Vax Tech

Vaccines have been an incredibly important tool in improving public health preventing millions of deaths each year from tuberculosis, diphtheria, tetanus, pertussis, polio, measles, hepatitis B, and Hib disease (WHO 2009 Fact Sheet).  For that reason governments, multi-lateral health agencies, private donor organizations, NGOs, and companies have invested considerable time, effort, and money in creating a pipeline from discovery to delivery.  But clearly, there are major challenges to their wider use of immunization in both preventing and treating disease.  Foremost, current multilateral programs to subsidize the purchase and delivery of vaccinations, like UNICEF and the GAVI Alliance, are not funded sufficiently to meet the all need in the low- and lower-middle income countries (a total of 107 countries).  WHO estimates the cost gap to be about $2 billion per year, or almost the amount that is spent now ($2.5 billion) (WHO Immunization Challenges).  Technical and scientific challenges to inventing new vaccines are multiple including the selection of antigens and adjuvants to induce an immunological response, especially against target organisms with multiple subtypes or those with high rates of evolution (Oyston and Robinson 2012 and the 2011 BVGH report, Vaccine Landscape for Neglected Disease).  The clinical testing of vaccines, since they are used in otherwise healthy people and often children, is extensive and expensive (CDC Vaccine Testing ).  The manufacturing of vaccines poses a host of technical issues including assuring the safety of inactivated viral vaccines, purification, and product characterization (Rathore et al. 2012).  There are also technical challenges in the delivery of vaccines, such as managing a long supply chain, keeping the doses cool, and administering via injection, all difficult in resource-constrained areas, (PATH Project Optimize).

Fortunately, academics, product development programs (PDPs), research institutes, and companies, large and small, are working on solutions (a good way to keep up with progress is through the FierceVaccines newsletter).  I wondered which technologies that had reached a point where the major vaccine companies were willing to investment in them, thus suggesting which may eventually be deployed in global immunization programs.

Earlier last month I posted about the acquisition of Inviragen by the Japanese pharma company, Takeda (“More Toes in the Water”).  I surmised the purchase may have been motivated by Inviragen’s lead candidate, a Dengue fever vaccine which had advanced into the next stage of a Phase II trial recently, and others in the pipeline, and not its technology.  I also noted that Takeda purchased another privately-held vaccine company in 2012, Montana-based Ligocyte (Takeda press release).  Ligocyte has proprietary technology for making VLP (virus-like particle) vaccines, several of which are in development.  VLP vaccines have the protein structure of the target virus but lack its genetic material and therefore are non-replicating but can represent the  all of the external structures needed to stimulate an immune response.  Their production is simpler in that multiple types of expression platforms (including plant cells) can be used to make VLPs rather than growing a virus in its natural target cell (Pharma Tech article).  Takeda’s investment in VPL technology is a relatively safe bet; four VLP vaccines have been approved and marketed (GlaxoSmithKline’s Engerix  against hep B and Cervarix against HPV and Merck’s Recombivax HB and Gardasil, also HepB and HPV [Mellado et al. 2010]).  I am guessing Takeda may combine the Ligocyte technology for designing vaccines for developing world diseases and Inviragen’s experience in testing them.

GlaxoSmithKline (GSK) went farther afield into new technology than Takeda when it bought Okairos, a venture-capital-backed Swiss firm, in late May for $325 million (FierceBiotech press release).  Okairos’s approach is to stimulate a T-cell immune response rather than a B-cell (antibody-producing) response which is needed for effective response to some infections (e.g., influenza, HIV, and hepatitis C) using an antigen produced by the body cells (typically muscle cells) after infection by an adenovirus genetically engineered to include the antigen’s genes (Okairos Fact Sheet and Platform).  The company, which spun out from Merck in 2007, developed its technology on relatively little funding, less than $20 million (FierceBiotech article) and has advanced it into the clinic.  The company’s pipeline includes clinical stage candidates for malaria, hepatitis C, HIV, and respiratory syncytial virus (Pipeline).  Okairos seems to be a good fit for GSK’s interests in global vaccines markets.

Also in a publication last month, scientists at Novartis, the Venter Institute, Synthetic Genomics, Inc., the US Biomedical Advanced Research and Development Authority, and the German Institut für Virologie, described a practical method of applying synthetic biology to the rapid design and production of vaccines to pandemic-type viruses (Dormitzer et al. 2013).  Specifically, the scientists designed a vaccine to a new strain of influenza that had appeared in China last year and had it ready to be put into production cell lines in less than two weeks.  According to the Venter Institute press release (JCVI press release):   “The researchers focused on three technological areas–speedy synthesis of DNA cassettes to produce influenza RNA genome segments, improved accuracy of rapid gene synthesis by improving error correction technology, and increased yields of hemagglutinin (HA), which is the essential vaccine antigen.”  Also as noted in the release, the team developed a new technique that may reduce manufacturing complexity by reproducing the synthetic virus in the same cell line that can be used in vaccine antigen production.  The implication is that world health agencies could mount a response to a emerging disease in that a central facility could rapidly generate a cell line for distribution and production in multiple countries.  In an article in the Boston Globe (Globe article), Marc Lipsitch, an epidemiologist and director at the Harvard School of Public Health, said “It’s a big deal if it works on a large scale.”  The Globe also had a nice graphic comparing timelines of the new approach and that used by Novartis to make a H1N1 vaccine in 2009 (Globe graphic).

Technology marches on.

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Down at the A&P

One may remember that in my posting last week (“Playing the Long Game”), I mentioned that the big pharma company, Novartis, was trying its hand at improving the delivery of health services in rural India.  Based on the limited information I had, Novartis started the program, called Arogya Parivar (“Happy Family” in Hindi), in 2007, and that it involves infrastructure development and health education, now reaches 42 million people, is “generating profits,” and is intended to be a sustainable, scalable business to improve health.  Interested in understanding the model, its economics, and potential for being replicated in other settings by Novartis or its competitors, I looked for more information.  Unfortunately while I found additional details, I did not come up with a description of its business and operating plan or an analysis of its potential and welcome any suggestions on sources of better information.

Novartis provides a general description of Arogya Parivar (AP) as part of its corporate responsibility/access to health care/social business webpage (Novartis CR), and AP’s top guy, Anuj Pasrija, Head of Social Business, Emerging Markets Group (Pasrija profile), has given a few presentations on the program, e.g., to the Associated Chambers of Commerce and Industry of India in November 2010 (Pasrija presentation) and at a corporate social responsibility conference in June 2011 (CSR conference).  I also found two laudatory reviews of AP with some details by an international PR firm (Incanus article) and an Indian-based social enterprise blog (Beyond Profit blog) and a recent “case” write-up by Jain et al. in the International Journal of Business and Management Cases (Jain et al 2012).

From these sources, I summarize AP’s primary features as follows:

  • A grassroots health education program covering diseases specific to a region provided by local, Novartis-trained “health educators” who refer patients to doctors, liaise with local health-related NGOs, and apparently sell drugs on a 10% commission basis;
  • An outreach program through “heath camps” provided by doctors who visit under-served villages and conduct free basic exams (it is not clear if these doctors also sell drugs);
  • A program run with micro-financing institutions to improve the ability of doctors and pharmacies to maintain stocks of drugs and/or improve their operations; and
  • The packaging of AP’s products (80 pharmaceutical, generic, and over-the-counter drugs) in small-quantity (several days of doses), low-priced packs [it is not said how this sales strategy affects compliance].

But while Jain et al. report AP is monitoring the “number of people covered in a health education and awareness program, number of health camps conducted, number of new patients diagnosed and number of doctor referral cards distributed,” they do not provide these data, and apparently AP is not measuring subsequent improvement to the health of its participants.  Based on the numbers from Jain et al. and Incanus article, it looks to me as AP is very widely dispersed, perhaps even overly dilute, that is, a small number of AP employees or affiliates covering a large territory.  There is one supervisor and eight health educators for each “cell,’’ of which in 2009 there were 280, each including between 180,000 and 200,000 inhabitants.  In terms of direct contact, each educator is said to have 30 “patients” or about 0.12% of those in his/her territory.  AP is said to conduct 500 health camps per month which, guessing at 500 attendees each, means the camps reach about 0.05% each month or less than one percent in a year.  As for the economics, Jain et al., as well as the Novartis web page, state AP “achieved break-even within 30 months, and since 2007, sales have increased 25-fold” without giving specifics.  Novartis is apparently satisfied with the economics.  Jain et al. report that Novartis plans to expand the program to cover 350 million people in India in ten years, and Novartis notes on its web page that it is testing similar programs in selected Asian and sub-Saharan countries.

To get more specifics, I turned to a database complied by the Center for Health Market Innovations (CHMI), a project started in early 2010 with Gates and Rockefeller foundation grants that “identifies, analyzes, and connects programs working to improve health and financial protection for the poor.”  I have posted on and praised the CHMI effort (but think less of its utility) (“Innovate or Die” and “Market Tested and Not Yet Approved”).  But two of the weaknesses of the CHMI methodology (self-identification and reporting of results) foiled me:  AP was not in their database.  While I give Novartis and AP an “A” for effort, I’m still in the dark about the program’s business model and potential for improving health among the poorest.  What I (and others struggling with the delivery challenge) needs is something like a Harvard Business School marketing case study like one that was done on the Aravind Eye Hospital chain of India (HBS case list).

Of course, the business model of offering low-priced, low-margin but essential products is a classic one.  In 1912, the founders of the Great Atlantic and Pacific Tea Company, better known as A&P, set up the first in the US, no frills, cash-and-carry Economy Store in Jersey City, NJ, which started an extraordinary period of growth that resulting in 4,638 stores in 1920 and 15,418 stores and $1 billion in sales in 1929 (A&P history).  Can AP be the A&P of health care for the neediest?

Playing the Long Game

One of the buckets that I beat regularly in this blog is that it will be worth the effort for biopharmaceutical and medical device companies to figure out how to make and sell affordable products to rest of the world, to those billions without access to the well-funded medical system that we in the “developed” world enjoy.  While I have noted and written about a handful of the biggest of these companies putting their toes in the ROW markets (see last week’s “To Boldly Go” and “Putting the Biz into BoP”), I’ve seen very little reporting data by companies on the money they’ve made doing so.  Until now.  This week it was reported in an article in Reuters that the strategy taken by GlaxoSmithKline’s Developing Countries and Market Access operating unit (DCMA) is working (Reuters article).

The two-year-old DCMA’s strategy includes:

  • focusing half its efforts on drug and vaccine sales and half on reputation-building in 40 African and 10 Asian countries;
  • having its performance measured on sales volume rather than profits;
  • pricing it products competitively (no more than a quarter of the UK price for patented drugs and generics at a small premium to the cheapest competing product);
  • shooting for modest profit margins (20% vs. 32% for the rest of GSK);
  • winning repeat business with public-sector payers; and
  • building out the marketplace by reinvesting 20% of the unit’s profits back into healthcare infrastructure through NGOs like Save the Children, African Medical and Research Foundation, and CARE International.

As reported in the article, the unit’s revenues are expected to be about $230 million this year (a tiny part of GSK’s overall sales of $40 billion or so), but are growing fast, more than triple the 2010 sales.  So far, so good.

But what may this success mean to the people who really matter to GSK and the other big companies, the investment analysts whose opinions guide the investment fund managers who have trillions of dollars to move about the world economy?  So far as I can tell (which is not too far), almost all health technology industry analysts do not include companies’ performance in the ROW markets in their buy/sell/hold recommendations, with one exception.  In 2010, team at UBS Ltd. issued a report, “Global Pharma: Doing well by going good?” (UBS report, UBS report).  In it, Amusa et al. analyzed a number of global pharma and stated:  “GlaxoSmithKline … is the clear leader in pharma at access to medicines and performs best along our Sustainability/ESG Framework.  We expect 70% of GlaxoSmithKline’s incremental £12.5bn sales generation from 2010 to 2015 to come from emerging and less developed markets.  Novartis, J&J and Merck also score well.”  It remains to be seen if UBS continues to rate the pharma companies on emerging/ROW market performance and uses the GSK/DCMA’s recent data and moreover, if other analysts and investors wake up to this type of valuation and the potential for long-term profit growth.

GSK’s strategy for emerging/ROW markets is not the only one being tried as was pointed out in a report recently published by FSG, a not-for-profit consulting group with roots in the Harvard Business School, called “Competing by Saving Lives:  How Pharmaceutical and Medical Device Companies Create Shared Value in Global Health” (FSG report).  Although I am puzzled by FSG’s rubic of “shared value” (I think they mean both the seller and the buyer benefit and receive value in a transaction, but isn’t that the basis of commerce?), I appreciated the report’s recognition of the limits of philanthropy and the potential profit for both companies and societies in global health and for its profiles of ten health tech companies’ emerging/ROW market strategies.  Unfortunately, as I noted in a post earlier this year on a similar report by German Federal Ministry of Economic Cooperation and Development and Endeva (“Putting the Biz into BoP”), the authors do not synthesize their findings into practical business advice, which I recognize would be a challenge since, as they note, the profiled companies’ efforts are still in an “experimental stage.”

That being said, the report’s authors offer the following (fairly generic) recommendations to health tech companies:

  • “Shift from defensive to affirmative engagement with patients [customers?] in low- and middle-income countries,” which I take to mean explain your goals and methods better to NGOs, governments, and customers who may not understand that sustainability (and progress in global health) requires profitability (although this recommendation appears to me to be self-serving for a consulting company);
  • “Innovate and capture knowledge on health product delivery,” an  important and unsolved problem that all the global health players need to concentrate on (e.g., see my post “NTD TD”);
  • “Invest early to gain first-mover advantage,” a standard business rubric that should be replaced by “learn from your competitors’ mistakes;” and
  • To both companies and the “implementation partners” (NGOs), form partnerships and learn from each other, good advice since NGOs are already operating in the markets (e.g., see my post “More Bang for the Buck” on working with drug procurement groups like Medicines Transparency Alliance [MeTA]).

While all of the report’s profiles are worth reading for the range of tactics being tried, I found Novartis’s most interesting because, unbeknownst to me, since 2007 Novartis has had a program called Arogya Parivar with the goal of developing a sustainable, scalable business to reach the large number of underserved rural Indians.  The plan involves extensive infrastructure development, now reaches 42 million people, is “generating profits,” and seems to be improving health.  Apparently, Novartis has created a Social Business unit to extend the program in India and replicate it in other Asian and African companies.  It would be interesting to look at the program’s profitability and replicability since a key to success in business is finding out what works and using as much as possible, and, as I have noted before, the success in the long game requires figuring out how to turn global health challenges into business opportunities.

The Three-Point Shot

As an amateur in the field of the global health, I have no special training or experience in the disciplines of the professionals- public health, epidemiology, microbiology, medicine, public policy- and so appreciate publications that synthesize the knowledge of experts into a digestible form.  Hence my recent rereading of a 2010 report on vaccines by Paul Wilson of the Médecins Sans Frontières Campaign for Essential Medicines (MSF Campaign) was worthwhile (“Giving Developing Countries the Best Shot,” 2010 report).  The report is a good accounting of the roles of the major players, including the biopharma industry, and is balanced; it doesn’t beat the drum for more for donor- and government-based solutions that the MSF, while clearly a force for good in the world, often advocates stridently.

The report starts with the good news that, in many of developing countries, immunization programs are in place and are preventing disability and death in millions of people for a good number of diseases:  tuberculosis, polio, measles, diphtheria, tetanus, pertussis, Hepatitis B, Haemophilus influenza type b, rubella, mumps, and yellow fever.  The less-than-good news is that the primary buyers of basic vaccines, the ministries of health of the low- and middle-income countries and the primary international financing authority, the Global Alliance for Vaccines and Immunization (GAVI), have been affected by the global economic depression and will not be able to meet the growing need.  GAVI (Global Alliance for Vaccines and Immunization), is projected to be under-funded in the near term, in part due to declining donor income and in part to its commitments to purchase the newer pentavalent (diphtheria, tetanus, pertussis, hepatitis B, and Hib disease), pneumococcal, and rotaviral vaccines.  The result is that GAVI will be supporting fewer purchases, and its goal of serving as a “pull” to encourage more companies to develop vaccines for global markets will be compromised.

For the biopharma industry, the good news is that, although public sector purchasing will be constrained, sales of vaccines in the low- and middle-income, “emerging” market, countries (LMIC) is projected to increase at 10% over the next five years (GEN article) and therefore will be an increasing part of the overall world market which is estimated as $34 billion in 2012.  The report notes the major biopharma players (the multinational vaccine companies, GlaxoSmithKline [GSK] and Sanofi, and the new-comers, Merck, Novartis, and Pfizer) have a major challenge in creating pricing strategies that are both affordable to LMIC buyers and have returns-on-investment sufficient to support product innovation (and investor expectations).  The current strategy is to have different prices in different countries (high in high-income countries to low in lower-income) and for large purchasers like GAVI and the Pan American Health Organization’s Revolving Fund which purchases vaccines for Central and South America.  My reading of the report is that the healthy competition from LMIC vaccine companies and an increase in pricing information will drive the major companies to be more creative in both their pricing and their business development.  In the latter category, the multinational vaccine companies may:

  • partner with LMIC vaccine companies to gain local manufacturing capacity and regional market access (Sanofi’s $1 billion investment in India, FierceVaccines article);
  • participate in the donor-supported vaccine product development programs to defray development costs of LMIC products (like GSK’s participation in the Malaria Vaccine Initiative, GSK press release);
  • use corporate venture funds to buy into possible game-changing technologies specific to LMIC products (like adjuvants to stretch doses and products that do not require refrigeration), and
  • participate in efforts to advance regulatory harmonization and strengthen national or regional regulatory authorities.

For other players, I read the report as a basis for more deal-making.  The LMIC vaccine manufacturers may:

  • build technical capacity, especially for multivalent vaccines and manufacturing, through sponsored/joint research with biotech companies, in addition to investing in internal R and D, and
  • bid on public sector tenders to increase competition.

For the biotech companies, the advice is to:

  •  look for out licensing and collaboration opportunities with the LMIC companies; and
  •  join vaccine PDPs for visibility and possible funding.

For US universities and research institutions:

  • use more open licensing policies and aggressive marketing to facilitate technology transfer to multiple innovators and suppliers especially in the LMIC; and
  • work with other institutions to set up IP pools and technical advisory groups to enable licensing and technology transfer of vaccine-related technologies.

With the goal being lower costs for existing vaccines and new and better vaccines, the three-point shot is to increase competition, expand markets  through public sector procurements and transparency, and innovate with better technology transfer and development.

Holy Grail Horse Race

Those of you who follow this blog closely will likely realize the importance of this posting; it’s number 53 and therefore marks delivery of a full year of quality insight and analysis in global health, at least, I hope so.  You may also note that it has a new look:  a new layout, more blue and less green color, easier-to-read font, and a Tag Cloud to find postings.  Given the anniversary, I am updating a posting from about a year ago.

In my 10/28/09 posting, I described an effort to develop an inhaleable, dry-powder measles vaccine, a holy grail for public health since it has the potential to lower costs and speed delivery significantly (less infectious waste, need for refrigeration and skilled vaccinators, expense to prepare and package) for a disease that still infects 30 million people each year and kills about 100,000 despite a world-wide vaccination program.  The specific vaccine is a product of Aktiv-Dry LLC (Aktiv-Dry), a 2002 spin out from the University of Colorado, which uses a dry-powder preparation method invented by Dr. Robert Sievers.  The program has $20 million in funding from the Gates Foundation, and in my original posting, I posited the funding and company staffing may be insufficient to get the vaccine through trials.

What’s been the clinical progress?  At the Gates Foundation website, a project summary states the Phase 1 trial would start in 2009 (Gates Challenges), but apparently it did not.  An Aktiv-Dry press release set the start of Phase 1 in 2010, but there is no news on the company website (Aktiv-Dry News) or the website of its subsidiary, Aktivax (Aktivax), which was formed in 2008 as a dry powder vaccine manufacturer.  Aktiv-Dry’s partner for the trial is the for-profit Serum Institute of India, one of the world’s largest supplier of the current measles vaccine, as well as many other “rest-of-world” products (Serum Institute).  In May 2010, Dr. Seivers stated that the Serum Institute’s trial would start in the summer (Science Daily article) or later in the year (CBS article).  So if someone has registered the trial or is recruiting for it, she/he ain’t talking.

Interestingly, the dry-powder approach is in a race with the liquid aerosols through the WHO Gates-funded Measles Aerosol program (WHO program) which started in 2002 with the goal of licensure  of a vaccine in 2008.  It is evaluating three liquid aerosol delivery devices and, as a late starter, the Aktiv-Dry vaccine.  At least one of these devices is being tested by the Serum Institute and completed Phase 1 successfully in May 2010 (India Express article).  In theory, the dry powder approach has several advantages over the liquid, principally that the diluents could be a source of contamination and the delivery equipment is more complicated, although, as with all inhaled medicines, dose control is the biggest problem (c.f., Papania 2003).  If a pharma company were managing the comparison, they’d hold on the liquid aerosol trials until the dry powder’s safety was indicated in Phase 1 and then go to Phase 2 with the most promising, hence the apparent delay in the Aktiv-Dry/Serum Institute Phase 1 is puzzling.  But since the WHO program has multiple “partners” (more than 30 institutions are listed), management is likely by committee and slow.

Also of note is that other dry powder inhaled vaccines are under development (I am differentiating between vaccines which are inhaled into the lungs and intranasal vaccines, like FluMist, which are deposited into the nasal passages). The Gates Foundation gave $8.3 million to the not-for-profit, Medicine in Need (MEND) to create dry-powder versions of the TB vaccine and others (MEND PR), but, although the TB trials were to start in 2009 (Genome Web article), no progress has been reported.  There is also for-profit interest in dry powder vaccines.  LigoCyte, a venture-backed start up in Montana, has dry powder vaccine for norovirus which was started in Phase 1 in 2007 and was reported as safe in April 2010 (LigoCyte PR) and an anthrax vaccine in works (NCBI article).  One of their investors is a major supplier of global vaccines, GlaxoSmithKline.   Another company, Oriel Therapeutics, was an University of North Carolina spin out based on a powder formulation process (UNC Spinouts) that was purchased this year by Sandoz, the generic drug division of Novartis, a big vaccine-maker (WSJ article).  Although the company’s pipeline comprosed two dry powder drugs not vaccines, one of the founders, Tony Hickey, made but not tested a dry powder ‘flu vaccine (AAPS article) and was involved in the preclinical testing of the MEND TB vaccine (PNAS article).

In the race for the first inhaled vaccine for a global disease, I’m switching horses from Aktiv-Dry/Serum Institute/Gates, since it seems their management structure is delaying the trials, and backing the dark horse, Sandoz/Novartis, who I am betting sees a huge dual market opportunity in storable, transportable, and easy-to-use world-wide vaccines.

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.

Peloton Partnering: A Friend for FRIND

In 2008, Dr. Paul L. Herrling, Head of Corporate Research at Novartis and Chairman of the Board of the Novartis Institute for Tropical Diseases (NITD), proposed a plan to fund and manage the development treatments for the neglected diseases.  His plan, called the Fund for R&D in Neglected Diseases (FRIND) (published in Global Forum Update on Research for Health Volume 5 [Global Health Update]) would provide funding and management of the preclinical development and clinical testing of treatments in the “pipeline” now managed by academic institutions, product development partnerships (PDPs), and companies.  Funds would come from foundations and governments and would be granted to projects incrementally based on results.  “Portfolio Management Teams” similar to those of pharmaceutical companies would allocate funds (and perhaps provide guidance) to projects.  The net result would be better allocation of resources and decrease in the later stage attrition.

Practically, implementing FRIND faces the hurdle of persuading the entrenched interests to cede control and the donors to fund yet-another potentially huge bureaucracy.  FRIND is a good idea and I wish Dr. Herrling success but also propose a more modest effort as a complement to FRIND.  I propose to create a low-cost service for anyone or organization intending to develop a product for a global health disease (treatment, diagnostic, or vaccine) and needing to:

-establish proof of concept;

-generate data to justify continued funding; or

-create sufficient value in the product to attract a licensee.

Peloton Partnering, named after the group of bicycle racers who benefit from each other’s momentum, will be a web-based community of life sciences industry professionals interested in global health and wiling and able to contribute some time to advancing global health product development. The initial aim of the network will be to match those participants with product development needs to those with product development expertise (e.g., design and execution of POC experiments, ADME/tox, clinical trials) or with business development or sales and marketing expertise to collaborate on specific projects pro bono.  In my experience, several hours of thoughtful and constructive advice can be invaluable to small organizations with limited resources.

Of course, there are wrinkles to work out, e.g.,

-confidentiality (there is none, just old-fashion trust);

-liability (none permitted);

-credibility of participants (reliance on peer-recommendation);

-performance metrics (mostly subjective);

-communication across distance and possibly cultures (video conferencing?); and

-donated time really isn’t free (maybe donors will get social responsibility credits for their organizations).

There are probably other snags I haven’t thought of.  The Peloton Partnering effort would be grass-roots-based and low-budget and a complement to the top-down, big-budget approach of FRIND.

The success of volunteers coaching and mentoring businesses is well-established through the success of programs like SCORE (SCORE) which matches retired executives with US small businesses, university-based venture mentoring programs like MIT’s Venture Mentoring Service (MIT VMS) and regionally-based programs like Innovate St. Louis (Innovate STL).  The Lemelson Foundation has an international entrepreneur mentoring program (Recognition and Mentoring Program; RAMP) and the National Collegiate Inventors and Innovators Alliance has a social venture mentoring program (Venture Well).  I have also heard about, but have few details for, a proposed network for supporting companies of the “global south” that has a mentoring component (the Global Health Accelerator as described by Frew et al. in Health Affairs (“A Business Plan To Help The ‘Global South’ In Its Fight Against Neglected Diseases;” Health Affairs). There is also an on-line collaborative community of academic researchers for drug discovery for neglected disease, the Tropical Disease Initiative (TDI).

Peloton Partnering would be only a part of addressing the challenge of developing and delivering affordable global health products but it seems to me doable and worthwhile.  I’ll be test-marketing the idea over the next months and will appreciate hearing any comments.