Events Hosted by NEWDIGS (attendance by Invitation)
|July 9, 2014
||Cambridge, MA, “The Next Act: What’s Needed to Make Orphan Drugs Readily Available to People with Rare Diseases.” Co-hosted by NORD and MIT LFE.
|June 4-5, 2014
||Cambridge, MA, NEWDIGS Quarterly Workshop
|April 2-3, 2014
||London, “Global Updates on Accelerated Access to Innovative Medicines for Patients in Need,” Workshop Co-hosted by EMA, IMI, EFPIA, & MIT NEWDIGS.
Events and Presentations
|August 25, 2014
|Boston, Tufts Center for the Study of Drug Development, in partnership with the Manhattan Institute’s Project FDA. Building a 21st Century Health Care System: Aligning Policy, Accelerating Cures, Delivering Hope. Panel: “Using Big Data to Support Patient-Centered Innovation.” Gigi Hirsch (MIT).
|June 15-19, 2014
||San Diego, DIA 2014. (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.
|June 13, 2014
|Boston, Global Clinical Scholars Training Program @ Harvard Medical School. “Overview of NEWDIGS & Adaptive Licensing,” Gigi Hirsch (MIT).
|May 8, 2014
||Washington DC, NORD Corporate Council Meeting. “Overview of NEWDIGS-Adaptive Licensing,” Thomas Unger (Pfizer).
|March 26, 2014
||Vienna, DIA EuroMeeting 2014. “Creating an Adaptive Pathway for Medicines to Patients–Could this Be An Approach That Fulfills the Needs of All Decision-Makers? A Roundtable Discussion.” Moderator: Andrzej Rys (European Commission, Belgium); Hans-Georg Eichler (EMA); Jurgen Windeler (IQWiG, Germany); Tomas Salmonson (CHMP/EMA); Carole Longson (NICE); Chris James (Motor Neurone Disease Association, United Kingdom); Anton Hoos (GSK).
|February 13-14, 2014
||San Francisco, 21st International Molecular Medicine Tri-Conference, Leaders in Precision Medicine Symposium. “Adaptive Licensing as an Enabler for Precision Medicine,” Panel: Hans-Georg Eichler (EMA), Kenneth Oye (MIT), Ed Pezalla (Aetna), Mark Trusheim (MIT), & Thomas Unger (Pfizer).
|February 10, 2014
||Washington DC, DIA 2014. (1) “Adaptive Licensing and Benefit-Risk,” John Ferguson (Novartis). (2) “Benefit-Risk Assessment from Inception to Maturity: Aligning Regulatory and Industry Goals,” Panelists: Hans-Georg Eichler (EMA) and Robyn Lim (Health Canada).
|February 3-6, 2014
||Washington DC, HTAi Forum. Origins and Current Thinking on Adaptive Pathways. Hans-Georg Eichler (EMA)