Michele Fiscella, Ph.D., Director, Clinical Immunoassays, Human Genome Sciences
Michele Fiscella is Director of the Clinical ImmunoAssays Department at Human Genome Sciences. His department supports both HGS preclinical and clinical programs by developing and/or validating assays for PK, Immunogenicity, Neutralization, and Biomarkers. In addition, his fully GLP compliant labs receive and test preclinical and clinical samples for most HGS programs. Michele also oversees the interactions with CROs for outsourced assays. Prior to joining the Clinical ImmunoAssays Dept, he worked in the Preclinical Discovery and the Antibody Departments developing functional assays and preclinical models for discovery and early stage programs. He joined HGS in 1999 after 8 years at the NCI in Bethesda and Frederick.
Maureen Deehan, Ph.D., Head, Pharmacology, Experimental Science & Translational Medicine, NovImmune SA
Dr. Maureen Deehan is Head of Pharmacology, in the Experimental Science & Translational Medicine Department at NovImmune, in Geneva, Switzerland. The group supports preclinical and clinical programs by developing assays for target validation, in vitro pharmacology, pharmacokinetics, immunogenicity, safety, and biomarkers. Following graduation from the Faculty of Medicine, University of Glasgow, Scotland she pursued an academic career for 6 years in immune cell signaling and then moved to industry where she has now achieved over 10 years experience in Pharma. Dr Deehan is currently a member of the European Immunogenicity Platform.
Frank F. Weichold, M.D., Ph.D., Director, Clinical Pharmacology and DMPK, Translational Science, MedImmune, LLC
Currently, Dr. Weichold is leading teams in Clinical Pharmacology, DMPK, as a Director at MedImmune LLC, Gaithersburg, MD. Prior, he directed research and clinical development of vaccines at the Aeras Foundation. As a tenured Professor at Morgan State University, he developed and managed independent research programs and trained MS and PhD students. He held a faculty position at the University of Maryland Biotechnology Institute to study signal transduction pathways that affect immune responses. During five years of postdoctoral education, Dr. Weichold worked at the National Institutes of Health in Bethesda, Maryland, first at the LTCB (NCI) where he researched immune pathologies in HIV infection, then at the Hematology Branch of the NHLBI where bone marrow transplantation immunology was the focus of his studies. Dr. Weichold is an Adjunct Professor at MSU, and holds a M.D., and a Ph.D. in Immunology from the Humboldt University in Berlin, Germany.
Jörgen Dahlström, Ph.D., MBA, Scientific Director, ImmunoDiagnostics, Thermo Fisher Scientific
Steve J. Swanson, Ph.D., Executive Director, Medical Sciences, Clinical Immunology, Amgen, Inc.
Dr. Swanson joined Amgen in 1999 to build the Clinical Immunology Department whose mission was to focus on anti-therapeutic antibody issues. This department supports functions including development, validation, and performance of all immunoassays and bioassays for the detection of antibodies directed against Amgen’s therapeutic proteins. In addition, the cellular immunology group within Clinical Immunology as part of Amgen Medical Sciences investigates cellular interactions through FACS, LSC, confocal microscopy, and other imaging techniques and contributes to biomarker work to support product development.
Priya Sriraman, Ph.D., Principal Scientist, DMPK, F. Hoffmann-La Roche
Priya Sriraman, Ph.D. is a Senior Principal Scientist in the DMPK department at Hoffmann-La Roche in Nutley, NJ. She currently leads a group involved in development and validation of bioanalytical assays for protein therapeutics, for PK and immunogenicity assessments. Her group supports programs from discovery through preclinical and clinical development and post-marketing commitments, either in-house or at CROs. Prior to joining Roche, she was at GE-Healthcare where she worked on development of high-throughput cell-based assays for drug discovery. Priya received her Bachelor’s degree from Birla Institute in Pilani, India and her Ph. D. in cell biology and biochemistry from Rutgers, the state university of NJ.
Murty Chengalvala, Ph.D., Program Director/Senior Scientist, Immunology Services, Covance
After spending about 20 years at Pfizer (formerly Wyeth), Murty joined Covance about 5 years ago. He has vast experience in discovery and development of biologics/vaccines and small molecule drug candidates in a variety of therapeutic areas including oncology and infectious diseases. Murty has published more than 50 papers in peer-reviewed scientific journals and wrote several review articles.
Stephen Keller, Ph.D., Associate Director II, Pre-Clinical & Clinical Development Sciences, GPRD Abbott Biotherapeutics Corp.
Stephen Keller, Ph.D. is Associate Director of Preclinical and Clinical Development Sciences at Abbott Biotherapeutics in Redwood City, CA (ABR). 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.
Deborah Finco, Ph.D., Senior Principal Scientist, Immunotoxicology COE, 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. 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 has authored/co-authored numerous publications dealing with immunogenicity in recent years.
Josi Holz, M.D., CMO, Ablynx NV
Josi Holz joined Ablynx as Chief Medical Officer in June 2007. She oversees the pre-clinical and clinical development of Ablynx’s Nanobody drug candidates resulting in a significant advancement of the clinical development activities. Josi continues to be instrumental in the transition from technology platform to product portfolio and her focus on translational research activities enables the rapid transition from research candidates into pre-clinical and clinical development.
Josi holds a Medical Doctor's degree from the University of Marburg, Germany. She started her career in 1995 with Bristol-Myers Squibb (Munich, Germany), and she has since held senior managerial and research roles in several biotechnology and pharmaceutical companies including: GPC Biotech, Allos Therapeutics Inc. and Gilead/OSI Pharmaceuticals. Prior to joining Ablynx, Josi held the position of Vice President Drug Development at U3 Pharma AG. She has advanced small molecules and biologics from early to advanced stages of clinical development.
Jim McNally, Ph.D., Senior Principal Scientist, Pfizer, Inc.
Paul Chamberlain, NDA Advisory Board
Paul CHAMBERLAIN is a biopharmaceutical product specialist who specializes in presenting immunogenicity risk assessments to European and North American regulatory agencies. He works with Sponsors to develop strategies for evaluating the probability that a product might induce an undesirable immune response, as well as preparing expert reports on signal interpretation to support regulatory submissions. He is a Member of the NDA Advisory Board.
Daniela Verthelyi, M.D., Ph.D., Chief, Immunology, Therapeutic Proteins, CDER/FDA
Dr. Verthelyi received her MD from the University of Buenos Aires and a PhD from the Virginia Tech in USA, and then completed a fellowship training in Immunology at the Section in Retroviral Immunology of the Center for Biologics Evaluation and Research of the FDA before joining the Laboratory of Immunology of Division of Therapeutic Proteins and eventually becoming its Chief. Dr Verthelyi’s laboratory, established in 2002, studies innate immune response modulators in several disease models. She has authored over 50 peer reviewed articles, chairs the NIH/FDA Cytokine interest Group, and received of the FDA's ‘Excellence in Laboratory Sciences Award, among other honors.
Patrick Liu, M.D., Ph.D., Global Head, Bioanalytical Sciences and Technologies, Teva Pharmaceutical Industries, Ltd.
Dr. Patrick Liu is currently a Senior Director of the Global Bioassays and Technologies at Teva. He is also the Global Head who is managing multiple sites around the globe in support of product biological evaluation, PK/PD and immunogenicity assessment for both innovative biologics and biosimilars development. Prior to joining Teva, Dr. Liu was an Associate Director at Genentech and a Director at Tanox, where he had played leadership role in bioanalytical sciences for the development and commercialization of biological new molecule entities (NMEs) in the fields of oncology, hematology, immunology, allergy and infectious diseases, with numerous patent applications and publications. Dr. Liu had practiced medicine with specialty in Endocrinology and PhD in Molecular Biology.
Roy Jefferis, Ph.D., C.Chem., FRSC, MRCP, FRCPath, D.Sc., Professor Emeritus, School of Immunity & Infection, University of Birmingham UK
Following the BSc and PhD in Chemistry I moved to the Medical School and research into the structure and function of antibody molecules, in health and disease. Our studies revealed the functional profile of the IgG subclasses and the profound influence that glycosylation can have on the activation of effector mechanisms, in vitro and in vivo. Extension to the engineering and design of recombinant antibody therapeutics led to consultancies with the biopharmaceutical industry. In consideration of published research I was elected Member of the Royal College of Physicians (MRCP) and Fellow of the Royal College of Pathologists (FRCPath).
Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic Proteins, Biotechnology, CDER/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.
Wim Jiskoot, Ph.D., Professor, Division of Drug Delivery Technology, Leiden University
Wim Jiskoot is professor at the Division of Drug Delivery Technology at Leiden University. His main research areas are vaccine delivery and unwanted immunogenicity of therapeutic proteins in relation with protein structure and formulation. Previous positions: staff member at the Department of Pharmaceutics at Utrecht University (1998-2006); head of the Department of Bacterial Vaccine Development at the National Institute of Public Health and the Environment (RIVM), Bilthoven (1994-1998). He (co)authored about 180 papers and book chapters.
Theodore W. Randolph, Ph.D., Gillespie Professor of Bioengineering, Chemical and Biological Engineering, University of Colorado
Ted Randolph received his Ph.D. in Chemical Engineering at the University of California, Berkeley. He worked as a post-doctoral fellow at the Ecole Polytechnique Federale de Lausanne, and then joined the Department of Chemical Engineering at Yale University as an Assistant Professor. After promotion to Associate Professor, he was named to Yale’s first John J. Lee Junior Professorship Chair in Chemical Engineering. In 1993, Dr. Randolph accepted the Patton Associate Professorship Chair in the Department of Chemical Engineering at the University of Colorado. He currently serves as the Gillespie Professor of Bioengineering, co-Director of the University of Colorado’s Center for Pharmaceutical Biotechnology, and Director of the NIH Leadership Training in Pharmaceutical Biotechnology Program. Dr. Randolph is a National Science Foundation Presidential Young Investigator, and received the AIChE Professional Progress Award and the American Pharmacist’s Ebert Prize. His research interests include biopharmaceutical formulation, lyophilization of proteins, protein-solvent interactions in non-aqueous environments, and protein refolding. Dr. Randolph is an inventor on numerous patents, some of which form the basis for two companies that he has founded: RxKinetix, Inc. (now owned by Endo Pharmaceuticals), a company formed to commercialize new extended-release drug delivery technologies, and BaroFold Inc., a company that uses high-pressure protein refolding technology to develop and produce new protein therapeutics.
Manoj Rajadhyaksha, Ph.D., Director, Bioanalytical Sciences, Regeneron, Inc.
Dr. Manoj Rajadhyaksha has obtained his basic training in Molecular Immunology at Roswell Park Cancer Institute at SUNY Buffalo, NY. After his PhD graduation, he joined IMMCO Diagnostics Inc, where he held positions of increasing responsibility. In his diagnostic career, Dr. Rajadhyaksha identified the autoantigen for Celiac disease and established a 510K approved diagnostic test to diagnose celiac disease. He now holds a US patent for this discovery and the diagnostic test. Dr. Rajadhyaksha later moved to Centocor (now Janssen) where he led the effort of establishing cell based Neutralizing antibody assay unit and also directed bioanalysis for preclinical immunogenicity and biomarkers. Dr. Rajadhyaksha then moved to Pfizer where as an Associate Research fellow he was leading the PDM efforts in Pfizer Neuroscience Therapeutic Area on multiple projects. He also led a group that was responsible for the development of preclinical & discovery phase bioanalytical assays for PK, biomarker and Immunogenicity for all biologic products in the Neuroscience, Oncology, and Cardiovascular Therapeutic areas product pipeline. At present, Dr. Manoj Rajadhyaksha directs the Bioanalytical Science Department at Regeneron Pharmaceuticals Inc, overseeing various aspects of preclinical, clinical, PK, biomarker, and immunogenicity assays. Overall Dr. Rajadhyaksha has total of three patents, two SBIR grants, more than thirty 510K approved commercial diagnostic tests for various autoimmune diagnostics disorders and several publications to his credit in various areas he has worked in.
Vibha Jawa, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.
Dr. Vibha Jawa is a Principal Scientist at Amgen in the Department of Clinical Immunology since Dec 2003. She obtained her Ph.D. in Biochemistry with a thesis work studying the immune mechanisms behind autoimmune diseases. This was followed by a postdoctoral fellowship at University of Pennsylvania where she did extensive work in monitoring the immune response to gene therapy viral vectors. As a Principal Investigator and Clinical Immunology representative on several of Amgen’s drug development teams, she is responsible for developing and validating immunoassays capable of detecting anti-drug antibodies. Her current research interests include understanding the immune responses due to particles in formulated biotherapeutics, identifying immune cell derived cytokine signatures as biomarkers for early drug development and efficacy, immunogenicity prediction of immunogenic epitopes using in silico and in vitro technologies to understand the role of T cells in immune response to drug products.
Valerie Quarmby, Ph.D., Director and Principal Scientist, BioAnalytical Sciences, Genentech, Inc.
Dr. Quarmby is a Principal Scientist and Director of the Department of BioAnalytical Sciences at Genentech. At Genentech, Dr Quarmby and her group are responsible for developing bioanalytical methods and strategies for non-clinical, clinical and post-marketing studies and for in vitro characterization of protein therapeutics. These data, methods and strategies are critical components of IND, BLA, sBLA, NDA and CTD filings. Dr Quarmby has been actively involved in development programs for many protein therapeutics, including: Nutropin AQ, Nutropin Depot, Xolair, Raptiva, Rituxan, Avastin, Lucentis. Dr Quarmby is an active member of AAPS, and is the co-author of several AAPS sponsored industry guidance documents. Dr Quarmby holds a B.Sc. from the University of London, England and a Ph.D. in Hormone Physiology from the Imperial Cancer Research Fund and the University of London. Dr Quarmby was an NIH Visiting Postdoctoral Fellow, then joined the Laboratories for Reproductive Biology and the Department of Pediatric Endocrinology at the University of North Carolina in Chapel Hill. Prior to joining Genentech, Dr Quarmby worked in the field of clinical diagnostics at Bio-Rad Laboratories and at Endocrine Sciences/Esoterix.
Timothy Hickling, Ph.D., Associate Research Fellow, PDM Immunogenicity Sciences, Pfizer, Inc.
Dr. Tim Hickling is currently investigating the immunogenicity of biotherapeutics at Pfizer. He obtained his Biochemistry degree (1995) and Immunology Doctorate (1998) from the University of Oxford. He carried out post-doctoral training at Glaxo and the MRC’s National Institute for Medical Research before taking up a lectureship at the University of Nottingham. Tim has worked on various aspects of innate and adaptive immunology in infectious and inflammatory diseases. Tim joined Pfizer in 2007 and has worked on early stage vaccines and from early discover to late stage development of biotherapeutics.
Jack Ragheb, M.D., Ph.D., Principal Investigator, Immunology, Therapeutic Proteins, CDER/FDA
Jack A. Ragheb, M.D. Ph.D. is a Senior Regulatory Research Officer and Principal Investigator in the Division of Therapeutic Proteins/OBP/OPS/CDER/FDA and an Attending Physician on the Allergy Immunology Service, NIAID, National Institutes of Health, Bethesda, MD. A graduate of the Johns Hopkins University and School of Medicine, he performed his clinical training at the Johns Hopkins Hospital and National Institutes of Health. A recipient of numerous research awards, his work and publications has spanned the fields of retrovirology, gene therapy, immune activation, and clinical trials in immune tolerance. He is actively investigating the use of humanized mouse models to predict the immunogenicity of therapeutic proteins.
Mazor Ronit, M.Sc., Laboratory of Ira Pastan, Molecular Biology, NIH
Amy S. Rosenberg, M.D., Director, Division of Therapeutic Proteins, CDER/FDA
Dr. Amy Rosenberg is a graduate of the Albert Einstein College of Medicine. Following medical residency training, she was a post-doctoral fellow in the laboratory of Dr. Alfred Singer at the NCI, where she focused on the cellular mechanisms of allograft rejection. In 1988 she moved to CBER, FDA, progressing from Staff Fellow to Director of the Division of Therapeutic Proteins in 2000. While maintaining a research program in immunology, her main regulatory focus is on the immunogenicity of therapeutic protein products, including product and patient factors that impact immunogenicity, and immune tolerance induction to preclude immune responses that abrogate product efficacy.
Annie de Groot, Ph.D., Professor, Research, Immunology & Informatics, University of Rhode Island
Dr. Anne De Groot is internationally known for her research on the role of T cell epitopes in the human immune response to vaccines and biotherapeutics. She earned her medical degree from the University of Chicago in 1983, which was followed by training at New England Medical Center in Internal Medicine and Infectious Disease, and additional training at the National Institutes of Health in Tropical Medicine and Vaccinology. She has authored more than 160 articles and chapters, and she is founder, CEO and chief scientific officer of EpiVax (established in 1998), an innovative biotechnology company based in Rhode Island that seeks to accelerate the development of vaccines based on immunoinformatics. She is also the founder and scientific director of the Institute for Immunology and Informatics, the first center of excellence focused on immunoinformatics in the world. Dr. De Groot and other members of her company also dedicate their time to developing innovative initiatives to improve access to healthcare for those who would otherwise not be able to afford it.
Sathy Balu-Iyer, Ph.D., Associate Professor, Pharmaceutical Sciences, SUNY-University at Buffalo
Dr. Sathy Balu-Iyer (formerly S. Balasubramanian) is a Professor in the Department of Pharmaceutical Sciences at SUNY – University at Buffalo. His interdisciplinary research involves biophysical, immunological and Pharmaco kinetic/dynamic approaches to rationally develop long acting and less immunogenic protein therapeutics. He is the principal investigator on a NHLBI/NIH funded project and serves as Co-I on a NCI/NIH project. He has authored over 60 peer-reviewed publications, over 100 meeting abstracts/presentations and is an inventor on 20 patents/patent applications. The Awards he received include Biotechnology Innovation Award-2012 from American Association of Pharmaceutical Scientists (AAPS) and Inventor of the year Award - 2011 from Niagara Frontier Intellectual Property Law Association. He serves on editorial advisory and editorial boards of several international journals including Journal of Pharmaceutical Sciences and International Journal of Clinical Research and Drug Development. He is a member of American Association of Pharmaceutical Scientists and American Society for Biochemistry and Molecular Biology. He obtained his post-doctoral training in Drug delivery from SUNY – University at Buffalo.
Mazor Ronit, M.Sc., Laboratory of Ira Pastan, Molecular Biology, NIH
Ronit Mazor is a member of the Laboratory of Molecular Biology at the National Cancer Institute. She received a B.S. and M.S. from Tel-Aviv University and after working in industry for several years in Luminex Corporation is now completing her PhD with Ira Pastan. The topic of her thesis is the identification and removal of T cell epitopes in non-human proteins.
Robert J. Kubiak, Ph.D., Research, Translational Sciences, MedImmune LLC
Robert Kubiak heads a research group responsible for validation of bioanalytical methods at MedImmune, Gaithersburg. He worked on development and validation of immunoassays at Tandem Labs, PPD and Meso Scale Discovery. He holds a doctorate in Medicinal Chemistry from University of Illinois at Chicago and a Master’s Degree in Biotechnology from John Hopkins University.