Policies on pre-approval access (‘early access’, ‘expanded access’ etc.) have come into focus since the enactment of the US 21st Century Cures Act. Driven by the requirements of the Act,…
Stuart BellAugust 17, 2019
Rapid economic and demographic changes are causing a boom in the Chinese market for pharmaceuticals. This offers opportunities for pharma companies, but the landscape is complex, and understanding the changes…
flowerhausJanuary 25, 2019
Dr. Stefan Fraenkel, Executive Vice President, Inceptua Pharma Understand how to commercialize via partnering in Europe and other markets outside of the USA. Dr. Stefan Fraenkel, Executive Vice President, Commercial…
Stefan FraenkelNovember 1, 2018
With the raised profile of pre-approval access (thanks in part to Right-to-Try and the 21st Century Cures Act) there has been a noticeable increase in the number of companies and…
Stuart BellSeptember 26, 2018
The US is the most straight forward of all countries for collecting data within an Early Access Program (EAP), due to clear guidelines, requirement for a protocol and site contracting.…
Stuart BellMay 1, 2018
Pre-approval access (early access, expanded access, named patient supply etc.) is a hot topic at present, especially with the high-profile discussions around Right-to-Try which are making the headlines around the…
Stuart BellFebruary 28, 2018