Day 1 | Day 2 | Speaker Bios
Jay A. Berzofsky, M.D., Ph.D., Chief, Vaccine Branch, Center for Cancer Research, National Cancer Institute (NCI), National Institutes of Health
Dr. Jay Berzofsky was appointed Chief of the new Vaccine Branch, Center for Cancer Research, National Cancer Institute, in 2003, after being Chief of the Molecular Immunogenetics and Vaccine Research Section, Metabolism Branch, National Cancer Institute, NIH, since 1987. He graduated Summa cum Laude from Harvard (1967), and received a Ph.D. and M.D. from Albert Einstein College of Medicine. After interning at Massachusetts General Hospital, he joined NIH in 1974. Dr. Berzofsky's research has focused on antigen processing and presentation by MHC molecules, the structure of antigenic determinants, cytokine and regulatory cell control of T cell function and avidity, and translation to the design of vaccines for AIDS, malaria, cancer, and viruses causing cancer. He has over 440 scientific publications. Dr. Berzofsky has received a number of awards, including the U.S. Public Health Service Superior Service Award, the 31st Michael Heidelberger Award, the McLaughlin Visiting Professorship, the Australasian Society for Immunology Visiting Lectureship, the Tadeusz J. Wiktor Memorial Lectureship, and the Herschel Zackheim Lectureship Award. He is past President of the American Society for Clinical Investigation, a member of the Association of American Physicans, and a Fellow of the American Association for the Advancement of Science, and was elected Distinguished Alumnus of the Year for 2007 by the Albert Einstein College of Medicine. He was also elected Chair of the Medical Sciences Section of the American Association for the Advancement of Science (AAAS) for 2007-2008. In 2008, he received the NIH Director’s Award and the NCI Merit Award.
Bali Pulendran, Ph.D., Professor, Pathology, Emory University School of Medicine
Area of Research: Basic Immunology/Virology/Vaccinology/Systems Biology
Dr. Bali Pulendran is a Charles Howard Candler Professor of Pathology and Laboratory Medicine, and Director of the Innate Immunity Program, and the NIH U19 Center for Systems Vaccinology, at the Emory Vaccine Center, Emory University in Atlanta. He received his undergraduate degree from Cambridge University, and his Ph.D from the Walter & Eliza Hall Institute, in Melbourne Australia, under the supervision of Sir Gustav Nossal. He then did his post-doctoral work at Immunex Corporation in Seattle. Dr. Pulendran’s work focuses on understanding the mechanisms by which the innate immune system regulates adaptive immunity and harnessing such mechanisms in the design of novel vaccines against global pandemics. More recently, he has begun to apply systems biological approaches to predicting the efficacy of vaccines, and deciphering new correlates of protection against infectious diseases. Dr. Pulendran’s research is published in front line journals such as Nature, Science, Cell, Nature Immunology, and The Journal of Experimental Medicine. Furthermore, Dr. Pulendran is the recipient of numerous grants from the National Institutes of Health, and from The Bill and Melinda Gates Foundation, serves on the editorial boards of The Journal of Clinical Investigation and The Journal of Immunology, serves on the Aids Vaccine Research Subcommittee, and is frequently invited to speak in the plenary sessions of many national and international conferences.
Sean Tucker, Ph.D., Founder, VP Research & CSO, Vaxart, Inc.
Dr. Tucker founded Vaxart in 2004. Dr. Tucker received his Ph.D. in Immunology from the University of Washington and previously held research and development positions of increasing responsibility at Genteric, SyStemix, and Dow Chemical. Nathalie Garçon, Pharm.D., Ph.D., VP, Head of Global Adjuvant Centre for Vaccine Development, GSK Biologicals
Nathalie Garçon, Pharm.D., Ph.D., VP, Head of Global Adjuvant Centre for Vaccine Development, GSK Biologicals
Nathalie Garçon completed her biological Pharmacist PhD degree in 1983 and her PhD in immunotoxicology and immunopharmacology in 1985, followed by a year in England as a postdoctoral research fellow at the Royal Free Hospital in London, undertaking research on liposomes in vaccines. She then moved to the USA where she spent four years at Baylor College of Medicine in Houston, Texas, first as a postdoctoral research fellow, then as assistant professor, working on vaccine delivery systems and immunopotentiators. Nathalie joined SmithKline Beecham Biologicals – now GlaxoSmithKline – in 1990 where she set up and led the vaccine adjuvant and formulation group. She provides leadership within GSK in the field of adjuvants, from discovery to registration and commercialisation of adjuvanted vaccines. Her responsibilities have moved from manager formulation research, to Vice president, head of Global Research and R&D in North America. She now heads the Global Adjuvant Center for Vaccine Development. Her expertise in vaccinology extends from research to manufacturing, in particular covering immunology, adjuvant and formulation technologies, analytical methods, animal experimentation and toxicology evaluation and testing.
Israel Rios, M.D., CMO & Senior VP, SciClone Pharmaceuticals, Inc.
Israel Rios, M.D. has served as Chief Medical Officer since joining SciClone Pharmaceuticals, Inc. in October 2005. Dr. Rios has over 30 years of experience in the biotechnology and pharmaceutical industries. Dr. Rios is responsible for the design and oversight of all clinical trials, clinical operations, drug safety and the evaluation of new development candidates. He serves as an officer and senior vice president in the company and is a member of the Senior Management Team. From 2003 to 2005 he served as Vice President of Clinical Affairs for Dendreon Corporation and was responsible for all clinical and operational activities related to the development of late-stage immunotherapeutic candidates for androgen independent prostate cancer (AIPC) and advanced breast cancer. From 1993 to 2003, Dr. Rios was at Berlex Laboratories (the U.S. affiliate of Schering AG of Germany ) most recently as Vice President of Oncology Development, where he oversaw the development of Fludara, Campath and Betaseron. From 1984 to 1993, Dr. Rios was Senior Director of Anti-Infective Clinical Research at Marion Merrell Dow, Inc. where he directed the clinical development and helped manage the New Drug Application (NDA) submissions of several anti-infective products. From 1978 to 1984, Dr. Rios held several escalating positions at Bristol-Myers, most recently as Director of Clinical Research. Dr. Rios earned his M.D. degree at the Central University of Venezuela. He completed his internship and residency in internal medicine at Mount Sinai Hospital in Hartford , Connecticut , and his fellowship in infectious diseases at Hartford Hospital in Hartford , Connecticut.
Michael Vajdy, Ph.D., CEO, EpitoGenesis, Inc.
Dr. Michael Vajdy is co-founder and CEO of EpitoGenesis Inc. since November of 2008. Dr. Vajdy is a Mucosal Immunologist with 20 years of experience in designing mucosal and systemic adjuvants and vaccines, studying mucosal and systemic B and T cell immune induction mechanisms and long-term immunological memory. Following Ph.D. studentship at Goteborg University under the supervision of Dr. Nils Lycke, a prominent Mucosal Immunologist, Dr. Vajdy completed his first post doctoral fellowship with Dr. Katherine Knight, then President of the American Association of Immunologists. Dr. Vajdy completed his second post doctoral fellowship with Dr. Marian Neutra, an expert in Mucosal Biology and M cells of the intestinal Peyer’s patches. Dr. Vajdy was recruited to Chiron Corporation, later acquired by Novartis Vaccines and Diagnostics Inc., where he remained for 9.5 years with increasing responsibilities including project leadership for a vaccine manufacturing platform technology. He also held simultaneous academic positions as Adjunct Clinical Assistant Professor with the Department of Internal Medicine, Division of Infectious Diseases and as Visiting Associate Professor at Department of Medical Microbiology and Immunology, University of California, Davis. He was also a Faculty Member with the Graduate Group, Department of Comparative Pathology, University of California, Davis. In these capacities, he trained a Ph.D. student and 3 post-doctoral fellows and wrote collaborative NIH grants. Dr. Vajdy has authored 50 papers and book chapters. He is the editor of a book entitled “immunity against mucosal pathogens” (Springer, 2008).
William M. Egan, Ph.D., Vice President, PharmaNet Consulting
Dr. Egan has over 30 years experience in the development and regulation of biologics. In his current capacity as Vice President in the Consulting Division at PharmaNet, Dr. Egan advises clients on strategic planning and development of biologics, primarily vaccines and therapeutic proteins; he has consulted on regulatory submissions from pre-IND meetings through to BLA license applications and post-marketing changes. Dr. Egan joined PharmaNet in 2005, after spending 28 years at the FDA’s Center for Biologics Evaluation and Review and its precursor agencies. Dr. Egan was the Office of Vaccines Research and Review’s Acting Director for one and a half years prior to his retirement from FDA in 2005. During his career at FDA, Dr. Egan also held positions as Deputy Director of OVRR (1995 – 2005), OVRR Associate Director for Research (1993 – 2005), and Chief of the Biophysics Laboratory (1983 – 1995). During his tenure at OVRR, Dr. Egan represented the Agency to various National and International organizations and to the US Congress.
Dr. Egan received his Ph.D. in Chemistry from Princeton University and prior to joining CBER was a Post-doctoral fellow at the Division of Physical Chemistry at the Lund Institute of Technology (Sweden) and a Senior Staff Fellow at the National Institutes of Health (Bethesda, MD). Dr. Egan is the author or co-author of over 100 scientific publications, primarily in the area of structural characterization of bio-macromolecules.
Dr. Egan is a member of a number of profession societies, including the International Association for Biologicals, for which he is co-chair for the Human Vaccines Scientific Committee. Dr. Egan is also a member of the Vaccines and Virology Expert Committee for the US Pharmacopeia.
Shan Lu, M.D., Ph.D., Professor, Medicine, University of Massachusetts Medical School
Dr. Lu received his medical degree from Nanjing Medical College in 1982, and his doctorate in 1991 from the University of Massachusetts, Worcester. His lab’s main interest is to understand the immunogenicity of protein antigens. The human immunodeficiency virus type-1 (HIV-1) envelope proteins (Env) is used as a model system in our lab. Env, a two-subunit protein, is generated during the posttranslational cleavage process from a single precursor polyprotein. Env heterodimers are further organized into an oligomeric complex. Env conformation is critical for the interaction of HIV-1 with a number of viral receptors. Our work is to understand the immunogenicity of various Env subunits from different HIV-1 strains and to find the Env structures that HIV-1 uses to escape from host immune surveillance. Such information will be used to design novel HIV-1 vaccines. Direct DNA immunization using eukaryotic expression vectors to make proteins in vivo is a unique approach we have been using to study the immunogenicity of protein antigens. We are also working to further improve this evolving technology by studying the roles of cytokines and adjuvants in inducing the desired immune responses by direct DNA immunization.
Alfredo Nicosia, Ph.D., CSO, Okairos
Alfredo Nicosia, Ph.D. is Chief Scientific Officer at Okairos. He holds a degree in Chemistry from the University of Rome and has gained extensive experience in vaccine research and immunology. During his career, he held a number of positions in basic research Institutions including the EMBL in Heidelberg, FRG where he was Staff Scientist and in pharmaceutical Companies such as Merck where he was Senior Director. More recently, Dr. Nicosia cofounded Okairos, a clinical stage biopharmaceutical company dedicated to the development of genetic vaccines. At Okairos, he has contributed to the development of vaccine candidates for HCV and Malaria. Dr. Nicosia has published more than 90 peer-reviewed manuscripts and holds a number of patents and patent applications.
Niranjan Y. Sardesai, Ph.D., Senior VP, Research & Development, Inovio Biomedical Corporation
Dr. Sardesai has broad operating and consulting experience in biotechnology and pharmaceuticals. He was SVP, Research & Development, with VGX Pharmaceuticals and, with the merger of VGX with Inovio Biomedical in June 2009, became SVP, Research & Development, of the merged company. Dr. Sardesai is responsible for leading the company's product development programs in infectious disease and cancer vaccines and vaccine delivery systems. He currently serves as the PI on an NIAID funded HVDDT contract for the development of HIV vaccines. Prior to VGX, Dr. Sardesai was the founder and President of NVision Consulting Inc., a strategy consulting firm focused on entrepreneurial companies in the biopharma/lifesciences industry, and he served as Director R&D at Fujirebio Diagnostics, Inc. At FDI, Dr. Sardesai oversaw all aspects of R&D activities and expansion of the oncology portfolio. Products developed under his leadership include new-to-the-world tests for mesothelioma (MESOMARKT), bladder cancer and a multi-marker test for ovarian cancer. Dr. Sardesai also served as a senior scientist at IGEN International, Inc. developing a high-throughput screening platform for drug discovery. He has authored over 30 peer-reviewed publications and filed several patents. Dr. Sardesai received a Ph.D. in Chemistry from the California Institute of Technology and an MBA from the Wharton School of the University of Pennsylvania, where he was the recipient of the Shils-Zeidman Award in Entrepreneurship. He completed fellowships at Scripps Research Institute and Massachusetts Institute of Technology. Dr. Sardesai received his M.Sc. in Chemistry from the Indian Institute of Technology.
Linda McAllister, M.D., Ph.D., Chief Medical Officer & VP, R&D, PharmaJet, Inc.
Dr. McAllister was formerly Assistant Clinical Professor of Medicine at UCSF and Attending Physician in the SFGH ER and UCSF with responsibility for patient care and staff supervision. She worked at Affymetrix, Celera and at Roche where she was Director of Technology Management. Most recently, she was EVP & CMO at Arbor Vita, where she managed the FDA approval of devices for detecting influenza and cervical cancer/HPV. Her B.S. is from Caltech; her medical degree is from Stanford, and her doctorate is also from Stanford University (Neuroscience Program, Dr. Corey Goodman in Molecular Genetics of Neuronal Development). Her Post-doctoral Fellowship at Stanford was in the lab of Dr. Patrick O. Brown, in Genetic Applications of DNA Microarrays.
Tarek Hamouda, M.D., Ph.D., M.B.A., Director of Vaccines, NanoBio Corporation
Dr. Hamouda received his MD and PhD in microbiology and immunology from the Faculty of Medicine, Cairo University. He then moved to the United States and had his post-doctoral training at Wayne State University working on the development of cure for HIV using Herpes simplex virus virion host shut-off gene.
In 1997, he joined Dr. James Baker’s Laboratory at the University of Michigan where he directed the development of novel broad-spectrum antimicrobial nanoemulsions. His research also involved the use of the emulsions as immuno-adjuvants for prophylaxis of influenza viral infection. His efforts contributed to the foundation of a start-up company “NanoBio” to commercialize the nanoemulsions as topical antimicrobials and vaccine adjuvant.
Dr. Hamouda joined NanoBio in 2001 and directed NanoBio’s preclinical research. This led to the advancement of 4 products to clinical trials, the granting of 6 patents and the publication of 11 peer reviewed articles.
Currently, he is leading the preclinical development of intranasal influenza vaccine using the nanoemulsion as a vaccine adjuvant platform. He is also consulting on other related vaccine programs. During his career, he played a leadership role, managed budget, directed research programs, supervised GMP manufacturing, filed patents, secured grants, wrote papers and was involved in teaching. Recently, Dr. Hamouda obtained his MBA degree from MSU to add business academic knowledge to his business experience.
Mario Amacker, Ph.D., Head Process Development & Manufacturing
Mario Amacker joined Pevion Biotech Ltd. in 2003 as a group leader of the development of virosome-based formulations and successfully promoted Pevion Biotech’s technology platform. He was appointed to the position of Head Process Development and Manufacturing in July 2009. Prior to joining Pevion Biotech Ltd., he was project manager at Gnothis SA (Lausanne, Switzerland) and responsible for the development of enzymes used in single-molecular sequencing by fluorescence correlation spectroscopy. From 1998 to 2000 he held a post-doc position at the Swiss Cancer Research Institute (ISREC, Epalinges, Switzerland) and performed basic research on human telomerase. Mario Amacker holds a PhD in Biochemistry from the University of Zurich (Switzerland) and a Master’s degree in Biochemistry and Molecular Biology from the Swiss Federal Institute of Technology.
Arin Ghasparian, Ph.D., CSO, Virometix AG
Dr. Ghasparian studied chemistry at the University of Zurich. After receiving his diploma in 2004 he joined the group of Prof. Robinson at the University of Zurich as a PhD student, where he worked on synthetic vaccine design and co-invented the SVLP technology. After a short period as a postdoctoral researcher he co-founded Virometix AG in late 2009, where he is now CSO.
Zhengrong Cui, Ph.D., Associate Professor, College of Pharmacy, The University of Texas at Austin
Dr. Cui earned his Ph.D. degree in Pharmaceutics from the University of Kentucky. His postdoctoral training was done at the University of Pittsburgh. Dr. Cui was an assistant professor of pharmaceutics at the Oregon State University College of Pharmacy from 2004 to 2009. In January 2010, he joined UT-Austin College of Pharmacy as an Associate Professor. Dr. Cui’s research focuses on vaccine and drug delivery.
Mei X. Wu, M.D., Ph.D., Associate Professor, Wellman Center for Photomedicines, MGH/Harvard Medical School
Dr. Mei X. Wu received her Ph.D. from Utah State University in 1992, after which she was trained as a post-doctoral fellow at Massachusetts Institute of Technology (MIT) and then at Dana-Farber Cancer Institute, Harvard Medical School (HMS). She became an instructor in 1995 at HMS and an assistant professor in 1999 at Baylor College of Medicine. She relocated to Massachusetts General Hospital/HMS in 2003. Her laboratory studies the molecular mechanisms and signaling pathways in association with autoimmune diseases, protective immune responses, and immune-suppression.
One of the major focuses in her laboratory is the study of the biological function of a stress-responsive gene named Immediate Early responsive gene X-1 (IEX-1). IEX-1 is one of the cell survival genes regulated by the NFκB transcription factor. IEX-1 targets an intrinsic inhibitor for mitochondrial FoF1-ATPase named IF1 to degradation, which distinguishes IEX-1 from other anti-apoptotic genes like the Bcl-2 family.
Another line of research in her laboratory is to unravel a complex interaction between Gαi2- and Gαi3-dependent signaling in directing lymphocyte trafficking in vivo. Her laboratory takes advantage of many newly-developed technologies at Wellman to answer questions pivotal to the modulation of immune response.
Dr. Wu’s research has been continuously supported by various competitive funds from the National Institutes of Health (NIH), the Department of Defense, the American Cancer Society, the Crohn’s & Colitis Foundation of America, and the American Heart Association. Dr. Wu was named an American Cancer Society Research Scholar in 2003 and the recipient of the Senior Research Award from the Crohn’s & Colitis Foundation of America in 2007. She also received an Independent Scientist Award from NIH in 2006.
Marli Watt, M.D., Clinical Safety Physician, Clinical Safety, CSL Limited
Marli currently works at CSL Limited in Melbourne, Australia, as both a Clinical Safety Physician and as the Head of Pharmacovigilance & Quality Operations, in Clinical Research & Development. The majority of her professional life was spent working as a primary care physician / obstetrician, and then in public health with a particular focus on health care policy and management. She has been working in the pharmaceutical industry for 5 years and has been described as passionate and pedantic about ensuring patient safety!
Day 1 | Day 2 | Speaker Bios