Publications

Group's Publications

Pulford DJ, Coleman LM, Smith KM, Ribeiro J, Prucka SK. Addressing Educational Gaps in Biomarker and Pharmacogenomics Research Knowledge among IRB/IEC Members. Clinical Researcher 2016 Oct 1: 30(5): 28-33.

Tremaine L, Brian W, DelMonte T, Francke S, Groenen P, Johnson K, Li L, Pearson K, Marshall JC The Role of ADME pharmacogenomics in early clinical trials: perspective of the Industry Pharmacogenomics Working Group (I-PWG). Pharmacogenomics. 2015 Dec;16(18): 2055-67

Brian W, Tremaine LM, Arefayene M, de Kanter R, Evers R, Guo Y, Kalabus J, Lin W, Loi CM, Xiao G Assessment of drug metabolism enzyme and transporter pharmacogenetics in drug discovery and early development: perspectives of the I-PWG. Pharamacogenomics. 2016 Apr;17(6): 615-31.

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.

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.

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.
https://onlinelibrary.wiley.com/doi/epdf/10.1111/j.1467-8519.2006.00473.x

Salerno RA, Lesko LJ. Pharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) Proposal. Pharmacogenomics. 2004 Jan;5:25-30.
https://www.futuremedicine.com/doi/pdf/10.2217/14622416.5.1.25

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.
https://accp1.onlinelibrary.wiley.com/doi/epdf/10.1177/0091270003252244

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.