PRELIMINARY PROGRAM. CASSS Bay Area Discussion Group. Co-chairs: Judy Chou, Medivation Lance Wong, Strand Bio

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1 PRELIMINARY PROGRAM CASSS Bay Area Discussion Group Co-chairs: Judy Chou, Medivation Lance Wong, Strand Bio South San Francisco Conference Center October 13,

2 Table of Contents Conference Program Partners.. 3 Acknowledgements.4 General Information 5 Scientific Program Summary..6 Program and Speaker Abstracts..7 Roundtable Discussion Point Sheets...9 Note Paper.17 2

3 The Organizing Committee gratefully acknowledges the Conference Program Partners for their generous support of this Bay Area Discussion Group Program Program Partners Agilent Technologies Covance Genentech, a Member of the Roche Group ProteinSimple 3

4 Acknowledgements Special Thanks to all the Program Committee Members who helped develop this Bay Area Discussion Group Program Committee Kris Antonsen, BioMarin Pharmaceutical, Inc. Dawn Benson, Coherus Min Chen, Ultragenyx Pharmaceutical Judy Chou, Medivation Kathleen Francissen, Genentech, A Member of the Roche Group Malou Gemeniano, Boehringer Ingelheim Vinaya Kapoor, Johnson & Johnson David Passmore, Bristol-Meyers Squibb Aran Paulus, Thermo Fisher Scientific Joanne Severs, Bayer Lance Wong, Strand Bio DBA Christopher Yu, Genentech, A Member of the Roche Group Eike Zimmermann, Boehringer Ingelheim Roundtable Facilitators Greg Cantin, Five Prime Therapeutics Sianna Castillo, BioMarin Pharmaceutical, Inc. Jenny Chen, Nektar Therapeutics Raghu Chitta, Bayer Guifeng Jiang, Boehringer Ingelheim Weijun Li, Bayer Rob McCombie, Genentech, a Member of the Roche Group Roma Panjwani, Boehringer Ingelheim Steve Rabin, Janssen Research & Development, Johnson & Johnson Karin Regnstrom, Boehringer Ingelheim Audio Visual: Michael Johnstone, MJ Audio-Visual Productions 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 3:45 p.m. We will accept walk-in registrations. Roundtable Session There are 7 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: Table Topic 3: Table Topic 4: Table Topic 5: Table Topic 6: Table Topic 7: Transferring Processes and Analytical Methods to CMOs/CROs Phase Appropriate Comparability Assessments 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, October 13, :00 09:00 Registration and Continental Breakfast 09:00 09:30 CASSS Welcome and Introductory Comments Kathleen Francissen, Genentech, A Member of the Roche Group 09:30 10:15 FDA Recommendations for Comparability Studies to Support Manufacturing Changes Joslyn Brunelle, CDER, FDA 10:15 11:00 Biopharmaceutical Method Transfer as Part of the Quality System Camille Dycke, Genentech, a Member of the Roche Group 11:00 11:30 AM Break 11:30 12:15 Panel Discussion Moderated by: Lance Wong, Strand Bio 12:15 13:15 Lunch Panel Members: Joslyn Brunelle, CDER, FDA Judy Chou, Medivation Camille Dycke, Genentech, a Member of the Roche Group Sara Wright, Boehringer-Ingelheim 13:15 14:00 Roundtable Discussions 14:00 14:30 PM Break and Roundtable Summaries Created 14:30 15:30 Summary of Roundtable Discussions by Table Facilitators 15:30 15:45 Closing Remarks 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 FDA Recommendations for Comparability Studies to Support Manufacturing Changes Joslyn K Brunelle, CDER, FDA Manufacturers of biotechnology products frequently make changes to manufacturing processes of products both during development and after approval. Common manufacturing changes include: scale up, site changes, changes in equipment, new cell line/master cell bank, and/or formulation changes. Pre-change and Post-change products should be assessed for comparability, which involves an analysis of relevant physicochemical and biological characterization data to assess whether there are any significant differences in the quality attributes of the product. For many biotechnology products, quality attributes include potency and both product-related and processrelated impurities. Analytical comparability exercises typically include some combination of release testing, extended characterization methods, and stability studies (real time and stressed conditions). However, the amount of information varies depending on your stage of development (Phase 1, Phase 3, or post-approval). If comparability cannot be demonstrated, then non-clinical or clinical studies may be needed to assess whether any differences would negatively impact the safety or efficacy of the product. The basic principles of ICH Q5E (Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process) will be outlined. Examples of comparability studies at different stages of clinical development will be provided. 8

9 Roundtable Discussion Points TABLE 1 TOPIC: FACILITATORS: SCRIBE: Transferring Processes and Analytical Methods to CMOs/CROs Guifeng Jiang, Boehringer Ingelheim Steve Rabin, Janssen Research & Development, Johnson & Johnson Eike Zimmermann, Boehringer Ingelhheim SCOPE: BULLET POINTS FOR DISCUSSION: 9

10 TABLE 2 TOPIC: FACILITATORS: SCRIBE: Phase Appropriate Comparability Assessments Rob McCombie, Genentech, a Member of the Roche Group Roma Panjwani, Boehringer Ingelheim Joanne Severs, Bayer SCOPE: BULLET POINTS FOR DISCUSSION: 10

11 TABLE 3 TOPIC: FACILITATORS: SCRIBE: Powering Bioassays for Transfer Comparability Karin Regnstrom, Boehringer Ingelheim Fengrong Zuo, Medivation SCOPE: BULLET POINTS FOR DISCUSSION: 11

12 TABLE 4 TOPIC: FACILITATORS: SCRIBE: Bridging Analytical Methods Jenny Chen, Nektar Therapeutics Raghu Chitta, Bayer Christopher Yu, Genentech, a Member of the Roche Group SCOPE: BULLET POINTS FOR DISCUSSION: 12

13 TABLE 5 TOPIC: Statistical Based Approach for Analytical Method Transfer FACILITATORS: SCRIBE: Greg Cantin, Five Prime Therapeutics Weijun Li, Bayer David Passmore, Bristol-Meyers Squibb Company SCOPE: BULLET POINTS FOR DISCUSSION: 13

14 TABLE 6 TOPIC: Tech Transfer Considerations for Breakthrough Therapy Designation FACILITATORS: SCRIBE: Vinaya Kapoor, Johnson & Johnson SCOPE: BULLET POINTS FOR DISCUSSION: 14

15 TABLE 7 TOPIC: FACILITATORS: SCRIBE: Transfer Considerations for Inspections (Post Approval Commitments) Sianna Castillo, BioMarin Pharmaceutical, Inc. Malou Gemeniano, Boehringer Ingelhheim SCOPE: BULLET POINTS FOR DISCUSSION: 15

16 TABLE 8 This is the first time CASSS is offering this Career Development and Understanding the Industry Roundtable Topic at our Bay Area Discussion Group. This table topic will be held during the lunch hour. Seating will be on a first come, first serve basis for the first 10 attendees. TOPIC: FACILITATOR: Career Development/Understanding the Industry Malou Gemeniano, Boehringer Ingelheim SCOPE: 16

17 NOTES: 17