Agenda – 2nd Medical Affairs Seminar

  • Day One
  • Day Two

Day One

 December 7, 2017

9:15AM – 10:30AM

OPENING KEYNOTE
Biotechnology and Pharmaceutical Sciences: Gems From the Past, Critical Perspectives and Patient-Centricity

Pravin Chaturvedi, Ph.D., Chairperson, Scientific Advisory Board, NAPO PHARMACEUTICALS

10:30AM – 11:00AM

Morning Break

 MEDICAL AFFAIRS IN EARLY R&D

11:30AM – 12:15PM

Workshop Panel
Panelists:
Pravin Chaturvedi, Ph.D., Chairperson, Scientific Advisory Board, NAPO PHARMACEUTICALS
Eric Olson, CSO, SYROS PHARMA
Barry Lubarsky, Ph.D., Senior Medical Director, Medical Affairs, ALKERMES

12:15PM – 1:15PM

Lunch

 MEDICAL AFFAIRS FROM SUBMISSION TO APPROVAL

1:15PM – 2:45PM

Part One: Helping Get to “Yes”
WORKSHOP PANEL
Getting to Approved: How Does Medical Affairs Help? From NDA to Advisory Committee — Linkage to the Treatment Community

Panelists:
Mark De Rosch, Ph.D., SVP Regulatory Affairs, Quality Assurance, and CMC, AKEBIA THERAPEUTICS
Elizabeth Dorn, Ph.D., Director Medical Affairs, VERTEX PHARMACEUTICALS
Shahin Gharakhanian, M.D., DPH, Principal and CMO, SG MD CONSULTING LLC; Former Vice President, Medical Affairs, VERTEX PHARMACEUTICALS

2:45PM – 3:15PM

Afternoon Break

3:15PM – 5:00PM

Part Two:
Building It Right – Obtaining Buy-in and Creating the Right Medical Affairs Team
INTRODUCTION PRESENTATION
Foundations for a Launch-Ready Medical Affairs Organization

David Rowe Wood, Ph.D. Director MSLs; Pulmonology, Rheumatology and Ophthalmology, MALLINCKRODT PHARMACEUTICALS

WORKSHOP PANEL
Building and Operating the Right Medical Affairs Team

Panelists:
David Rowe Wood, Ph.D., Director MSLs; Pulmonology, Rheumatology and Ophthalmology, MALLINCKRODT PHARMACEUTICALS
John White, M.S., V.P. Field-Based Medical Programs, THE MEDICAL AFFAIRS COMPANY
Jeff Rosenbaum, MBA, Partner and Co-Founder, DOVETAIL CONSULTING GROUP

5:00PM – 5:15PM

Day One Wrap-Up
Barry Lubarsky, Ph.D., Senior Medical Director, Medical Affairs, ALKERMES

5:15PM – 5:15PM

Day One Concludes


Day Two

 December 8, 2017

8:00AM – 9:00AM

Breakfast

9:00AM – 9:15AM

Expectations of Day Two
Barry Lubarsky, Ph.D., Senior Medical Director, Medical Affairs, ALKERMES

9:15AM – 10:00AM

KEYNOTE
CEO: Chief’s Expectations of Product Launch and Medical Affairs

Rick Russell, CEO, STALLERGENES GREER NORTH AMERICA

10:00AM – 10:30AM

FIRESIDE CHAT
Rick Russell, CEO, STALLERGENES GREER NORTH AMERICA

10:30AM – 11:00AM

Morning Break

 MEDICAL AFFAIRS IN LAUNCH

11:00AM – 12:45PM

WORKSHOP PANEL
Experiences Through Launch

Panelists:
Elizabeth Dorn, Ph.D., Director Medical Affairs, VERTEX PHARMACEUTICALS
Kanchan Relwani, M.D., Vice President, Medical Strategy, Medical Affairs, ALKERMES PLC
Kerry Costello, MBA, Marketing Strategy Consultant, KC CONSULTING LLC
Gigi Shafai, Pharm.D., Director of Medical Affairs, AKEBIA THERAPEUTICS

12:45PM – 1:30PM

Lunch

 MEDICAL AFFAIRS POST-APPROVAL

3:30PM – 3:45PM

Day Two Wrap-Up
Shahin Gharakhanian, M.D., DPH, Principal and CMO, SG MD CONSULTING LLC;; Former Vice President, Medical Affairs, VERTEX PHARMACEUTICALS
Barry Lubarsky, Ph.D., Senior Medical Director, Medical Affairs, ALKERMES

3:45PM – 3:45PM

Seminar Concludes