LEAPS Monthly Recap: March 2021

Eric NormanLEAPS, News


Margaux Hall to co-lead Fit-for-Purpose RWE evaluation

Margaux Hall, Partner at Ropes and Gray and valued collaborator in the NEWDIGS FoCUS (Financing of Cures in the US) Project, will be co-leading a new workstream in LEAPS focused on developing a framework that will guide our approach to evaluating the “readiness” of “fit-for-purpose” RWE for use in stakeholder-specific decision-making processes. We are grateful for her thought leadership in this challenging and vital area of transformation for LEAPS, and more broadly, for Downstream System Innovation.


Dr. Hans-Georg Eichler to co-author publication on RWE in personalized medicine access and reimbursement

Dr. Hans-Georg Eichler, will be retiring next month from his current position of Senior Medical Officer of the European Medicines Agency (EMA). After his retirement, he will be co-leading the development of an invited publication for Clinical Pharmacology and Therapeutics (CP&T) focused on the role of RWE in access and reimbursement decisions for personalized medicines. This important article will advance themes initially elucidated in our collaboration with Dr. Eichler, former Visiting Scholar at MIT, in the NEWDIGS Adaptive Licensing Project (2011-2013).


Dr Gigi Hirsch hosts fireside chat at the MIT Sloan Healthcare and Bioinnovations Conference

On February 26, Dr Hirsch hosted a conversation with Bill Sibold, Executive Vice President & Head of Sanofi Genzyme, Sanofi, entitled, “The Value of Downstream Innovation—Improving Patient Access to Groundbreaking Therapies.” They discussed the reality that developers of all sizes share the responsibility to help make therapies available, not only to produce them quickly. “Lessons from the real world, how medicines are reaching patients and working—or failing to—can meaningfully influence the early stages of development,” said Dr Hirsch. “Recognizing the potential value, the challenge becomes, how to interpret and apply those lessons to everyone’s benefit.”

Dr Hirsch will also speak at the Precision Medicine World Conference on June 18th. 


LEAPS 2021 Design Labs

June 10–11 and November 30–December 1. By invitation only.