“Overview of NEWDIGS & Adaptive Licensing”Gigi Hirsch (MIT).

(1) “Adaptive, Progressive or Risk-Based Licensing Models: What Approaches Could Be Considered by Mature and Emerging Markets?”Panel Moderator: Lawrence Liberti (CISR). Hans-Georg Eichler (EMA) – An Update on International Developments. (2) “How Can Studies that Inform Relative Effectiveness Best Be Incorporated into Global Drug Development Plans?” Panel Moderator: Chris Chinn (GSK). Mark Trusheim (MIT) – Overview of the NEWDIGS Janus Initiative.

Invited case study presentation: “NEWDIGS – What they have discovered as critical elements.”Tony Hoos (Medicines 4 Patients)

Improving Risk Regulation: From Crisis Response to Learning and Innovation. “Session 2.3 – Managing Uncertainty over the Life Cycle of Drug Development and Use: Enhancing Adaptability and Flexibility in Pharmaceutical Regulation.”Ken Oye (MIT), Tony Hoos (M4P), Hans-Georg Eichler (EMA).

“Session 5: Adaptive Licensing.”Tomas Salmonson (CHMP, MPA), Robert Hemmings (MHRA), James Anderson (GSK).

New Trial Pathways and Better Patient DataCo-hosted by IMI, EMA, NEWDIGS, and EFPIA “Overview the NEWDIGS Janus Initiative.” Mark Trusheim (MIT Sloan School of Management & MIT Center for Biomedical Innovation).

Keynote panel discussion: “Enterprising Breakthroughs and Catalyzing Collaboration in the Pursuit of Life-Transforming Rare Disease Treatments.”Gigi Hirsch (MIT).