Biosimilars Keynote Address
Sarah Yim, M.D., Acting Director for Therapeutic Biologics, Office of New Drugs. Therapeutic Biologics and Biosimilars Team, CDER, FDA
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Welcome and Introduction
Chester “Chip” Davis, Jr., JD., President & CEO, AAM
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Developing Complex Generic Products, How to Ensure Success!
Gregg DeRosa, MS., VP, Generic Clinical R&D and Internal Clinics, Teva Pharmaceuticals
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Robert Lionberger, PhD, Vice President, PAREXEL Consulting
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Emerging Technologies: How Can the Generic Industry Participate and Benefit?
Ajaz Hussain, PhD., President, The National Institute for Pharmaceutical Technology & Education (NIPTE)
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Sau (Larry) Lee, PhD, Director, Office of Testing and Research (OTR), OPQ, CDER, FDA
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Judy Murrah, Chief Information Officer, Applied DNA Sciences
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The Importance of Global Regulatory Harmonization for Biosimilars
Suzette Kox, MSc, Pharm., Secretary General, International Generic and Biosimilar medicines Association
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Transition from BsUFA I to BsUFA II
Moderator: Marcy Macdonald, RAC, Consultant/President, MJM Regulatory Consulting, LLC
Hillel Cohen, PhD, Executive Director, Scientific Affairs, Sandoz Inc., a Novartis Division
Brian McCormick, JD, Vice President & Chief Regulatory Counsel, Teva Pharmaceuticals
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Andrew Kish, MSPPM, Office Director, Office of Program and Strategic Analysis (OPSA), CDER, FDA
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Payer Strategies to Drive Biosimilars Access & Savings
Amy Gutierrez, PharmD, Senior Vice President and Chief Pharmacy Officer, Kaiser Permanente National Pharmacy Programs and Services
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Imminent Approvals – Enhancing Access
Edward (Ted) Sherwood, Director, Office of Regulatory Operations (ORO), OGD, CDER, FDA
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Acquisitions/Licensing and Mergers – What Are the Regulatory Requirements and Strategies to Consider?
Donal Parks, MBA, MPM, Division Director, Division of User Fee Management and Budget Formulation (DUFMBF), Office of Management (OM), CDER, FDA
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Scott Tomsky, VP, Regulatory Affairs, Generics, North America, Teva Pharmaceuticals
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CDR Leo Zadecky, RPh, MS, Senior Program Management Officer, Drug Shortage Staff (DSS), Office of Center Director (OCD), CDER, FDA
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Biosimilars Action Plan Scorecard: Is FDA Helping Adoption?
Chad Landmon, Partner, Axinn, Veltrop & Harkrider LLP
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Gillian Woollett, Senior Vice President, Avalere Health
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Biosimilars at the Bar
Eva Temkin, JD, Acting Director of Policy, Office of Therapeutic Biologics and Biosimilars, CDER, FDA
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Drug Substance and Drug Product Manufacturers- Partnering to Improve the Process
Siva Vaithiyalingam, PhD, Vice President Regulatory Affairs, Cipla LTD
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Martin Ehlert, PhD, VP, Research & Development, Apotex Pharmachem
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Ee-Sunn (Joanne) Chia, PhD, Branch Chief, Division of Lifecycle API (DLCAPI), ONDP, OPQ, CDER, FDA
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Office of Business Informatics and Office of Pharmaceutical Quality: FDA Study Data Standard for Submissions and Electronic Submissions Update – What Sponsors Need to Know
Heather Crandall, Operations Research Analyst, Division of Database Management and Services and Solutions (DDMSS), Office of Business Informatics (OBI), Office of Strategic Programs (OSP), CDER, FDA
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Susanne Lenk, Computer Scientist, Division of Drug Quality and Compliance Services and Solutions (DDQCSS), OBI, OSP, CDER, FDA
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Jonathan Resnick, Project Management Officer, DDMSS, OBI, OSP, CDER, FDA
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Geoffrey Wu, PhD, PMP, CPH, Associate Director, OLDP, OPQ, CDER, FDA
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OC/OGD/OPQ Keynote Address
Donald Ashley, JD Director, Office of Compliance (OC), CDER, FDA
Sally Choe, PhD Director, Office of Generic Drugs (OGD), CDER, FDA
Michael Kopcha, PhD, RPh, Director, Office of Pharmaceutical Quality (OPQ), DCER, FDA
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ORA Keynote Address
Alonza Cruse, CDER. Director, Office of Pharmaceutical Quality Operations Office of Regulatory Affairs (ORA), CDER, FDA
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Keynote Address
Patrizia Cavazzoni, M.D. Deputy Director for Operations, CDER, FDA
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The USP of Today
Ronald Piervincenzi, PhD. Chief Executive Officer, United States Pharmacopeial Convention
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Drug/Device Combination Products, Challenges and Opportunities
Henri Akouka Associate Director, R&D, Teva Pharmaceuticals
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Lisa Bercu, JD. Regulatory Counsel, Division of Policy Development (DPD), OGDP, OGD, CDER, FDA
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Ashley Boam, Director, Office of Policy for Pharmaceutical Policy (OPPQ), OPQ, CDER, FDA
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Michael Spagnola, M.D. Medical Officer, Division of Clinical Review(DCR), Office of Bioequivalence (OB), OGD, CDER, FDA
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Róisín Wallace, VP, Head of Global Device Development, Mylan Inc.
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Controlled Correspondence: The Evolution and Opportunity
Rosario LoBrutto, PhD. Head of Scientific Affairs, Sandoz, Inc. (A Novartis Division)
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Robert Pollock, RPh, MS. Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.
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Janice Brown, Branch Chief, OPPQ, OPQ, CDER, FDA
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Xiaohui (Jeff) Jiang, PhD. Deputy Director, DTP, ORS, OGD, CDER, FDA
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Paramjeet Kaur, PhD. Bioequivalence Reviewer, Division of Bioequivalence II (DBII), OB, OGD, CDER, FDA
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Rebalancing U.S. Trade Policy
Tahir Amin, Co-Founder and Co-Executive Director, I-MAK
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What’s Up with FDA’s Integrated Facility Evaluation Processes?
Goff Baker, Principal, American Pharmaceutical Consulting
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Vidya Pai, Ph.D., M.S., Facility Reviewer and Quality Assurance Lead (Acting), Division of Inspectional Assessment (DIA), Office of Process and Facilities, OPQ, CDER, FDA
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Labeling Best Practice and Strategies for Reviews
Courtney Canale, M.S., Head of U.S. Labeling, Regulatory Affairs, Mylan Pharmaceuticals
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Marshall Florence, PharmD, Labeling Reviewer, Division of Labeling Review (DLR), Office of Regulatory Operations (ORO), OGD, CDER, FDA
Huijeong (Ashley) Jung, PharmD, PhD, CPH, Labeling Reviewer, DLR, ORO, OGD, CDER, FDA
Charlene Peterson, PharmD., Labeling Reviewer, DLR, ORO, OGD, CDER, FDA
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The Changing Landscape of Patents, Hatch-Waxman and the BPCIA
Karin Hessler, JD., Assistant General Counsel, AAM
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Emerging State Legal Issues
Tara Ryan, JD., Vice President, State Government Affairs, AAM
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Assessment of Risks, Challenges and Opportunities in Conducting Foreign Bioequivalence Studies
Kumar Ramu, PhD., Sr. Vice President & GM, QPS Holdings LLC
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Nageshwar Thudi, PhD. Senior Director, Global Gx Clinical R&D- PD/CE Studies, Teva Pharmaceuticals
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Post Approval Changes: Best Practices and Strategies
Billie Wiltison, Senior Director, Regulatory Affairs, Vertice Pharma
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COMPLEX PRODUCT WORKSHOP
Markham C. Luke, MD, PhD., Director, DTP, ORS, OGD, CDER, FDA
Robert Lionberger, PhD., Director, ORS, OGD, CDER, FDA
Kris Andre, M.S., Associate Director for Regulatory Affairs, ORS, OGD, CDER, FDA
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