Wellington Sun, M.D., Director, Division of Vaccine Review and Product Applications (DVRPA), Office of Vaccine Evaluation and Research (OVRR), CBER, FDADr. Wellington Sun is currently the Director, Division of Vaccines and Related, Products Applications, CBER within the US FDA. Dr. Sun earned his B.A. at Harvard University in Physics & Chemistry, and his medical degree from the Uniformed Services University of the Health Sciences in Infectious Diseases. Dr. Sun was with the Walter Reed Army Institute of Research for eleven years before joining the Centers for Disease Control & Prevention as Chief of the Dengue Branch. In 2008, Dr. Sun joined CBER at the FDA in order to be part of a science-based public health institution, and to help develop infectious disease vaccines with global impact, while working with a team of professionals dedicated to public service.
Jayanthi Wolf, Ph.D., Research Fellow, Biologics Safety Assessment, Merck & Co.Dr. Jayanthi Wolf is an Associate Director in the Department of Safety Assessment at Merck Research Laboratories in West Point, Pennsylvania. She leads the Biologics Safety Assessment group, which includes laboratories supporting the development of vaccines, biologics and siRNAs. She is also a nonclinical compound manager for vaccines and biologics in early and late stage development. Dr. Wolf received her Ph.D. in Molecular Biology from Princeton University in 2001 and joined Merck & Co. Inc. as a senior research scientist in the Department of Bioprocess R&D, where she developed assays for the release and characterization of live virus vaccines. In 2004, she joined the Department of Safety Assessment and focused her efforts as a nonclinical compound manager and scientific leader within Biologics Safety Assessment.
Jeffrey Ulmer, Ph.D., Head, External Research, Novartis Vaccines & Diagnostics, Inc.Dr. Jeffrey Ulmer received his B.Sc. with honors from the Department of Chemistry at the University of Regina in 1978 and was the recipient of the Merit Award of the Society of Chemical Industry. He received his Ph.D. in biochemistry from McGill University in 1985 and completed his postdoctoral training in the laboratory of Nobel laureate Dr. George Palade in the Department of Cell Biology at Yale University School of Medicine. At Merck Research Laboratories he conducted seminal studies on DNA vaccines, and is currently Head, Immunology & Cell Biology at Novartis Vaccines and Diagnostics. His group is responsible for discovery and technology development of vaccines and adjuvants; and production, purification, and characterization of recombinant protein-based vaccines. He has published over 150 scientific articles, is on the editorial boards of Expert Opinion on Biological Therapy and Human Vaccines, and is on the Scientific Advisory Committee of the Duke University Multiscale Integrative Immunology for Adjuvant Development program.
Else Marie Agger, M.Sc., Ph.D., Associate Director, Department of Infectious Disease Immunology, Head of Section, TB Vaccine Research, Statens Serum Institut
Else Marie Agger, M.Sc., Ph.D., is Associate Director and TB vaccine research Head of Section at the Department of Infectious Disease Immunology, Statens Serum Institut in Denmark. She holds a Ph.D. degree within immunology from the University of Copenhagen.
Else Marie Agger has extensive experience within adjuvant research, TB vaccine research and preclinical development of vaccines. She has been involved in the coordination of vaccine delivery optimisation within the EU-funded TBVAC consortium and also has previous experience as work-package leader within an EU-funded project focusing on adjuvantation of influenza vaccines. Else Marie Agger is the co-inventor of several adjuvant patents and has published more than 50 papers within vaccine and adjuvant research.
John Doukas, Ph.D., Senior Director, Pre-Clinical Safety and Efficacy, Vical, Inc.John Doukas currently serves as Senior Director, Preclinical Safety and Efficacy, at Vical Incorporated (San Diego, CA). He received a Ph.D. in Cell and Molecular Biology from Boston University, and then trained as a postdoctoral fellow at Harvard Medical School in the Department of Pathology at Brigham and Women's Hospital. This was followed by faculty positions at the University of Massachusetts Medical School, with dual appointments in the Departments of Medicine and Pathology, where his laboratory focused on the vascular biology of inflammatory and ischemic tissue damage. Moving to industry, he progressed through several positions at Selective Genetics (San Diego, CA), contributing to gene therapy programs in oncology, tissue repair, and cardiovascular diseases. He next joined TargeGen (San Diego, CA) at its start-up, leading the company's pharmacology efforts and advancing several small molecules to clinical trial, in particular for cardiovascular disease and ophthalmology indications. In 2008 he joined Vical to oversee the company's preclinical development efforts in their work to commercialize DNA-based therapies, including cancer immunotherapies and infectious disease vaccines.
Joseph Blattman, Ph.D., Assistant Professor, Immunology, School of Medicine, University of Washington
Dr. Blattman obtained his Ph.D. in Rafi Ahmed’s lab, at Emory University, Atlanta, USA, studying T cell fate during chronic viral infection. Following postdoctoral fellowships in the labs of Rafi Ahmed and Phil Greenberg (Fred Hutchinson Cancer Research Center, Seattle, USA), Dr. Blattman established his own lab at the Fred Hutchinson Cancer Research Centre, investigating strategies to abrogate inhibition of IL-2 production by negative regulatory proteins in CD8 T cells in order to enhance CD8 T cell survival and function during adoptive immunotherapy of tumors and viral infection.
Dr. Blattman also co-directs the Mouse Immunology Core, funded by the Bill and Melinda Gates Foundation, where his group is developing genetically modified mice to evaluate the immunogenicity of novel HIV vaccines. Dr. Blattman is spending a short sabbatical in Linda Klavinskis’ lab at King’s College London studying immunodominance of HIV-1 vaccine elicited CD8 T cells.
Alexander von Gabain, Ph.D., Strategic Advisor, Intercell AGAlexander von Gabain obtained his Ph.D. in Genetics at the University of Heidelberg and held a post-doctorate position at the Stanford University. In the 1980s and 1990s he was Professor at the University of Umeå and at the Karolinska Institute in Stockholm, Sweden, as well as an advisor to pharmaceutical and biotech companies. From 1992 to 1998 he was Chair of Microbiology of the University of Vienna at the Campus Vienna Biocenter, Austria and has helped to build the public private partnership of the Vienna Biocenter/IMP. In 1998 he co-founded Intercell AG and led the company as CEO until it was successfully floated on the Vienna Stock Exchange in 2005. From 2005 to 2009 he was Member of the Executive Management Board and CSO of the Company. His research interests are in the fields of microbial gene expression, host-parasite interactions, and immunology. He has published more than 100 publications and book chapters and is authoring numerous patents. He is full professor of Microbiology at the Max Perutz Laboratories of the University of Vienna, and foreign adjunct professorship at the Karolinska Institute, Stockholm, member of several professional organizations and serves on the boards of biotech enterprises, including TVM Capital, Munich. In 2008, he was appointed into the Governing Board of the European Institute of Innovation and Technology (EIT) where he is involved in the innovative entrepreneurship agenda. His achievements have been acknowledged by prestigious industrial awards, academic prizes, honourable memberships, including the Swedish Royal Academy of Engineering Science.
Christian Spyr, Ph.D., Head, Clinical Development & Project Management, Pevion Biotech Ltd.Christian A. Spyr, PhD, Head of Project Management & Clinical Development Christian Spyr joined Pevion Biotech Ltd. in 2009. His responsibilities include the advancing of the company's candidate vaccines through state-of-the-art clinical development and ensuring accordance with today's regulations. Prior to joining Pevion Biotech Ltd., he gathered experience in vaccine development while working as Clinical Development Manager, Project Manager and Program Manager at Berna Biotech Ltd. (Bern, Switzerland, later part of Crucell N.V.) in the fields of influenza and pediatric combination vaccines. As such, he successfully led development projects through various development phases up to market launch. Christian Spyr obtained his PhD from the University of Bern, Switzerland, where he was engaged in basic research on the relationship of viral structure and function.
Michael Vajdy, Ph.D., Co-Founder, President and CSO, EpitoGenesis, Inc.Dr. Michael Vajdy is Co-founder, President and Chief Scientific Officer of EpitoGenesis, Inc., established in 2008. Dr. Vajdy is a mucosal immunologist and Vaccinologist with over 20 years of direct academic and industry 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, and product development. Following his Ph.D. Studentship at Goteborg University under the supervision of Dr. Nils Lycke, a prominent mucosal immunologist, Dr. Vajdy completed post doctoral fellowships with Dr. Katherine Knight, then President of the American Association of Immunology and Dr. Marian Neutra, a renowned expert in mucosal biology and M cells of the intestinal Peyer’s patches and mucosal HIV vaccine development. Dr. Vajdy was recruited to Chiron Corporation (later Novartis Vaccines and Diagnostics, Inc.) where his work was instrumental in the development of mucosal and systemic vaccine products against various infectious diseases. Dr. Vajdy advanced one of these products, i.e. HIV-env, to non-human primate studies in which he demonstrated vaccine efficacy in protection against SHIV challenges. A clinical trial, based on Dr. Vajdy’s results from this macaque study was then conducted. He remained there 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 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 student/fellows and wrote collaborative NIH grants. Dr. Vajdy has authored over 50 manuscripts and book chapters; he is the editor of a book entitled “Immunity against Mucosal Pathogens” (Springer, 2008) and has been PI or Investigator on several NIH grants.
Adrian Bot, M.D., Ph.D., Vice President, Research, MannKind CorporationAdrian Bot, M.D., Ph.D. is a Vice President of Research at MannKind Corporation, Valencia – CA. He obtained his M.D. at the University of Medicine and Pharmacy in Timisoara – Romania and his Ph.D. in Biomedical Sciences at Mount Sinai School of Medicine in New York. He was later a Guest Scientist at the Scripps Research Institute in La Jolla and Scientist, Principal Scientist and Director of Immunology Research at Alliance Pharmaceutical Corp. in San Diego before joining Allecure Pharmaceuticals, then MannKind Corp as a Director of Research and Development. Dr. Adrian Bot's background is in theoretical and experimental immunology, cancer research and drug development. He authored and co-authored more than 75 research articles, reviews, book chapters and monographs, in basic and applied immunology. Dr. Bot holds patents and patent applications on DNA vaccines, microparticle-based technologies, immune therapeutic approaches and innovative drugs for autoimmune diseases and oncology, in various stages of development from early research to clinical. He is on several scientific advisory panels, such as the Medical Science Review Committee of the Juvenile Diabetes Research Foundation. Dr. Bot was a former Associate Editor of Journal of Immunology and is the current Editor in Chief of the International Reviews of Immunology.
Mark J. Newman, Ph.D., Vice President, Research and Development, GeoVax Inc.Dr. Newman is a graduate of the Ohio State University (B.Sc. and M.Sc.) and received his Ph.D. in Immunology from the John Curtin School of Medical Research, the Australian National University. He completed four years of post-doctoral training at Cornell University and the National Cancer Institute, National Institutes of Health and served as a full time member, Assistant Professor, of the Louisiana State University faculty prior to joining the Biotech industry 1in 1989. He served in senior scientific management roles at PaxVax (San Diego), Pharmexa (Horsholm, Denmark), Epimmune (San Diego), Vaxcel (Atlanta), Apollon (Philadelphia) and Cambridge Biotech (Boston) where he directed research, preclinical development and early stage clinical testing of protein, peptide, plasmid DNA and viral vectored vaccines and multiple vaccine adjuvants prior to joining GeoVax in 2010. Dr. Newman has co-authored more that 100 scientific papers, reviews and book chapters during his professional career. He is a named co-inventor on six issued US patents and one European patent, all related to vaccine technologies. He has also been awarded multiple USA government and foundation grants and contracts to support research and early stage clinical development in the field of vaccines.
Shan Lu, M.D., Ph.D., Professor, Medicine, University of Massachusetts Medical SchoolShan Lu is a Professor of Medicine, both at the University of Massachusetts Medical School. Dr. Lu's laboratory has been working in novel vaccine research for the last 18 years and has been one of the pioneer groups in heterologous prime-boost vaccinations.
Lynda Tussey, Ph.D., Vice President, Immunology, VaxInnateDr. Tussey joined VaxInnate in 2004 from Purdue Pharma where, as Program Leader of Immunotherapeutics , she led the overall development of Purdue Pharma's cancer vaccine program. Prior to Purdue, Dr. Tussey was a Senior Research Fellow in Viral Vaccines at Merck Research Labs where she oversaw the development of novel immune based assays for assessing T cell function and was responsible for the evaluation of human T cell responses to Merck's HIV-1 vaccines. Prior to Merck, Dr. Tussey served as Program Leader at GlaxoWellcome, where she designed and executed the overall strategy for immunotherapeutic approaches to the treatment of chronic HCV infection. Dr. Tussey received her B.S. from the University of North Carolina, and her Ph.D. in Genetics from the University of California, Berkeley. Her awards and honors include a GlaxoWellcome QRCC Award for Collaborative Research, a Wellcome Trust Hitchings-Elion Foundation Fellowship for study at the University of Oxford and a NRSA Individual Research Fellow Award for study at the University of North Carolina-Chapel Hill. Dr. Tussey has authored over 30 publications in the fields of Genetics, Immunology and Vaccines.
Alcide Barberis, Ph.D., Head, Research and Collaborations, Telormedix SAAlcide Barberis is currently Head of Research and Collaborations at Telormedix SA, Lugano, Switzerland. He has been the scientific founder of two Swiss biotech companies, ESBATech AG and Oncalis AG, and has over 13 years management experience in the biotechnology industry, as well as many years of scientific experience in the public and corporate research sector. Dr. Barberis has directed highly innovative research teams both as lecturer and group leader at the University of Zürich and as manager in his biotech companies. He holds a Ph.D. in Molecular Biology and Biochemistry from the University of Zürich, has been scientist at Harvard University and at the San Raffaele Research Institute, and is author on more than 50 scientific publications and inventor on more than 10 patent families.
John H. A. Amery, Ph.D., Principal Scientist, BioTherapeutics Pharmaceutical Sciences, Pfizer R&DJohn Amery has spent the last 9 years in Biopharmaceutical research and development at Pharmacia and Pfizer. During this time he has been supporting the manufacture, formulation, and testing of recombinant proteins, peptide conjugates, synthetic nucleotides, and polysaccharides. In recent years his focus has been delivering vaccine conjugates and novel adjuvants to the clinic along with CMC documentation to the regulators. Dr. Amery received his BS (1992) and MS (1996) in BioChemical Engineering from the University of Missouri, Columbia. He received his PhD in Engineering from the University of Nebraska, Lincoln in 2004.
Indresh Srivastava, Ph.D., Director, Purification and Analytical Development, Staff Scientist Vaccine Production Program Laboratory, Vaccine Research Center, NIAID, NIHDr. Srivastava is recognized as an expert in the field of vaccine research particularly in immunogen design, purification and characterization of vaccines. He has been working in the field for more than 25 years, and has published more than 75 scientific papers in peer reviewed journals, authored several reviews and book chapters. In addition, he has served on NIH special emphasis study sections focused on HIV Vaccines. He is on the editorial board of Current HIV Research, and a reviewer for 10 International Journals. He has a broad training and experience both in basic research, Academic and Industrial After spending more than 12 years at Chiron/Novartis, Dr. Srivastava has joined the Vaccine Research Center, NIAID/NIH to lead the purification and analytical development of vaccine candidates. Prior to joining Chiron, he was an Assistant Professor (Research) in Microbiology and Immunology, Medical College of Pennsylvania, Philadelphia.
Niranjan Y. Sardesai, Ph.D., SVP, Research & Development, Inovio PharmaceuticalsDr. 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 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 and a MVI-PATH funded program for the development of malaria 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 (MESOMARK™), 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.
Alma Fulurija, Ph.D., Head, Immunology, Ondek Pty Ltd.Dr. Alma Fulurija is Head of Immunology at Ondek Pty Ltd and also holds the position of Adjunct Senior Lecturer at the University of Western Australia. Ondek is developing a new vaccine and drug delivery system called the "Helicobacter pylori Platform Technology" (HPPT). HPPT is based on a genetically modified H. pylori bacterium capable of producing antigens or peptides while attached to the stomach wall. The HPPT can either elicit an immune response for vaccination purposes or transport therapeutic peptides across the stomach wall into the blood stream. Dr. Fulurija's research activities involve understanding the immune responses specific to H. pylori for the delivery of foreign antigens, with a strong focus on the development of an Influenza vaccine. She is a member of the Senior Management Team and is also responsible for Regulatory Affairs and Clinical Development related to HPPT.
Dr. Fulurija has extensive experience in the biotechnology industry, specifically vaccine development. She was awarded her PhD in Pathology/Immunology from University of Western Australia and subsequently received post-doctoral training at the WHO Collaborating Centre for Immunology and Vaccinology in Geneva and spent a further five years as a Lead Scientist with Cytos Biotechnology, a Swiss biotech company specialising in therapeutic vaccines for chronic diseases. She relocated back to Australia in 2007 to join Ondek Pty Ltd and to take up the Adjunct position.
Michael Vajdy, Ph.D., Co-Founder, President and CSO, EpitoGenesis, Inc.Dr. Michael Vajdy is Co-founder, President and Chief Scientific Officer of EpitoGenesis, Inc., established in 2008. Dr. Vajdy is a mucosal immunologist and Vaccinologist with over 20 years of direct academic and industry 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, and product development. Following his Ph.D. Studentship at Goteborg University under the supervision of Dr. Nils Lycke, a prominent mucosal immunologist, Dr. Vajdy completed post doctoral fellowships with Dr. Katherine Knight, then President of the American Association of Immunology and Dr. Marian Neutra, a renowned expert in mucosal biology and M cells of the intestinal Peyer's patches and mucosal HIV vaccine development. Dr. Vajdy was recruited to Chiron Corporation (later Novartis Vaccines and Diagnostics, Inc.) where his work was instrumental in the development of mucosal and systemic vaccine products against various infectious diseases. Dr. Vajdy advanced one of these products, i.e. HIV-env, to non-human primate studies in which he demonstrated vaccine efficacy in protection against SHIV challenges. A clinical trial, based on Dr. Vajdy's results from this macaque study was then conducted. He remained there 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 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 student/fellows and wrote collaborative NIH grants. Dr. Vajdy has authored over 50 manuscripts and book chapters; he is the editor of a book entitled "Immunity against Mucosal Pathogens" (Springer, 2008) and has been PI or Investigator on several NIH grants.