The Good, the Bad, and the Ugly

Recently Bernard Munos, former pharma exec and now principal of his InnoThink Center for Research in Biomedical Innovation, published an analysis of output of the pharmaceutical industry’s research and development effort and found the industry’s claim to innovation to be modest at best.  As described by FierceBiotech (FierceBiotech review) (the article is available to those with a Nature subscription at Munos 2013), Dr. Munos looked at the NMEs (new molecular entities or drugs that are not rehashes of already-approved drugs) approved 2000-2012 (a total of 353) and found of those with known mechanisms of action (324, leading me to wonder how a drug can get approval without the FDA requiring that the applicant knows how it works) about half had novel actions and half did not.  From this finding, he concluded “there does not seem to be enough [known] mechanisms able to yield multiple drugs, to support an industry. The drug hunter’s freedom to roam, and find innovative translational opportunities wherever they may lie is an essential part of success in drug research,” and ”… if innovation cannot be ordained, pharmaceutical companies need an adaptive–not directive–business model.”  My interpretation of this conclusion is that big pharma may be more successful in finding truly new drugs if its R and D is driven by an understanding of the pathology of disease (any and all diseases) rather than a goal of adding drugs to a company’s existing franchises, that is, the diseases for which the company has drugs already.  Of course, one could say that big pharma does not want (or need) to be innovative; it just needs to find drugs that can offer some (maybe even marginal) improvement over current treatments and that society (us) agrees are worth a price that includes a high profit margin.  Or if it wants to be innovative, it could figure out how make affordable meds for the rest of the world.

But on to the good.  One company that seems to be trying an adaptive R and D model with the goal of pumping up its drug discovery effort is GlaxoSmithKline plc (GSK) (I apologize for writing another post on this company).  Several weeks ago, GSK announced that it was actively soliciting academic researchers for participation in its Discovery Partnerships with Academia program (DPAc) through a “competition” called Discovery Fast Track (GSK press release).  Specifically academics are invited to submit a “therapeutic hypothesis” with supporting data (cell-based assays are OK) which is judged by a panel of GSK scientists on several factors (lots more detail at Discovery Fast Track).  Awarded to a winner (up to 20 announced by August) will be a free trip to Philadelphia to present to the GSK reviewers and the opportunity to be evaluated for DPAc participation (about 10 to be selected).  As noted on the Fast Track website, “If your concept is chosen, GSK will collaborate with you to test the full diversity of our compound collection using our pharmacological screening platforms to discover active compounds. We will share key results from the screen to provide you with the best possible chemical probes to interrogate your translational biological assays.”  So, although the evaluation does not get the academic investigator funding, it does get her/him a 50/50 chance at a multi-year DPAc collaboration with funding and the aim of generating a clinical candidate (e.g., Vanderbilt DPAc announcement).  So the good is that academic researchers can test their concepts for drugs (not drugs themselves which academics rarely discover) in an industrial-strength drug discovery program with a small chance of contributing to finding a treatment for a disease.  Also good is that GSK is trying a new way to identify and support academics with novel concepts of disease pathology through which it can find clinical candidates with novel mechanisms of action, an approach that should be more effective than the prevalent franchise-driven, serendipitous process.  Also good is that GSK seems not to be putting any market-driven preconditions on participation in Fast Track or DPAc (What GSK Is Looking For).  Any potential therapy, including those for diseases of the rest of the world and that may lead to drugs with low profit margins, is welcome.

The bad is that participation requires commitment at an early stage in research, and there are lots of hoops to jump through and paper to read for the researcher and her/his institution to understand the commitment (e.g., Terms and Conditions).  But, from my experience on both sides of the table, having more information, even if it is written by lawyers, is better than less.  My read is that GSK, in keeping with its (relatively recent) corporate value to be transparent, has done a good job of protecting both sides’ interests in the potential results of the programs.

The ugly is that some people, even those who should know better or at least should take time to read the relevant information, may suspect GSK of trying to misappropriate university intellectual property.  For example, it was reported that shortly after the GSK press release, the UCLA vice chancellor for research and his associate vice chancellor sent an email to all faculty advising they not participate because the GSK terms and conditions are in conflict with their obligation to report all discoveries to UCLA for evaluation for patent protection (Pharmalive article).  The concern being that, by applying to the GSK program and making public her/his concept for treating a disease, the investigator, and her/his assignee, the university, may lose a chance to get a patent and future intellectual property rights.  I think there are several reasons why this concern is unfounded.  First, GSK states explicitly that the applicant should not submit any confidential information and should contact the university technology transfer office (TTO) before applying.  Also last week the company added a few more hoops (“enhancements”) to the process to involve the TTOs, like requiring explicit approval (GSK Enhancements).  Second, one should note that at this early stage of research, the best the university could do is file a patent application on a “method” of finding drugs to treat a disease, and the patent courts have raised the requirements for obtaining method of treatment patents over the past few years.  An applicant needs to provide an example compound that demonstrates the method in an animal model, so the university’s application will be lacking in the required “reduction to practice.”  Third, patents on methods of finding don’t have much commercial value since the methods can be used before a patent issued (likely several years) and there are allowances for use after it is issued (for a discussion of these two points, see a 2008 post by UCSF’s TTO director at MySDScience.com blog).

As I have noted in previous posts about university technology transfer and the obligation of universities to apply their research results to social good (like global health), universities should welcome anyone willing to put resources into getting something useful out of their research regardless if there is a risk that some time off in the future (for drug discovery maybe decades) the university is not in a position to tap a revenue stream.  Fortunately, it looks like other universities are not reacting like UCLA, and several are actively promoting participation the Fast Track/DPAc program (e.g., Princeton meeting notice).  I hope GSK gets lots of applicants especially those with ideas for treating global diseases and is successful in finding innovative drugs, especially for world markets, and other companies imitate its success.

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