Larry Tremaine1, William Brian, Terrye DelMonte, Stephan Francke, Peter Groenen, Keith Johnson,Lei Li, Kimberly Pearson & Jean-Claude Marshall, Pfizer Inc., Worldwide Research & Development, Department of Pharmacokinetics, Dynamics & Metabolism, Eastern Point Road, Groton, CT 06340, USA Sanofi, Disposition, Safety & Animal Research, 55 Corporate Drive, Bridgewater, NJ 08807, USA Bristol Myers Squibb, Clinical Sample Strategy & Operations, Exploratory & Clinical Translational Research, 311 Pennington Rocky Hill Rd, Pennington, NJ 08534, USA Janssen Research & Development, 1400 McKean Rd, PO Box 776, Spring House, PA 19477, USA Actelion Pharmaceuticals Ltd, Translational Science, Gewerbestrasse 16, 4102 Allschwil, Switzerland Veritas Genetics Inc., 99 Conifer Hill Drive, Danvers, MA 01923, USA Novartis Institutes for Bio Medical Research, Inc., 250 Massachusetts Avenue, Cambridge, MA 02139, USA Author for correspondence: Tel.: +1 860 441 5056 This email address is being protected from spambots. You need JavaScript enabled to view it.
The Role of ADME PGx in Early Clinical Trials

William Brian, Larry M Tremaine, Million Arefayene, Ruben de Kanter, Raymond Evers, Yingying Guo, James Kalabus, Wen Lin, Cho-Ming Loi & Guangqing Xiao Sanofi, Translational Medicine and Early Development, 55 Corporate Drive, Bridgewater, NJ 08807, USA Pfizer Inc., Worldwide Research and Development, Department of Pharmacokinetics, Dynamics and Metabolism, Eastern Point Road, Groton, CT 06340, USA Biogen, Early Development Sciences, 14 Cambridge Center, Cambridge, MA 02142, USA Preclinical Pharmacokinetics and Metabolism, Actelion Pharmaceuticals Ltd., Gewerbestrasse 16, CH-4123 Allschwil, Switzerland Merck & Co, Pharmacodynamics, Pharmacokinetics and Drug Metabolism, 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA Eli Lilly and Company, Drug Disposition, Lilly Corporate Center, Indianapolis, IN 46285, USA Novartis Pharmaceuticals, 1 Health Plaza, East Hanover, NJ 07936, USA Novartis Institutes for Biomedical Research,Drug Metabolism and Pharmacokinetics, One Health Plaza, East Hanover, NJ 07936-1080, USA Pfizer Inc., Worldwide Research and Development,Department of Pharmacokinetics, Dynamics and Metabolism,10646 Science Center Drive, San Diego, CA 92121, USA Biogen, Preclinical PK and In vitro ADME, 14 Cambridge Center, Cambridge, MA 02142, USA Author for correspondence: Tel.: +1 908 981 3285 This email address is being protected from spambots. You need JavaScript enabled to view it.
I-PWG Preclinical PGx article for Pharmacogenomics FINAL 06Apr16

Patterson SD, Cohen N, Karnoub M, Truter SL, Emison E, Khambata-Ford S, Spear B, Okony IE, Sproule R, Barnes D, Bhathena A, Bristow M, Russell C, Wang D, Warner A, Westelinck A, Brian W, Snapir A, Franc MA, Wong P, Shaw PM. Prospective Retrospective Biomarker Analysis for Regulatory Consideration: A White Paper from the Industry Pharmacogenomics Working Group (I-PWG). Pharmacogenomics. 2011 Jul;12(7):939-51

Franc MA, Warner AW, Cohen N, Shaw PM, Groenen P, Snapir A. Current Practices for DNA Sample Collection and Storage in the Pharmaceutical Industry, and Potential Areas for Harmonization: Perspective of the I-PWG. Clin Pharmacol Ther. 2011 Apr;89(4):546-53

Warner AW, Bhathena A, Gilardi S, Mohr D, Leong D, Bienfait KL, Sarang J, Duprey S, Franc MA, Nelsen A, Snapir A. Challenges in Obtaining Adequate Genetic Sample Sets in Clinical Trials: The Perspective of the Industry Pharmacogenomics Working Group. Clin Pharmacol Ther. 2011 Apr;89(4):529-36

Ricci DS, Broderick ED, Tchelet A, Hong F, Mayevsky S, Mohr DM, Schaffer ME, Warner AW, Hakkulinen P, Snapir A. Global Requirements for DNA Sample Collections: Results of a Survey of 204 Ethics Committees in 40 Countries. Clin Pharmacol Ther. 2011 Apr;89(4):554-61.

Franc MA, Cohen N, Warner AW, Shaw PM, Groenen P, Snapir A. Coding of DNA Samples and Data in the Pharmaceutical Industry: Current Practices and Future Directions-Perspective of the I-PWG. Clin Pharmacol Ther. 2011 Apr;89(4):537-45.

Education Task Force, Industry Pharmacogenomics Working Group. Understanding the Intent, Scope and Public Health Benefits of Exploratory Biomarker Research, a Guide for IRBs/IECs & Investigational Site Staff. Published on I-PWG web site (www.i-pwg.org). December 2009. [Download ]

Education Task Force, Industry Pharmacogenomics Working Group. Pharmacogenomics Informational Brochure for IRBs/IECs & Investigational Site Staff. Published on I-PWG web site (www.i-pwg.org). December 2008. [Download ]

Bromley CM, Close S, Cohen N, Favis R, Fijal B, Gheyas F, Liu W, Lopez-Correa C, Prokop A, Singer JB, Snapir A, Tchelet A, Wang D, Goldstaub D. Designing Pharmacogenetic Projects in Industry: Practical Design Perspectives from the Industry Pharmacogenomics Working Group The Pharmacogenomics Journal September 2008. [Abstract ].

Renegar G, Webster CJ, Stuerzebecher S, Harty L, Ide SE, Balkite B, Rogalski-Salter TA, Cohen N, Spear B, Barnes DM, Brazell C. Returning genetic research results to individuals: points to consider. Bioethics. 2006 20: 24-36.

Salerno RA, Lesko LJ. Pharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) Proposal. Pharmacogenomics. 2004 Jan;5:25-30.

Lesko LJ, Salerno RA, Spear BB, Anderson DC, Anderson T, Brazell C, Collins J, Dorner A, Essayan D, Gomez-Mancilla B, Hackett J, Huang SM, Ide S, Killinger J, Leighton J, Mansfield E, Meyer R, Ryan SG, Schmith V, Shaw P, Sistare F, Watson M, Worobec A. Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop. Journal of Clinical Pharmacology. 2003 Apr;43:342-58.

Anderson C, Gomez-Mancilla B, Spear BB, Barnes DM, Cheeseman K, Shaw P, Friedman J, McCarthy A, Brazell C, Ray SC, McHale D, Hashimoto L, Sandbrink R, Watson ML, Salerno RA, on behalf of The Pharmacogenetics Working Group. Elements of Informed Consent for Pharmacogenetic Research; Perspective of the Pharmacogenetics Working Group. Pharmacogenomics Journal 2002;2:284-92.

Spear BB, Heath-Chiozzi ME, Barnes DM, Cheeseman K, Shaw P, Campbell DA, et al. Terminology for sample collection in clinical genetic studies. Pharmacogenomics Journal 2001; 1: 101-103.