January 13 - 17, 2014
Renaissance Hotel and Palm Springs Convention Center Palm Springs, California

A Community Dedicated to the
Evolving Field and Future of Biotherapeutics

SPEAKER BIOGRAPHIES

Alahari Arunakumari, Ph.D., President, AHA Bioconsultants LLC
Dr. Alahari Arunakumari is an experienced Biologics Process Development professional with expertise in microbial and mammalian production systems through progressive biopharmaceutical industry career for more than 18 years at Medarex, Bristol Myers Squibb and Enzon.
She has provided strategic, managerial and technical leadership in Biologics process and product development over 7 years atMedarex, especially for the production of recently approved Ipilimumab, the anti-CTLA4 human monoclonal antibody and for more than 14other protein therapeutics that resulted in >10 INDs fordifferent phases of clinical trials.Several Humabprocesses weredevelopedand transferred to internal manufacturing facility and CMOs and a process was validated at scale for launch and commercialmanufacturing during this period.
She has constantly improved the biologic processes by innovative technology development to reduce the overall development time from DNA to IND and, manufacturing efficiency by high cell density fermentations and high capacity purification schemes. Implemented cost-effective manufacturing processes by streamlining production cell line development time, escalating antibody expression levels and incorporated economical non-affinity purification processes. These processes are effective in handling upstream high productivity with minimum facility fit modifications in different manufacturing facilities for technology transfer and scale-up.
Organized and lead inter disciplinary teams to address the regulatory updates for biologic processes such as process validation and QbD programs.She is knowledgeable in Biologics manufacturing, quality systems and regulatory requirements for Biologic applications to agencies.

Jessica Molek, Ph.D., Principal Scientist, Downstream Process Development, GlaxoSmithKline
Jessica Molek currently works in Biopharmaceutical Development at GlaxoSmithKline. She is a group leader focusing on the development of harvest and filtration unit operations for the purification of antibodies and other therapeutic proteins. She earned her Ph.D. in Chemical Engineering from the Pennsylvania State University in 2008 under the direction of Dr. Andrew Zydney studying membrane based separation methods for PEGylated proteins. Jessica Molek graduated from Lafayette College in 2003 with a B.S. in Chemical Engineering.

Albert J. Courey, Ph.D., Professor, Chemistry & Biochemistry, UCLA
Albert J. Courey received his doctoral training under the mentorship of James C. Wang at Harvard University studying biophysical properties of supercoiled DNA and the role of DNA supercoiling in gene regulation. He then went on to postdoctoral studies in the laboratory of Robert Tjian at UC Berkeley, where he studied mechanisms of transcriptional activation, with a particular focus on the human transcription factor Sp1. In 1990, Dr. Courey joined the faculty in the Department of Chemistry & Biochemistry at UCLA where he is currently department chair. Since 1996, Professor Courey has served as an instructor in an intensive yearly postgraduate course in “Protein Purification and Characterization” offered by Cold Spring Harbor Laboratory.
At UCLA, the Courey research group studies mechanisms of gene regulation in Drosophila development with an emphasis on the biochemical basis of pattern formation. More recently, the Courey lab has also begun to study the role of the ubiquitin family protein SUMO in cell biology and development. Professor Courey is the author of a textbook entitled Mechanisms in Transcriptional Regulation (Blackwell Publishing, 2008).

David Smith, Ph.D., Senior Scientist, Nuffield Department of Clinical Laboratory Sciences, University of Oxford
Dr. Smith is investigating proteins associated with malaria at the University of Oxford in the United Kingdom. Dr. Smith assisted in the early development of the CK tag at the University of Nebraska Medical Center, and also serves as a scientific advisor to Purtein LLC in the further development of the CK tag technology. 

Giorgio Carta, Ph.D., Lawrence R. Quarles Professor, Department of Chemical Engineering, University of Virginia

Giorgio Carta received his PhD in chemical engineering from the University of Delaware in 1984 and is currently the Lawrence R. Quarles Professor at the University of Virginia, Charlottesville, Virginia. He has published extensively in the area of protein chromatography and biocatalysis, is the holder of two US patents, co-author of Section 16 Adsorption & Ion Exchange of Perry's Chemical Engineers' Handbook, and co-author of the book "Protein Chromatography - Process Development and Scale-Up" published by Wiley-VCH in 2010. He has served on the Organizing Committee of the International Symposium on Preparative Chromatography - PREP annually since 1997 and as Chair of PREP2009 and PRE2011. He is currently serving on the editorial boards of the journals “Separation Science” and “Technology and Adsorption,” as editor of the “Biotechnology Journal,” and as a Member of the Board of the International Adsorption Society.

John T. Mehl, Ph.D., Senior Research Investigator, Bristol-Myers Squibb
Dr. John Mehl is currently Sr. Research Investigator at Bristol-Myers Squibb, Princeton, NJ in the Department of Bioanalytical and Discovery Analytical Sciences.  He has extensive experience in biological mass spectrometry analyzing small molecule drugs, biotherapeutics, and vaccines, and worked for several years at Merck & Co., West Point, PA.   A large part of his recent work has been focused on the development of methods for quantifying proteins in biological matrices.  These include monoclonal antibodies, PEGylated proteins, and integral membrane proteins.  He obtained a Ph.D. in analytical chemistry from Vanderbilt University, under Prof. David M. Hercules and was a post-doctoral research fellow at MIT under Prof. Steve R. Tannenbaum.

David S. Waugh, Ph.D., Chief, Protein Engineering, Senior Investigator, Macromolecular Crystallography Lab, Center for Cancer Research, NCI NIH 
Dr. Waugh graduated from Yale University in 1982 with a B.S. in Molecular Biophysics & Biochemistry. He earned his Ph.D. in Biochemistry & Molecular Biology from Indiana University in 1989 under the direction of Dr. Norman Pace. After two years as a Postdoctoral Fellow in Dr. Robert Sauer's laboratory at the Massachusetts Institute of Technology, he became Director of the Macromolecular Engineering Laboratory at Hoffmann-La Roche. In 1996, Dr. Waugh established the Protein Engineering Section of the ABL Basic Research Program at NCI-Frederick. He moved to the NCI Center for Cancer Research in 1999 and gained tenure as a Senior Investigator in 2005.

David O’Connell, Ph.D., Senior Scientist, School of Medicine, University College Dublin
My background is in the study of protein-protein interactions and the design of new expression and purification strategies. I achieved my primary Bachelor of Science degree at University College Cork, Ireland majoring in Microbiology and performing early biomedical research on Pseudomonas Aeruginosa from the lungs of Cystic Fibrosis patients, developing a novel arbitrarily primed PCR DNA fingerprinting technique, to type sputum isolates. I studied for my PhD in molecular biology while employed as a research assistant in a start-up company, BioResearch Ireland, housed in University College Dublin, Ireland. This research focused on the cloning of novel ion channel proteins and their expression in cell culture for radioligand binding assays. I performed my thesis project on isolation and identification of two new purinergic ion channels P2X2 and P2X5, which I subsequently brought to Cold Spring Harbor USA, for electrophysiological characterization. I performed postdoctoral research in the laboratory of James D Marks at the University of California at San Francisco where I developed and characterized phage and phagemid display systems for human antibodies and humanized mouse monoclonal antibodies to botulinum toxin as part of a US Dept. of Defense project.
As a senior scientist with my own lab at the Conway Institute of Biomolecular & Biomedical Research in UCD, I have focused on the characterization of calcium control of protein-protein interactions using high content protein microarrays to identify functional interaction networks of calmodulin, secretagogin and sorcin. In addition to a number of original research articles I have submitted a number of patents in the area of affinity tag purification.
Through the combination of protein engineering and methodology development for high throughput interaction screening I have developed an exciting and completely new methodology for very high efficiency purification of functional proteins. Using this approach I have also developed a novel class of nanoparticle borne scFv that represent a terrific solution to a number of analytical processes and that are under design for therapeutic applications. I am currently establishing a company vehicle for development of these novel biologics.

David Bienvenue, Ph.D., Associate Director, VLST Corporation
David worked at Dendreon Corporation for ~5 years performing downstream process development on recombinant cancer antigen fusion proteins. Subsequently, he has moved to VLST, and in his current role as Associate Director of Protein Sciences and Target Discovery, he is tasked leading the efforts to express, purify and characterize viral proteins, as well as determine their binding partners using VLST’s proteomics platform.

Yan-ping Yang, Ph.D., Director, Downstream Purification, Bioprocess Research and Development, sanofi pasteur
Dr. Yan-ping Yang has over 22 years of experience in vaccine research and development with Sanofi Pasteur. She joined the Research department of Sanofi Pasteur (formerly Connaught Laboratory) in 1989, involved in various bacterial and viral vaccine development projects, from antigen discovery, protein purification, biophysical/ biochemical characterization, animal model development to immunological assays, with numerous patents and publications. She became the Director of Downstream Purification, BioProcess Research & Development in 2001, and responsible for purification process development of new vaccines, process scale up, and technology transfer, etc. Yan-ping received Ph.D. in Biochemistry from the University of Missouri-Columbia, USA.

Richard R. Burgess, Ph.D., Professor, Oncology, McArlde Lab for Cancer Research, School of Medicine, University of Wisconsin, Madison
Dr. Richard R. Burgess is James D. Watson Emeritus Professor of Oncology at the McArdle Laboratory for Cancer Research at University of Wisconsin-Madison. He founded the UW Biotechnology Center in 1984 and was its Director until 1996. He obtained his B.S. in Chemistry at Caltech in 1964 and his Ph.D. in Biochemistry and Molecular Biology with James D. Watson at Harvard in 1969. After postdoc training in Geneva, Switzerland from 1969-71, he joined the faculty of the Department of Oncology at the University of Wisconsin-Madison in 1971. He has published more than 242 research papers on the biochemistry and molecular biology of RNA polymerase, transcription factors and gene expression; and on protein biotechnology and purification. He has trained 32 Ph.D. and 9 M.S. students. He was co-editor with Murray Deutscher of the Methods in Enzymology volume 463, Guide to Protein Purification, 2nd Edition, published October, 2009. Dr. Burgess teaches University of Wisconsin courses on Protein Purification and Characterization and Topics in Biotechnology. He is Editor-in-Chief of the journal, Protein Expression and Purification and is Chair, and has been an instructor since 1992, of the 2-week lab course on Protein Purification held each April at Cold Spring Harbor Laboratory. He was the recipient of the 1982 Pfizer Award for outstanding contributions to enzyme chemistry and the 1999 Waksman Medal for discovery of the first transcription factor, RNA polymerase sigma subunit. He was awarded the USDA Honor Award for work in developing Biopulping, an environmentally friendly technology, June 1997. In 2003 he was elected a Fellow of the American Academy of Microbiology. In 2008 he was elected as a Fellow of the AAAS.

Sabine Suppmann, Ph.D., Protein Expression and Purification Core Facility, Max Planck Institute of Biochemistry
Scientist since 2005
Max-Planck Institute of Biochemistry MPIB
Microchemistry Core Facility
Head of Recombinant Protein Production,

Scientist 2002 – 2004
F. Hoffmann-La Roche, Basel, Switzerland
Project leader in the Applied Immunology Department
Area of research: Antigen presentation

Scientist 2000 – 2002
Helmholtz Center Munich, Institute for Human Genetics
Area of research: Molecular mechanisms of neurodegeneration and neuroprotection in the retina

Post-doctoral Scientist 1997 - 2000
Helmholtz Center Munich, Institute for Clinical Cell Biology
Area of research: The role of anti-oxidative enzymes in inflammation, immune responses and neurodegeneration

Ph.D. 1992 - 1997
Dr. rer. nat. (Ph.D. in Microbiology)
Degree from the Ludwig-Maximilians-University LMU,
Munich, Germany
Ph.D. Thesis carried out at the Institute of Microbiology
University of Munich
Title: "Design of new Selenoproteins”

Diploma in Biology 1992
Dipl. Biol. in Microbiology
Examination in microbiology, biochemistry, botany.

1991 - 1992
Diploma thesis carried out at the Institute of Microbiology, University of Munich, in collaboration with H. Senn,
Hoffmann-La Roche.
Supervisor: Prof. Dr. A. Böck

Studies of Biology 1986 - 1991
Ludwig-Maximilians-University LMU, Munich, Germany

Baccalaureat 1977 - 1986
Max-Born-Gymnasium, Germering

Michael C. Wiener, Ph.D., Associate Professor, Department of Molecular Physiology and Biological Physics, the University of Virginia

Dr. Wiener received his B.S. (Physics) from the University of Rochester, and his Ph.D. (Physics and Biophysics) from Carnegie Mellon University. After postdoctoral stints with Dr. Stephen H. White (University of California, Irvine) and Dr. Robert M. Stroud (University of California, San Francisco), Dr. Wiener was recruited by the University of Virginia, where he is currently Associate Professor of Molecular Physiology and Biological Physics and a member of the Center for Membrane Biology. Research of the Wiener Lab is in three primary areas: structure and function of the TonB-dependent bacterial transport pathway; eukaryotic membrane protein structural genomics (Membrane Protein Structural Biology Consortium); and development of novel structural biology methods.

Philip N. Bryan, Professor, Institute for Bioscience and Biotechnology Research, and Department of Bioengineering, University of Maryland
Philip Bryan obtained a Ph. D. with Donald Olins at the Biology Division of Oak Ridge National Laboratory where he used biochemical and biophysical approaches to characterize nucleosome structure. His postdoctoral work with Max Birnstiel at the University of Zurich and William Folk at the University of Michigan investigated the role of chromatin structure on the expression of developmentally regulated genes. From 1989 to the present he has applied of genetic, biochemical and biophysical methods to the study of protein folding and enzymology at the University of Maryland where he is a professor in the Institute for Bioscience and Biotechnology Research and the Department of Bioengineering. He founded Potomac Affinity Proteins, LLC in 2004 to translate fundamental principles of protein folding and enzymology into protein-based devices for protein purification, ultra-sensitive detection and therapeutics.


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Training Seminars 

Mon-Tues, January 13-14 

Biologics Formulation and Delivery  

 


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