Genotoxicity Testing for Pharmaceuticals - Current and Emerging Practices
Date: April 17, 2008
Time: 8:30 a.m. - 9:30 a.m.
Location: Pharmatek Laboratories, Inc.
Speaker: Grace M. Furman, Ph.D., D.A.B.T., CEO and President, Paracelsus, Inc.
Presentation Summary
Also referred to as "mutagenicity studies", genotoxicity studies (now the preferred term) are used to assess a drug's potential to cause genomic damage that could induce cancer and/or heritable defects. These short-tem studies include a battery of mammalian and non-mammalian in vitro and in vivo tests designed to detect a compound's ability to cause an increase in genetic alterations (e.g., primary DNA damage, chromosomal aberrations). Registration of new pharmaceuticals requires a comprehensive assessment of their genotoxic potential. Current regulatory expectations for such testing in the US, EU and Japan are described in two guidance documents published in 1995 and 1997 by the International Conference on Harmonisation (ICH). Since publication of those guidance documents, there have been new developments and a wealth of data on both in vitro and in vivo genotoxicity assays with the potential to add value to the guidance given in the original guidelines. This seminar will provide an introduction to genotoxicity testing of novel small molecule therapeutics, an overview of the currently-recommended testing battery, and a glimpse into the not-too-distant future of genotoxicity testing as regulatory expectations evolve to keep pace with the rapid advancement of science.
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About the Speaker
As CEO/President of Paracelsus, Inc., Grace provides professional toxicology services to the pharmaceutical industry as an independent consultant. Grace began her professional career in Cincinnati as a divisional toxicologist in Procter & Gamble's Health Care Sector. After a brief stint as a consumer products toxicologist, Grace's interests turned towards the pharmaceutical industry. Grace migrated to San Diego to accept a position as sole toxicologist with DepoTech Corporation (now Pacira Pharmaceuticals, Inc.), where she was instrumental in building the preclinical development group. Grace's first opportunity to explore independent consulting came several years later as a result of corporate restructuring and a concurrent lack of professional prospects within the San Diego area. Later that same year, an attractive position within Agouron Pharmaceuticals, Inc. lured Grace back into industry. Through a subsequent series of mergers and acquisition, the Agouron opportunity ultimately developed into a Senior Director position within Pfizer's Global R&D division which Grace held through 2006. In late 2006, Grace founded Paracelsus, Inc. and became its first (and only) employee. Paracelsus commenced conducting business as a corporate entity in January 2007. Grace's area of professional expertise relates to regulatory toxicology as applied to development of novel small molecule therapeutics. Grace received her Ph.D. in Biomedical Sciences with a specialization in toxicology from Northeastern University in Boston, MA. She also holds a B.S. in toxicology and is a Diplomate of the American Board of Toxicology.
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