By Rob Wright
This year’s 2nd Annual Disruptive Innovation to Advance Clinical Trials for Pharma, Biologics & Devices conference was held September 13 to 14, in Boston. Having doubled in the number of attendees from last year’s event, it is fairly obvious that the Conference Forum’s executive director, Valerie Bowling, has landed on a topic which resonates loudly with the pharmaceutical industry. Perhaps this is why 5 of the top 10 pharmaceutical companies (Pfizer, Novartis, Merck, J&J, and Lilly) had representatives speaking and sharing best practices on what they are doing differently at their companies to disrupt the old ways of drug discovery and development. But if these ideas are so good, why are they sharing them? Shouldn’t they keep them a secret so as to be a competitive advantage? If that is what you are thinking, then you are still stuck in the old way of approaching drug discovery.
Open Access Collaboration
One of the most controversial presentations demonstrating the need to think differently came from Chas Bountra, Ph.D. The chief scientist at the Structural Genomics Consortium (SGC) and professor of translational medicine at the University of Oxford presented the SGC model to reduce waste in clinical development — open access collaboration.
Bountra pointed out several problems with the way “we” currently do drug discovery. For example, many companies have the same targets, are working in parallel, and in secret. This is a problem because the largest attrition for novel targets (> 90%) occurs at clinical proof of concept (phase 2a/b). Think of it this way. Ten drug companies are working on developing the same drug. Nine out of 10 companies will fail. Because the work is done in secret and outcomes are not shared, companies are destined to duplicate failure over and over. Bountra points out how this duplication is not only wasteful, but results in patients being unnecessarily exposed. The solution, a public-private partnership to take pioneer targets through to Phase 2 — proof of clinical mechanism (POCM). He advocates the creation of intellectual property (IP) only on developable assets, after positive POCM studies. Further, he recommends the publication of all negative studies immediately and positive studies after a small delay. Bountra believes this approach is in keeping with the objective of generating clinically de-risked targets which pharma can then convert into new drugs. The benefits of such a model include the pooling of resources and quick and free access to global academia. The rapid publication reduces duplication and saves patients. The key to the successful execution of this model (and probably the most difficult for pharma leaders to embrace) is the “no IP” policy prior to POCM.
Bountra believes pharma should look at these activities as “precompetitive,” pointing out that there is no real benefit/advantage to having IP prior to Phase 2a/b when the majority of these targets are destined to fail. More can be gained by the sharing of this precompetitive information. Once the target has POCM, he would advise it be put up for auction, with specific timelines for patent exclusivity. The concept of “no IP” and the sharing of precompetitive information may seem risky and counterintuitive. In my next blog, I’ll discuss three companies that demonstrated the benefit of sharing precompetitive information.