Welcome to. January 26, The Mayflower Hotel Washington, DC USA

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1 Welcome to January 26, 2015 The Mayflower Hotel Washington, DC USA

2 Mission Statement Provide a venue for biotechnology/biological product discussion that focuses on relevant CMC issues throughout the lifecycle of the product Foster collaborative technical and regulatory interactions Share information with the regulatory agencies to assist them in merging good scientific and regulatory practices

3 CMC Strategy Forum History The CMC Strategy Forum was launched in 2002 from the well established WCBP Symposium. To date, 35 Forums have been held in the US (typically 3 per year) resulting in the publication of 27 white papers on a wide variety of CMC topics. The CMC Forum Europe was launched in 2007 with support from the Biotech Working Party/EMA and quickly became a successful annual event.

4 CMC Strategy Forum History The CMC Forum Japan was launched in 2012 with support from the PMDA and JPMA and has been very successful for the first three years. The inaugural CMC Forum Latin America was launched in August 2014 with support from ANVISA (Brasil), local industry, as well as multiple LatAm regulatory agencies and was very successful. The 2 nd CMC Forum Latin America will be held in August 2015.

5 CMC Strategy Forum Global Steering Committee Siddharth Advant, Kemwell Biopharma, USA John Dougherty, Eli Lilly and Company, USA Junichi Koga, Daiichi Sankyo Co., Ltd., Japan Steven Kozlowski, CDER, FDA, USA Rohin Mhatre, Biogen Idec, USA Anthony Mire-Sluis, Amgen Inc., USA Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland (Chair) Ilona Reischl, BASG / AGES, Austria Anthony Ridgway, Health Canada, Canada Nadine Ritter, Global Biotech Experts, LLC, USA Mark Schenerman, MedImmune, USA Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland Karin Sewerin, BioTech Development AB, Sweden

6 Find out more about past CMC Strategy Forums Look under ARCHIVES for past Forum information and publications.

7 CMC Forum Format The Forum has two components: - Presentations and case studies (frame the discussion) - Workshops where open dialogue and exchange of ideas among participants is highly encouraged Typically each workshop will address about 3 specific questions related to a given topic The workshop success is dependent on active engagement of the participants

8 North America Program Committee Siddharth Advant, Kemwell Biopharma Yves Aubin, Health Canada John Bishop, CBER, FDA Barry Cherney, Amgen Inc. JR Dobbins, Eli Lilly and Company Julia Edwards, Biogen Idec John Hennessey, Novadigm Therapeutics, Inc. Joseph Kutza, MedImmune, A member of the AstraZeneca Group Kimberly May, Merck & Co., Inc. Anthony Mire-Sluis, Amgen Inc.

9 North America Program Committee continued Stefanie Pluschkell, Pfizer, Inc. Nadine Ritter, Global Biotech Experts, LLC Reb Russell, Bristol-Myers Squibb Company Dieter Schmalzing, Genentech, a Member of the Roche Group Timothy Schofield, MedImmune, A member of the AstraZeneca Group Zahra Shahrokh, STC Biologics, Inc. and ZDev Consulting Jeffrey Staecker, Genzyme, a Sanofi company Andrew Weiskopf, Biogen Idec

10 Sustaining Program Partners Diamond Program Partner Genentech, a Member of the Roche Group Platinum Program Partners AbbVie, Inc. Biogen Idec MedImmune, A member of the AstraZeneca Group Silver Program Partner Pfizer, Inc.

11 Forum Program Partners Amgen Inc. Genzyme, a Sanofi company Gilead Sciences Janssen Pharmaceutical R&D, LLC Merck & Co., Inc. National Institute of Standards and Technology (NIST) Novo Nordisk A/S

12 Leading Media Partners BioProcess International International Pharmaceutical Quality Media Partners American Laboratory American Pharmaceutical Review The Analytical Scientist BioProcessing Journal BioTech International Genetic Engineering & Biotechnology News LCGC North America The Medicine Maker / The Pathologist Pharmaceutical Outsourcing RSC Advances separationsnow.com Technology Networks Limited

13 Special Thanks to CASSS Staff: Karen A. Bertani, CMP, Director of Meetings (CMC Forum Manager) Stephanie L. Flores, CAE, Executive Director Anna Lingel, Project Coordinator Linda Mansouria, CMP, CMM, Manager of Meetings & Events Renee Olson, Senior Program Manager Catherine Stewart, Director of Finance Audio-Visual Support: Michael Johnstone MJ Audio-Visual Productions

14 CMC Strategy Forum January 2015 Combination Products for Biopharmaceuticals: Emerging Trends in Development, GMPs and Regulatory Expectations Forum Co-Chairs: Sarah Kennett, CDER, FDA, USA Andrew Weiskopf, Biogen Idec, USA Scientific Organizing Committee: Siddharth Advant, Kemwell Biopharma, USA Jee Chung, CDER, FDA, USA Gary Hartman, Amgen Inc., USA Mark Lee, CBER, FDA, USA Lana Shiu, CDRH, FDA, USA John Towns, Eli Lilly and Company

15 CMC Strategy Forum January 2015 Attendees pre-registered 196 (Combo Products) Attendees pre-registered 161 (Host Cell Proteins) Number of regulators pre-registered 50 (total) Number of companies represented 88 (total) Number of countries represented 15 (Australia, Austria, Brasil, Canada, China, Denmark, France, Germany, Ireland, Japan, Netherlands, Sweden, Switzerland, United Kingdom, USA)

16 CMC Strategy Forum Summer 2012 Such delivery devices fall under the device regulations and have vastly different design, development, and validation requirements than the protein drug product itself the regulatory environment has changed whereby biological drug product, in even simple delivery systems, are now considered combination products

17 A lot can happen in 2 ½ years FDA s pen, jet, related injectors guidance finalized FDA glass syringe guidance to supplement ISO cgmp Requirements for Combination Products become effective More experience gained with Design Controls, Human Factors guidance, etc.

18 A lot can happen in 2 ½ DAYS!