Agenda Links: Day 1
AGENDA: DAY 2
TUESDAY, JUNE 27, 2017
MORNING PLENARY SESSION
8:00 am
Welcome and Introduction
Cynthia (Bongiovanni) Ramirez, R.Ph., M.S.J.
Director, Pharma/Device Events, Global Health Care, LLC., Bellevue, WA, Former Director, USP Compliance & Ethics, Bristol Myers-Squibb, Plainsboro, NJ (Co-Chair)
Director, Pharma/Device Events, Global Health Care, LLC., Bellevue, WA, Former Director, USP Compliance & Ethics, Bristol Myers-Squibb, Plainsboro, NJ (Co-Chair)
8:10 am
International Medical Affairs
Michael Joachim, JD
Global Business Partner, Ethics and Business Integrity, Sanofi Genzyme, Cambridge, MA
Global Business Partner, Ethics and Business Integrity, Sanofi Genzyme, Cambridge, MA
8:50 am
Medical Affairs Personnel as Speakers — When is it Scientific Exchange and When is it Promotion?
Kathryn Pryze
US Medical and Scientific Compliance Director, AstraZeneca, Wilmington, DE
US Medical and Scientific Compliance Director, AstraZeneca, Wilmington, DE
Donna White, CCEP
Vice President, Contracts and Compliance, Chiesi USA, Inc., Cary, NC
Vice President, Contracts and Compliance, Chiesi USA, Inc., Cary, NC
9:30 am
Performance Measures for Medical Affairs
Kevin L. Espinoza, MBA
Global Vice President, Ethics and Compliance, BTG International; Former R&D Compliance Officer, Forest Laboratories (now Allergan), Durham, NC
Global Vice President, Ethics and Compliance, BTG International; Former R&D Compliance Officer, Forest Laboratories (now Allergan), Durham, NC
Cynthia (Bongiovanni) Ramirez, R.Ph., M.S.J.
Director, Pharma/Device Events, Global Health Care, LLC., Bellevue, WA, Former Director, USP Compliance & Ethics, Bristol Myers-Squibb, Plainsboro, NJ
Director, Pharma/Device Events, Global Health Care, LLC., Bellevue, WA, Former Director, USP Compliance & Ethics, Bristol Myers-Squibb, Plainsboro, NJ
10:00 am
Break
10:30 am
Risk and Accountability in Medical Affairs: A Panel on Best Practices in Monitoring, Auditing, and Investigations
Kevin Ryan, JD, MS
Senior Director, Risk and Accountability, Novo Nordisk, Princeton, NJ
Senior Director, Risk and Accountability, Novo Nordisk, Princeton, NJ
Donna White, CCEP
Vice President, Contracts and Compliance, Chiesi USA, Inc., Cary, North Carolina
Vice President, Contracts and Compliance, Chiesi USA, Inc., Cary, North Carolina
Mark DeWyngaert, MBA, PhD
Managing Director, Huron Life Sciences, New York, NY (Moderator)
Managing Director, Huron Life Sciences, New York, NY (Moderator)
11:15 am
The Role of Medical Affairs with Payors: Health Economics Outcomes Research and Real World Evidence
Pamela Lonzer, MJ
US Medical Advisor, Shire; Former Associate Director, Global Medical Affairs Compliance, Baxalta; Former Assistant Director, Research and Development-Global Compliance, Astellas Pharma, Chicago, IL
US Medical Advisor, Shire; Former Associate Director, Global Medical Affairs Compliance, Baxalta; Former Assistant Director, Research and Development-Global Compliance, Astellas Pharma, Chicago, IL
12:00 pm
Luncheon
AFTERNOON CLOSING JOINT PLENARY SESSION WITH SECOND PHARMACEUTICAL SUMMIT ON BUSINESS AND COMPLIANCE ISSUES IN MANAGED MARKETS
1:00 pm
Welcome and Keynote Address: The Politics and Policy Issues of the Pharmaceutical Marketplace
Susan Dentzer
President and Chief Executive Officer, The Network for Excellence in Health Innovation (NEHI); Analyst on Health Policy, The News Hour, Washington, DC
President and Chief Executive Officer, The Network for Excellence in Health Innovation (NEHI); Analyst on Health Policy, The News Hour, Washington, DC
1:30 pm
View from the Marketplace: Rewarding Results: Moving Forward for Value-Based Contracting for Biopharmaceuticals
Catherine Davis Ahmed, MBA
Director, Policy and Outreach, Familial Hypercholesterolemia Foundation, Washington, DC
Director, Policy and Outreach, Familial Hypercholesterolemia Foundation, Washington, DC
Jim Clement, MHA
Executive Director, Cost of Care and Supply Chain Strategy, Aetna; Former National Account Manager, PBMs and Specialty Pharmacy, Genentech, Inc.; Former Director, Pharmaceutical Contracting, Express Scripts, Inc., Hartford, CT
Executive Director, Cost of Care and Supply Chain Strategy, Aetna; Former National Account Manager, PBMs and Specialty Pharmacy, Genentech, Inc.; Former Director, Pharmaceutical Contracting, Express Scripts, Inc., Hartford, CT
David Hartenbaum, MD, MBA
Executive Director, Account Management, Merck, Philadelphia, PA
Executive Director, Account Management, Merck, Philadelphia, PA
Dorothy Hoffman, MPP (Invited)
Director, Healthcare Transformation and Policy Partnerships, Eli Lilly and Company, Indianapolis, IN
Director, Healthcare Transformation and Policy Partnerships, Eli Lilly and Company, Indianapolis, IN
Surya Singh, MD
Executive Vice President and Chief Medical Officer, CVS/Specialty, Boston, MA
Executive Vice President and Chief Medical Officer, CVS/Specialty, Boston, MA
Susan Dentzer
President and Chief Executive Officer, The Network for Excellence in Health Innovation (NEHI); Analyst on Health Policy, The News Hour, Washington, DC (Moderator)
President and Chief Executive Officer, The Network for Excellence in Health Innovation (NEHI); Analyst on Health Policy, The News Hour, Washington, DC (Moderator)
2:45 pm
A Prosecutor’s Perspective
Gregg Shapiro, JD
Assistant US Attorney, US Attorney’s Office, District of Massachusetts, Boston, MA
Assistant US Attorney, US Attorney’s Office, District of Massachusetts, Boston, MA
3:30 pm
Networking Break
4:00 pm
PhRMA’s Perspective on Public Policy Considerations for Expanding Value-Based Contracting
Michelle Drozd, ScM
Deputy Vice President, Policy and Research, Pharmaceutical Research & Manufacturers of America (PhRMA), Washington, DC
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Deputy Vice President, Policy and Research, Pharmaceutical Research & Manufacturers of America (PhRMA), Washington, DC
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Julie Ritchie Wagner, JD
Assistant General Counsel, PhRMA; Former Senior Counsel, Office of Counsel to the Inspector General, US Department of Health and Human Services, Washington, DC
Assistant General Counsel, PhRMA; Former Senior Counsel, Office of Counsel to the Inspector General, US Department of Health and Human Services, Washington, DC
4:45 pm
Recent FDA Draft Guidances on Manufacturer Communications and the Memorandum on Off-Label Communications
Kellie B. Combs, JD
Partner, Ropes & Gray, Washington, DC
Partner, Ropes & Gray, Washington, DC
5:30 pm
Pre-Approval Information Exchange with Payors
Soumi Saha, JD, PharmD
Assistant Director of Pharmacy and Regulatory Affairs, Academy of Managed Care Pharmacy (AMCP); Former Director of National Pharmacy Controls, Kaiser Permanente, Alexandria, VA
Assistant Director of Pharmacy and Regulatory Affairs, Academy of Managed Care Pharmacy (AMCP); Former Director of National Pharmacy Controls, Kaiser Permanente, Alexandria, VA
6:00 pm
Summit Adjournment
Agenda Links: Day 1