Nonclinical Testing of Vaccines: Report from a Workshop
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Nonclinical Testing of Vaccines: Report from a Workshop Jan Willem van der Laan, Roy Forster, Brian Ledwith, Marion Gruber, Sarah Gould, Lawrence Segal and Andrée Penninks Drug Information Journal 2009 43: 97 DOI: 10.1177/009286150904300115 The online version of this article can be found at: http://dij.sagepub.com/content/43/1/97
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WORKSHOP REPORT
Jan Willem van der Loan Centre for Biological Medicines and Medical Technoloa, National Institute for Public Health and the Environment, Bilthoven, Netherlands Roy forster CIT, Evrewr. France Brian Ledwith Merck Research Laboratories, West Point, Pennsylvania Marion Grrber US Food and Drug Administration, Rockville, Maryland Sarah Govld Sanofi-Pasteur. France Lawrence SegaI GSK Biologicals, Wavre. Belgium Andre Penninks TNO-Phanna. Zeist, Netherlands
Key Words Vaccines; Nonclinical evaluation: Safety testing; Developmental and reproductive toxicology: Adjuvants: DNA vaccines; Therapeutic vaccines Corresponderce Address Jan Willem van der Laan, Centre for Biological Medicines and Medical Technology, National Institute for Public Health and the Environment, PO Box I , 3720 BA Bilthoven, Netherlands (email: jan-willem.van.der.laan@ rivm.nl).
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Nonclinical Testing of Vaccines: Report From a Workshop Vaccine research and development is a heterogeneous and intense active a m , encompassing the development of many differentkinds of novel preventive and thempeutic vaccines (eg, against infectious, allergic, and autoimmune diseases, cancer; etc). Induded in this is the development of differenttypes of vaccines (eg,DNA vaccines, novel mtes of administmtion, novel adjuvants, and immune system modulation). llis poses challenges regarding approaches to preclinical evaluation of theseprahccts. Published regulatory guidance has not always kept up with scientif-
INTRODUCTION Vaccines have long been, and may still be, special pharmaceutical products. A t least in Europe it was not until 1993 that vaccines became regulated by legislative instruments (Directive 93/142 under Directive 65/65) to fulfill all European requirements for human pharmaceutical products (as laid down in Directives 75/318 and 75/319). In the United States, vaccines are regulated as biological products by the FDAs Center for Biologics Evaluation and Research (CBER) under Section 351 of the Public Health Service Act (42 USC 262) as well as specific sections of the Food, Drug and Cosmetic Act (FD&C Act, 505b). In the 1990s. a process was initiated to defi
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