Trade/Professional Association Representatives:
Gilbert S. Banker, Ph.D. - AAPS
William W. Bradley – CHPA
John B. Cox – AAPS
Kenneth R. Heimlich, Ph.D. – AAPS - Chair
Tobias Massa, Ph.D. – PhRMA
David C. Pang, Ph.D. - AAPS
Jerome P. Skelly, Ph.D. - AAPS
FDA Representatives
Ajaz S. Hussain, Ph.D. – FDA
Eric Sheinin, Ph.D. –FDA
Helen N. Winkle – FDA
Observers:
Steve Byrn, Ph.D. – DSTC
Edmond Fry - PDA
Elizabeth Lane, Ph.D. – GPhA
Arnie Repta, Ph.D. -
Welcome and Opening Remarks
The meeting was called to order at 8:45 AM with Kenneth Heimlich presiding.
The meeting was held at the Harrison’s Room, Hyatt, Indianapolis, IN.
Minutes of June 26, 2000
The minutes of the June 26, 2000 Board of Directors meeting was approved.
Update on Member Organization Support
All member organizations, except Consumer Healthcare Products Association
(CHPA), contributed their membership assessment fee. In addition, Penwest Pharmaceuticals
Co. donated $5,000 to PQRI. An invoice was sent to Eli Lilly and Co for anticipated
donation of $50,000.
Fund Raising Status
Fund raising letters were sent out to potential contributors during the
2nd week of August 2000. The next phase is to contact the Tier I
companies. The Chair generated a list of 33 Tier I companies. Each Board member
was assigned several of these companies to follow-up. The list of the assignments
will be sent to all board members as soon as it is collated.
The Chair met with the PDSC of PhRMA to apprise them of the status of the fund raising activities. It was evident that improved communication with PDSC and PQRI is needed. The Chair, long with Dr. Massa and Mr. White will address the issues.
Recognition Program
In view of the contribution from Penwest and the potential contribution from
Lilly, it was felt that the companies should be recognized. A recognition plan
will be addressed by AAPS with possible recognition of donors at the PQRI press
conference on December 12, 2000, National Press Club.
Report from Steering Committee
Process Mapping of CMC Processes – A Working Group will be formed to carry out this project for CMC planning and review. Charles Lowe at Motorola has been identified as a possible investigator.
IPAC – The group petitioned to join PQRI at the Working Group level. It would like to investigate projects regarding CMC-related problems of aerosols, e.g., plume geometry, etc., under the auspices of PQRI. IPAC is willing to fund the projects. The Steering Committee is considering accepting the offer from IPAC.
Blend Uniformity Working Group – The Steering Committee and the Drug Product Technical Committee collaborated with the Blend Uniformity Working Group to make the Blend Uniformity Workshop a success. The Working Group will generate a project plan. Members of the Blend Uniformity Working Group will be generate the proposal and perform the project. The Board should be apprised of any funding requirements
Report on Blend Uniformity Workshop
The workshop was held on September 7-8, 2000. 173 regular and 20 government
paid registrants attended with 16 speakers participating in the proceedings.
PQRI received a net income from the workshop.
Board Members Attendance at Workshop
Board members should attend PQRI workshops and be visible. The motion: to
waive the registration fee for board members to attend PQRI workshops was approved
by all Board members.
Press Conference
A PQRI press conference has been arranged at the National Press Club, 10:00
AM, Tuesday, December 12, 2000. Kenneth Heimlich, Tobias Massa, Helen Winkle,
and Jack Cox will be featured in the press conference. Dr. Jane Henney, FDA
Commissioner has been scheduled to speak at a luncheon at the National Press
Club on the same day. Hopefully, she may join the press conference. All Board
members have agreed to attend.
PQRI Board of Directors Meeting
The next Board meeting will be held in December 12, 2000 after the press
conference.
The meeting adjourned at 10:30 AM.