I-PWG Biomarker Brochure

I-PWG Biomarker Brochure

Representatives from 15 member companies attended.  Issam Zineh of FDA gave his impressions of the FDA’s March Advisory Committee.

The Group discussed the progress of its papers for publication and agreed a schedule for review and approval.  Thanks were expressed to all those who have been involved in the work to date.

The Education Task Force reported that progress was being made with the latest brochure and that a slide deck was being prepared for the use of I-PWG members.

The next teleconference will be on June 8.

Representatives from 16 companies attended the meeting, along with a representative from the FDA and legal and administrative support from Covington & Burling LLP.  Amir Snapir welcomed members, including Boehringer Ingelheim which was attending for the first time.

Linda Surh of GSK gave a presentation on Pharmacogenetics in PK trees: as tools to share knowledge and learning across experts.  Linda's slides and associated materials are available to members on the Group's website.  There was an extended discussion after the presentation.

Nadine Cohen gave a presentation on the proposal for a Regulatory Information Repository.  Nadine's slides, an edited version of those shown at the Face to Face meeting, are also available to members on the website.  After some discussion, it was agreed that a small core group would work on the proposal with a view to bringing it back to the full Group at a later date.

20 members from 14 companies attended the meeting. Members from new companies were introduced.

It was agreed that the FDA workshop, which had just ended, had been a great success and had opened new avenues of collaboration with the agency and new areas of interest for I-PWG.

Reports summarizing work completed in 2009 and looking forward to 2010 were received from Task Force leaders. Proposals for new projects were put forward and there were preliminary discussions about their merits and practicality. It was agreed that the proposals would be reviewed in more detail at a later date.

More than 20 people from 14 member companies attended. Federico Goodsaid of FDA made a presentation.  There was one guest.

Amir Snapir, the new Chair of I-PWG welcomed members and guests.  

Federico Goodsaid of the FDA gave a presentation on VXDS and the proposed Feedback Form on which FDA, I-PWG and other groups are co-operating.  Federico’s slides and the latest version of the Feedback Form had been circulated to members ahead of the meeting.  The Group welcomed the presentation and exchanged views on the best way to proceed.  

Amir Snapir noted that any developments relating to the FDA Workshop (Bethesda, Maryland 2-4 February) would be posted on the I-PWG website.

Amir Snapir reported that more than 30 people from 14 companies were currently scheduled to attend the I-PWG Face to Face meeting to be held in Washington DC on Friday 5 February.  The agenda had been posted on the I-PWG website but members were encouraged to contribute additional items, especially suggestions for new projects.  

Amir Snapir noted that Purdue Pharma had become a member of the Group and that most if not all of the 2009 members had committed to renew their membership.  

It was agreed that the February 9 teleconference would be cancelled and that Face to Face would be the only meeting in February.  The next teleconference will be on March 9.

21 people from 12 companies were present.

Amelia Warner welcomed new participants from Merck.

Peter Shaw reported on progress on the February FDA /DIA /I-PWG workshop and the Group welcomed the news that the DIA was preparing to send out a flyer to participants.

Reports were received from Task Force leaders. The Group congratulated the Task Forces on their work to meet the tight deadlines imposed by the need to have documents ready for the February workshop

Amir Snapir noted that the I-PWG website had been upgraded and that additional work was planned for the end of the year.

Amir Snapir confirmed that the Group would meet Face to Face in February on the day after the workshop. An agenda was being prepared and would focus on the work program for 2010.