Welcome to the CMC Strategy Forum Latin America 2015

Transcription

1 Welcome to the CMC Strategy Forum Latin America 2015 On behalf of the CMC Strategy Forum Global Steering Committee and the CMC Strategy Forum Latin America Scientific Program Committee, we would like to extend to you a warm welcome to the 2 nd meeting of the CMC Strategy Forum Latin America We are very pleased that with the strong support from the Brasilian National Health Surveillance Agency (ANVISA); as well as Grupo FarmaBrasil; Interfarma (Association of Pharmaceutical Research, Brasil); ISP, (Public Health Institute, Chile); DIGEMID (General Directorate of Medicines, Supplies and Drugs, Peru); COFEPRIS (Federal Commission for the Protection against Sanitary Risk, Mexico); ANMAT (National Administration of Drugs, Foods and Medical Devices, Argentina) and with the continued organization by CASSS and the support of the EMA (European Medicines Agency) the US FDA (United States Food and Drug Administration), that we are continuing with the CMC Strategy Forum Latin America The Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant to Latin America and will feature an opening regulatory session Regulatory Convergence: Recent Trends in the Regulations of Biotherapeutic Products in Latin America - that will include presentations from ANVISA Brasil, ANMAT Argentina, DIGEMID Peru, ISP Chile, COFEPRIS Mexico, Finnish Medicines Agency (representing the European Medicines Agency) and the US FDA. The technical sessions will include discussions on: Cold Chain Management and Qualification for Biological Products Transportation; Characterization, Control and Regulation of Protein Glycosylation; and Technology Transfer for Biopharmaceuticals. 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 panel discussions that have been designed to stimulate exchange of ideas and information. 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 would also like to acknowledge the generosity of our program partners for the continued support of the Forum series.

2 ACKNOWLEDGEMENTS CMC STRATEGY FORUM LATIN AMERICA SCIENTIFIC PROGRAM COMMITTEE: Reginaldo Braga Arcuri, Grupo FarmaBrasil, Brasil Adriana Diaféria, Grupo FarmaBrasil, Brasil John Dougherty, Eli Lilly and Company, USA Daniel Durand, Amgen Brasil, Brasil Rocio Delgado Montero, DIGEMID, General Directorate of Medicines, Supplies and Drugs, Peru Marcelo Moreira, ANVISA National Health Surveillance Agency, Brasil Fabiola Muñoz, ISP, Public Health Institute, Chile Ana Padua, F. Hoffmann-La Roche Ltd., Brasil Ronaldo Pires, Interfarma, Association of Pharmaceutical Research, Brasil Marcelo Quintao, Grupo FarmaBrasil, Brasil Carmilia Jimenez Ramirez, Gilead Sciences, USA Zunilda Ruiz, DIGEMID, General Directorate of Medicines, Supplies and Drugs, Peru Priscila Scheinberg, Orygen Biotecnologia, Brasil Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland Vanessa Schiavo, Libbs Farmacêutica, Brasil Orlando Vitor da Silva, Eli Lilly do Brasil Ltda., Brasil Vanessa Lucas Xavier, ANVISA National Health Surveillance Agency, Brasil CMC STRATEGY FORUM GLOBAL STEERING COMMITTEE Siddharth Advant, KemWell Biopharma, USA John Dougherty, Eli Lilly and Company, USA Steven Kozlowski, CDER, FDA, USA Junichi Koga, Daiichi Sankyo Co., Ltd., Japan Rohin Mhatre, Biogen, USA Anthony Mire-Sluis, Amgen Inc., USA Marcelo Moreira, ANVISA Brasilian National Health Surveillance Agency, Brasil Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland Ilona Reischl, BASG/AGES, Austria Anthony Ridgway, Health Canada, Canada Nadine Ritter, Global Biotech Experts, LLC, USA Daisaku Sato, PMDA Pharmaceutical and Medical Devices Agency, Japan Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland Mark Schenerman, MedImmune, A member of the AstraZeneca Group, USA Karin Sewerin, BioPharma Linx AB, Sweden

3 The Organizing Committee gratefully acknowledges the pharmaceutical and biotechnology industry for their generous support of the CMC Strategy Forum Latin America 2015 SUSTAINING DIAMOND FORUM PARTNER F. Hoffmann-La Roche Ltd. FORUM PARTNERS

4 LEADING MEDIA PARTNERS BioProcess International International Pharmaceutical Quality MEDIA PARTNERS The Analytical Scientist BioProcessing Journal The Medicine Maker The Pathologist separationsnow.com Technology Networks

5 07:30 17:30 Registration in the CMC Strategy Forum Latin America 2015 Scientific Program Summary Monday, 24 August :30 08:45 Continental Breakfast in Café da Manhã 08:45 09:15 CASSS Welcome and Introductory Comments Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland CMC Strategy Forum Latin America 2015 Welcome and Introductory Comments Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland Regulatory Convergence: Recent Trends in the Regulations of Biotherapeutic Products in Latin America Plenary Session In the Session Chairs: Thomas Schreitmüller, F. Hoffmann-La Roche Ltd. and TBA An Update/Overview on Regulatory Convergence, Predictability, Transparency and Priority Reviews 09:15 09:30 Marcelo Moreira, ANVISA, Brasilian Health Surveillance Agency, Brasil 09:30 09:45 Edith Roxana Vásquez Alayo, DIGEMID, General Directorate of Medicines, Supplies and Drugs, Peru 09:45 10:00 Fabiola Muñoz, ISP, Public Health Institute, Chile 10:00 10:15 TBA ANMAT, National Administration of Drugs, Foods and Medical Devices, Argentina 10:15 10:30 Adriana Hernández Trejo, COFEPRIS, Federal Commission for the Protection against Sanitary Risk, Mexico 10:30 11:00 AM Break in the 11:00 11:15 Niklas Ekman, Finnish Medicines Agency, Finland 11:15 11:30 Sarah Kennett, CDER, FDA, USA

6 Monday, 24 August continued 11:30 11:45 Reginaldo Braga Arcuri, Grupo FarmaBrasil, Brasil 11:45 12:00 Antônio Britto, Interfarma, Association of Pharmaceutical Research, Brasil 12:00 13:15 Hosted Lunch in the 13:15 14:45 PANEL DISCUSSION Questions and Answers Edith Roxana Vásquez Alayo, DIGEMID, General Directorate of Medicines, Supplies and Drugs, Peru Reginaldo Braga Arcuri, Grupo FarmaBrasil, Brasil Antônio Britto, Interfarma, Association of Pharmaceutical Research, Brasil Niklas Ekman, Finnish Medicines Agency, Finland Sarah Kennett, CDER, FDA, USA Marcelo Moreira, ANVISA, Brasilian Health Surveillance Agency, Brasil Fabiola Muñoz, ISP, Public Health Institute, Chile Adriana Hernández Trejo, COFEPRIS, Federal Commission for the Protection against Sanitary Risk, Mexico TBA ANMAT, National Administration of Drugs, Foods and Medical Devices, Argentina 14:45 15:15 PM Break in the Characterization, Control and Regulation of Protein Glycosylation Workshop Session In the Session Chairs: Leda dos Reis Castilho, Universidade Federal do Rio de Janeiro and Thomas Schreitmüller, F. Hoffmann-La Roche Ltd. 15:15 15:45 Glycosylation of Biosimilar MAbs The Challenge of Assessing Similarity ByoungOh Kwon, Celltrion Healthcare Co., Ltd., Korea 15:45 16:15 TBA Martin Blüggel, Protagen Protein Services GmbH, Germany 16:15 16:45 TBA 16:45 18:00 Panel Discussion Questions and Answers Martin Blüggel, Protagen Protein Services GmbH, Germany ByoungOh Kwon, Celltrion Healthcare Co., Ltd., Korea TBA TBA TBA TBA

7 Monday, 24 August continued 18:00 19:30 Networking Reception in the 19:30 Adjourn Day One

8 08:00 17:00 Registration in the 07:30 09:00 Continental Breakfast in the Tuesday, 25 August 2015 Technology Transfer for Biopharmaceuticals Workshop Session In the Session Chairs: Erika Esteves Balestero, Eli Lilly do Brasil Ltda. and Vanessa Schiavo, Libbs Farmacêutica 09:00 09:30 Quality Assessment for Tech Transfer Cláudio Cabral, Instituto Butantan, Brasil 09:30 10:00 How to Overcome the Challenges of Stability Studies with the Global Tech Transfer Trends Mary Cromwell, Genentech, a Member of the Roche Group, USA 10:00 10:30 The Importance of Establishing Analytical Comparability in the Successful Transfer of Manufacturing Processes from One Region to Another Christina Vessely, Biologics Consulting Group, Inc., USA 10:30 11:00 AM Break in the 11:00 12:15 PANEL DISCUSSION Questions and Answers Michael Baganski, Merci & Co., Inc., USA (invited) Cláudio Cabral, Instituto Butantan, Brasil Mary Cromwell, Genentech, a Member of the Roche Group, USA Rodrigo Caoelho Pinto, Biomanguinhos, Brasil (invited) Mauricio Seigelchifer, mabxcience, Argentina (invited) Christina Vessely, Biologics Consulting Group, Inc., USA 12:15 13:30 Hosted Lunch in the Cold Chain Management and Qualification for Biological Products Transportation Workshop Session In the Session Chairs: Daniel Durand, Amgen Brasil and Ana Padua, F. Hoffmann-La Roche Ltd. 13:30 14:00 Current Strategies on Cold Chain Management and Product Transport Validation Anthony Mire-Sluis, Amgen Inc., USA

9 Tuesday, 25 August continued 14:00 14:30 Challenges Faced by Manufacturers in the Cold Chain Transportation and Different Scientific Approaches Adopted Christopher Renz, Genentech, a Member of the Roche Group, USA 14:30 15:00 Sharing Expectations on New Guideline under Development by ANVISA Bernardo Oliveira, ANVISA, Brasilian Health Surveillance Agency, Brasil 15:00 15:30 PM Break in the 15:30 16:45 PANEL DISCUSSION Questions and Answers Elisa da Silva Braga Boccia, PVPAF Guarulhos Aeroporto, Brasil (invited) Gabriela Calza, Johnson & Johnson Comércio e Distribuição Ltda., Brasil (invited) Anthony Mire-Sluis, Amgen Inc., USA Liana Montemor, Polar Técnica, Brasil (invited) Bernardo Oliveira, ANVISA, Brasilian Health Surveillance Agency, Brasil Christopher Renz, Genentech, a Member of the Roche Group, USA (invited) 16:45 17:00 Closing Remarks 17:00 Adjournment

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