LONDON, October 2, 2018 /PRNewswire/ --
Thousands of patients fighting rare and life threatening diseases rely on early access to novel medications as a viable treatment option. In a collaborative effort to create a national framework for managing many of the challenges of early access, a number of universities in the US, including the University of Michigan, are planning to implement a new standard for how to run these programmes.
Early access programmes come with a host of complications including cost efficiency, data capture and ethical selection concerns. It is therefore becoming increasingly difficult to satisfy growing patient needs in a timely and effective manner without additional risk to the pharmaceutical manufacturers.
Allison Morgan, Managing Director, Metis Clinical said in a recent interview with Pharma IQ that there are a number of considerations which can restrict the effectiveness of an Early Access programme. For example, typically unless it is stipulated by the authorities for safety reasons, companies cannot ask for information over and above the standard of care. These stringent data guidelines are first and foremost to protect the patients, but can also create challenges in regard to accessing treatment results.
With the establishment of this new effort to expand vulnerable patients, more patients will be able to gain access to experimental drugs, devices and biologics. With many countries and organisations looking to learn from this framework, the Early and Managed Access Programmes Forum will be looking at the transformation of expanded access to maximize support and study through this national network in the US.
If you would like to hear more about how this new framework will improve hospitals' use of FDA Expanded Access program for use of new drugs, biologics and devices Kevin Weatherwax, Managing Director, Michigan Medicine, who is involved in this effort, will be speaking at the Early and Managed Access Programmes Forum where he will be presenting a case study on:"Transforming Expanded Access to Maximize Support and Study (TEAMSS): A Plan to Create a National Network for Expanded/Early Access in the United States".
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SOURCE Pharma IQ