WIPO Wipeout?

Recently, I reconnected with a colleague about his project to employ an open innovation model to find candidate compounds for treating neglected diseases (to be the topic of another post) and was reminded of a post I wrote a couple years ago on open innovation.  In “Window Dressing” (November 2011), I wrote somewhat dismissively about WIPO Re:Search, a program initiated by the World Intellectual Property Organization (a division of the United Nations) and several major pharma companies to “share valuable intellectual property (IP) and expertise with the global health research community to promote development of new drugs, vaccines, and diagnostics to treat neglected tropical diseases, malaria, and tuberculosis.”  There has been a fair amount of interest among the not-for-profit side of the global health community in the open innovation drug development model since it allows these groups (e.g., academics and the product development programs or PDPs) to access resources of pharma/biotech companies and possibly leverage them into products for the diseases of the impoverished (for a good summary of open innovation for global health, see the 2011 Results for Development Institute report, “Open Source for Neglected Disease:  Magic Bullet or Mirage?”).  I had several reasons for my lack of enthusiasm for Re:Search:

  • Access to IP is insufficient (and in many cases not needed) for the kind of early-stage product development supported by Re:Search; more important is access to the data and materials underlying the IP;
  • The rights to use the IP without further licensing and possible payment (royalties) are limited to the WHO list of neglected diseases and to the least developed countries as defined by the World Bank, meaning that any resulting products are financially unattractive to subsequent licensees (e.g., Chagas disease is a neglected disease that afflicts millions in Central and South America but commercialization of a new drug will require an additional license) (for details, see Re:Search Guiding Principles);
  • Programs of this type have bureaucracies that stifle rather than encourage collaboration and innovation; and
  • Databases are only useful if they are extensively populated, and companies need to put effort into contributing to the Re:Search database and responding to requests.

My take was that Re:Search may be a good first step in encouraging early stage product development for neglected diseases but it does not address the major needs:  positive feedback or incentives to coordinate efforts to generate product prototypes that are likely to be successful (or even advance to the next step) and attracting investors with risk capital and companies with the expertise and interest in bringing those prototypic products into commerce.

Since my colleague spoke highly of his experience in finding collaborators through Re:Search, I thought a revisit was in order and evaluated the program’s performance on four factors over the past two years.

Number and quality of items in the database:  the database (at Database Search) has 247 items in it, up from 140 when it was initiated, so not quite doubled.  Of these, 92 are listed as being IP, and therefore not so useful in my mind, and 56 are listed as Preclinical Candidates.  Most of the items in the latter category are drug or vaccine candidates that emerged from one or two disease-relevant in vitro screens and therefore are likely to have no in vivo data, e.g., on toxicity or metabolism.  A few items seem to be mis-categorized methods.  I also looked at the Marketed Products and Other Type of Data or Services categories.  The first was not interesting, comprising six Sanofi drugs for which one could obtain samples.  The second was much more interesting, a list of 49 institutions and companies offering their drug discovery services, like screening, pharmacokinetics, medicinal chemistry, and biomarkers.  There were also plugs for NIH’s Clinical Testing Center and a Department of Defense biomanufacturing RFP.  The descriptions of the services did not include key details, like cost (I am assuming the cost will be less than that charged by a commercial service), and to get more information, one needs to contact the Partnership Hub run by BIO Ventures for Global Health (BVGH), which may be OK, if BVGH is responsive and helpful.

Number of collaborations with materials and/or data transfer and/or funding:  the Re:Search site has a list of completed agreements (at Agreement List), 37 of which are for collaborations.  I think the most important are those transferring compounds with data, since they are most likely to facilitate drug discovery, and found nine from company to academic institution, two company to company, and one academic to company.  The number of transfers without data from company to academic were nine, and there were five company to academic transfers of know-how.  This is substantial progress, although, of the total, most were made between about one-quarter of the more than 45 participating organizations.  It would be interesting to know if the number of collaborations was increasing, if the parties obtained what they asked for, and what the time from agreement initiation to completion was.

Number of licenses:  as far as I can tell, there have been no licenses completed for the development of products, one of the important goals of the program.  Of course, product development is a multi-year process and my guess is that institutions receiving materials and/or data are not thinking about getting to a candidate product.  The base licensing terms are already set and the licensors supposedly willing, so I see no reason (except effort) not to execute a license; better to do so before generating data that may show value.  Bottom line is that this part of the program is untested.

Buzz generation:  my quick web search found very little news about Re:Search and almost no comments from the professional non-profit global health community.  I did find two articles on the program: a 2012 article in Nature Reviews Drug Discovery (Frantz 2012) and a 2013 article in Pharmaceutical Patent Analyst (Dent et al. 2013).   The latter was written by the BVGH Partnership Hub managers, and they wrote that their role is to “proactively facilitate” collaborations; however, it seems to me they are responding to requests.  If the service is proactive, a more concerted advertising effort among drug discovery researchers, academic and corporate, is needed to attract users.

Overall, I have upped my grade of Re:Search from a C- to a B and am hoping for significant growth in the next year and not expecting a wipe out (or a slow motion crash).

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