I-PWG 8 March 2011

 Anita Nelsen was in the chair.    Twenty-two  people attended from 17 companies. 

 FDA Draft Guidance on PGx in Early Phase Clinical Studies

Issam Zineh reported on the published version of the draft guidance.  The Group discussed its options for responding to the call for comments.

Sampling Papers for Publication

Amelia Warner reported that the four papers accepted by Clinical Pharmacology and Therapeutics had appeared in the April issue.  The Group thanked all those involved in the project. 

Sampling Workshop

Amelia Warner reported that the Sampling Workshop was likely to take place in September in either Philadelphia or Washington DC.  She undertook to circulate more information as soon as it was available. 

Retrospective Manuscript

It was noted that legal approval was almost complete.

I-PWG meeting with FDA

A revised list of potential discussion topics had been circulated ahead of the meeting. It was agreed that the companies would rank them in order of preference.   The date for the meeting was still uncertain.

Next meeting

The next meeting will be at 9:00 am Eastern US, 2:00 pm London time on Tuesday 12 April 2011. 

Anita Nelsen was in the chair.    Twenty-four  people attended from 16 companies. 

VXDS Task Force

It was reported that after a delay of several months a group had now been formed to analyse the data collected by survey in 2010. 

Prospective/Retrospective Draft for Publication

It was reported that a final draft of a paper for publication was ready for circulation to the entire group with a view to speedy progress towards formal review and submission.

Regulatory Information Task Force

It was reported that work continued on the development of a Q&A website

I-PWG meeting with FDA/New Projects

It was reported that plans for the meeting were progressing but that there was still no clear date.

Sampling Workshop and Papers for Publication

It was reported that the four papers are likely to publish in April in the journal Clinical Pharmacology and Therapeutics

The group is collaborating with a third party on the workshop and it is hoped that a definite date will set before too long.

Next meeting

The next meeting will be at 9:00 am Eastern US, 2:00 pm London time on Tuesday 8 March 2011. 

Anita Nelsen was in the chair.    Seventeen  people attended from 11 companies.  Issam Zineh of FDA also attended.

Anita was welcomed to her first meeting as chair.  She expressed appreciation for the group’s confidence and particularly for Amir’s very effective efforts as her predecessor.  

I-PWG meeting with FDA

There was continued discussion about the format and agenda of the proposed meeting between I-PWG (and others) and FDA in the first quarter of 2011.  The Chair led a discussion of proposed and possible topics for the meeting, building upon the results of the meeting previously held with FDA in 2009.  A short list of possible topics was tentatively agreed to, but the Chair also urged further off-line comments and suggestions  in light of the discussion.

Sampling Workshop

It was reported that DIA will coordinate this meeting in early May 2011 in Bethesda, Maryland.

Next meeting

The next meeting will be at 9:00 am Eastern US, 2:00 pm London time on Tuesday 8 February 2011.  

Amir Snapir was in the chair.  Twenty people attended from 12 companies. 

I-PWG meeting with FDA

There was continued discussion about the format and agenda of the proposed meeting between I-PWG (and others) and FDA in the first quarter of 2011. 

Manuscripts for publication

All four papers have been accepted for publication.  The journal expects to publish a commentary from the FDA in the same issue.  Confirmation of the date of publication is awaited.

Sampling Workshop

It was reported that the DIA has agreed to be the main sponsor of the meeting.  A Scientific Advisory Panel, including I-PWG members and other stakeholders, is being formed. The target date is May 2011.  More details will be made available as soon as possible. 

Reports from Task Forces

The Group reviewed the work of the task forces during 2011.   The Education Task Force continues to work on web content and a generic slide set.  Work on analysis of the VXDS survey will begin in early 2011 and the Pg-Pd and Retrospective Task Forces hope to circulate draft papers to the full group in the first months of 2011.  Some other projects remain on hold in order to enable members to work on the preparations for the FDA meeting and the sampling workshop.

Next meeting

The next meeting will be at 9:00 am Eastern US, 2:00 pm London time on Tuesday 11 January 2011.  Anita Nelsen of GSK will be in the Chair.

Amir Snapir was in the chair.  Twenty-two people attended from 14 companies.  Representatives of IPPC attended part of the meeting and gave a presentation.

Collaboration with IPPC

Following last month’s meeting and the attendance of some I-PWG members at a meeting with IPPC on 21 October, two representatives of IPPC gave a presentation on the work of the International Pharmaceutical Privacy Consortium (http://www.pharmaprivacy.org/).  Members agreed that there was scope for collaboration between the two Groups. 

 I-PWG meeting with FDA

There was an extended discussion about the format and agenda of the proposed meeting between I-PWG (and others) and FDA in the first quarter of 2011. It was agreed that if the meeting is to take place before 31 March, the Group must provide FDA with a final proposal for the agenda before the end of the year.  

Manuscripts for publication

Final acceptance of the papers was awaited.  The journal proposes to solicit a comment on the papers from the FDA.

Sampling Workshop

It was reported that discussions were continuing with a third party organisation about the administration of the meeting.  A Scientific Advisory Panel, including I-PWG members and other stakeholders, is being formed. The target date is May 2011 and it is hoped that a final agenda will be in place by the end of the year. 

Reports from Task Forces

Recommendations for Good Storage Practices

The task force has decided to omit analysis from the proposed paper.  This project will be placed on hold until the FDA meeting and the Sampling Workshop are over.

Other Business

The Group hopes to meet Face to Face in the first half of 2011.

Next meeting

The next meeting will be at 9:00 am Eastern US, 2:00 pm London time on Tuesday 14 December.