March 8, 2016 Patient data, at the end of the day, belongs to individual people. We are sensitive to that and I think having the input of an independent external ethical advisory board shows just how careful we are being, which is important for the public to know. Having convened that group and meeting with them regularly is a very big step forward.
April 18, 2016
The webinar will introduce the concept of drivers of effectiveness and will provide an overview of the methods which can be used to identify them early during the drug development plan.
May 10, 2016
This webinar on “Synthesis and integration of real-world evidence in network meta-analyses and outcome prediction” will give the participants an understanding of important methodological key deliverables achieved by the IMI GetReal team.
February 7, 2016
When asked about the issues around harnessing health data in Europe in Washington DC on October 27th, Prof Hans Georg Eichler, Senior Medical Officer of the European Medicines Agency responded, "I come from an area with hysterical data protection.”[1] Why would a regulator feel this way? Surely, Europe’s public health systems have access to health data that is second to none?
January 27, 2016
When it comes to sharing health data, solving the technical solutions of data sharing is more straightforward than structuring workable collaboration models that satisfy both data owners and researchers alike, says Bart Vannieuwenhuyse, Senior Director Health Information Sciences, Janssen Pharmaceutica; Coordinator EMIF.
December 14, 2015
Europe’s world-leading science base is fuelling innovation in advanced therapies, which a growing volume of clinical data indicates will address a diversity of unmet medical needs, delivering better health and generating economic benefits.
November 25, 2015
After years of painstaking research, cell, gene and tissue therapies are turning in unprecedented evidence of efficacy in phase I/II. Unlike the old model, where the sole focus would now be on phase III, companies need to work simultaneously on manufacturing, logistics, pricing and getting the product to the patient, says Keith Thompson.
November 25, 2015
Positive data in the phase III trial of TiGenix’s Cx601 allogeneic cell therapy indicates it could provide a one-off treatment for complex perianal fistulas, a complication of Crohn’s disease. The results open up a completely new avenue for treatment of patients who do not respond to existing therapies, says Eduardo Bravo, CEO of Tigenix.
November 19, 2015
With more companies advancing innovative therapies to the end of phase II, the funding requirements of European biotech are spiralling. A new initiative is required to create large and liquid funds to support the next stage of growth and ensure Europe reaps the benefits – both medical and commercial – of its excellent research, says Emil Pot.
November 12, 2015 - London
After huge investment in the basic science and translation to the clinic, Europe’s advanced therapies companies are accumulating data, which indicate these products have an unprecedented effect. Now effort is needed to develop manufacturing, organise logistics, agree reimbursement and ensure patients get the benefits. Vital Transformation reports for EBE from the ARM Conference.