Cambridge Healthtech Institute’s Inaugural
Novel Vaccines Part One: Adjuvants, TLRs & DNA Vaccines
Norman W. Baylor, Ph.D., President and CEO, Biologics Consulting Group, Inc.
Dr. Baylor joined Biologics Consulting Group after 20 years with the Food and Drug Administration (FDA), most recently as the director of the Office of Vaccines Research and Review (OVRR).
In his prior position at the FDA’s Center for Biologics Evaluation and Research, Dr. Baylor was responsible for planning, developing, and administering CBER’s broad national and international programs and operational activities involving vaccines and related products. He has also served as the FDA's liaison to CDC's Advisory Committee on Immunization Practices, and the DHHS National Vaccine Advisory Committee. Dr. Baylor continues to serve as an expert advisor to the World Health Organization in addition to providing strategic consulting to BCG clients in the areas of vaccines and vaccine-related products.
Nathalie Garçon, Ph.D., PharmD., Vice President, Head, Global Vaccine Centre for Adjuvants and Technology Innovation, GlaxoSmithKline
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.
Mark C. Poznansky, M.D., Ph.D., Associate Professor, Medicine, Harvard Medical School, and Director, Vaccine and Immunotherapy Center, Infectious Diseases Medicine, Massachusetts General Hospital
Mark C. Poznansky MD, PhD is an Associate Professor of Medicine at Harvard Medical School and Attending Physician in Infectious Diseases Medicine at the Massachusetts General Hospital. Dr. Poznansky runs a laboratory funded by the NIH, Juvenile Diabetes Research Foundation, The Marsha Rivkin Center and private foundations at MGH. Dr. Poznansky’s laboratory defines molecular mechanisms for novel immune processes and explores the relevance of these mechanisms to novel approaches to vaccines and immunotherapies for cancer and infectious diseases. In practical terms, Dr. Poznansky and his lab team work at the interface between the discovery and development of novel vaccines/immunotherapies and the execution of proof of principle experiments in validated animal models of infectious diseases and cancer. He brings his passion and wealth of personal experience of medical discovery, translational medicine and the development of novel products for patients to the newly created Vaccine and Immunotherapy Center at MGH which he directs. He is also the scientific founder of Celtaxsys, serves on the scientific advisory board of ACTx and is a scientific consultant to Novelos and the St. Joseph’s Translational Research Institute in Atlanta. Dr. Poznansky also serves in the Innovation Liason Program at MGH which works at the interface between inventive scientists at MGH and the Ventures and Licensing Office. Dr. Poznansky also serves as a mentor for junior scientists at MGH, in the Boston Scientific Careers Program, and at Cambridge University and Imperial College in England.
Danilo Casimiro, Ph.D., Executive Director, Vaccine R&D, Merck Research Laboratories
Dr. Danilo Casimiro is Executive Director and Department Head of MRL Vaccine Discovery Operations. He received his B.S. and M.S. degrees from Chemistry the University of the Philippines, PhD degree in Biochemistry from the California Institute of Technology. He joined the Merck Research Laboratories in 1996. He has over 15 years of vaccine research and development experience at Merck & Co where he grew with increasing responsibilities for the R&D programs. He has held several programmatic and organizational leadership positions which include those overseeing the Viral Vaccine Discovery Group, the Clinical Assay Laboratories for the HPV, HIV, and Influenza programs, HIV Vaccine R&D team and the Vaccine Technologies Discovery Group, among others. He has contributed to the selection & nomination of a total of twelve (12) novel vaccine candidates and a monoclonal antibody (anti-IGFIR) for clinical development. He has contributed to 2 late-stage vaccine programs and the licensure of Merck’s Gardasil HPV vaccine. He has served on numerous advisory committees to the Bill and Melinda Gates Foundation (BMGF) Global Health, International AIDS Vaccine Initiative, HIV Vaccine Enterprise, Human Vaccine Project, and USAID. Dr. Casimiro currently holds 24 vaccine patents and 3 applications; he is the author of 2 book chapters and 95 peer-reviewed journal articles, 76 of which are in the area of infectious diseases and vaccinology. He has published in prominent journals such as Nature, Nature Medicine, Lancet, Science, Journal of Virology, Journal of Infectious Diseases, PLos One, Journal of Immunology and Vaccine.
John Hiscott, Ph.D., Program Director, Vaccine & Gene Therapy Institute of Florida
John Hiscott, Ph.D. is a Program Director at the Vaccine and Gene Therapy Institute of Florida. He earned his doctorate from New York University Medical Center, and completed post-doctoral training at the University of Zurich in Switzerland. Prior to joining VGTI-Florida, Dr. Hiscott was Professor and Director of the Molecular Oncology Group at Jewish General Hospital, McGill University in Montreal. Dr. Hiscott’s work has focused on the innate immune response to virus infection and human retrovirus pathogenesis. He is also investigating the use of oncolytic viruses as novel experimental cancer therapeutics. For his research accomplishments, Dr. Hiscott has earned numerous awards and distinctions, including the Milstein Award, given by the International Society of Interferon and Cytokine Research for scientific achievement. He was the recipient of Scientist and Senior Scientist scholarships from the Canadian Institutes of Health Research, the Distinguished Service Award from the Israel Cancer Research Fund, an Award for Excellence in Medical Research from Jewish General Hospital, the Beijerinck Award in Virology from Leiden University Medical Center, The Netherlands and is a member of Canada’s Who’s Who. He is a member of several scientific journal editorial boards, and in 2006 was appointed Editor-in-chief of Cytokine and Growth Factors Review, a leading immunology review journal.
Andrew Geall, Ph.D., RNA Vaccine Platform Leader, Vaccine Delivery & Formulation Research, Novartis Vaccines & Diagnostics, Inc.
Andrew J. Geall, Ph.D. is the RNA Vaccine Platform Leader at Novartis Vaccine and Diagnostics (Cambridge, USA). He has undergraduate degrees in Chemical Engineering and Pharmacy and completed his Ph.D. in gene therapy at the University of Bath U.K. in 1999. Before joining Novartis in 2006, Dr. Geall was manager of the Pharmaceutics department at Vical (San Diego). He led the formulation development of the company’s DNA vaccine program and was responsible for production of the gene delivery systems for clinical trials. He joined Novartis Pharma to lead siRNA delivery efforts and in 2008 moved to the Vaccines Research division to establish the RNA Vaccine Platform and has made a major contribution to the patent estate for this novel technology.
Shan Lu, M.D., Ph.D., Professor, University of Massachusetts Medical School
Shan Lu, MD, PhD, MHA is a pioneer in DNA vaccines. In the last two decades, while most other scientists used DNA vaccines for the induction of T cell responses, he has used DNA immunization to elicit high quality antibody responses against HIV-1, bioterrorism (plague, smallpox, anthrax and botulinum) and emerging pathogens (SARS, seasonal and pandemic influenza), pathogens causing chronic infectious diseases (hepatitis viruses and h-CMV) and pathogens causing neglected infectious diseases, including diarrhea. Dr. Lu is a professor in the Department of Medicine, University of Massachusetts Medical School. He is the current President of International Society for Vaccines (ISV).
David B. Weiner, Ph.D., Professor, Pathology and Laboratory Medicine, Chair, Gene Therapy and Vaccine Program, CAMB, University of Pennsylvania Perelman School of Medicine
David Weiner is Professor of Pathology and Laboratory Medicine, Co-Program leader of Tumor Virology at the Abramson Cancer Center, and Chair of the Gene Therapy and Vaccines Graduate Program, at the University of Pennsylvania. He has worked extensively in the areas of molecular immunology and viral pathogenesis, on the development of gene-based vaccines and immune therapies. His laboratory helped found the field of DNA vaccines and was the first to report on its application to HIV vaccine development and the first to report on and develop applications in cancer immune therapy. Importantly and atypically, his laboratory and collaborators were the first to move DNA vaccines to human clinical studies, establishing their initial safety and immunogenicity. His group has been instrumental in the recent resurgence in interest in the DNA vaccine field due to developing second generation synthetic enhanced vaccines and delivery approaches which have radically improved this technology. These new approaches exhibit improved immune potency in NHP and humans. His laboratory has published 340+ peer reviewed scientific research publications, reviews and 8 books/special volumes. Dr. Weiner is an avid supporter of scientific education and graduate and post graduate student training. He has served on advisory boards as well as a consultant to academic organizations or industry. His service includes work with vaccine important organizations such as - NIH, FDA, NIBSC, WHO, EU Commission, Gates foundation, Pfizer, Inovio, BMS, Medimmune, Novartis, Merck, J & J, VGXi among others. Dr. Weiner, among other honors, was elected a fellow of the American Association for the Advancement of Science in 2011 and is an NIH Directors Transformative Research Award Winner.
Philip R. Dormitzer, M.D., Ph.D., Head, US Research, Global Head of Virology, and Vice President, Novartis Vaccines
Philip R. Dormitzer, M.D., Ph.D. is Head of US Research, Global Head of Virology, and Vice President at Novartis Vaccines in Cambridge, Massachusetts. He is a practicing physician, who is board certified in Internal Medicine. After studying anthropology at Harvard College and carrying out a field study of the Efe Pygmies in the Ituri Forest of Zaire, he completed his M.D. and Ph.D. in Cancer Biology at Stanford University. Dr. Dormitzer completed house-staff training in Internal Medicine at Massachusetts General Hospital and a fellowship in the Harvard Combined Infectious Diseases Training Program. He conducted his fellowship research in the Laboratory of Molecular Medicine, led by Dr. Stephen Harrison. As an Assistant Professor of Pediatrics at Harvard Medical School, Dr. Dormitzer led a structural virology laboratory. The Dormitzer group and its collaborators determined the structures of the rotavirus neutralization antigens by NMR spectroscopy, X-ray crystallography, and near atomic resolution electron cryomicroscopy. At Novartis, as Senior Project Leader for Viral Vaccine Research, he led global vaccine research projects. In 2009, these projects included the research component of the Novartis response to the H1N1v influenza pandemic, supporting the development and licensure of three pandemic influenza vaccines in the most rapid vaccine response in history. As Head of the Viral Advanced Programs Global Team, he coordinated scientific and industrial functions to advance novel viral vaccine projects toward licensure, with a primary focus on an engineered RSV F subunit vaccine candidate, intended for maternal immunization. As Head of US Vaccines Research, he now leads approximately 70 scientists based at the Novartis Vaccines Cambridge Research Center in their mission to discover new vaccines, support vaccine development, and sustain licensed vaccines. The team’s technology platforms include structurally engineered antigens, adjuvants that target toll-like receptors, and self-replicating messenger RNA vaccines. In a BARDA-funded collaboration with the J. Craig Venter Institute and Synthetic Genomics Vaccines, Inc., the team developed a process to synthesize influenza vaccine seed viruses and deployed the technology in response to the H7N9 influenza outbreak in China.
Anna-Karin Maltais, Ph.D., CSO, Eurocine Vaccines AB
Dr. Maltais is an immunologist by training and holds a Ph.D. in Immunobiology from the Karolinska Institute, Sweden, where she focused on vaccine adjuvants and vaccine delivery. She has previously worked as Vice President, Corporate Development at Cyto Pulse Sciences Inc., a U.S. company focusing on vaccine administration by electroporation. Dr. Maltais has over 10 years’ experience of clinical trials of new vaccines and has solid experience in vaccine development. She has published most actively in the area of DNA vaccines and vaccine delivery by electroporation (primarily under her former family name Roos). Dr. Maltais has been employed at Eurocine Vaccines as Business Development Manager since 2011 and is the Head of Research and Development (Chief Scientific Officer, CSO) since September of 2012.
Kathy Holtz, Ph.D., Formulation Development Scientist, Protein Sciences Corporation
Kathy Holtz received her Ph.D. in Biochemistry from Boston College, and is currently employed at Protein Sciences Corporation as a formulation development scientist.
William M. Egan, Ph.D., Senior Expert, Novartis Vaccines & Diagnostics
After receiving a PhD degree in Chemistry from Princeton University and serving as a post-doctoral fellow in the Division of Physical Chemistry at the Lund Institute of Technology (Sweden), Dr. Egan joined the National Institutes of Health in 1975. Dr. Egan subsequently began his FDA career at the Bureau of Biologics (currently, the Center for Biologics Evaluation and Research) where he was a researcher and reviewer in the Division of Bacterial Products. In 1981, Dr. Egan became the Chief of the Biophysics Laboratory and, following an organizational restructuring of Biologics in the early 1990’s, Dr. Egan became the Associate Director for Research for the Office of Vaccines Research and Review (OVRR) and, in 1995, the Deputy Director for OVRR. In December, 1999, Dr. Egan became the Acting Director for OVRR, a position he again assumed in 2003 and held until January, 2005, when he retired from FDA. Dr. Egan then joined the consulting division of PharmaNet, a global CRO, where he was Vice President, Consulting; at PharmaNet, Dr. Egan provided consulting services to the Vaccines, Allergenics, and Biopharmaceutical Communities. Dr. Egan remained at PharmaNet until January, 2012, when he joined Novartis Vaccines and Diagnostics in his current position as Scientific Affairs Senior Expert.
Dr. Egan’s research career focused primarily on the structure (including dynamic structure) and function of bio-macromolecules, including proteins, DNA, and bacterial polysaccharides, primarily through the use of NMR spectroscopy. Dr. Egan is the author and co-author of over 110 scientific publications. Among other scientific organizations, Dr Egan is a member of the International Alliance for Biological Standardization (IABS: formerly the International Association for Biologicals) where he serves as a Board Member and co-chair for the Human Vaccines Committee. Dr. Egan was a member of the Vaccines and Virology Expert Committee for the US Pharmacopeia from 2005 to 2010.
Tod Merkel, Ph.D., Principle Investigator, Laboratory of Respiratory and Special Pathogens, Center for Biologics Evaluation and Research (CBER), FDA
Tod Merkel received his B.S. in biology from the University of Illinois in 1985 and his Ph.D. in microbiology from the University of Virginia in 1992. Dr. Merkel did his post-doctoral fellowship at the National Institutes of Health from 1992 to 2000 where he utilized molecular and genetic approaches to identify genes involved in the regulation of expression of virulence factors in Bordetella pertussis and developed improved vaccine strains for the production of Pertussis vaccines. In 2000 he moved to the Center for Biologics Evaluation and Research at the FDA where he is a tenured Principle Investigator in the Laboratory of Respiratory and Special Pathogens. He directs a research program with the aim of characterizing the interaction between the respiratory pathogens Bordetella pertussis and Bacillus anthracis with the human host. In addition to his research responsibilities he is responsible for the review of vaccine applications for B. pertussis and B. anthracis-related products. He also provides scientific input for policy decisions related to bacterial products under review or expected to come under review within the Center for Biologics Evaluation and Research.
James D. Cherry, M.D., M.Sc., Distinguished Research Professor, Pediatrics, David Geffen School of Medicine, UCLA, and Attending Physician, Pediatric Infectious Diseases, Mattel Children’s Hospital
Dr. Cherry is a Distinguished Research Professor of Pediatrics at the David Geffen School of Medicine at UCLA and a member of the Division of Infectious Diseases at Mattel Children’s Hospital UCLA. He received his BS degree from Springfield College, Massachusetts in 1953 and his MD degree from The University of Vermont in 1957. He subsequently received an MSc degree in Epidemiology in 1983 from The London School of Hygiene and Tropical Medicine. Dr. Cherry served his pediatric internship and residencies at Boston City Hospital, Boston, Massachusetts and Kings County Hospital in Brooklyn, New York. He had a fellowship in Infectious Diseases in Medicine in 1961 -1962, at the Harvard Medical School and Thorndike Memorial Laboratory, Boston City Hospital. He had faculty appointments at the University of Vermont, University of Wisconsin, St. Louis University and since 1973 at UCLA. He is board certified in Pediatrics and Pediatric Infectious Diseases. Dr. Cherry has carried out research related to pediatric infectious diseases for over the last 50 years and relating to this he has over 650 publications in journals and in textbooks. He is the coeditor of the “Textbook of Pediatric Infectious Diseases” (the 7th edition in 2014). During the last 45 years his research has been primarily related to vaccine preventable diseases. During the last 37 years, his investigations have been predominantly related to pertussis and its prevention.
Erik L. Hewlett, M.D., Professor, Medicine and of Microbiology, Immunology and Cancer Biology, University of Virginia School of Medicine
Erik L. Hewlett, MD, is Professor of Medicine and of Microbiology, Immunology and Cancer Biology at the University of Virginia School of Medicine. He received his BA degree in Philosophy and Biology from Westminster College, Fulton, Missouri and his MD degree from the Johns Hopkins University School of Medicine in Baltimore. Following his residency in internal medicine at New York Hospital/Memorial Sloan-Kettering Cancer Center/Cornell Medical School, he conducted post-doctoral research at the National Institutes of Health in the Clinical Endocrinology Branch (NIAMDD) on toxins of Bordetella pertussis.
Dr. Hewlett joined the faculty of Case-Western Reserve University School of Medicine and in 1980 moved to the University of Virginia in the Division of Geographic Medicine, Department of Medicine. His NIH-funded research is on bacterial toxins and their roles in pathogenesis of infectious diseases, particularly cholera, pertussis, anthrax and antibiotic-associated diarrhea. He served as Senior Associate Dean for Research from 1992-2010 and has been on the board of UVA Patent Foundation (now Licensing and Ventures Group) since 1994, serving as chair since 2005. He is currently an Innovation Associate with UVA Innovation in the Office of the Vice President for Research and works with investigators across the University to identify and support interdisciplinary projects, especially those involving biomedical sciences. He is on numerous review/oversight boards, including those for the Ivy Bio-innovation Fund, Coulter Translational Research Partnership, Virginia Bioscience Health Research Corporation and i6 Virginia Innovation Partnership and is UVA liaison to the recently established ATCC-UVA Post-doctoral Fellowship Program. In addition, Dr. Hewlett has served on multiple study sections and external review groups and was a member of the FDA Science Board from 2008-2011.
Dr. Hewlett received the University of Virginia Alumni Association Distinguished Professor Award in 2012 and the State Council of Higher Education for Virginia (SCHEV) Outstanding Faculty Award in 2013, for his research, teaching, clinical and administrative activities.
Lee M. Wetzler, M.D., Associate Program Director for Research, Infectious Diseases, Professor, Medicine, and Associate Professor, Microbiology, Boston University School of Medicine
Medical School: SUNY/Health Science Center, Syracuse NY (1982)
Residency: University of Michigan Medical Center, Ann Arbor MI (1985)
Post Residency: Post-doctoral Fellow, Laboratory of Bacterial Pathogenesis and Immunology, The Rockefeller University, New York NY (1987), Research Associate/Assistant Professor, Laboratory of Bacterial Pathogenesis and Immunology, The Rockefeller University, New York NY (1991), Fellow in Infectious Disease, Maxwell Finland Laboratory for Infectious Diseases, Boston Medical Center, Boston MA (1994)
Ofer Levy, M.D., Ph.D., Senior Associate Physician in Medicine, Boston Children’s Hospital, and Professor, Pediatrics, Harvard Medical School
Dr. Ofer Levy was born and raised in New York City where he graduated from the Bronx High School of Science. After graduating from Yale College (B.S., Molecular Biophysics and Biochemistry), Dr. Levy entered the Medical Scientist (MD/PhD) Training Program at New York University School of Medicine where he studied neutrophil-derived antimicrobial proteins and peptides under the mentorship of Drs. Peter Elsbach and Jerrold Weiss. Inspired by his wife Sharon’s example, he chose Pediatrics and completed both residency and fellowship (Infectious Diseases) at Boston Children’s Hospital. He is currently a principal investigator and staff physician in the Division of Infectious Diseases, Boston Children’s Hospital and Associate Professor at Harvard Medical School. Dr. Levy’s laboratory is focused on translational development of novel in vitro platforms to model age-specific vaccine safety and efficacy and in the development of novel pediatric vaccine formulations.
Cambridge Healthtech Institute’s Inaugural
Novel Vaccines Part Two: Emerging Vaccine Technologies
Bolyn Hubby, Ph.D., Senior Director, Head, Vaccine and Phage R&D, Synthetic Genomics Vaccines, Inc.
Dr. Hubby is the Senior Director, Head of Vaccine and Phage R&D at SGVI. Dr. Hubby has spent more than twelve years in the biotechnology industry leading product development efforts from early concept stages into clinical evaluation. Prior to joining SGVI, Dr. Hubby was at Liquidia Technologies, a nanotechnology company, where she helped build and lead the company's life science business and vaccine focus. As Executive Director of Vaccines, she helped advance Liquidia's platform technology into the clinic and built a portfolio of programs that attracted a major licensing deal with a leading pharmaceutical partner. Prior to Liquidia, Dr. Hubby was the Head of Discovery Immunology at AlphaVax, Inc., a clinical stage company that is commercializing a unique RNA replicon vector to develop vaccines for infectious diseases, biodefense, and cancer. While at AlphaVax, she designed and developed replicon vaccine candidates for infectious disease and cancer immunotherapy targets and many of these were advanced into clinical evaluation. In addition, her team was responsible for improving the immunogenicity of the platform. Dr. Hubby received her Ph.D degree from the University of Georgia, Center for Tropical and Emerging Diseases and Department of Cellular Biology.
Yongqun (Oliver) He, D.V.M., Ph.D., Associate Professor, Microbiology and Immunology, Affiliated Member, Center for Computational Medicine and Biology (CCMB), Member, Comprehensive Cancer Center, University of Michigan
Dr. Yongqun “Oliver” He is an associate professor in the University of Michigan Medical School, Ann Arbor, MI, USA. Dr. He is experienced in both vaccinology and computer sciences. His primary interests are host-vaccine interaction mechanism analysis, vaccine development, vaccine informatics, and bioinformatics. His group has developed the VIOLIN vaccine database and analysis system that includes many widely used programs such as the Vaxign vaccine design program. Dr. He initiated and leads the development of the community-based Vaccine Ontology (VO). VO has been used in many different applications. He has published over 90 peer-reviewed papers and book chapters. Dr. He is also an editorial board member of several journals. More information about Dr. He and his laboratory is available at: http://www.hegroup.org/.
Mark Bagarazzi, M.D., CMO, Inovio Pharmaceuticals
Mark Bagarazzi, M.D., is Chief Medical Officer and Senior Vice President of Clinical Development for Inovio Pharmaceuticals. Prior to joining Inovio, Dr Bagarazzi was Director of Worldwide Regulatory Affairs for Vaccines and Biologics at Merck Research Laboratories where he was responsible for the licensure of RotaTeq™ and lead the development team for Merck’s vaccine for the prevention of herpes zoster (shingles), ZOSTAVAX™. He was previously an assistant professor of pediatrics at Drexel College of Medicine where he served as director of the Pediatric HIV/AIDS program at St. Christopher’s Hospital for Children in Philadelphia and is currently a guest lecturer on vaccines and immunotherapeutics at the University of Pennsylvania, School of Medicine. Previously, he had been a guest lecturer at Johns Hopkins University. He is a patent holder and has authored or co-authored dozens of scientific papers, focused on the subject of DNA vaccines. He has been board certified in both Pediatrics and Pediatric Infectious Diseases and is a Fellow of the American Academy of Pediatrics. He received his training in pediatrics at St Christopher’s Hospital for Children and completed his fellowship in pediatric infectious diseases at Children’s Hospital of Philadelphia where he was an instructor at the University of Pennsylvania, School of Medicine. Bagarazzi holds a B.S. in electrical engineering magna cum laude from New Jersey Institute of Technology and received his MD degree with honors from New Jersey Medical School of the University of Medicine and Dentistry of New Jersey.
Damien Soghoian, Ph.D., Researcher, Virology, Harvard University
Damien Soghoian received his B.S. in Biology from Caltech and worked at Caltech as a technician and teaching assistant until beginning his Ph.D. in the Walker Lab and as part of the CHAVI-ID group at the Ragon Institute. Damien studies HIV-specific CD4 t cell resp0onses, particularly cytolytic CD4 T cell responses – those CD4 T cells that have the unique ability to kill.
Diviya Sinha, Ph.D., Technical Instructor, Biology, Massachusetts Institute of Technology (MIT)
Diviya obtained her Bachelor of Technology degree in Chemical Engineering from the Indian Institute of Technology, Kanpur in 2009 where she was awarded both the General Proficiency Medal for the best Academic Performance and the Proficiency Medal for the best Senior Thesis upon graduation. Diviya joined the Massachusetts Institute of Technology (MIT) Chemical Engineering PhD program in the Fall of 2009 as a Charles and Hilda Roddey Fellow, and is currently working on her doctoral thesis “Low-Frequency Sonophoresis-Assisted Transcutaneous Immunization” with Professors Daniel Blankschtein and Robert Langer. She has presented her research at the Skin Vaccination Summit 2013 held in Seattle, WA (partially funded by a Dow Travel Award), and has a PhD minor in Immunology. Her research is funded by NIH and the Ragon Institute of MGH, MIT, and Harvard. In addition to her doctoral research, Diviya obtained a MSCEP (Master of Science in Chemical Engineering Practice) degree from MIT in 2011, and was awarded the Rosemary Wojtowicz Award in recognition of her personal integrity and commitment to the practice school program.
W. Nicholas Haining, B.M., B.Ch., Assistant Professor of Pediatrics, Harvard Medical School, and Scientific Co-Leader, HSCT Program, Pediatric Oncology, Dana-Farber Cancer Institute Children’s Hospital, and Associate Member, Broad Institute of Harvard and MIT
Dr. Haining took his undergraduate and medical degrees at the Oxford University, before relocating to the US to complete his medical training in pediatric oncology at Children's Hospital, Boston, and Dana-Farber Cancer Institute. He is currently an Assistant Professor of Pediatrics at Harvard Medical School, and holds joint clinical appointments at Children's Hospital, Boston, and Dana-Farber Cancer Institute in the Hematopoietic Stem Cell Transplant Program. Dr. Haining's laboratory is focussed on developing molecular predictors of T cell immunity, and discovering novel immunomodulatory drugs. Using cross-species genomic analysis, his group has shown that memory differentiation in T and B cells employs a common transcriptional program. He has gone on to show that this fundamental memory differentiation program is disrupted in dysfunctional T cells from chronic viral infection. He is now applying this knowledge in two areas: 1) to develop gene-expression-based predictors of immune function that would help predict clinical outcome in chronic viral infection and cancer; and 2) to conduct high-throughput chemical genomic screens to identify modulators of memory differentiation. Drugs identified in these screens would help boost the efficacy of vaccines and rescue defective immune responses.
Sean Du, Ph.D., COO, Altravax, Inc.
Dr. Sean Du is Chief Operating Officer of Altravax, Inc, responsible for advancement of lead vaccine candidates to preclinical and clinical development, the establishment and implementation of commercialization and licensing strategies, and identification of new business and market opportunities. Prior to joining Altravax, Dr. Du was Executive Director, Institute of Vaccine Research at Simcere R&D Center from 2010 to 2013, where he successfully established and managed the Institute, initiated innovative vaccine projects including a therapeutic vaccine for chronic hepatitis B infection, and led the preclinical development of a Vero cell-based rabies vaccine culminating in clinical trial approval from The China Food and Drug Administration (CFDA). He also played a leading role in the engagement and evaluation of vaccine-related collaborations and M&A opportunities for Simcere Pharmaceutical Group. In 2010, Dr. Du was a Co-founder of Altravax, Inc where he served as Director of Vaccine Research responsible for vaccine discovery and preclinical programs. From 2001 to 2009 he worked in the Department of Infectious Disease at Maxygen, Inc holding positions of increasing responsibility. His Team was responsible for the discovery and development of vaccine candidates against HIV, pandemic influenza, chronic hepatitis B, and equine encephalitis using Maxygen’s proprietary MolecularBreeding™ technologies. Dr. Du received a B.S. degree in microbiology from Shandong University in 1989, an M.S. degree in microbiology from the Chinese Academy of Sciences (Beijing) in 1992, and a Ph.D. in biological sciences from the University of Delaware in 1998. He undertook postdoctoral training in molecular biology, biochemistry, and cell biology at Columbia University from 1998 to 2010 under the guidance of Prof. Martin G. Low, a Fellow of the Royal Society of Great Britain. Dr. Du has published over ten peer-reviewed research papers, presented at over thirty international conferences, and been frequently invited to speak at various academic and international vaccine events.
Fabio Bagnoli, Ph.D., Project Leader, Novartis Vaccines and Diagnostics
Graeme Mardon, Ph.D., Professor, Developmental Biology & Pathology, Baylor College of Medicine
Dr. Graeme Mardon received his B.S. in 1980 with a double major in Biology and Chemistry from Haverford College. Following a four-year research associate position with Dr. Harold E. Varmus studying the viral oncogene src at the University of California in San Francisco, Dr. Mardon began graduate school at the Massachusetts Institute of Technology in 1984. He received his Ph.D. in 1990 in the laboratory of Dr. David C. Page where he studied genes located in the sex-determining region of the mouse Y chromosome. Dr. Mardon then conducted his postdoctoral work with Dr. Gerald M. Rubin at the University of California in Berkeley from 1990 to 1994 studying genes required for normal eye development in the fruit fly Drosophila melanogaster. Dr. Mardon joined the faculty at Baylor College of Medicine in 1994 where he has established a research program studying the molecular genetics of developmental neurobiology using both the fruit fly Drosophila and the mouse as animal model systems. Over the last decade, Dr. Mardon has employed genomics approaches to study retinal development in Drosophila and humans and more recently to study TB and HIV in African children.
Liisa K. Selin, M.D., Ph.D., Professor, Pathology, University of Massachusetts Medical School
Dr. Liisa K. Selin received her B.Sc. degree (Biology and Psychology) in 1974 and M.D. degree in 1979, both from Dalhousie University, Halifax, Nova Scotia. She is Board Certified in Internal Medicine (1984, in Canada), with fellowship training in infectious diseases. She also completed her PhD training in microbiology and immunology at the University of Manitoba, Winnipeg, Manitoba (Canada) in 1993 followed by 2 years of postdoctoral training at the University of Massachusetts Medical School, Worcester, MA. She joined the faculty in the Dept. of Pathology at the University of Massachusetts Medical School as an Instructor in 1994 and was promoted to her present position as Professor in 2007. Dr. Selin has studied the role of T cells in response to viral infections; specifically, initially identifying and focusing on the phenomenon of heterologous immunity, whereby memory T cell responses to pathogens can influence the outcome to subsequent infection with unrelated pathogens. The effects of heterologous immunity are now known, at least in part, to be mediated by cross-reactive T cell responses and mediate both protective effects, immune enhancement and can induce immunopathology. In the past decade she has published and spoken on numerous aspects of the heterologous immunity and CD8 T cell cross-reactivity.
Linda F. Powers, CEO, Chairman of the Board, Northwest Biotherapeutics, Inc.
Ms. Powers is the CEO of Northwest Biotherapeutics, a biotech company developing DCVax® personalized immune therapies for solid tumor cancers. Prior to becoming CEO in 2011, Ms. Powers served for 10 years as a Managing Director of Toucan Capital, an investment fund specializing in regenerative medicine and immune therapies. She also has over 15 years’ experience in corporate finance and restructurings, M&A, joint ventures and intellectual property licensing. Ms. Powers serves on a number of Boards, including M2GEN (at Moffitt Cancer Center), the Trudeau Institute, the Chinese Biopharmaceutical Association, the Rosalind Franklin Society, and the Maryland Stem Cell Research Commission. For more than 6 years, Ms. Powers taught an internal course at the National Institutes of Health on medical product development and commercialization. Ms. Powers holds a B.A. from Princeton University, and a J.D. from Harvard Law School.
Liangfang Zhang, Ph.D., Associate Professor, Nanoengineering and Moores Cancer Center, University of California, San Diego
Dr. Liangfang Zhang received his Ph.D. in Chemical & Biomolecular Engineering from the University of Illinois at Urbana-Champaign (UIUC) in 2006 under the supervision of Prof. Steve Granick. He was a postdoctoral associate in the laboratory of Prof. Robert Langer at MIT during 2006-2008. He joined the Department of Nanoengineering at the University of California, San Diego (UCSD) as an Assistant Professor in July 2008 and was promoted to an Associate Professor with tenure in March 2012. Dr. Zhang’s research interests focus on the design, synthesis, characterization and evaluation of nanostructured biomaterials for drug delivery to improve or enable treatments of human diseases, with particular interests in cancers and bacterial infections. He has published near 80 peer-reviewed articles and holds 31 patents on these topics. He has received the ACS Victor K. LaMer Award (2009), UCSD Best Teacher Award (2011), ACS Unilever Award (2012), and the MIT Technology Review’s TR35 Innovator Award (2013).
Rajan George, Ph.D., President & CSO, Akshaya Bio, Inc.
Dr. Rajan George is the Founder, President and Chief Scientific Officer of Akshaya Bio Inc., a biotechnology company developing vaccines as well as other biotherapeutic agents.
Previously, Dr. George was Executive Vice President and Chief Technology Officer of Paladin Biosciences, a division of Paladin Labs Inc. (TSX:PLB), Edmonton, Alberta, Canada. He holds Adjunct Faculty appointment in the Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada. The focus is on the development of therapeutic vaccines for chronic viral infections such as Hepatitis B and Hepatitis C.
Dr. George is the co-inventor of Chimigen® Vaccine Platform technology which received the Alberta Science and Technology award for innovation in 2004. He was the recipient of a Grand Challenges Explorations grant from the Bill & Melinda Gates Foundation in 2009. Dr. George was Senior Vice President of Research and Development and a founding member of ViRexx Medical Corp., (TSX:VIR, AMEX:REX), Edmonton, Alberta, Canada, before Paladin acquisition. Previously, a Research Scientist at the Glaxo Heritage Research Institute, University of Alberta, Edmonton, Canada, where the field of research was Hepatitis B virology and antiviral therapy. Dr. George received a Ph.D in Biochemistry from the Indian Institute of Sciences (Bangalore, India). He also had postdoctoral training at the University of Wisconsin in Madison, WI, USA and the University of Alberta (Edmonton, Alberta, Canada).
J. Robert Coleman, Ph.D., MBA, Co-Founder, Executive Vice President, Vaccine Development, Codagenix, Inc.
Dr. Coleman, together with Dr. Eckard Wimmer and Dr. Steffen Mueller co-discovered the SAVE technology and co-founded Codagenix, Inc. His work focuses on rational gene design for vaccine construction. He has multiple high impact publications, is the primary investigator on externally funded research projects, and has project management skills in small business and biotechnology. Dr. Coleman completed his MBA in finance while simultaneously co-founding Codagenix Inc., and teaching/researching as an Assistant Professor. Dr. Coleman’s cross-functional skill set (strong science and finance) is capable of enhancing and expediting R & D milestones and allows him to lead all facets of the R & D process. He has a B.S. in Cell Biology from Tulane University, a PhD in Molecular Microbiology from Stony Brook University, and a MBA from The New York Institute of Technology.
Mark Szczypka, Ph.D., Senior Director, Applications and New Product Development, Pall Life Sciences
Mark Szczypka is the Senior Director of Applications and New Product Development at Pall Life Sciences. Highly skilled in the field of cell culture applications, Mark previously held executive positions as President of SoloHill Engineering Inc., Director of Nephrology and Oncology at OncoImmune, and Senior Director Research and Development at RenaMed Biologics. In addition to his 15 years of experience in cell culture, Mark has been published in numerous scientific journals. He received his Ph. D. in Biological Chemistry from the University of Michigan and completed his postdoctoral research at the University of Washington. Mark was awarded a Howard Hughes Research Scientist fellowship during his tenure at the University of Washington, and his work in gene therapy was published in the Journal Neuron and was highlighted on World News tonight.
Adrienne V. Li, Ph.D., Senior Scientist, Vedantra Pharmaceuticals, Inc.
Dr. Li joined Vedantra Pharmaceuticals in October 2012 after completing her doctoral work at the Massachusetts Institute of Technology in Cambridge, Massachusetts. Dr. Li focused on developing polymer and lipid-based nanoparticles for vaccine and immunotherapy applications. Before attending MIT, Dr. Li received her B.S. and M.S. in Biomedical Engineering from Johns Hopkins University. During her doctoral, Dr. Li worked as a Research Assistant in the lab of Dr. Darrell Irvine. Her work focused on using Inter-cellular Multilammullar Vesiscles for mucosal vaccine delivery. Dr. Li’s focus at Vedantra is the formulation of ICMVs with our target adjuvants and in-vivo vaccine studies.
Tarek Fahmy, Ph.D., Associate Professor, Biomedical Engineering, Engineering & Applied Science, Yale University
Dr. Fahmy is an associate professor of Biomedical and Chemical, Environmental Engineering at Yale University. He is also an associate professor of Immunobiology at the Yale School of Medicine. Prior he worked for the DuPont Co. for 5 years in the polymers research and development division. He has a record for synthesis, design and application of multifunctional nanosystems for vaccines, immunotherapy and immunodiagnostic applications with over 85 publications, 7 book chapters and 15 patents in those areas. His background is multidisciplinary spanning training in biological physics, immunology and engineering. Dr. Fahmy is a Biomedical Engineer by training (Bachelors from University of Delaware), masters from Johns Hopkins University and his PHD from Johns Hopkins School of Medicine. He has been a faculty at Yale (Biomedical Engineering and Chemical Engineering) since 2005. He is the recipient of the NSF Career Award and the Wallace Coulter Foundation Career Awards. He is also the co-recipient of the American Society of Transplantation Branch-out Award. Dr. Fahmy is a co-founder of several start-up companies from Yale. He collaborates extensively with national and international investigators and industries on the application of nanotechnology for challenging problems in therapy and diagnosis.
Michele Stone, Ph.D., PMP, Director, Vaccines, Liquidia Technologies
Michele Stone, Ph.D., Director of Vaccines at Liquidia Technologies, has over ten years of industrial experience in vaccine development and molecular diagnostics. Dr. Stone obtained her Ph.D. from the University of Maryland, Baltimore in the field of Biochemistry/Molecular. Her Ph.D. thesis focused on further defining natural genetic transformation in Haemophilus influenza, and her postdoctoral work pertained to the field of Physiology, specifically Muscular Dystrophy. She began her industrial career at Aeras Global TB Vaccines working toward the development of TB vaccines. After several years, she transitioned her focus to the field of molecular diagnostics at Canon US Life Sciences. Her contributions aided in the development of a novel PCR device that will revolutionize the field of molecular diagnostics and personalized medicine. Dr. Stone’s passion for TB vaccine development prompted her to return to Aeras, where she continued to lead efforts in the development of new TB vaccine candidates. While at Aeras, Dr. Stone was responsible for viral, protein, DNA, and RNA platform vaccine development. These efforts included managing collaborations with various government, academic, and industrial partners. Several of these partnerships and collaborations have produced novel TB candidates that are in late pre-clinical/clinical development. Dr. Stone’s desire to advance novel vaccine development brought her to Liquidia. Liquidia is currently advancing vaccine development through the use of PRINT (particle replication in non-wetting templates) technology. PRINT is a novel nanoparticle platform providing compositional flexibility with the ability to specify size and shape in formulating vaccines. At Liquidia, Dr. Stone is responsible for advancing the pre-clinical development of novel vaccine targets utilizing PRINT technology. Her role includes the management of various industrial, academic, and non-profit partnerships. The outcome of these collaborations indicates that PRINT technology may provide specific advantages over current vaccine platforms.