Pictures at an Exhibition Take Two

In a post a couple years ago (in March 2010 to be exact), I wrote about seeing a traveling exhibit of photographs, “Treasured Lands,” landscape photographs of National Park, and about hearing a talk by the photographer, Dr. Quang-Tuan Luong (“Pictures at an Exhibition”).   As I learned, Dr. Luong drove, hiked, backpacked, and kayaked his way through 58 parks from the Dry Tortugas NP off Florida to Wrangell-St. Elias NP in eastern Alaska, mostly alone and hauling a heavy 5X7 large format camera to capture expansive vistas and unique views.  The project took 15 years and was completed in 2002, and now his series of more than 10000 photos can be seen at his online gallery (e.g., Zion NP which I visited in May).  They are only part of 32000 or so images from his world travels found at Terragalleria.  I wrote that I enjoyed the photos for their composition, lighting, and sense of place and for evoking my memories of experiencing nature and appreciating the world we humans should be thankful to inhabit.  I thought, and still do, that, since the US has a poet laureate, we should also have a landscape laureate, the first being Dr. Luong, a truly inspirational guy.

In my previous post, also I mentioned a several talented and inspired people who are applying their experience and skills to the challenges of global health.  Here’s an update of several I mentioned before and a few additions:

Amit Srivastava:  Amit is a former vaccine researcher at Boston Children’s Hospital and is now in the health care practice of Boston Consulting Group and will be joining the pneumonial diseases group at the Gates Foundation as a Program Manager (Amit’s Profile).

Anup Akkihal:  I met Anup when he was completing his management degree at MIT and since then he has been building a company in India, Logistimo, that offers cell phone-based supply-chain management tools for low resource settings; such tools are critical in both getting needed products to rural areas and in getting products to market ultimately improving service and increasing profitability;

Davinder Gill:  Davinder and I were colleagues at Wyeth and he became the head of Pfizer’s biotherapeutics group after the merger.  He is now CEO of Hilleman Laboratories, a laboratory in India that is developing technologies for affordable vaccinations.

Karolina Maciag:  Karolina is a student in the MD/PhD program at Harvard Medical School and a researcher at the Broad Institute, and we met through her promotion of global health as a coordinator of the MIT and Harvard chapters of Universities Allied for Essential Medicines (Karolina’s Profile).

Kevin Killeen:  Kevin is a biotech industry veteran and CEO of Matrivax, a pre-revenue company in Boston that is developing cost-effective manufacturing methods for conjugate vaccines.  Such techniques are important in bringing down the cost of the latest generation of high-tech vaccines (“Greasing the COGs”);

Manish Bhardwaj:  I have met Manish only once when he was kind enough to meet for an interview I wrote up in my April 2013 post, “Reality Check”.  He’s a technology-company-founder-turned-global-health-entrepreneur, but unlike others (including me) he’s spent months (and still is spending) living and working in the poor communities his technology is intended to help (see Innovators in Health).

Marcia de Souza Lima:  Marcia is an ophthalmologist with multiple years of experience in the pharmaceutical industry, a founder of the Releef Initiative, a source for affordable drug development news, and is the Director, Programs and Operations, at the Global Network for Neglected Tropical Diseases, an advocacy and networking division of the Sabin Vaccine Institute.

Michael Pollastri:  Michael and his project to accelerate neglected disease drug discovery was the subject of my post last week (“Shameless Plug”).  He was a pharma company researcher and is now a professor of chemistry and chemical biology at Northeastern University (Pollastri).

Patrick Beattie:  Patrick is director of operations and a key employee at Diagnostics for All, one of the few “not-for-profit-only” companies developing diagnostics for low-resource environments (DFA).  I had the pleasure of working with him as a volunteer for the company in the past and look forward to the launch of their first product.

That’s it for this week.  Have a merry Gift-Giving and –Receiving Day.

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Where Does This PATH Lead?

PATH, formerly the Program for Appropriate Technology in Health, is a high-profile, global health non-profit based in Seattle and a favored recipient of Gates Foundation funding, receiving more than $1 billion from the foundation since 1998 (McCoy et al. 2009).  The organization undoubtedly has done and is doing good work, but my business reflex is to look at organizations as a potential investor might:  what’s the mission, is it being met, and will my investment yield the return I want.  From that perspective, PATH comes up short.

I usually start with an organization’s mission statement.  For PATH it is  “to improve the health of people around the world by advancing technologies, strengthening systems, and encouraging healthy behaviors (PATH FAQ).”  So I know I need to measure their success by the extent to which they are improving health, however measured.  I red-flag the three-mode approach; technology development, health care delivery infrastructure development, and behavior modification seem too disparate in methods and resources to be accomplished successfully under one organization.  Next I try to check their organizational structure; is it integrated across their mission so use their resources efficiently or are there vertical silos focused on different objectives?   No org chart is given; there is an executive team, a “shared services” team (essentially operations support), and “Program Leaders,” nineteen managers with either programmatic or country responsibilities (Prgm Leaders), forming a matrix that is either horizontal and vertical silos or a harmonious whole.  Another red flag.

What is PATH doing to accomplish its mission?  There is a clear statement about one thing PAH does not do:  it does not grant funds to other programs or nonprofits (FAQ), so if you’re looking for funding for your pet project, look elsewhere.  The list of projects on the PATH website (Projects) is impressive and extensive, 83 by my count, covering a wide range of topics in global health, everything from a song contest to increase AIDS awareness (Kenya) to the development of a malaria vaccine (Malaria Vaccine Initiative).  How does PATH accomplish such a wide range of work, requiring many different skills?  Apparently by “partnering” with other organizations, but since there are many ways to partner and, since PATH it does not give grants, I assume that PATH has contractual relationships with its partners.  Contracting can be a very efficient way part of a business:  a needed product or service is delivered at a known price by a contractee selected through a competitive bidding process.  The contractor needs to be good at writing contract specifications and then managing the contract post award.  So I look for PATH’s RFP (request for proposals) process; but the website has only one relevant page and only one project for bid (RFP).  So I guess that the 83 current projects resulted from a robust RFP process in the past; alternatively the partners/contractees/grantees were selected through subjective criteria (cronyism), another red flag.

My next stop is the PATH 2008 Annual Report to find out how PATH is reporting on its progress.  The majority of the Report is composed of descriptions of projects and the people involved- a good approach for communicating PATH’s work- but specific outcomes are few and far between.  I found three quantitations of the results of PATH’s projects in 2008:

– Nearly 9,000 girls were vaccinated with an HPV vaccine in Peru (HPV Vaccine);

– In Kenya, PATH and partners extended HIV counseling and testing to 146,000 individuals, reached more than 100,000 pregnant women with services to prevent transmitting HIV to their children, trained more than 500 health workers to counsel and test HIV patients, offered support groups to 45,000 adults and children living with HIV/AIDS, and provided financial, educational, and health assistance to 35,000 children orphaned or left vulnerable by HIV (Kenyan Health); and

– PATH and the Chengdu Institute built a Japanese encephalitis vaccine manufacturing facility which exported more than 31 million doses (JE Vaccine).

This is great progress, but the organization’s documentation and measurement of how it is fulfilling its mission is less than I expect.   Clearly, PATH is good at writing about its projects (there are hundreds of publications listed on its website, Pubs), but which of these report a measurable improvement in health is not clear.  Perhaps the enterprise is too successful and too wide-ranging to be able to consolidate and report its progress.  But I would expect that an organization funded at nearly $200 million annually would want have a better idea of how it is doing and share it with the public.

My last stop is the financial statement (in the Report and at Finances), which I read an amateur, trying to  get a rough idea of the relation between the input and output.  2008 input (described as revenue) was $187 million, mostly from contracts (obligated) and grants (unobligated) from foundations, corporations, US government, and NGOs (it’s not clear how these are apportioned).  Output (expenses) was 86% of the total in “program services” (funding for the projects) of which I deduce $80 million went to outside organizations (“sub-agreement” and “sub-contracts” line items) and $82 million went to internal project funding (it is not clear what proportion of the internal project funding went to managing the sub-contractees).  The good news is that their overall overhead (their “Support Services” category) is low:  about 12% of total expenses.  I’d appreciate a better description of the sources of their funds, how much is being passed through to other organizations, and what it costs to manage that pass-through.

My conclusion (acknowledging my less-than-thorough review):  PATH is well-funded and has improved health for some (e.g., those receiving vaccines and HIV counseling in 2008), but as a current investor (through my Federal taxes), I question whether their business model is sound and if they are delivering on their mission.  As a potential investor (there are three requests for donations on the PATH home page), I’ll go elsewhere.

PDP Performance Measurement

The good news is that there are more than a dozen product development partnerships (PDPs) working to develop products to diagnose or treat the diseases that afflict many of the world’s citizens.  Started in the 1990s and funded primarily by donor dollars (a total of about $450 M through 2007), the PDPs have been making incremental progress on more than 60 projects with a handful of products now in use/commerce (Dahlberg/IFPMA).  While their progress is appreciated, it is reasonable to expect the PDPs also use their funding as effectively as possible and report on their overall performance, as was pointed out last November by Dr. Melinda Moree, CEO of BIO Ventures for Global Health (Moree Post) and last week by her colleague, Dr. Orin Levine (Levine Post).  Such performance measurement would be a useful tool for PDPs to evaluate their internal project portfolios and operations in the near term and, in the long term, should we be so lucky as to have multiple PDPs (or companies) pursuing similar targets and competing for funding/investment, provide a way for donors/investors to make more rational donation/investment decisions.

I found one published study of the evaluation of PDP performance, a 2007 report by FSG Social Impact Advisers (FSG Report) which was supported by the Gates (thanks, again, Bill and Melinda) and Rockefeller Foundations on behalf of the “PDP Funders Group,” apparently a group of PDP donors formed in 2004 [but now missing-in-action; anyone have an update on this group?].  The authors conducted extensive research (interviewing representatives of more than 50 organizations and companies) and found:

-donors vary widely in the breadth and depth of performance oversight;

-current PDP performance measurement methods lack structure and comprehensiveness; and

-although PDPs monitor R and D project performance, they differ considerably in the way they do it and in the way they use the results in managing or explaining their activities.

However, the authors step back from proposing a evaluation methodology; rather, they propose adoption of an “evaluation framework” that they say “serves as the first tangible manifestation of a more integrated and collaborative approach to performance measurement” and “provides a platform to enable each PDP and its donors to engage in discussions around performance issues and decide jointly on the specific metrics that best reflect the unique priorities of individual PDPs.”  The FSG bottom line recommendation is yet another group be formed (“a new ‘performance measurement partnership’ be established between donors and PDPs to improve the value of donor-sponsored evaluations and internal management reviews by PDPs”). Not useful.

Surprising to me is that FSG Advisers (or others in the global health field as far as I can tell) did not reference the most obvious source for measuring of R and D performance:  the pharmaceutical industry.  Many techniques have been developed and used internally to evaluate performance and to manage R and D projects and portfolios and downsizing/merging.  Externally, similar techniques are used by professional investment firms to rate investments and conduct due diligence.  (A few source of information are below.)

I am assuming that PDPs have adopted of these methods to evaluate, reassess, add to, and trim their project pipelines, but don’t publicize their methods.  After all, one of the mantras of biotech/pharma project management is that it is better to eliminate projects quickly and early and redirect resources to other opportunities than to concentrate on a few, increasingly expensive projects.  PDPs are/should be doing this.  In addition, a widely-used external evaluation method will be needed as new sources of funding for the PDPs emerge to allow inter-PDP comparisons.  These include:

-a PDP “Financing Facility” as proposed by IAVI and other PDPs to the WHO Expert Working Group for Financing R and D (http://www.who.int/phi/public_hearings/second/contributions/HollyWongInternationalAIDSVaccineInitiative.pdf);

-a centrally-managed R and D fund (the FRIND proposed by Paul Herrling, Herrling Editorial); (see a review of these at Knowledge Ecology International) and

-program-related investments as being implemented by the Gates Foundation (my posting of January 14).

PDP performance measurement:  what am I missing?

Business Insights report 2005: http://www.globalbusinessinsights.com/content/rbhc0138t.pdf

Journal of Commercial Biotechnology article 2008: http://www.palgrave-journals.com/jcb/journal/v14/n4/abs/jcb20086a.html

Portfolio Management Conference 2008: http://www.healthtech.com/Conferences_Archive.aspx?id=78504

Consulting company primer 2010: http://www.ngpharma.com/article/A-Strategic-RD-Portfolio-Management-Primer/

Official US Government Global Health Program

Is there one?  One would hope so given our superpower status (at least until China cashes in the US treasuries it holds).  Obviously many government agencies, branches, and departments have some role in affecting the health of the rest (majority) of the world’s population.  Prominent are the USAID, USDA, and the departments of Defense and State, and less prominent are the Peace Corp, FDA, CDC, and NIH (e.g., the new NIH Therapeutics for Rare and Neglected Diseases).  Last May (2009), one of our national think tanks (image of brains floating in a vat), the Institute of Medicine (sister to the National Academies of Science and Engineering, IOM), released a report advocating for a national program on global health (IOM Report).  Called “The US Commitment to Global Health- Recommendations to the New Administration,” it followed a similar report in 1997 (the recommendations of which apparently had no effect), was funded by multiple government agencies and five foundations (Gates, Google, Merck, Wellcome Trust, and Rockefeller), and had esteemed authors and reviewers.  Just to note, all the authors and reviewers were from academia, NGOs, or PDPs (product development programs); not one from a for-profit or corporation except for two reviewers (Pepsi and ExxonMobil).  I suspect that the biotech/pharma industry would have something to contribute (Not interested?  Not invited?)

The report had a stirring bottom line:  that the US needs to “live up to its humanitarian responsibilities” and “highlight health as a pillar of US foreign policy” (page 1).  It states this highlighting should include:

– creation of a White House level interagency group chaired by a senior official [a “global health” czar?];

-doubling the US’s global health-dedicated spending from $7.5B in 2006 to $15B in 2012; and

-allocation of this budget across programs supporting the 2000 Millennium Development Goals (MDG) and non-communicable diseases (most would be applied to HIV/AIDS, malaria, and TB).

While it would be nice to have some high level coordination, visibility, and advocacy, is the recommended spending in proportion to the problem and to the potentially available resources?  As noted in the report, although the US government spends the greatest absolute amount of any country on global health aid, it is at the bottom of the developed countries in terms of percentage of gross national income (0.16% compared to an average of 0.45%) and does not spend close to the MDG target of 0.54% of GNI.  And the US effort is more narrowly focused than that of the Gates Foundation’s whose spending of $1.7B per year demonstrates a greater breadth, depth, and inventiveness, the last not a strong point of the government (my posting of November 24).  Perhaps funds could be found by re-programming some of the budget for new weapons like the Joint Strike Fighter which has a current estimated procurement cost of $250B (about $100M per plane).

I was also amazed that the report didn’t mention some of the innovations in the funding, delivery, and research in global health and use them as exemplars for the US effort.  Specifically,

– the success of the Global Alliance for Vaccines and Immunization in increasing childhood immunization rates funded through the International Finance Facility for Immunizations (my posting of January 21);

– the progress in health care delivery using profit incentives (my posting of December 17)

– the potential for emerging pharmaceuticals market (my posting of October 20); and

– the Gates Foundation’s efforts to stimulate innovation through small grants with simplified applications and rapid review (for academic researchers at least, my posting of November 24).

Moreover, the report only mentions a possible role of for-profits in addressing global health; the strongest statement is on page 6:  “Through new models of collaboration, the private sector is responding to pressures and opportunities to apply technology and business acumen to enduring social problems.”  No specifics are offered on what the global health czar should do or say to involve the private sector in the government effort or what the government could do to aid their response.

I am clearly not an expert on government policy (I’d need at least a PhD and a government grant to be one), but here are several of my wild-and-crazy suggestions:

– the NIH SBIR and STTR programs could have set-asides for global health product development (my posting of November 5);

– the TRND, now funded at $24M for both rare and neglected disease therapeutic discovery, could be more generously funded and offer no-cost screening services to all PDPs;

– the current r and d tax credits could be amplified in some way for companies developing global health products, and the credits could be transferable to generate income for companies with no tax liability;

– the FDA’s much-lauded priority review voucher program could be extended to include the granting of priority review “options” to companies whose products reach pre-approval milestones;

– the FDA could grant drugs for neglected diseases some type of  exclusivity for US markets similar to that granted orphan drugs;

– recipients of Federal funding could be required to provide no cost licenses to Federal inventions to companies developing global health products (my posting of November 12); and

– the USAID could ramp up its support for innovation in diagnostics and services by streamlining and making more competitive its grants and contracting process and hold the recipients accountable for delivery of results.

Unfortunately, the IOM report and recommendations seem to me to be more of the status quo and therefore disappointing.  I am not sure if the authors intended irony by using as a preface a quote from the philosopher/poet/scientist Johann Wolfgang von Goethe:  “Knowing is not enough; we must apply.  Willing is not enough; we must do.”  But it’s ironic to me.

GSK in the Lead but Who Will Follow

GlaxoSmithKline, one of the bigger of Big Pharma, lengthened its lead in the global health business again by announcing several initiatives to address the health needs of the world’s under-served populations.  GSK, or more specifically, its CEO, Andrew Witty (visionary, iconoclastic, wrong-headed?), described them in a speech on January 20:

– Patent Pool:  BIO Ventures for Global Health will administer the GSK/Alnylam program for the user-friendly licensing of patents for neglected disease drug development, but more importantly, the pool will include access to know-how and data associated with the patents (a concern of mine; see my posting 10/8/09);

– Open Lab:  GSK will welcome up to 60 scientists and their projects from academia and biotech companies to its drug discovery unit in Tres Cantos, Spain, and fund a number of these through a fund, started at $8M;

– Compound Library:  GSK will publish on the web the results of a 5-year screening study of its 2 million compounds against the malaria parasite, including structures and data.

Witty also announced a “sustainable” pricing strategy for its malaria vaccine (“RTS,S”) now in late stage testing.  The price will be set at the cost of product plus a small profit (he mentioned 5%) with the profit earmarked for GSK’s neglected disease drug research. Although he noted during the Q and A that this type of pricing would be product-specific (e.g., it did not apply to HIV therapeutics since HIV was not a neglected disease), I think this is a great precedent, but will also propose that, since $200M of the $500M of the vaccine development cost was donated by the Gates Foundation (as Witty noted), 2% of the 5% should go back to the Gates to support global health product innovation in other companies.

For the specifics, you can view the speech and Q and A at the Council on Foreign Relations website (CFR) and read the press release (GSK PR) and Andrew’s blog posting (GSK blog).

All good so far, with the devil being in the details.  I am looking forward to see how one applies for space and funding at Tres Cantos (I have a couple projects in mind) and how BVGH will administer the patent pool since one role of the administrator should be to qualify licensees and issue licenses.  In its press release, BVGH mentions only it “will organize disease-specific meetings that identify the gaps in expertise and intellectual property … [and] will then help global health researchers work with industry to fill these gaps ….” (BVGH PR).  It is also unclear if GSK will license out any of the anti-malaria hits it is not pursuing.  Still, these initiatives plus its other neglected disease programs (e.g., African Malaria Partnership grants, collaboration with Medicines for Malaria Venture, 19 products in development [GSK GH]) clearly put GSK ahead in the race.  But is there a race and who else is in it?

A quick look at the rest of Big Pharma finds two categories; those companies that have made addressing global health a priority in their drug discovery and corporate social responsibility (CSR) programs and those that haven’t.  In the first category are:

1)  GSK:  for the reasons above, but some skeptics, using their broadest, tarriest brushes, would say the GSK wants to distract attention from its record of influence-buying, market-rigging, price-gouging, and general capitalistic rapacity.  Other skeptics may say that so long as the bottom line isn’t negatively affected, shareholders won’t care and will let Andrew be Andrew.

2)  Novartis:  has an active free/affordable medicine access program, two institutes for global health drug/vaccine development, and foundation for “sustainable” development  (Novartis Access), and launched (with Medicines for Malaria Venture) the only pediatric med for malaria in 2009 (Coartem Dispersible).

3)  Merck:  a long-time donor of its meds for neglected disease with a serious commitment to affordable access to its HIV drugs and vaccines (Merck Access).

4)  Pfizer:  has long-term fellows program that places employees with global health non-profits, medicine donations, a health care delivery improvement program, and a relatively small and ineffective grants program (Pfizer GH).

5)  sanofi-aventis:  has a low profile meds access program and some drug development, primarily for malaria, but its vaccine group has a dengue fever vaccine in development (SA Access).

Global health is a low priority for:

6)  Roche:  has taken a small step in GH drug development through a collaboration with OneWorldHealth and has concentrated on HIV drug development and access (Roche GH).

7)  Eli Lilly:  says its is willing to “share” its expertise but has only one serious global disease drug development program in TB which has dual market appeal (Lilly GH).

8)  AstraZencea:  has only a program for TB drug development (AZ GH).

9)  Johnson and Johnson: seems to have minimal interest in neglected diseases for a global company, says it is “enhancing access” to its HIV meds (JNJ GH).

10)  Abbott:  claims to have a commitment to affordable pricing but no commitment to GH product development (Abbott GH).

11)  Bristol-Myers Squibb:  has a minimally-endowed foundation that gives grants, a few of which are relevant to GH (BMS GH).

Not much of a race, yet.

The Gates Foundtion: For-Profits Need not Apply?

Since 1996, the Bill and Melinda Gates Foundation has put its considerable resources to work to “ensure that life-saving health advances reach those who need them most” (Gates Global Health Overview).  But, due to the extent and range of the foundation’s giving, it has been difficult to figure out who is receiving what and why.  Recently, McCoy et al. analyzed the foundation’s global health funding and published their findings in The Lancet (McCoy et al. 2009, Lancet citation).  They reported that in 1996-2007 the foundation gave more than 1000 grants for a total of $9 billion primarily to:

-global health partnerships, like the Global Fund to Fights AIDS, Tuberculosis, and Malaria; the Global Alliance for Vaccine and Immunizations (GAVI); and Global Alliance for Improved Nutrition ($5.85 billion was given to 20 organizations);

-nongovernment and non-profit organizations involved in research, health-care delivery, and public awareness/advocacy ($3.3 billion to 100 organizations with the bulk going to Seattle-based PATH which has received close to $1 billion); and

-universities and research hospitals ($1.84 billion to 78 institutions).

To give an idea of scale, the authors note that the amount spent by the foundation in 2007 ($1.65 billion) was almost the same as WHO’s budget that year.  The authors acknowledge, though, that knowing the final disposition of the funds is problematic since many of the recipients re-granted the money, and I assume tracking all of their disbursements was belong the paper’s scope.  Hence, figuring out how much funding went into specific efforts, such as my interest, creating those life-saving health advances through product testing, manufacture, and distribution (product development), will require more investigation.

What is clear from their analysis is that the foundation does not directly fund for-profit organizations, for example, companies developing products for global health (with one exception, Aktiv-Dry LLC; see my posting of October 28).  This is a notable omission for an foundation built with profits from the selling products that many people found worth buying.  One would think that directly funding product development in companies, with appropriate milestones and pricing guarantees, would be worth a try.  But, in general, foundations rarely give grants or make investments in for-profits, although this bias seems to be eroding as foundations seek that sustainable solutions that have not resulted from charity alone, and funding companies carries the baggage of possible adverse publicity.

There is one avenue for companies to receive direct funding from the Gates Foundation.  The Grand Challenges Explorations, a grant program started in 2008 and intended to “to expand the pipeline of ideas to fight our greatest health challenges,” is open to applicants from any type institution  (Grand Challenges Explorations).  The program has an initial grant of $100K, a mercifully short application (2 pages) and review time (4 months), and  successful projects have the opportunity to receive additional funding of $1 million although the approval process seems yet to be determined.  The applications are reviewed by unnamed reviewers who have “broad expertise and experience in discovering inventive approaches to daunting issues” without identification of the applicants.

Since its start, the program has made 262 grants, totaling about $8 million per year (less than 5% of total granted annually by the foundation).  I reviewed the list of recipients and found academics well-represented but few companies (17 or 6.5%).  The difference has at least two explanations:  few companies applied and/or company-based scientists submitted uncreative or non-innovative ideas.  Without reviewing the applications, one can’t say, but I would think that the Grand Challenge Explorations Program would be well-served by encouraging, maybe favoring, scientists and organizations that, in addition to having a creative idea, also have the experience, resources, and motivation to convert the idea into a solution.  Or perhaps, when awarding the $1 million grants, the foundation could require the awardees to be teamed with a entity with experience in developing and delivering products.  It will be interesting to see which of the 262 ideas, and how, result in solutions.

Is there a Bottom Line Behind the Headline?

Recently, the Welcome Trust, the British giant philanthropy, and Merck and Co., a leading member of Big Pharma, announced a “first of its kind” joint venture to advance vaccine development for diseases of the low-income countries (September 17, 2009, Merck press release).  While the venture’s objectives and funding are commendable, after a closer look for the bottom line (i.e., creating affordable, new vaccines) I’m inclined to view it as a well-intentioned effort that will fall short.

As described in the release, Welcome and Merck, specifically Merck’s Indian subsidiary, MSD, are going 50/50 on about $130 M of funding in a 7-year commitment to set up and operate a R and D facility in India that will develop new vaccines and possibly improve existing vaccines for developing world use.  The facility, named the Hilleman Laboratories after Maurice Hilleman, the outstanding vaccinologist of the 20th century, has as its vision, as given in the press release but oddly not on the Laboratories’ website (Hilleman Laboratories):  “A Sustainable, Not-For-Profit Operating Model to Turn Innovative Science into Practical Solutions for Those in Greatest Need.”  Although not made explicit in the release or on the website, the Operating Model seems to be that the Laboratory will invent (or acquire from academia?) candidate vaccines, conduct preclinical studies (with direct help form Merck?: “The Hilleman Laboratories will work to advance projects to ‘proof of concept’ by providing key expertise in product development and optimization that is typically available only within large vaccine companies”), conduct some degree of CMC/manufacturing development (“The Hilleman Laboratories will also work with vaccine manufacturers to ensure production can be scaled and that the vaccines are affordable”), and then?  It is not clear who/what/how will handle the clinical testing, registration, manufacturing, and distribution, i.e., the heavy lifting needed to get a vaccine into people’s arms.  Maybe no-cost licensing to PDPs (product development partnerships) already working on vaccines like the Sabin Vaccine Institute, Malaria Vaccine Initiative, International AIDS Vaccine Initiative, and Global Solutions for Infectious Disease?  Nothing beyond “productive partnerships” is mentioned.  Maybe out-licensing to for-profits with dual market objectives?  The press release has no comment on a business development/licensing function, just a hint that the founders “envisage” that the Lab will receive compensation for its innovations when used in higher income markets.

Further, it is not clear who in the organization will have the experience to watch the bottom line and build a truly sustainable operation that can deliver the goods.  The Chief Executive Officer is Altaf Lal, clearly a highly experienced scientist and bureaucrat.  The two named advisors are from the UK government and WHO.  Granted Dr. Lal is probably building his organization now, but I would hope he is engaging professional (non-academic) vaccine developers as employees and former/current biotech/Pharma executives as advisors.  I’m sure BIOVentures for Global Health could be helpful in the recruiting process for both employees and advisors.

So what’s in this for Merck?  Certainly good (and deserved) PR.  A cynic may say also a chance to guide the Laboratories’ project selection away from the development of competing products, but this is not likely since Merck has a solid history of corporate responsibility in global health (its donation of ivermectin to treat onchocerciasis/river blindness began in 1987) and has substantial R and D and access programs (Merck GH CR).  I would hope that Merck sees the Laboratories as an opportunity to attract academic ingenuity and generate vaccine candidates for its pipeline, i.e., get serious about making profitable vaccines for low-income markets.  Although the funding is helpful ($10M per year is less than half of one percent of its overall R and D budget), Merck’s direct involvement in the commercialization stages (i.e., product realization) is needed and would truly make the Hilleman Laboratories a venture and an innovation in developing affordable vaccines.