GUD Knight

About a month ago, the US FDA announced that it had granted a Canadian company, Paladin Therapeutics, approval to sell a drug called Impavido® to treat leishmaniasis, a nasty, protozoan infection that occurs annually in about 1.3 million, mostly poor, people and causes 20-30,000 deaths (WHO Fact Sheet). The press release in FierceBiotech also stated that Paladin received a Tropical Disease Priority Review Voucher (PRV), only the third one granted. The PRV process is intended to encourage development of drugs for neglected diseases, and the FDA will expedite review of a drug submitted by the holder of a PRV, and the company has sales sooner as a result. And since it is transferable, the holder can also sell it, although none have been sold (or used) to date. I found it interesting that the FDA would make the announcement and not the company and was more perplexed when I found that Paladin was no longer in business, having been purchased in 2013. But before untangling that web, I looked up background on Impavido.

Impavido is the name trade-marked by the Æterna Zentaris Inc., a German company, for a drug with the generic name of miltefosine. Miltefosine was designed and developed in the 1980s as an anti-cancer drug, was found to be a broad spectrum antimicrobial, and developed as the first (and only) oral treatment for chronic leishmaniasis by ASTA Medica (later Zentaris GmbH), the WHO Special Tropical Diseases Programme, and the government of India in the 1990s. Subsequently, Zentaris got approvals for Impavido in Germany, India, and Central and South America (the last through licensees), and miltefosine is made by at least one Indian generics company for the domestic market (nicely summarized by Dr. Anthony Crasto in his blog, New Drug Approvals, and at docguide.com). So why isn’t Impavido/miltefosine being widely used to treat leishmaniasis (which has three forms- visceral, also known as kala-azar and the most serious form; cutaneous, the most common; and mucocutaneous)? I looked at the Drugs for Neglected Diseases Institute’s (DNDi) website since this grant-supported, not-for-profit has a major program to develop visceral and cutaneous leishmaniasis drugs (DNDi Strategy), but could not find a clear reason. My read is that DNDi believes that the drug’s course of treatment (28 days) and immediate improvement may result in poor patient adherence and development of resistance, the drug’s potential fetal toxicity makes it unsafe for reproductive-age women, and its cost is too high for monotherapy (about $80 per course at the current WHO-negotiated preferential price). Dorlo et al. had a more positive assessment in their 2012 review, concluding that, as a well-tolerated and oral drug, miltefosine should be a viable option for many patients.

What about Impavido’s use as a treatment? All rights to the drug were bought by Paladin, a successful, Montreal-based specialty pharma retailer founded by Jonathan Goodman, from Zentaris in 2009 (PRNewswire release). Paladin apparently continued Zentaris’s commitments to its licensees and WHO purchasers, selling about $2.5 million worth out of total annual sales of $200 million. In November, 2013, Endo Health Solutions, Inc., a US-based specialty pharma company, bought Paladin for about $2 billion in cash and stock (Reuters article), in part to extend its product line and in part to reduce its US corporate tax liability. Since the acquisition was done through an Irish holding company, some analysts call the deal an end-run around the IRS (e.g., Zerohedge.com blog), interesting but not relevant. What is relevant is that Mr. Goodman negotiated retaining Impavido ownership as one of the assets for his new company, Knight Therapeutics, which he founded just after the Paladin sale. Knight is off to a good start with $60 million invested by Mr. Goodman, another $180 million from other investors (Cantech Letter), and an IPO on the Toronto Stock Exchange in March (Waterhouse article). Why did Mr. Goodman keep Impavido as the company’s first product? It’s not clear to me. According the two above-cited sources, Knight licensed Impavido’s non-US rights to Endo so will get about $500K in annual royalties (peanuts for a company with a market capitalization of about $140 million), and Knight has the drug’s PRV (value to be determined). According to the company website (Knight Products), it is developing a commercialization plan for the drug for the US market, although leishmaniasis is very rare so revenues are likely to be small.

Mr. Goodman is clearly an experienced and successful entrepreneur, building Paladin from a start-up to a public company, and is wealthy from the Endo deal (he owned one-third of Paladin’s stock as reported in a Globe and Mail article). He also has a different perspective on life after an almost fatal bicycle accident in 2011 that I, as a road biker and commuter, can relate to. Two weeks ago, Mr. Goodman posted a note called To Define Success in which he wrote “Success is defined by the good we do for others.” He ended with:

The more you practice the cycle of giving, the easier and more rewarding it becomes – it is now my new addiction (I gave my bicycle to my cousin). Anyone can repair our world. Anyone can make a difference. Any currency can be used, whether it is money, knowledge or your time. Knight’s stock ticker is GUD, not derived from Goodman, but for the hope we all do good.

My humble suggestion is that Mr. Goodman use his money, knowledge, and time to get Impavido used to treat as many of the 12 million people with leishmaniasis as possible.

Shameless Plug

As I noted in last week’s post, I reconnected recently with a colleague who has an interest in accelerating the discovery of drugs for neglected diseases via a data-sharing platform.  Michael Pollastri is an associate professor of chemistry at nearby Northeastern University and a ten-year veteran of the pharmaceutical industry, and I have mentioned him and his work on repurposing existing drugs to target parasites in previous posts (e.g., “A Rare Request, an Orphan Offer”).  Mike is starting a web-based portal for sharing of data and ideas among medicinal chemists trying to develop new drugs for the neglected diseases (ND), which in this case, includes the thirteen WHO-listed neglected tropical diseases and the two better-known global diseases, tuberculosis and malaria.  All are diseases of poverty, have low mortality but high morbidity with long periods of suffering and often a lifetime of disablement, and hence have a devastating effect on societies in the endemic areas (Kaiser Fnd Fact Sheet).  Although there are drugs to treat most of these diseases, new drugs are needed to cure rather than treat, to overcome or prevent resistance, and to make widespread treatment easier, affordable, and less toxic.  As for current efforts, the leading product development program, the Drugs for Neglected Disease initiative (DNDi) has programs for Human African Trypanosomiasis, Chagas, pediatric HIV, leishmaniasis, malaria, and filariasis, and the Gates Foundation has prioritized filariasis, onchocerciasis (river blindness), and soil-transmitted helminthic infections in a recent call for proposals in its Grand Challenges Round 10.

Mike’s reasons for the portal are sound.  A major bottleneck in finding new drugs (not only for neglected disease but all disease) is finding lots and lots of “maybe drugs,” chemical structures that have biological activity in predictive assays and can be run through more assays and tinkered with to find non-toxic, bioactive, and potentially therapeutic versions that can be tested in humans.  It is medicinal chemists that design and tinker with the structures to optimize their activities along the multiple parameters required by the desired drug.  So, since the universe of potential structures is vast, the number of possible targets immense, and the design and testing cycle fast, Mike wants to see more sharing of ideas, advice, and results, especially negative ones, early in the process, before the years of data accumulation needed for a publication.  He also sees the portal increasing opportunities to form collaborations; to share preferred assays, endpoints, and models; to bundle work to get better prices from contract research companies; to aggregate and organize data for extraction of insights; and to promote the drug profiles desired by organizations (and companies) looking for candidates to develop into products.  Mike also notes that the product development programs like DNDi, Medicines for Malaria Ventures, and the TB Alliance seem to have only modest pipelines and few or no back-up compounds for their clinical leads and need more maybe drugs.  Also getting industrial-strength collaborators to further test the maybes is getting easier now that a number of the major pharmaceutical companies are supporting ND drug discovery, e.g., by making their compound libraries available and participating in data- and resource-sharing efforts like Re:Search (see last week’s post) and GlaxoSmithKline’s Tres Cantos Open Lab Foundation.

As for models of collaborative ND drug discovery, Mike mentioned two to me:  the successful search for a synthetic pathway to make a pure form of the anti-parasite drug, praziquantel (Woelfe et al. 2011) and the on-going OpenSourceMalaria project (OSDD- Malaria).  As for the mechanics of the portal, he may utilize the software and considerable expertise of Collaborative Drug Discovery, Inc., a company in California I have mentioned previously (“Drug Development on the Cheap”) and which is the host of a public access “vault” of structure-activity data for ND research (CDD Public Access).  One big bug in the ointment of Mike’s proposed portal is intellectual property rights and whether/how to protect them.  He told me that access would be password-protected and limited to those who agree to confidentiality to assure that pre-patent-application disclosure did not occur (I think he may need a legal opinion on this).  Also, some academic research administrators get antsy about their researchers disclosing pre-publication data, as UCLA did when GlaxoSmithKline requested proposals for funding recently (“The Good, the Bad, and the Ugly”).  Other than the concern for obviating later patents, there is the problem of “confusion” of who invented what should any participant of the portal (really his/her institution or company) file an application.  Theoretically, a patent may have value; practically, it will have none (one of the reasons these diseases are neglected).  But for academic institutions that have over-staffed technology transfer offices and lots of money to throw at patents and for companies concerned that their own patents will be open to challenge, the problem needs to be addressed.  As I noted last week, the WIPO open innovation program, Re:Search, requires participants to agree to grant no-cost, limited licenses to the other participants, but this solution generates a huge overhead that Mike’s effort can’t afford.  I thought up three alternatives that kick the can down the road and require minimal bureaucratic involvement upfront.  The participating parties could agree not to assert any resulting patents against each other or they could agree that everyone is prospectively granted an non-exclusive license under any subsequent licenses that result or everyone agrees everything goes into the public domain and there are no patents.

Not surprising, the other bug is money and right now, like many entrepreneurs, Mike is taking the crowd-funding route to raise $25K to support a pilot version of the portal.  If you looking to increase your 2013 tax deductions, you should check out his site at Fight NTDs.  Long term support of the what are likely to be modest operating costs could come through participant fees (may be from a big pharma who sees the value) or from grants from the government (unlikely) or foundations (more likely).  One obvious source (for all things global health) is the Gates Foundation, but Mike says his approaches to Gates and two of the groups it funds, DNDi and BVGH/Re:Search, have not been fruitful.  I think more probing of Gates is warranted since it is heavily invested in PATH that has an open source ND project (OneWorldHealth Share) and at least one of its program officers has written about the value of medicinal chemistry and data-sharing in drug discovery (Elliott 2012).  Mike’s portal is too good an idea to flounder, but it needs money and a snappy name.

Over to the Dark Side

Back now from my trip out to the wild, wooly, and wet west, I noted a story by Luke Timmerman, ace biotech reporter for Xconomy Seattle, that Tachi Yamada, former president of the global health program at the Bill and Melinda Gates Foundation, had joined the venture capital firm of Frazier Healthcare Ventures as a senior executive-in-residence (Xconomy article).  While his colleagues and associates in the non-profit world may view his move as one step closer to perdition, I had the opposite reaction, hoping that he will carry his idealism and enthusiasm for global health solutions into the for-profit world and create a model for venture capital investment in companies with global health products.  With further research though, I’m not sure if Dr. Yamada will stick with his new job for a couple of reasons.

First, Dr. Yamada’s work experience doesn’t fit well with the venture capital business; he has no track record in identifying and funding ideas and people who develop commercially valuable products.  Although the Xconomy article notes that he oversaw the Foundation’s Grand Challenges in Global Health grant program (Grand Challenges), which has given more than half a billion dollars away since 2005 and in that sense has been a great source of seed capital for advancing novel ideas that would not have been funded through traditional sources, he did not run it as a venture capital program.  The overwhelming majority of the funding has been given to academic groups and not companies and without an expectation (or an accounting) of a return as I noted in my post of 11/24/09.  The Foundation has taken a few, small steps to become an investor (really a co-investor) in early-stage companies, e.g., their recent investment in Liquidia Technologies which I wrote about with faint praise in my post of 4/14/11.  But as I noted in my post of 1/14/10, although the Foundation has announced in September 2009 that it intended to use $400 million to make “program-related investments,” except for Liquidia, no investments have materialized.

Also, the psychology, language, style, personalities, and atmospherics of a VC firm are different from his previous work environments, although he is familiar with Frazier since, as the Xconomy article notes, he has been a part tine advisor to them.  The best venture capitalists take an active interest and involvement in the operations, planning, funding, and management of the of companies they invest in, which makes sense since they have a chunk of money at risk unlike foundations.  Running a big bureaucracy, as Dr. Yamada did at the Gates and as chairman of r and d at GlaxoSmithKline, is a far cry from helping a small company with their nuts and bolts, like choosing the right CMO to design the clinical trials that will make or break them.  Lots of hand-holding, cajoling, and maneuvering is used and it is not clear to me if he is up to or interested in this role.  In my limited experience, executives-in-residence are also positioned to become interim CEOs for portfolio companies when they need to be put back on track.

So it doesn’t look like Dr. Yamada will have they typical venture capitalist role, and the Frazier press release on his joining the firm was not particularly informative (Frazier press release).  In the Xconomy article, Jamie Topper, a general partner at Frazier, is quoted as saying Dr. Yamada will “open doors, find new opportunities, help us build our existing opportunities, and get access to international markets” which is a pretty general statement.  And although Mr. Timmerman notes Frazier may be interested in global health (“Topper did say that global health is ‘incredibly important’ and that Yamada will help the firm better understand how to invest in it.  “I think there’s opportunity there,” Topper says. “I’m not sure we’ll invest in 15 companies in it, but some of our companies are engaging in it now.”), I looked at Frazier’s existing 12 biotech investments and saw only two (Chimerix and Kalidex) that may have products applicable to global health  (Frazier portfolio).  So if Frazier has a global health investment strategy, it is low-key at best.

I am guessing that Dr. Yamada’s principal role will be to open doors to China’s billionaires, who, although they may be lukewarm to giving money for global health through foundations (PRI article), are likely to invest in new biotech ventures  (e.g., the recent launch of the biotech, Ascletis, with a $100 million from a Chinese investor [FierceBiotech article]), and, since VC firms can always use more backers, China’s nouveau riche is a likely source.  To the extent he is willing to persuade them and his colleagues at Frazier that global health companies are reasonable investments, the better for everyone.  Good luck on your new venture, Dr. Y.

Deal of the Year 2011

For those of you with a better memory than mine, you likely remember last October’s Big Deal announced between Pfizer, the world’s biggest (annual revenues of $70 B plus) and most at-risk (due to patent expirations) pharma, and Biocon, India’s small (annual revenues of under $150 M), up-and-coming biotech company (Biocon, Biocon).  In it, Pfizer purchased marketing rights and supply contracts for four of Biocon’s generic insulin analogues as part of its strategy to backstop its branded (patent-protected) drug business, which has had a series of trial-stage failures (FierceBiotech article), and to have products for the emerging, middle-income markets like India and China.  Diabetes is a major global health problem; according to the WHO, 220 million are affected worldwide and 80% of the diabetes deaths occur in low- and middle-income countries (WHO fact sheet).  In Vivo, a bioindustry trade publication, thought highly enough of the deal to name it the Alliance Deal of the Year:  “the union of these two companies is, in fact, blatantly ambitious and could have far reaching implications. It demonstrates a new way of doing business for pharma, touching on an battery of industry hot topics: biosimilars, pricing flexibility, diversification and emerging markets.” (In Vivo blog).

The specific dollars involved were relatively modest.  Pfizer paid Biocon $200 M upfront and will pay $150 M when certain milestones (e.g., at approval or sales levels, “additional amounts linked to Pfizer’s sales of any insulin products” according to the Wall Street Journal, WSJ article), but apparently not royalties.  In comparison, GlaxoSmithKline paid Acetlion $150 M upfront and up to $3 B later for an insomnia treatment in 2008 only to pull the plug on disappointing Phase III data early this year (FierceBiotech article).  Thus is the power of a patented but unproven product (and for a non-life-threatening condition of the developed world) to command big bucks.

Biocon also could have done better on the marketing terms.  Pfizer will have exclusive rights to commercialize Biocon’s drugs globally except in Germany, India, and Malaysia, where Biocon will have co-exclusive rights, but more co-exclusives would have been better since Biocon sells other products in 27 countries and, since the deal is not exclusive to Pfizer, Pfizer can shop for cheaper sources.  Biocon also has the task of getting approvals for the products which, although is good experience for a growing company, is expensive.  Biocon has also said it will be spending $300 M over three years to build manufacturing capacity to supply Pfizer (WSJ article), a good investment but major commitment.

The four products are all biosynthetic analogues of human insulin, the mainstay of diabetes control since Lilly came out with the first version, Humulin, in 1983.  Worldwide sales of such products is about $14 B annually (Bloomberg article).  Specifically the products are:

Product Stage Branded Product
Recombinant Human Insulin Approved in 23 countries Humulin by Lilly, Novolin by Novo Nordisk
Glargine Approved in India Lantus by Sanofi-Aventis
Aspart Preclinical Novolog by Novo Nordisk
Lispo Preclinical Humulog by Lilly

For Biocon, the deal provides capital to grow now, income as the lead product gets approval in the EU (2012) and US (2015), and international recognition as a player.

Of course, behind every great company there is a great woman and Biocon is driven by Kiran Mazumdar-Shaw, whose story is a primer on entrepreneurship.  As described in a recent article (Bloomberg article, Bloomberg article), Ms. Mazumdar-Shaw, whose father was a brew master like my grandfather, started Biocon in a garage in 1978 with a few thousand dollars, overcame gender discrimination and starting up in a low-resource environment, has ably guided the company to a market cap of more than $1 B, and has a personal wealth of $900 M (Economic Times article).  Biocon is diversified (more than 40 products, contract manufacture and research services [Biocon fact sheet]) and innovative with two novel drugs in late development, including an oral insulin (IN105) (Biocon pipeline).  Ms. Mazumdar-Shaw also is trying to change the equation in global health care through the Biocon Foundation which was started in 2004 with the mission “to provide sustainable and affordable healthcare/educational services to under-served rural and urban communities in India” (Biocon Foundation).  In health care the Foundation has two main projects:

  • an insurance plan called Arogya Raksha Yojana which in 2005 had about 70,000 member paying less that $3 each per year (ARY), and
  • a chain of seven clinics which served 22,000 in 2008-09 (ARY clinics).

The foundation’s big plan is “to set up large ‘health cities’ in every state capital and large hospitals in every district” creating “at least 20,000 beds within the next 3-5 years in various parts of the country.”  Its partner is India’s (and maybe the world’s) largest pediatric hospital, Narayana Hrudayalaya, which is both profitable and charitable (Wikipedia article and UNDP case study).  I like the concept of a biotech/pharma selling directly to a hospital chain at low but profitable prices to serve a social good, and I guess that is what Biocon and Narayana Hrudayalaya are thinking.  As for the Deal of Year 2011, I hope Pfizer realizes the value of a partner like Biocon and gives them a fat option fee for IN105.  If any of my former Wyeth BD colleagues survived the Pfizer takeover, I hope they can see that tie-ins with innovative, emerging market companies are good hedges against getting stuck at the bottom of a patent cliff.

BIO Break

I put my 2010 corporate earnings into negative territory this week by attending the world’s largest confab of biotech and pharmaceutical companies- the Bio Industry Organization’s BIO 2010, held May 2-6, at McCormick Place Convention Center, Chicago, IL (BIO 2010).  I am guessing that there are more than 15,000 attendees here, representing about every aspect of the for-profit life sciences sector, from the world’s largest (e.g., Pfizer with annual revenues of more than $50 billion) to the most modest (self-employed consultants like me).  It is the end of the third of four days and I am sitting outside the convention complex at the edge of one the world’s largest bodies of fresh water, Lake Michigan, and enjoying the mild temperatures, the coming evening light, and a view of a horizon so flat and blue that it strikes one as unreal.  Seagulls circling, bikers speeding down the bike path, joggers trotting along, everyone who passes by on his/her own mission while my head spins with information overload.  BIO is its own world, powered by the 15,000 plus attendees, each with their own story to tell, their own business objectives, personal hopes and dreams, and multiple reasons for congregating at this meeting.   I just had an interesting chat with a chap from the CDC (Centers for Disease Control) who does emerging infectious disease surveillance.  What about the fungal infection that gained notoriety by growing deep in the lungs of a few unfortunates who happened to enjoyed the woods of the Pacific Northwest?  Not to worry, only 30 cases so far and the CDC has issued an alert:  bronchitis plus back country experience means treat aggressively with anti-fungals (good advice for most of us but too late for the index cases, his bread and butter).  But Rift Valley Fever has shown up in Germany in tourists how have been in South Africa; stay in the cities if you are going to the World Cup (not me).  Of course, soccer hooliganism is a greater threat.  The CDC is concerned since the bugs are evolving but a pandemic is not in the cards (yet).  I am reassured, have another Pinot Grigio, and admire the view out the windows of the Vista Ballroom.

Take this conversation and multiply it by 50 and you’ll have an idea of my neural overload.   Everyone I have met has a story, a life history that I have put in context to my own meager experience (relative to the other 6.8 billion others on Earth).  Last night I met two sisters at O’Grady’s bar on Michigan Avenue at a Boston University-sponsored event who, chance would have it, grew up in Newton, five miles from where I live now, who are trying to get their recently-widowed mother connected with nice men about her age.  Yes, I know such a person and we exchanged email addresses and we’ll see what stories that result from the almost-random encounter.  Today in the multi-football field-sized exhibit hall, I am approached by a familiar face.  It is Konrad Powell-Jones (I wish I had a hyphenated name) who I haven’t seen in more than ten years.  We shook hands exchanged cards, and I’ll follow up since he is is still working in Toronto, and Toronto is the home of the McLaughlin-Rotman Center, a fairly big name in global health (Rotman Center).    From his card, I conclude he is doing the solo practitioner gig like me; maybe he can connect me there.  In the to-be-continued category is Pieter Stolk of euSEND, a new organization based in the Netherlands which, according to the article the BIO 2010 newsletter, is aimed at developing “concrete solutions for neglected disease in an economically sustainable manner.”   I missed him so left my card at the Holland pavilion and will try to connect with him tomorrow when I am volunteering as a room monitor at the Global Biotechnology Issues session.  At lunch I sat in on a panel presentation by three luminaries who are concerned about the US (and international) public “irrationality” preventing governments from approving biotech-generated plants and products.  Did you know that subsistence farmers in India want use a BT-engineered eggplant called Brinjal but an Indian agricultural minister has subverted the approval process, apparently for political purposes (Brinjal Paper)?   I didn’t.

A bit of a disappointment was the Partnering for Global Health Forum held on Monday and organized by BIO Ventures for Global Health (BVGH).  I was hoping to learn from my betters about how to direct the biotech/pharma interest (and experience) in making money in the “emerging markets” like China, Brazil, and India into investment in new products and services for the “under-served” emerging markets, too.  To be fair, I haven’t digested all that I heard, and there were two announcements at the meeting that I have yet to study:  the Clinton Foundation’s access to medicines program is connecting with companies and a South African agency and MIT joined the Open Innovation Pool (BIO PR).  I offer one contrast though:  the lunch time speaker at the Global Health Forum lunch illustrated his talk with photos of kids who were dying but offered no solutions but on Thursday morning the chair of the session entitled “Solving Challenges in Global Health Diagnostics, Creating Opportunities in Global Markets” had four speakers who are.  I’d rather attend the latter and skip the global health voyeurism.

The sun is going down here lakeside so I’ll meander over the excursion boat that is loading up with meeting attendees for what appears to be an invitation-only event.  No problem getting on, a business card and I am welcome.  It is an event by Chempetitive, a life sciences marketing group (Chempetitive) to publicize a relatively new “Illinois Medical District.”  Which is what?  The ticket-takers don’t seem to know, but on board there is pizza, a pianist at a Kimball grand piano, and an open bar.   I take a glass of Chablis on the bow deck, fire up my iPod, and enjoy the setting sun gleaming off the buildings of the skyline of one of the greatest of US cities.  But I can’t help but wonder why I was born to a privileged life as opposed to one of 20,000 lives cut tragically short today by a preventable disease.

USAID and Innovation

The recent Life Science Innovation Northwest conference (held March 16-17 in Seattle, Innovation NW) had a prominent yet unusual luncheon keynote speaker.  It was Dr. Rajiv Shah, the new administrator of the US Agency for International Development which is better know for its role in international aid rather than innovation in biotech.  Dr. Shah has substantial credentials for his new position and has ties to the Seattle area; he has an MD from the University of Pennsylvania and served as Chief Scientist at the  Department of Agriculture and as deputy director of policy and finance for the Gates Foundation’s Global Health Program (Shah Bio).  Although I was unable to find a text or video version of his talk, I saw he was interviewed by Luke Timmerman, national biotechnology editor for Xcomony, one of the best sources for news on emerging technology-based companies in the US (Xconomy).  In response to being asked what he saw was the USAID’s role in promoting Gates-type private-pubic partnerships and getting innovations in drugs, diagnostics, and vaccines  “out in the field and actually helping people in poor countries,” Dr. Shah said:  “We make a significant amount of direct investment in research and product development.”  And then he clarified his statement (a bit):  “We buy a lot of health commodities for low-income communities and low-income countries. They range from contraceptive commodities to malaria drugs to vaccines for children. That significant purchasing power could be used to create financial incentives for more technology development.”  (Shah Interview)

As a part-time advisor to several startups in global health that are scrounging about for funding, the first comment caught my attention.  First, I noted that USAID is not one of the agencies that have strong research programs and are subject to the Small Business Innovation and Research (SBIR) set aside, not that the SBIR program has had any role in promoting global health (GH) product development to date.  As I noted in my posting of November 5, 2009, only $15 million of the NIH’s annual $700 million SBIR funding goes into global health-related R and D.  Next I went to Grants.gov (Grants.gov), the website that lists recently posted grant opportunities for the entire government.  There are 104 USAID-sponsored RFAs (requests for applications) listed, covering a range of topics from implementation of good government practices to delivery of HIV/AIDs care, but none were specifically for technology development nor did the few I looked at in detail include such funding.  The RFAs are in keeping with the USAID’s mission of aid delivery and the standard government practice of hiring contractors to put our billions to work.   I note that, in the interview, Dr. Shah stated that one of his agency’s goals is to improve the contracting process by emphasizing monitoring results and involving more NGOs and non-profits organizations, which, to my thinking, would be a revolution in international aid.

Next, I checked the USAID website and found that the primary global health group is the Bureau of Global Health (Bureau of Global Health) which was funded at $4.15 billion in fiscal year 2007 (update needed, please).  The Bureau seems also be the key department for implementing the Global Health Initiative as announced by President Obama last May (GHI Statement).  The resulting headline was widespread and welcome (“$63 billion over 6 years”), but details were lacking.  Presumably the Bureau’s guidance for spending its share ($10 billion in FY 2010?) is provided by the Implementation of the Global Health Initiative Consultation Document (GHI Document), which, again, has no mention of product R and D support.  I found a similar story at the website for the Bureau’s Neglected Tropical Disease Initiative (NTD Initiative) which lists as its goals: monitoring and evaluation for integrated control programs; drug supply and delivery; operational research for improving implementation of mass drug administration; and selecting countries for inclusion in the Initiative.  No R and D support is mentioned, not even a listing of their current contractors (NTDI Contracts).

Clearly, Dr. Shah is interested in a role for the USAID in promoting innovation, and perhaps has a task force working on the specifics.  As he mentioned, as a buyer of global health products, USAID can create financial incentives, but only if the specifications for the needed products and the demand (quantity and price) are clear (and attractive) to prospective suppliers.  Rather than RFAs, the Agency could put out requests for proposals (RFPs) specifically aimed at developing the needed products with an attached advance purchase commitment (like the AMCs for vaccine used by GAVI which Dr. Shah worked on while at the Gates).  Clearly most of the Agency’s annual funding must be applied to purchasing and deploying current products to address the immense current need, but some portion could be used for stimulating the development of the next generation of products.  As an example, currently USAID is looking for two contractors to help them spend $450 million dollars in TB care over the next 5 years (TB Care RFA).  The RFA mentions the lack of useful (rapid and low-cost) diagnostics for HIV, TB, and MDR TB but not from where these products will come; at least the contractors could be required to purchase such products, should they be available, at some specific amount or percentage of diagnostics purchases.  This type of RFP could be done for a number of needed products; Dr. Shah alluded to publishing some kind of needs list to stimulate product development in the interview (“We’ll publish a focused, prioritized list of what the challenges are out there”).  I hope it appears soon with product specifications and terms for AMCs.

In addition, the USAID clearly knows a lot about the environments in which the next generation products will be used (and perhaps has a role in creating them), has relationships with the recipient countries’ governments which regulate and register new products, and knows the methods and costs of product delivery.  All of this experience and knowledge should be useful to companies seeking to enter the global health market and could be shared.  The USAID already has a large archive of documents resulting from their work (USAID Documents), perhaps it could be the basis for the Agency’s outreach effort to biotech companies interested in global health.

Pictures at an Exhibition

One of our best local museums, the Museum of Our National Heritage, is hosting a traveling exhibit, “Treasured Lands,” a collection of landscape photographs taken at 58 National Parks over a 15-year period by Dr. Quang-Tuan Luong (MONH), and I had the pleasure of viewing them this past weekend.  Hauling a heavy 5X7 large format camera, Dr. Luong drove, flew, hiked, backpacked and kayaked his way through parks from the Dry Tortugas NP off Florida to Wrangell-St. Elias NP in eastern Alaska to Haleakala NP in Hawaii, mostly alone but occasionally with his wife, to capture expansive vistas and unique views.  Completed in 2002, his series of park photos, more than 7000 in number, can be seen at his online gallery (Terragalleria) which includes another 14000 or so images from his world travels.  Having visited a few of the parks myself and tried to photograph landscapes, I have an appreciation for the composition, lighting, and sense of place he captures.  Each photo reflects a tremendous effort and patience and evokes memories of my experience of nature and appreciation of the world we humans should be thankful to inhabit.  I’m no expert, and not one for prizes and contests, but if the US has a poet laureate, Dr. Luong should be our landscape laureate.  Being an artist is a tough way to make a living and being a landscape photographer seems even harder, so I wish him well and will continue to be inspired by his work, both the process and the output.

But what’s this got to do global health?  Meeting and hearing Dr. Luong last week reminded me of the many talented and inspirational people I’ve met over the past year who are applying their experience and skills to the challenges of global health.  I ‘m proud to know the following:

Anup Akakihal:  Anup has degrees in biophysics and logistics and is building a cell phone-based inventory system for pharmacies to be deployed in low-resource settings in India and elsewhere via his company, Logistics for Global Good (Akakihal);

Jeffery Blander:  for more than 15 years Jeff has worked in the public health field as a practitioner, teacher, and innovator specializing the deployment of global health technologies, and is the co-founder of the non-profit foundation, Bienmoyo (Blander);

Marcia de Souza Lima:  Marcia is an ophthalmologist with multiple years of experience in the pharmaceutical industry and is now the chief medical officer of a non-for-profit company called Releef Initiative (Releef) and is the originator of the LinkedIn group, Pharma Professionals for Global Health (PPGH);

Kevin Killeen:  Kevin is a biotech industry veteran and now VP for research and business development for a Boston startup, Matrivax (Matrivax), which is developing cost-effective conjugate vaccines;

John McCoy:  John is using his 25 years of biotech/pharma experience to develop glycan-based products with nutritional and anti-diarrheal properties for developing world applications as CSO of Glycosyn, Inc. (Glycosyn);

Michael Pollastri:  Michael is a professor of chemistry and chemical biology at Northeastern University, who, after several years in industry, is working on new methods of drug discovery for the neglected infectious disease (Pollastri); and

Una Ryan:  well-know and -respected for her leadership of Avant Immunotherapeutics during its development of several vaccines including two with developing world application (against cholera and enterotoxic E. coli) and advocacy for global health issues, Una is now CEO of Diagnostics for All, a not-for-profit venture developing inexpensive, paper-based diagnostics (DFA).

As another random plug, I mention the upcoming meeting that BVGH and BIO are organizing in conjunction with this year’s BIO conference (Partnering for Global Health Forum, PGHF) and to note that, in addition to the Forum, there are sessions at BIO 2010 with global health implications, e.g.:

-Building Vaccine Capacity in Developing Countries

-New Development Opportunity—Partnering With a Not-for-Profit Company in Neglected Diseases

-Widely Accessible Diagnostic Technologies

-Conquering the Diseases of the Developing World

-Role of Indian Biotech Industry in Promoting Global Health

-Solving Challenges in Global Health Diagnostics, Creating Opportunities in Global Markets.

Specific information on these and others are at the conference site (BIO Sessions).