Speaker Biographies

Jeffrey Ahlgren obtained his Ph.D. from the University of Illinois in Urbana-Champaign, where he studied the comparative biochemistry and physiology of antifreeze glycopeptides found in most Antarctic fish.  After graduation, he became a post-doctoral researcher in the Department of Biochemistry at Duke University in the laboratory of Dr. Robert Hill, where he studied glycosyltransferase enzymes associated with O-linked glycoprotein production.  He then joined the USDA’s Agricultural Research Service and worked at the National Center for Agricultural Utilization Research laboratory in Peoria, Illinois, where he studied bacterial fermentation of various polysaccharides.  He joined Wyatt Technology as an Application Scientist in 2002, and was based in the Santa Barbara headquarters of the company until 2019, when he relocated to San Diego, which is in the company’s Southwestern region.

• Characterization and Analytics for Cell and Gene Therapies

Dr. Allen has led antiviral therapeutic discovery, preclinical profiling, and GMP manufacturing efforts for fifteen years, including development of countermeasures against emerging biothreat pathogens. He currently heads development of SARS-CoV-2 neutralizing antibody therapeutics at Sorrento as well as development of oncolytic virus-based therapeutics for the treatment of solid tumors.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development
• Recombinant Protein Expression and Production

I have a BS in Pharmacological Chemistry from the University of California, San Diego and have been working in the industry for 10 years. I have a background with experience in Manufacturing, Process Development, Quality Control, and Analytical Development working on a range of different products including peptides, vaccines, liposomes, and biologics. My experience spans from early development through late-stage and commercial.

• Detection and Characterization of Particulates and Impurities

Rich Altman has 30 years of experience in protein expression and production. In early 2019, he joined Thermo Fisher Scientific as a Field Application Scientist. Previously, he worked for several pharmaceutical companies, including Amgen, Alexion, Bayer, and Upjohn, 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.

• Recombinant Protein Expression and Production
• Protein Purification and Recovery
• Cell Line Development Strategies

Dr. Bandaranayake received his PhD in Immunology from the University of Washington, Seattle. During his graduate studies he worked on the signaling pathways in B cell lymphoma and invented a lentivirus-based mammalian protein production platform called Daedalus. Soon after graduating, Dr. Bandaranayake was offered a Research Faculty position at Albert Einstein College of Medicine in New York where he built a high-throughput mammalian protein production platform for the discovery and development of therapeutic proteins. Dr. Bandaranayake was then recruited to the Fred Hutch (Seattle) as Director of Immunology and Automation for a therapeutic development program where he specialized in antibody discovery and development. His work on bispecific antibodies was licensed to Link Immunotherapeutics late in 2019. Dr. Bandaranayake is a co-founder of Link Immunotherapeutics and VP of Immuno-Oncology.

• Bispecific Antibodies and Combination Therapies

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.

• Protein Purification and Recovery

2015 – Sanofi – Biologics Research Protein Therapeutics ¦ 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

• Higher-Throughput Protein Production and Characterization

Dr. Blackstock is a Senior Scientist at Generation Bio, working on developing scalable cell culture processes for the manufacturing of non-viral gene therapy molecules. Prior to joining Generation Bio, he served as a scientist at the National Institutes of Health’s (NIH) Vaccine Production Program, where he focused on developing cell culture manufacturing processes for a variety of clinical vaccine molecules, including nano- & virus-like particles, fusion proteins, and mAbs. Dr. Blackstock received a Ph.D. in Chemical Engineering from the University of Delaware, and a B.S. in Chemical Engineering from the University of Alabama.

• Cell Line Development Strategies

Dr Boon received his Ph.D. in biochemistry at the University of Amsterdam. In 2003, he was one of the founders of Bioceros BV, now Polpharma Biologics, where he currently holds the position of CSO. In addition, he held positions as CSO for MacroZyme BV, 4AZA Bioscience NV, FF Pharma and VP preclinical for PanGenetics BV and Tanox. Dr Boon is an author of over 240 papers in international scientific journals in the field of medical biotechnology.

• Cell Line Development Strategies

George has a BS in chemistry and a PhD in Biochemistry. His graduate studies under Prof. Alan Marshall at Florida State University focused on development and optimization of hydrogen/deuterium exchange mass spectrometry to study protein-protein interactions. Shortly after he graduated, he joined the technical development group at Biogen in 2011 where his job responsibilities focus on the biophysical characterization of proteins and gene therapy products.

• Characterization and Analytics for Cell and Gene Therapies

Christopher founded Consulting on Advanced Biologicals Ltd at the end of 2009 in order to focus his activities within the Regenerative Medicine sector. Advbiols Ltd provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd, A Novartis Pharma AG Co. and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time Christopher was involved with National implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.

• Characterization and Analytics for Cell and Gene Therapies

Dr. Bunting joined Ipsen Bioinnovation as Director of Protein Sciences in 2018. Prior to working at Ipsen, Karen was a Science Director at Albumedix Ltd., formerly Novozymes Biopharma UK, heading the Molecular Biology and Fermentation department in R&D. Previously, she led a research team as a Wellcome Trust Career Development Fellow at the Institute of Genetics, University of Nottingham, following post-doctoral work at the Institute of Cancer Research in London. She obtained a B.Sc in Microbiology from Imperial College, London and carried out her Ph.D. studies jointly between the Crystallography department at Birkbeck College, London and the department of Medical Microbiology, Imperial College Medical School. Dr. Bunting has 25 years’ experience in the field of structural biology and the engineering of proteins, protein-protein and protein-DNA complexes, from protein design through molecule production to characterisation.

• Optimizing Biotherapeutic Discovery

Dr. Burgess-Brown is an Associate Professor and the Principal Investigator of the Biotechnology Group at the SGC, responsible for managing all biotech research for the Oxford site. Her team develops high-throughput screening processes from cloning to expression, purification, and mass spectrometry analysis of human proteins for structural and functional studies. Dr. Burgess-Brown obtained a First Class degree in Applied Biochemical Sciences from the University of Ulster in 1997, then worked as a molecular biologist for SmithKline Beecham. She received her Ph.D. in Molecular Microbiology at the University of Nottingham in 2001, and then moved back to industry to work on high-throughput cloning and validation of therapeutic cancer antigens for Oxford Glycosciences and subsequently, Celltech R&D.

• Higher-Throughput Protein Production and Characterization

Michael D. Burkart is currently, Professor in the Department of Chemistry and Biochemistry, University of California, San Diego, an Associate Director at the California Center for Algae Biotechnology and a Teddy Traylor Faculty Scholar. He holds a Ph.D. in Organic Chemistry from the Scripps Research Institute.

• Protein Purification and Recovery

Cesar Calero-Rubio, Ph.D., is currently a member of the Biologics Drug Product Development and Manufacturing group at Sanofi. He has more than 6 years of experience studying and developing formulations for biologic modalities, including poly-peptides, enzymes, nanobodies, fusion proteins, monoclonal antibodies, multi-specifics and genomic therapies. He leads and enables Drug Product development and manufacturing workflows for early and late-stage clinical programs. He received his Ph.D. in Chemical Engineering from the University of Delaware working with Prof. Christopher J. Roberts and is an active contributor to the scientific and industrial literature involving protein physical stability, molecular liabilities and developability assessments, in-use administration studies and protocol, long-term DP stability, and challenges in the manufacturing of biologic modalities.

• Detection and Characterization of Particulates and Impurities
• Protein Aggregation and Emerging Analytical Tools

Jen Carlstrom is a Senior Application Scientist in the Global Discovery Applications group at PerkinElmer.  She received her PhD in Chemistry (with an emphasis in Biochemistry) from the University of Colorado, Boulder in 2007. Prior to joining the PerkinElmer team in 2012, she was a postdoctoral researcher in molecular biology at the Universitat Wien in Vienna, Austria. Her current role is to utilize the PerkinElmer portfolio to develop new applications for drug discovery. 

• Characterization of Biotherapeutics

Dr. Richard Cavicchi earned his Ph.D. in physics at Cornell University, was a post-doc at AT&T Bell Labs, and then joined the research staff at the National Institute of Standards & Technology in 1989. His recent work has focused on relating orthogonal measurements of protein aggregates.

• Protein Aggregation and Emerging Analytical Tools

No bio available.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development

Henry Chiou is product development and business Director for Transfection and Expression within Cell Biology, Life Sciences Solutions at Thermo Fisher Scientific. He and his teams have developed products such as the Expi™ family of 293, CHO and Sf9-based expression systems, Lipofectamine™ 3000, and other Lipofectamine-family transfection reagents. Henry has authored multiple publications on mammalian transient expression and frequently teaches courses and lectures on this subject. Prior to joining Thermo Fisher, Henry worked in small to mid-sized biotech companies on non-viral gene therapy. Henry received his doctorate from Harvard University in Molecular Pharmacology, following which he completed a postdoctoral fellowship in viral expression systems at the University of Pennsylvania.

• Cell Line Development Strategies

Mark received his training from: BA Biophysics at UC Berkeley, PhD Biochemistry at University of Illinois Urbana-Champaign, and conducting postdoctoral work at ETH-Zürich and Biozentrum of University of Basel. His work experience has spanned from being an Organic Chemist at Microgenics developing chemical conjugation of enzymes; Chemistry Professor at Seton Hall University getting grants on prokaryotic membrane protein biochemistry; Research Investigator at Abbott Labs on Mammalian Membrane Protein Drug Discovery; Associate Director at Janssen Research and Development leading the Process Analytical Sciences Team responsible for clinical development of biotherapeutics, cell, and gene therapies. He is now CSO for Tavotek Biotherapeutics working on differentiated products for auto-immune and oncology diseases.

• Higher-Throughput Protein Production and Characterization

Dr. Danny K. Chou is a biopharmaceutical industry veteran with expertise in biopharmaceutical characterization, formulation development, and emerging technologies for protein aggregate/subvisible particle analysis. Currently, Dr. Chou is the Founder and President of Compassion BioSolution, a biopharmaceutical consultancy and Contract Development Service provider that serves clients throughout the world. Dr. Chou has over 20 years of experience in the pharmaceutical industry, both as a pharmacist and pharmaceutical scientist. Over the past 15 years he has led the development of formulations for numerous therapeutic modalities ranging from peptides, growth factors, mAbs, ADCs, and bispecific antibodies. Prior to starting Compassion BioSolution, Dr. Chou was a Senior Scientist and Group Leader at Gilead Sciences, where he successfully built up state-of-the-art analytical capabilities for the company and converted IV formulations of monoclonal antibodies to high concentration formulations that are more stable and can be easily administered by subcutaneous injection. Prior to this, Danny was employed by Genzyme and Amgen, where he played critical roles in drug product process development, manufacturing technical support, and pharmaceutical development. Since founding Compassion BioSolution, Danny has developed stable pharmaceutical dosage form for clients ranging from small start-up biopharmaceutical companies to Fortune 500 pharmaceutical companies. Danny received his PhD from the University of Colorado Center for Pharmaceutical Biotechnology under a NIH Fellowship and his PharmD from the University of Florida.

• Detection and Characterization of Particulates and Impurities
• Protein Aggregation and Emerging Analytical Tools

Dr. Clarke has over 15 years of experience developing enabling solutions to support cell and gene therapies. He is the Global Head of Cell Therapy at HemaCare, a leading provider of source material for clinical development and commercial manufacturing of cell-based therapies. His previous roles include Global Product Manager for Charter Medical's cell therapy and bioprocessing single-use systems portfolio and Director of Research and Development for BioLife Solutions. Dominic currently serves as the Co-chair for the International Society for Cell and Gene Therapies' Process and Product Development Committee with efforts directed towards translating research and process development from bench to clinic.

• Characterization and Analytics for Cell and Gene Therapies

Itzel received her B.Sc. degree in Chemistry from UNAM in 2013. She then joined the research group of Prof. Tuomas P.J. Knowles at the University of Cambridge, where she worked developing novel microfluidic tools for studying protein misfolding diseases. After her doctoral studies she moved to the group of Prof. Adriano Aguzzi at the University Hospital Zurich, Switzerland, where she was the recipient of a Swiss Excellence fellowship for postdoctoral researchers and of a Forschungskredit from the University of Zurich. In October 2020 she joined Novo Nordisk as an industrial postdoc, in collaboration with Prof. Paolo Arosio's laboratory at the Institute for Chemical and Bioengineering at ETH Zurich.

• Detection and Characterization of Particulates and Impurities

Bernardo leads application and business development at Halo Labs. Previously Bernardo was a Postdoctoral Associate at Cornell University, where he also obtained his M.S. and Ph.D. degrees in Mechanical Engineering. His wide range of technical experience includes particle analysis, detection and manipulation, drug delivery devices, microfluidics, nanophotonics and bioenergy production.

• Detection and Characterization of Particulates and Impurities

Dr. Daneman received his Bachelor of Science from McGill University in Montreal, Canada, majoring in Biochemistry. He then received his Ph.D in Developmental Biology from Stanford University, where he studied the molecular mechanisms that regulate blood-brain barrier formation in the laboratory of Dr. Ben Barres. Dr. Daneman then started his own lab as a Sandler Fellow at UCSF, before moving to a position as Assistant Professor in the departments of Pharmacology and Neuroscience at the University of California, San Diego, where he focuses his studies on understanding the molecular mechanisms that regulate blood-brain barrier (BBB) function during health and disease. In his lab, he uses a combination of cellular, molecular, and genetic approaches to understand the mechanisms of BBB formation and function, addressing important questions. The overall goal of his work is to elucidate these mechanisms, such that we will be able to develop therapeutics to modulate the barrier to treat neurological diseases. He has received a number of honors, including the Klingenstein-Simons Award in Neuroscience, the Rita Allen Foundation Milton E. Cassel Scholar Award, the AAA Young Investigator Award, and the ASPET Neuropharmacology Early Career Award.

• Biotherapeutic Targeting Strategies

No bio available.

• Characterization and Analytics for Cell and Gene Therapies

Dr. Desjarlais is the Senior Vice President, Research and CSO at Xencor, Inc. Since joining Xencor in 2001, Dr. Desjarlais has overseen the company’s engineering, discovery, and preclinical work on antibodies and other proteins. With his coworkers, Dr. Desjarlais has developed several novel technologies for the optimization of antibodies and other proteins, including a platform for generation of bispecific antibodies, and has led the discovery of multiple therapeutic antibody candidates, including CD3 bispecific antibodies, checkpoint bispecific antibodies, and cytokine-Fc fusions for treatment of a variety of diseases. Dr. Desjarlais oversees all of Xencor’s discovery research and preclinical activities, from project conception and candidate generation through preclinical proof-of-concept and early development. Prior to Xencor, Dr. Desjarlais was an Assistant Professor of Chemistry at Penn State University (1997-2001), where he developed and tested methods for the de novo design of protein sequences. He began his work in the field of protein design as a Jane Coffin Childs Fellow at UC Berkeley. Dr. Desjarlais holds a PhD in Biophysics from the Johns Hopkins University and a BS degree in Physics from the University of Massachusetts, Amherst.

• Bispecific Antibodies and Combination Therapies

Scott K. Dessain is an American oncologist, research scientist, who is a professor at Lankenau Institute for Medical Research and an attending medical oncologist at Lankenau Medical Center, both in Wynnewood, Pennsylvania.[1] He also is co-founder and chief technology officer of Immunome, Inc., a biotechnology company in Philadelphia specializing in development of native human cancer antibodies targeted against cancer antigens. Dessain developed a technology that caused cells to glow, which had been licensed for use by others.

• Biotherapeutic Targeting Strategies
• Optimizing Biotherapeutic Discovery

Dr. Dror is an Associate Professor of Computer Science in the Stanford Artificial Intelligence Lab, where he leads a research group that uses molecular simulation and machine learning to elucidate biomolecular structure, dynamics and function, and to guide the development of more effective medicines. He collaborates extensively with experimentalists in both academia and industry. Before joining Stanford, Dr. Dror served as second-in-command of D. E. Shaw Research, a hundred-person company. He earned graduate degrees in Computer Science and Biology at MIT and the University of Cambridge.

• Biotherapeutic Targeting Strategies

Dr. DuBridge received his BA in Biology from the University of California at San Diego and his PhD in Genetics from Stanford University. After completing his postdoctoral studies at Genentech, Dr. DuBridge was one of the founding scientists of Cell Genesys, Inc. where he was responsible for setting up systems to create genetic knockouts in primary human cells. He later became the Director of the Massively Parallel Signature Sequencing (MPSS) project at Lynx Therapeutics and his group was responsible for setting up the first next generation sequencing platform. Dr. DuBridge led the New Technologies and Antibody Engineering groups at Eos and then PDL Biopharma, during this time his group humanized numerous therapeutic antibodies and developed a new antibody engineering platform called PxP. In 2010 Dr. DuBridge founded Full Spectrum Genetics to develop a novel, high throughput mutation profiling system to create detailed structural maps of protein binding sites. In 2015 FSG developed the S4 system for rapidly creating affinity matured antibodies from selected single substitution CDR libraries. Later that year Harpoon Therapeutics licensed the S4 technology and Dr. DuBridge joined Harpoon to help engineer inherently active bispecific T cell engagers. Maverick was spun out of Harpoon to develop conditionally active bispecific T cell engagers in 2017 with funding from Takeda Pharmaceuticals. Currently Dr. DuBridge is CTO and EVP of Research at Maverick Therapeutics.

• Biotherapeutic Targeting Strategies

Franck Duong is professor in the Department of Biochemistry, University of British Columbia, Canada. He obtained is PhD at the University of Marseille, France. His research focus on the cell membrane system, with interest in translocases, ABC transporters and other membrane receptors. His laboratory has expertize with membrane mimitics nanodiscs, detergent, and SMA polymers. His laboratory recently developed the peptidisc, for rapid and efficient incorporation of membrane proteins in detergent-free nanoparticles.

• Protein Purification and Recovery

Dr. Durocher obtained his Ph.D. in Biochemistry at the Université de Montréal. He joined the NRC in 1995 to work on the production of membrane receptors and recombinant proteins for various industrial partners involved in drug discovery projects. He manages a section of 30 scientists and 4 Ph.D. students involved in protein expression and stable CHO cell line development for internal projects and external clients. His research activities focus on improving large-scale transient gene expression (LSTGE) platforms using HEK293 and CHO cells for r-protein production, and on developing and engineering stable CHO pool and clonal cell line platforms for r-protein manufacturing. Dr. Durocher is also an Assistant Professor at the Département de biochimie et médecine moléculaire at the Université de Montréal.

• Cell Line Development Strategies

Pierre-Olivier has developped his career in France and Switzerland.

He has a PhD in Plant Molecular Biology and Virology and wide experience in characterization of Endogenous Retroviruses present in the Chinese Hamster Ovary (CHO) cell lines.

• Recombinant Protein Expression and Production

RheoSense in-house rheologist, Dr. Stacey Elliott, obtained her extensive experience and rheological knowledge through her education at Carnegie Mellon University and Princeton as well as her experience at both Alcon and DuPont. She has a passion for rheology and believes it is essential for any material. 

• Protein Aggregation and Emerging Analytical Tools

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 and has more than 20 years’ experience of developing antibodies for immunotherapy of cancer. Dr. Ellmark´s research interest is focused on developing mono- and bispecific antibodies, in particular CD40 targeting therapies, for tumor directed immunotherapy of cancer.

• Bispecific Antibodies and Combination Therapies

Dr. Esposito is currently the Director of the Protein Expression Laboratory (PEL) and Project Lead for the RAS Reagents Core at the Frederick National Laboratory for Cancer Research in Frederick, Maryland. The 33 employees in the PEL clone, express, and purify proteins from a variety of host organisms in support of the NCI RAS Initiative and for investigators at the National Institutes of Health. In addition, the PEL invents and develops novel technologies for improving protein expression and production, focused heavily on baculovirus expression technology and combinatorial cloning. Prior to his role as director, Dr. Esposito led the Clone Optimization Group in the PEL for nine years and was responsible for the generation of over 15,000 expression clones, 400 new expression vectors, and several technological innovations in protein expression. Dr. Esposito received his B.A. in Chemistry at La Salle University in Philadelphia, and his Ph.D. in Biochemistry in the laboratory of Dr. John Scocca at the Johns Hopkins University Bloomberg School where he studied bacteriophage site-specific recombination. Dr. Esposito then worked as a postdoctoral fellow in the laboratory of Dr. Robert Craigie at the NIDDK, where he studied the protein-DNA interactions involved in the HIV integration reaction. Prior to joining the FNL in 2001, Dr. Esposito worked for three years as a Staff Scientist in the Protein Engineering group at Life Technologies, where he helped to develop the Gateway recombinational cloning system. Dr. Esposito has published more than 70 peer-reviewed manuscripts in the fields of protein expression and DNA recombination.

• Recombinant Protein Expression and Production
• Protein Purification and Recovery
• Cell Line Development Strategies

Dr. Fischer is currently the Head of Cell Biology in the Bioprocess Development Biologicals department at Boehringer Ingelheim. From 2017 to 2019, he led the Cell Line Development lab in the Contract Manufacturing Business Unit at BI. Before joining BI, he worked with Novartis Pharma in Basel, Switzerland. He studied Pharmaceutical Biotechnology (B.Sc) and Biomedical Engineering (M.Sc), and holds a Ph.D. in Pharmaceutical Biotechnology from Ulm University as a Fellow of the International Graduate School in Molecular Medicine Ulm. Dr. Fischer has authored more than 30 publications in peer-reviewed scientific journals and 3 book chapters, mainly in the field of cell line development and cell line engineering. Furthermore, he is an active reviewer for the journals Nature Metabolism, Biotechnology & Bioengineering, Biotechnology Journal, and Biotechnology Progress.

• Recombinant Protein Expression and Production

Sarel Fleishman is an associate professor at the Weizmann Institute of Science, where his research team develops a computational protein-design methodology to address challenges in biochemistry and protein engineering. As a postdoc with David Baker in Seattle (2007-2011), Sarel developed the first accurate methods for designing protein binders, culminating in the design of broad-specificity influenza inhibitors. At the Weizmann Institute (2011-), his team developed protein design methods to the level of accuracy and reliability required to design large and complex proteins such as enzymes, antibodies, and vaccine immunogens — a protein that was designed in the Fleishman lab has recently been approved for mass production as a vaccine for malaria. The team recently developed a fully automated method, called PROSS, for dramatically improving the stability and expressibility of recalcitrant proteins and several design methods for improving affinity, specificity, and catalytic rates in antibodies and enzymes. Current focuses include developing methods for designing large repertoires comprising millions of enzymes or antibodies for one-shot isolation of highly active, specific, and stable binders, inhibitors, or enzymes. Among Sarel’s academic awards were the Clore Ph.D. Fellowship (2003-2006), the Science Magazine award for a young molecular biologist (2008), a postdoctoral fellowship (2006-2009) and a career-development award (2012-2015) from the Human Frontier Science Program, European Research Council Starting and Consolidator Grants (ongoing), the Alon Fellowship, the Henri Gutwirth Prize, and the Weizmann Scientific Council Award.

• Higher-Throughput Protein Production and Characterization

Dr. Ayano Fukuhara is currently the president of U-Medico Inc. which is a spin-off CRO company of Osaka University in Japan. She received her Ph.D. in Applied Life Science from Osaka Prefecture University in 2012. Prior to joining U-Medico, she had about 5 years of experience at Nippon Boehringer Ingelheim Co., Ltd. Her area of expertise includes formulation development and analysis for biopharmaceuticals.

• Characterization of Biotherapeutics

Upon finishing his studies in Pharmaceutical Sciences, Dr. Furtmann pursued his interdisciplinary Ph.D. thesis in Computational Life Sciences and Pharmaceutical Chemistry at the University of Bonn, focusing on computer-aided design, synthesis, and biological evaluation of protease inhibitors. After starting his professional career at Merck KGaA as Principal Scientist, he joined Sanofi in 2016 as Lab Head for Bioinformatics within the Biologics Research department. Currently, Dr. Furtmann is heading the Data Science & Computational Design group to support the discovery of next-generation protein therapeutics.

• Optimizing Biotherapeutic Discovery

Raja Ghosh obtained his doctorate degree in Engineering Science from Oxford University, United Kingdom. He is currently Professor of Chemical Engineering at McMaster University, Canada. His research interests are primarily in the areas of equipment design and process development for membrane and chromatographic separations. Application areas that interest him include purification and analysis of protein biopharmaceuticals, membrane bioreactors for mammalian cell culture, and water treatment. He has authored two books, Protein Bioseparation Using Ultrafiltration and Principles of Bioseparations Engineering, and has published over 130 research papers. His awards and accolades include a Commonwealth Scholarship and a Canada Research Chair position.

• Protein Purification and Recovery

I am currently leading the recombinant protein production efforts of the RAS Initiative at the Frederick National Laboratory in Frederick, MD.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development

Dr. Victor Greiff is Associate Professor for Computational and Systems Immunology at the University of Oslo. His work focuses specifically on the development of machine learning, computational and experimental tools for the analysis, prediction and engineering of adaptive immune receptor repertoires.

• Optimizing Biotherapeutic Discovery

Dr. Griffiths has worked as a virologist for more than 20 years. He earned his Ph.D. from the University of Cambridge, UK and performed post-doctoral work at Harvard Medical School. He started his own group at Texas Biomedical Research Institute in San Antonio, where he gained an interest in Risk Group 3 and 4 viruses that require high and maximum containment. In 2018 he moved to Boston University and the National Emerging Infectious Diseases Laboratories. Most of his group's research is focused on understanding the pathogenesis of these viruses to permit development of vaccines and therapeutics, which are tested in a variety of models. Since the start of the SARS-CoV-2 pandemic, they have pivoted to support mitigation efforts. These have included development of assays to quantify immune responses, evaluation medical countermeasures in vitro and in animal models, and assessments of inactivation methods.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development

Soleil Grisé is an Application Specialist at Nicoya, a biotechnology company specializing in Surface Plasmon Resonance (SPR) platforms. Her interest in life sciences and finance led her to pursue a BSc from the University of Waterloo and CFA level 1. Soleil is passionate about leveraging technical information to develop products that accelerate scientists' research. Her diverse background inspires a comprehensive perspective to provide strategic solutions to leading biotechnology and pharmaceutical organizations.

• Higher-Throughput Protein Production and Characterization

Harsha Gunawardena obtained his Ph.D. from Purdue University where his thesis research was carried out in advanced multi-source ion traps to facilitate the manipulation, reactivity (ion parking) of gaseous ions. He was a post-doctoral fellow at the Lineberger comprehensive cancer center, at The University of North Carolina at Chapel Hill, where his research focused on developing and refining quantitative platforms to support investigators in large-scale proteomics studies in the basic sciences to clinical research. He was a co-investigator for the National Cancer Institute’s Clinical Proteomics Tumor Analysis Consortium (CPTAC) and was a member of UNC ENCODE consortium. He has over 100+ research publication and proceedings and 3 patents. His industry career as scientist started at Bayer Health Care providing mass spectrometry and bioanalytical support of plasma-based therapeutics. He later worked at Amgen applying proteomics methods to support biomarker programs in discovery. His current role at Janssen R&D uses mass spectrometry to support discovery and early development programs.

• Cell Line Development Strategies

Andrew Hanneman, Ph.D. is Scientific Advisor at Charles River Laboratories Biologics Testing Solutions in Shrewsbury, Massachusetts. Dr. Hanneman has been an Analytical chemist specializing in biological molecules for over 30 years, with more than 15 years’ experience in biotherapeutic protein characterization using mass spectrometry. Dr. Hanneman has led groups specializing in glycoprotein analysis and conducted projects with diverse range of large molecules at various biopharma companies in the Greater Boston area.

• Characterization of Biotherapeutics

Dr. John E. Harlan is a Principle Research Scientist in Pharmaceutical Discovery at AbbVie, Inc., located in North Chicago, Illinois. As part of Protein Sciences in Global Biologics Research, his work involves the production and characterization of protein therapeutic candidates across multiple therapeutic areas. In addition, his lab is actively exploring next-generation antibody-drug conjugation technologies. Prior to joining the Pharmaceutical Products Division of Abbott Laboratories as a staff scientist, Dr. Harlan did his post-doctoral training with Steve W. Fesik in the Structural NMR department at Abbott Laboratories. He received his Ph.D. degree in Biochemistry from the Department of Biochemistry and Molecular Biology at the University of Chicago. For his doctoral work, he studied hydrodynamics and ligand interactions of prostaglandin H2 synthase 1 with Dr. R. Michael Garavito. Dr. Harlan received a BA in Biology and Chemistry from Alma College, Alma, Michigan.

• Higher-Throughput Protein Production and Characterization

Andrea Hawe is Co-founder and Chief Scientific Officer of Coriolis Pharma, a science-driven contract research organization, supporting drug product development of biopharmaceuticals (protein, peptides, oligonucleotides ATMPs, vaccines, etc.), with focus on formulation development, lyophilization technologies, and analytics (GMP and non-GMP). Dr. Hawe received her Ph.D. degree in Pharmaceutical Technology from the Ludwig Maximilian University of Munich, Germany in the field of protein lyophilization and formulation. Prior to founding Coriolis Pharma in 2008, she worked as a postdoctoral 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 50 articles in peer-reviewed journals.

• Detection and Characterization of Particulates and Impurities
• Characterization of Biotherapeutics

Elizabeth Hecht joined the Department of Microchemistry, Proteomics & Lipidomics in Genentech in 2018. She obtained her MS in food chemistry and PhD in analytical chemistry from North Carolina State University. She works on native and top-down mass spectrometry research projects in the areas of structural biology, antibody therapeutics, and new biotherapeutic modalities.

• Biotherapeutic Targeting Strategies
• Characterization and Analytics for Cell and Gene Therapies
• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development
• Higher-Throughput Protein Production and Characterization
• Detection and Characterization of Particulates and Impurities
• Bispecific Antibodies and Combination Therapies
• Protein Aggregation and Emerging Analytical Tools
• Recombinant Protein Expression and Production
• Protein Purification and Recovery
• Optimizing Biotherapeutic Discovery
• Cell Line Development Strategies
• Characterization of Biotherapeutics

Dr. Heidaran joined PAREXEL International as Vice President of Technical in December of 2018. He has close to 9 years prior experience as a Biologist and as a Master Reviewer in OTAT, and as a facility reviewer and inspector in the Division of Manufacturing and Product Quality (DMPQ). During his tenure at OTAT, in addition to his review responsibilities, he also served as Acting Team Lead and Branch Chief briefly and as a DCGT representative to several FDA and CBER wide working groups and outside organizations such as USP. He has also been involved in various standard development activities, cell-based product manufacturing initiatives and various compliance activities. Mo is currently member of USP Bio3 Complex Biologic Expert Committee, ISCT Legal and Regulatory Affairs Committee and contributor to the A-Gene Project sponsored by the Alliance for Regenerative Medicine (ARM). Dr. Heidaran has a multidisciplinary academic and industrial background in basic and applied cell biology and innovative cell therapy and tissue engineering product development. He also has hands-on industrial experience in manufacturing of cell therapy and tissue engineering products for about 15 years in small and large size Biotech companies. His long lasting scientific interest is to understand the molecular control mechanisms that regulate growth and differentiation of stem cells in the three-dimensional microenvironments. He is also founder and first chair of prestigious Gordon Research Conference in “Signal Transduction by Engineered ECMs.” Mo received his formal training at the National Cancer Institute where he served as a Senior Staff Scientist for about 6 years and 3 years as an IRTA fellow studying signal transduction by receptor tyrosine kinases. Dr. Heidaran holds a Ph.D. in biochemistry from the University of South Carolina, and received his formal training at the National Cancer Institute. Prior to FDA, he served as R&D Director at both Celgene and Becton Dickinson. He has been an ad hoc reviewer and member of editorial boards of several peer reviewed publications. He also holds 25 issued patents and 54 pending patents and his work has appeared in more than 50 scientific publications.

• Characterization and Analytics for Cell and Gene Therapies

Andrew Henry studied with Professor Tony Rees at the University of Bath, using homology modeling to help reduce the immunogenicity of therapeutic antibodies. This work continued at Oxford Molecular and Millennium Pharmaceuticals. Andrew has worked for Chemical Computing Group customer support group since 2003 and is now a Principal Scientist, focusing on the biologics field.

• Optimizing Biotherapeutic Discovery

Louis Hersh received a Ph.D. in Biochemistry from Brandeis University, where for his thesis he elucidated the mechanism of action succinylCoA-acetoacetate transferase. Following a postdoctoral stint at the NIH, where he studied one-carbon metabolism, he joined the faculty at UT Southwestern. He left UT Southwestern to chair the Department of Molecular and Cellular Biochemistry at the University of Kentucky. His laboratory is currently studying peptidases and their role in diabetes and Alzheimer’s disease. He also heads the Protein Core at the University of Kentucky, which among other services, is involved in nanobody production.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development

Kevin Heyries, Ph.D. is the co-founder of Vancouver-based AbCellera and has led the development of AbCellera's antibody discovery platform that combines proprietary immunizations, microfluidics, high-throughput imaging, genomics, deep computation, artificial intelligence, and automation. Dr. Heyries has led antibody discovery programs and now leads the company’s business development and strategy activities.

• Optimizing Biotherapeutic Discovery

Dr. Ho is a Senior Investigator, the Deputy Chief of the Laboratory of Molecular Biology, the Head of the Antibody Therapy Section, and the Director of the Antibody Engineering Program at the National Cancer Institute (NCI). He received his PhD from the University of Illinois at Urbana-Champaign, where he generated anti-idiotypic antibodies as cocaine antagonists. He completed a postdoctoral fellowship with Ira Pastan at the NIH, where he engineered immunotoxins targeting CD22 and mesothelin for the treatment of B cell leukemias and mesothelioma. Dr. Ho's laboratory at the NCI has been studying the biology of cancer driven by cell surface proteins, such as glypicans (e.g. GPC3, GPC2) as a new family of tumor antigens, in broad scientific fields of molecular and cellular biology with a focus on ligand/receptor interactions, Wnt/Yap signaling, antibody and protein engineering, structure biology, functional genomics, and cancer immunotherapy.

• Optimizing Biotherapeutic Discovery

Mark Howarth has been a group leader in Oxford University Department of Biochemistry since 2007. In 2017 he spun-out the company SpyBiotech, applying peptide superglue to enhance vaccine development, and was awarded the Royal Society of Chemistry Norman Heatley prize. He did postdoctoral studies at MIT with Alice Ting, where he developed monovalent streptavidin and single molecule probes for tracking neurotransmitter receptors. His doctoral work was with Tim Elliott at Southampton University on MHC class I-peptide quality control. His current work is on innovating ultra-stable protein interactions through engineering of bacterial peptide superglues. These tools are being applied to diagnostic devices, enzyme organization, and immuno-engineering.

• Protein Purification and Recovery

Steven Huhn is molecular and cell biologist focused on application of bleeding edge technologies to improve existing platforms. Steven completed his PhD in 2015 under the guidance of Dr. Zhiyuan Shen in the Cancer Institute of New Jersey. His research demonstrated the importance of DNA repair and mitotic proteins responsible for genomic integrity. Following graduation, Steven characterized novel CRISPR technologies for Cell Line Development purposes at Bristol Myers Squibb. Currently, Steven is focused on evaluating novel sequencing, genome engineering, and genomic characterization technologies in the context of bioproduction and cell therapy at Merck, under the guidance of Dr. Zhimei Du.

• Cell Line Development Strategies

Dr. Ippolito initially studied physics at Reed College before completing training in B-cell immunology at The University of Alabama at Birmingham, The University of Cologne (Germany), and The University of Texas at Austin. He is Research Assistant Professor at UT Austin in Molecular Biosciences where he spearheads antibody technology development and the investigation of human immunity.

• Optimizing Biotherapeutic Discovery

Anass Jawhari holds a Ph.D. in Biochemistry and Structural Biology from Louis Pasteur University (Strasbourg, France) and an HDR (Habilitation to Supervise Research) from the Sorbonne University (Paris, France). He worked as a researcher at the IGBMC (Illkirch, France), the Scripps Research Institute (La Jolla, US), and at the Gene Center (Munich, Germany) before joining Transgene as Research Investigator, CALIXAR as Head of Structural Biology/Business Development Manager, and finally, Chief Scientific Officer in charge of technology platform development, internal pipeline execution, and pharma project coordination, in addition to serving as Business Development Executive. Dr. Jawhari enjoys being at the interface between science and business, as well as between fundamental research and drug discovery. He has over 20 years’ experience in Research & Development projects, dealing with infectious diseases, oncology, and CNS disorders. He is an expert on macromolecular assemblies of soluble (transcription machinery) and membrane proteins (GPCR, ion channels, transporters). He is also a member of different membrane proteins consortia (GPCR and ion channels), and serves as Advisor for different biotech/pharma and Editorial board member of different world-leading journals, such as Nature Research. Dr. Jawhari is passionate about science and delighted to design and apply new tools to enable drug discovery of challenging MP targets for unmet medical needs. He is thrilled to provide support and assistance to pharma/biotech drug discovery scientists as an independent consultant.

• Biotherapeutic Targeting Strategies

No bio available.

• Bispecific Antibodies and Combination Therapies

Dr. Joshi is Faculty (Instructor) in the Department of Medicine at Brigham and Women’s Hospital, Harvard Medical School, Boston, USA. After obtaining his Ph.D. degree from Indian Institute of Technology Bombay, India in 2013, he did his postdoctoral fellowship at Brigham and Women’s Hospital, where his work was focused on the development of inflammation-responsive drug delivery systems for multiple therapeutic applications. Dr. Joshi’s prime research focus is drug delivery and biomaterials. Technologies developed by Dr. Joshi have been patented, published, and licensed to 2 different startups in Boston (Alivio Therapeutics and Frequency Therapeutics)--one already advancing through Phase 2 trials. In 2012, he was recognized by MIT’s Technology Review Magazine (TR35) as being one of the top innovators and was also awarded the prestigious Lockheed Martin India Innovation award for his work. Dr. Joshi’s work has been highlighted in multiple media outlets and scientific journals around the world, including The Economist, Science Daily, Journal of American Medical Association (JAMA), Fierce Biotech, Medical Xpress, and Nature Reviews Rheumatology.

• Biotherapeutic Targeting Strategies

Stefanie Kall is the Product Marketing Manager for the Prometheus line of instruments from NanoTemper. She formerly worked as their Applications Specialist in the Midwest region. She received a biochemistry PhD from University of Illinois in Chicago for her work characterizing inhibitors for kinases via X-ray crystallography. She also has a MSc in Biotechnology from Northwestern and a BSc from (The) Ohio State University in Biochemistry.  

• Characterization of Biotherapeutics

Cavan received his Ph.D. in Pharmaceutical Chemistry from the University of Kansas under the supervision of Professor David Volkin. After completing his Ph.D., he pursued a postdoctoral research fellowship in the Polymers and Complex Fluids group at the National Institute of Standards and Technology under the guidance of Dr. Steven Hudson. Currently, Cavan leads a scientific group within Late Stage Formulation Sciences at AstraZeneca.

• Protein Aggregation and Emerging Analytical Tools

Dr. Karanicolas is a Professor of Molecular Therapeutics at Fox Chase Cancer Center. He was granted a Ph.D. from The Scripps Research Institute in 2003, for his work using molecular dynamics simulations to study protein folding. He then moved to a postdoc at the University of Washington, where he studied protein design and added a wetlab component to his research. He started his lab at the University of Kansas in 2008, focusing on developing structure-based approaches for modulating protein function using small molecules. He moved his lab to Fox Chase in 2016 to pursue translational applications of his research.

• Biotherapeutic Targeting Strategies

Dennis Karthaus achieved his Master's degree in Biotechnology at the University of Applied Sciences Bremerhaven. In 2012, he joined IBA and became responsible for protein production in mammalian cells. Over the years, he has been leading many research and development projects in the field of protein expression, purification, and assays. Currently, he is also doing his Ph.D. in collaboration with the Institute of Technical Chemistry of the Leibniz University Hannover. Since May 2019, he has been leading the Protein Products and Assay department at IBA.

• Protein Purification and Recovery

Elizabeth Kellogg is an Assistant Professor in the Department of Molecular Biology and Genetics. The Kellogg lab uses single-particle cryo-electron microscopy to determine the structures of proteins that ar important for genomic organization and integrity.

• Optimizing Biotherapeutic Discovery

Dr. Kemp is the Director of Process Development at ViaCyte, working to characterize and optimize the manufacturing process of an innovative stem cell-derived product aiming to treat diabetes. With a passion for biology and technology, as well as a proficient understanding of cGMP and regulatory requirements, she has had a strong career focus on scaling up cell production processes and implementing process improvements. She earned her Ph.D. in Developmental Biology from the Free University of Brussels, Belgium, and continued her training as a postdoctoral fellow at the Salk Institute for Biological Studies in La Jolla, CA, focusing on the transcriptional regulation of human pluripotent stem cells. She has led process development teams for cell-based products at Shire, Stemedica Cell Technologies, and Vital Therapies.

• Biotherapeutic Targeting Strategies
• Characterization and Analytics for Cell and Gene Therapies
• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development
• Higher-Throughput Protein Production and Characterization
• Detection and Characterization of Particulates and Impurities
• Bispecific Antibodies and Combination Therapies
• Protein Aggregation and Emerging Analytical Tools
• Recombinant Protein Expression and Production
• Protein Purification and Recovery
• Optimizing Biotherapeutic Discovery
• Cell Line Development Strategies
• Characterization of Biotherapeutics

Andrew Kennedy is the Global Product Manager for the Peptides Business of Gyros Protein Technologies and an experienced process development peptide chemist. After completing his PhD in Organic Chemistry at the University of Glasgow under the supervision of Professor Graeme Cooke, he then went on to specialize in Peptide Chemistry Process Development and Manufacturing with a major peptide manufacturer. He has also held several senior scientist positions in the medical devices field focusing on verification and validation of novel medical devices and release of products to market. Currently, Dr Kennedy specializes in novel peptide synthesis applications and development of automated SPPS technologies with Gyros Protein Technologies.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development

Professor, Rizwan Hasan Khan has received his Ph.D. in Biotechnology from Aligarh Muslim University, Aligarh, India during the period of 1992-1996. Currently he is working in the area of protein structure, function, protein misfolding / aggregation and amyloid induction and inhibition at Aligarh Muslim University. Basically my research is focussing on many aspects of protein misfolding and aggregation such as designing suitable molecules for inducing aggregation in proteins to understand the mechanism of protein aggregation, to find out the molecular mechanism of toxicity of protein aggregates using neuronal cell lines and animal models, to find and synthesize new suitable drug molecule for the treatment of debilitating protein aggregation diseases. We had published paper in journals like Scientific Reports, Biomacromolecules, Langmuir, PLoS ONE, Biochemistry, BBA, BBRC etc. He is in editorial member of several reputed journals including IJBM, Plos One, CPPS, JBB, Journal of Biophysics etc. He has worked with Prof. I.J.Goldstein at University of Michigan USA as BOYSCAST Fellow and with Prof. Steve Perkins at University of London as Commonwealth Fellow. He has guided 23 PhD thesis and completed 12 research projects. He had published around 285 papers in the journals of international repute with H index of 55 and total citation around 11076. His teaching interest is in the field of Biochemistry/Biotechnology for postgraduate. His two patents are under process. He is a task force member of DBT BUILDERS program. He is Fellow member of BRSI. He is also Member of Protein Society. International Comparative Research Base (2009-14) A Bibliometric Analysis National Science and Technology Management Information System (NSTMIS)Department of Science & Technology (DST) Ranked 3rd to our research group on the basis of publication.

• Protein Aggregation and Emerging Analytical Tools

I received my Masters degree in Organic chemistry in India. In addition, I obtained PhD degree in chemistry from University of Kentucky in 2010. Then I joined University of Minnesota for Postdoctoral training in the Department of Chemistry until 2012. I joined BioVision Inc where I built a team focused on designing, manufacturing and analytics for metabolic enzymes for commercial use. Then I pivoted to Gene Therapy when I joined Brammer Bio (now a part of Thermofisher Viral Vector Services) as principal scientist and led the team for developing analytical assays for viral vectors. Furthermore, in 2018, I joined Sangamo Therapeutics as a Senior Scientist for helping build analytical team on developing assays for viral vectors. I left Sangamo to join Asklepios Biopharmaceuticals (North Carolina) as the Director of Analytical Development but after a short duration, I rejoined Sangamo Therapeutics as an Associate Director where I am overseeing analytical development for early and late phase viral vectors.

• Characterization and Analytics for Cell and Gene Therapies
• Detection and Characterization of Particulates and Impurities

Dr. Kielczewska holds a Ph.D. degree from McGill University in Human Molecular Genetics. After her graduate studies, she joined the biotechnology company, Inimex Pharmaceuticals, where she co-discovered the mechanism of action of the lead molecule (now in Phase 3 clinical trials). Since 2011, she has been holding roles of increasing responsibility at Amgen British Columbia. She currently heads the Cell Sciences group, and leads a number of therapeutic and reagent antibody discovery programs utilizing in vivo and in vitro discovery technologies.

• Optimizing Biotherapeutic Discovery

Chava Kimchi-Sarfaty currently leads a group at the FDA within the Division of Plasma Protein Therapeutics, Office of Tissues and Advanced Therapies (OTAT) that investigates various blood coagulation factors with a specific focus on the genetic determinants of coagulation factor biosynthesis and structure. She is also the Acting Deputy Associate Director for Research of the Office. She reviews and chairs pre-INDs, INDs and BLAs for recombinant proteins and plasma derivatives products such as von Willebrand factor, ADAMTS13, factor VIII, FIX, thrombin and fibrinogen.

• Characterization of Biotherapeutics

Harald Kolmar is full professor at the Technische Universität Darmstadt, Germany where since 2005 he heads the Department of Applied Biochemistry. He holds a PhD and habilitation in biochemistry and molecular genetics from University of Tübingen and Göttingen. 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.

• Bispecific Antibodies and Combination Therapies

Edward Kraft is currently a Senior Scientific Manager and Team Leader at Genentech, with an extensive background in high-throughput protein purification systems and protein design. He has over 10 years of experience creating and contributing to workflows that rely on the collaboration of biology, automation, informatics, and vendors for effective solutions for protein production efforts. His experience covers all major protein expressions systems, and focuses on small-scale production and analysis of protein classes other than antibodies.

• Recombinant Protein Expression and Production

Joshua LaBaer is one of the nation’s foremost investigators in the rapidly expanding field of personalized diagnostics. His efforts focus on the discovery and validation of biomarkers — unique molecular fingerprints of disease — which can provide early warning for those at risk of major illnesses, including cancer and diabetes. Formerly founder and director of the Harvard Institute of Proteomics, LaBaer was recruited to ASU’s Biodesign Institute as the first Piper Chair in Personalized Medicine in 2009. The Virginia G. Piper Center for Personalized Diagnostics (VGPCPD) has a highly multidisciplinary staff of molecular biologists, cell biologists, biochemists, software engineers, database specialists, bioinformaticists, biostatisticians, and automation engineers. VGPCPD applies open reading frame clones to the high throughput (HT) study of protein function. In addition, his group invented a novel protein microarray technology, Nucleic Acid Programmable Protein Array, which has been used widely for biomedical research, including the recent discovery of a panel of 28 autoantibody biomarkers that may aid the early diagnosis of breast cancer. LaBaer earned his medical degree and a doctorate in biochemistry and biophysics, from the University of California, San Francisco. He completed his medical residency at the Brigham and Women’s Hospital and a clinical fellowship in oncology at the Dana-Farber Cancer Institute, both in Boston. He has contributed more than 150 original research publications, reviews and chapters. LaBaer is an associate editor of the Journal of Proteome Research, a recent member of the National Cancer Institute’s Board of Scientific Advisors, Chair of the Early Detection Research Network Steering Committee and recent president of the U.S. Human Proteome Organization.

• Cell Line Development Strategies

Dr. Lee is a Professor in the Department of Biological Sciences at KAIST (http://bs.kaist.ac.kr/~acelab/). He is also Scientific Director at the Section for CHO Cell Line Engineering, Novo Nordisk Foundation Center for Biosustainability, DTU. Dr. Lee received his B.S. and M.S. degrees in Chemical Engineering at Seoul National University, and Ph.D. degree in Chemical Engineering at the University of Michigan. He joined KAIST in 1991. He has co-authored 248 research articles, currently serves as an Editorial Board Member for major biotechnology journals, and has served as an industrial consultant and collaborator to numerous biotechnology companies on CHO cell culture engineering for therapeutic protein production.

• Cell Line Development Strategies

Jae Seong Lee is currently an Assistant Professor in the departments of Molecular Science and Technology and Applied Chemistry & Biological Engineering at Ajou University, South Korea. Dr. Lee earned his B.S and Ph.D. in Biological Sciences from KAIST, South Korea. His research has focused on the genetic and metabolic engineering of mammalian cells, particularly CHO cells, for high-level production of recombinant proteins. His current research interests are development of efficient, mammalian genome editing technologies and rational design of various mammalian cells, using synthetic biology approaches.

• Cell Line Development Strategies

Dr. Lemos Duarte has training in molecular modeling, proteomics, biochemistry, cell biology, and molecular pharmacology. During her work as a Ph.D. student, she found that kinases recognized a consensus site formed by distinct non-contiguous parts of the folded substrate protein. These findings have received significant recognition, as evidenced by the cover art of her first author publication. During Dr. Lemos Duarte’s first postdoc at Ludwig Institute of Cancer at the University of California, San Diego, she acquired skills in genome editing technology. These skills allowed her to deeply examine the specific signal transduction pathways in mitotic cell-cycle progression and chromosome segregation. Currently, Dr. Lemos Duarte is engaged in several different projects of high disease relevance, including Alzheimer’s Disease, substance abuse, and addiction. Her findings have started to receive wide attention, as seen from a number of invitations to scientific meetings and publications in high-impact journals. Most recently, Dr. Lemos Duarte wrote an article detailing the fundamental mechanisms of how different drugs of abuse act.

• Biotherapeutic Targeting Strategies

Dr. Lewis is an Associate Professor of Pediatrics and Bioengineering at the University of California, San Diego. He received his BS in biochemistry at Brigham Young University, and his PhD at UC San Diego, where he focused on proteomics and developing novel approaches for analyzing biological big data using genome-scale systems biology modeling techniques. Dr. Lewis completed his postdoctoral training at the Wyss Institute at Harvard Medical School, where he worked on genome editing and the use of systems biology for the interpretation of genetic screens. Dr. Lewis' lab integrates all of his previous work by focusing heavily on the use of systems biology and genome editing techniques to map out and engineer the cell pathways controlling mammalian cell growth, protein synthesis, and protein glycosylation.

• Cell Line Development Strategies

Jonathan F. Lovell is an Empire Innovation Associate Professor of Biomedical Engineering at the State University of New York at Buffalo. He received his PhD in Biomedical Engineering from the University of Toronto. Dr. Lovell’s work has been recognized with multiple awards including the NIH Early Independence Award (2013), the Biomedical Engineering Society Young Investigator Award (2015), the NSF CAREER award (2016), the Porphyrin Society Young Investigator Award (2018) and the Basic Research Award of the International Photodynamic Association (2019). Dr. Lovell’s research interests include developing new drug and vaccine nanoplatforms. Dr. Lovell has co-authored over 100 peer reviewed manuscripts.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development

Dr. Luo is currently a scientist at Amgen. She is involved in the extractables and leachables (E/L) program, associated with the compatibility and safety of single-use packaging, delivery systems, and manufacturing processes, and is author/co-author of papers related to impurity risk assessment of E/L from single-use systems in therapeutic proteins. Previous to this role, she worked as a Senior Scientist in Scientific and Laboratory Services at Pall Corporation. She obtained her Ph.D. in Chemistry from the University of Miami.

• Protein Purification and Recovery

Dr. Magee is the Director of Business Development for the Life Science division at Daylight Solutions and is working to deliver disruptive mid-IR sensor and microscopy tools into the biomedical and pharmaceutical markets.

Prior to joining Daylight, Dr. Magee worked in a variety of applications, sales and business development roles within the Life Sciences analytical and spectroscopic instrumentation sector including most recently with Protetin Simple and ThermoFisher Scientific.

• Bispecific Antibodies and Combination Therapies

Dr. Martin Ian Malgapo is currently a Biochemistry Postdoctoral Research Fellow at Cornell University. He graduated Magna Cum Laude with a B.S. in Chemistry from the University of the Philippines in 2010, with a specialization in synthetic organometallic chemistry. He then expanded his repertoire of scientific research skills by pursuing a Ph.D. in Chemistry at Cornell University, this time specializing in protein biochemistry, enzymology, and structural biology. Aside from carrying out laboratory research, Dr. Malgapo is passionate about mentoring and teaching undergraduate students and learning new skills to make him a well-rounded scientist.

• Recombinant Protein Expression and Production

R. Kenneth (Ken) Marcus is University Professor of Chemistry, starting his career at Clemson in 1986. Throughout his career, Marcus’ research group focus has been the development of novel chemical instrumentation. His current research program can be broken down to two, diverse fields of chemical analysis. In the first case, ionization sources based on microplasma technologies are being developed to deliver information on the elemental, isotopic, and molecular levels. The incredible versatility of the liquid sampling-atmospheric pressure glow discharge (LS-APGD) source is demonstrated through support of DTRA, NNSA, Oak Ridge National Laboratory, Merck Pharmaceuticals, Advion, the National Institute for Innovation in the Manufacture of Biopharmaceuticals (NIIMBL), and the Advance Mammalian Biomanufacturing Innovation Center (AMBIC). The second, diametrically opposite, focus is the use of capillary-channeled polymer fibers for the chemical separation of proteins. Here again, funding from diverse sources has included the National Science Foundation and Merck. Potentially most impactful has been a year-old collaboration with Dr. Terri Bruce (CLIF) using the fibers for the separation of exosomes; “the next big little thing.” Exosomes are integral components in intercellular communication, and thus the spread of disease, as well as potentially powerful biomarkers for clinical diagnosis and as biotherapeutic drug delivery vehicles. The same platform is also being developed for the purification of viruses which are important as well in clinical diagnosis and in the production of biotherapeutics. Marcus has been recognized through numerous awards at both the University, state, national, and international levels. He is a Fellow of four learned societies, the Royal Society of Chemistry (London), the American Association for the Advancement of Science, the Society for Applied Spectroscopy, and the National Academy of Inventors. He serves on the advisory boards of three international journals.

• Protein Purification and Recovery

Claire is the senior Research Software Engineer for the Oxford Protein Informatics Group (OPIG), the research group of Professor Charlotte Deane at the University of Oxford. She completed her DPhil in 2016 in the same group, on the topic of protein loop structure prediction, with a focus on antibody H3 loops. She continues to work in the field of antibody research, and is responsible for maintaining the tools and web servers of the SAbDab-SAbPred platform.

• Optimizing Biotherapeutic Discovery

Dr. Mason led research to develop transient expression systems in plants for robust production of recombinant proteins using geminiviral replicons. He directed research that developed a recombinant immune complex (RIC) vaccine for Ebola virus, and modular systems based on the Ebola RIC and hepatitis B core antigen virus-like particles (VLP) for display of heterologous antigens, showing immune synergy by co-delivery of RIC and VLP that display the same antigen.

• Recombinant Protein Expression and Production

He Meng is a Senior Scientist of Analytical Development at Sanofi Biologics Development. He is responsible for the development, qualification and validation of physicochemical analytical methods using an aQbD approach to support the release and stability testing of biologics in preclinical and clinical development, including antibodies, enzyme replacement therapies and gene therapies. He also serves as an analytical team lead for an early stage program and contributes to the preparation of CTD analytical sections for a late stage program for global regulatory filing.

• Detection and Characterization of Particulates and Impurities
• Characterization of Biotherapeutics

Dr. Tim Menzen is Chief Technology Officer (CTO) of Coriolis Pharma. He is a pharmacist by training, and received his Ph.D. in the group of Prof. Dr. Wolfgang Frieß at the LMU in Munich, Germany, where his research focused on temperature-induced unfolding, aggregation and interaction of mAbs, which resulted in three publications. In 2014, Dr. Menzen joined Coriolis Pharma, where he led formulation development projects for biologics for 3 years, and was involved in the implementation of novel technologies. In his current role as CTO, he is involved in internal research projects at Coriolis and in scientific relations, including collaborations with partners from industry and academia. He is also past Chair of the AAPS Biopharmaceutical Product Attributes and Biological Consequences (PABC) Community.

• Characterization and Analytics for Cell and Gene Therapies

Dr. Messing received his Ph.D from Johns Hopkins School of Medicine in 2008, studying structural biology in the lab of Mario Amzel. While in the lab, he solved the structures of viviparous14, a dioxygenase in maize and key enzyme in abscisic acid production, and the structure of the RNA, pyrophosphohydrolase BdRppH, from Bdellovibrio bacteriovorus involved in RNA decapping. He subsequently moved on to the Laboratory of Fred Dyda at NIDDK, where he worked on transposases and solved the structure of TnpA(REP) from E. coli. In 2015, he joined the Protein Expression Laboratory at Frederick National Labs, where he purifies difficult-to-produce protein reagents for the RAS Initiative.

• Recombinant Protein Expression and Production

Dr. Carl Mieczkowski has focused on biologics characterization and developability in industry for 12 years in both Discovery and Development. He has served at Janssen, Bristol-Myers Squibb, and Merck. Carl earned his Ph.D. in Chemistry at Berkeley studying Protein Kinase regulation using biochemical, mass spec, and crystallographic approaches. Carl also was a 2-time US finalist in International Latin dance.

• Protein Aggregation and Emerging Analytical Tools

Silvia obtained her BSc in Pharmacy (2003) and Ph.D. in Analytical Chemistry (2007) from University of the Basque Country (UPV/EHU, Spain), being her work focused on the development of LC-MS and GC-MS analytical platforms for the identification and quantification of environmental, pharmaceutical and nutritional significance compounds. On 2008 she joined Shirota Functional Foods S.L. company (Reus, Spain) working on the development of chromatographic techniques based on Mass Spectrometry for the identification and quantification of bioactive compounds in natural sources and biological samples with the aim to evaluate their health benefits. In September 2012, Silvia joined NIBRT becoming part of the GlycoScience and Contract Research teams as a postdoctoral researcher in the Mass Spec Lab and working on academic and contract research projects with Biopharma companies. In September 2016 I joined the Characterisation and Comparability Laboratory leaded by Jonathan Bones as an Applications Scientist to collaborate with Thermo Fisher Scientific on the development of new applications for the characterisation of biopharmaceuticals (monoclonal antibodies, fusion proteins, ADCs, etc) and the associated processes used for their production.

• Characterization of Biotherapeutics

Somaieh Mohammadi is a Staff Scientist at FUJIFILM Diosynth Biotechnologies, UK working in the Data Science group on Statistics and Computational Engineering. She obtained her PhD in Chemical Engineering from Newcastle University in 2014. Prior to joining FUJIFILM Diosynth Biotechnologies, she was a research associate in the School of Chemical Engineering and Advanced Materials, Newcastle University from 2014-2015.

• Protein Purification and Recovery

Prem Swaroop Mohanty is a Life Sciences Product Specialist and Product Marketing Manager at Benchling. He holds an MBA from UC Berkeley, a MS from U of Illinois, Chicago, and a B.Pharm from U of Mumbai. He has over 13 years of industry experience across biopharma R&D, strategy consulting, and software product marketing. Prior to Benchling, Prem was a Sr. Consultant at Navigant, a Scientist at Allergan, and Research Scientist at deCODE.

• Cell Line Development Strategies

Over 20 years of experience working in biotech, coordinating efforts focused on the discovery and development of novel biologic-based therapies. Began biotechnology career at Human Genome Sciences, where directed genomic-based target discovery programs and the preclinical development of various protein and mAb-based therapeutics for the treatment of cancer, metabolic, and autoimmune diseases. 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. At MacroGenics, 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. Obtained PhD from University of Glasgow and performed post-doctoral work at the Roche Institute of Molecular Biology; co-authored over 70 peer-reviewed manuscripts and 40 issued US patents.

• Bispecific Antibodies and Combination Therapies

Clayton Moore completed his Master’s of Bioinformatics at the University of Guelph where he developed a computational modelling protocol to analyze the structure and function of novel viral proteins. His data-driven mindset led him to Rapid Novor, where he is helping researchers better understand and characterize their most important proteins.

• Biotherapeutic Targeting Strategies

Haresh More is a Sr. Research Investigator at Bristol-Myers Squibb and works in Drug Product Development organization. His work at BMS is focused on late-stage formulation development and process development for biologics.

• Protein Aggregation and Emerging Analytical Tools

Liviu Movileanu has received his PhD degree in biophysics from the University of Bucharest (1997). He has acquired postdoctoral positions at the University of Missouri (Kansas City, Missouri, USA, 1997-1998) and the Texas A&M University Health Science Center (College Station, Texas, USA, 1999-2004). He is now a Professor at Syracuse University, Departments of Physics, and Biomedical and Chemical Engineering. Liviu Movileanu is also affiliated to the BioInspired Institute, Syracuse, New York. Currently, his research group is funded by the National Institutes of Health. His expertise areas include single-molecule and membrane biophysics, chemical and synthetic biology, bionanotechnology and nanomedicine, biosensors and functional biomaterials, biological statistics, and numerical analysis of stochastic biological processes.

• Higher-Throughput Protein Production and Characterization

Professor Munro is a Senior Group Leader at the Australian Institute for Bioengineering and Nanotechnology, The University of Queensland and Director of the NCRIS funded National Biologics Facility. His research is focused on the development, engineering and production of Biologics (complex, protein-based therapeutics) using mammalian cell culture systems. Prof. Munro is also Program Director of the CEPI funded Rapid Response Vaccine pipeline and in this role has been part of the UQ team developing a clinical stage vaccine candidate for COVID-19. Prior to this, he was Executive Director of Process Development at Amgen Inc., based in California where he led various activities spanning cell line development to biological characterisation and attribute sciences. Prof. Munro has a PhD in Protein Biochemistry from UQ and completed postdoctoral studies in cell biology and developmental genetics at the Department of Cell Biology, Harvard Medical School and the Wellcome Trust and Cancer Research UK Gurdon Institute, University of Cambridge.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development

No bio available.

• Characterization of Biotherapeutics

Dr. Nasr received his Ph.D. in Pharmaceutical Sciences from Northeastern University, and did post-doc fellowship training at Harvard Medical School. Currently, he's a group leader at Brigham and Women’s Hospital in the Renal and Engineering in Medicine divisions within the Department of Medicine.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development

Ho Leung Ng completed his BA at Harvard University, PhD at UCLA, and postdoctoral fellowship at UC Berkeley in the areas of structural biology and crystallography. After leaving UC Berkeley, Dr. Ng worked with Brian Kobilka at ConfometRx on GPCR crystallography. Dr. Ng then moved to the University of Hawaii as an Assistant Professor and later to Kansas State University as Associate Professor. His current research focuses on experimental and computational structure-based drug design for GPCRs, nuclear receptors, and kinases. Dr. Ng is also interested in applications of machine learning for chemistry and drug design.

• Recombinant Protein Expression and Production

Currently the Senior Vice President of Research and Translational Sciences at Xilio Therapeutic, Inc., Dr. O'Hagan was most recently at Merck Research Laboratories, where he led the Oncology Discovery program with responsibility for Translational Oncology. He was previously a founding scientist and research leader at AVEO Pharmaceuticals. Over 25 years in oncology R&D across industry and academia, he has helped to advance multiple biologics and small molecule programs through clinical proof of concept and approval.

• Biotherapeutic Targeting Strategies

After training in Viral Immunology at Imperial College London and the MRC Laboratory of Molecular Biology, Cambridge, UK, Ms. O'Rourke's major focus is expression of glycoproteins in mammalian cells for vaccine antigen development.

• Recombinant Protein Expression and Production

Erica Ollmann Saphire, PhD is a Professor of the La Jolla Institute for Immunology. Her research explains, at the molecular level, how and why viruses like Ebola and Lassa are pathogenic and provides the roadmap for medical defense. Her team has solved the structures of the Ebola, Sudan, Marburg, Bundibugyo and Lassa virus glycoproteins, explained how they remodel these structures as they drive themselves into cells, how their proteins suppress immune function and where human antibodies can defeat these viruses. A recent discovery revealed why neutralizing antibodies had been so difficult to elicit against Lassa virus, and provided not only the templates for the needed vaccine, but the molecule itself: a Lassa surface glycoprotein engineered to remain in the right conformation to inspire the needed antibody response. This molecule is the basis for international vaccine efforts against Lassa. Dr. Saphire was also the galvanizing force behind the Viral Hemorrhagic Fever Immunotherapeutic Consortium and is the Director of this organization. This consortium, an NIH-funded Center of Excellence in Translational Research, unites 44 previously competing academic, industrial and government labs across five continents to understand and provide antibody therapeutics against Ebola, Marburg, Lassa and other viruses. Dr. Saphire’s work has been recognized at the White House with the Presidential Early Career Award in Science and Engineering, with young investigator awards from the International Congress of Antiviral Research, the American Society for Microbiology, and the MRC Centre for Virus Research in the United Kingdom. She has been awarded a Fulbright Global Scholar fellowship from the United States Department of State and a Mercator Fellowship from Deutsche Forschungsgemeinschaft, to develop international collaborations using cryoelectron microscopy to further global health.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development

Dr. Shane Olwill has spent over 15 years in oncology focused drug discovery with a specific interest in the development of novel biologics. Shane leads the Pieris’ Translational Department where he is responsible for the development of a proprietary product pipeline of Next Generation Therapeutics across Immuno-Oncology and Respiratory Disease. This work includes the generation of tumor localized T cell agonists for oncology including PRS-343 a 4-1BB HER2 bispecific undergoing clinical evaluation and a panel of inhaled biologics for treatment of diseases such as Asthma and IPF. Prior to joining Pieris, Shane was Director of Research at Fusion Antibodies Ltd. He received his PhD in Molecular Hematology / Oncology from University of Ulster, UK.

• Bispecific Antibodies and Combination Therapies

Dr. Javin Oza is an assistant professor of Chemistry and Biochemistry at California Polytechnic State University (Cal Poly) in San Luis Obispo, CA. Javin received his Ph.D. from the University of California at Santa Barbara in Biomolecular Science and Engineering and completed his postdoctoral work at Northwestern University in Bioengineering. Javin works at the interface of biochemistry and biological engineering. Javin’s research group is motivated by the integration of hypothesis driven science and engineering-type thinking to is innovate ways to manufacture and engineer proteins through the use of cell-free systems.

• Cell Line Development Strategies

Dr. Anthony Partridge is a Senior Principal Scientist at MSD Singapore where he leads programs in the early discovery space. Previously, he was Senior Director of Biology at Pharmaron Beijing where he led a team focused on assay development/validation, screening, and built a world-class compound management facility. As an In Vitro Pharmacology Capability Lead at Merck, he pioneered collaborative efforts with pharmacology-based CRO partners. Prior to this, he was a Senior Scientist in the Pharmacology group at Merck Montreal. Dr. Partridge began his industry based career at Élan Pharmaceuticals in San Francisco. He received his B.Sc. from the University of Guelph (1998), his Ph.D. from the University of Toronto (2003) and completed post-doctoral training at Scripps/UCSD (2003-2006).

• Biotherapeutic Targeting Strategies

Dr. Paudel is a Product Development Scientist at ACROBiosystems. He obtained his PhD in Chemistry and Biochemistry from University of Delaware. His expertise is primarily in structure and chemical biology, proteomics and enzymology. 

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development

Anthony worked in the stem cell industry for several years developing methods for cellular reprogramming using mRNA overexpression approaches.  Anthony has been in the biotech industry for over 13 years prior to leading protein development at R&D Systems beginning in 2018.  He is focusing new product development on expanding R&D System’s portfolio of proteins for Immuno-Oncology, Regenerative Medicine, and most recently Coronavirus-related research applications.  

• Protein Aggregation and Emerging Analytical Tools

Theodore W. Peters, Ph.D. Senior Scientist, Bioprocess Development Ted has over five years of experience in the biopharmaceutical industry developing clonal CHO cell lines for the production of therapeutic antibodies. In his current role, Ted is interested in elucidating sources of genetic drift in CHO cells in an effort to identify cell lines that can maintain stable expression. Ted received his Ph.D. at the University of Colorado - Health Sciences Center and continued his training at the Buck Institute for Research on Aging as a postdoctoral scholar.

• Cell Line Development Strategies

Dr. Lee is a bioinformatician/data scientist with a decade of experience working in structural biology, protein modeling, protein-protein interactions, cytometry, and NGS. He leads protein design at Synbio Technologies, developing new platforms/methods in antibody discovery, NGS, and bioinformatics. He received a PhD degree (chemistry) from the University of Houston.

• Optimizing Biotherapeutic Discovery

Mike Piazza is a Systems Integration Manager at Nicoya, with proven expertise in improving R&D and decision making in the biotechnology sector. Mike acquired his PhD in chemistry from the University of Waterloo and has years of experience in leveraging SPR platforms to solve pain points of client’s research and drug discovery programs. At Nicoya, Mike identifies, confirms, and interprets performance issues related to individual assays and instrument modules.

• Higher-Throughput Protein Production and Characterization

I completed my Ph.D. at the Weizmann Institute of Science, Israel focusing on Vesicular Protein Trafficking. My postdoc work focused on protein folding and disulfide bond formation and reduction, with Prof. Jon Beckwith from Harvard Medical School. Following my postdoctoral, I took positions in the biotechnology/biopharmaceutical industry and worked in small and large-cap companies such as Amgen and Merck. In the last 3.5 years, I work with Applied Molecular Transport developing downstream processes for the company pipeline protein therapeutics. The company utilizes the E. coli to produce its proteins, which necessitate a unique downstream process involving inclusion body isolation, solubilization and refolding, by which restoring biological activity and efficacy. This work resulted in several patent applications. 1. Methods and Compositions for Protein Refolding and purification 2. Compositions, Formulation and Interleukin Production and Purification.

• Protein Purification and Recovery

Dr. Prajapati earned her Ph.D. degree in Pharmaceutical Chemistry at the University of Kansas. She currently holds a position as Scientist 1 at AstraZeneca PLC. Her research focuses on the effect of UV and visible light on proteins, and the role of protein- and buffer-derived radicals on degradation of polysorbate.

• Detection and Characterization of Particulates and Impurities
• Characterization of Biotherapeutics

Dr. Erik Procko leads an independent research team at the University of Illinois, Urbana-Champaign, investigating and engineering membrane protein systems through Big Data mutagenesis, structure-guided design and artificial evolution. His group has a strong interest in host-pathogen interactions, including how viral spikes engage their receptors and undergo structural changes. This work builds on Dr. Procko's post-doctoral research with David Baker at the University of Washington, where he computationally designed artificial proteins to inhibit viral factors. Prior to this, he completed his doctoral studies in 2008 at Harvard University investigating mechanisms for display of antigens to the immune system.

• Biotherapeutic Targeting Strategies
• Characterization and Analytics for Cell and Gene Therapies
• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development
• Higher-Throughput Protein Production and Characterization
• Detection and Characterization of Particulates and Impurities
• Bispecific Antibodies and Combination Therapies
• Protein Aggregation and Emerging Analytical Tools
• Recombinant Protein Expression and Production
• Protein Purification and Recovery
• Optimizing Biotherapeutic Discovery
• Cell Line Development Strategies
• Characterization of Biotherapeutics

Arvind Ramanathan is a computational biologist in the Data Science and Learning Division at Argonne National Laboratory and a senior scientist at the University of Chicago Consortium for Advanced Science and Engineering (CASE). His research interests are at the intersection of data science, high performance computing and biological/biomedical sciences. His research focuses on three areas focusing on scalable statistical inference techniques: (1) for analysis and development of adaptive multi-scale molecular simulations for studying complex biological phenomena (such as how intrinsically disordered proteins self assemble, or how small molecules modulate disordered protein ensembles), (2) to integrate complex data for public health dynamics, and (3) for guiding design of CRISPR-Cas9 probes to modify microbial function(s).He has published over 30 papers, and his work has been highlighted in the popular media, including NPR and NBC News. He obtained his Ph.D. in computational biology from Carnegie Mellon University, and was the team lead for integrative systems biology team within the Computational Science, Engineering and Division at Oak Ridge National Laboratory. More information about his group and research interests can be found at http://ramanathanlab.org.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development

Dr. 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. He holds a B.S. (2003) and M.S. (2004) in Biomedical Engineering from Northwestern University (Evanston, IL, USA). He completed his Ph.D. thesis at Ecolé Polytechnique Féderale de Lausanne (EPFL, Switzerland) in Bioengineering and Biotechnology (2008). Dr. Reddy did post-doctoral research at the University of Texas, Austin (2008-2011).

• Optimizing Biotherapeutic Discovery

Dr. Richardson is in the standards pipeline development group within global biologics at USP, leading efforts to develop standards for emerging technologies such as cell and gene therapy. In previous roles at Advanced BioScience Laboratories and Foundation Fighting Blindness, he led translational science activities for the development of vaccines and biologics to prevent and treat infectious diseases and retinal disease. Trained as a virologist, Jim has also held positions responsible for performing viral clearance testing at Viromed Biosafety and AAV vector development and characterization at Genovo/Targeted Genetics.

• Characterization and Analytics for Cell and Gene Therapies

Gabriel Rocklin did his Ph.D. research at the University of California, San Francisco, supervised by Brian Shoichet and Ken Dill. As a postdoctoral fellow with David Baker at the University of Washington, he pioneered the use of large-scale protein design to understand protein biophysics. In 2019 he started his independent lab in the Department of Pharmacology and Center for Synthetic Biology at Northwestern University. There, his group develops high-throughput methods to understand protein biophysics and to design new protein therapeutics.

• Higher-Throughput Protein Production and Characterization

Sara joined the Early Expression & Supply team at AstraZeneca in 2018. In this role, she is focusing on the development of a transient expression platform for biotherapeutics production. She has more than ten years experience in the R&D sector delivering publicly and commercially funded collaborative projects. Her main area of expertise is upstream process development and scale-up in both microbial and mammalian systems. She holds a PhD in Molecular Biology from the Spanish National Research Council (CSIC).

• Cell Line Development Strategies

My research interests lie in elucidating the mechanistic functional details of transmembrane and membrane-associated proteins. To date I have predominantly focused on membrane transporter proteins of the ABC superfamily (ATP Binding Cassette), and proteins involved in cellular trafficking, but recently I have expanded this to include secondary active transporters, tetraspanins, ion channels and GPCRs (G-protein coupled receptors). I am really keen to develop new methods and as such have played a major role in developing the SMALP (styrene maleic acid lipid particle) technology for membrane protein extraction, purification, structural and functional characterization.

• Recombinant Protein Expression and Production

Dr. Rue obtained her Ph.D. from Johns Hopkins University in Baltimore, MD, where she studied the assembly and budding of lentiviruses with Janice Clements. She then did a post-doc in Scott Emr’s lab at UCSD, where she characterized key proteins in the Multivesicular Body Protein Sorting Pathway. Dr. Rue joined the Antibody Therapeutics group at GNF in 2007, and while in that role, she and her team built workflows for automated protein production. She now manages the Advanced Automation Technologies group at GNF.

• Higher-Throughput Protein Production and Characterization

Dr. Karla Satchell is a Professor of Microbiology-Immunology at Northwestern University Feinberg School of Medicine since 2000. She is also the Principal Investigator for the NIAID-funded Center for Structural Genomics of Infectious Diseases, a multi-site center in high-throughput structure determination for microbial pathogens. In 2020, the Center dedicated significant resources to structural biology of SARS-CoV-2, including efforts to provide structural biology data to support development of novel drugs, vaccines, and therapeutics. Across all areas of research, she has published more than 100 research articles. She has also been elected as a Fellow for the American Academy of Microbiology and the American Association for the Advancement of Science.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development

Dr. Schöneich is the Takeru Higuchi Distinguished Professor and Chair in the Department of Pharmaceutical Chemistry at The University of Kansas. He received his Ph.D. in Chemistry in 1990 from the Technical University Berlin, Germany. Between 1987 and 1991 he worked in the Department of Radiation Chemistry at the Hahn-Meitner Institute in Berlin, Germany. 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 about 275 papers in the field of peptide and protein oxidation reactions.

• Detection and Characterization of Particulates and Impurities
• Characterization of Biotherapeutics

Dr. Preeti Sharma is a Postdoctoral Researcher in Dr. David Kranz’s laboratory in the department of Biochemistry at University of Illinois Urbana Champaign. Dr. Sharma works in the areas of protein engineering and cancer immunology. She has 10 years of experience in engineering immune receptors, and is interested in the development of these engineered receptors for diagnostic and therapeutic applications in cancer and autoimmune disorders. Dr. Sharma has a Ph.D. in Biochemistry from University of Illinois Urbana-Champaign. She has published 11 peer-reviewed scientific articles, and is co-inventor on patent applications that describe engineered chimeric antigen receptors targeting cancers with glycosylation defects.

• Biotherapeutic Targeting Strategies

Dr. Sheff completed his Ph.D. in Bioanalytical Chemistry at the University of Calgary, where he focused on developing hydrogen-exchange mass spectrometry techniques to improve the analysis of increasingly complex sample types and protein interactions. As a Research Associate and former post-doctoral Fellow, I continue to work in structural mass spectrometry at the National Research Council. Here, I am focused on understanding the mechanism underlying the delivery of therapeutic antibodies across the blood brain barrier. Additionally, I am also building up our structural proteomics toolbox for the characterization of antibodies and their interactions.

• Biotherapeutic Targeting Strategies

Dr. Shen is the Associate Director and Head of Process Development & Manufacturing at Bolt Biotherapeutics. She has served scientific leadership roles in Process Development and Manufacturing Science departments at various biotech companies, including XOMA, Bayer, BioMarin, and Grifols. She holds a Ph.D. degree in Chemical Engineering from University of California, Davis. Dr. Shen provides scientific and project management leadership with a specialty in recombinant protein and mAb conjugates process improvement, scale-up, technical transfer to bioprocess manufacturing internally and externally, and has had extensive CDMO management experience. She also has solid troubleshooting and problem-solving skills, and encourages contract manufacturers to deliver high efficiency and better quality under accelerated timelines.

• Protein Purification and Recovery

Anupam Singhal earned his PhD from the University of British Columbia and has over 15 years of experience in nanotechnology and microfluidics at UBC, the University of Toronto and Stanford University.  His work has been cited over 600 times and resulted in several patents for molecular disease diagnosis, antibody discovery, and development of production cell-lines for biologics. At Berkeley Lights, Anupam leads the development of next-generation platforms for the discovery and development of antibody therapeutics.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development

Ms. Siska is an Analytical and Formulation Biochemist with more than 20 years of biotech industry experience. She specializes in biophysical characterization and formulation development of various therapeutic molecules, including monoclonal antibodies, Fc-fusion constructs, and enveloped viral vaccines.

• Protein Aggregation and Emerging Analytical Tools

Dr. Skretas graduated from the School of Chemical Engineering at the National Technical University of Athens (Greece) in 1998 and received his Ph.D. in Chemical and Biological Engineering from Princeton University (USA) in 2006. He then moved on to the University of Texas at Austin (USA) to carry out post-doctoral research under the guidance of Professor George Georgiou. In 2010, he received a Marie Curie International Reintegration Fellowship to return back to Greece and the National Hellenic Research Foundation. Since then, Dr. Skretas has been Principal Investigator at the Institute of Chemical Biology, where he currently holds the rank of Research Associate Professor. He has recently been awarded with a Consolidator Grant by the European Research Council (ERC) to develop engineered bacteria that will function as a discovery platform for new drugs against diseases caused by protein misfolding and aggregation. Dr. Skretas is also Founder and Chief Executive Officer of ResQ Biotech, an early-stage drug discovery company established in 2019 at the Patras Science Park.

• Recombinant Protein Expression and Production

Dan joined Numab in 2019 and leads the Translational Science team. He began his career in industry at Oxford Glycosciences, UK in 2002 developing antibody based therapeutics in the field of Oncology. He then spent 7 years at Genzyme, a Sanofi company, where he helped to establish the antibody therapeutics group of Genzyme in Cambridge, UK. He led the protein engineering and molecular biology teams and was responsible for leading therapeutic programs in oncology and immunology. Dan moved to Switzerland in 2012 and worked for Molecular Partners as VP, Biology and led a team responsible for the preclinical biological characterisation of protein based therapeutics in immune-oncology, oncology, immunology and ophthalmology. He was also instrumental in collaborations with Roche, Janssen, Allergan and Immunogen. Dan holds a PhD in molecular immunology from the University of Reading, and performed a postdoc at the Department of Pharmacology at the University of Oxford, where he studied signaling pathways of platelet activation.

• Bispecific Antibodies and Combination Therapies

Peter Soler earned a Ph.D. from the University of California at Berkeley, and holds a B.S. in Chemical Engineering from Florida State University, Tallahassee, FL, with a double major in Biomedical Engineering and Biomedical Mathematics. Currently, Peter is the Automation Lead for Drug Product Development at Bristol-Myers Squibb. Peter was instrumental in designing the automated buffer exchange workflow for BMS and has been responsible for bringing the system into production. Peter oversees all automated drug product screening workflows for both small and large molecule and seeks to better digitize the information collected during the development of an asset. Peter is a champion of new technology and working with teams to usher in digital transformation.

• Protein Aggregation and Emerging Analytical Tools

With research background in the areas of baculovirus-insect cell technology, protein recovery and protein characterisation, Dr. Somasundaram has the knowledge and skills to work on both the upstream and downstream of protein production. As a Research Scientist at Pfizer Biologics Development Centre, he has developed robust downstream processes for biosimilars production. At the ARC Training Centre for Biopharmaceutical Innovation, he led a team of post-graduate students on developing continuous chromatography and membrane-based protein separation processes to improve production rate and reduce operational expenses. Currently, as the Strategy and Operations Manager at the Protein Expression Facility housed at the University of Queensland, he is leading the operations of the facility to ensure the highest level of efficiency in the provision of research services in recombinant protein production to advance academic and industry research.

• Recombinant Protein Expression and Production

Dr. Jamie Spangler earned a Bachelor of Science degree in Biomedical Engineering at Johns Hopkins University and went on to complete a PhD in Biological Engineering at MIT under the supervision of Professor K. Dane Wittrup. She conducted postdoctoral training in Professor K. Christopher Garcia’s lab at Stanford University School of Medicine, and then launched her independent research group at Johns Hopkins University in July 2017, jointly between the departments of Biomedical Engineering and Chemical & Biomolecular Engineering. Dr. Spangler’s lab, located in the Translational Tissue Engineering Center at the School of Medicine, applies structural and mechanistic insights to re-engineer existing proteins and design new proteins that therapeutically modulate the immune response. In particular, her group is interested in engineering immune molecules such as antibodies, cytokines, and growth factors for targeted treatment of diseases such as cancer, infectious diseases, and autoimmune disorders. Dr. Spangler’s work has been recognized with honors including a National Defense Science and Engineering Graduate Fellowship, a Leukemia & Lymphoma Society Career Development Fellowship, a V Foundation Scholar award, and a Maryland Stem Cell Research Fund Discovery award.

• Biotherapeutic Targeting Strategies
• Characterization and Analytics for Cell and Gene Therapies
• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development
• Higher-Throughput Protein Production and Characterization
• Detection and Characterization of Particulates and Impurities
• Bispecific Antibodies and Combination Therapies
• Protein Aggregation and Emerging Analytical Tools
• Recombinant Protein Expression and Production
• Protein Purification and Recovery
• Optimizing Biotherapeutic Discovery
• Cell Line Development Strategies
• Characterization of Biotherapeutics

Dr. Kuldip Sra has over 25 years been work experience in biotech and pharmaceutical industries. Currently, Dr. Sra is Executive Director, Late Stage Analytical Development at Crisper Therapeutics. Previously Dr. Sra has worked at Kite Pharma/Gilead where was Director of QC. Dr. Sra was involved in developing , validating analytical assays for lot release of Kite pharma’s autologous cell therapy clinical products and also in release of clinical lots. At Kite in QC labs, rapid analytical lot release methods were implemented to release drug product lots within 7 days. In the past, Dr. Kuldip Sra has worked at MedImmune/AstraZeneca Company for 15 yrs. Dr. Sra led Vaccine Analytical Development and Characterization group at MedImmune.

• Characterization and Analytics for Cell and Gene Therapies
• Characterization of Biotherapeutics

I have a B.S. in Biology from University of Massachusetts Amherst. I grew up in the Boston area and started my career at Millennium Pharmaceuticals in Cambridge, focused on mammalian cell expression. I subsequently moved to San Diego (Takeda California) and worked in a group entirely focused on protein production, both reagents and therapeutics. After a few years, I moved to Vancouver, BC where I currently work at Zymeworks in the Protein Engineering group. My current role is transient production of antibodies and other proteins, from high throughput to large scale.

• Recombinant Protein Expression and Production

Dr. Lawrence A. Stern is an Assistant Professor in the Department of Chemical and Biomedical Engineering at the University of South Florida. Dr. Stern earned his bachelor’s degrees in chemical engineering and chemistry from Virginia Tech in 2011 and his doctorate in chemical engineering from the University of Minnesota under the mentorship of Dr. Ben Hackel in 2017. He completed his postdoctoral training under the mentorship of Drs. Christine Brown and Stephen Forman in the T Cell Therapeutics Research Laboratory at City of Hope, where he was the recipient of a Postdoctoral Fellowship Award from the Tobacco-Related Disease Research Program of California. Dr. Stern’s research interests lie in developing novel protein selection methods and applying protein engineering principles to design ligand- and cell-based therapies to fight a variety of diseases. As a graduate student, he optimized and originated yeast surface display selection methods using mammalian cell monolayers directly as targets for isolating functional binding proteins and applied these methods to evolve a variety of non-antibody ligands for diagnostic and therapeutic use. During his postdoctoral studies, Dr. Stern applied his protein engineering knowledge to investigate the impact of various biophysical properties on chimeric antigen receptor activity, leading to the development of potent CARs with remarkably weak binding affinity. The Stern Lab now focuses on expanding these lessons to engineer new treatment strategies.

• Bispecific Antibodies and Combination Therapies

Lars obtained his PhD in virology at the Robert-Koch Institute (Berlin) and joined Glycotope already 15 years ago. He was responsible for different tasks as cell line engineering or project leader of the phase II clinical asset FSH-GEX®. For two years he headed the BD at Glycotope prior to become responsible for the service activities. At FyoniBio he heads the cell line development, process development and MS based analytical department.

• Cell Line Development Strategies

Dr. Takagi received his Ph.D. from Tokyo Institute of Technology in 1990. He then went on to become an Assistant Professor in the Department of Biological Sciences at the Tokyo Institute of Technology through 1998. In 1995-1996, he became a Visiting Research Fellow at Scripps Research Institute in La Jolla, CA. In 1998, Dr. Takagi became a Visiting Assistant Professor at the Center for Blood Research at Harvard Medical School and in 1999, an Instructor as well. Starting in 2002, he switched to the Department of Pediatrics as an Assistant Professor. In 2003, he returned to Japan as a Professor at the Institute for Protein Research at Osaka University. Then in 2017, he co-founded and became Director of MiraBiologics Inc.

• Characterization of Biotherapeutics

Sean Taylor holds a Ph.D. and an MBA from McGill University and has spent the past ten years publishing articles, providing seminars, workshops and training videos to help the global scientific community achieve excellent data from western blotting, qPCR and digital PCR experiments. He has managed teams of Field Application Scientists (FAS) in Canada for over a decade who have helped thousands of scientists achieve their research goals. In his current role as North American FAS Manager for GenScript, he leads a dedicated team to continue the tradition of providing pertinent and timely information to help the scientific community overcome research hurdles to accelerate the production of high quality, publishable data, cost-effectively.

• Higher-Throughput Protein Production and Characterization

Srivalli N. Telikepalli received a B.A. degree in Chemistry at Cornell University in 2008 and a Ph.D. in Pharmaceutical Chemistry from the University of Kansas in 2014. Her graduate work was focused on understanding the formation of protein aggregates/particles, their characterization, and their possible correlations to immunogenic responses. In 2014, she started working as a Research Chemist at the National Institute of Standards and Technology. She has contributed to the development of the NIST Monoclonal Antibody Reference Material and a subvisible protein-like particle reference material. Her work focuses on developing protein-like particle standards that enable more robust characterization of proteinaceous particles in biotherapeutics. She received a United States Department of Commerce Gold Medal Award in 2017 for her contributions.

• Detection and Characterization of Particulates and Impurities

Dr. Trinklein is the Chief Technology Officer at Teneobio. Teneobio employs a sequence-based approach for antibody discovery that leverages next-generation sequencing and high-throughput functionally assays to develop fully-human multi-specific antibodies. Prior to Teneobio, Dr. Trinklein was a co-founder of SwitchGear Genomics, a venture-backed company that was acquired in 2013. Dr. Trinklein served as the Technical Director of the Stanford ENCODE project and received his Ph.D. from Stanford University. Dr. Trinklein has published over 20 peer-reviewed papers and is an inventor on over 15 patents.

• Bispecific Antibodies and Combination Therapies

Mihriban has over 15 years’ experience in biologics drug discovery and development across biotech and pharma. She joined Adaptate from F-star where she was Senior Vice President of Drug Discovery, overseeing all internal and collaborative bispecific antibody programmes from concept through to candidate selection. Previously she held key scientific roles within antibody generation and technology development at Domantis and later in Biopharm R&D at GSK. She holds a PhD in Biochemistry from the University of Sussex and is currently studying for an executive MBA at the Judge Business School at the University of Cambridge.

• Bispecific Antibodies and Combination Therapies

Dr. Uchiyama, PhD, is Professor in the department of Biotechnology, Graduate School of Engineering, Osaka University, Japan, and is also currently Visiting Professor at Kyoto University and ExCELLS, Japan. His research topics are science-based engineering in the field of solution biophysics of protein and colloidal particles, especially by using various kinds of biophysical methods, such as analytical ultracentrifugation, mass spectrometry (especially native MS and HDX-MS), and calorimetry. His research interests include energetic understanding of immune-related proteins and virus vectors for gene therapy. Container closure system for biopharmaceuticals with better quality and more safety is also in his recent scope. He has published more than 200 peer-reviewed papers, including those in high impact journals, such as Nature and PNAS, and is on the Editorial Advisory Board for the Journal of Pharmaceutical Sciences. In addition, Dr. Uchiyama has received Young Investigator Awards from the Protein Society of Japan, and is a member of the organizing committee of the Protein Society of Japan and the project committee of the Japan Association of Animal Cell Technology.

• Protein Aggregation and Emerging Analytical Tools

No bio available.

• Optimizing Biotherapeutic Discovery

Dr. Van Deventer completed undergraduate studies at Stanford University, his Ph.D. at the California Institute of Technology, and postdoctoral work at the Massachusetts Institute of Technology. He is currently an Assistant Professor at Tufts University. The Van Deventer Laboratory works at the interface of protein engineering, synthetic biology, and chemical biology. Primary interests include engineering yeast to better accommodate alternative genetic codes, and engineering more “druglike” proteins using a combination of yeast display and noncanonical amino acids. In 2019, Dr. Van Deventer was awarded an R35 Outstanding Investigator Award for Early Career Researchers from the U.S. National Institutes of Health, and in 2020, he was named an “Emerging Investigator” by the journal, Molecular Systems Design & Engineering.

• Optimizing Biotherapeutic Discovery

Scientist with 12 years of experience in discovery and development of biotherapeutics for therapeutic and diagnostic applications.

• Characterization of Biotherapeutics

Dr. Vincentelli joined the AFMB lab in 2001 to set up one of the first high-throughput protein production facilities in Europe. Prior to joining the AFMB, he spent eight years producing proteins for structural analysis at EMBL (Germany). Since 2001, his team was involved in nine European-wide collaborative projects, and developed automated protocols for protein expression screening, protein production, protein-DNA, and protein-protein interaction studies.

• Higher-Throughput Protein Production and Characterization

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.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development
• Bispecific Antibodies and Combination Therapies
• Recombinant Protein Expression and Production

No bio available.

• Higher-Throughput Protein Production and Characterization

Sally Ward completed her PhD research in the Department of Biochemistry at Cambridge University in 1985 under the mentorship of Professor David Ellar. From 1988 to 1990, she carried out research on antibody repertoire technology in Sir Greg Winter’s laboratory at the MRC Laboratory of Molecular Biology in Cambridge. In 1990 she joined the University of Texas Southwestern Medical Center, Dallas, as an Assistant Professor. From 2002-2014, she was a Professor in the Department of Immunology at the same institution and in 2004 was appointed to the Paul and Betty Meek-FINA Professorship in Molecular Immunology. Since 2014, she has been a Professor at Texas A&M University Health Science Center, and has recently been appointed as Director of Translational Immunology and Professor of Molecular Immunology at the Centre for Cancer Immunology in Southampton, U.K. In 2010, she was a founding co-organizer of the Gordon Research Conference ‘Antibody Biology and Engineering’. She is currently vice president of the Antibody Society. Her interdisciplinary research involves the use of a combination of fluorescence imaging, protein engineering and in vivo studies to develop antibody-based therapeutics to treat cancer and autoimmunity.

• Biotherapeutic Targeting Strategies

Tim Whitehead is an Associate Professor at the University of Colorado, Boulder in the Dept. of Chemical and Biological Engineering. He has won an NSF CAREER award, holds 6 patents (5 licensed), and has published over 50 research articles in journals like Science, Nature Biotechnology, and Nature Methods.

• Higher-Throughput Protein Production and Characterization

James studied a BA in Natural Sciences followed by a PhD in protein chemistry at the University of Cambridge. He joined NanoTemper Technologies in Munich in 2012, where he helped establish multiple new technologies. He joined Refeyn in 2019 as the Sales Director to develop a methodology called mass photometry.

• Characterization and Analytics for Cell and Gene Therapies

Dr. Williamson is the Protein Production Lead at UCB, and has been with the organization since joining as a research scientist in 2015. She currently leads a team of scientists in Protein Expression and Purification who provide non-antibody protein reagents for global preclinical discovery projects. Prior to their acquisition by UCB, Jess and the Protein Production team were part of Beryllium Discovery, a CRO specializing in gene to structure services. She completed her Ph.D. at Yale University in Molecular Biophysics and Biochemistry and a postdoc at Harvard Medical School, during both of which she studied the structure and assembly of challenging systems, like amyloid and membrane proteins. In addition to her role, Jess advocates for ED&I (Equity, Diversity and Inclusion), Women in Leadership, and environmental sustainability practices at UCB.

• Recombinant Protein Expression and Production

While at the University of Minnesota for a PhD in chemical engineering, he gained expertise in protein engineering and pursued interdisciplinary projects which focused on protein stability and library design, molecular imaging of cancer biomarkers, high-throughput sequence analysis software, and exploring the behavior of metastatic tumors. Later, as a postdoctoral fellow for the Howard Hughes Medical Institute at Brandeis University, his work explored how ancestral enzymes can efficiently evolve under harsh conditions within continuous growth bioreactors. As an assistant professor at Michigan State University (CHEMS & IQ), his protein engineering research group integrates computational and experimental approaches to explore complex biological systems and develop protein therapeutics.

• Bispecific Antibodies and Combination Therapies

David Wood is currently a professor of Chemical and Biomolecular Engineering at The Ohio State University, where he continues to work on self-cleaving tag technologies for research and biopharmaceutical applications. He holds an undergraduate degree from Caltech with a double major in biology and chemical engineering, as well as a PhD from Rensselaer Polytechnic Institute in Chemical Engineering, and has experience in downstream processing and proess development at Amgen and Bristol Myers Squibb. He has published over 50 papers, book chapters and reviews in protein engineering, and holds several patents on technologies developed in his lab. Most recently, he is a co-founder of Protein Capture Science; a company formed to commercialize his split-intein technology for protein purification.

• Protein Purification and Recovery

Speaker Background

Chia-Yun (Dora) Wu joined KBI Biopharma’s Upstream Process Development as a senior associate in 2018. Her experience includes clinical and commercial process development for Fc fusion protein, bi-specific antibodies, and monoclonal antibodies. Dedicated to innovation in cell culture process, Dora’s focuses include perfusion and high-density bioprocess. Prior to KBI, Dora worked at Altor Bioscience in Miramar, Florida for 2 years as an associate scientist. Dora received her MS degree in Biotechnology from Northwestern University

• Recombinant Protein Expression and Production

I joined Amgen in 2015 from Celgene San Diego and earlier Pfizer La Jolla. My current research focuses on attribute impact assessment to support biotherapeutics development, including in vitro immunogenicity risk evaluation. My previous research background at Celgene and Pfizer is drug metabolism and pharmacokinetics.

• Detection and Characterization of Particulates and Impurities

Dr. Xu is a Senior Scientist in the Analytical Development department of Biogen (Cambridge, MA). He obtained his Ph.D. in Analytical Chemistry from Fudan University. Later, he joined NYU Medical Center as a postdoctoral researcher working on mass spectrometric analysis of proteins. He has been with Biogen since 2009. His expertise includes development of analytical methods, and characterization of protein therapeutics using separation methods and mass spectrometry. Over the last ten years, he has participated in the development of a large number of biopharmaceutical programs, including monoclonal antibodies, Fc fusion proteins, bi-specific antibodies, biosimilars, and AAV gene therapies. He has published 30+ peer-reviewed papers in scientific journals.

• Cell Line Development Strategies

Amy Y. Xu completed her BSc degree in Medicinal Chemistry and later, a Ph.D. in Chemistry both from the University of Auckland, New Zealand. Upon completion of her Ph.D. in 2016, she moved to the US to take up a postdoctoral position at the University of Massachusetts Amherst, where she investigated the phase behaviors of protein and polyelectrolyte systems. From 2017 to 2020, she worked as a postdoctoral research fellow at NIST / University of Maryland, where she developed the characterization technique of using small-angle X-ray/Neutron scattering to study protein-protein interactions and colloidal stability of concentrated monoclonal antibody formulations. From August 2020, she joined the Department of Chemistry at Louisiana State University as an Assistant Professor. Her current research interests cover the broad aspects of biotherapeutics, from the development of monoclonal antibody formulations to the characterization of antigen/adjuvant interactions in vaccines.

• Detection and Characterization of Particulates and Impurities
• Characterization of Biotherapeutics

Alexei Yeliseev is a Staff Scientist, head of the protein biochemistry group at the National Institute on Alcoholism and Alcohol Abuse, National Institute of Health. His research focuses 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.

• Protein Purification and Recovery

Daniel Yoo is a Senior Scientist at Amgen in the Biologics group of Therapeutic Discovery where he is responsible for protein drug discovery and development for a variety of therapeutic programs. His areas of expertise include protein purification and analytics, high throughput processes, protein folding, chemical modifications, lab automation and informatics. Daniel Yoo received his Bachelor’s degree in Biology at the University of Rochester in 2003. Prior to joining Amgen, he worked as a research associate in the laboratory of Dr. Reid Johnson at the UCLA School of Biological Chemistry studying the role of the E. coli nucleoid protein Fis in chromosome compaction and gene regulation.

• Higher-Throughput Protein Production and Characterization

Dr. Zhang is Professor of Nanoengineering and Bioengineering and Director of Chemical Engineering Program at the University of California San Diego. He received his B.E. and M.S. degrees in Chemical Engineering from Tsinghua University, and his Ph.D. in Chemical & Biomolecular Engineering from the University of Illinois at Urbana-Champaign in 2006, under the supervision of Professor Steve Granick. He was a postdoctoral associate in the laboratory of Professor Robert Langer at MIT from 2006-2008. He then joined the department of Nanoengineering at UC San Diego as an Assistant Professor in 2008, and was promoted to Professor in 2014. Dr. Zhang has made seminal contributions to the field of bioengineering and nanomedicine. He has published 218 peer-reviewed articles in highly regarded journals. In 2017, 2018 and 2019, he was among the Thompson Reuters list of “Highly Cited Researchers”. He is an inventor of 108 patents and patent applications worldwide. He has received numerous mainstream recognitions, including the Victor K. LaMer Award (2009) and Unilever Award (2012) from the American Chemical Society, MIT Technology Review’s TR35 Innovator Award (2013), Allan P. Colburn Award (2014) from the American Institute of Chemical Engineers, Popular Science’s Brilliant 10 Award (2016), U.S. Department of State ASPIRE Award (2017), and Kabiller Young Investigator Award (2017). Professionally, Dr. Zhang was recently elected to the College of Fellows of the American Institute for Medical and Biological Engineering (AIMBE) in 2015, and to the Fellows of the American Association for the Advancement of Science (AAAS) in 2018.

• Hindsight Is 2020: Application of Accelerated Vaccines and Therapeutics Development

Professor Zhou’s laboratory applies protein chemistry, analysis and engineering to biology and medicine. One program is “Hybrid Modality Engineering of Proteins”—a platform to introduce non-canonical chemical moieties and/or scaffolds into peptides and proteins to confer novel functions otherwise unavailable, such as photomedicine. The second is to devise chemo-enzymatic methodologies to characterize protein modifications, such as crosslinking, isoaspartic acid formation (asparagine deamidation) and methylations. In collaboration with biologists and clinicians alike, we also investigate their biological effects, and moreover, as critical attributes in protein pharmaceuticals. Over the past decade, Professor Zhou has been actively collaborating and consulting with biotech and pharm companies on biotherapeutics, enzymes and protein chemistry. These collaborations have led to the elucidation of product and process-related modifications (many of which were previously unknown). He also developed and now teaches a new advanced course entitled “Chemistry and Design of Protein Pharmaceuticals,” as well as workshops on antibody-drug conjugates (ADC), and training courses for scientists from industry, academia, and regulatory agencies in the US, China, and APEC economies.

• Detection and Characterization of Particulates and Impurities

Dr. Qun Zhou is a Senior Principal Scientist in the Protein Engineering group of Biologics Research, Sanofi in the U.S. He has been working at biopharmaceutical companies for more than twenty years at Genzyme/Sanofi. He was involved in the development of multiple recombinant enzymes/proteins/protein conjugation currently being used in the clinics or in clinical trial. Most recently, he has been involved in the research of antibody through Fc-engineering or glycoengineering/conjugation.

• Optimizing Biotherapeutic Discovery

Ms. Znidarsic is a Process Development Engineer in the Proteins Technical Development group at Biogen’s RTP North Carolina facility, where her focus is on development of early- and late-stage downstream manufacturing processes for the production of mAbs and Fc Fusion proteins manufactured at 1kL – 18kL scales. This includes development of protein capture and polishing steps using current mAb platform conditions, as well as evaluating non-platform alternatives for more complex proteins or complex impurity separations. In addition, my responsibilities include evaluation of innovative solutions for process improvement, increased throughput, reduction in COGs, and evaluation of disruptive technologies.

• Protein Purification and Recovery

Dr. Andrew L. Zydney is the Bayard D. Kunkle Chair and Professor of Chemical Engineering at The Pennsylvania State University. Dr. Zydney also serves as Director of the Penn State Center of Excellence in Industrial Biotechnology, as well as the Penn State site in the Membrane Science, Engineering, and Technology (MAST) Center. Professor Zydney's research is focused on the application of membranes in bioprocessing, including the purification of monoclonal antibodies, vaccines, and gene therapy agents. He is the most recent recipient of the Alan S. Michaels Award for Innovation in Membrane Society and Technology (from the North American Membrane Society) and the ACS Separations Science and Technology Award (from the American Chemical Society), and he is a past recipient of the AIChE Gerhold Award for Excellence in Separation Science and the Excellence in Biological Engineering Publications.

• Protein Purification and Recovery