Clinical Development/ Regulatory
Clinical Development & Regulatory, Monday 17 August 2020
last published: 25/Aug/20 17:55
Clinical Development & Regulatory, Monday 24 August 2020
09:50
BREAK
10:05
Chairperson’s opening remarks
Ellen Coleman, President And Chief Executive Officer, VOZ Advisors
10:10
Keynote Address: Rare diseases in the time of Covid-19
Jeremy Levin, Chairman and Chief Executive Officer, Chairman, BIO, Ovid Therapeutics
10:35
Keynote Address: The future of rare diseases: developing and accessing the next generation of therapies
Emil Kakkis, Chief Executive Officer, Ultragenyx Pharmaceutical
10:55
Keynote Panel: Patient involvement in drug development for rare diseases – examining how patients are driving meaningful development and what companies are doing to incorporate patient input throughou
Neena Nizar, President, The Jansens Foundation
Jessica Scott, Head of R&D Patient Engagement Office,, Takeda Pharmaceuticals
Amy Mckee, Vice President, Regulatory, Parexel Consulting, Parexel International
Dara Richardson-Heron, Chief Patient Officer, Pfizer
Yann Le Cam, Chief Executive Officer, EURORDIS
11:45
EXHIBITOR HALL BREAK
13:50
BREAK
14:10
ROUNDTABLE 1: Balancing the Patient Experience & ROI – understanding when to incorporate patient accommodations into study programs and balancing short and long term financial goals
Amanda Finlayson, Therapeutic Strategy Lead, ClinEdge
14:10
ROUNDTABLE 2: Forecasting & epidemiology - rare-disease epidemiology methods and resources to support commercial forecasts
David Lapidus, President, Lapidus Data
14:10
ROUNDTABLE 3: Expanded Access Programs- How EAPs can complement rare disease drug development and optimize commercial launch
Sam Lucas, SVP, Expanded Access Programs, Durbin
Julia Campbell, VP, Client Strategies and Services, Durbin
Todd Galles, VP, US Business Development, EAPs, Durbin
14:10
ROUNDTABLE 4: FDA updates - Office of Orphan Product Development
Janet Maynard, Director, Office Of Orphan Products Development, Food And Drug Administration, U.S. Food and Drug Administration
Lewis Fermaglich, Medical Advisor, Office of Orphan Products Development,, FDA
15:10
BREAK
17:00
Keynote Panel: Examining industry strategies for leveraging patient data and AI to advance rare disease patient identification, R&D, and commercialization
Moderator: Oodaye Shukla, Chief Data Officer, HVH Precision Analytics, now EVERSANA
Thomas Abbott, Head, Real World Data And Evidence, Astellas Pharma
Sonalee Agarwal, Vice President Of Value And Evidence Strategy, Alnylam Pharmaceuticals
Sean Khozin, Global Head Of Data Strategy, Johnson & Johnson
last published: 25/Aug/20 17:55
