Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition
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1 TUESDAY, DECEMBER 10, 2013 Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition 8:30am Welcome Remarks and Announcements Andrew I. Gavil Director, Office of Policy Planning 8:40am Opening Remarks Edith Ramirez Chairwoman 8:50am Road Map to Morning Presentations Susan DeSanti 9:00am Lessons for Regulation of Follow-On Aaron Kesselheim, M.D., J.D., M.P.H Biologics from Experiences with Small Assistant Professor of Medicine Molecule Drugs Brigham and Women s Hospital/ Harvard Medical School 9:15am The Rigorous FDA Review Process for Emily Shacter, Ph.D. Biosimilars and Interchangeables Independent Consultant ThinkFDA, LLC Page 1
2 9:35am Consumer Overview of Biosimilars Leigh Purvis, M.P.A. Senior Strategic Policy Advisor AARP 9:50am Current State of Follow-On Biologics Ronny Gal, Ph.D. in the United States and Europe Senior Research Analyst Bernstein Research 10:10am 10 Minute Break 10:20am Introduction to State Jessica S. Mazer, J.D. Biosimilar Substitution Laws Assistant Vice President of State Affairs Pharmaceutical Care Management Association 10:35am Industry Perspective on Geoffrey Eich, M.B.A. State Substitution Laws Executive Director, R&D Policy 10:50am Customer Perspective on Biosimilars Steven B. Miller, M.D., M.B.A. Senior Vice President & Chief Medical Officer Express Scripts 11:05am Innovation of Interchangeable Biosimilars Bruce Leicher, J.D. Senior Vice President & General Counsel Momenta Pharmaceuticals, Inc. 11:20am 10 Minute Break. Page 2
3 11:30am Panel Discussion State Substitution Laws Moderators: Elizabeth Jex, Office of Policy Planning Susan DeSanti, Western Regional Office Panelists: Geoffrey Eich, M.B.A. Executive Director, R&D Policy Ronny Gal, Ph.D. Senior Research Analyst Bernstein Research Aaron Kesselheim, M.D., J.D., M.P.H. Assistant Professor of Medicine Brigham and Women s Hospital/Harvard Medical School Bruce Leicher, J.D. Senior Vice President & General Counsel Momenta Pharmaceuticals, Inc. Jessica S. Mazer, J.D. Assistant Vice President of State Affairs Pharmaceutical Care Management Association Mark McCamish, M.D., Ph.D. Global Head, Biopharmaceutical Development Sandoz International GmbH Steven B. Miller, M.D., M.B.A. Senior Vice President & Chief Medical Officer Express Scripts Leigh Purvis, M.P.A. Senior Strategic Policy Advisor AARP Sumant Ramachandra, M.D., Ph.D., M.B.A. Senior Vice President & Chief Scientific Officer Hospira, Inc. Emily Shacter, Ph.D. Independent Consultant ThinkFDA LLC Gillian Woollett, M.A., D.Phil. Senior Vice President Avalere Health Page 3
4 12:30pm Lunch Break (On Your Own) 1:30pm Road Map to Afternoon Presentations Elizabeth Jex 1:40pm Introduction to Drug Naming Roger Williams, M.D. Chief Executive Officer United States Pharmacopeia 1:55pm Effect of Naming on Competition Mark McCamish, M.D., Ph.D. and Innovation Global Head, Biopharmaceutical Development Sandoz International GmbH 2:10pm Industry Perspective on Paul Eisenberg, M.D., M.P.H., F.A.C.P., F.A.C.C. Naming Conventions Senior Vice President, Global Regulatory Affairs & Safety 2:25pm Lessons for the U.S.: Biosimilar Sumant Ramachandra, M.D., Ph.D., M.B.A. Market Development Worldwide Senior Vice President & Chief Scientific Officer Hospira, Inc. 2:40pm Reference Biologic Perspectives Emily Alexander, J.D. On Naming Director of U.S. Regulatory Affairs Biologics Strategic Development, AbbVie Inc. Page 4
5 2:55pm Consequences of Biologics Naming Policies Gillian Woollett, M.A., D.Phil. Senior Vice President Avalere Health LLC 3:10pm Private Payor Perspective on Growth Harry Travis, B.S. Pharm., M.B.A. of Specialty Medicines and Naming Vice President, General Manager Aetna Specialty and Home Delivery Pharmacy 3:25pm 15 Minute Break 3:40pm Panel Discussion Naming and Pharmacovigilance Moderators: Elizabeth Jex, Office of Policy Planning Susan DeSanti, Western Regional Office Panelists: Emily Alexander, J.D. Director of U.S. Regulatory Affairs Biologics Strategic Development, AbbVie Inc. Paul Eisenberg, M.D., M.P.H., F.A.C.P., F.A.C.C. Senior Vice President, Global Regulatory Affairs & Safety Helen Hartman, Ph.D. Director, Worldwide Regulatory Strategy Pfizer Inc. Aaron Kesselheim, M.D., J.D., M.P.H. Assistant Professor of Medicine Brigham and Women s Hospital/Harvard Medical School Mark McCamish, M.D., PhD. Global Head, Biopharmaceutical Development Sandoz International GmbH Page 5
6 Leigh Purvis, M.P.A. Senior Strategic Policy Advisor AARP Sumant Ramachandra, M.D., Ph.D., M.B.A. Senior Vice President & Chief Scientific Officer Hospira, Inc. Harry Travis, B.S. Pharm., M.B.A. Vice President, General Manager Aetna Specialty and Home Delivery Pharmacy Roger Williams, M.D. Chief Executive Officer United States Pharmacopeia Gillian Woollett, M.A., D.Phil. Senior Vice President Avalere Health LLC 4:45pm Concluding Remarks Andrew I. Gavil Director, Office of Policy Planning Page 6
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