New:
Event: Genomic and Biomarker Development: Data Analysis Techniques
Background:
The Pharmacogenetics Working Group is a voluntary and informal association of pharmaceutical companies engaged in research in the science of pharmacogenetics. The Group was initially established in response to regulatory requests for non-competitive information from industry about such research. The Group provides such information, sometimes in the form of papers in peer-reviewed journals, and sponsors educational and informational programs intended to promote a better public understanding of pharmacogenetic research and its development. The Group’s discussions, activities and programs are open and transparent. They are limited exclusively to non-competitive matters. Organizational and procedural rules have been adopted by the Group and by the companies they represent.
The PWG works closely with the US Food and Drug Administration, European Medicines Evaluation Agency and regulators and policy groups to ensure that its activities are relevant to their programs and needs. Among other steps, it seeks to engage these bodies in discussion and information sharing and asks their continued help in identifying non-competitive issues, which the Group could provide information on or other assistance.
Examples of issues, which the PWG has already addressed:
- To come to a consensus with respect to definitions on terminology specific to PGx research and to communicate these definitions to regulatory bodies and interested parties.
- To propose a set of elements of informed consent specific to PGx research, for obtaining informed consent in different types of PGx studies.
- To be proactive in the development of agency guidance for phramacogenomics in regulatory decision making, for example by facilitating guidance for submission and review of genomic data.
Ways by which the PWG intends to disseminate information:
- By the submission of publications describing the outcome of discussions within the PWG on PGx issues in readily accessible scientific journals,
- By maintaining a site on the internet, outlining the general organization and objectives of the PWG as well as including the proceedings of its meetings,
- By the organization of workshops, alone and with other parties interested in PGx, such as regulatory bodies or scientific organizations.
Membership:
The Group consists of representatives from pharmaceutical companies engaged in PGx.
Its rules specify that "the Group shall be limited to companies that are actively engaged in (a) the development, manufacture, marketing, and sale of pharmaceutical products and (b) research in the science of pharmacogenetics" The Group reserves the right to limit the number of Member Companies if this becomes necessary or appropriate to ensure the Group’s efficient operation.
Organization:
The Group holds teleconferences at regular (monthly) intervals and meets approximately twice annually. Smaller groups may draft materials for the Group's consideration. The activities are coordinated and administered by a Chair, to be selected annually from among the participants by the Group. The Chair is to be rotated from one member company to another each year. Meeting summaries are available on the web.
Each member company is to bear an equitable share of the Group's costs, including the costs of meetings (excluding participant travel), teleconference costs, and the costs of external legal and any other consultants. Apart from legal counsel, no immediate need is seen for external consultants
Publications:
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.C Anderson, B Gomez-Mancilla, BB Spear, DM Barnes, K Cheeseman, P Shaw, J Friedman, A McCarthy, C Brazell, SC Ray, D McHale, L Hashimoto, R Sandbrink, ML Watson, and RA Salerno on behalf of The Pharmacogenetics Working Group.
Elements of Informed Consent for Pharmacogenetic Research; Perspective of the Pharmacogenetics Working Group.
Pharmacogenomics Journal 2002;2(5):284-92.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(4):342-58.
Salerno RA, Lesko LJ.
Pharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) Proposal.
Pharmacogenomics. 2004 Jan;5(1):25-30Renegar 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(1): 24-36
Chair
Nadine Cohen, J&J - June 2006 - June 2007
Chair-elect
Past Chairpersons:
Lea Harty (Pfizer) - June 2005 - June 2006
Mark Watson (GSK) - June 2004 - June 2005
Ronald Salerno (Wyeth) - June 2003 - June 2004
Julie Friedman (BMS) - June 2002 - June 2003
Diane Barnes (Abbott) - June 2001 - June 2002
Susan Ray (GSK) - August 2000 - June 2001
Administrative Support:
Jenny Green (Covington & Burling):
jgreen@cov.com
Contacts:
Nadine Cohen
NCohen2@prdus.jnj.com
Other pages on this site:
This lists all companies, which are members of the PWG.
On this page a number of links is included towards other groups focusing on pharmacogenetics. Also included is a section on pharmacogenetics-related guidelines, which are available on the internet.
The PWG has agreed on a number of definitions on PGx-relevant terms (see also the PWG publication on this topic)