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INDUSTRY TRENDS IN PRE-APPROVAL ACCESS TO MEDICINES

February 20, 2020 | (03:00am)
USA (United States of America)
SHARESHARESHARE
Expanded access to medicines (pre-approval access, early access, compassionate use, named patient supply) is becoming more and more a part of the standard development and launch process of bringing a pharmaceutical product to market. The focus of pipelines on rare diseases and oncology, combined with a heightened awareness of access delays, is driving this change from Top 10 Pharma down to small biotechs. Done well, expanded access can help patients access your medicine sooner, can contribute to a positive corporate reputation, allow data to be captured from the first patients outside of a trial setting and gain early market share. Done badly, expanded access can damage goodwill amongst patients and physicians, cause supply chain and regulatory issues and can negatively impact your commercial roll-out and reputation.