Minutes of the Bioequivalence Focus Group

Meeting Date: Tuesday January 8, 2013 Time: 12:00 pm EDT

Location:Tele-Conference

Attendance:Murray Ducharme (chair), Charlie DiLiberti, Yu Chung Tsang, Mario Gonzalez, Chuck Bon, Derek Gaines, Laszlo Endrenyi, Chandra Vattikonda, Zaidoon Al-Zubaidy, Robert Lepage, Elliott Offman, Raja Velagapudi

Apologies:Izzy Kanfer (traveling), Panos Macheras (could not dial in from Europe)

Not in Attendance:HenningBlume,Sethu Kavuri, Leon Shargel, Ranadheer Ravula

Happy New Year was wished to all members on the call. Due to the timing of the call Dr. Izzy Kanfer, Past BEFG Chair, could not attend because of travel plans.

The agenda for the call was distributed to all members on December 18, 2012. The agenda was followed and the following topics were discussed and brainstormed among members:

1)2013 AM session Proposals

Nine sessions were proposed in partnership with other FGs (including the Generic FG) within the RS section. Six of these went into Round 2 for selection and at this time at least 2 sessions were selected. The sessions selected were:

  • A Sunrise session proposed and organized by Panos Macheras entitled “Poorly Explored Issues in Bioequivalence Assessment” planned for Wednesday November 13 7-8h15 am
  • A Roundtable session proposed and organized by Murray Ducharme entitled “Global Clinical Regulatory Requirements for Inhalation Products” planned for Thursday November 14 from 9 to 11ham.

Lessons learned during this process were that 1) there was no apparent link between what were considered to be the “highest rated” sessions by the RS group during the August 2012 Jamboree and the sessions that did eventually got the highest rating by the same RS group in November, and 2) Very few Sunrise Sessions are proposed apparently by the different FGs, and so proposals for Sunrise Sessions have a much higher probability of being selected. We should remember this next year when we submit proposals.

**UPDATE AFTER THE CONFERENCE CALL:

3 sessions were approved (not 2) for the BE FG. The 3rd one was:

A mini symposium proposed and organized by Izzy Kanfer entitled “Strategies and Issues in the design and data analysis of skin adhesion, irritation and sensitization studies for BE evaluation of transdermal/topical patch generic drug products”

4 other important sessions were approved where the BE FG is a supporting FG:

  1. A symposium entitled “Effect of Recent regulatory changes at FDA on generic drug development and approval process”
  2. A symposium entitled “Regional approaches to Bioequivalence requirements”
  3. A Roundtable entitled “Dissolution methods , the similarity factor and their application in regulatory files: Scientific and regulatory standards for accessing product performance using the similarity factor, F2, as a criteria for orally complex dosage forms”
  4. A symposium entitled “Are generic non-biological complex drugs (NBCD) therapeutically equivalent?

2)Important upcoming dates

  • The abstract deadline of NBC May 13 is Feb 13. The abstract deadline for AM November 13 is May 8.
  • Session proposals for NBC 2014 need to be drafted before the April 2013 Jamboree. So Murray would like the members to propose sessions for the first week of April 2013 at the latest.
  • Session proposals for the AM 2014 need to be drafted before the July 2013 Jamboree. Murray needs members to make proposals for the second week of July 2013 at the latest.

3)Steering committee

Izzy and Murray have discussed revamping the BE FG Steering committee to better align it with the proposed AAPS recommendations and make it more effective. Recommendations are that a steering committee be formed of 5 to 10 members maximum, including the Chair and the past Chair. Members should come from diverse locations and with diverse expertise, student participation is encouraged, and we could also propose a maximum number of consecutive years that a member could be on the steering committee, and members should be replaced in an overlapping manner so that not all members are changed at the same time to allow for better continuity.

Izzy and Murray are looking for feedback from members on all these and other criteria, and a proposal will be put forward soon so that we have an updated Steering Committee for the BE FG.

Chuck proposed that the whole FG be involved with the committee and not just the members per se. To this end he proposed to make sure that the minutes be available to anyone within the FG for them to see. He also proposed that there would be a clear mechanism put in place so that anyone who would like to be part of the steering committee and fit the criteria be able to do so.

4)Thoughts about what we should accomplish in 2013 besides session programming

Members were encouraged to suggest and to think about what should be accomplished in 2013 as additional objective(s) for the BE FG.

5)Other

  1. AAPS Blog: AAPS has a blog directly on their website where members can start discussions. Members were encouraged to visit it and see if they want to start discussions this way versus posting discussions on the AAPS BE FG section on Linkedin, for example.
  1. eLearning: Raja presented the AAPS eLearning initiative, what has been done, what is upcoming, and responded to questions from the members regarding price and CE credits among others.
  1. AAPS Fellow nomination: The deadline for Fellow nomination is March 15 2013.
  1. Other business: Raja asked what members thought would be the most important new concepts and ideas in BE in 2013. Yu Chung highlighted the posting of a draft Warfarin guidance from OGD just before Christmas and that presents new BE criteria for NTI drugs. It was agreed among members that this would be a very important development for this year within BE and that this would need to be discussed and brainstormed upon further.

Members were thanked for their participation on the call, and the Teleconference was adjourned at 13h00 EST.

BE FG Jan 8 2013 Minutes(finalized 15/JAN/2013)Page 1 of 2