C.S. Lewin, M.B.A. Ph.D., Head, Strategic Immunization Planning, Novartis Vaccines and Diagnostics
Clement Lewin is Head of Strategic Immunization Planning for Novartis Vaccines and has over 15 years of experience in a variety of roles. He started his vaccines career at Merck Vaccines Division holding a variety of domestic and international marketing positions and then moved to Chiron Vaccines where as Vice President Strategic Planning & Business Intelligence he played a key role in the PowderJect acquisition and then became Vice President Government Affairs & Immunization Policy for the US. Prior to joining Novartis he was Vice President of Marketing, Policy and Strategy at Acambis responsible for their strategic planning and helping the company secure a ten year $450 million contract to supply smallpox vaccine to the United States Government .Clem obtained a BSc and PhD from the University of London and was a Research Fellow at the Universities of London and Edinburgh publishing over 50 papers on fluoroquinolones. He left research and then obtained an MBA with distinction from Cornell University and joined the life sciences practice of Pittiglio Rabin Todd & McGrath specializing in product development issues. In August of 2009 Clem was appointed to the National Vaccine Advisory Committee and since 2004 has served as the BIO liaison representative to the Advisory Committee on Immunization Practices. He has been on the advisory board. of Bio Ventures for Global Health and a board member of the Alliance for Biosecurity.
Alan R. Shaw, Ph.D., Chairman, Chief Scientific Officer, VaxInnate Corporation
Alan R. Shaw, PhD is Chairman and Chief Scientific Officer at VaxInnate Corporation where he is responsible for scientific and medical conduct of the company’s efforts to develop new vaccines incorporating pathogen associated molecular patterns. He joined VaxInnate in 2005 following a 15year career at Merck Research Laboratories where he was responsible for R&D leading to the licensure of Varivax®, ProQuad®, Zostavax®, RotaTeq® and Gardasil®. Prior to joining Merck, Dr. Shaw was a Senior Program Executive at Biogen S.A in Geneva, Switzerland where he led projects on hepatitis B vaccines, malaria vaccines, cytokines and their inhibitors, and cell trafficking. Dr. Shaw was the Chairman of the International Federation of Pharmaceutical Manufacturers’ Association Biologicals Committee and has extensive experience in national and international vaccine development and policy matters.
Melissa Malhame M.B.A., Senior Director, Dynavax Technologies Corp
Melissa Malhame., MBA is the Sr. Director of Marketing and Product Management at Dynavax Technologies. Melissa has worked during the past fifteen years in various vaccine marketing, sales and business development positions of increasing responsibility with Merck Vaccine Division, and Dynavax Technologies. Her responsibilities have included Market Research and Business Development, Promotion Management, Physician and Institutional Sales and Sales Management and Product Management with Merck. At Dynavax Melissa has had responsibility as Project Leader of their lead Phase 3 hepatitis B vaccine, HEPLISAV, including the negotiation and management of a collaboration between Dynavax and Merck for development of the vaccine. Ms. Malhame holds a MBA from Cornell University's Johnson Graduate School of Management in marketing and general management.
Sunil Mehta, Director, Technology Development, KBI Biopharma, Inc.
Dr. Sunil Mehta is Director of Technology Development at KBI Biopharma, Inc., where he leads the development and commercialization of KBI Biopharma’s proprietary single-use kSep® technology that has diverse bioprocessing applications. Prior to joining KBI, he worked at Centocor (a Johnson & Johnson subsidiary) in Pharmaceutical Development where he developed innovative microbial and mammalian processes and invented a method to identify and isolate high titer-producing clones. Dr. Mehta has developed expertise ranging from R&D to commercial manufacturing through his work experience at Mojave Therapeutics, Inc. and Roche. Dr. Mehta received his Ph.D. in Molecular Pharmacology, Physiology, and Biotechnology from Brown University and his undergraduate degree from Birla Institute of Technology and Science in India. Dr. Mehta is an established technology leader, who has delivered several invited seminars and holds a number of key patents.
Roman Necina, Ph.D., Site Director Vienna, Intercell, A.G.
Work experience:
February 2010 – present: VP Quality & Regulatory Compliance, Intercell AG.
August 2008 - January 2010: COO-US, Intercell, USA,
December 2007 – July 2008: VP Quality & Regulatory Compliance, Intercell AG.
2002 – November 2007: VP Biopharmaceutical Production & Process Science, Boehringer Ingelheim.
Main responsibilities:
June 2007 – November 2007: Managing Director
2002 - November 2007: Production Manager
2002 – November 2007: Biological Safety Agent
March 1999 – March 2002: Head of Process Science, Boehringer Ingelheim Austria
April 1998 – February 2002: Protein Chemist, Boehringer Ingelheim Austria
1994 – 1996: Consultant for Biosepra INC, Boston/MA/USA
1993: Protein Chemist, Biosepra INC, Boston/MA/USA
Education:
March 1994 – June 1998 Ph.D. Thesis: „Identification and Design of Peptide Ligands for Affinity Chromatography“, Institute of Applied Microbiology, University of Natural Resources and Applied Life Sciences, Vienna, Austria
H. James White, P.E., Executive Director, Engineering & Technical Services, Technical and Quality Operations, Novavax, Inc.
H. James White, P.E., is currently the Executive Director, Engineering & Technical Services for Novavax, Inc. He has over 20 years experience in the design, construction, and operation of biopharmaceutical development and manufacturing infrastructure from early clinical to commercial scale operations. He has worked in biologics operations with companies such as MedImmune and Neose Technologies, as well as in engineering and construction consulting for firms such as Jacobs Engineering and BioKinetics. In his current role, Mr. White is responsible for development of Novavax’s regional production facility concept to meet the rapid response needs for vaccine production under pandemic conditions. Novavax, Inc. is a clinical-stage biotechnology company creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like particle (VLP) technology.
Henry L. Hebel, COO, VGXI Inc.
Mr. Hebel joined VGXI, Inc. in 2001 and currently serves as the Company’s Vice President and Chief Operating Officer. He was previously employed by Qiagen, Inc. where he served as Key Account Manager of the “pAlliance” strategic joint venture. Mr. Hebel worked on the team that launched this venture and was responsible for sales, marketing and project management activities. Prior to that, Mr. Hebel worked for Valentis, Inc. (formerly GeneMedicine, Inc.) where he served as Senior Manager of Bioprocessing. There his team designed, built and operated a cGMP manufacturing facility that manufactured plasmids for human clinical trials through Phase II, as well as developed novel manufacturing scale-up techniques. Mr. Hebel has additional development and manufacturing experience from Tanox Biosystems, Inc. While at Tanox, he worked on antibody product development. Mr. Hebel holds a Bachelor of Science and MBA from Texas A&M University.
Norman Baylor, Ph.D., Director, Office of Vaccines Research and Review , Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, FDA
Dr. Norman W. Baylor is currently the Director of the Office of Vaccines Research and Review (OVRR) in the Food and Drug Administration’s Center for Biologics Evaluation and Research. Prior to his position as Director, Dr. Baylor served as Deputy Director of OVRR and Associate Director for Regulatory Policy. He has evaluated and facilitated the development and licensure of numerous new vaccines such as acellular pertussis, varicella, combinations vaccines, pneumococcal conjugate, and HPV during his career at FDA. Dr. Baylor received his B.S. degree in medical microbiology from the University of Wisconsin, Madison, and his M.S. and Ph.D. degrees in microbial genetics and molecular microbiology, respectively from the University of Kentucky. Dr. Baylor also currently serves as FDA’s liaison to CDC’s Advisory Committee on Immunization Practices, the DHHS National Vaccine Advisory Committee, and the Advisory Commission for Childhood Vaccines and most recently as a representative of the International Advisory Committee (IAC) to the Malaria Eradication Research Agenda (MalERA). Dr. Baylor has also served as an expert advisor to the World Health Organization on several global vaccine initiatives. He has been with the FDA for nearly 18 years.
Debbie Higgins, Vice President, Vaccine Development, Neugenesis Corporation
Debbie Higgins has more than 25 years of experience in infectious diseases and vaccine development. Prior to joining Neugenesis in 2009 to direct the vaccine development initiative, she spent 20 years involved in vaccine development programs at Chiron (now Novartis) and Dynavax Technologies. Areas of focus included the development and use of adjuvants including MF59™ and CpGs, influenza, HIV, hepatitis B, papilloma and anthrax vaccine programs. Her earlier experience includes positions in viral research at Cold Spring Harbor Laboratory and CDC, with backgrounds in molecular biology and immunology.
Volker Sandig, Ph.D., Vice President, Cell & Vector Biology, Probiogen, A.G.
Volker Sandig, CSO of ProBioGen AG, has founded the company's cell line program in 2000 focussing on the development of pharmaceutical high producer cell lines and creation of designer cell lines customised for manufacture of vaccines and recombinant proteins as well as technologies for improvement of glycoprotein products. Under his supervision the AGE1 family of cells lines was created and optimised for industrial production processes. Volker Sandig received his Ph.D. in molecular biology from Humboldt University, Berlin after finishing his medical training. As an expert in viral vectors and gene regulation, he contributed to the HIV vaccine programme at Merck and Co. Inc. developed adenovirus manufacturing systems and designed experimental strategies for virus-based tumour treatments at the Max Planck Society.
Thomas Muster, Ph.D., Chief Executive Officer, Avir Green Hills Biotechnology, A.G.
Dr. Thomas Muster is CEO/CSO and co-founder of AVIR Green Hills Biotechnology. He obtained his PhD in Biotechnology from the University of Natural Resources and Applied Life Sciences in Vienna and is Associate Professor for Virology. Prior to AVIR Green Hills Dr. Muster worked as a Research Fellow at the Mount Sinai School of Medicine in New York and was Head of Viral Oncology at the Department of Dermatology at the Medical University in Vienna. Dr. Muster contributed to several key inventions in vaccine development such as the discovery of a conserved antigen on HIV and the interferon antagonist NS1 of influenza virus. Thomas also co-authored more than forty publications in the field of virology.
Trevor Deeks, Ph.D., Senior Director, Manufacturing Operations and Engineering, Contract Manufacturing Group, Emergent BioSolutions Inc.
Trevor has over 30 years of experience in pharmaceutical manufacturing, development, quality assurance and validation, including senior management roles with major pharmaceutical manufacturing companies. He is a Qualified Person and a registered pharmacist. He has also worked as a consultant managing a number of troubleshooting, inspection readiness, validation and development projects. Over the last 10 years a significant proportion of this work has focussed on Biologicals. He has published over 30 papers in peer-reviewed journals and contributed to a number of books including one on Bioprocess Validation. He is an active presenter at PDA, ISPE and Pharmaceutical Society conferences and has sat on PDA, BSI, CEN, ISO and European Pharmacopoeia Commission expert working groups. He is a Past Chairman of the Parenteral Society and was Editor-in-Chief of the European Journal of Parenteral Sciences from 1996-2000.
Timothy Lee, Ph.D., Deputy Director, Bulk Manufacturing, Sanofi Pasteur
Dr. Timothy Lee received his Ph.D. in Biochemical Engineering at the University of London, UK. The area of research was focused on the mechanical and catalytic stability of immobilized enzymes. He then did a post-doctoral fellowship at sanofi pasteur, Canada, where he was involved in the optimization of primary recovery processes for bacterial systems, mainly focusing on micro-filtration, centrifugal and chromatographic separations. As a senior development scientist within sanofi pasteur, Dr. Lee has played a key role in the development of different bacterial media, fermentation and clarification optimization and scale-up as well as the transfer of processes to Industrial operations for manufacturing. He has also published several patents and presented extensively globally over the last several years, outlining the work performed in the industry. He continues to interact extensively with vendors to find new technologies to improve and simplify the industrial operation for the manufacture of vaccines. He is currently a deputy director within Industrial operations.
Simon Hsu, Ph.D., Principal Scientist, Vaccine Process Biochemistry, MedImmune, Inc.
Simon Hsu joined MedImmune in 2006 and he is leading the purification development for cell-based vaccines. The cell-based vaccine program started out with the live attenuated influenza virus vaccine and recently expanded into recombinant subunit vaccines. MedImmune Vaccine, located at Mountain View, CA, is one of the five companies awarded HHS contracts in 2006 to develop cell-based influenza vaccines to help the United States prepare for a pandemic. Prior to joining MedImmune, Simon worked at Alexion Pharmaceuticals and Gen-Probe. He has more than 16 years of experience in downstream process development in the biotechnology industry after his PhD in biochemical engineering from Purdue University. His broad expertise covers various production platforms from solid phase synthesis, mammalian cell culture, bacterial fermentation, to virus culture with scales up to 10,000 liters.
Michael Hanna, Ph.D., Chairman & Chief Executive Officer, Vaccinogen, Inc.
Dr. Michael G. Hanna, Jr., formed Vaccinogen, Inc., and successfully licensed/acquired the Intracel assets in June 2006. He previously served as Chairman (Emeritus) and Chief Scientific Officer of Intracel Resources. Before Intracel and PerImmune, Inc. merged in January 1998, Dr. Hanna served as President and Chief Executive Officer of PerImmune, Inc. From 1985-1994 he was the Chief Operating Officer of Organon Teknika/Biotechnology Research Institute and Sr. Vice President of Organon Teknika Corporation, a subsidiary of Akzo Nobel, N.V., The Netherlands. Prior to that (1975-1982) Dr. Hanna was Director of the National Cancer Institute, Frederick Cancer Research Center (NCI-FCRC). Dr. Hanna received a doctoral degree in experimental pathology and immunology from the University of Tennessee. He has over 225 publications to his credit, has 10 patents in immunotherapy and has been the recipient of numerous honors, and served on many editorial boards
Tom Jin, M.D., Scientist, Principal Investigator, Technique Operations & Manufacturing, Aeras Global TB Vaccine Foundation
Dr. Tom H. Jin, Scientist and Principle Investigator for Research and Development at Aeras Global TB Vaccine Foundation, a non-profit organization dedicated to the development of Tuberculosis vaccines, manages the Fill/Finish section for the multiple candidates in pre-clinical and clinical trials. Dr. Jin received his M.D. from Lanzhou University in China, and his post doctoral training at National Institute of Child Health and Human Development, NIH. Dr. Jin developed the first Haemophilus influenzae type b (Hib) polysaccharide conjugate vaccine for China. Before he moved to Aeras, as a Research Fellow at NIH, his research was focused on the new generation of meningitis and measles vaccines.
Rinaldo Zurbriggen, Ph.D., Co-founder, Pevion Biotech, and Senior Program Manager, Lonza, Ltd.
Rinaldo Zurbriggen was co-founder and Chief Scientific Officer of Pevion Biotech. Prior to joining Pevion Biotech, Rinaldo Zurbriggen was head of the virus research department at Berna Biotech, where he was responsible for the development of virosome-based vaccines from 1996 on. During this period his department enabled Berna Biotech to register the first virosome-based vaccine (Epaxal) in Europe. Rinaldo Zurbriggen is a leading expert for virosomes and has published more than 50 papers in peer-reviewed scientific journals in this field. Rinaldo Zurbriggen earned his degree at the University of Fribourg, Switzerland. Currently, he is Senior Program Manager at Lonza.
Bill Enright, M.A., M.Sc., President & Chief Executive Officer, Vaxin, Inc.
William “Bill” Enright joined Vaxin in June 2008 and currently serves as a Director, President & CEO. Prior to joining Vaxin, Mr. Enright spent six years with GenVec, Inc. with increasing responsibilities including the Head of Business Development. Mr. Enright was responsible for helping to build GenVec’s vaccine business including approximately $140M of funding for vaccine related initiatives and moving four vaccines into clinical development. Mr. Enright brings more than 20 years of experience in a variety of positions within the life science/biotech industry, including time as a consultant, a bench scientist and 12 years with Life Technologies, Corp. (previously Invitrogen), working in various senior level licensing, business management, manufacturing and research roles. Mr. Enright received a Master of Arts in Molecular Biology from SUNY at Buffalo and a Master of Science in Business Management from Johns Hopkins University.
Herman van Herk, M.Sc., Scientist, Up-Stream Process Development, Crucell Holland B.V.
Herman van Herk graduated in Bioprocess Engineering at Wageningen Univerisity, The Netherlands. As part of his studies, he investigated the metabolism of Hybridoma cells at Diosynth (now part of Merck & Co.). Herman started his professional career at Crucell in 2004, in the Up Stream Process Development group. Together with his team he was involved in development and technology transfer of production processes for adenovirus based vaccines like Malaria, Ebola, HIV and Tuberculosis.
Albert Price, Ph.D., Technical Director, Influenza, Protein Sciences Corporation
Albert Price is currently Technical Director – Influenza at Protein Sciences Corporation in Meriden, CT. Prior to joining Protein Sciences he was a senior scientist at VaxInnate Corporation working on vaccines for infectious diseases including influenza, Dengue Fever, malaria, respiratory syncytial virus (RSV) and human papilloma virus (HPV). Prior to joining the vaccine industry Dr. Price was a postdoctoral fellow in the Department of Cell Biology at the Yale University School of Medicine. He holds a PhD in biochemistry from Dartmouth Medical School and is a graduate of Bates College.
Mark W. Thompson, R. Ph., Ph.D., Director, Vaccine Process Biochemistry, Vaccine Development, MedImmune, Inc.
Mark W. Thompson, RPh, PhD, is the Director of Vaccine Process Development at MedImmune, LLC. His expertise is the development of viral vaccines (e.g., live, attenuated parainfluenza virus 3 (PIV3), respiratory syncytial virus (RSV), bovine/human PIV3 RSV F, and RSV SH), which are in Phase 1/2a clinical trials, and live, attenuated seasonal and pandemic influenza vaccines produced in Madin Darby canine kidney (MDCK) cells and eggs. In addition, Dr. Thompson has extensive experience in the purification of other clinical vaccine products (e.g., HPV-16, calicivirus virus-like particles [VLPs]) and subunit vaccines (e.g., prostate-specific antigen, hepatitis E glycoprotein, KSA oncoprotein, malarial proteins MSP-1 and EBA-175). Before joining MedImmune, Dr. Thompson was Associate Director of Downstream Purification at Wellstat Biologics Corporation, where his group developed an affinity-based chromatography process for purifying Newcastle disease virus as a live, oncolytic therapeutic agent for human use. He has a BS Pharm degree from Purdue University and a PhD from The Ohio State University.
C. Brent Oswald, Ph.D. Associate Director, VMSC–Bioanalytics, Merck Manufacturing Division
Brent Oswald is currently an Associate Director in Merck Manufacturing Division's Vaccine Manufacturing Science and Commercialization (VMSC) – Bioanalytics department. He has 20 years of experience at Merck with vaccine development, mostly within the Bioprocess R&D area of Merck Research Laboratories, and more recently in the manufacturing division (since 2008). During his tenure at Merck, Brent has supported and managed analytical development (assay development, validation and transfer), and product characterization, for many of Merck's vaccine products including VAQTA (for Hepatitis A), RECOMBIVAX (for Hepatitis B), and GARDASIL (for HPV). Prior to joining Merck, Brent received his Ph.D. in Medicinal Chemistry from UNC-Chapel Hill and did post-doctoral studies in protein biochemistry at Duke University.
Michael Dekleva, Ph.D., Senior Director, Worldwide Regulatory Affairs, Merck Sharp & Dohme, Corp.
Michael Dekleva, Ph.D., is Senior Director of World Wide Regulatory Affairs at Merck Sharp & Dohme, Corp. He received his doctoral degree (microbiology) from The Ohio State University in Columbus, Ohio and completed post-graduate work (protein biochemistry) at the University of Wisconsin-Madison.
During his career at Merck, Dr. Dekleva held a variety of positions related to vaccine development and manufacturing. These included leadership roles in technical operations to support vaccine manufacturing, and validation of vaccine and sterile pharmaceutical processes and equipment. Dr. Dekleva joined Regulatory Affairs in 2004, and currently is the Regulatory Therapeutic Area Lead for pediatric vaccine products.
Jonathan Liu D.V.M., Ph.D., Director, Research & Development, Vaccine Development, MedImmune, Inc.
Dr. Liu is a vaccine specialist with more than 20 years experience in conducting R&D and managing more than 14 different biological and vaccine development projects in Pfizer (formerly Genetic Institute), Sanofi Pasteur (formerly Acambis) and AstraZeneca (MedImmune). His work in vaccine and biological research, manufacturing sciences, regulatory affairs and human clinical investigations has been published in more than 110 scientific journals and conference presentations. His current responsibilities include overseeing vaccine R&D, participating in vaccine portfolio management and maintaining functional excellence.
Tony Hitchcock, B.Sc., Head, Manufacturing Technologies, RecipharmCobra Biologic Ltd.
Tony has over 24 years of experience in the large-scale manufacture of biopharmaceuticals. He has held positions in the Blood Products Laboratory (Elstree) and at Zeneca Pharmaceuticals in the protein process development department. Tony was a founding staff member of RecipharmCobra and has been responsible for the development of much of RecipharmCobra’s DNA manufacturing technology. Tony has published several papers in the field and is an inventor on two families of RecipharmCobra’s process patents. He also has extensive experience in downstream recovery and purification operation with a range of protein and complex biopharmaceuticals, including plasmid DNA, virus and phage projects, and has managed both manufacturing and process development functions including USP functions. More recently he has presented at a number of international meetings and published articles on the use of single use technologies in the biopharmaceutical industry.
He is currently a member of the UK Bioprocess Research Industry steering committee and has recently been appointed to the scientific advisor board of the Centre of Excellence in Biopharmaceutical at Manchester University.