Melissa Malhame M.B.A., Sr. Director Marketing and Product Management, Dynavax Technologies
Melissa Malhame., MBA is the Sr. Director of Marketing and Product Management at Dynavax Technologies. Melissa has been in the vaccine industry for 15 years in marketing, sales and business development positions of increasing responsibility with Merck Vaccine Division, and Dynavax Technologies. Her responsibilities have included Market Research, Product Management and Sales 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 as well as the formation and management of an agreement with Novartis on influenza vaccine development. Ms. Malhame holds a MBA from Cornell University's Johnson Graduate School of Management.
Clement Lewin, M.B.A. Ph.D., Head, Strategic Immunization Planning, 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.
Bernd 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.
At the same time Bernd was appointed as head of the Clinical Research Center of Hannover Medical School. In this position he is currently organizing and supervising >40 Investigator Initiated clinical trials (IITs) and is legally representing Hannover Medical School as sponsor.
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.
Patricia Seymour, Senior Consultant, Bioprocess Technology Consultants, Inc.
Patricia Seymour, M.B.A., CSCP, is a Senior Consultant with BioProcess Technology Consultants and has over 20 years of experience in the biotechnology industry. Her expertise spans the development and commercialization spectrum, including biologics and small molecule development and manufacturing, supply chain strategy and management and operations leadership. Ms. Seymour was formerly Sr. Director, Global Investigational Supply Operations at Millennium. She previously held positions at Covance, Collaborative BioAlliance, ImmunoGen, Dana Farber Cancer Institute and Sloan Kettering. Ms. Seymour received her B.S. from Villanova University and her M.B.A. from Boston University and is a Certified Supply Chain Professional (APICS).