I-PWG Biomarker Brochure

I-PWG Biomarker Brochure

Amir Snapir was in the chair.  Eighteen people attended from 12 companies.  Jennifer Green and Charles Lister attended from Covington Burling LLP.

I-PWG meeting with FDA

The Group discussed the progress on the agenda for a proposed meeting with FDA in the first quarter of 2011.

Collaboration with IPPC

The work of the International Pharmaceutical Privacy Consortium (http://www.pharmaprivacy.org/) was described.  It was noted that there was overlap between IPPC and I-PWG both in terms of membership and in some areas of activity.  IPPC had invited I-PWG members to participate in a meeting to explore the potential for collaboration  and it was agreed that a representative from IPPC should be invited to join the I-PWG meeting in November or December to provide more information about its work. 

Manuscripts for publication

Peer review of all four manuscripts has been completed.  The issues raised by the review process are being addressed and a further update will be presented at the next meeting. 

Reports from Task Forces

The Retrospective Analysis Task Force reported that it expects to circulate a draft paper to the Group.

The Regulatory Information Repository Task Force continued to discuss methodology. 

Next meeting

The next meeting will be at 9:00 am Eastern US, 2:00 pm London time on Tuesday 9 November.