MAPPs newsletter NEW HEADER
  NEWSLETTER August 2016  
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In this newsletter we cover the The DIA 2016 Session ”Europe and the US: Making Outcomes-Based Health Care Possible” that was held on 29 June 2016 in Philladephia, US.
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  Panel Review
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HansGeorgEichler - 300x300 “Pre and post licensing should not be two different lives, it’s one continuous life”: A Report From The DIA 2016 Session ”Europe and the US: Making Outcomes-Based Health Care Possible”
 
On 29 June 2016, key stakeholders and decision-makers in the field of real-world evidence met to take part in the DIA 2016 seminar “Europe and the US: Making Outcomes-Based Health Care Possible”. As Europe and the US continue to examine ways to develop therapies on the basis of their “real world” performances, the session aimed to discuss benefits and challenges of outcomes-based health care, as well as the remaining barriers to implementation.


Speakers taking part were:
  • Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, European Union
  • Gigi Hirsch, Executive Director, Massachusetts Institute of Technology (MIT) Center For Biomedical Innovation
  • Richard Bergström, Director General,, European Federation of Pharmaceutical Industries and Associations (EFPIA)
  • Steve Rosenberg, Senior Vice President and General Manager, Oracle Health Sciences
  • Duane Schulthess, Managing Director, Vital Transformation, (moderator)
READ THE FULL REVIEW
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   EMA Releases Report on Adaptive Pathways Pilot 
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Final Report on the Adaptive Pathways Pilot
Adaptive pathways can be defined as a prospectively planned, iterative approach to bringing medicines to market. The iterative development plan will initially target the development to a well-defined group of patients that is likely to benefit most from the treatment. This is followed by iterative phases of evidence gathering and progressive licensing adaptations, concerning both the authorised indication and the potential furthertherapeutic uses of the medicine, to expand its use to a wider patient population as more data become available.
 
A key aspect of adaptive pathways is the involvement of all relevant decision-makers in the process across the life span of the medicine, including those who decide about patient access in the Member States: to help determine which medicines could be appropriate for adaptive (iterative) development; to jointly agree a data generation plan to meet the needs of regulators and health technology assessment bodies (HTAs) and to ensure that the use of the medicine is well monitored and managed.
 
The aim of this collaboration is to achieve better patient access to important medicines.


READ FULL THE REPORT HERE
 
   EFPIA statement on the EMA report
 
EFPIA welcomes the report's statement that adaptive pathways can foster multi-stakeholder dialogue, bringing regulators, interested HTAs, healthcare professionals and patients. We also note the project's findings that agreement between stakeholders can be reached on a prospective approach to evidence generation. EFPIA supports the Increased participation of patients in the adaptive pathways model, as a means of accelerating access to medicines for those candidates who would most benefit from this.

READ THE FULL STATEMENT
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  EFPIA Brussels Office
 
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Leopold Plaza Building
Rue du Trône 108
B-1050 Brussels (Belgium)
Tel: +32 (0)2 626 25 55
E-mail:
anna.szczepanska@efpia.eu
or science-policy@efpia.eu
 
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