Welcome to the CMC Strategy Forum Europe 2017

Transcription

1 Welcome to the CMC Strategy Forum Europe 2017 The 11 th annual CMC Strategy Forum Europe, organized by CASSS, will explore a number of critical topics focused on improving the quality in development and manufacturing of biopharmaceutical products. A series of plenary sessions and workshops led by experts from global regulatory agencies, academia and industry seek to explore emerging aspects of CMC technology and regulation in areas where existing modalities and systems are undergoing change. Topics will include: Regulatory Update from Around the World; The Continuing Evolution of Product Characterization; Manufacturing Process Development and Control Strategies; Statistical Tools to Evaluate Quality Attributes for Comparability and Biosimilarity; and Opportunities and Obstacles for Accelerated CMC Development. The EBE session will present updates on the following concept papers: A Risk-based Approach to Setting Sterile Filtration Bioburden Limits; A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-derived Injectable Drug Products; and Drug Device Combination Products, as well as the workshop topic: ATMPs Specific Challenges in Development and Commercialization. The CMC Strategy Forum is designed to maximize dialog between participants. Presentations are relatively short and focused and set the agenda for the panel discussions to engage all the participants who have experience and expertise to share. It should be important for you to attend this event as we come together to discuss important issues on how to ensure product safety and efficacy for the patients we serve. We would like to thank the speakers and panel members 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.; IPSEN Biopharm Ltd.; MedImmune, A member of the AstraZeneca Group; Merck & Co., Inc.; Novo Nordisk A/S and Pfizer, Inc. We are grateful for the expert management from CASSS and the audio-visual expertise of Michael Johnston from MJ Audio-Visual Productions. Their experience and guidance in the preparation of this Forum has been invaluable.

2 ACKNOWLEDGEMENTS CMC STRATEGY FORM EUROPE PROGRAM COMMITTEE Sandra Patricia Auguste-Bowler, LEO Pharma A/S, Denmark Seán Barry, Health Products Regulatory Authority (HPRA), Ireland (Co-chair) Brigitte Brake, Federal Institute for Drugs and Medical Devices (BfArM), Germany Emmanuelle Charton, EDQM, Council of Europe, France Niklas Ekman, Finnish Medicines Agency, Finland Chana Fuchs, CDER, FDA, USA Ralf Gleixner, Merck Serono, Switzerland Jason Hampson, Amgen Inc., USA Kowid Ho, F. Hoffmann-La Roche Ltd., Switzerland (Co-chair) Brendan Hughes, Bristol-Myers Squibb Company, USA Ronald Imhoff, Janssen Biologics BV, Netherlands Alistair Kippen, IPSEN Biopharm Ltd., United Kingdom (Co-chair) Ingrid Markovic, CBER, FDA, USA Jens Bjørn Nielsen, Novo Nordisk A/S, Denmark Fionnuala O Driscoll, Eli Lilly SA Irish Branch, Ireland Bridgett O Shea, Pfizer Ireland Pharmaceuticals Limited, Ireland Ilona Reischl, Austrian Agency for Health and Food Safety (AGES), Austria Mark Schenerman, MedImmune, A member of the AstraZeneca Group, USA Martin Schiestl, Sandoz Biopharmaceuticals, Austria Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland Jolanda Westerlaken, UCB Pharma sprl, Canada CMC STRATEGY FORUM GLOBAL STEERING COMMITTEE Siddharth Advant, Celgene Corporation, USA Daniela Cerqueria, 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 Anthony Mire-Sluis, AstraZeneca., USA Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland (Chair) Ilona Reischl, AGES-Austrian Agency for Health and Food Safety, 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

3 The Scientific Organizing Committee gratefully acknowledges the program partners for their generous support of the CMC Strategy Forum Europe STRATEGIC DIAMOND PROGRAM PARTNER F. Hoffmann-La Roche Ltd. 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. SILVER PROGRAM PARTNERS Amgen Inc. Bristol-Myers Squibb Company BRONZE PROGRAM PARTNER IPSEN Biopharm Ltd. FRIEND of CASSS PROGRAM PARTNER Novo Nordisk A/S

4 The Scientific Organizing Committee gratefully acknowledges the following media for their promotional consideration of the CMC Strategy Forum Europe series. LEADING MEDIA PARTNERS BioProcess International International Pharmaceutical Quality MEDIA PARTNERS American Laboratory / LabCompare American Pharmaceutical Review BioPharm International BioProcessing Journal Genetic Engineering & Biotechnology News G.I.T. Laboratory Journal LC/GC Europe Pharmaceutical Outsourcing Royal Society of Chemistry separationsnow.com Technology Networks

5 European Biopharmaceutical Enterprises (EBE) Satellite Session Monday, 22 May :30 08:30 Breakfast in the Garden Room Restaurant (Breakfast is included in the CMC Strategy Forum group sleeping room rate; other attendees / guests can pay individually for breakfast if they are not included in the group room rate) 07:30 12:00 Registration in the Muckross Suite Foyer 08:30 08:45 Welcome and Introduction to the European Biopharmaceutical Enterprises (EBE) Ongoing Activities and Initiatives in the Muckross Suite Markus Goese, F. Hoffmann-La Roche Ltd., Switzerland Concept Paper 2017 Update: New Initiatives In the Muckross Suite Session Chairs: Ronald Imhoff, Janssen Biologics BV and Fionnuala O Driscoll, Eli Lilly S.A. Irish Branch 08:45 09:00 Risk-based Approaches regarding Bioburden Sampling and Limits on ID Sampling of Biologics API Karoline Bechtold Peters, Novartis Pharmaceuticals Corporation, Switzerland 09:00 09:15 A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-derived Injectable Drug Products Tapan Das, Bristol-Myers Squibb Company, USA 09:15 09:30 Drug Device Combination Products Serge Mathonet, Sanofi, France 09:30 10:00 Panel Discussion Questions and Answers 10:00 10:30 Networking Break in the Muckross Suite Foyer ATMP - Specific Challenges in Development and Commercialization Workshop In the Muckross Suite Session Chairs: Ronald Imhoff, Janssen Biologics BV and Fionnuala O Driscoll, Eli Lilly S.A. Irish Branch 10:30 10:45 EU Regulatory Activities for ATMPs Ilona Reischl, AGES-Austrian Agency for Health and Food Safety, Austria 10:45 11:00 Critical Quality Attributes for C&GT Products Enabling Comparability Assessments through Product Development Ben Thompson, GlaxoSmithKline, United Kingdom

6 Monday, 22 May continued 11:00 11:15 The Imlygic Story: A Winding Road to Innovation Michael Abernathy, Amgen Inc., USA 11:15 11:30 A Living Medicine: How to Cope with CMC Requirements in the Development of Cell Therapy Products of Autologous and Allogeneic Origin Wilfried Dalemans, TiGenix, Belgium 11:30 12:00 Panel Discussion Questions and Answers 12:00 12:15 Concluding Remarks Veronique Debaut, European Biopharmaceutical Enterprises (EBE), Belgium

7 Monday, 22 May continued CMC Strategy Forum Europe 2017 Scientific Program Summary 12:15 14:00 Buffet Lunch in the Garden Room Restaurant 13:15 17:00 Registration in the Muckross Suite Foyer 14:00 14:15 CASSS Welcome and Introductory Comments in the Muckross Suite Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Introduction / Welcome to the 11 th European CMC Strategy Forum Alistair Kippen, IPSEN Biopharm Ltd. Regulatory Updates from Around the World Plenary Session in the Muckross Suite Session Chairs: Kowid Ho, F. Hoffmann-La Roche Ltd. and Alistair Kippen, IPSEN Biopharm Ltd. 14:15 14:45 Biopharmaceuticals A Regulatory Perspective Maeve Lally, Health Products Regulatory Authority (HPRA), Ireland 14:45 15:15 EU Update on Regulatory Developments Pascal Venneugues, European Medicines Agency (EMA), United Kingdom 15:15 15:45 Regulation of Biological Products in Ghana and the Economic Community of West African States (ECOWAS) Region Eric Karikari-Boateng, Foods and Drug Authority, Ghana 15:45 16:15 Networking Break in the Muckross Suite Foyer 16:15 16:45 TBD Chana Fuchs, CDER, FDA, USA 16:45 18:00 Panel Discussion Questions and Answers Chana Fuchs, CDER, FDA, USA Eric Karikari-Boateng, Foods and Drug Authority, Ghana Maeve Lally, Health Products Regulatory Authority (HPRA), Ireland Patrick Owusu-Danso, Foods and Drug Authority, Ghana Pascal Venneugues, European Medicines Agency (EMA), United Kingdom

8 Monday, 22 May continued 18:00 19:00 Welcome Reception in the Malton Gardens 19:00 Adjourn Day One

9 Tuesday, 23 May :30 08:45 Breakfast in the Garden Room Restaurant (Breakfast is included in the CMC Strategy Forum group sleeping room rate; other attendees / guests can pay individually for breakfast if they are not included in the group room rate) 08:00 17:00 Registration in the Muckross Suite Foyer The Continuing Evolution of Product Characterization Workshop Session One in the Forum Rooms E-J Session Chairs: Brendan Hughes, Bristol-Myers Squibb Company and Mark Schenerman, MedImmune, A member of the AstraZeneca Group 09:00 09:10 Introduction 09:15 09:40 Technical Innovations Impact on Regulatory Expectations for Product Characterization Steffen Gross, Paul-Ehrlich-Institut, Germany 09:40 10:05 Analytical Control Strategy for Co-formulated Biologics Product Amit Katiyar, Bristol-Myers Squibb Company, USA 10:05 10:30 Review of Activity Testing for Pfizer Biologic Molecule Brian Hassett, Pfizer Ireland Pharmaceuticals, Ireland 10:30 10:55 Analytical Characterization of Biologic-Biologic Combinations Methal Albarghouthi, MedImmune, A member of the AstraZeneca Group, USA 11:00 11:30 Networking Break in the Muckross Suite Foyer 11:30 12:30 Panel Discussion Questions and Answers Methal Albarghouthi, MedImmune, A member of the AstraZeneca Group, USA Emmanuelle Charton, EDQM, Council of Europe, France Steffen Gross, Paul-Ehrlich-Institut, Germany Brian Hassett, Pfizer Ireland Pharmaceuticals, Ireland Amit Katiyar, Bristol-Myers Squibb Company, USA 12:30 14:00 Buffet Lunch in the Garden Room Restaurant

10 Tuesday, 23 May continued Manufacturing Process Development and Control Strategies Workshop Session Two in the Muckross Suite Session Chairs: Ralf Gleixner, Merck Serono and Ronald Imhoff, Janssen Biologics B.V. 14:00 14:10 Introduction 14:15 14:40 Approvable Process Control Scientific Thinking above Creative Marketing Amanda Shipman, MHRA-Medicines and Healthcare Products Regulatory Agency, United Kingdom 14:40 15:05 Use of Quality by Design principles for Developmennt of an Integrated Control Strategy Girish Pendse, Eli Lilly and Company, USA 15:05 15:30 Analytical Control Strategies: From Molecular Understanding to CQAs, Specifications and Lifecycle Management Garry Takle, Merck, Sharp & Dohme, USA 15:30 15:55 Implementation of an Online UV Monitoring System in Tinzaparin Sodium: A Case Study in Approaches to Manufacturing Development and Strategies to Improve Efficiencies with Regulatory Robert Kelly, LEO Pharma, Ireland 16:00 16:30 Networking Break in the Muckross Suite Foyer 16:30 17:30 Panel Discussion Questions and Answers Chana Fuchs, CDER, FDA, USA Robert Kelly, LEO Pharma, Ireland Greg Naugle, Amgen Inc., USA Girish Pendse, Eli Lilly and Company, USA Amanda Shipman, MHRA-Medicines and Healthcare Products Regulatory Agency, United Kingdom Garry Takle, Merck, Sharp & Dohme, USA 17:30 Adjourn Day Two 18:15 22:30 Off-property Event Transportation will be provided

11 Wednesday, 24 May :30 08:45 Breakfast in the Garden Room Restaurant (Breakfast is included in the CMC Strategy Forum group sleeping room rate; other attendees / guests can pay individually for breakfast if they are not included in the group room rate) 08:30 17:00 Registration in the Muckross Suite Foyer Statistical Tools to Evaluate Quality Attributes for Comparability and Biosimilarity Workshop Session Three in the Muckross Suite Session Chairs: Niklas Ekman, Finnish Medicines Agency and Martin Schiestl, Sandoz Biopharmaceuticals 09:00 09:10 Introduction 09:15 09:40 A Regulatory Statistician s View on Statistical Approaches for Comparability Assessment: Experiences and Future Perspectives Andreas Brandt, BfArM-Federal Institute for Drugs and Medical Devices, Germany 09:40 10:05 Practical Considerations for the Comparative Assessment of Quality Attributes Thomas Stangler, Sandoz Biopharmaceuticals, Austria 10:05 10:30 Criteria for Comparability Martijn van der Plas, CBG-MEB, Netherlands 10:30 10:55 Applying Scientific Considerations and Statistical Approaches in Analytical Similarity Assessment Jennifer Liu, Amgen Inc., USA 11:00 11:30 Networking Break in the Forum Foyer, Level 1 11:30 12:30 Panel Discussion Questions and Answers Andreas Brandt, BfArM, Germany Beverly Ingram, Pfizer Ireland Pharmaceuticals, Ireland Jennifer Liu, Amgen Inc., USA Thomas Stangler, Sandoz Biopharmaceuticals, Austria Peter Stjärnkvist, Medical Products Agency (MPA), Sweden Martijn van der Plas, CBG-MEB, Netherlands 12:30 14:00 Buffet Lunch in the Garden Room Restaurant

12 Wednesday, 24 May continued Opportunities and Obstacles for Accelerated CMC Development Workshop Session Four in the Muckross Suite Session Chairs: Chana Fuchs, CDER, FDA and Jason Hampson, Amgen Inc. 14:00 14:10 Introduction 14:15 14:40 Opportunities for Accelerated Cell Line Development Christopher Frye, Eli Lilly and Company, USA 14:40 15:05 Risk-based Speed: Approaches for Fast to FIH and Right First Time Commercialization Rachel Dinges, Bristol-Myers Squibb Company, USA 15:05 15:30 Registration Enabling Campaign for Accelerated Development: A PPQ Strategy with Minimal Early Investments to Enable Fast to Market Development for a Promising Monoclonal Antibody John Eschelbach, Genentech, a Member of the Roche Group, USA 15:30 15:55 A Holistic Regulatory Approach to Accelerated CMC Development Seán Barry, Health Products Regulatory Authority (HPRA), Ireland 16:00 16:30 Networking Break in the Muckross Suite Foyer 16:30 17:30 Panel Discussion Questions and Answers Seán Barry, Health Products Regulatory Authority (HPRA), Ireland Brigitte Brake, BfArM-Federal Institute for Drugs and Medical Devices, Germany Rachel Dinges, Bristol-Myers Squibb Company, USA John Eschelbach, Genentech, a Member of the Roche Group, USA Christopher Frye, Eli Lilly and Company, USA Trent Munro, Amgen Inc., USA 17:30 17:45 Closing Remarks and Invitation to CMC Strategy Forum Europe 2018 Kowid Ho, F. Hoffmann-La Roche Ltd. 17:45 Adjournment

13 EBE Satellite Session