Ax-S Pharma is the leading education resource on Expanded Access to new medicines, worldwide.
Our 3-month set of weekly webcasts, accredited education videos, and additional multi-media resources available in a single-login “3D” virtual conference site.
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The fusion of clinical research and modern healthcare delivery
November 2020 – March 2021
5 Core Topics
Ax-S Pharma brings together world leaders from industry, medicine, and policy centers to provide members an unparalleled range of information and perspective on the integration of research and healthcare.
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Our programming includes accredited material for Continuing Education
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The Expanded Access Summit®, our flagship event, is the world’s largest annual conference on pre-market access to medicines. The Summit focused on feasibility for all stakeholders and the integration of well-designed access programs in the modern clinical development process.
Expanded Access Explained
Global and Large Scale
Most countries allow “treatment-use” of new pre-market medicines for serious unsolved health conditions. Since 1987, Expanded Access Programs in the U.S. have been used to treat more than 250,000 patients in a range of serious diseases.
In Harmony with Ongoing Research
EAPs have been used widely to enroll large numbers of on-label patients who are outside the inclusion/exclusion criteria of a product’s research trials. Properly designed Expanded Access trials or “Expanded Access programs” (EAPs) have also helped to recruit and retain eligible patients in research trials, and in many cases generated structured data that sped the development and market approval of the particular product. Despite widespread misconception, we have found no evidence of an authorized EAP impeding the enrollment of any research study or negatively impacting clinical development of the particular product.
Bringing Inclusivity to Clinical Development
Expanded Access regulations require that treatment is the primary objective in these programs and therefore grant EAP sponsors privileges that would not be appropriate for research trials. Compared to the cost of clinical research, the per-patient cost of Expanded Access can be very low. To learn more about the regulation, history, or best practice of Expanded Access in any country, contact us here.
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