Attendees: * denotes chair
Academia/Industry Representatives:
Larry L. Augsburger - AAPS
William Bradley – CHPA
John B. Cox – AAPS
Shawn F. Dressman, Ph.D. – USP
Edmond M. Fry – PDA
Sylvia Gantt – PQRI
Thomas Garcia, Ph.D., BUWG (by telephone)
* Tobias Massa, Ph.D. – Lilly
Deborah Miran - GPhA
David C. Pang, Ph.D. – AAPS
Frederick A. Sexton, Ph.D. - ISPE
Marshall Steinberg - IPEC
Alice E. Till, Ph.D. – PhRMA
Thomas X. White PhRMA
FDA Representatives:
Ajaz Hussain, Ph.D.
Vinod Shah, Ph.D.
Helen N. Winkle
Meeting convened at 9:15 a.m., Tobias Massa, Chairman, presiding.
Welcome and Opening Remarks
Tobias Massa welcomed the Steering Committee (SC) to the meeting and introduced new PQRI Executive Secretary, Sylvia Gantt.
Approval of Minutes
A motion was made and passed to approve the Minutes of the December 7, 2000 Steering Committee meeting without modifications.
Board of Directors Update
William Bradley reported on the activities of the Board during its meeting of December 12, 2000. Eli Lilly & Co. contributed $50,000 to the funds for PQRI research projects. The Board will begin a second phase of fundraising in an effort to accumulate funds in excess of $1,000,000. This matter will be discussed in greater detail at its upcoming meeting on March 2nd, 2001.
Tom Garcia and Jim Prescott Article
Tom Garcia and Jim Prescott authored an article, Solid Dosage and Blend Uniformity Troubleshooting in Manufacturing, which will be published in Pharmaceutical Technology. The authors requested the use of PQRI logo in the article. Ajaz Hussain stated that the article is excellent and needed only minor modifications. The SC determined that the use of the PQRI logo in this article is not appropriate, since the work was performed outside the purview of the Blend Uniformity Working Group (BUWG). However, acknowledgement of the Institute will be welcomed.
BUWG Plan and Budget
The draft proposal/research plan was delivered to Ajaz Hussain on February 5, 2001 for his review prior to submission to the SC. The FDA Blend Uniformity Committee will review the document and report back to the Blend Uniformity Working Group and the Drug Product Technical Committee on its adequacy. Toby Massa believed that the working group had some good working concepts on stratified sampling reported during the presentation by BUWG at the last SC meeting. The SC felt that a proposal that details the number of projects, the data needed, the cost for administrative support, etc., is needed Further discussion will continue following review by FDA and the Technical Committee.
Drug Product Technical Committee (DPTC) Update
Ajaz Hussain reported for Sid Goldstein, Chairman of the Technical Committee. DPTC would like to have resolution on issues such as conflict of interest, intellectual property ownership, authorship credit for publications, reimbursement of academics, etc. The SC stated that the Policies and Procedures Subcommittee are addressing these issues.
DPTC was concerned about a Gold Sheet article with verbatim reproduction of the BUWG Workshop and inappropriate conclusions. The SC directed Sid Goldstein to establish a relationship with the publisher, request to review materials before publication and assist the publisher in correcting any inaccuracies in the reporting.
Packaging Working Group – To date, eight members have been identified for the Working Group. Julie Clifford of Alcon and Don Kline of FDA will also be asked to join.
Manufacturing Changes Working Group – The group is still searching for possible projects on an optimal approach in dealing with the limitation of SUPAC, risk-based CMC efforts and a decision-tree approach based on unit operations and/or type of changes (i.e., wet granulation to direct compression). Ajaz Hussain would like to move toward a decision-tree approach and will talk to PhRMA staff regarding this matter.
Drug Substance Technical Committee (DSTC) Update
An orientation/training program has been scheduled at the AAPS headquarters on March 20th, 2001. The training will encompass information on PQRI and its policies/procedures, as well as individual breakout sessions for the three working groups: Particle Size (Physical Properties), Drug Substance Specifications and Impurities.
Biopharmaceutics Technical Committee (Biopharm TC)
The group has started to make progress and is focusing on issues related to dissolution profile similarity (SUPAC-IR); BCS-based Class II (ionizable drugs); and waiver of food-effect BE studies. The lost one on waiver of food-effect BE studies is a major new project at FDA.
Science Management Technical Committee (SMTC)
It is essential to find a chairman for this important PQRI technical committee for the initiation of the Mapping projects. His/her first responsibility would be to map the CMC process with the intent of streamlining and adding value. The member organizations of SC were requested to find someone within their companies who might qualify for this leadership position. FDA employees could also be included in this pool of chairman possibilities
FDA Funds for PQRI Projects
Helen Winkle mentioned that FDA has $150,000 available for PQRI research projects. Most members of the SC were not aware of such funding. Availability of these funds will be made known to the technical committees and working groups.
Recognition Subcommittee
There was open discussion of what can be presented to contributors to PQRI in order to recognize their contributions. Some of the ideas suggested were sending a thank you letter immediately, announcement on the PQRI web site, a banner with the names of all contributors shown and displayed at the AAPS annual meeting, as well as individual banners on vendor booths at the AAPS annual meeting, updating the PQRI brochure with names of contributors, pictures of contributors giving the checks, or contributors could use the PQRI logo on advertising.
Counterfeit Drugs
FDA requested the assistance of PQRI in the issue of counterfeit drugs. The SC determined that while it is the desire of PQRI to assist FDA in as many projects as possible, solutions to the issue of counterfeit drugs are not within the scope of PQRI’s mission to provide scientific evidence to generate or modify FDA guidelines or regulations. PQRI could, however, act as a facilitator to bring industry leaders and essential Agency personnel together to resolve and/or identify solutions. FDA can also hold stakeholders meetings. Once these tasks have been delineated, then any research projects could be assigned to the PQRI technical committees/working groups to resolve.
Annual Meeting for PQRI
A PQRI meeting was held previously in May of 1999. It was agreed that the ECAC would take a look at the possibility of holding a meeting in 2001. This would be a one-day internal meeting for all individuals currently involved in PQRI Board, Steering Committee, Technical Committees and Working Groups. The meeting may be held in the Washington, D.C. area in August/September, 2001. Ed Fry, Chair of ECAC will initiate the process with the assistance of Sylvia Gantt, the Executive Secretary.
Finance Support for Academics
In view of the lack of funds at the present time, the SC recommended that representatives from academia should use telecommunication as much as possible. It was suggested that PQRI might be able to fund one meeting per year for an academic representative from each Technical Committee and Working Group. Guidelines have to be established for such funding. However, this suggestion has to be approved by the Board of Directors
Future Meeting Dates
Sylvia Gantt will send calendars for the months of March through December for Committee members to record their dates of unavailability. A final schedule will be determined.
Other Business
Tom White of PhRMA announced his retirement effective the 22nd of February, 2001.
A motion was made by Jack Cox and seconded by Tobias Massa to recognize Tom for his outstanding service to PQRI. PQRI has benefited from his input and he has been invaluable in the development of PQRI as an organization.
Motion passed unanimously.
NAPM and GPhA
It was confirmed that the two organizations have now merged.
Technical Committee/Working Group Working Relationship
PQRI must enforce the preparation and presentation of a project plan with study protocols from each working group. The SC determined that the working groups need more education on guidelines and especially the need for them to know FDA guidelines. It was agreed that the technical committees should take a more proactive role in the projects assigned to their respective working groups. This will include: 1) the technical committees reporting at each SC meeting on the progress of the groups, 2) the chairs will walk through the guidelines to explain how the working group is impacting on the guidelines and 3) one pagers should be developed on each project to indicate what research the working groups are addressing. It is imperative that the technical committees are on board to monitor, enforce and carry through.
Meeting adjourned at 1:40 p.m.Next Meeting
Next scheduled meeting Friday, March 16, 2001 at the AAPS headquarters in Arlington, VA.