials in microbes. Manipulating the transport of electrons, small molecules, and even signals across these cellular boundaries is a vital component of most synthetic biology applications, and we are developing the tools and methods to engineer membrane proteins and other protein superstructures to meet this grand challenge.

Vice President, Drug Discovery
Mihriban has over 15 years’ experience in antibody engineering and discovery and has successfully managed a number of internal and collaborative drug discovery projects to candidate selection. Prior to joining F-star, she worked in technology enhancement in Biopharm R&D at GlaxoSmithKline (GSK) and in the selection and optimisation of lead domain antibodies at Domantis. Mihriban holds a PhD in Biochemistry from University of Sussex, UK, and a BSc in Biology from Middle East Technical University, Turkey.

Professor, Department of Biotechnology
Susumu Uchiyama has been studied solution properties and structures of proteins for 20 years using various biophysical methods such as analytical ultracentrifugation, differential scanning calorimetry and mass spectrometry and so far, he has more than 180 publications in international journals. Recent scope of his study focuses on the rational formulation developments of therapeutic proteins and quantitative analysis of protein aggregates.

Postdoctoral Fellow
Performed doctoral studies at the University of Tartu, Estonia, in molecular virology during which established a novel HPV drug screening platform. Afterwards worked at Icosagen as a postdoctoral scientist where obtained training in cell line engineering and antibody discovery. In 2017 joined Dev Sidhu’s group at the University of Toronto where I have been establishing a pipeline for GPCR therapeutic antibody discovery.

Director, CHO Cell Line Development, The Novo Nordisk Foundation Center for Biosustainability
Bjørn Voldborg has more than 20 years of experience working with recombinant protein expression from both academic and industrial settings. Bjørn was team leader in the biotech company Pharmexa A/S, responsible for molecular cloning and expression of protein-based drug candidates. From this he went to the NNF Center for Protein Research at the University of Copenhagen as Head of the Protein Production Unit, and since 2012 Bjørn has been heading the CHO Cell Line Engineering project at the NNF Center for Biosustainability at the Technical University of Denmark, a project dedicated to the engineering of improved protein production cell factories.

Senior Manager, Technical R&D
Moritz von Stosch works as Senior Manager at Technical R&D of GSK Biologicals, Belgium. He is a process systems engineer by education with a Diplom in Chemical Engineering from the RWTH-Aachen University and PhD in Biochemical Engineering from the University of Porto. Before joining GSK, Moritz worked as a Lecturer at the School of Chemical Engineering and Advanced Materials at Newcastle University, where his research focused on the development of novel hybrid modeling methods and their application to enable more efficient process operation/design.

Associate Director, Vector Downstream Process Development
Yogesh Waghmare, currently heads downstream vector process development group at Bluebird bio. In this role, he is focused at developing LVV purification processes which can meet quality, robustness and demand. Prior to joining Bluebird bio, Yogesh was part of Sanofi-Genzyme where he played various roles including Manufacturing Sciences, Late stage process development and continuous chromatography development. His areas of expertise include next generation process development, process characterization and process modeling. Yogesh has a decade of experience in the industry and holds PhD in Chemical Engineering from Louisiana State University.

Head, Pharmaceutical Development Biologicals
As Head of Pharmaceutical Development Biologicals Kerstin is responsible for the early and late stage formulation and process, the parenteral primary packaging and parenteral combination product development of biologicals. She started her career 2000 at Boehringer Ingelheim and held several positions during this time.

Laboratory Head, Biologics Lead Optimization, Project Leader, Ophthalmology
Ernst Weber, Ph.D., is Laboratory Head at Bayer AG. After receiving his Ph.D. in Biochemistry from the University of Halle (Germany), he conducted his Postdoc work as an EMBO fellow at the MRC-LMB in Cambridge focusing on protein engineering. In 2008 he joined Bayer Innovation where he developed new HTS compatible molecular biology technologies with applications in the optimization of function and expression of single proteins or even complete enzymatic pathways. 2012 he moved to Bayer Pharmaceuticals and is here responsible for antibody optimization and a project leader in lung and inflammatory research. Since 2015 he coordinates the bispecific antibody platform.

Applications Team Leader USA
Thomas Weber, PhD, studied Molecular Medicine at the University of Erlangen, Germany and received his PhD in Molecular Imaging. Before and after a PostDoc at the UCSD, Thomas worked in the development of therapeutic antibodies at Roche and U3 Pharma. He went on to become an expert in the biophysical characterization of antibody binding properties at Dynamic Biosensors, where he now is the Applications Team Leader for all evaluation and customer projects in the USA.

R&D Scientist
Brian Webster is an immunologist and virologist with a long-standing interest in how immune signaling pathways can be repurposed to different ends, either unconsciously by viruses or consciously by people. He did his doctoral studies in the Gladstone Institutes at UCSF on viral competition in Hepatitis C virus infections, and postdoctoral work at the International Center for Infectiology Research in Lyon, France on the role of dendritic cells and interferon signaling in Dengue virus infections. During his tenure in the pharmaceutical industry, he has performed work on automated CAR-T production at Lentigen Technology with a focus on how native immune signaling affects CAR-T production and function.

Vice President, Research and Development
Dr. Welch received his PhD in 1996 for work in the laboratory of Dr. Michael Yarus at the University of Colorado at Boulder where he studied of the role of 23S ribosomal RNA in translation. From 1998 to 2002, Dr. Welch worked on development and application of directed protein evolution technologies at Maxygen. Subsequently, he held positions in protein engineering technology development at Kosan Biosciences and Applied Biosystems before joining DNA2.0 in 2007 as Director of Gene Design.

Senior, Application Scientist

Principal Scientist and Group Leader
Graduated in medical biochemistry at the Medical Faculty of Uppsala University in Sweden. Did post docs at the London Research Institute of Cancer Research UK and at the Gurdon Institute, University of Cambridge, UK. In 2013, moved to industry to Medimmune to work on novel format of biological drugs. Since 2015 leads the blood-brain barrier program at Ossianix.

Professor, Dept. of Molecular Medicine, Beckman Research Institute; Member, Cancer Immunotherapeutics Program, City of Hope Comprehensive Cancer Center
Dr. Williams received his PhD at Columbia University, developing solid state NMR techniques to measure protein dynamics. He went to EMBL Heidelberg as an Alexander von Humboldt Postdoctoral Fellow to learn crystallography, solving the crystal structure of Src kinase. He continued his postdoctoral studies at Columbia Presbyterian, focusing on structural and biochemical investigations of the dynein motor complex. He took his first faculty position at Thomas Jefferson, where he developed chemically-induced, molecular traps. There, he initiated his efforts to address the on-target, off-tissue toxicities of monoclonal antibodies. He moved to the Beckman Research Institute at City of Hope (in 2008) where he and his group continued protein engineering efforts to address adverse immune related side effects of immune checkpoint inhibitors. He and his group also discovered and subsequently developed the meditope technology. Through these efforts, he and his group has published, patented and spun out two biotech companies, Meditope Biosciences Inc. and Akrivea Therapeutics.

Principal Scientist
Andrew Wollacott, PhD, is currently a Principal Scientist at Visterra, Inc., a clinical-stage biopharmaceutical company. He has over 15 years of experience in biotechnology and protein engineering and design research. At Visterra, Dr. Wollacott leads a research team developing computational methods to support discovery of novel therapeutic mAbs. Prior to Visterra, Dr. Wollacott was the Lead of Protein Design at Monsanto, working on the design and engineering of anti-herbicidal enzymes and protein-based insect toxins for crop protection. As a post-doctoral fellow, Dr. Wollacott worked with Dr. David Baker at the University of Washington on development of methods for de novo enzyme design.

Senior Lecturer, Chemical and Biological Engineering
Dr. Tuck Seng Wong is a Senior Lecturer from the Department of Chemical and Biological Engineering at the University of Sheffield. He is leading a Biocatalysis & Synthetic Biology group in Sheffield and his key research focus is sustainable biomanufacturing using engineered enzymes or microbes. His passion in engineering of biology is inspired by his research supervisors and mentors including Prof. Frances Arnold (Caltech), Prof. Ulrich Schwaneberg (Bremen), Prof. Sir Alan Fersht (Cambridge) and Prof. Alexander Steinbüchel (Münster). Dr. Wong obtained his BEng in Chemical Engineer (1st class honour) from the National University of Singapore, followed by an MSc and PhD in Biochemical Engineering (special distinction) from the Jacobs University Bremen in Germany. He was a recipient of the MRC Career Development Fellowship and more recently the Royal Academy of Engineering Industrial Fellowship. He was also one of the 10 young academics appointed into the EPSRC Early Career Forum in Manufacturing Research in 2014 and a finalist of the Synthetic Biology Leadership Excellence Accelerator Program (LEAP) in 2015. He has published over 40 papers, mostly in the areas of protein engineering and synthetic biology.

Professor, Chemical & Biomolecular Engineering
David Wood is a Professor of Chemical and Biomolecular Engineering at The Ohio State University. He received his undergraduate degree from Caltech in 1990 with a double major in Chemical Engineering and Molecular Biology, and has worked on Neupogen® manufacturing at Amgen and downstream process development at Bristol Myers Squibb. He completed his PhD in 2001 at Rensselaer Polytechnic Institute, and held a previous faculty position at Princeton, where he received the NSF Career Award. He has significant expertise in protein purification using self-cleaving tag methods, and their potential applications in the biopharmaceutical industry.

Principal Scientist, Biomedicine Design
Liliana Wroblewska is a Principal Scientist leading Molecular and Synthetic Biology group at Biomedicine Design Department, Pfizer, Inc. She completed PhD training at the Georgia Institute of Technology, Atlanta, where she studied the landscape of physics-based force fields in the context of protein structure prediction. Then she moved to Ron Weiss's lab at MIT, Cambridge as a Postdoctoral Scholar to work in the field of mammalian synthetic biology. She worked on RNA-based regulation, engineering in vivo biosensors for interrogation of cellular states, and using synthetic biology to study transcriptional and posttranscriptional regulation in mammalian cells with the focus on cross-talk, insulation and orthogonality in complex cellular environments.

Scientist, Biochemical and Cellular Pharmacology
I graduated from Fudan University in China with a BS in Life Sciences, and then obtained my PhD degree in Biochemistry from University of Illinois at Urbana-Champaign. After my graduate study, I joined Trait Product Development at Dow AgroSciences where I developed a high-throughput LC-MS/MS screening platform to support stacked trait product development. I joined Amgen after two and half years at Dow Agro, working in Process Development. I was mainly responsible for developing and qualifying analytical methods for the characterization and release testing to support investigational new drug (IND) filings. Now I work at Biochemical and Cellular Pharmacology in R&D at Genentech.

Chief Executive Officer
Dr. G. George Wu is an experienced senior executive and scientist with proven track record in cancer cell biology, early stage cancer drug discovery and development, and antibody discovery. Dr. Wu is the CEO and founder of Amberstone Biosciences, an early-stage company located in orange county aiming to develop cutting-edge microfluidics based single cell technologies to sharply reduce the timeline for therapeutic antibody and TCR discovery. Dr. Wu held various positions as a scientist or senior executive with profit & loss responsibility in two biotech companies.

Principal Scientist
Sam Wu works in Biotherapeutics industry since 2001 and currently works at Janssen BioTherapeutics, Janssen R&D. Sam’s research interest is to explore structure-functional relationship of antibody and antigen. Sam leads a group for Epitope mapping of lead mAbs in Biologics Development Science. He also developed comprehensive approaches for epitope mapping of neutralizing monoclonal antibodies to understand the mechanism of actions.

CEO
Mingjie received his MSc degree in Computer Science from Western University in 2006 and received his MBA from Richard Ivey School of Business in 2016. He is currently the co-founder at Rapid Novor Inc. Prior to co-founding Rapid Novor, he was the Chief Operating Officer at a bioinformatics software company.

Staff Scientist, Group Leader, LMBB
Alexei Yeliseev is a Staff Scientist at the National Institute on Alcoholism and Alcohol Abuse, National Institute of Health. He heads the protein biochemistry group focusing on developing technologies for expression, purification, and functional and structural characterization of G protein-coupled receptors. In addition to his research work he serves as a member of editorial board of Protein Expression and Purification and Journal of Receptor, Ligand and Channel Research.

Scientist, Protein Technologies
Dr. Yin has over 8 years of experience working in mammalian cell culture and focusing on novel platform development. She worked at the Protein Technologies Mammalian Expression group at Amgen Massachusetts, supporting both large molecule and small molecule drug development. Prior to Amgen, she completed a postdoctoral fellowship in Dr. Michael J Betenbaugh's lab at Johns Hopkins University. She focused on cell line engineering, media supplement development and omics analysis in CHO cells. Dr. Yin did her doctorate at Chinese Academy of Sciences (Beijing).

Professor, Department of Pharmaceutical Sciences
Bruce Yu is Professor of Pharmaceutical Sciences and Director of the Bio- and Nano-Technology Center at the University of Maryland School of Pharmacy. His research interests include imaging agents, biomaterials, and noninvasive analytics. His current research focus is biomanufacturing and biopharmaceutical quality control. He received the 2004 Kimmel Scholar Award and the 2005 US Presidential Early Career Awards for Scientists and Engineers.

Technical Development Scientist
Jonathan Zarzar received his M.S. in Biomedical Engineering from the University of Southern California. Since 2009, he has worked within the Pharma Technical Development organization at Genentech supporting the development of multiple biologics. His current research interests include developing computational models to predict protein stability as well as molecule developability. In addition to his development responsibilities, he currently co-leads Genentech’s Process Development Rotational Program where he co-manages a group of 17 research associates and engineers.

Principal Scientist, Pharmaceutical Sciences
Dr. Jingtao Zhang is a principal scientist in the Department of Pharmaceutical Sciences of Merck Research Laboratories at West Point, Pennsylvania. Over the 10 + years’ industrial tenure, he has extensive experiences in diverse modalities including synthetic peptides, small molecules, synthetic conjugates, and oligonucleotides. His current role is in the preformulation and drug delivery research supporting the development of synthetic peptides, oligonucleotides, and small molecule therapeutics. He also co-leads a cross-functional technology development group to boost the biophysical characterization capability within Merck Pharmaceutical Sciences. His current research interest is in biophysical characterization, peptide aggregation, and drug delivery technology development. His past roles were in the formulation, biophysical characterization, and analytical testing of siRNA drug delivery systems to advance the clinical development of siRNA therapeutics. Prior to Merck, he received his PhD in Chemical Engineering from the University of Wisconsin-Madison in 2007. He published and presented more than 50 times in peer-reviewed journals and international conferences.

Senior Scientist, Preformulation
Jun joined Abbvie in 2016 and worked as a senior scientist in preformulation group to provide technical leadership and support in drug-like property characterization of various biomolecules to facilitate lead optimization, candidate selection, formulation development and process development. Prior to joined Abbvie, Jun had worked in Eli Lilly and Company for 5 years and mainly focused on biophysical characterization and formulation development. After obtained PhD degree in Biochemistry and Molecular Biology in University of Calgary in Canada, she did her postdoc study with Dr. Elizabeth Topp in Purdue University.

Associate Professor, Integrative Structural and Computational Biology
Dr. Zhang leads a multidisciplinary group working on chemical and structural biology of membrane proteins. Membrane proteins account for about one third of human genes and comprise more than 50% of human drug targets. Our laboratory develops novel methodologies and chemical tools enabling their structural and functional characterizations. A major interest is to study the interactions between membrane proteins and lipids that govern the protein stability and function. We are also interested in the development and discovery of small molecule therapeutics targeting membrane proteins of great biological and biomedical significance including transporters, GPCRs and channels. Towards this end, we have devoted efforts to solve membrane protein structures for drug binding and mechanistic studies. Developing synthetic methodologies to make biologically relevant molecules is another component of our laboratory.

Associate Director, Cell Culture & Fermentation Sciences
Jie Zhu is an R&D associate director in Cell Culture and Fermentation Sciences at Medimmune/AstraZeneca, where she currently leads a team of scientists responsible for generating clinical candidate cell lines to produce therapeutic proteins starting from vector engineering, cell line generation and characterization using CHO and NS0 host platform. Since joined Medimmune in 2005, she has held positions with increased level of responsibilities including developing and implementing novel technologies on protein expression, host cell line engineering and characterization to increase the predictability and efficiency of cell line development process. She received her BS from Fudan University in Shanghai, China and PhD from Harvard University School of Public Health, in Genetics and Cancer biology, followed by postdoctoral training at National Cancer Institute, NIH in the Experimental Immunology Branch.

Director, Cell Biology
Jonathan Zmuda, PhD is a Director of Cell Biology in the Life Sciences Solutions Group at Thermo Fisher Scientific in Frederick, MD (USA). Dr. Zmuda leads a team of scientists dedicated to developing new technologies for cell biology applications including protein expression, advanced cell culture and rare cell analysis. Dr. Zmuda received his PhD in Cell Biology from the University of Maryland, College Park and his undergraduate degree from Dickinson College in Carlisle, PA.

Professor, Department of Pediatrics, College of Medicine
My research program pursues two goals: to develop a better recombinant Adeno-associated virus (rAAV) vector for tissue-specific delivery of therapeutic transgenes, and to develop novel platforms for scaling up production of rAAV vectors for clinical trials. Over the last 27 years I received an extensive training in the field of gene therapy, served as a founding Director of the Vector Core Laboratory at the Gene Therapy Center of the University of Florida, and later established my own research laboratory at the UF Dept. of Pediatrics. My recent projects are related to the development of stealth rAAV vectors based on combinatorial capsid libraries and directed evolution of viruses of parent serotypes isolated from evolutionary distant reptilian species.

Distinguished Professor, Chemical Engineering
Dr. Andrew L. Zydney is currently Distinguished Professor of Chemical Engineering at The Pennsylvania State University, having served as Head of that Department from 2004-2014. Dr. Zydney is also Director of the newly formed Center of Excellence in Industrial Biotechnology at Penn State and the Bayard D. Kunkle Chair in Engineering. Professor Zydney is the Editor-in-Chief of the Journal of Membrane Science. Professor Zydney's research is focused on bioprocessing and membrane technology, with a particular emphasis on the use of membrane systems for the purification of biotherapeutics. He has published more than 200 articles on these topics, and is the most recipient of the Gerhold Award for Outstanding contributions to Separation Science and Technology given by the AIChE. He previously received the Excellence in Biological Engineering Publications Award from the AIChE.