Welcome to the CMC Strategy Forum Europe 2015 Improving Biopharmaceutical Product Quality: Moving Implementation Forward

Transcription

1 Welcome to the CMC Strategy Forum Europe 2015 Improving Biopharmaceutical Product Quality: Moving Implementation Forward The ninth annual CMC Strategy Forum Europe, organized by CASSS - An International Separation Science Society, 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; Product Development Acceleration Strategies; Tools and Enablers for Biosimilar Development; Practical Application of QbD-enabled Control Strategies; CMC Information and Link to Clinical Trials; Update on Medical Device/Combination Products; and Principles, Implications and Benefits of Applying QbD to Analytics. 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. Forum Co-Chairs: Niklas Ekman, Finnish Medicines Agency, Finland Jason Hampson, Amgen Inc., USA Jolanda Westerlaken, UCB Pharma srl, Canada Scientific Organizing Committee: Brigitte Brake, Federal Institute for Drugs and Medical Devices (BfArM), Germany Emmanuelle Charton, EDQM, France John Dougherty, Eli Lilly and Company, USA Chana Fuchs, CDER, FDA, USA Ralf Gleixner, F. Hoffmann-La Roche Ltd., Switzerland Kowid Ho, F. Hoffmann-La Roche Ltd., Switzerland Brendan Hughes, Bristol-Myers Squibb Company, USA Ronald Imhoff, Janssen Biologics BV, Netherlands Alistair Kippen, MedImmune Limited, United Kingdom Nanna Aaby Kruse, Danish Medicines Agency, Denmark Ingrid Markovic, CBER, FDA, USA Inger Mollerup, Novo Nordisk A/S, Denmark Ilona Reischl, AGES Austrian Federal Office for Safety in Health Care, Austria Mark Schenerman, MedImmune, A member of the AstraZeneca Group, USA Martin Schiestl, Sandoz Biopharmaceuticals, Austria Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland Karin Sewerin, BioTech Development AB, Sweden Lance Smallshaw, UCB Biopharma srl, Belgium

2 The Scientific Organizing Committee gratefully acknowledges the program partners for their generous support of the CMC Strategy Forum Europe SUSTAINING DIAMOND PROGRAM PARTNER F. Hoffmann-La Roche Ltd. SUSTAINING PLATINUM PROGRAM PARTNER AbbVie, Inc. Biogen Idec MedImmune, A member of the AstraZeneca Group GOLD PROGRAM PARTNER Novo Nordisk A/S SILVER PROGRAM PARTNER Amgen Inc. CMC Biologics BRONZE PROGRAM PARTNER Bristol-Myers Squibb Company UCB Pharma srl FRIEND of CASSS PROGRAM PARTNER Merck & Co., Inc.

3 The Scientific Organizing Committee gratefully acknowledges the following media for their promotional consideration of the CMC Strategy Forum series. LEADING MEDIA PARTNERS BioProcess International International Pharmaceutical Quality MEDIA PARTNERS The Analytical Scientist BioProcessing Journal BioTech International Genetic Engineering & Biotechnology News LCGC Europe The Medicine Maker The Pathologist RSC Advances (Analyst/Analytical Methods) separationsnow.com Technology Networks

4 European Biopharmaceutical Enterprises (EBE) Satellite Session Monday, 4 May :30 12:00 Registration in the Foyer Scandinavian Ballroom 08:30 08:45 Welcome and Introduction to the European Biopharmaceutical Enterprises (EBE) Ongoing Activities and Initiatives in the Markus Goese, F. Hoffmann-La Roche Ltd., Switzerland Concept Paper Update In the Finland / Norway Rooms Session Chairs: Ronald Imhoff, Janssen Biologics BV and Karin Sewerin, MedImmune Limited (consultant) 08:45 09:15 A Risk-based Approach to Setting Sterile Filtration Bioburden Limits Stephen Chang, MedImmune, A member of the AstraZeneca Group, USA 09:15 10:00 Panel Discussion Question and Answers Karoline Bechtold-Peters, F. Hoffmann-La Roche Ltd., Switzerland Stephen Chang, MedImmune, A member of the AstraZeneca Group, USA Teresa Pepper, Amgen Limited, United Kingdom Harry Yang, MedImmune, A member of the AstraZeneca Group, USA 10:00 10:30 AM Break in the Foyer Scandinavian Ballroom Use of Prior Knowledge for Biotech Products Workshop In the Finland / Norway Rooms Session Chairs: Ronald Imhoff, Janssen Biologics BV and Karin Sewerin, MedImmune Limited (consultant) 10:30 10:45 Prior Knowledge Used in Platform Technologies Case Study Ranga Godavarti, Pfizer, Inc., USA 10:45 11:00 Mathematical Modelling as a Platform for API Process Development Ernst Hansen, Novo Nordisk A/S, Denmark

5 Monday, 4 May continued 11:00 11:15 Prior Knowledge from a Development Perspective Kristopher Barnthouse, Janssen R&D, LLC, USA 11:15 12:00 Panel Discussion Questions and Answers Kristopher Barnthouse, Janssen R&D, LLC, USA Chana Fuchs, CDER, FDA, USA Ernst Hansen, Novo Nordisk A/S, Denmark Kowid Ho, F. Hoffmann-La Roche Ltd., Switzerland Godavarti Ranga, Pfizer, Inc., USA Mats Welin, Medical Products Agency, Sweden 12:00 12:15 Concluding Remarks Piers Allin, European Biopharmaceutical Enterprises (EBE), Belgium

6 Monday, 4 May continued CMC Strategy Forum Europe 2015 Scientific Program Summary 12:00 13:15 Buffet Lunch in Mama s & Papa s Restaurant 13:00 17:00 Registration in the Foyer Scandinavian Ballroom 13:15 13:30 CASSS Welcome and Introductory Comments in the Finland / Norway Rooms Mark Schenerman, MedImmune, A member of the AstraZeneca Group, USA Introduction / Welcome to the 9 th European CMC Strategy Forum Jason Hampson, Amgen Inc., USA Regulatory Updates from Around the World Plenary Session in the Finland / Norway Rooms Session Chairs: Niklas Ekman, Finnish Medicines Agency and Jolanda Westerlaken, UCB Pharma srl 13:30 13:50 The Landscape of Drug Development and the Role of the Regulator Christian Schneider, Danish Medicines Agency, Denmark 13:50 14:10 PMDA Regulatory Updates: Approach to Making Further Progress Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA), Japan 14:10 14:30 EMA Update on Regulatory Developments Pascal Venneugues, European Medicines Agency (EMA), United Kingdom 14:30 15:45 Panel Discussion Questions and Answers Ofra Axelrod, Israeli Ministry of Health, Israel Chana Fuchs, CDER, FDA, USA Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Robin Levis, CBER, FDA, USA Christian Schneider, Danish Medicines Agency, Denmark Pascal Venneugues, European Medicines Agency, United Kingdom 15:45 16:15 PM Break in the Foyer Scandinavian Ballroom Update on Medical Device/Combination Products Plenary Session in the Finland / Norway Rooms Session Chairs: Chana Fuchs, CDER, FDA and Karin Sewerin, BioTech Development AB 16:15 16:30 Update from the CMC Strategy Forum January 2015 and EU Regulator s Reflection on the Role of EMA versus Notified Bodies Ilona Reischl, AGES Austrian Federal Office for Safety in Health Care, Austria

7 Monday, 4 May continued 16:30 16:45 The Role of EMA versus Notified Bodies in Ensuring Fulfillment of the Essential Requirements as Defined in the Medical Device Directive, Council Directive 93/42/EEC Case Study Farzana Hussain, Novo Nordisk A/S, Denmark 16:45 17:00 The Role of Notified Bodies in Defining Risk Assessment for a Recombinant Protein Used in a Medical Device Case Study Karin Sewerin, BioTech Development AB, Sweden 17:00 17:30 Panel Discussion Questions and Answers 18:15 22:30 Welcome and Networking Event at Carlsberg Brewery Transportation will be provided

8 Tuesday, 5 May :00 17:00 Registration in the Foyer Scandinavian Ballroom 08:30 08:45 Announcements by Jolanda Westerlaken, UCB Biopharma srl Tools and Enablers for Biosimilar Development Workshop Session One in the Finland / Norway Rooms Session Chairs: Brigitte Brake, BfArM, Federal Institute for Drugs and Medical Devices and Martin Schiestl, Sandoz Biopharmaceuticals 08:45 08:50 Introduction 08:50 09:15 TBD Thomas Stangler, Sandoz Biopharmaceuticals, Austria 09:15 09:40 Critical Considerations for Analytical Tools in Biosimilar Development Jennifer Liu, Amgen Inc., USA 09:40 10:05 An Update on Regulatory Expectations for Biosimilars Seán Barry, Health Products Regulatory Authority (HPRA), Dublin, Ireland 10:05 10:30 AM Break in the Foyer Scandinavian Ballroom 10:30 11:30 Panel Discussion Questions and Answers Seán Barry, Health Products Regulatory Authority (HPRA), Ireland Emmanuelle Charton, EDQM, France Niklas Ekman, Finnish Medicines Agency, Finland Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Jennifer Liu, Amgen Inc., USA Christian Schneider, Danish Medicines Agency, Denmark Thomas Stangler, Sandoz Biopharmaceuticals, Austria 11:30 12:45 Buffet Lunch in Mama s & Papa s Restaurant Establishing a Link between the Quality Control Strategy & the Clinical Trials Experience Workshop Session Two in the Finland / Norway Rooms Session Chairs: Inger Mollerup, Novo Nordisk A/S and Ilona Reischl, AGES 12:45 12:50 Introduction 12:50 13:15 Linking IMPD Experience and Commercial Control Strategy: A Regulator s Perspective Mats Welin, Medical Products Agency (MPA), Sweden

9 Tuesday, 5 May continued 13:15 13:40 A Pilot Study to Link CMC CQA Data to Clinical Experience John O Hara, UCB Celltech, United Kingdom 13:40 14:05 Translating Clinical Experience into the Quality Control Strategy Romain Le Deun, Voisin Consulting Life Sciences, France 14:05 14:35 PM Break in the Foyer Scandinavian Ballroom 14:35 15:35 Panel Discussion Questions and Answers Brigitte Brake, BfArM, Federal Institute for Drugs and Medical Devices, Germany Michael Defellippis, Eli Lilly and Company, USA Romain Le Deun, Voisin Consulting Life Sciences, France Robin Levis, CBER, FDA, USA Karen Miller, Amgen Inc., USA John O Hara, UCB Biopharma srl, Belgium Mats Welin, Medical Products Agency (MPA), Sweden 15:45 16:15 Networking Break in the Foyer Scandinavian Ballroom Principles, Implications and Benefits of Applying QbD to Analytics Workshop Session Three in the Finland / Norway Rooms Session Chairs: Emmanuelle Charton, EDQM, Alistair Kippen, MedImmune Limited and Thomas Schreitmüller, F. Hoffmann-La Roche Ltd. 16:15 16:20 Introduction 16:20 16:45 QbD in Analytics Enhancement of Method Development and Facilitation of Change Management Christof Finkler, F. Hoffmann-La Roche Ltd., Switzerland 16:45 17:10 The Application of QbD Concepts to Analytical Methods: Enabling Efficient, Rapid and Effective Bioprocess Development Brian Fahie, Biogen Idec, USA 17:10 17:35 Analytical QbD Applied to Analytical Methods for Therapeutic Proteins Opportunities and Challenges Annick Gervais, UCB Pharma srl, Belgium 17:35 18:00 Experimental Design and Modeling to Improve HPLC Method Performance for Small Molecules John Kauffman, CDER, FDA, USA

10 Tuesday, 5 May continued 18:00 19:00 Panel Discussion Questions and Answers Keith Chidwick, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom Brian Fahie, Biogen Idec, USA Christof Finkler, F. Hoffmann-La Roche Ltd., Switzerland Annick Gervais, UCB Pharma srl, Belgium John Kauffman, CDER, FDA, USA Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Nanna Aaby Kruse, Danish Medicines Agency, Denmark 19:00 Adjourn

11 Wednesday, 6 May :30 17:00 Registration in the Foyer Scandinavian Ballroom 09:00 09:15 Announcements by Jason Hampson, Amgen Inc. Practical Application of QbD-enabled Control Strategies Workshop Session Four in the Finland / Norway Rooms Session Chairs: Ralf Gleixner, F. Hoffmann-La Roche Ltd. and Jason Hampson, Amgen Inc. 09:15 09:20 Introduction 09:20 09:45 An Approach for Control Strategy from the MedImmune QbD Pilot Program Timothy Schofield, MedImmune, A member of the AstraZeneca Group, USA 09:45 10:10 Optimizing the Control Strategy for a Commercial Mab Product Based on Enhanced Product and Process Understanding: Experience to Date from US and EU Filings Jay Higgins, Amgen Inc., USA 10:10 10:35 Regulatory View on the Application of Enhanced Pharmaceutical Quality Systems for Establishing Real Time Release Mechanisms Steffen Gross, Paul-Ehrlich-Institut, Germany 10:35 11:00 AM Break in the Foyer Scandinavian Ballroom 11:00 12:00 Panel Discussion Questions and Answers Keith Chidwick, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom Steffen Gross, Paul-Ehrlich-Institut, Germany Jay Higgins, Amgen Inc., USA Dieter Schmalzing, Genentech, a Member of the Roche Group, USA Timothy Schofield, MedImmune, A member of the AstraZeneca Group, USA 12:00 13:15 Buffet Lunch Mama s & Papa s Restaurant Product Development Acceleration Strategies Workshop Session Five in the Finland / Norway Rooms Session Chairs: Brendan Hughes, Bristol-Myers Squibb Company and Ronald Imhoff, Janssen Biologics BV 13:15 13:20 Introduction 13:20 13:45 Regulatory Updated and Consideration on the EU Adaptive Pathway Nanna Aaby Kruse, Danish Medicines Agency, Denmark

12 Wednesday, 6 May continued 13:45 14:10 Enabling Speed to Patient Starting in the Early Biologics Development Space Henrik Andersen, Bristol-Myers Squibb Company, USA 14:10 14:35 Manufacturing Readiness Considerations for Expedited Development Programs Earl Dye, Genentech, a Member of the Roche Group, USA 14:35 15:00 US Regulatory and Quality Implications for Biotechnology Product Development Chana Fuchs, CDER, FDA, USA 15:00 15:30 PM Break in the Foyer Scandinavian Ballroom 15:30 16:30 Panel Discussion Questions and Answers Henrik Andersen, Bristol-Myers Squibb Company, USA Earl Dye, Genentech, a Member of the Roche Group, USA Chana Fuchs, CDER, FDA, USA Markus Goese, F. Hoffmann-La Roche Ltd., Switzerland Jason Hampson, Amgen Inc., USA Nanna Aaby Kruse, Danish Medicines Agency, Denmark Rohin Mhatre, Biogen Idec, USA 16:30 16:45 Closing Remarks and Invitation to CMC Strategy Forum Europe 2016 Jolanda Westerlaken, UCB Pharma srl 16:45 Adjournment

13 EBE Satellite Session