December, 2021
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LIVE ✦ CONTENT - EST
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LIVE ✦ CONTENT - EST
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LIVE CONTENT — YOUR TIME. REAL TIME. | *Please note all times are EST
LIVE ✦ CONTENT 10:45am - 11:00am15 mins
Organizer and Co-Chair’s Welcoming Remarks
- Nielsen Hobbs - Editor, The Pink Sheet
- Michelle Benz - Conference Producer, Pharma & Life Sciences, Informa Connect
LIVE ✦ CONTENT 10:45am - 11:00am15 mins
Co-Chair’s Opening Remarks
- Charlotte Jones-Burton, MD, MS - Vice President Global Clinical Development, Nephrology, Otsuka Pharmaceuticals
LIVE ✦ CONTENT 10:45am - 11:00am15 mins
Co-Chair’s Opening Remarks
- Nielsen Hobbs - Editor, The Pink Sheet
LIVE ✦ CONTENT 11:00am - 11:15am15 mins
OPENING ADDRESS ● FDA Priorities for 2021 and the FDA Response to the Pandemic
- Stephen Hahn - FDA Commissioner, U.S. Food and Drug Administration (FDA)
LIVE ✦ CONTENT 11:00am - 11:45am45 mins
Drug Development and the Supply Chain in the Aftermath of the Pandemic
- Bowman Cox - Executive Editor, Manufacturing, Pharma Intelligence
- Jonathan Kimball - Vice President, Trade & International Affairs, Association for Accessible Medicines
- Omar Hafez - Managing Partner, Avalere Health
LIVE ✦ CONTENT 11:00am - 11:45am45 mins
Assess the Impact of the 2020 Elections on Drug Pricing Reform
- Rujul Desai - Of Counsel, Covington & Burling LLP
- Juliette Cubanski, PhD - Deputy Director, Program on Medicare Policy, Kaiser Family Foundation (KFF)
- Robert Dubois, MD, PhD - Interim President & CEO, Chief Science Officer and Executive Vice President, National Pharmaceutical Council
- Walid Gellad, MD, MPH - Director, Center for Pharmaceutical Policy & Prescribing, University of Pittsburgh
- John Murphy, III - Vice President, Deputy General Counsel, Biotechnology Innovation Organization
LIVE ✦ CONTENT 11:15am - 11:45am30 mins
FIRESIDE CHAT ● A Review of Current Priorities for CBER and How the Pandemic is Impacting FDA Resources, Efficiencies and Shifts in Processes
- Sarah Karlin-Smith - Senior Writer, The Pink Sheet and Scrip
- Peter Marks, MD, PhD - Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA)
LIVE ✦ CONTENT 11:45am - 12:15pm30 mins
FIRESIDE CHAT ● A Review of Current and Future Priorities for CDER
- Derrick Gingery - Senior Writer, The Pink Sheet and Scrip
- Patrizia Cavazzoni, MD - Acting Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)
LIVE ✦ CONTENT 12:30pm - 1:30pm60 mins
Part 1: Achieving Diversity in Clinical Trials — An Internal Approach
- Charlotte Jones-Burton, MD, MS - Vice President Global Clinical Development, Nephrology, Otsuka Pharmaceuticals
- Eliseo Pérez-Stable, MD - Director, National Institute on Minority Health & Health Disparities, National Institutes of Health
- Dara Richardson-Heron, MD - Chief Patient Officer, Pfizer
- Quita Highsmith, MBA - Chief Diversity Officer, Genentech
- Richardae Araojo - Associate Commissioner for Minority Health and Director of the Office of Minority Health & Health Equity (OMHHE), U.S. Food and Drug Administration (FDA)
LIVE ✦ CONTENT 12:30pm - 1:15pm45 mins
Innovating Clinical Trial Design for Rare Disease Drug Development
- Frank Sasinowski - Director, Hyman, Phelps & McNamara
- Kathleen Donohue, MD - Clinical Team Leader, Division of Gastroenterology & Inborn Errors Products (DGIEP), OND, CDER, U.S. Food and Drug Administration (FDA)
- Bradley Glasscock, PharmD - Group Vice President, Head of Global Regulatory Affairs, BioMarin Pharmaceutical Inc.
- Janet Wittes, PhD - President, Statistics Collaborative, Inc.
LIVE ✦ CONTENT 1:15pm - 2:00pm45 mins
Navigating the Regulatory Landscape Post COVID-19
- Rebecca Wood - Partner and Leader of the FDA Practice, Sidley Austin LLP
- Alicyn Campbell - Head of Digital Health for Oncology R&D, AstraZeneca
- John Concato - Deputy Division Leader, Office of Medical Policy, U.S. Food and Drug Administration (FDA)
- Paul Kluetz, MD - Deputy Director, Oncology Center of Excellence, U.S. Food and Drug Administration (FDA)
- Jeffrey Chasnow - Senior Vice President and Associate General Counsel, Pfizer
LIVE ✦ CONTENT 1:30pm - 2:15pm45 mins
Realizing the Full Promise of RWE in Drug Development
- Richard Gliklich, MD - CEO, OM1
- Amy Abernethy, MD, PhD - Principal Deputy Commissioner of Food & Drugs, and Acting Chief Information Officer, U.S. Food and Drug Administration (FDA)
- Jane Barlow, MD, MPH, MBA - Senior Advisor, MIT Center for BioMedical Innovation/NEWDIGS
- Solomon Iyasu, MD, MPH - Vice President and Global Head of Pharmacoepidemiology, Merck
LIVE ✦ CONTENT 1:45pm - 2:30pm45 mins
Addressing Challenges and Opportunities in Cell and Gene Therapy Development
- Michael Werner - Co-founder and Senior Policy Counsel, Alliance for Regenerative Medicine
- Katherine High, MD - Co-Founder, Spark Therapeutics
- Daniela Drago, PhD, RAC - Senior Director, Regulatory Sciences, Biogen
- Peter Marks, MD, PhD - Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA)
- Jennifer Brogdon, PhD - Executive Director, Head of Cell Therapy Research, Exploratory Immuno-Oncology, Novartis Institutes for Biomedical Research (NIBR)
LIVE ✦ CONTENT 2:30pm - 3:15pm45 mins
Assess the Potential for Collaborative Approaches between FDA Regulatory Programs and CMS Reimbursement
- Sarah Karlin-Smith - Senior Writer, The Pink Sheet and Scrip
- Peter Bach, MD, MAPP - Director, Center for Health Policy & Outcomes, Department Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center
- Rachel Sachs - Associate Professor of Law, Washington University in St. Louis
- Jeet Guram, MD - Senior Advisor, Office of the Commissioner, U.S. Food and Drug Administration (FDA)
LIVE ✦ CONTENT 2:45pm - 3:30pm45 mins
The New Clinical Trial — Trends in Decentralization and Digital Enablement
- Isaac Rodriguez-Chavez, PhD, MHSc, MSc - Senior Vice President, Scientific & Clinical Affairs, Global Center of Excellence for Decentralized Clinical Trials, PRA Health Sciences
- Anne-Marié van der Merwe - Global Program Regulatory Director, Innovation, Regulatory Affairs, Novartis Pharmaceuticals
- Judy Sewards - Head, Clinical Trial Experience, Global Product Development, Pfizer
- Jonathan Cotliar - Chief Medical Officer, Science 37
LIVE ✦ CONTENT 3:00pm - 3:45pm45 mins
Defining and Demonstrating Value in Rare Disease
- Craig Martin - Interim Chief Executive Officer, Global Genes
- Patroula Smpokou, MD - Clinical Team Leader, DGIEP, OND, CDER, U.S. Food and Drug Administration (FDA)
- Annie Kennedy - Chief of Policy & Advocacy, EveryLife Foundation
- Michelle Leeds - Vice President, Reputation & Risk Management, Syneos Health
LIVE ✦ CONTENT 3:30pm - 3:40pm10 mins
Closing Remarks
- Nielsen Hobbs - Editor, The Pink Sheet
LIVE ✦ CONTENT 3:45pm - 4:30pm45 mins
Patient Engagement and Regulatory Decision-Making
- Adora Ndu, PharmD, JD - Vice President, Regulatory Affairs; Global Head of Policy, Research, Engagement (PRE) & Reg International, BioMarin Pharmaceutical Inc.
- Anne Rowzee, PhD - Associate Director, Policy, Office of Tissues & Advanced Therapies(OTAT), Center for Biologics Evaluation & Research (CBER), U.S. Food and Drug Administration (FDA)
- Eleanor Perfetto, PhD, MS - Executive Vice President, Strategic Initiatives, National Health Council
- Elisabeth Piault-Louis - Senior Director, Scientific Lead, Digital Health for Oncology R&D, AstraZeneca
- Theresa Kehoe, MD - Director (acting), Division of General Endocrinology, Office of Cardiology, Hematology, Endocrinology & Nephrology (OCHEN), OND, CDER, U.S. Food and Drug Administration (FDA)
LIVE ✦ CONTENT 4:00pm - 4:45pm45 mins
Evolving Diagnostic Testing to Support Treatment Decision-Making
- Anthony Sireci, MD, MSc - Vice President, Diagnostics Development & Medical Affairs, Loxo Oncology at Lilly
- Samuel Caughron, MD - President & CEO, MAWD Pathology Group
- Mark Fleury - Principal, Policy Development, Emerging Science, American Cancer Society Cancer Action Network, Inc