PRELIMINARY PROGRAM. Midwest Discussion Group. Co-chairs: James Carroll, Pfizer, Inc. Kathy Lee, Eli Lilly and Company

Transcription

1 PRELIMINARY PROGRAM Midwest Discussion Group Co-chairs: James Carroll, Pfizer, Inc. Kathy Lee, Eli Lilly and Company Eli Lilly and Company Campus June 2,

2 Table of Contents Conference Program Partners.. 3 Acknowledgements.4 General Information 5 Scientific Program Summary..6 Program and Speaker Abstracts..8 Roundtable Discussion Point Sheets...9 Note Paper..14 2

3 The Organizing Committee gratefully acknowledges the Conference Program Partners for their generous support of this inaugural Midwest Discussion Group Program Partners AbbVie, Inc. Agilent Technologies Cook Pharmica, LLC Covance, Inc. Pfizer, Inc. 3

4 Acknowledgements Special Thanks to all the Program Committee Members who helped develop this Midwest Discussion Group Program Committee Leslie Bloom, Pfizer, Inc. Michael Boyne, BioTech Logic James Carroll, Pfizer, Inc. Sarah L. Demmon, Eli Lilly and Company John (J.R.) Dobbins, Eli Lilly and Company John Dougherty, Eli Lilly and Company Don Eisenhauer, AbbVie, Inc. Will Hatcher, Cook Pharmica Julie Heflin, AbbVie, Inc. Michelle Frazier, AbbVie, Inc. Kathy Lee, Eli Lilly and Company Michelle Lytle, Eli Lilly and Company Khalid Mahmood, Eli Lilly and Company Ed Moore, University of Illinois Ned Mozier, Pfizer, Inc. Lakshmy Nair, Baxter Healthcare Joshua Pecenica, Purdue University Lesley Redfern, AbbVie, Inc. Ashley Ruth, CDER, FDA Veda Walcott, Cook Pharmica Roundtable Facilitators Roland Buhler, AbbVie, Inc. Brian DiPaolo, AbbVie, Inc. Julie L. Heflin, AbbVie, Inc. Jose Martinez-Velez, Cook Pharmica CASSS Staff Stephanie L. Flores, CAE, Executive Director Anna Lingel, Registration Manager Linda Mansouria, CMP, CMM, Conference Manager 4

5 General Information Name Badges Please wear your name badge throughout the day. Registration The registration desk will be open at 8:00 a.m. to 3:00 p.m. We will accept walk-in registrations. Roundtable Session There are 6 roundtable topics for you to determine which table topic you would like to be involved in the discussion. The 6 table topics are: Table Topic 1: Table Topic 2: Transferring Processes and Analytical Methods to CMOs/CROs Phase Appropriate Comparability Assessments Table Topic 3: Table Topic 4: Table Topic 5: Table Topic 6: Table Topic 7: Powering Bioassays for Transfer Comparability Bridging Analytical Methods Statistical Based Approach for Analytical Method Transfer Tech Transfer Considerations for Breakthrough Therapy Designation Transfer Considerations for Inspections (Post Approval Commitments) Tables are set with 10 seats to a table. Table topics are on a first come, first serve basis. These roundtables will include two facilitators, whose role is to help assist the discussion and ensure a lively exchange, and a scribe, whose role is to make general, anonymous notes about the discussion so others can have a chance to view the discussion even if they could not participate. The discussion notes will be shared with all attendees during the summary period of the program. 5

6 Scientific Program Summary 08:00 15:00 Registration THURSDAY, June 2, :00 09:00 Registration and Continental Breakfast 09:00 09:30 CASSS Welcome and Introductory Comments John Dougherty, Elly and Company 09:30 10:15 Joslyn Brunelle, CDER, FDA 10:15 11:00 Jeff Staecker, BioPhia Consulting, Inc. 11:00 11:15 AM Break 11:15 12:00 Panel Discussion Moderated by: James Carroll, Pfizer, Inc. and Kathy Lee, Eli Lilly and Company 12:00 13:00 Lunch Panel Members: Michael Boyne, BioTech Logic Joslyn Brunelle, CDER, FDA Ashley Ruth, CDER, FDA Jeff Staecker, BioPhia Consulting, Inc. 13:00 13:45 Roundtable Discussions 13:45 14:15 PM Break and Roundtable Summaries Created 14:15 15:00 Summary of Roundtable Discussions by Table Facilitators 15:00 15:15 Closing Remarks Michael Boyne, BioTech Logic, Inc. and Khalid Mahmood, Eli Lilly and Company 6

7 Successful Strategies for Tech Transfer Program Abstract Transfer of manufacturing processes is critical part of drug development to accommodate transition to commercial process, scale changes and site changes. These may occur within an organization or to contract manufacturing facilities. Issues such as scale, equipment, facility infrastructure, and analytical methods transfer should be considered in order to ensure consistency of product quality attributes. The phase of development drives the amount of data needed to support successful transfer of a manufacturing process using a risk-based approach. Generally, early phase transfers require less data. However, by phase 3 and post-licensure/approval the expectations are that a more thorough evaluation will be performed and rigorous analytical comparability data will be evaluated. Depending on the changes required to transfer the process and the evaluation of the analytical comparability data, additional clinical studies may be required to support the manufacturing site transfer. Analytical methods are often transferred during drug development and post-licensure/approval. Again the methods may be transferred to laboratories within company (e.g. analytical development labs to QC for clinical material batch release testing), or to contract analytical labs. The US FDA expects method transfer to occur under a transfer protocol that details the parameters evaluated with predetermined acceptance criteria. Considerations for successful transfer include sufficient number product lots tested at both the originating laboratory and the new laboratory as well as a statistically sound evaluation of the data generated at both labs. This workshop will provide insight into the transfer of a manufacturing process and the transfer of analytical methods to alternative sites that commonly occur during drug development. 7

8 Speaker Abstracts 8

9 Roundtable Discussion Points TABLE 1 TOPIC: FACILITATORS: SCRIBE: Transferring Processes and Analytical Methods to CMOs/CROs Jose Martinez-Velez, Cook Pharmica Will Hatcher, Cook Pharmica SCOPE: BULLET POINTS FOR DISCUSSION: 9

10 TABLE 2 TOPIC: FACILITATORS: SCRIBE: Phase Appropriate Comparability Assessments Brian DiPaolo, AbbVie, Inc. J.R. Dobbins, Eli Lilly and Company SCOPE: BULLET POINTS FOR DISCUSSION: 10

11 TABLE 3 TOPIC: Powering Bioassays for Transfer Comparability FACILITATORS: SCRIBE: Josh Pecenica, Purdue University SCOPE: BULLET POINTS FOR DISCUSSION: 11

12 TABLE 4 TOPIC: FACILITATORS: SCRIBE: Bridging Analytical Methods Julie L. Heflin, AbbVie, Inc. Ned Mozier, Pfizer, Inc. SCOPE: BULLET POINTS FOR DISCUSSION: 12

13 TABLE 5 TOPIC: Statistical Based Approach for Analytical Method Transfer FACILITATORS: SCRIBE: Brad Evans, Pfizer, Inc. SCOPE: BULLET POINTS FOR DISCUSSION: 13

14 TABLE 6 TOPIC: Tech Transfer Considerations for Breakthrough Therapy Designation FACILITATORS: SCRIBE: Michelle Frazier, AbbVie, Inc. SCOPE: BULLET POINTS FOR DISCUSSION: 14

15 TABLE 7 TOPIC: FACILITATORS: SCRIBE: Transfer Considerations for Inspections (Post Approval Commitments) Roland Buhler, AbbVie, Inc. Ashley Ruth, CDER, FDA SCOPE: BULLET POINTS FOR DISCUSSION: 15