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.

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

The Group welcomed the announcement that Anita Nelsen of GSK had been elected as Chair of I-PWG for 2011.

The Group discussed the progress of its papers for publication.  Peer review of two papers had been completed but the results were not available.  Review of the other papers was ongoing.

The Industry Sampling Task Force updated the Group on its plans for the a workshop  which it hopes to run in the first quarter of 2011.  A draft agenda had been circulated and productive meetings had been held with FDA and DIA.

A new Task Force on Recommendations for Good Storage and Analysis Practice had had its first meeting and agreed to work towards publication of an article or White Paper.

There was preliminary discussion about a draft agenda for a meeting with FDA in 2011 to follow up on the successful meeting in Spring 2009.

The next teleconference will be on October 12.

Eighteen people from 13 member companies attended.

It was reported that the four manuscripts had been submitted to review before publication.  They will be reviewed as a group.  If the papers are accepted, they will be sent to the FDA for commentary.

The Industry Sampling Task Force updated the Group on its plans for the a workshop on issues related to DNA sampling which it hopes to run in the first quarter of 2011. The Education Task Force reported that progress is being made on a slide deck for the use of I-PWG members.  Reports were also received from other Task Force leaders.

The Group considered proposals for two new projects, one related to variability in PK and the other related to writing recommendations for practices for handling, storing and analyzing samples collected for biomarker research.

The next teleconference will be on September 14.

 

Fifteen people from 10 member companies attended. Professor Bartha Knoppers of McGill University gave a presentation on Consent, Privacy and the Use of Data and Samples.

The Group discussed the progress of its papers for publication.

The Industry Sampling Task Force presented the draft agenda for a workshop it hoped to run in the first quarter of 2011. The Education Task Force reported that progress was being made on a slide deck for the use of I-PWG members.

The next teleconference will be on August 10.

Representatives from 16 member companies attended.

Elisa Siriglia of EFPIA, the EFPIA co-ordinator for ICH, provided an update on ICH E17.

I-PWG Task Force leaders reported on work in progress. It was noted that four manuscripts had been circulated to member companies for legal review and members were urged to do everything possible to meet the 18 June deadline.

It was noted that the Industry Sampling Task Force would be presenting a poster at the DIA Annual Meeting.