NICE announces collaboration with NEWDIGS. (November 21, 2004)  More info.


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

November 20, 2014
Cambridge, MA, Biogen Idec Early Payer Scientific Advice Workshop. Panel Discussion: “Future and Emerging Trends in Early Advice and Adaptive Licensing.” Gigi Hirsch (MIT).
October 21, 2014
London, Royal College of Physicians. Innovation in Clinical Trials: New Trial Pathways and Better Patient Data, Co-hosted by IMI, EMA, NEWDIGS, and EFPIA. “Overview the NEWDIGS Janus Initiative.” Mark Trusheim (MIT Sloan School of Management & MIT Center for Biomedical Innovation).
October 21-22, 2014
Alexandria, VA, NORD’s 2014 Rare & Orphan Disease Products Summit. Keynote panel discussion: “Enterprising Breakthroughs and Catalyzing Collaboration in the Pursuit of Life-Transforming Rare Disease Treatments.” Gigi Hirsch (MIT).
October 13-15, 2014
Brussels, TOPRA Annual Symposium 2014. “Session 5: Adaptive Licensing.” Tomas Salmonson (CHMP, MPA), Robert Hemmings (MHRA), James Anderson (GSK).
October 13-14, 2014
Paris, IRGC Annual Conference 2014 – 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).
October 1-2, 2014
London, Centre for Innovation in Regulatory Science (CIRS). Invited case study presentation: “NEWDIGS – What they have discovered as critical elements.” Tony Hoos (Medicines 4 Patients)
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)

2013 Events
2012 Events
2011 Events
2010 Events