Pfizer, GSK, and Schering-Plough currently have a new class of anti-HIV drugs in phase 2 of development. These CCR5 antagonists represent a novel approach –they target a host cellular receptor rather than a viral enzyme. Clinicians and patients are excited about the potential to add a new type of weapon to the anti-HIV arsenal.
Yesterday I attended a meeting on CCR5 antagonists hosted by the Forum for Collaborative HIV Research in Washington, DC. Attendees included representatives of US and European regulatory authorities, academic researchers from around the world, government research institutes, diagnostic companies, patient advocates, foundations, and pharmaceutical companies.
Using a collaborative, problem-solving approach, the group identified and discussed some of the details of common regulatory issues, diagnostic challenges, and resistance issues. The regulators were able to share their views and concerns and get substantive feedback from the other parties. Pharmaceutical companies were able to learn more about what’s expected of them and why. It was a good use of time for all involved and will help improve phase 3 trial design.
To my knowledge, this type of broad and deep collaboration only exists in the HIV world. I’ve written recently about how the Forum has tackled other issues such as pediatric formulations. It would be worthwhile to consider how to bring the various parties together on specific topics at regular intervals in other fields.May 24, 2005