Wednesday, September 5, 2018

CDER Keynote Address
Patrizia Cavazzoni, M.D., Deputy Director for Operations, CDER, FDA
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Data Integrity
Frances Zipp, President & CEO, Lachman Consultant Services, Inc.
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Derek Glover Head of Global Quality Systems and Compliance, Mylan Pharmaceuticals Inc.
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Sarah Barkow, PhD, Lead Consumer Safety Officer, Office of Manufacturing Quality, Office of Compliance, FDA
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Howard Sklamberg JD, Partner, Akin Gump Strauss Hauer & Feld LLP
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Carmelo Rosa, BS, MS, PsyD, Director, Division of Drug, Quality I, Office of Compliance, FDA
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Drug Pricing and Update on State Legal Issues
Jonathan Janow, JD, Partner, Kirkland & Ellis LLP
Matthew Rowen, JD, Associate, Kirkland & Ellis LLP
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Stephanie Trunk, JD, Partner, Arent Fox LLP
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Global Experience with Biosimilars
Hillel Cohen, PhD, Executive Director, Scientific Affairs, Sandoz Biopharmaceuticals
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Kyung-Ah Kim, Vice President of Biosimilar Development, Samsung Bioepis
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Marc-Alexander Mahl, M.D., Executive Vice President, Business Unit Generic Drugs, Fresenius Kabi President, Medicines for Europe
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Perspectives on the Future of ICH
Nicholas Cappuccino, Jr., PhD, Vice-President, Head of Quality and Scientific Affairs, Dr. Reddy’s Laboratories, Inc. Chair, Science Committee IGBA
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C. Michelle Limoli, PharmD, Senior International Health Science Advisor, CBER, FDA
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Theresa Mullin, PhD, Associate Director for Strategic Initiatives, CDER, FDA
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Jerry Stewart, JD, MS, RPh, Deputy Vice President, Scientific and Regulatory Advocacy, PhRMA
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USP Stakeholder Engagement Through Monograph Development
Jen Devine, JD, Vice President, Global Legal Affairs, USP
Elizabeth Miller, PharmD., Vice President, U.S. Regulatory Affairs and Public Policy, USP
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Biosimilars Regulatory Expectations & Experiences
Gillian Woollett, MA, DPhil, Senior Vice President, Avalere Health LLC
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What’s Important to Consider When Developing a Complex Generic Drug?
Robert Iser, MS, Vice President, PAREXEL Consulting
Robert Lionberger, PhD, Director, Office of Research Standards (ORS), OGD, FDA
Kiran Krishnan, PhD, Senior Vice President Global Regulatory Affairs, Apotex Inc.
Marcy MacDonald, RAC, Vice President, Regulatory Affairs, Amneal Pharmaceuticals
Wayne Talton, Head of Global Regulatory Affairs, Mylan Inc.
Scott Tomsky, MS, BS, Vice President, Generics Regulatory Affairs, North America, Teva Pharmaceuticals
Molly Ventrelli, Vice President, Regulatory Affairs, Fresenius Kabi USA, LLC
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Thursday, September 6, 2018

OPQ Keynote Address
Ashley Boam, Director, Office of Policy, OPQ, CDER, FDA
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Successfully Managing Priority Generic Submissions
Robert Iser, MS, Vice President, PAREXEL Consulting
Kiran Krishnan, PhD, Senior Vice President Global Regulatory Affairs, Apotex Inc.
Aloka Srinivasan, PhD, Vice President, Regulatory Practice, Lachman Consultant Services, Inc.
Scott Tomsky, MS, BS, VP, Generics Regulatory Affairs, North America at Teva Pharmaceuticals
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Breaking Through on Biosimilars: Market Development & Access
Alex Brill, CEO, Matrix Global Advisors
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Biosimilars Reimbursement
Molly Burich, MS, Director, Public Policy: Biosimilars and Reimbursement, Boehringer Ingelheim Pharmaceuticals, Inc.
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FDA Hiring and Retention Initiative – An Overview of the Agency’s HR Process
Melanie Keller, Acting Associate Commissioner for Scientific and Clinical Recruitment, Office of Medical Products and Tobacco, FDA
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FDA’s Center for Drug Evaluation and Research: Informatics Initiatives to Modernize the Generic Drug Review Process
Jonathan Resnick, Project Management Officer, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA
Jonathan Rappaport, MBA, PMP, Director, Division of Regulatory Review and Drug Safety Services and Solutions, OBI, OSP, CDER, FDA
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Legal Issues in GDUFA, FDARA, and Administration Proposals
Kurt Karst, JD, Director, Hyman, Phelps & McNamara, P.C.
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Mark Schwartz, JD, Director, Hyman, Phelps & McNamara, P.C.
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Emerging Legal Issues in IP and Paragraph IV Litigation
Frederick Ball, JD, Partner, Duane Morris LLP
Patrick Gallagher, PhD, Partner, Duane Morris LLP
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The Role of Variability in Biosimilar Development
Hillel Cohen, PhD, Executive Director, Scientific Affairs, Sandoz Biopharmaceuticals
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Uninsured, Underinsured and Disaster Access – Direct Relief
Amalia Adler-Waxman, Vice President, Global Head Social Impact and Responsibility, Teva Pharmaceuticals
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Jason Patnosh, Associate Vice President, Partnerships and Resource Development, NACHC
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Thomas Roane, Director of Strategic Initiatives, Direct Relief
Damon Taugher, Director of US Programs, Direct Relief
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Update on GDUFA and BsUFA User Fees
Donal Parks, MBA, MPM, Director, Division of User Fee Management and Budget Formulation Office of Management, FDA
Beena Alex, MPH, Lead Management Analyst, Division of User Fee Management and Budget Formulation, Office of Management (OM), CDER, FDA
LCDR Evelyn Hong, PharmD, Program Manager, Division of User Fee Management and Budget Formulation, OM, CDER, FDA
CDR Timothy Jetton, RPh, RAC, Program Management Officer, Division of User Fee Management and Budget Formulation, OM, CDER, FDA
Gisa Perez, MBA, Branch Chief, Division of User Fee Management and Budget Formulation, OM, CDER, FDA
LCDR Hanah Pham, PharmD, Facilities Team Lead, Generics Branch, Division of User Fee Management and Budget Formulation, OM, CDER, FDA
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Friday, September 7, 2018

OGD Updates
Kathleen Uhl, M.D., Director, Office of Generic Drugs (OGD), Food and Drug Administration
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Bridging the Education Gap: Accelerating the Understanding of Biosimilars to Optimize Patient Care
Leah Christl, PhD, Associate Director for Therapeutic Biologics Director, OND Therapeutic Biologics and Biosimilars Staff (TBBS) Office of New Drugs, CDER, FDA
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Drug Competition Action Plan and Biosimilars Action Plan (BAP)
Leah Christl, PhD, Associate Director for Therapeutic Biologics and Director of OND Therapeutic Biologics and Biosimilars Staff (TBBS), Office of New Drugs, CDER, FDA
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Maryll Toufanian, JD, Director, Office of Generic Drug Policy, OGD, FDA
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Old, New, and Future Challenges in Bioequivalence
Charlie DiLiberti, President, Montclair Bioequivalence Services LLC
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The 5 Year Financial Plan for GDUFA and BsUFA
Jay Tyler, Chief Financial Officer, FDA
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Biosimilars at the Bar
Elaine Herrmann Blais, JD, Partner, Goodwin Procter LLP
Scott Lassman, JD, MA, Partner, Goodwin Procter LLP
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GDUFA II Complex Products: Pre-ANDA Meeting Process
Kris Andre, MS, Associate Director, Regulatory Affairs, ORS, OGD, FDA
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Serialization for Today and Tomorrow
Lloyd Mager, Manager Strategic Initiatives Supply Chain Operations, AbbVie Inc.
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