PRE-CONFERENCE SHORT COURSES
Deborah Finco, Ph.D., Immunogenicity Lead, Immunotoxicology COE, Drug Safety R&D, Pfizer, Inc.
Deborah Finco is a senior principal scientist in the Immunotoxicology lab in Drug Safety Research and Development at Pfizer Inc. in Groton CT. She received her B.S. in Microbiology from the University of Georgia and her M.S. in Microbiology/Immunology from Louisiana State University. She joined Pfizer in 1998 and served as the Immunogenicity Assay Lead for the Immunotoxicology Center of Excellence for the past eight years. More recently she is supporting immunotoxicology issues related to both small and large molecules. Previously she worked in the Animal Health Division at Pfizer and before that in Quality Control at Merial Inc. She has extensive experience in developing in vivo and in vitro assays to determine vaccine efficacy and potency. Her work has supported numerous approvals for animal health vaccines. Her more recent work has focused on the development of immunoassays and bioassays to meet regulatory guidelines with respect to immunogenicity of biological therapeutics. She participates on several American Association of Pharmaceutical Scientists (AAPS) subcommittees to assist with writing white papers for assay validations.
Jaya Goyal, Ph.D., Senior Scientist, Clinical Science & Technology, Biogen Idec, Inc.
CONFERENCE
Michael Tovey, Ph.D., Director, Research, Laboratory of Biotechnology & Applied Pharmacology, ENS Cachan
Michael G. TOVEY, Ph.D, is INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology at the Ecole Normale Supérieure de Cachan, Cachan, France. He is the author of more than 200 articles on interferon, cytokines, biotechnology, and immunogenicity. He is a member of numerous scientific boards and is French representative for the ISICR International Council. He is chair of the International Cytokine Standards Committee, a member of the ISICR Meetings Committee, and a member of the European Adjuvant Advisory Committee. He is editor-in-chief of Detection and Quantification of Antibodies to Biopharmaceuticals:Practical and Applied Considerations, and Associate Editor of the Journal of Interferon and Cytokine Research.
Marie T. Rock, Ph.D., Vice President, Protein Bioanalysis, Midwest BioResearch LLC, a Wil Research Company
Over 30 years experience in all phases of drug development, specialized knowledge of clinical pathology and immunochemistry, biomarker development and protein therapeutics. Authored over 75 publications, two books, drug metabolism sections of IND and NDA and analytical methods sections of BLA regulatory documents, speaker at numerous national and international meetings. She now serves on the Editorial Board of the Journal of Immunoassay and Immunochemistry, is an active member of AAPS, currently serving as Chairman of the Ligand Binding Assay Focus Group Steering Committee, is involved in training programs and collaborative activities with the regulatory agencies.
Sam Song, M.D., Senior Scientist, Immunoassay Development, Merrimack Pharmaceuticals, Inc.
Albert Torri, Ph.D., Senior Director, Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc
Albert Torri is a Senior Director of Bioanalytical Sciences at Regeneron Pharmaceuticals in Tarrytown, NY. He received his Ph.D. in Biochemistry from the University of Alabama at Birmingham and conducted his post-doctoral studies at Johns Hopkins University. He then joined the Bristol-Myers Squibb Company where he served as a Senior Research Investigator and member of the Discovery Working Group. In his current position at Regeneron Pharmaceuticals, he directs assay development and sample analysis efforts. Responsibilities include the development, validation and automation of PK, PD and immunogenicity assays to support preclinical and clinical studies of biologics, as well as the analysis of all clinical samples.
Tobias Manigold, M.D., Lab Head, Immunosafety, Hoffmann-La Roche
Tobias Manigold, MD graduated from Heidelberg medical school in 2001 and completed his doctoral thesis on monokine regulation in Hepatitis B Virus-infected patients the same year. From 2001-2003 Dr. Manigold completed his post-doctoral fellowship at the liver disease section of NIDDK, NIH in Bethesda studying the impact of T regulatory cells on the HCV-specific CD8 memory T-cell pool in infected chimpanzees. In the following years he conducted the first T-cell epitope studies on Andes Virus infected patients as a study director of the hantavirus immunology group at Universidad del Desarrollo in Santiago de Chile. Since 2009 he holds the position as labhead immunosafety at Hoffmann-La Roche in Basel, Switzerland. His primary research focus is administration related reactions to therapeutic mAbs as well as translational aspects in the area of immunosafety (e.g. immunogenicity). Dr. Manigold worked as a physician at the university hospitals of Heidelberg and Basel and continues to serve as a lecturer for medical students. He has multiple publications in top-ranked journals and serves as a reviewer for peer-reviewed journals, mainly in the areas of infectious diseases and immunology.
Melissa Cheu, M.S., Principal Research Associate, BioAnalytical Assays, Genentech, Inc.
Melissa obtained her BA in Molecular Cell Biology and MS in Biomedical Laboratory Science. She joined Genentech as a Research Assistant in 1991 and is currently a Principal Research Associate in the BioAnalytical Sciences department. Her responsibilities include oversight of CROs, responding to regulatory inquiries, validation of PK and ATA assays, interpretation of ATA data, and oversight of bioanalysis in support of multiple non-clinical and clinical programs.
Kristina Howard, D.V.M., Ph.D., FDA Commissioner’s Fellow, Therapeutic Proteins, Pharmaceutical Sciences, CDER, FDA
Kristina E. Howard, D.V.M., Ph.D. joined the FDA in 2010 as an FDA Commissioner’s Fellow working in the Division of Therapeutic Proteins in CDER/OPS/OBP. She received her veterinary degree from the Virginia-Maryland College of Veterinary Medicine, Blacksburg, VA and is a practicing veterinarian. Her doctoral training in Immunology was completed at North Carolina State University, Raleigh, NC, where she was appointed to faculty in 2004. She has extensive experience working with a variety of animal models in research. She has received numerous research awards and has publications focusing on viral immunology and vaccine trials. Her current research interests focus on the use of humanized mouse models to better predict the biologic effects of therapeutic proteins in humans.
Holly W. Smith, B.A., Senior Research Scientist, Investigative Toxicology, Eli Lilly and Company
Holly Smith is currently a Senior Research Scientist with Eli Lilly and Company in the Investigative Toxicology Division. She received her BA degree in Microbiology at Miami University (Oxford, Ohio) and has over 25 years of experience in the immunotoxicology field, providing immunocompetence and immunogenicity evaluations for nonclinical safety studies. She has extensive expertise in the development of immunoassays and interpretive assessment of potential immunogenicity for biotechnology products and is co-author on several immunogenicity white papers and position papers. Her interests also include identification and development of biomarkers for monitoring preclinical drug-induced target organ toxicities.
Matthias Hofmann, Ph.D., Senior Investigator, Bioanalytics, Novartis Institutes for Biomedical Research
Matthias Hofmann graduated with a Diploma degree in Biochemistry from the University of Tübingen, Germany in 1999. In 2002 he received his Ph.D. in Immunology on his work on T cell avidity and autoimmunity. He then started as post-doctoral fellow at the Novartis Institutes for Biomedical Research, working on quantification and characterization of graft-infiltrating lymphocytes. From 2005 Dr. Hofmann was responsible for the development and GMP-compliant validation of potency and impurity assays for release and stability assessments of biologicals within Novartis Biologics. In 2009 he switched to the bioanalysis group, where his lab is responsible for development, validation, and transfer of PK, PD and immunogenicity assays, as well as for sample analysis under GLP.
Robert G. Hamilton, Ph.D., D. ABMLI, Professor, Medicine and Pathology, Clinical Immunology and Allergy, Johns Hopkins University School of Medicine; Director, John Hopkins Dermatology, Allergy & Clinical Immunology Reference Laboratory
Dr. Hamilton is a Professor of Medicine and Pathology and Director of the Dermatology, Allergy and Clinical Immunology Reference Laboratory at the Johns Hopkins University School of Medicine. He teaches, performs research and directs a federally licensed clinical immunology laboratory that performs diagnostic allergy testing. For the past 12 years, he has served as coordinator for the College of American Pathologist’s Diagnostic Allergy Inter-laboratory Proficiency Survey which monitors ~ 150 North American laboratories performing diagnostic allergy testing. He currently serves on the College of American Pathologist’s Diagnostic Immunology Resource Committee that oversees proficiency testing and as the chairman of the FDA’s Allergenic Products Advisory Committee. His current research focuses on the assessment of immunogenicity and allergenicity of a selection of new drugs.
Deborah Finco, Ph.D., Immunogenicity Lead, Immunotoxicology COE, Drug Safety R&D, Pfizer, Inc.
Deborah Finco is a senior principal scientist in the Immunotoxicology lab in Drug Safety Research and Development at Pfizer Inc. in Groton CT. She received her B.S. in Microbiology from the University of Georgia and her M.S. in Microbiology/Immunology from Louisiana State University. She joined Pfizer in 1998 and served as the Immunogenicity Assay Lead for the Immunotoxicology Center of Excellence for the past eight years. More recently she is supporting immunotoxicology issues related to both small and large molecules. Previously she worked in the Animal Health Division at Pfizer and before that in Quality Control at Merial Inc. She has extensive experience in developing in vivo and in vitro assays to determine vaccine efficacy and potency. Her work has supported numerous approvals for animal health vaccines. Her more recent work has focused on the development of immunoassays and bioassays to meet regulatory guidelines with respect to immunogenicity of biological therapeutics. She participates on several American Association of Pharmaceutical Scientists (AAPS) subcommittees to assist with writing white papers for assay validations.
Sue Richards, Ph.D., Group Vice President, Clinical Laboratory Sciences, Genzyme Corp.
Sally Fischer, Ph.D., Senior Scientist & Group Leader, Bioanalytical Research and Development, Genentech, Inc.
Sally obtained her BS in Chemistry and Ph.D. in Biochemistry. She joined Genentech as a Scientist in 2000 and is currently a Sr. Scientist/group leader in the bioanalytical research and development department. Her group supports all bioanalytical strategy and assay development for Pharmacokinetics (PK) as well as Anti-Therapeutic Antibody (ATA) measurements for all non-oncology indications as well as assay development support for biomarker measurements for various programs.
Pankaj Oberoi, Ph.D., Director, Scientific Services and Director, Research & Development, Meso Scale Discovery
Stephen Keller, Ph.D., Associate Director, Pre-Clinical and Clinical Development Sciences, Abbott Biotherapeutics Corp.
Stephen Keller, Ph.D. is Head of Preclinical and Clinical Development Sciences at Abbott Biotherapeutics in Redwood City, CA (ABR). After receiving his B.S. in Physiology at U.C. Davis, Dr. Keller spent 4 years developing diagnostic assays for Baxter Healthcare in Seattle. He then went on to complete his Ph.D. in Human Genetics at the University of Utah, where he studied gene expression involved in leukemic cell transformation. Following graduate school, Dr. Keller began his biotech career at Protein Design Labs which, after several name changes, was eventually bought by Abbott Laboratories. His group is responsible for Toxicology, Bioanalytical Sciences, and PK/PD support for all biotherapeutic drug candidate programs at ABR. He is a member of the American Association for Pharmaceutical Scientists (AAPS), active in the LBABFG, and enjoys a game of catch.
Brian Schlain, Lead, Non-Clinical Statistician, Biostatistics, Biogen Idec, Inc.
Mr. Schlain has an MS in Biostatistics from UCLA, where he also did extensive doctoral work in Biostatistics. Mr. Schlain has written numerous statistical application publications, among which are 2 recent papers, one on setting immunogenicity cut points with non-normal data and another on a cut point algorithm for a 2-step anti-JC virus (screening + confirmation) assay. He is currently working as a Lead Statistician in Nonclinical Statistics at Biogen IDEC, where one of his key responsibilities is to provide statistical support for the development of immunogenicity assays.
Meena Subramanyam, Ph.D., Senior Director, Clinical Science & Technology, Biogen Idec, Inc.
Dr. Meena Subramanyam is the Senior Director of the Clinical Science & Technology Division (CST) at Biogen Idec, Inc., in Cambridge, Massachusetts. The CST department is involved in developing and validating bioanalytical assays to measure pharmacokinetics, pharmacodynamics and immunogenicity, as well as patient stratification assays to support translational medicine initiatives to monitor efficacy and/or toxicology/safety profile of drugs in Non-Clinical & Clinical Development. Dr. Subramanyam joined Biogen in 1998. Prior to that, Dr. Subramanyam served as Associate Director of the Experimental Therapeutics Department at Ares Advanced Technology of the Merck Serono group in Massachusetts. Dr. Subramanyam received her Ph.D. degree in Microbiology from Miami University at Oxford, Ohio and did her post-doctoral training at the Tufts University School of Medicine in the Department of Pathology. Dr. Subramanyam has several publications to her credit in peer-reviewed journals, and is a regularly featured speaker in International Scientific Conferences.
Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic Proteins, Biotechnology, FDA
Dr. Susan Kirshner received an M.Sc. from University of North Carolina School of Public Health in the field of environmental toxicology. She received a Ph.D. in Immunology from the Weizmann Institute of Science, where she worked on the development of a biological therapeutic. Dr. Kirshner’s post-doctoral training was at the National Cancer Institute in the area of transcriptional regulation of MHC class I genes. Dr. Kirshner worked both in the government and industry before joining the Division of Therapeutic Proteins in the Office of Biotechnology Products at the US FDA over 8 years ago. She is currently the Associate Chief of the Laboratory of Immunology at the FDA.
Robin Thorpe, Ph.D., FRCPath, Head, Biotherapeutics Group, National Institute for Biological Standards and Control, UK
Robin Thorpe PhD, FRCPath, is Head of the Biotherapeutics Group at the National Institute for Biological Standards and Control (NIBSC). Recent interests include the unwanted immunogenicity of biologicals, development of improved bioassays for cytokines, the immunology of monoclonal antibodies and cytokine contamination of biological products. He attends meetings of the Biologicals Working Party & Biosimilars Working Party of the CHMP at the EMEA. He is a member of the British Pharmacopoeia Commission (MHRA) Expert Advisory Group NOM, the British Pharmacopoeia Panel of Experts on Biological and Biotechnological Products and chairman of the Working Group on Monoclonal Antibodies of the European Pharmacopoeia. Dr Thorpe is a member of the Biologicals & Vaccines Expert Advisory Group of the CHM. He is the Chairman of the IUIS nomenclature subcommittee for chemokines and the standardisation and nomenclature committee of the International Cytokine Society. He is a biologicals advisor to the WHO INN program. Dr Thorpe is an author on over 200 publications in scientific journals and books. He is an associate editor for the journal Cytokine, Biotherapeutics section editor for Biologicals and editorial board member of the Journal of Immunological Methods & Current Analytical Chemistry.
Oliver Wildner, M.D., Professor, Virology, Division of Biotechnology, Paul-Ehrlich-Institute, Federal Institute for Vaccines and Biomedicines
Oliver Wildner. M.D. is clinical assessor for Advanced Therapy Medicinal Products (ATMP) at the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany. He is a medical doctor with full medical license, completed 5 year fellowship in Laboratory Medicine and Professor of Medical Virology at the Ruhr-University Bochum, Germany. During the time as active scientist he worked in the area of oncolytic viruses, vaccination against tumors and persistent retroviral infections at the National Institutes of Health (NIH, NHGRI), Bethesda, Charité, Berlin, Germany and Ruhr-University Bochum, Germany. He authored 49 publications in peer reviewed journals with more than 750 citations.
Ethan M. Shevach, M.D., Chief, Cellular Immunology Section, Laboratory of Immunology, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Dr. Shevach received his A.B. and M.D. degrees from Boston University. After clinical training in internal medicine and allergy/immunology, he spent two years as a fellow in the Laboratory of Immunology of NIAID, and was appointed a tenured senior investigator in 1973. He is presently Chief, Cellular Immunology Section, Laboratory of Immunology. Dr. Shevach is the author of over 400 papers in the field of Immunology and his research interests over the years have included antigen presentation and processing, T lymphocyte activation, pathogenesis of autoimmunity, and most recently the role of regulatory T cells in immune responses. He served as Editor-in-Chief of the Journal of Immunology from 1987 to 1992 and as Editor-in-Chief of Cellular Immunology from 1996 to 2007. He is a member of the editorial boards of several journals including Immunity, Journal of Experimental Medicine, the Journal of Clinical Investigation, and Human Immunology.
Melody Sauerborn. Ph.D., Post Doc, Pharmaceutics University of Utrecht, and CEO, ADA InVivo BV
Dr. Sauerborn spent most of her undergrad years in well-known institutes such as the Centers for Disease Control and Prevention in Atlanta to widen her knowledge in immunology and hemorrhagic fever viruses. After acquiring her Masters in Infectious Diseases she joined the lab of Prof. Schellekens and Prof. Jiskoot, two experts in immunogenicity of recombinant human therapeutics, to shed more light on the immunological aspects of antibody formation against aggregated protein therapeutics. Based on her promising data obtained during her PhD she recently started a spin-off, ADA InVivo BV. ADA InVivo is the first company offering in vivo immunogenicity testing of protein drugs.
Sandeep Kumar, Ph.D., Principal Scientist, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.
Sandeep Kumar is interested in protein structure-function relationships. He received his Ph.D. Computational Molecular Biophysics from Indian Institute of Science, Bangalore and performed postdoctoral research on protein stability at National Cancer Institute -Frederick. Between 2002 and 2007, Sandeep served worked at Georgetown Univ., Indian Institute of Technology-Kanpur and Johns Hopkins University. Sandeep joined Pfizer in 2007 and has been involved in computational modeling of biotherapeutic drug candidates. He has been working on issues related to aggregation, immunogenicity, disulfide bond scrambling and other physico-chemical liabilities in therapeutic antibodies. Sandeep has been promoting cost-saving, rational structure based strategies for design and selection of highly potent biotherapeutics with improved stability and safety. Sandeep has contributed towards 43 research papers, review articles and book chapters so far.
Fiona A. Harding, Ph.D., Senior Principal Research Scientist, Biologics Technologies, Abbott Biotherapeutics Corp.
Fiona A. Harding received her Ph.D. in Microbiology and Immunology from the University of Rochester, Rochester, New York. Her thesis detailed the immunoglobulin genomic organization in the little skate, Raja erinacea, and T cell responses in the frog Xenopus laevis. She characterized CD28 signaling in mouse CD4+ and CD8+ T cells as a postdoctoral fellow with Dr. James P. Allison at the University of California, Berkeley. Fiona was supported in her postdoctoral research by an Irvington Institute Fellowship grant. Since completing her postdoctoral studies, Fiona has worked at numerous biotechnology companies in the San Francisco Bay Area. These include GenPharm International (now Medarex), Genencor International (Danisco) and Protein Design Labs (now Abbott Biotherapeutics). She is currently a Senior Principal Research Scientist at Abbott, where she has been able to combine her two favorite scientific topics: immunoglobulin structure and function, and cellular immunology.
David W. Scott, Ph.D., Professor & Vice Chair, Research, Department of Medicine, Uniformed Services, University of Health Sciences, Bethesda
David W. Scott, Ph.D. is Vice Chair for Research in the Department of Medicine at the Uniformed Services School of Health Sciences (USUHS) in Bethesda, MD. An alumnus of Antioch College, Dr. Scott received his M.S. degree from the University of Chicago and Ph.D. from Yale University in 1969. Following a post-doctoral fellowship at Oxford University, UK, he joined the faculty at Duke University in 1971, where he initiated his NIH-funded studies on immune tolerance mechanisms. In 1983, he was named Dean's Professor of Immunology at the University of Rochester, a post he held for 11 winters. Dr. Scott thereafter became Head of the newly formed Immunology Department at the Holland Lab of the American Red Cross, and moved to the University of Maryland School of Medicine in 2004. He assumed his current position at USUHS in September 2010.
Dr. Scott has contributed to over 200 research papers on several subjects in immunology, focusing on immunologic tolerance, and its application in autoimmune diseases, hemophilia and gene therapy. He is the author of two textbooks, including a monograph entitled, The Nature of Immunologic Tolerance, and recipient of a number of awards, including the Distinguished Service Award, from the American Association of Immunologists (2004), a Boerhaave Professorship at Leiden University Medical School, The Netherlands (2006) and the 2009 Scientific Achievement Award from the AAPS. Active in science education, Dr. Scott has been chair of Education committees at the ASM and AAI. He has also served on the editorial boards of major immunologic journals, and as a member of NMSS, JDRF and NIH Study Sections.
Matthew Baker, Ph.D., CSO, Antitope Ltd.
Dr Baker is a founder and the Chief Scientific Officer of Antitope Ltd, a Cambridge (UK) based company which specializes in assessing and reducing the immunogenic potential of biologics. He has held senior management positions at a number of companies including Biovation (subsidiary of Merck KGaA), CTL Ltd and Whatman BioSciences. As an academic researcher Dr Baker has a background in B and T cell immunology and completed post-doctoral positions in Cambridge, UK after obtaining his PhD in cellular immunology at University of Birmingham, UK.
Daniela Verthelyi, M.D., Ph.D., Chief, Laboratory of Immunology, Therapeutic Proteins, CDER, FDA
Mary Cromwell, Ph.D., Senior Scientist & Associate Director, Protein Analytical Chemistry, Genentech, Inc.
Miranda van Beers, Ph.D., Research Scientist, Analytics, Bioprocessing Technology Institute, A*STAR
Miranda van Beers obtained a master degree in Chemical Engineering at the Eindhoven University of Technology in the Netherlands. During her PhD she studied the immunogenicity of recombinant human interferon beta in immune tolerant mice under the supervision of Prof. Dr. Huub Schellekens (Utrecht University) and Prof.Dr. Wim Jiskoot (Leiden University). In 2008 she worked as a visiting scientist in the group of Prof.Dr. Theodore W. Randolph at the Colorado University in Boulder, USA, on surface-induced aggregation of interferon beta. Since January 2011 Miranda is working as a research scientist Analytics at the Bioprocessing Technology Institute in Singapore. She obtained her PhD in Pharmaceutical Sciences in April 2011.
John den Engelsman, Ph.D., Analytical Development and Validation, Merck, Sharpe & Dohme
Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group, Inc.
Nadine Ritter has been a protein scientist for over 25 yrs, first as funded academic research in bone biology, followed by a move to the biotechnology industry in 1998. There, she acquired direct experiences as a senior scientist at Abbott Laboratories, conducting analytical studies to support product quality testing and regulatory filings. She was then recruited to become Director of Analytical Services at BioReliance, performing contract R&D, GLP and GMP studies and tests. During her tenure there, her lab generated considerable product characterization, comparability, release and stability data to support the development and commercialization of a wide array of biopharmaceutical products. For the last 9 yrs, she has been a senior biotech CMC consultant, collaborating with industry, academic and regulatory scientists to promote continued advancements in the field of biotechnology products and laboratory sciences. Additionally, for over 12 yrs she has been a biotech industry trainer and an instructor in post-graduate academic programs for applied biotechnology. Dr. Ritter is on the board of several biotechnology professional organizations, academic institutions and journals. She has given invited presentations around the world, and has written numerous articles and book chapters as a subject matter expert. She is a recognized leader in the technical, quality and regulatory elements of analytics for a variety of biotechnology, biological and biosimilar products.