Across Europe there is disparity in the average time for new drugs to be approved and accessible to patients. There are a number of factors delaying these processes. Stuart Bell,…
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,…
Underlining the tendency, a poll in one of the DIA sessions revealed that 30% of the industry delegates attending the meeting believe that RWD may actually be more relevant than…
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…
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…
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…
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.…
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…