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Innovations in Prevention & Treatment: Global Trends in Vaccine Platform Development

Thursday, October 13th, 9:30am - 10:45am

This session will highlight global advances in technologies for new vaccines.  Advances in recombinant, cellular and protein sciences as well as the availability of adjuvants may allow for significant improvements in vaccine technology. These advances should lead to both new and improved preventive vaccines through their ability to elicit broad antigenic responses and streamline manufacturing techniques.  In addition, they may lead to the development of therapeutic vaccines to treat complex immune diseases such as cancer, Alzheimer’s and other chronic conditions.  Companies will present scientific and clinical data and discuss their approaches to and uses for these new platforms.

Moderator:

  • Phyllis Arthur, Senior Director, Vaccines, Immunotherapies and Diagnostics Policy, Biotechnology Industry Organization

Panelists:

  • Stephen W. Cook, PhD, Vice President, Head of Worldwide Vaccine Registration Management & Regulatory Operations, GlaxoSmithKline Biologicals
  • Stanley C. Erck, President & CEO, Novavax, Inc.
  • Peter Khoury, Vice President, Global Marketing, Baxter International 
  • Jueren Lou, Director of Technoogy, Shanghai Biological Product Research Institute
  • Dr. Jean-Denis Shu, Medical Director, Sanofi Pasteur China 

   Who's Who


 

Stephen W. Cook, PhD. - Dr. Cook is Vice President and Head of Worldwide Vaccine Registration Management & Regulatory Operations for GlaxoSmithKline Biologicals based in Belgium. In this role, he has responsibility for the definition and implementation of regulatory strategy to ensure that GlaxoSmithKline Beecham Biologicals assets are registered globally. He also has responsibility for operational support (eg, databases, eCTD) for the regulatory function. Prior to this, and from 2003 to end 2007, he was Vice President for Regulatory Affairs in the Asia Pacific area (based in Singapore) for GlaxoSmithKline with overall responsibility for all GSK regulatory activities in that region of the world. Dr Cook joined the pharmaceutical industry in 1986 working in the area of Active Pharmaceutical Ingredient (API) manufacture and Quality Assurance before moving into Regulatory Affairs in 1993. He is experienced in the registration of medicinal products and vaccines in Europe and has extensive first hand experience of regulatory affairs across the International region (ie, Asia, Africa, Central Eastern Europe, Latin America and the Middle East) for both pharmaceutical and biological products.Dr Cook is a graduate of the University of Strathclyde (Glasgow, UK) where he completed a BSc (Hons.) in Applied Chemistry and then an MSc followed by a PhD in Analytical Chemistry. He is a Member of the Royal Society of Chemistry and a Chartered Chemist. He was granted the designation of Chartered Scientist (CSci) in 2004 by the (UK) Science Council. He has been a Member of The Organisation of Professionals in Regulatory Affairs [previously the British Institute of Regulatory Affairs] since 1994. He has participated in various APEC LSIF activities, delivered training and lectures on ICH country regulatory requirements and presented at many conferences on subjects as diverse as the drug development process, quality control, electronic document management, BSE/TSE, batch release requirements for vaccines and the role of regulatory affairs in the pharmaceutical industry.

Stanley C. Erck. -  Mr. Erck was named President & Chief Executive Officer of Novavax, Inc. in April 2011. Until then, Mr. Erck was the Executive Chairman of the Board of Directors of Novavax since February, 2010. From 2000-2008, Mr. Erck served as President and Chief Executive Officer of Iomai Corporation, leading the company through an initial public offering and a merger with Intercell, an Austrian vaccine company, and through the development of a late-stage infectious disease product candidate. Prior to Iomai, Mr. Erck served as President and Chief Executive Officer of Procept, a publicly traded immunology company; as Vice President, Corporate Development at Integrated Genetics (now Genzyme), and in management positions within Baxter International. Mr. Erck currently sits on the Board of Directors of MacCyte and MdBio Foundation. He received his undergraduate degree from the University of Illinois and his Masters in Business Administration from the University of Chicago Graduate School of Business.

Peter H. Khoury, PhD, MBA. - Dr. Khoury is Global Vice President for Baxter Vaccines. He obtained his doctorate in Microbiology from Syracuse University in 1991, studying the effects of heat shock proteins on the resistance of bacterial endospores. Dr. Khoury also holds a MBA from Cornell University's Johnson Graduate School of Management in marketing and general management. Peter has worked during the past seventeen years in various sales and marketing positions of increasing responsibility with Merck Vaccine Division, and Baxter Vaccines. His responsibilities have included Business Development, Promotion Management, Physician and Institutional Sales, Product Management, Database and Direct Marketing, International Marketing, and Global Market Strategic Development. He has been a key member of the launch teams for various pediatric and adult vaccine products. Dr. Khoury's current responsibilities in his position as Vice President, Global Marketing for Baxter International (BioScience Division) includes both vaccines sales and marketing for Latin America, North America, Asia, and the Pacific Region, government contracting, and business development.

Jean-Denis Shu - Medical Specialist qualified in France
Member of the Chinese Association of Biological Products
Member of the Reduction Committee of the Chinese Journal of Biologicals

Medical Director for Sanofi Pasteur China, Dr. Shu is widely recognized as a vaccine expert in China, with proven track-record in medical and marketing management and strong resource network in China. His past professional experiences also include Regional Director North Pacific for Chiron Vaccines (now Novartis Vaccines), Chief Representative China for Aventis Pasteur, and Medical and Regulatory Affairs Manager for Pasteur Merieux Connaught (based in Lyon, France). Dr Shu was the author of several articles and books on vaccinology and vaccines.
A French citizen born in Shanghai, Dr. Shu is bi-cultural and tri-lingual (English, French and Chinese). He earned a Certificate of Finance and Accounting from Wharton School, a MBA from the European School of Management (ESCP-EAP) in Paris, a Diploma of Specialization on Gynecology-Obstetrics from Medical and Pharmacy College of Besancon in France, and a Medical Degree, B. Med. from Medical University of Shanghai II, in China. Dr Shu spent five years as Foreign Physician in French hospitals.