BVGH: RIP or Reboot?

Recently, I heard from a colleague that last November BIO Ventures for Global Health (BVGH) released most its employees and essentially ceased operations.  Checking the website for validation, I found two managers listed and no news or blog postings since August 2012 (BVGH).  Well-known in the global health sector, BVGH is/was a San Francisco-based organization that was founded in 2004 with the mission “to engage companies to drive partnerships and invest in global health initiatives that result in the new drugs, vaccines, and diagnostics that will save lives in poor countries.”  BVGH was primarily funded by grants (mostly from Gates, Rockefeller, and the bioindustry trade organization, BIO), so I assume the proximal cause of its demise (or substantial reduction in operations, your pick) was non-renewal of its grants, but I also think it had deeper problems.  While BVGH succeeded in increasing visibility for the role of biotech innovation in global health and in generating a several useful tools, it suffered from not having a clear understanding of its client base, a too diffuse mission, and poor operational execution.

Way back in 2004, BVGH was one inspiration for my interest in global health.  I was peripherally involved with the organization then as a volunteer member of a “Technical Advisory Group” tasked with selecting a contractor to write a business case for new product opportunities in malaria.  That project did not come off and, although I did a few bits of volunteer work afterward, I never ascended to the inner circle of advisers and only followed progress from afar.  As regular readers know, BVGH has been one of my favored topics for posts and I often offered prescriptions for improvement.  To test the power of my foresight with the 20/20 vision of hindsight, here is a retrospective of my advice.

In one of the earliest posts I wrote in September 2009 (“BVGH at a Critical Juncture”), I noted the departure of the founding director and suggested four projects for the new director to purse to better serve the organization’s designated clients, biotechnology companies.  These were:

  • advocating for an SBIR program specific to the development of products for neglected disease;
  • pushing for a change in the R and D tax credit program to favor R and D for neglected diseases;
  • working with the not-for-profit product development partnerships (PDPs) to offer a resource database for companies seeking drug development guidance especially in the design, funding, and initiation of clinical trials; and
  • improving its partnering conferences by bringing in potential investors in global health, e.g., “social impact” funds, to attract  companies needing investment.  Not surprising, none were tried by BVGH.

In “Beached” in August 2010, I wrote that BVGH was headed in a direction away from it client base of biotech companies and that was not a good sign.  I criticized their mission statement as weak and uninformative, the redesigned website as emphasizing individual donations and using pictures of crying or smiling kids, and their resource list as not being updated in two years.  I noted a lack of progress on their “Global Health Connect” plan and their move their from a good place to influence US government policy (DC) to a sunnier clime (San Francisco), and, while applauding their lead role in administering the IP pool started by GlaxoSmithKline (later to become part of Re:Search, see below), wrote the organization seemed to be struggling to find its way.

In “Nuts and Bolts” (May 2011), I reported on my participation in the second BVGH-organized “Partnering Forum for Global Health”, this one in conjunction with the annual BIO meeting.  I noted several ways to improve the event:

  • include speakers with practical experience in getting products on the market;
  • make the breakout sessions more interactive by giving the panelists’ presentations to attendees in advance to generate questions, discussion, and action items;
  • track participants and outcomes to demonstrate the value of participating;
  • invite specific participants who may have deals to pitch or those needing deals; and
  • engage participants with the attendees of the more mainstream BIO conference, e.g., by including special session titled “how to sell your idea for a global health product” in which attendees go into the exhibit hall to pitch their ideas and share what they learned from the many attendees who are there to find money and deals to make or keep their companies profitable.  This Forum was also the last.

In “Window Dressing”  (November 2011), I criticized BVGH for diverting its attention from advocating for the biotech industry and its involvement in global health to managing a United Nations-backed patent and research database called Re:Search.  I wrote that I thought the program had several fatal flaws, like limiting sales of resulting products to the most unprofitable markets and providing no uniform license format.  I concluded that Re:Search was a nice start, but without commitment of all the needed information, technical expertise, and funding and an orientation toward commercialization, it will be pretty useless in generating innovations for global health (for the program’s current status see Re:Search press room).

In my post in April 2012, “BD Needy”, I criticized BVGH’s lack of business orientation as illustrated by one of its primary offerings, the Global Health Primer, a database of global health R and D programs at PDPs, universities, and companies (last fall BVGH transferred the management of the Primer to Emory University [GH Primer]).  I wrote that while the Primer is a good first step in that it provides information, it is passive and marginally helpful to companies wanting to enter or build their global health businesses.  I recommended that BVGH provide tools and information more useful in business development; for example, for each project, BVGH should report the quality of participation (e.g., funds, personnel) of each partner and which party was the originator so one can follow the money and figure out who is funding what.  BVGH could find and list technologies relevant to global health products that are available for companies to license from academic and research institutions and opportunities for PDPs to work with biotech companies as partners rather than contractors.  It could also report on which major pharma companies have experience in developing and commercializing which products, which developing world companies are seeking biotech partners, and, most importantly, identify whom to contact.  I concluded that building relationships and developing business takes time, planning, research, analysis, and dedicated people, and, after eight years, it was time for BVGH to undertake more proactive business development effort for itself and its customers.

Alas, in my most recent post on BVGH last November (“Downsize or Down Hill?”), I reported on its reorganization, loss of funding, and shift of focus from projects like its reports (see my positive review of BVGH Case Studies in the post, “Converting Inspiration to Investment”) and the Primer to managing Re:Search.  I offered several ideas for BVGH to improve its finances and reorient its efforts, suggesting that BVGH could reduce its operating expenses by finding a less expensive office location than San Francisco and paying its executives more modestly (the 2010 BVGH Form 990 has the top four managers’ compensation plus outside consultants expenses at $1.4 million or about 50% of all expenses [BVGH 2010 Form 990]).  To increase its income, in addition to passing the hat among the usual donors for its new projects (below), I wrote BVGH could get a revenue stream by starting a low-cost consortium with fees based on company size with the product offering being networking opportunities and by providing custom consulting and report writing by using volunteer consultants to keep operational costs low (at one time, BVGH solicited volunteers on its website but I never got a response to my offers).

As for short-term, low-cost, client base-building projects, I suggested BVGH:

  • build a value proposition and pitch deck for global health R and D and use it at any and all venues including going on the road to the mid-sized biotechs and pharmas who may find a small market products (under $100 million) attractive;
  • create a newsletter specifically aimed at companies with interest in markets in ROW and ROW companies interested in new product opportunities;
  • attend and represent the interests of US-based biotech companies at international business meetings;
  • assemble a database of low-cost resources to help biotechs with their preclinical work;
  • run a business development plan competition for companies with products in development needing partners to gain visibility and engage potential partners; and
  • find sponsors for and conduct a global health venture accelerator ala MassChallenge (MC).

While this post may turn out to be like Samuel Clemens’s comment that reports of his death were greatly exaggerated, I hope the BVGH advisory board retools the organization and relaunches it.  Sometimes rebooting works.  BVGH’s basic premise is sound and its successful execution is very much needed.

Downsize or Downhill?

Last week, I noted with some dismay a press release by BIO Ventures for Global Health (BVGH), one of the few organizations advocating for greater participation by the biotech/pharma industry in developing new products for global health.  The release (BVGH PR) announced the transfer of the management of BVGH’s Global Health Primer, an on-line catalog of products and companies engaged in global health (Primer), to the Emory University Institute for Drug Development.  While the transfer is not particularly disconcerting, the reasons given in the release for it are.  Don Joseph, whom I have met in his capacity of BVGH CEO, said the transfer was “[d]ue to funding cuts which affected our ability to update and expand the Primer,” apparently the cuts being a loss of Gates Foundation funding (i.e., “Finally, I want to thank the Gates Foundation for their support over the past several years, …”).  The next paragraphs imply that BVGH is downsizing, reorging, and re-focusing in response to the diminished funding.  Don will “transition out” of his CEO spot and into the chair of the BVGH board, the CEO position will be eliminated, and Jennifer Dent, Vice President, Commercialization and Alliance Management, will become president.  Finally, “Going forward, BVGH will focus its efforts on WIPO Re:Search….”  Big sigh.  As some may remember, I wrote about WIPO (World Intellectual Property Office) Re:Search when it was launched in November 2011 and thought it not particularly useful in advancing global health product innovation and not a good fit with BVGH’s mission (“Window Dressing”).  Re:Search allows “qualified” researchers to view and use data and patents donated by the inventor companies for neglected disease product development (Re:Search), a good idea as far as it goes.  But all product development requires funding, and recently, I found very modest progress reported at the Re:Search website and no report of new money committed to product development projects by the participants (November 2012 Snapshot).

This more passive, less proactive tack by BVGH was also reflected in a recent report the organization wrote with one of its sponsors, the Bioindustry Organization (BIO):  “Biotechnology:  Bringing Innovation to Neglected Disease Research and Development” (BVGH/BIO report).  Although in the preface the authors stated the report offers “actionable information for product developers from academia, government agencies, biotechnology companies, and non-profit product development partnership (PDPs) to help spark new partnerships and collaborations with bio-technology innovators to drive new drugs, vaccines, and diagnostics” and “concrete recommendations to help biotechnology companies increase their commitment and investment in neglected disease R&D through partnering,”  I found it to be a restatement of existing ideas and, worse, provided no specific actions BVGH can or will take to “spark new partnerships and collaborations.”  My read is that BVGH’s actionable information and concrete recommendations were basically that interested parties should talk and collaborate more.

Earlier this year I wrote a post on why BVGH needed to undertake a serious business development effort with its potential customers, the estimated 97% of biotech companies that BVGH has reported are not engaged in global health product development, to sell them on the idea of entering the global health business.  Rather than building a database like the Primer to “track” product development and writing reports on summarizing the work of others, BVGH should generate information and tools to enable companies to find the funding and partners needed to build their global health businesses (“BD Needy”).  Specifically, I thought BVGH could:

  • find relevant technologies for companies to license from academic and research institutions;
  • point out opportunities for PDPs (the non-profit product development programs) to bring in biotech companies as partners rather than contractors;
  • for each project in the Primer, report the quality of participation (e.g., funds, personnel) of each partner and which party was the originator so one can follow the money and figure out who is funding what (a challenge); and
  • report on which major pharma companies have experience in developing and commercializing which products and which developing world/emerging market companies are seeking biotech partners and, most importantly, identify whom to contact.

While I am at it, here are a few more ideas for BVGH:

  • build a pitch deck and use it at any and all venues including going on the road to the mid-sized biotechs and pharmas who may find a small market products (under $100 million) attractive;
  • create a newsletter specifically aimed at companies with interest in markets in ROW and ROW companies interested in new product opportunities;
  • represent the interests of US-based biotech companies at international business meetings that may be unaffordable, e.g., the World Vaccine Congress Asia (WVCA 2013), Medifest (Medifest), and MedExpo (MedExpo);
  • assemble a database of low-cost resources to help biotechs with their preclinical work, e.g., the PATH Point-of-Care Diagnostics Center, (PATH POC) and the NIAID Translational Research Resources (NIAID  resources);
  • run a “business development plan competition” for companies with products in development needing partners to gain visibility and engage potential partners; and
  • run more interactive and practical Partnering for Global Health Forums with more company people (see my post, “Nuts and Bolts”).

If funding is the problems, in addition to passing the hat among the usual donors (Gates, Rockefeller, BIO), BVGH could get a revenue stream by:

  • starting a low-cost consortium with fees based on company size with the product being networking opportunities; and
  • offering custom consulting and report writing but keep operational costs low by using volunteer consultants (I remember BVGH did this when it first started since I was on an ad hoc committee on business models).

BVGH could also reduce its operating expenses, for example, by finding a less expensive office location than San Francisco or paying its executives more modestly (the BVGH Form 990 for 2010 has the top four managers’ compensation plus outside consultants expenses at $1.4 million or about 50% of all expenses [BVGH 2010 Form 990]).

But then I may be too late.  Have a Happy Thanksgiving.

See Change

The 15,000-plus presenters, exhibitors, politicos, scientists, execs, salespeople, and hangers-on who attended last week’s Bio Industry Organization’s (BIO) 2012 International Convention here in Boston have all returned to their regular jobs and I am back to scribbling this week’s post at the last minute.  The BIO convention (as is the nature of conventions) is all about selling products, making the connections that will lead to sales, and learning where the next sales may be made, so most BIO 2012 attendees were focused on the serving the health needs of those with high incomes, but this year I noted some change in the sea of selling.  By my casual survey of session descriptions and attendance and conversations with attendees and exhibitors, more interest was shown in opportunities outside the major markets than in the half-dozen conventions I have attended before.  Moreover, I noted investment analysts, execs, venture capitalists, reporters, and scientists (who invent and make products), not only non-profit types, participating the out-of-the-main-channel sessions.

Here’s a recap of the sessions I noted, seven of which I was able to attend:

  • Driving Innovation in Global Health:  Why Biotechnology is Key-  I did not attend this press briefing by BIO Ventures for Global Health (BVGH), the advocacy organization partly backed by BIO itself, at which the group brought attention to its finding that 40% of small-medium biotech companies are conducting some type of global health product development (I reviewed this report in my post, “BD Needy”).  I hope they got good attendance.
  • A Practical Guide to Global Health:  Shared Experiences from Biotech Companies on Making Global Health Work for You-  I commented on this session, also organized by BVGH, in last week’s post and add that the “shared experiences” were fine but a “practical guide” it was not (but I hope one is in the works).
  • Global Biotechnology Forum:  The BRICS and Beyond-  another session I missed but its theme was how governments in emerging market countries are supporting biotech companies (including funding) to address pressing health needs, and attendance list was more than 50 persons.
  • Exploring Innovative Models for Investment in Global Health:  A Discussion about Unique Partnerships in Working Towards Solutions for Global Health-  I’m sorry I missed this session since it explored “the various models available for engagement with these funding groups [venture capitalists, governments, non-governmental organizations, and companies] in the development of vaccines, therapeutics, and diagnostics and how companies are working across these funders to develop new models for investment in global health.”  About 50 people had signaled an interest in attending.
  • Vaccines Beyond 2012:  Sustainable Business Solutions to Accelerate Global Access- as I noted in my comments in last week’s post (“BIO Bits”), Sanofi’s commitment to global health and pediatric vaccines was evident at this session which had about 40 attendees including those from major (e.g., Merck) and biotech companies (e.g., Novadigm).
  • Increasing Cancer Drug Availability in Resource-Limited Settings:  Models for the Future-   as I noted last week, the situation is dire and requires innovation in funding and distribution, not so much new drugs (which compose the major of drugs being developed by the US pharma/biotech industry).
  • Leveraging New Development Paradigms to Address Infectious Diseases in the 21st Century-  this session (another I missed) addressed the need for new vaccines that can be made quickly (and cheaply) against agents with multiple variants.
  • Traditional Manufacturers Beware: How Disposable Technology is Changing the Biomanufacturing World-  this session spoke to the shift of the biomanufacturing industry (makers of vaccines and biological drugs) away from large volume, high capital factories to small volume, regional, and flexible (able to make many products) plants.  As I have written in several earlier posts (e.g., “More Grease on the COGs”), this trend is important in lowering the cost of products as well as addressing the public health needs of developing countries.  In a side conversation with a rep from Xcellerex, a disposable technology company recently purchased by GE Health, I learned their sales team has made and is making sales calls all over the world.
  • Innovative Approaches to Financing R&D for Global Health-  as noted last week, I had hoped to learn more about the Gates Foundation’s program-related investment program, now funded to more than $1 billion (to used for all the Foundation’s interests including global health), but was disappointed.  The program could be structured like an investment firm, doing due diligence, making significant inputs, gaining board seats, and in general being more proactive in starting up global health companies.  Perhaps the other 30 or so attendees learned more than I.
  • Biologics and Biosimilars in Latin America:  Are New Regulations and Guidelines in Brazil, Mexico and Argentina a New Model for Drug Regulation?:  biosimilars is a hot button issue for the industry since the established players want to limit competition (e.g., Amgen has a Director of Brand Protection) and the emerging biotech industry wants a piece of the action (and governments want cheaper drugs).  I assume (wasn’t there) the new regulatory policies spell out what level of proof is needed for establishing “similarity,” likely including some number of trials and manufacturing process approval, but not as high a barrier as that recently set by the USFDA.
  • Emerging Markets Become Strategic Markets:  Biotechs Looking Internationally for R&D, Manufacturing, and Market Opportunities-  another session I missed and based on my review of the almost 100 prospective attendees, there was a lot of interest among reps from companies in the mid-income emerging market countries like Russia and Brazil as well as US and EU companies looking to sell into these markets.
  • Building the Global Pathway for Product Safety and Quality Manufacturing of Biologics and Drugs- I attended this session because of the importance to companies that want to sell products outside their home country.  The session turned out to be quite technical but I came away with an appreciation of the complexity of the global supply chain for drug manufacture (80% of the drug ingredients for US drugs come from outside the US) and the need for better and more universal standards and inspections.  FDA, multinational pharma companies, and a logistics trade group (Bio Supply Management Alliance) are working on this but have a long way to go.
  • Thinking Outside the Box:  A New IP-Sharing Model Brings Biopharma, Government Agencies, and Non-Profits Together to Accelerate R&D Collaborations for Neglected Tropical Diseases-   the new sharing model was the BVGH-managed Re:Search database and partnering “hub” on which I have written previously (“Window Dressing”).  I garnered some new information on Re:Search, e.g., no announced partnerships have yet resulted but 15 are in discussion.  I also learned that a relatively new product development program (PDP), the Center for World Health and Medicine at St. Louis University, was making progress in new therapies for neglected diseases (and rare diseases) but is approaching a funding crunch.

Do fourteen sessions (including mine) on neglected diseases, emerging and public markets, and low-margin products out of 125 offered at BIO 2012 and several hundred attendees out of 15,000 indicate a sea change in the biotech/pharma industry?  No.  But the trend is in the right direction.

BIO Bits

I am abbreviating this week’s post since I’ve been busy attending BIO’s International Convention.  This annual confab is held in Boston every third year and last fall I was fortunate to have my proposal for a panel session on “Accelerating Access to Pubic Sector Markets” accepted by the program reviewers.  Also fortunately, I was able to garner the participation of a crackerjack panel (Una Ryan, CEO, Diagnostics for All; Inder Singh, former Executive Vice President, Clinton Health Access Initiative and now CEO Transform Health; Eric Olson, Cystic Fibrosis Franchise Lead, Vertex; Michael Watson, VP Vaccination Policy and Advocacy, Sanofi Pasteur; Ellen Strahlman, Senior VP and Global Head, Neglected Tropical Diseases, GlaxoSmithKline) that provided expert and useful insight to the Monday session attendees, who numbered about 15.  So as a substitute for my usual rambling, here is a selection of interesting bits I gleaned from the biofest, starting with my panel.

Accelerating Access:  during the Q and A, Don Joseph, CEO of BIO Ventures for Global Health, asked the panelists what is needed to get companies involved in global health product development, and the “wish list” was:

-more information on country-specific disease burdens to better gauge demand and reduce uncertainty;

-more information on disease pathologies, mechanisms, and targets;

-global harmonization of trade rules and regulation;

-government intervention to minimize middleman markups that make drugs expensive; and

-SBIR set asides for global health product companies.

A Practical Guide to Global Health:  while PDPs are doing a good job of getting product candidates into human testing, they expect a “hand off” to big pharma but are doing little if anything to make it happen, resulting in a “last mile” problem, that is, products may not reach patients.  My naïve idea is that they need to do more business development before and during trials to identify partners.

Palm PCR:  of course everyone knows that PCR (polymerase chain reaction) technology is used to increase the number of copies of a DNA molecule in the first step in reading its sequence of bases and therefore making it possible to tell if a DNA sample is from a pollywog or a psychotic killer.  I knew PCR machines were getting smaller but my jaw dropped when I saw the Palm PCR at the exhibit hall booth of Ahram Biosystems of Korea which, as names implies, is a hand-held DNA amplifier (Palm PCR).  It is fast (30 minutes for 1000 bases), reasonably priced at $3000 to $6000, and come in bright colors.  Now we need a palm sequencer so that scientists in the field like epidemiologists (and CSI) can tell really fast what animal, plant, or bug they’ve sampled.

Sustainable Vaccine Business Solutions:  Sanofi is serious about vaccines for global health.  In addition to a pipeline of about 16 vaccines, half of which intended to meet developing world needs (e.g., the soon-to-launch dengue vaccine and a TB vax in collaboration with the Statens Serum Institute), the company has some type of partnership with ten or so regional manufacturers and so will be in position to make and distribute vaccines at the lowest cost.

Cancer Drug Access:  I have written about the recent shortages of mainstay cancer drugs in the US (“Drug Bust”, 9/29/11) and learned at this session that the rest-of-world (ROW) situation is much worse- shortages, poor quality, and high prices.  The sad news is that the problem is complicated by weak health care systems and the lack of government support for cancer care (e.g., the most used ROW cancer drug is morphine for palliative care).  The less sad news is that, due to the low labor costs, some patients can be treated and cured at a fraction of the US cost (e.g., $100 to cure a case of cervical cancer).  Overall, a tough problem with few advocates.

Innovative Financing for Global Heath R and D (or PRIs Revealed):  as acknowledged by one panel member, David Farnum, the PRI (program-related investment) officer of the Bill and Melinda Gates Foundation (BMGF), the financing presented was not really innovative, just new to the BMGF.  I had hoped to learn more about the BMGF’s PRI program, specifically the rationale behind the investment of $10 million in Liquidia, a company with a “nanotechnology” platform and no global health focus.  Unfortunately the concerns I wrote about in a post last year (“BMGF Ventures LLP”, 4/14/11) were confirmed.  David described the three-year-old, $400 million PRI fund as “experimental,” and it looked like an uncontrolled experiment to me.  To date investments had been made almost randomly with unspecified amounts given to start-ups like Liquidia (others were not named but David said “a couple more are in the pipeline”) and into investment funds that somehow, somewhere seem to do something in global health (specifics were lacking).  The good news is that the experiment has been judged a success and the BMGF is assigning $1 billion to PRIs; the bad news is that there is no application or submission process so it looks like the PRI group will operate like the rest of BMGF- giving big chunks of money to insiders without established investment criteria or performance expectations.  Neal Fowler, Liquidia’s CEO, gave a few details of their deal:  it started by a chance meeting, BMGF got a board observer seat (not voting like the rest of the company’s investors), and the BMGF has been a great partner, which I took to mean undemanding of progress on global health products.  Neal mentioned the company is working on applying their technology to a pneumo vaccine, but did not give any details.  The company website refers to completion of a Phase 1/2a trial (Liquidia Vaccines) but not to published results.

Top O’ the Hub with Samsung Biologics:  the company held a nice reception at this landmark restaurant which, at 50 stories up in the Pru building, has great views of Boston and surrounds.  I enjoyed the food and drink and a conversation with one of their BD people who declined to confirm a plan I had suggested in a recent post, to sell very low cost biological drugs to the developing world (“Discount Drugs”, 5/24/12).  My suggestion to acquire new and possibly cost-saving technologies from academics was better accepted, and I wished them well in becoming the Wal-Mart of biosimilars.

Another half day at BIO today (Thursday) and if I hear any earth-shaking news, I’ll write about it.

BD Needy

BIO Ventures for Global Health (BVGH), an advocacy group now based in San Francisco, issued a report last week, “Developing New Drugs and Vaccine for Neglected Diseases of the Poor:  The Product Developer Landscape” (BVGH report).  As I have noted in previous posts on BVGH, I’m enthusiastic about the organization’s mission- to encourage the biotech industry to address the unmet medical needs of the developing world- but have been disappointed in its execution.  In one of my early posts, I praised a BVGH case studies report as a good start in highlighting partnering opportunities in global health (“Converting Inspiration to Investment” 9/27/09) and have appreciated its sponsorship of past Partnering for Global Health meetings, but more recently posited that the group’s involvement in the World Intellectual Property Organization’s Re:Search database was not a productive use of its resources (“Window Dressing” 11/3/11).  The aim of this recent report is to provide an overview of products being developed and is based on information in BVGH’s searchable database, the Global Health Primer (Primer), specifically, the Primer’s disease-specific Pipeline listings which identify products and developers (but, I note, is not business development-friendly because it lacks links to the listings’ sources and company contacts).  My major beef with the report though, is that, while it provides several novel insights into the complicated world of biotech/pharma product development, it seems aimed at providing advice to government and foundation policy-makers, not to company executives or investors, and therefore is not helpful in building global health business.

To their credit, the report authors are thorough in covering many aspects of the topic.  The report parameters include the full range of global health diseases (the “big three” of HIV, tuberculosis, and malaria; the neglected diseases; and “other” diseases of poverty), drugs and vaccines in development (except for drugs to treat HIV), developers by country and type (academia, product development programs [PDPs], biotech and big pharma companies), and degree of collaboration as measured by number of partners in each project.   This last parameter is an important one but hard to pin down, as the authors note, since they could not determine the quality of participation (e.g., funds, personnel) of each partner in a given project and which party was the originator so one cannot follow the money and figure out who is funding what and why.  The report’s findings I thought notable are:

-Academic/research institutions are have some role (as originators, co-equal partners, contractors?) in almost half of the products under development;

-An institution’s primary partners is a PDP and secondarily is either a biotech company or “other” institution (not sure what the latter is);

-PDPs partner extensively, but mostly with academic institution (>50% of their partners) and less so with biotech (34%) and big pharma (20%) companies;

-Only a small percent of all biotech companies are involved in global health product development (3% or 104 out of 3853) (looks to me as if BVGH needs to do more business development);

-Biotech companies often go without partnering (about 40% of their projects) and don’t spend much, only about $600K each (the authors used data from the G Finder report [G Finder 2010]), but importantly focus their efforts on the preclinical stage, an important link between inventors and clinical testing; and

-For the big pharmaceutical companies, the most involved were GlaxoSmithKline, Novartis, and Sanofi, accounting for 66% of the 64 products in development and, not surprisingly, they participated as partners primarily in the clinical testing stages.

While the report’s authors acknowledged that their analysis of the financial and quality character of the partnerships (pages 38 and 40), they seem to miss the primary potential utility of a report of this type and the Global Health Primer.  Rather than using these tools to “track” and report, BVGH should be generating information and tools to enable companies to build their global health business.  It could point out what are the opportunities for companies to license from academic and research institutions and for PDPs to bring in biotech companies as partners rather than contractors.  BVGH could report on which major pharma companies have experience in developing and commercializing which products, which developing world companies are seeking biotech partners, and most importantly, identifying whom to contact.  Building relationships and developing business takes time, planning, research, analysis, and dedicated people, and, in the case of the global health business, lots of pushing.  Now in its eighth year, it is time for BVGH to do less pontificating and more pushing.

Window Dressing

Last week on October 26, a new organization was launched that will accelerate the development of new treatments for global health, or so it was said.  With much fanfare (and a webcast), WIPO, the World Intellectual Property Organization (WIPO), one of the 16 specialized agencies of the United Nations (whose hyperbolic tagline is “Encouraging Creativity and Innovation”), BIOVentures for Global Health (BVGH), other prominent organizations, universities, and pharma companies launched a “consortium” called Re:Search (BVGH press release).  As I understand it, Re:Search is not the kind of consortium whose members combine money, personnel, and effort toward a common goal, but is a “voluntary endeavor” to “to encourage and support research and development of Products [sic] for NTDs [neglected tropical diseases]” (Guiding Principles).  While Re:Search will include, at some point, a Partnership Hub and Supporting Activities (details not given), the only function up and running is a searchable database of “available intellectual property [IP] assets, information, and resources” provided by the pharma companies, NIH, and others.  The idea is that academic researchers and companies will license the big pharma leftovers and, my assumption, use them to write publications (academics) or develop global health products (companies).  As a few readers may remember, I have posted on a similar effort managed by BVGH, the Pool for Open Innovation Against Neglected Tropical Diseases (NTD Pool, NTD Pool) (“Checking the Pool’s Temperature,” 5/26/11) and on the NTD Pool’s predecessor, a database of 800 patents provided by GlaxoSmithKline (GSK) and Alnylam (“Swimming in the Patent Pool,” 10/5/10).

In my previous posts, I noted a number of problems that limited the pools’ usefulness and, after reading through the Re:Search site (Re:Search) found the same problems:

  • academic researchers don’t need licenses since no patent-owner will seek an injunction against research (bad publicity and a damage award would be zero);
  • although the licenses are to be royalty free, the rights are limited to the least developed countries (the LDCs are listed) and the “neglected tropical diseases” (NTDs also listed), tuberculosis, and malaria; hence  major opportunities, both in terms of public health and in making a profit, are excluded.  For examples, Chagas disease is a listed NTD but none of the countries where it is endemic except for Haiti are LDCs (Mexico, Central America, and South America have  8 to 11 million people infected, CDC Chagas).  Similarly, dengue is endemic in at least 100 countries in Asia, the Pacific, the Americas, Africa, and the Caribbean with 50 to 100 million infections yearly, mostly among children (CDC Dengue) and fewer than half are on the LDC list.  The Re:Search Guiding Principles acknowledge this problem and request that licensors “consider in good faith the issue of access to these products for all developing countries” (Guiding Principles), but good faith consideration only goes so far.  And the focus on NTDs ignores the fact that non-infectious disease (e.g., heart disease, diabetes, cancer) are major health burdens in the developing world;
  • licenses will be negotiated on a case-by-case basis, meaning lots of lawyers, time, and money will be required; and
  • there is no requirement to provide the stuff that is really needed for product development.  As stated in the Principles, “physical materials, regulatory data or know-how, including information relevant to manufacturing” are not necessarily available.  All assets are provided and licensed at the providers’ discretion.

I checked out the Re:Search database (Search) and found it pretty limited, containing a total 140 items, 63 of which are from companies and most of the rest from NIH.  Individual items have lots of data fields for useful information, but most fields are blank.  I looked at the Preclinical Candidates category, in which there are 16 entries, all from AstraZeneca (AZ) or Esai, and most are identified as potential inhibitors of noninfectious disease pathways, which is OK but not encouraging as starting points for NTD drugs.  In the Resources category, GSK and AZ are offering guest researcher positions at their facilities to guest researchers and funding for projects (GSK), but apparently these are not for people from companies.  I’m sure the intent is to add to the database, but right now it is slim pickins.

I also noted that it looks like BVGH scored some contractual money from WIPO since it will be the “Partnership Hub Administrator” and will be responsible for helping interested persons find “available licensing and research collaboration opportunities, networking possibilities, and funding options.”  I’m guessing this means BVGH will host more conferences with nice receptions, but since the orientation of Re:Search is research at non-profit institutions as opposed to product development by low/no-profit companies, I don’t see how it fits with BVGH’s mission “to engage companies to drive partnerships and invest in global health initiatives” since the “investment” by the big pharma providers is negligible and small companies and startups are not welcome.  I also noted that my alma mater, MIT, is involved in some way, but they are not listed as a provider, user, or supporter.  A collaborator without commitment or consequence?  As I have noted before, pools of IP available for licensing for global health product development are a nice start, but without commitment of all the needed information, technical expertise, and funding and an orientation toward commercialization, they are pretty useless.

Well, I hope all involved enjoyed their trips to Geneva last week.

USAID Rhetoric or Reality

I was not able to attend the Partnering for Global Health Forum on June 27, the third in a series organized by Bio Ventures for Global Health (BVGH) and held in conjunction with the big biotech-fest, BIO 2011, in Washington, DC.  The Forum has a laudable aim (“creating new market-based solutions that speed the development of drugs, vaccines, and diagnostics for the world’s poorest,” BVGH What We Do), but after attending previous two meetings,  I noted room for improvement (my postings of 5/6/10 and 5/11/11).  To catch up, I have been viewing the video archive of the meeting , thanks to BVGH ( PGH Webcast Recordings), and started with the pre-lunch remarks by Dr. Rajiv Shah, the relatively new administrator of the USAID,  due in part to the major role the USAID has in implementing the US global health-related projects (budgeted at about $10 billion in 2010-11), and in part because he seems like the right person given his background and statements, for example, to get the USAID “to focus our efforts on facilitating a continuum of invention and innovation from bench to bush” (Barmes Lecture 2011).

Last year in my posting of 4/1/10 (and reprise posting of 6/2/11), I reviewed a speech Dr. Shah gave at a Life Science Innovation meeting in which he implied that the USAID would be promoting innovation and global health product development.  I recommended the agency do so by putting out requests for proposals (RFPs) for applicants (especially companies) to develop and  deliver needed products with an attached advance purchase commitment, specifying desired performance, quantity and price.  In this way, the USAID, as a buyer of global health products, would create financial incentives, an attractive market for prospective suppliers.  So I was disappointed in his remarks at the Forum in that he was addressing an audience that included representatives of biotech, diagnostic, and medical device companies looking for funding or investment for global health products, but made no mention of the role of companies in his agency’s global health mission.  The closest he came was to say that the USAID wants to “build markets” and “accelerate the introduction of new technologies,” but was shy on specifics.

Dr. Shah did mention specifically one program sponsored by the USAID, Saving Lives at Birth:  A Grand Challenge for Development (SLB), which has as one of its three goals the promotion of the development of new technologies (the others are finding ”new approaches to provide high-quality care at the time of birth” and “empowering and engaging pregnant women and their families”).  Maternal health is a major need (and a Millennium Development Goal) and that need has inspired many new, but apparently mostly uncommercialized, technologies (e.g., there are about 120 listed in the Innovation Index maintained by the company, Maternova, MN Index).  So how does the SLB intend promote the invention of new technology or better yet apply those that exist?  Apparently, the most ineffective way:  a grants program that gives money away to those who have a good grant-writing staff.

The SLB has some good aspects:  a fast turn-around time between application and award (4-5 months), a substantial amount of money to work with ($16.25 million in 2011-12, USAID RFA), longer term commitment (5 years and a total of $50 million (SLB Press Release), and at least the intent to fund the commercialization (use) of products, i.e., projects involving the “transition to scale of integrated innovations” (SLB Grants).  Not-so-good aspects are:

  • three (rather than one) overarching goals;
  • five international sponsors who may not be on the same page all the time;
  • limits to the amounts awarded to “seed” project (no more than $250K) and “transition” projects ($2 million);
  • review of applications by staff unfamiliar with the innovation process (the reviewers are not identified);
  • no intent to encourage grantees to coordinate their projects, when justified; and
  • no statement about performance measurements (maybe this is in the application).

An alternative to the grant approach is the model adapted from the venture capital industry by venture acceleration “contests,” for example, the Mass Challenge (MC).  Applicants, typically young people who have caught the entrepreneurial bug, pitch their start-ups to a experienced and skeptical business-types with the awards being a mix of money, incubation space, coaching, and professional services.  Successful “pitchers” are those with unique ideas, a shot at customers (someone who thinks their product or service has value), and a realistic plan (time and money) for execution.  The aim is not necessarily to create new companies, although that does happen, but to invest in people who want to innovate, that is, create something that has value (products, services) from nothing.  Unfortunately, the cash involved is enough to give the venture founders some momentum but is not sufficient as seed capital.

If Dr. Shah really wants to figure out how to accelerate technology development for global health, he needs to hang out more with entrepreneurs and founders and mangers of small companies.  After his remarks, one questioner asked what his agency could do to bridge the valley of death- the critical period when a small company is trying to get sufficient proof of the value of their core technology and/or its first customers- and his response was that he was trying to make the USAID easier to work with and to increase “deal flow” which will help companies with products to sell but not those with products in development.  In his Barmes Lecture on Global Health earlier this year, Dr. Shah said:  “We will develop at USAID a center of excellence to accelerate product development and field introduction, bringing in industry experts and academic fellows to inform our thinking and investing seed capital in promising ideas wherever they’re found. … There’s been a huge amount of progress in the last decade in the knowledge of how to aggressively scale new interventions and technologies and we want to capture and harness that.  We will work with firms to make sure their biomedical products can reach the poorest people in the poorest countries. And we will leverage our commodity procurement systems to prioritize buying new technologies so that we can get volumes up and prices down in more creative and innovative ways.”  Got it; when?