(SC1) Process Validation and Quality by Design for Vaccines
Trevor Deeks, Ph.D., Senior Director, Manufacturing Management Services, Emergent BioSolutions
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 5 years most of his work has focused on vaccines.
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.
Sheila Magil, Ph.D., Senior Consultant, Bioprocess Technology Consultants, Inc.
Sheila Magil, Ph.D., Senior Consultant of BioProcess Technology Consultants, has over 20 years of experience in analytical method development for small molecules, peptides and biologics. Her expertise includes quality, protein and peptide chemistry, and formulation development. She was formerly Senior Manager of Analytical Development and Quality Control at Biomeasure, Inc., and previously held positions at Waratah Pharma, Alkermes, Bion, and HHMI at Mass. General Hospital. Dr. Magil has implemented quality systems and has managed external analytical and QC activities for multiple biopharmaceutical products. Dr. Magil holds a Ph.D. in Biochemistry from the University of Minnesota.
Timothy Schofield, Head of Nonclinical Statistics Services, Arlenda Inc., Co-Chair, Statistics Expert Committee, USP
Timothy Schofield is Managing Director and Head of Non-Clinical Statistical Services for Arlenda Inc., a statistical consulting and software company providing support to the pharmaceutical, devices, and pharmaceutical testing industries. Prior to joining Arlenda Tim was Director in the U.S. Regulatory Affairs department of GlaxoSmithKline where he provided regulatory support to vaccines, as well as head of the Nonclinical Statistics department in Merck Research Labs, supporting development and manufacture of Merck pharmaceuticals, biologics, and vaccines. In addition to his service to GSK and Merck, Tim has held several positions on industry and regulatory committees. He was elected to the PhRMA Biostatistics and Data Management Technical Group in 2002 where he represented nonclinical statistics for 3-years, and is an active member of the AAPS CMC Statistics Expert Team since 2004. Tim also served as liaison to the PhRMA Biologicals and Biotechnology Subcommittee, where he was co-chair of the Specifications and Formulation Working Group. In that role he led efforts to publish a PhRMA white paper on A Rational Approach for Setting and Maintaining Specifications for Biological and Biotechnology–Derived Products. He is also a coauthor on a PhRMA white paper on Quality by Design for Biotech Products. Tim is co-chair of the USP Statistics Expert Committee and a member of the USP Bioassay Validation ad hoc Panel where he led efforts to write Chapter (1033) Bioassay Validation. He co-edited a special edition of Biologicals on Stability Evaluation of Vaccines, a compilation of papers stemming from WHO implementation meetings in Korea and Geneva. He received a Bachelor of Science degree in mathematics in 1973 from Lafayette College, Easton, PA, and a Master of Arts degree in statistics in 1976 from the University of Pennsylvania in Philadelphia.
(SC2) Vaccine Business Opportunities – Speaker Bios
C.S. Lewin, M.B.A., Ph.D., Head, Medical Affairs and Immunization Policy, Region North America, Novartis Vaccines and Diagnostics
Clement Lewin joined Novartis in 2008 and is currently Head of Medical Affairs Immunization Policy for North America. Clem has over 15 years of vaccines industry experience in a variety of marketing, scientific affairs and policy roles. He started his career in Vaccines at Merck Vaccines Division where he held a variety of domestic and international marketing positions contributing to the launch of Varivax® and the early marketing planning activities for Gardasil®, ProQuad®, Rotateq® and Zostavax®. He was also at Chiron Vaccines as Vice President Strategic Planning & Business Intelligence and then Vice President Government Affairs & Immunization Policy for the US after playing a key role in the $800 million PowderJect acquisition. Prior to joining Novartis he was Vice President of Marketing, Policy and Strategy at Acambis responsible for Government Affairs, the Strategic Planning process and Marketing playing a key role in licensing ACAM2000 and securing a ten year $450 million contract with the United States Government to supply the vaccine. In addition to his experience in vaccines, Clem was at Bayer Pharmaceuticals as Director of Global Scientific Affairs for their anti-infective franchise.
Clem obtained his BSc and PhD from the University of London. After 5 years as a Research Fellow at the Universities of London and Edinburgh. During that period he published over 50 papers in peer reviewed journals on mechanisms of action and resistance to antibacterials. He left research to obtain an MBA with distinction from Cornell University and then 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. He has also served as the BIO liaison representative to the Advisory Committee on Immunization Practices since 2004 and is on the advisory board of Bio Ventures for Global Health. He was a board member of the Alliance for Biosecurity and is often an invited speaker on vaccine and biodefense related topics.
Bernd Eisele, M.D., CEO, Vaccine Project Management, GmbH
Dr Bernd Eisele graduated from Heidelberg Medical School in 1986. He began his career in industry as Clinical Project Manager at Behringwerke AG in 1988. In various positions Bernd was responsible for the clinical development of recombinant and transgenic products in clinical phases I – III. In 1996 Bernd joined Solvay Pharmaceuticals GmbH in Hannover, Germany, and was responsible for the international phase III development program of the company’s lead cardiovascular product. In 1997 he became Medical Director and Head of Medical Marketing for Canada, Asia, the Middle East, Australia, New Zealand, and South Africa. In 2002 he was appointed Global Product Director for psychiatry and became responsible for the world-wide marketing of Solvay Pharmaceuticals’ psychiatry products. From February 2003 to March 2008 Bernd was Head of Research & Development at VPM, a Vaccine development organization, founded by the German Federal Ministry of Research and Education (BMBF) and funded by Federal grants. Since April 1, 2008 he is head of VPM.
Due to his experience in the field of vaccines, Bernd, besides other national and international board activities, also collaborated in WHO vaccine consensus conferences, e.g. the WHO consensus conference on Standardization and Evaluation of BCG vaccines.
Donna C. Martin. M.S., M.B.A., CLP, Vice President, Corporate Development (M&A) Sanofi Pasteur
Donna Martin is VP of Corporate Development (Head of M&A) at Sanofi Pasteur, the vaccines division of Sanofi. Her primary focus is in identifying, evaluating and negotiating M&A transactions to support Sanofi Pasteur's growth. Donna has more than 20 years experience in vaccines business development, research, strategic planning and project management. Prior to joining Sanofi Pasteur in 2004, Donna held positions at Akzo Nobel’s Intervet division, where she co-led Intervet’s global Business Development function, and also at Wyeth Vaccines.
Donna has a MBA from the University of Rochester, William E. Simon Graduate School of Business Administration and a MS in Microbiology from the Medical College of Virginia.
Alan Shaw, Chairman, Chief Scientific Officer, VaxInnate, Inc.
Vaccine Quality throughout the Life Cycle – Speaker Bios
Richard W. Welch, Ph.D., Vice President, Process & Analytical Development, Emergent Biosolutions
Mario Amacker, Ph.D., Head, Process Development and Manufacturing, Pevion Biotech AG
Mario Amacker joined Pevion Biotech AG (Ittigen, Switzerland) in 2003 as a group leader of the development of virosome-based formulations. In July 2009, he was appointed to the position of Head of Process Development and Manufacturing. Prior to joining Pevion, he was project manager at Gnothis SA (Lausanne, Switzerland) and responsible for the development of enzymes used in single-molecular sequencing by fluorescence correlation spectroscopy. From 1998 to 2000 he held a post-doc position at the Swiss Cancer Research Institute (ISREC, Epalinges, Switzerland) and performed basic research on human telomerase. Mario Amacker holds a PhD in Biochemistry from the University of Zurich (Switzerland) and a Master’s degree in Biochemistry and Molecular Biology from the Swiss Federal Institute of Technology.
Todd L. Talarico, Ph.D., Senior Director, Industrial Process, Medicago-USA
Todd Talarico received a BS in Chemical Engineering from Penn State and a PhD in Microbiology from NC State. He did postdoctoral work at Burroughs Wellcome studying protein translocation and purification. Todd was the Director of Product Development at Apex Bioscience where he was responsible for a team that brought a PEGylated hemoglobin molecule from development to Phase III clinical trials. He began working in the vaccine field with AlphaVax where he was a Senior Director responsible for development and process scale up of a virus replicon particle vaccine. Currently Todd is the Senior Director of Industrial Process at Medicago-USA starting up the US operations involved in rapid construction and deployment of a facility designed to produce vaccines expressed in tobacco plants.
Albert Price, Ph.D., Technical Director, Process Development, 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 research 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, and began his career at Genzyme. He holds a PhD in biochemistry from Dartmouth Medical School and is a graduate of Bates College.
Robert J. Juba, Senior Director, Manufacturing and Clinical Supplies Management, Inovio Pharmaceuticals, Inc.
Rob Juba joined Inovio Pharmaceuticals in 2011 as Senior Director of Manufacturing & Clinical Supplies Management. He is responsible for the GMP production of Inovio’s novel SynCon® plasmid DNA therapeutic and prophylactic vaccine candidates, including HIV, HPV, influenza, prostate cancer and malaria. He also manages all investigational drug supplies for the company’s ongoing Phase I and Phase II clinical trials. Mr. Juba has a combined 18 years of experience in the pharmaceutical industry, specifically in the management of cGMP processes and operations. His experience includes senior manufacturing leadership positions at VGXI, Inc. and VGX Pharmaceuticals, and several positions at Merck including bulk vaccine network strategy for single-use manufacturing technology, technical expertise for bacterial vaccine manufacturing, and management of several contract manufacturing and filling projects for developmental vaccines (Rotavirus and HIV-1). Mr. Juba holds both Bachelor's and Master's Degrees in Chemical Engineering from the Massachusetts Institute of Technology.
Mike Schwartz, Ph.D., Associate Director, Regulatory Affairs, GlaxoSmithKline-Biologicals
Dr. Schwartz has been with GlaxoSmithKline since 2008, where he has worked in both Regulatory Affairs for vaccines and Quality Control for BioPharmaceuticals. His current position in Regulatory Affairs includes development and licensure of pandemic influenza vaccines. Prior to joining GSK, Dr. Schwartz worked in the vaccine quality control and CMC regulatory affairs area at Merck. He holds a Ph.D. in biochemistry from Northwestern University.
Norman W. Baylor, Ph.D., President and CEO, Biologics Consulting Group, Inc.
Dr. Norman W. Baylor is currently the President and CEO of Biologics Consulting Group, Inc. He was formerly the Director of the Office of Vaccines Research and Review (OVRR) in the Food and Drug Administration’s Center for Biologics Evaluation and Research. He has evaluated and facilitated the development and licensure of numerous new vaccines including all of the new generation combination vaccines during his 20 year career at FDA. Dr. Baylor served as FDA’s liaison to CDC’s Advisory Committee on Immunization Practices, the US Department of Health and Human Services National Vaccine Advisory Committee, and the Advisory Commission on Childhood Vaccines. Dr. Baylor also served as an expert advisor to the World Health Organization on several global vaccine initiatives including assessing national regulatory authorities worldwide.
Michael Dekleva, Ph.D., Senior Director, Vaccine Regulatory Affairs, Merck & Co., Inc.
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 a Regulatory Therapeutic Area Lead for a variety of vaccine products.
Cara Fiora, Ph.D., Microbiologist and Regulatory Scientist, Vaccines & Related Products Applications, CBER/FDA Professional Experience
Master Reviewer/Microbiologist - Food and Drug Administration/Center for Biologics Evaluation and Research/Office of Vaccines Research and Review, Division of Vaccines and Related Products Applications (FDA/CBER/OVRR/DVRPA). Sept 2007 – present. Senior Scientist. Office of Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Service (HHS). Science Applications International Corporation (SAIC). June 2006 – Sept 2007. Senior Scientist, Process and Product Development, Nabi Biopharmaceuticals, Rockville, MD. 2000 – 2006.
Education - BS Biology, BA Anthropology Tulane University, New Orleans, LA Ph D - University of Maryland, Baltimore, School of Medicine
Timothy Schofield, Head of Nonclinical Statistics Services, Arlenda Inc., Co-Chair, Statistics Expert Committee, USP
Timothy Schofield is Managing Director and Head of Non-Clinical Statistical Services for Arlenda Inc., a statistical consulting and software company providing support to the pharmaceutical, devices, and pharmaceutical testing industries. Prior to joining Arlenda Tim was Director in the U.S. Regulatory Affairs department of GlaxoSmithKline where he provided regulatory support to vaccines, as well as head of the Nonclinical Statistics department in Merck Research Labs, supporting development and manufacture of Merck pharmaceuticals, biologics, and vaccines. In addition to his service to GSK and Merck, Tim has held several positions on industry and regulatory committees. He was elected to the PhRMA Biostatistics and Data Management Technical Group in 2002 where he represented nonclinical statistics for 3-years, and is an active member of the AAPS CMC Statistics Expert Team since 2004. Tim also served as liaison to the PhRMA Biologicals and Biotechnology Subcommittee, where he was co-chair of the Specifications and Formulation Working Group. In that role he led efforts to publish a PhRMA white paper on A Rational Approach for Setting and Maintaining Specifications for Biological and Biotechnology–Derived Products. He is also a coauthor on a PhRMA white paper on Quality by Design for Biotech Products. Tim is co-chair of the USP Statistics Expert Committee and a member of the USP Bioassay Validation ad hoc Panel where he led efforts to write Chapter 1033 Bioassay Validation. He co-edited a special edition of Biologicals on Stability Evaluation of Vaccines, a compilation of papers stemming from WHO implementation meetings in Korea and Geneva. He received a Bachelor of Science degree in mathematics in 1973 from Lafayette College, Easton, PA, and a Master of Arts degree in statistics in 1976 from the University of Pennsylvania in Philadelphia.
Jane Halpern, Ph.D., Vice President, Regulatory Affairs, Novavax, Inc.
Dr. Halpern has more than 20 years of experience in the development of vaccines and biological products working in government, small biotechnology companies, and large pharmaceutical companies. She has worked in regulatory affairs in both U.S. and European settings. From 2002 until 2008, she worked at ID Biomedical Corporation, which was acquired by GSK Biologicals in 2005. During this time, she led the regulatory team that was responsible for obtaining accelerated approval of the seasonal influenza vaccine FluLaval in 2006. Prior to this Dr. Halpern served at the Center for Biologics Evaluation and Research at the U.S. Food & Drug Administration, where she was involved in the review and approval of numerous bacterial vaccines and other biologic products. She received her Bachelor's degree at the University of California, Davis, her Ph.D. from the University of Rochester, and completed postdoctoral training at the National Institutes of Health.
Kimberly Duffy, Associate Director, Global Vaccines, CMC Merck & Co., Inc.
Kim has a B.S. in Microbiology from Penn State University and joined Merck shortly after graduation. Kim has now been at Merck for 24 years, all of which has been in the vaccine manufacturing field. Kim's first position was as a technician in viral vaccine manufacturing and has since held a variety of positions in Quality Control, Laboratory Operations, and Vaccine Manufacturing. Kim joined the regulatory department in 2007 and is managing global CMC for commercial viral vaccines.
Marina Kirkitadze, Ph.D., M.B.A., Deputy Director, Head, Biophysics & Conformation Unit, Biochemistry Platform, Analytical R&D, Sanofi Pasteur
Marina Kirkitadze, Ph.D, MBA has nine years experience in Sanofi Pasteur, the vaccine division of Sanofi group. She is Head of Biophysics and Conformation Unit at Biochemistry Platform, Analytical R&D North America.
Marina's expertise is in the field of protein science and biophysics. Her main focus is characterization of protein component of vaccines, specifically, conformation and stability in solution and in adjuvanted form; addressing topics for Chemistry Manufacturing and Control (CMC). In recent years, her interest also extends on the analysis of raw materials, and particle sizing technologies.
Her contributions went towards CMC section in eBLA application for Adacel, new manufacturing facility submission, Pentacel, and most recently to Module 3 CTD of Hexaxim vaccine submission. Marina contributed to several projects over the years. Marina has published 22 peer-reviewed manuscripts and reviews on the biophysical study of herpes simplex virus capsid proteins, complement cascade proteins, amyloid-beta peptide, and adjuvanted vaccine antigens.
Indresh K. Srivastava, Ph.D., Senior Director, Protein Sciences Corporation
Jian He, Ph.D., Senior Research Chemist, Vaccine Analytical Development, Merck & Co., Inc.
Currently working as a Sr. Research Chemist in Merck Vaccine Analytical Development Department. My major function is: to support process development with basic science input into understanding the nature of vaccine production, purification and formulation processes; to provide analytical support for process monitoring and release of clinical supplies; to provide robust and validated assays for transfer to Manufacturing and to support the preparation of comprehensive IND, PLA and MAA documentation essential for facile licensure of vaccine products world-wide.
William Egan, Ph.D. Senior Technical Expert, Novartis Vaccines and 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.
Michele Pallaoro, Unit Head, Formulation Analytics, Formulation & Delivery, Novartis Vaccines & Diagnostics
Michele Pallaoro first graduated in Biology at the University of Rome La Sapienza then obtained a PhD in Biochemistry. After two years at the University of California where he grew his interest for Biochemistry and protein engineering he came back to Italy to take a junior research position in Merck Co. at IRBM. Here he made relevant contributions in several projects ranging from anti HCV to anti-tumoral programs. After ten years he moved to Novartis Vaccines and Diagnostics where he is currently leading the Formulation Analytical Unit. Michele Pallaoro is author or co-author several research papers and reviews in peer reviewed journals and holds several patents.