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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Procurement Power

All governments spend money, typically siphoned from their citizens’ pockets and nominally for the good of those citizens and society in general.  Governments in developing/emerging economy countries have increased their spending on improving health, although the amount varies widely, from tens of US dollars to several hundreds per person per year (Guardian datablog).  One action governments take to increase access to and affordability of medicines, vaccines, and other tools for better health is to procure large quantities of these products for use in their public health systems through a competitive bidding process.  If done right with clear specifications and rational minimum pricing (and no graft), procurement contracts can create a market for products and result in lower-cost, improved health care.  (For some background about procurement for global health, see my post, “More Bang for the Buck”, May 2012).

One of the world’s major emerging economy countries, Brazil, is apparently pursuing a multi-year plan to leverage its governmental health care spending to increase the capacity of the government and domestic companies to produce needed drugs and medical equipment.  However, I found only limited information on the plan and no analyses by the health economics community, leaving me wondering if its goal is production of low-cost products for domestic use only or if those state-subsidized companies will also become international suppliers of low-cost drugs and vaccines.

The most complete description of the plan I found was in a press release issued by the Brazilian Ministry of Health (MOH) last month (MOH press release).  To quote:  “In April this year, Minister Padilha announced a package of initiatives aimed at providing a further boost to national production.  Eight partnerships between public and private laboratories were entered into for the manufacture of medicines and equipment. … Through partnerships for productive development between public and private laboratories, the Ministry of Health aims to ensure access to high-cost treatments and expand services to SUS patients [the SUS is the national health service that has 180 million beneficiaries, or almost the entire population, see SUS facts].  63 partnerships are currently in place between 15 public and 35 private laboratories for the national production of 61 medicines and six types of equipment.  These partnerships account for R$ 5.9 billion [about US$2.6 billion] in public procurement and approximate annual savings of R$ 2.5 billion to the public coffers.”  But what drugs were being procured (patented? generic?), over what period of time, and at what price and how were the savings calculated?  Are the participating companies all domestic and how large?  Was the selection process competitive or political?

A key government agency for health in Brazil is the Oswaldo Cruz Foundation which does R and D, runs hospitals, educates and trains, publishes, and produces vaccines, drugs, reagents, and diagnostic kits (Fiocruz portal), and it does the last at a large scale.  According its Production and Innovation page, Fiocruz makes 40% of the drugs purchased by the MOH, hundreds of million of vaccine doses, and reagents for millions of diagnostic kits.  But other than lists of Brazilian and international company “partners” (Brazilian companies and international companies), I found no details on these partnerships.

From other sources, I learned that one important element of Fiocruz’s partnerships with non-Brazilian companies is a requirement that the procurement requires transfer of manufacturing technology for the product to Fiocruz.  As I noted in a post in July 2010 (“Fio Cruising”), Fiocruz and Chembio Diagnostics Inc. of Medford, NY, closed a procurement and tech transfer deal for HIV diagnostics, and in September 2009, Fiocruz and GlaxoSmithKline (GSK) completed a similar deal for GSK’s pneumococcal vaccine.  In the press release for the latter, GSK noted that since 1985 the company has had Fiocruz manufacture the its vaccines for Brazil for polio, Haemophilus influenza type b, measles, mumps, rubella, and rotavirus (GSK press release).  Another big pharma company has also transfer a drug and its manufacture to Fiocruz.  In 2011, Bristol-Myers Squibb, a long-time provider of HIV drugs to Brazil, agreed to transfer its process to make HIV drug, atazanavir, to Fiocruz under undisclosed terms (BMS press release).

More recently, the MOH demonstrated an interest in biologics other than vaccines when it completed an agreement to acquire a drug for a rare disease and a highly novel manufacturing technology.  As I mentioned in my post last week (“Soup to Nuts”), in June Fiocruz made a commitment to buy up to $280 million of an enzyme replacement therapy the rare lysosomal storage disorder, Gaucher’s disease, made by the Israeli company, Protalix Biotherapeutics, in exchange for transfer of the manufacturing process to a government facility over a seven-year period (GEN article).  Interestingly, the biotherapeutic is made in plant cells, not mammalian or yeast cells, the industry standards (Protalix platform).  Even more interesting (and curious), is that the MOH is also acquiring a plant-cell-based, biologics manufacturing technology from the US company, iBio, and putting it into a $170 million facility which will be built through a contract with GE Healthcare (iBio April press release and June press release).  Apparently, this deal was a follow-on to licenses granted in 2011 by iBio to the Brazilian government for use of its technology in making Fiocruz’s yellow fever vaccine (which is exported 70 countries) and other vaccines (Pharmaletter article).  And to add to its deal-making, last month the MOH announced that it plans to make an H1N1 vaccine using technology transferred from Sanofi and it initiated “27 partnerships with public and private labs to produce biopharmaceuticals, including an allergy vaccine, a growth hormone, a cicatrizing drug, and medications to treat cancer, arthritis and diabetes.  Through the partnerships, Brazil expects to produce a total of 25 biopharmaceutical drugs.” (Antara News article).

Clearly, Brazil is aiming at self-sufficiency, but this level of investment could lead to over-capacity for domestic needs and possibly an industrial base capable of producing low-cost pharmaceuticals and vaccines for non-major market, rest-of-world consumption.  As was noted in a Financial Times article on the 2009 pneumo vaccine deal with GSK, “Paulo Gadelha, president of the Fiocruz institute, which will produce the vaccine, stressed that the technology received could also be used to help it make other vaccines in future.  He said his institute was already pledging to provide technology transfer to make low-cost drugs and vaccines for African countries, in what could provide a challenge for large pharmaceutical companies” (Financial Times article).  More to follow, I hope.

Soup to Nuts

Although there’s a little voice inside my head telling me to get a life, I thought I would peck out another blog posting about a business model for bringing affordable pharmaceuticals profitably (or at least with a positive cash flow) to underserved markets.  The model I have doodled about in previous posts involves a company providing a high-value, but non-novel/off-patent biopharmaceutical drug (or vaccine) that is manufactured in a relatively low-cost manner and sold in volume with a modest mark-up, possibly to public sector buyers (e.g. government health agencies) and/or subsidized by multinational donors.  In the post, “Generics Play” (September 2011), I noted the Indian generic companies like the mid-tier pharma, Cipla, and the biotech, Biocon, are developing such “biosimilar” drugs and building manufacturing capacity.  In a follow-up the next week (“Biosimilar Fever”), I wrote about the  multi-national pharmaceutical companies’ interest and investment in developing biosimilars for the major markets of the US/EU/Japan and that, thanks to industry lobbying, the US FDA proposed a challenging approval path, making the EU market a better target for the biosimilar makers since the European Medicines Agency (EMA) has based its approval on the less-rigorous concept of proving “interchangeability.”

As for the manufacturing factors in the model, in “More Grease on the COGs” (December 2011), I noted that GE Healthcare, a multi-billion dollar division of GE, and the M+W Group, a multi-billion dollar German engineering and construction firm, announced that they had formed “a strategic alliance aimed at overcoming the lack of key biopharmaceuticals, especially in emerging nations … [and] will assist countries worldwide to become self-sufficient in the manufacture of vital biopharmaceuticals such as vaccines, insulin and biosimilars.”  To me, this alliance indicated the partners had concluded that middle-income countries are serious about becoming pharmaceutically independent and were willing to commit multi-hundreds of millions of dollars.  I also noted in a posting after BIO 2012 (“See Change”) that GE Healthcare seemed to be complementing its super-scale factory option by buying a local (Marlborough, MA) company, Xcellerex, for its flexible, modular, and relatively inexpensive biomanufacturing system.  Finally, in my post, “Discount Drugs” (May 2012), I wrote about the $2 billion launch of Samsung Biologics (by a company better known for its consumer electronics) and wondered if the company will apply biomanufacturing efficiencies analogous to those that allow $50 smart phones and also where it may find those new process efficiencies.

All of the above activity is evidence for big corporations (except for Biocon, which is India’s largest biotech) adopting a non-major market biosimilar business model, but none of these players has made a product and gotten it approved, let alone generated revenue, in a non-major market.  So I’ve been on the lookout for validation in the form of a venture-capital-backed start-up with an explicit mission statement of developing biosimilars for the non-US/EU/Japan, rest-of-world markets, and recently found one:  Epirus Biopharmaceuticals, Inc. (Epirus).

Epirus was apparently in stealth mode as “fourteen22, Inc.” and based in San Francisco in 2011-12 and now is located in an office in the Prudential Building here in Boston.  Epirus’s approach, which it has nicely branded as In Market, For Market(TM), is to “combine new technologies and strategies to address macroeconomic trends in emerging environments in order to deliver biosimilar products to patients” (Approach).  The new technologies are the single-use, disposable techniques and equipment that enable lower-cost, customizable biomanufacturing (branded as SCALE[TM]), and the new strategies are to contract with local/regional pharma companies, with the encouragement and possibly financial support of local governments, to enable testing, regulatory approval, and sale of biosimilars in regional markets.  As described in the company fact sheet (Fact Sheet), the company “is focusing on a range of emerging markets, including, Brazil, Turkey, Russia, MENA [Middle East, North Africa], and the ASEAN [ten countries of southeast Asia] markets,” but notably not India and China.  The financial rationale behind this soup-to-nuts approach with partners (product candidate through manufacture, testing, and approval) is that it sidesteps the regulatory and launch hurdles of the major market countries, shares the cost/risk with the partners who know the local markets (and regulators), and results in opportunities for selling multiple, regional contracts/licenses and for governmental subsidy.  For the company customers, the upside is increasing their manufacturing capability, product development experience, and eventually revenues in a regional market.

Epirus has an impressive management team and investment (unspecified amount) from three top notch firms:  5AM Ventures, Montreux Equity Partners, and TPG (Texas Pacific Group) Biotech.  The seven senior managers have had roles in multiple biotech/pharma companies each with lots of manufacturing and product development experience (I may know one, Mark Melville, who was with Wyeth Biopharma/Andover when I did business development for that group).  The board member representing TGP Biotech is Geoff Duyk (our paths intersected when he was an assistant professor at Harvard Medical School and I did tech transfer there) who has also been involved in another start-up for emerging market pharmaceuticals, moksha8.  The company has also made impressive progress on its lead product, a biosimilar for RemicadeÒ, an anti-inflammatory antibody sold by Janssen, that is in a Phase III trial, announcing in January the successful completion of a Phase I bioequivalency trial in the UK (News).  The company expects to launch this product and another unnamed protein therapeutic in 2014 and has four preclinical products (Capabilities).  Although the company has no partners for any of its products, it claims it is “in active discussions for regional partnerships in certain markets.”

I wondered how Epirus, a virtual company, had sufficient personnel to manage its own product development and market those products and its biomanufacturing platform globally (and wondered about the source of its product candidate and platform).  Epirus lists five corporations as “technology partners” who “help us deliver the EPIRUS Biopharmaceuticals solution to market.  Our partners have expertise in product development, infrastructure design and manufacturing,” although the nature of the relationships is not clear, i.e., who is paying whom.  One of the partners is GE Healthcare, probably the source of the manufacturing platform via its Xcellerex acquisition.  I am assuming that these partners have granted Epirus agency (a right to represent), but the idea of negotiating a geographically-specific, product/platform, technology support and transfer deal with multiple parties one of which may be an autocratic government and satisfying multiple suppliers makes my head spin.  Clearly, deal-making in emerging markets can be complicated (see the recent product and tech transfer agreement between Protalix and the Brazilian Ministry of Health, Protalix press release), so I look forward to Epirus’s first deal.

Epirus and other companies with a non-major market generics/biosimilars strategy would benefit from a harmonized approval system.  Currently the default is that most countries accept data accepted by the regulatory authorities of the US (the FDA) or the EU (EMA), but this default has limited the access to existing and new medicines in under-resourced countries (see my post, “Bottleneckrophobia”).  My suggestion was to build up the WHO’s Prequalification of Medicines Programme (PQP) into an approval agency specific for non-major markets.  Begun in 2001, the program reviews medicines for treating HIV/AIDS, tuberculosis, malaria, and more recently for reproductive health for eligibility for purchase by international procurement agencies like UNICEF.  These purchases are made by the countries of need, are often subsidized by donors (governments and foundations), and run into billions of dollars per year (PQP Fact Sheet).  Although the PQP has approved 240 products, it is slow (a two-year average for approvals) and only evaluates generic drugs which there are substantial data and sometimes US/EU approval on the original product.  Using the PQP or an improved version is probably not on Epirus’s radar but then its radar has lots of blips on it already.

Have a safe Fourth.

Start Up Mode

Networking is well known as a powerful tool to start up a new endeavor (like a new company or career) because it is a low-cost way to connect individual sellers (of a new product or new me) to the potential buyers (like investors or employers).  While in-person glad-handing/smoozing is the traditional and probably most effective way to network, the internet is ideal for networking across space and time, and sites that provide a platform for networking in global health have sprouted like weeds over the past years.  I‘ve written about some of these sites aimed at networking between companies that are developing products and services for global health (my postings of March 4 and April 8, 2010).  Here’s a quick update on three that I mentioned:

-Global Health Accelerator:  a program proposed by Singer et al. at the McLaughlin-Rotman Centre for Global Health in early 2010 and apparently is still not funded (MRC press release);

-Global Health Connect:  a new effort by BioVentures for Global Health (BVGH), “created to link biopharmaceutical research and development experts with product development partnerships, academic and government research organizations, NGOs, and developing country researchers with disease-specific clinical and scientific knowledge,” is up on the web (GHC), but does not seem to be functioning and is difficult to find since it does not have a link on the BVGH website; and

-Innovation Bridge: a site to provide technical expertise to developing world vaccine manufacturers, based at the University of Michigan is now not supported due to lack of funding (Innovation Bridge) but should not to be confused with the Developing World Vaccine Manufacturers Network which is a trade group and very active (DWVMN).

There’s also my idea for connecting companies to pro bono product and business development expertise (Peloton Partnering, my posting of December 3, 2009) that has gone nowhere due to competing interests.  So, given my enthusiasm for the application of the networking concept to global health, I jumped at a recent opportunity to become involved in an effort to facilitate the start and growth of developing world ventures utilizing the resources of one of our hometown academic powerhouses, Boston University.  The initiative, called Global Accelerators for Technology Entrepreneurs (GATE), is based in the university’s Office for Technology Development (OTD, their tech transfer office) which is headed Vinit Nijhawan, who was recruited as managing director in early 2008.  Vinit has deep experience in entrepreneurship and a strong interest in the role of business in world betterment (c.f. his comments on competing in emerging markets to the Wall Street Journal, WSJ citation) and is a key backer of GATE.  Other key university participants are Sean Lee, an OTD BD director, Beverly Brown, director of development for BU’s Center for Global Health and Development, and Paul McManus, director of BU’s Institute for Technology Entrepreneurship and Commercialization.  GATE is clearly in startup mode; it has a website  (GATE) and a blog (GATE blog), but both have little content.   GATE’s headline statement, which, in my humble opinion, needs some reworking, is “Accelerating the Future.  GATE is a collaboration of individuals pushing for technology commercialization from the developing world up rather than the developed world down.”

I became involved last month through a workshop at which the OTD solicited ideas and support from members of Boston’s academic, professional, and amateur (me) entrepreneurial community.  From my view, lots of good ideas were generated and participants were inspired; now the challenge is to vet, incorporate, and implement those ideas and to utilize energy and talent of those willing to help.  Based on what I have learned about new ventures over the past three years, I offer several pieces of advice:

-keep a low profile until the program is well-defined, -supported, and -staffed since missteps early on are amplified and hard to reverse (startups call it being in stealth mode) where

-well-defined means a clear and understandable mission statement, identified target customer (user), and product/service offering that is unique

-well-supported means having an approved university budget, and a plan for start up and long term funding (preferably not grants); and

-well-staffed means that, since start ups need constant attention, someone is working full time, paid or unpaid, to coordinate all the players for whom GATE is a 10% activity;

-test market services in a way that generates actionable information; and

-chose a board of advisers based on the expertise and enthusiasm they bring to GATE rather than their titles or past positions.

It also makes sense to look at comparable efforts (i.e., organizations that are also promoting technology-based entrepreneurship in the developing world) to learn from their experiences and to understand their potential as competition or collaborators.  I found the following organizations of interest:

-Venture Capital for Africa:  “VC4Africa aims to connect innovative entrepreneurs (and their ideas) with access to knowledge, markets and capital i.e. mentors, business partners and investors” (VC4Africa); has impressive linkage to groups of in-country entrepreneurs;

-Recognition and Mentoring Program (RAMP):  is a Lemelson Foundation program started in 2004 “to help entrepreneurs establish viable, replicable and scalable enterprises based on locally-developed technologies and entrepreneurial efforts” (RAMP);

-TechnoServe:  supports developing world businesses (primarily non-technology-based) with funding and advice since 1968 (TechnoServe);

-Appropriate Infrastructure Development Group:  is similar to TechnoServe with a focus on businesses that provide basic services such as electricity, sanitation, and clean drinking water (AIDG); and

– New Economy Venture Accelerator (NEVA):  is a new Colorado State University effort to incubate student-originated businesses aimed at developing world markets (NEVA).

I’m sure this list is not exhaustive, but it reminds me of another bit of advice:  to be successful GATE needs to provide a needed product at an affordable price in a way that can be sustained over time.

Beached

August has the reputation for being a slow month but with many of us squeezing in a vacation or in back-to-school mode it is more a matter of relativity.   Here in Beantown, the rental vans and cars with out-of-state plates clog the streets near the colleges, but at least the SUVs ferrying kids three blocks to the neighborhood schools aren’t out yet.  Since it’s likely no one is checking my blog right now, I’m taking a break by following up on some earlier postings, like hauling my boat onto the beach for repair.

In one of my first posting last September, I wrote about BIO Ventures for Global Health, the organization funded largely by the BIO, an industry trade group, and the Gates Foundation, which has the goal of “working to engage companies to drive partnerships and invest in global health initiatives to save lives in poor countries” (BVGH).  In that posting, I advised BVGH to focus on providing companies of all sizes rationales and resources for developing new or adapting existing products to non-US and EU (ROW) markets and offered four specific actions.  It looks to me they headed in another direction.  Their mission statement is weak and uninformative, they redesigned their website to emphasize individual donations and added pictures of crying or smiling kids (reminding me of the character on the Simpsons who is always saying “what about the children?”), their resource list though good has not been updated in two years, there’s been no progress on their “Global Health Connect” plan other than hiring a VP for it, and they moved their staff from a good place to influence the US government policy to a sunnier clime, San Francisco (BVGH PR).  While I applaud BVGH for taking a lead role in administering the IP pool (announced in January 2010) started by GlaxoSmithKline (my posting of October 5, 2009) (although I haven’t tried to use it so can’t speak to its utility), I think they are struggling to find their way.

In December 2009, I wrote about a plan first proposed in 2008 to fund and manage the development of treatments for neglected diseases called the Fund for R&D in Neglected Diseases (FRIND) (Global Health Update) and offered a much lower cost, less bureaucratic complementary plan called Peloton Partnering.   Peloton will be (if I get my act together) a web-based community of life sciences industry professionals who will contribute their product development expertise (e.g., design and execution of POC experiments, ADME/tox, clinical trials, business development) to any enterprise developing global health products, a way for facilitating “know-how” transfer in development and commercialization.  FRIND is in its third year of planning (Novartis PR) and given the many big budget programs competing for the few billions of dollars in grant and government aid, I don’t think it will get out of the planning stage.  Although my funding is all from my own pocket and I have made some progress in implementing Peloton (securing domain names and on-line submission space), I also have no launch date in sight.  Clearly though, the idea of utilizing biotech/pharma expertise better in global health is an idea worth pursuing.  As I have noted, BVGH is working on its Global Health Connect, and it is part of Frew et al.’s “Business Plan to Help the Global South” (Health Affairs, 2009; 28:1760–73).  And in 2005, the “non-profit pharmaceutical company,” Institute for OneWorld Health, received a $1 million grant to foster such collaborations but apparently with no result (IOWH PR).

In March 2010, I wrote about the idea of applying the techniques of “accelerated proof-of-concept” testing to lower the cost of and speed the development of treatments for neglected diseases.  This theme is one of several that make up the idea of open source innovation which is the idea of collaborators in not-for and for-profits sharing data and resources, including intellectual property, at no cost, although who has the leadership of a project and sponsors the commercialization of the results is not clear.  I noted one leader in providing web-based aggregation and analysis tools for medicinal chemistry (a key step in finding a drug) was Collaborative Drug Discovery (CDD), a California-based for-profit.  In May, CDD, GSK, the European Bioinformatics Institute, and the U.S. National Library of Medicine announced that they were working to together to connect structure-activity data on drug candidates for treating malaria generated by GSK with published information and make it analyzable with CDD’s tools (CDD PR).  Going forward, researchers, in addition to using the data, will be able to contribute their data to a public archive for use by others at no cost (except to the researchers’ tech transfer offices which will need to understand what is being released in the event they plan to claim IP rights).  Rightly described as a “new era in pubic-private collaboration in drug research,” the resource (which needs a snappy name) will be a model in open source drug discovery and, if successful, will multiple the number of lead compounds for malaria, with the next question being who/how will the results be further developed.  Another note for those interested in the resource and CDD’s tools, CDD is sponsoring its fourth annual Collaborative Drug Discovery meeting at UCSF on October 21.  The meeting has a great line up of speakers and no charge (Registration).

In May of this year, I wrote about my concern that the not-for-profit approach to commercializing (that, is actually getting products distributed and used) had few examples of success.  Further I noted that the how, who, and what of global health product commercialization is under development and, therefore, is ripe for innovation of its own, that is, from the for-profit view point, new business models are needed.  Last week, one of our local on-line and print organs of high-tech news, Mass High Tech, had articles on the challenges of finding those models.  In one, some nay-sayers and maybe-sayers are quoted and the founder of Seeding Labs, which recycles lab equipment to developing countries, is interviewed (“Life Science Firms”).  The second is an interview with the founder and the CEO of Diagnostics for All, a grant-funded diagnostics company with plans to parlay its IP into low-cost products for all markets (“Whitesides and Ryan”) (Potential COI notice:  I am an unpaid adviser to DFA).  I thought both articles and the accompanying editorial could have benefited from better preparation by the reporters who seemed to assume that the idea of creating affordable products for under-served markets was untenable (it’s not).  Anyway, hats off to MHT for covering this topic and I hope they continue to do so.

Back to my scraping.