Welcome to the CMC Strategy Forum We are pleased to welcome you to the CMC Strategy Forum. The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion. The meetings focus on relevant CMC issues throughout the lifecycle of a product and thereby foster collaborative technical and regulatory interactions. The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices. Outcomes of the Forum meetings are published in an appropriate peer-reviewed journal. Each meeting will focus on a CMC related issue such as product characterization, comparability, specifications, etc. The format of each meeting will consist of case studies and presentations by Industry and/or FDA experts to introduce the topic and the key issues of concern. Breakout sessions will then be conducted to allow for additional discussion on the technical and regulatory details of the topics. It is envisioned that the final outcome of the workshop discussions will be the development of a document to be submitted to the appropriate Regulatory Agency designees for their consideration in developing and/or clarifying good regulatory practice guidelines for biotechnology derived products. The success of the CMC Strategy Forum will depend on your active participation in discussing and raising issues pertaining to development of biologics. We encourage you to participate wholeheartedly in the workshops that have been designed to stimulate exchange of ideas and information. We would like to thank the speakers who are giving generously of their time and resources, and to you, for your attendance. We acknowledge the generosity of our program partners: AbbVie, Inc., Amgen Inc., Biogen, Bristol-Myers Squibb Company, Eli Lilly and Company, F. Hoffmann-La Roche Ltd., Genentech, a Member of the Roche Group, Janssen R&D, LLC, MedImmune, A member of the AstraZeneca Group, Merck & Co., Inc., National Institute of Standards and Technology (NIST) and Pfizer, Inc. We are grateful for the expert management from CASSS and the audio-visual expertise of Michael Johnstone from MJ Audio-Visual Productions. Their experience and guidance in the preparation of this Forum has been invaluable. ACKNOWLEDGEMENTS CMC STRATEGY FORUM NORTH AMERICA PROGRAM COMMITTEE Siddharth Advant, Celgene Corporation Yves Aubin, Health Canada John Bishop, CBER, FDA Barry Cherney, Amgen Inc. JR Dobbins, Eli Lilly and Company Julia Edwards, Biogen Sarah Kennett, CDER, FDA Joseph Kutza, MedImmune, A member of the AstraZeneca Group Kimberly May, Merck & Co., Inc. Anthony Mire-Sluis, AstraZeneca Stefanie Pluschkell, Pfizer, Inc. Nadine Ritter, Global Biotech Experts, LLC Dieter Schmalzing, Genentech, a Member of the Roche Group Timothy Schofield, GlaxoSmithKline Zahra Shahrokh, STC Biologics and ZDev Consulting Jeffrey Staecker, BioPhia Consulting, Inc. Andrew Weiskopf, Biogen Marcel Zocher, Bristol-Myers Squibb Company CMC STRATEGY FORUM GLOBAL STEERING COMMITTEE Siddharth Advant, Celgene Corporation, USA Daniela Cerqueira, ANVISA-Brasilian National Health Surveillance Agency, Brasil Yasuhiro Kishioka, PMDA-Pharmaceutical and Medical Devices Agency, Japan Steven Kozlowski, CDER, FDA, USA Junichi Koga, Daiichi Sankyo Co., Ltd., Japan Rohin Mhatre, Biogen, USA Ingrid Markovic, CBER, FDA, USA Anthony Mire-Sluis, AstraZeneca, USA Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland (Chair) Ilona Reischl, AGES-Austrian Federal Office for Safety in Health Care, Austria Anthony Ridgway, Health Canada, Canada Nadine Ritter, Global Biotech Experts, LLC, USA Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland Mark Schenerman, MedImmune, A member of the AstraZeneca Group, USA Karin Sewerin, BioTech Development AB, Sweden The Organizing Committee gratefully acknowledges the pharmaceutical and biotechnology industry for their generous support of the CMC Strategy Forum North America series: STRATEGIC DIAMOND PROGRAM PARTNERS F. Hoffmann-La Roche Ltd. Genentech, a Member of the Roche Group STRATEGIC PLATINUM PROGRAM PARTNERS AbbVie, Inc. Biogen MedImmune, A member of the AstraZeneca Group STRATEGIC GOLD PROGRAM PARTNERS Eli Lilly and Company Pfizer, Inc. STRATEGIC SILVER PROGRAM PARTNER Merck & Co., Inc. PROGRAM PARTNERS Amgen Inc. Bristol-Myers Squibb Company Janssen R&D, LLC National Institute of Standards and Technology (NIST) The Scientific Organizing Committee gratefully acknowledges the following media for their promotional consideration of CMC Strategy Forum North America January 2017: LEADING MEDIA PARTNERS BioProcess International International Pharmaceutical Quality MEDIA PARTNERS American Laboratory / LabCompare American Pharmaceutical Review Analyst / Analytical Methods BioProcessing Journal ChemComm / ChemSocRev / Chemical Science Genetic Engineering & Biotechnology News G.I.T. Laboratory Journal Green Chemistry / Integrative Biology LC / GC MedChemComm / Molecular BioSystems Pharmaceutical Outsourcing Royal Society of Chemistry separationsNOW.com Technology Networks The Analytical Scientist / The Pathologist Forum Abstract Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry FORUM CO-CHAIRS: Kathy Lee, Eli Lilly and Company, USA Jeffrey Staecker, BioPhia Consulting, Inc., USA SCIENTIFIC ORGANIZING COMMITTEE: Sarah Demmon, Eli Lilly and Company, USA Mark DiMartino, Amgen Inc., USA Hugo Hamel, Health Canada, Canada Ned Mozier, Pfizer, Inc., USA Julia O’Neill, Tunnell Consulting, Inc., USA Ramesh Potla, CDER, FDA, USA Timothy Schofield, GlaxoSmithKline, USA Business and regulatory drivers have led to increased activity of analytical and biological method transfers, in the biopharmaceutical industry. Method transfer may occur between labs at the same company site, between sites of a company, or between companies. This increased activity in method transfers is occurring in the absence of clear regulator expectations and comes at a time of increasing scrutiny from both regulators and industry in defining what is needed for successful transfers. Questions range from whether a formal transfer is required for moving QC operations to a new building at the same site to technical requirements and submission strategy for transfer of complex analytical methods between companies. During this forum regulators and industry experts will discuss issues and successes they are observing with method transfers, approaches and regulatory strategies for submitting transfers to regulatory agencies. CMC Strategy Forum Program Summary Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry Monday, January 23, 2017 07:30 – 17:00 Registration in the Senate Room 07:30 – 08:30 Breakfast in the Palm Court Ballroom, Lobby Level 08:30 – 08:45 CASSS Welcome and Introductory Comments in the Grand Ballroom Nadine Ritter, Global Biotech Experts, LLC CMC Strategy Forum Welcome and Introductory Comments in the Grand Ballroom Kathy Lee, Eli Lilly and Company Jeffrey Staecker, BioPhia Consulting, Inc. Regulatory Compliance Workshop Session One in the Grand Ballroom Session Chairs: Sarah Demmon, Eli Lilly and Company, Julia O’Neill, Tunnell Consulting, Inc. and Timothy Schofield, GlaxoSmithKline 08:45 – 09:10 Regulatory Perspectives on Analytical Method Transfer for Biopharmaceutical Products Ramesh Potla, CDER, FDA, Silver Spring, MD USA 09:10 – 09:35 Regulatory Expectations for Method Transfers: Health Canada’s Perspective Hugo Hamel, Health Canada, Ottawa, ON Canada 09:35 – 10:00 TBD Alfred Del Grosso, CBER, FDA, Silver Spring, MD USA 10:00 – 10:25 TBD Dawn Sailer, Eli Lilly and Company, Indianapolis, IN USA 10:30 – 11:00 Networking Break in the Palm Court Ballroom 11:00 – 12:15 PANEL DISCUSSION – Questions and Answers Alfred Del Grosso, CBER, FDA, USA Hugo Hamel, Health Canada, Canada Ramesh Potla, CDER, FDA, USA Dawn Sailer, Eli Lilly and Company, USA TBD TBD 12:15 – 13:45 Networking Lunch in the Palm Court Ballroom Monday, January 23 continued… Key Ingredients Needed for Successful Method Transfers: Cases Included Workshop Session Two in the Palm Court Ballroom Session Chairs: Mark DiMartino, Amgen Inc., Hugo Hamel, Health Canada and Ned Mozier, Pfizer, Inc. 13:45 – 14:10 Case Studies and the Validation and Transfer of Analytical Methods for mAbs and Vaccines to Enable Commercial Launch Jason Starkey, Pfizer, Inc., Chesterfield, MO USA 14:10 – 14:35 Practical Points in Method Tech Transfers: Three Scenarios Nadine Ritter, Global Biotech Experts LLC, Germantown, MD USA 14:35 – 15:00 Risk-based Approach to Method Transfer Jeffrey Staecker, BioPhia Consulting, Inc., Lake Forest, IL USA 15:00 – 15:25 A Balancing Act: Streamlining Method Transfer without Compromising Compliance or Science Julie Frost, Amgen Inc., West Greenwich, RI USA 15:30 – 16:00 Networking Break in the Palm Court Ballroom 16:00 – 17:15 PANEL DISCUSSION – Questions and Answers Julie Frost, Amgen Inc., USA Nadine Ritter, Global Biotech Experts LLC, USA Jeffrey Staecker, BioPhia Consulting Inc., USA Jason Starkey, Pfizer, Inc., USA TBD TBD 17:15 – 17:45 Recap of Program Summary Slide Presentation Nadine Ritter, Global Biotech Experts, LLC 17:45 – 18:00 Invitation to CMC Strategy Forum July 2017 18:00 – 19:15 Networking Reception in the Palm Court Ballroom Regulatory Compliance Session Chairs: Sarah Demmon, Eli Lilly and Company, Julia O’Neill, Tunnell Consulting, Inc. and Timothy Schofield, GlaxoSmithKline Analytical method transfer constitutes an integrated step in the method life cycle.