Yesterday I had the pleasure of participating on the keynote panel at the World Pharma Congress. My fellow panelists were Karim Dabbagh (Executive Director and Head, External R&D and Innovation Research Units, Pfizer Worldwide R&D) and Glen Gaulton (Professor, Pathology and Laboratory Medicine, Executive Vice Dean and Chief Scientific Officer, Perelman School of Medicine, University of Pennsylvania). The panel was expertly chaired by Rick Turner (PGCE Senior Scientific Director, Clinical Communications, Quintiles and Fellow, Society of Behavioral Medicine).
Our topic was, “Advancing Pharma R&D through Communications and Collaboration.” It was an exciting 90 minutes.
The issue of out-sourcing R&D isn’t new – but it’s mighty contentious. And it’s the new reality of drug development. But, if we are to learn any lesson from the CRO experience, it’s that while we say “partnership,” the danger is that it devolves into a vendor-like relationship. It’s the Golden Rule. He who has the gold makes the rules. Will that be acceptable to high-level, big ego Ivy Hall-ers?
And then there’s the issue of academic priorities, specifically tenure. Does industry funding carry the same weight as NIH grants when it comes to advancing a university career? Not at present. That will have to change.
Will university researchers pursue their programs with the same time-driven focus as their pharma counterparts? After all, there aren’t any quarterly analyst calls to worry about. And, as already mentioned, if the funding is viewed as secondary to “tenure-track” funding, how will the work be prioritized?
And then there’s the IP question. According to both Dabbagh and Gaulton, IP negotiations are generally smooth. That’s good news – but there’s a lot of road ahead on the R&D partnership superhighway.
CROs, at least know what needs to be done. Researchers (whether inside a company or a university) don’t. That’s why it’s called research. One issue that arose is the need for total sharing and absolute transparency between industry and academic partners on all levels of the engagement. Is this happening? Sometimes. The good news is that when it does occur – the relationship (and results) are more positive.
But talk with CROs and you’ll hear their frustration over being instructed what to do by their pharma masters. (In most cases their former employers.) Fortunately, that too is changing as the urgency of new and innovative clinical trial protocols and programs becomes self-evident.
Need drives change. Just as CROs are now really partnering with pharma to drive the development of personalized medicine, so too must academic researchers and their industry partners collaborate on the continued evolution of pharmaceutical innovation. It will take discipline and focus. It will be risky. And it will take will. There is a confluence of interest.
To borrow some FDA parlance, will industry/academic partnerships result in expedited pathways in drug development? It must – because if it is only viewed as a cost-saving mechanism it will fail.
“Change is not required. Survival is not mandatory.”
-- W. Edwards Deming
