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Higher-Order Protein Structure Speaker Biographies

2013 Archived Content

Horst Bierau, Ph.D., Scientific Advisor & Relation Manager, Analytical Development Biotech Products, Merck Serono 

Horst Bierau holds a Ph.D. in Biochemical Engineering from The University of Birmingham (UK). He has more than ten years of experience in biopharmaceutical product development and in particular, the field of protein characterization. In the past he has worked for Innogenetics in Belgium before he joined Serono in Italy in 2003. Currently, he is working as a Scientific Advisor and Collaboration Manager in Merck Serono's "Analytical Development – Biotech Products" organization in Rome, Italy.

Olivier Brass, Ph.D., Scientist, Discovery, Sanofi Pasteur 

Dr. Olivier Brass earned a Ph.D. in 1992 from University of Lyon, Fr, in the biophysical and molecular interaction field in collaboration with Industrial and Academic partners (CNRS, INSERM and INSA labs). He worked with different Pharma and Biotech companies focusing on pharmaceutically active proteins. This included responsibilities in Research, Development, Quality Control and Industrial Operation of API formulation (molecules, recombinant and purified proteins, and microorganisms). In 2001, he joined Sanofi Pasteur, Marcy l'Etoile, Fr, where he held various positions as project leader and team manager in R and IO. Since 2006, he had focussed on Formulation project from R&D to IO and specifically international corporate project for Early Vaccine stability assessment and stabilisation strategies. He led several initiatives enabling the formulation of different kind of vaccines (molecular, macromolecular, particle adjuvant, split and lived attenuated virus).

Erik Fernandez. Ph.D., Professor, Chemical Engineering, University of Virginia 

Prof. Fernandez joined the Department of Chemical Engineering at the University of Virginia after completing BS and PhD degrees in Chemical Engineering from Caltech and UC Berkeley, respectively, and a postdoc at UC San Francisco. His research interests are in protein aggregation and conformational stability during biopharmaceutical processing and formulation, as well as in the context of human disease. A particular interest of his lab has been the development of hydrogen-deuterium exchange techniques to obtain detailed information about the structure and distribution of proteins and protein aggregates. He is also interested in using structural information to guide protein design.

Otmar Hainzl, Ph.D., Lab Head Biophysical Characterization, Analytical Characterization, Hexal AG 

Otmar Hainzl studied biology at Technical University Munich and University of Nottingham. His doctoral thesis at TUM focused on the function of the molecular chaperone Hsp90 in cooperation with its co-chaperones, involving yeast genetics, enzymatic assays, binding studies and various HOS methods. In 2007 he joined Hexal AG (a subsidiary of Sandoz, the generic pharmaceuticals division of Novartis), now leading a lab with focus on biophysical characterization methods and target & receptor binding of molecules being developed at Sandoz Biopharmaceuticals. 

Carl Jone, Ph.D., Director, Analytical Development, UCB 

Carl joined UCB in 2009 and leads both Analytical Development for Biologicals and Knowledge Management. After gaining his Ph.D. in Japan (Tokyo Rika Dai) he continued to move around the world (Europe, Japan and Australia) working in both academia (UWA) and the biopharmaceutical industry (Ciba-Geigy, GSK, Serono, Merck, UCB). He began his interest on better understanding the higher order structure of proteins at Glaxo in the 1990's and this interest has continued throughout his career at Serono and now UCB.

Devendra (Davy) Kalonia, Ph.D., Professor of Pharmaceutics, Department of Pharmaceutical Sciences, University of Connecticut 

Devendra Kalonia is a Professor of Pharmaceutics in the School of Pharmacy and holds a joint appointment at the Institute of Material Sciences at the University of Connecticut. Various areas of his research interest include protein formulation, stability, characterization, unfolding, and interactions of proteins with excipients, protein aggregation, protein-protein interactions and protein rheology. He is a leader in the area of high concentration antibody solution rheology and formulation. He has active research collaborations with major biotech companies. He has presented invited talks at national and international meetings, and his work has been published in highly reputed journals. He has consulted with a large number of pharmaceutical and biotech companies.

Bruce Kerwin, Ph.D., Scientific Director, Drug Product Development, Amgen 

Dr. Bruce Kerwin is a Scientific Director at Amgen working within the Drug Product Development Department. He has worked in industry for the past 19 years with a focus on protein formulation development and more recently development of formulations for live viruses. Dr. Kerwin is an inventor on a number of patents and has published more than 40 scientific articles in multiple peer reviewed journals on subjects ranging from protein photolabeling to phosphorescence and protein formulation development.

Henryk Mach, Ph.D., Senior Investigator, Bioprocess Analytical and Formulation Sciences, Merck Research Laboratories 

Henryk is a member of Vaccine Drug Product and New Technology Development group at Merck Research Laboratories, focusing on applications of biophysical methods in vaccine development. He is an author of over 40 professional papers, book chapters and patents that reflect his research interests in the spectroscopy, virus assembly phenomena, and computational methods. Before joining vaccine development area at Merck in 1990, he was a research associate in Prof. Middaugh's laboratory at the University of Wyoming. Henryk received a M.S. degree in Biotechnology from Agricultural University of and Ph.D. in Biophysics from Jagiellonian University, both in Krakow, Poland.

Sorina Morar-Mitrica, Ph.D., Investigator, Biopharmaceutical Technologies, GlaxoSmithKline R&D 

Sorina Morar-Mitrica received her Ph.D. in Protein Chemistry from the University of North Carolina at Chapel Hill. After graduation she accepted a position with Diosynth Biotechnology where she worked on various aspects of protein drug development, including formulation and purification. Sorina joined GSK in 2007 as a Scientific Investigator within the Biopharmaceutical Technologies group, where she continues to work on formulation and delivery of protein drugs – with a main focus on biophysical characterization and high-throughput formulation.

Jie Nan, Ph.D., Wenner-Gren Fellow, Department of Molecular Biology, Uppsala Biomedical Center 

Dr. Jie Nan received her Ph.D. in structural biology at Peking University in 2009. She completed a postdoc in Prof. Ruedi Aebersold's lab where she acquired indepth knowledge about mass spectrometry. She is currently a Wenner-Gren Fellow at Uppsala Biomedical Center. Her major interest is to study the structures of protein and protein complexes using X-ray crystallography and mass spectrometry.

Dean Ripple, Ph.D., Leader, Bioprocess Measurements Group, National Institute of Standards and Technology 

Dean Ripple joined the National Institute of Standards and Technology as a post-doctorate in 1991. Since 2010 he has led the Bioprocess Measurements Group, which develops standards and sensing technologies in support of biotherapeutic manufacturing and health care. His research focuses on standards for the counting and characterization of particles in therapeutic proteins. He has a Ph.D. in physics from Cornell University and an M.S. in biotechnology from Johns Hopkins University.

Christopher Roberts, Ph.D., Associate Professor, Department of Chemical Engineering, University of Delaware 

Dr. Roberts is an Associate Professor in the Department of Chemical and Biomolecular Engineering at the University of Delaware. He received his BChE from UD, and his Ph.D. in Chemical Engineering from Princeton University. He joined the department in 2002 as an Assistant Professor after working in pharmaceutical R&D for Pfizer, Inc. as a formulation scientist. The Roberts laboratory focuses on fundamentals and applications of protein physical and chemical stability, (mis)folding, aggregation, kinetics, statistical mechanics, and phase behavior to address questions of biopharmaceutical product design and manufacturing. Selected honors include the AAPS New Investigator Award in Pharmaceutics and Pharmaceutical Technologies, the Ebert Prize from the Journal of Pharmaceutical Sciences, and the University of Delaware College of Engineering Excellence-in-Teaching award.

Erinc Sahin, Ph.D., Research Investigator, Biopharmaceutics, Drug Product Science & Technology, Bristol-Myers Squibb 

Completed B.S. in Molecular Biology & Recombinant Genetics (2001, Middle East Technical University, Turkey) and M.S. in Bioengineering (2003, Sabanci University, Turkey). Developed deeper interest and experience on self-assembly of (de novo designed) proteins/peptides and their polymer conjugates during Ph.D. (2008, University of Delaware, USA) on a joint project between Biochemistry and Materials Science & Engineering departments. Between 2008-2011, had the opportunity to study aggregation on a number of therapeutically relevant proteins via multiple collaborations with Roberts Group (Chemical and Biomolecular Engineering, University of Delaware, USA) and several research partners in industry and academia. Research Investigator in Bristol-Myers Squibb R&D (Drug Product Science and Technology, New Brunswick, NJ, USA) since March 2011, developing biopharmaceutical formulations.

Emily Shacter, Ph.D., Consultant, ThinkFDA, LLC; Former Chief, Laboratory of Biochemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, CDER/OPS, FDA 

Dr. Shacter was the Chief of the Laboratory of Biochemistry in the FDA's Division of Therapeutic Proteins in the Office of Biotechnology Products of CDER. She received her Ph.D. in Biochemistry from Johns Hopkins University in 1982, carried out basic research on cell regulation and cancer at the NIH for 12 years, and then joined the FDA in 1994. Prior to leaving the FDA this year, Dr. Shacter oversaw the review of regulatory submissions for novel and biosimilar therapeutic proteins covering a wide range of clinical indications. She helped develop CDER policy on the analytical characterization of protein products. Her research expertise in structure-function relationships was applied regularly to the review of protein therapeutics. Now ex-FDA, Dr. Shacter will be consulting to biotechnology companies and other interested parties.

Robert Simler, Ph.D., Staff Scientist, BioFormulations Development, Genzyme  

Robert Simler got his B.S. in Chemistry from Duke University in Durham, North Carolina and his Ph.D. in Chemistry from The Pennylvania State University where he worked for Dr. C. Robert Matthews on the thermodynamics and kinetics of multimeric protein folding. He has been with Genzyme for seven years in the BioFormulations Development group. His work focuses on novel approaches to preformulation utilizing spectroscopy and other biophysical techniques as well as evaluating and implementing technology to quantify and characterize subvisible particles.

Jie Wen, Ph.D., Senior Scientist, Global Cellular & Analytical Resources, Amgen 

Jie Wen is currently a Senior Scientist at Amgen Inc. He has been working in biophysical characterization at Amgen since 1992. His research interests include protein characterization and molecule assessment using DSC, ITC, Optim 1000, DSF, SEC-UV/LS/RI, and other biophysical techniques.

Thomas Scherer, Ph.D., Scientist, Late Stage Pharmaceutical Development, Genentech 

Dr. Scherer is currently a Scientist in the Late Stage Pharmaceutical and Process Development Department at Genentech, where he develops formulations for therapeutic protein products and contributes broadly to CMC and device development activities. His research activities include investigation into the formation and detection of sub-visible/sub-micron particulate, and the use of light scattering methods to characterize the thermodynamics of protein interactions and cosolutes in solution. Prior to joining Genentech in 2005, he held positions at Medimmune Vaccines and Wyatt Technology Corporation. Dr. Scherer obtained his Ph.D. degree in Polymer Science and Engineering in 1996 from the University of Massachusetts, Amherst, where he studied at the multidisciplinary interface of enzymology, microbiology and polymeric materials science.





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