by: Mark Corbett, Senior Vice President of Clinigen Global Access Programs

Patients around the world are in urgent need of new therapies. Many have exhausted available treatment options and cannot wait for promising new medicines to be approved and commercialized. Combine this need with the increased transparency of drug development pipelines, more informed patients and delays in market availability, and you create plenty of demand for access to new innovative medicines that meet a high degree of unmet medical need.

Fortunately, access programs (referred to by many terms including expanded access, named patient programs and compassionate use) can provide an ethical and regulatory-compliant solution.  Unfortunately, there is a lack of awareness and understanding of how these programs work and the value offered to all stakeholders including patients, physicians and the sponsoring company.   As a result, these programs are not deployed enough in situations that can be of significant benefit to patients.

Given the need and importance of these programs, it is essential that the pharmaceutical industry has an understanding of how they work and when best applied. On Tuesday, 14 October 2014,  I will provide an overview of patient access programs and provide guidance on their development and implementation. Including regulatory guidelines and share insight into practical considerations that affect program execution, including patient eligibility, stakeholder involvement, timing and logistics.

My talk will be based on a new ISPE white paper, Improving Access for Patients with Unmet Medical Needs – Overview and Best Practices for Success, which reflects a collaboration of an interdisciplinary team of industry experts.

Join me and other speakers as we participate in Day 2 of the Investigational Products Track. For more details about the session check the educational listings here http://www.ispe.org/2014-annual-meeting/learn#education.

 

 

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