Non-inferiority Trial Design at the Anti-Infectives Summit

Recently I had the pleasure of attending and presenting at the 3rd Annual Anti-Infectives Summit in Philadelphia. It was a good opportunity to interact and see presentations by people from medicinal chemistry, biochemistry, regulatory, and other backgrounds involved in drug discovery and research. I don’t deal much these days with the preclinical perspective, so it was a refreshing change of pace. I always appreciate the chance for cross-pollination of ideas with people from different areas.

There were a number of particularly good presentations, and one common theme that I saw was the borderline-inspiring enthusiasm by the researchers. You can always tell when someone truly loves what they do and is genuinely excited by their work – and I definitely saw that. Notables included Ying Zhang, MD, PhD, from Johns Hopkins, who opened my eyes in his presentation on issues with persister bacteria and Jennifer Schranz, MD from Cempra, who gave a great overview on the FDA’s expectations for clinical trials. She took what could have been a dry topic and infused it with energy and pace – I wish I could poach her to guest lecture in one of our drug information courses on this topic.

Something else that came out of the presentations was the increased emphasis on PROs (patient reported outcomes) in clinical trials. Considering that the immediate past-director of the NIH (Elias Zerhouni) made a statement about the increasing importance of the participatory medicine model…I think it was just a question of “when”, not “if”. That point spurred several interesting chats about PROs, ePatients, Phase IV, and the development of Pharmacovigilance 2.0.

Overall it was a very positive experience. I enjoyed some science refereshers, regulatory navigation tips, and insight into the future of anti-infective drug development.


Edit: I used an audience response system (aka clickers) in my presentation and included those slides here. However, I did not use the actual attendees’ responses in the slide deck I uploaded.