Immunogenicity Summit
Immunogenicity and Bioassay Summit

Speaker Biographies


Alessandro Sette, Ph.D., Principal Investigator, Center for Infectious Diseases, La Jolla Institute for Allergy & Immunology 

Dr. Sette is currently a Member and Head of LIAI's Division of Vaccine Discovery as well as chairing the Institute's Center for Infectious Diseases.  Dr. Sette's research focus is on understanding disease and developing intervention strategies based on the specificity of immune responses.

Dr. Sette graduated in Biological Sciences with a maximum cum laude degree from the University of Rome.  He began his postdoctoral work at the Laboratory of Pathology, C.R.E. Casaccia, Rome.  He remained there for five years before continuing his postdoctoral work at the National Jewish Center for Immunology and Respiratory Medicine in Denver, Colorado.  In 1988, Dr. Sette left Colorado to join with Howard Grey, M.D. at the newly founded biotechnology company, Cytel, in La Jolla, California, and was also appointed as an adjunct assistant professor in Immunology at The Scripps Research Institute.  He became Director of Immunology at Cytel in 1994, a position he held until he left in 1997 to found Epimmune, in San Diego, where he served both as Vice President of Research and Chief Scientific Officer until 2002, when he joined LIAI.

Li Xue, Ph.D., Principal Scientist. Pharmacokinetics Dynamics & Metabolism, NBE, Pfizer, Inc.  

I am an Immunologist, currently a principal scientist in Pharmacokinetics, Dynamics and Metabolism, Pfizer Inc. I provided bioanalytical support for the non-clinical and clinical development of biotherapeutic products. Current role involves formulating immunogenicity risk assessment and mitigation strategies for biotherapeutic products, development and implementation of new predictive immunogenicity tool kits and tracking immunogenicity key risk factors across Pfizer biotherapeutic portfolio. I am the AAPS TPIFG pre-existing antibody team lead, working with cross-industry colleagues to assess the clinical impact of pre-existing antibodies and recommendations for best practices.  Prior to joining Pfizer, I was a research fellow at Harvard Medical School researching various aspects of immune modulation.

Zuben E. Sauna, Principal Investigator, Hematology, CDER/FDA 

Dr. Sauna is a research-reviewer at the Department of Hematology, CBER, FDA. He is involved with the review of plasma-derived and recombinant protein-therapeutics and also leads an active research laboratory. His research interests lie in the next generation of therapeutic proteins and in pharmacogenomics. Dr. Sauna has over 60 research papers in high impact publications to his credit. He received his Ph.D. from Poona University, India with subsequent training at the National Cancer Institute.

Vera Brinks, Ph.D., Postdoctoral Researcher, Utrecht University, Utrecht Institute for Pharmaceutical Sciences; Currently Visiting Scientist, Laboratory of Immunology, Therapeutic Proteins, CDER/FDA  

Vera Brinks has been a postdoctoral researcher in the lab of Prof. Dr. Huub Schellekens at the department of Pharmaceutics, Utrecht University, the Netherlands since 2008. Her research focuses on elucidating the immune mechanisms underlying immunogenicity of therapeutic proteins using immune tolerant transgenic mouse models. Next to that she coordinates the Fabry antibody standardization initiative (FASI) which aims to standardize anti- alpha galactosidase antibody assays worldwide, and she is involved in several studies to assess quality of biosimilar erythropoietin and interferon beta products. In 2010 she has been awarded a Veni grant (Dutch governmental grant) for her research. Since January 2013 Vera has been working as exchange scientist in the lab of Dr. Jack Ragheb at the FDA (Bethesda) on immunogenicity of therapeutic proteins using the BLT mouse model.

Reipert Birgit, Ph.D., Director, R&D Immunology, Baxter BioScience  


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.

Steven 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.

Harald Kropshofer, Ph.D., Senior Personalized Healthcare Leader, Pharmaceutical Development, F. Hoffmann-La Roche Ltd. 

Dr. Harald Kropshofer is Senior Personalized Healthcare Leader in the Pharmaceutical Division of F. Hoffmann La Roche. He is located in the head quarter in Basel, Switzerland. He is globally accountable for clinical immunology and clinical immunosafety in late stage development – with a particular focus on risk mitigation related to immunogenicity, hypersensitivity and first infusion related side-effects of therapeutic proteins in the context of cardio-vascular, neurological diseases and oncology.

Dr. Kropshofer is biochemist and immunologist by training. Prior to joining Roche in 2001, he was Group Leader at the German Cancer Research Center in Heidelberg and at the Basel Institute for Immunology. He is Associate Professor in cell biology at the University of Heidelberg since 2000.

Dr. H. Kropshofer has more than sixty publications to his credit in peer-reviewed journals, and is a regularly featured speaker at international conferences in Europe and USA.

Sally Fischer, Ph.D., Senior Scientist and Group Leader, Bioanalytical Sciences, 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/validation for Biomarkers, Pharmacokinetics (PK), as well as Anti-Therapeutic Antibody (ATA) measurements for non-oncology indications. 

Ira Pastan, M.D., NIH Distinguished Investigator, Co-Chief, Laboratory of Molecular Biology, National Cancer Institute, National Institutes of Health 

Dr. Ira Pastan was educated at the Boston Public Latin School, Tufts College, and Tufts Medical School. He did his residency at the Yale School of Medicine (1957-1959) and came to NIH in 1959. 1970, he was appointed chief of the Laboratory of Molecular Biology.

Society memberships: American Society of Clinical Investigation, Association of American Physicians, American Society of Biological Chemists, American Society of Microbiology, American Society of Cell Biology, American Association for Cancer Research, Antibody Society. Honorary Member, Japanese Cancer Association, 2005

Honors and other special scientific recognition: Van Meter Prize; G. Burroughs Mider Lectureship, National Institutes of Health, 1973; Membership, National Academy of Sciences, 1982; American Academy of Arts and Sciences; Fellow, American Academy of Microbiology; Fellow, American Association for the Advancement of Science; DHHS Secretary’s Award for Meritorious Service, 2008; International Feltrinelli Prize for Medicine, 2009 and the Nathan Davis Award, 2010.

Research activities:
Dr. Pastan is developing a new therapy for cancer by making fusion proteins composed of the Fv portion of antibodies directed at receptor proteins on cancer cells fused to a genetically modified form of a powerful bacterial toxin, Pseudomonas exotoxin A. Three of these genetically engineered proteins, which are named recombinant immunotoxins, are being tested in humans with various forms of cancer.  One of these is HA22/Moxetumomab pasudotox; it targets CD22, and has produced many complete and durable remissions in chemotherapy resistant Hairy Cell Leukemia. Another is SS1P that targets the mesothelin antigen (discovered in the Pastan lab). When combined with chemotherapy SS1P has shown anti-tumor activity in a phase I trial of mesothelioma. The third is LMB2 (Anti-Tac(Fv)-P38 being evaluated in acute adult T cell Leukemia. Because immunotoxins are foreign proteins they induce neutralizing antibodies in patients with normal immune systems limiting their use. To overcome this problem he uses protein engineering to remove T and B cell epitopes to make less immunogenic immunotoxins that can be given for many treatment cycles. 

Larry Kauvar, Ph.D., Senior Vice President & CSO Trellis Bioscience 

Dr. Kauvar is the founder and Chief Scientific Officer of Trellis and was previously the founder and CSO of Telik, a small molecule drug company focused on oncology (TELK). He is also a co-founder of Promedior, a biologics company focused on fibrotic diseases. He holds 40 US patents for methods, tools and drug compounds and is one of the inventors of CellSpot™, Trellis' core technology for discovery of high quality therapeutic antibodies directly from human B lymphocytes. Dr. Kauvar holds an undergraduate degree from Harvard (1973), a PhD from Yale in Molecular Biophysics and Biochemistry (1978), and was a Jane Coffin Childs postdoctoral fellow at Caltech in the laboratory of Seymour Benzer.

Haiyan Jiang, Ph.D., Senior Director, Preclinical and Clinical Research, Biogen Idec Hemophilia 

David W. Scott, Ph.D., Professor and Vice Chair, Research, 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 both foundation and NIH Study Sections.

Takashi Kei Kishimoto, Ph.D., Chief Science Officer, Selecta Biosciences 

Dr. Kishimoto is the Chief Scientific Officer of Selecta Biosciences, a biotechnology company developing synthetic vaccines and immunotherapies based on a novel self-assembling nanoparticle technology.  Prior to joining Selecta, Dr. Kishimoto was Vice President of Research at Momenta Pharmaceuticals where he led multidisciplinary teams in inflammation, oncology, and cardiovascular disease.  Previously he was Senior Director of Inflammation Research at Millennium Pharmaceuticals, where he provided the scientific leadership for four programs in clinical development, and an Associate Director of Immunology at Boehringer Ingelheim.  Dr. Kishimoto received his doctoral degree in Immunology from Harvard University and his post-doctoral training at Stanford University. 

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