published 04/06/2002

Global epidemics of AIDS, tuberculosis and malaria are already decimating the world's population. There's a pressing need for new drugs and vaccines to check the spread of these infectious diseases, yet because the countries most severely affected are also among the world's poorest, and can't afford to pay industrialized-nation prices for new medicines, pharmaceutical companies have had very little incentive to develop them. However, with the advent of public-private partnerships, which have been designed to share the risks and costs of drug development, the tide is turning.

The world is in the throes of a deadly crisis: Aided and abetted by global commerce and international travel, infectious diseases -- especially tuberculosis, AIDS and malaria -- are sweeping across the planet, together claiming the lives of 10 percent of the world's population every single year.

The silently ticking clock in the lower right-hand corner of your screen is there to remind you of the enormity of this problem. For every minute that passes, two people will die of malaria and four will die of tuberculosis (TB). In the next 60 seconds, 10 individuals will become newly infected with HIV and 60 will contract TB. Some will become co-infected with HIV and TB.

Pandemic though these diseases might be, they hit developing nations the hardest. In fact, about 90 percent of all deaths attributable to infectious diseases occur in the world's poorer countries, which generally have neither the healthcare infrastructure nor the financial resources to stop these epidemics in their tracks.


And even if the nations of the South could afford the appropriate medications, the fact is that few effective drugs -- and virtually no vaccines -- actually exist. As well, these clever organisms have learned quickly how to evade whatever's thrown at them, making it harder still to devise the right treatments: HIV mutates like mad; strains of Mycobacterium tuberculosis have become multi-drug resistant; and Plasmodium falciparum hides from the immune system of its human host.

Even in the case of AIDS, whose eradication still ranks as a priority in countries of the industrialized North, new cures for these epidemic diseases are slow in coming. That's not because basic research efforts have bogged down, either. Quite the contrary: Scientists in academic, government and non-profit laboratories around the world have made significant progress in understanding how to attack these enemies.

The trick comes in turning basic discoveries into marketable products -- and at prices that developing nations can afford. Pharmaceutical companies, which most assuredly have the expertise to develop and commercialize drugs, have not had the incentive to invest in those for which they see no financial return. Pharmas would have to practically give away new medications to make them affordable in the developing world -- and even if they are willing to absorb the loss, they're still faced with myriad complex issues (including the protection of intellectual property rights).


But that's all about to change.

For one thing, global health has finally become a priority in the agenda of the world's richest nations (the G-8 nations). The governments of these countries have added their clout to long-standing health initiatives backed by the World Health Organization (WHO) and many other international non-profit groups.

They join the governments of developing nations, which have also committed themselves to active participation in global efforts at disease eradication.

Very importantly, philanthropic organizations have made global health a top priority. This is particularly true for the Bill and Melinda Gates Foundation, which has already provided more than $2 billion to support global health initiatives, including research into and development of new medicines and vaccines for treating these so-called "neglected diseases."

Pharmaceutical companies, too, have a social conscience: Some -- especially GlaxoSmithKline plc -- have been involved in collaborative R&D projects for years already; others have had their eyes opened by the world's reaction to the South African AIDS drug issue that erupted several years ago. When the South African government introduced an act that allowed cheap imports of AIDS drugs, as well as the manufacturing of generic versions of patented drugs, a coalition of 39 international pharmaceutical companies sued to protect their interests -- and raised such a furor of opposition that they finally dropped the lawsuit last spring. It was a public relations disaster, from which some pharmas are still recovering.

The pieces are all in place -- political will, money, scientific advances and corporate social responsibility. But to make them work together requires one more element -- social venture capital. This new business model, if you will, rests on the premise that the costs and risks of developing drugs and vaccines for neglected diseases must be shared with industry to ensure a public health dividend. Whereas traditional VCs expect a monetary return on their investment, social VCs expect a benefit to global health.

The instruments of social venture capital are public-private partnerships. The first of these, the International AIDS Vaccine Initiative (IAVI), was formed in 1996. The most recent -- The Global Fund To Fight AIDS, Tuberculosis & Malaria -- was launched early this year. There are plenty of others -- including The Global Alliance for TB Drug Development, The Malaria Vaccine Initiative (MVI) and The Medicines for Malaria Venture (MMV).

The new, not-for-profit public-private partnerships (PPPs) differ in the details, but they share some common traits. For one, each has a disease focus. For another, each identifies promising research projects, secures funds for those projects, and assists in bringing them forward through development. It's the way in which the PPPs accomplish this that's unique: They coordinate the activities of multiple players -- philanthropic foundations, universities, non-profit organizations, pharmaceutical and/or biotechnology companies and government agencies from developing countries as well as industrialized ones -- towards a common goal. And they structure these partnerships in such a way that the substantial costs of drug development are shared -- thus reducing the financial commitment and lowering the risk for each partner.


Of all the raging pandemics, tuberculosis is perhaps the most dangerous. Being highly contagious, TB has already infected one out of every three individuals on the face of the planet. And co-infection with HIV compounds the problem: The combination is lethal, each speeding the other's progress. In Africa, HIV is the single most important factor behind the increased incidence of TB over the last decade.

There are drugs for treating TB -- and they're generally able to cure the disease when patients adhere to the entire treatment regimen. However, since this requires a 6-9 month course and daily therapy must be directly observed by a healthcare worker, compliance rates are low. Inconsistent or partial treatment opens the door to single- or multi-drug-resistant strains of M. tuberculosis, which are on the rise everywhere -- including the U.S.

Despite the scary statistics, despite TB's re-emergence as a healthcare threat even in those industrialized nations that thought they had it licked, TB is still a so-called "neglected disease." That is to say, there hasn't been a new class of TB drugs developed in more than 30 years.

The Global Alliance For TB Drug Development (TB Alliance) is determined to change this situation. Formed in October 2000, the TB Alliance has already attracted $40 million in funding from philanthropic organizations-- a $25 million grant from the Bill and Melinda Gates Foundation (Gates Foundation) and $15 million from the Rockefeller Foundation -- and expects to garner a total of $150 million (from a number of sources, primarily governments) over the next five years.

Working as a virtual R&D organization, the TB Alliance will build a portfolio of TB drug candidates and manage their development through a series of outsourced projects. All the TB Alliance really holds is rights to intellectual property; it farms out the actual drug development.

Organization	Date Founded	Focus	Funding	Partners
Global Alliance for TB Drug Development (New York, Cape Town, Brussels)	October 2000	TB drugs	Gates Foundation ($25M); Rockefeller Foundation ($15M)	Chiron (2/02)

The Alliance's scientific advisory committee selects these projects from proposals submitted through a competitive process and then builds partnerships around each. These partnerships will always involve institutions in disease-endemic countries; they also include government or academic labs, non-government organizations, contract research organizations, and/or pharmaceutical or biotech companies, whose funding obligation can be met by in-kind donations of expertise, access to state-of-the-art technology or candidate compounds.

The focus throughout is on the development of TB drugs that will shorten the course of treatment, improve the treatment of latent TB infection and be effective against multi-drug resistant strains, while still remaining affordable to those countries that need them the most.


This business plan -- for that's exactly what it is -- was put together by Craig Wheeler, who was a senior member of The Boston Consulting Group's healthcare practice at the time, in partnership with the Rockefeller Foundation. "Rockefeller was one of the [original] instigators of public-private partnerships," he explained. Wheeler, who is currently the president of Chiron BioPharmaceuticals, had already worked with the Rockefeller Foundation to start the Medicines for Malaria Venture, which was launched in late 1999. "We partnered with Rockefeller for a series of projects; one was the TB Alliance."

Several principles guided the creation of these PPPs, Wheeler continued. "They should be run like private sector businesses, which are more efficient than public organizations." However, unlike businesses, the objective of a PPP is to create a social benefit, not a profit.

"Our original concept was to do whatever it takes to obtain the best technologies for developing drugs," Wheeler continued. "We needed an R&D arm and a business arm."

"Business development people [at biotech or pharma companies] recognize that we understand their language and we know how to do a deal," explained Maria Freire, CEO of the TB Alliance. "While we have a novel approach, our terms and conditions are defensible within the company."

For instance, a compound that's been sitting on a shelf will never make any money; if the TB Alliance licenses that compound, deals can be crafted in such a way that the participating company could have grant-back options for certain markets in exchange for reimbursement of the Alliance's development expenses. Moreover, the TB Alliance will still retain its rights to commercialize the drug for TB in developing countries. The company, on the other hand, is not restricted as to the drug's uses in developed-world markets.

For these partnerships to work, Freire continued, it's critical that the company's upper-level management is committed to the plan. "The decision has to be made at the corporate level as senior executives must be comfortable with the deal and stand by it before their shareholders. These are win-win situations."

The TB Alliance has already identified several promising drug candidates, and signed its first deal in February 2002. Under the terms of a memorandum of understanding with Chiron Corp., the TB Alliance will receive exclusive worldwide rights to develop Chiron's preclinical product PA-824 (a nitroimidazole-related compound) and its analogues as drugs for treating TB.

PA-824, which Chiron inherited as part of its $700 million acquisition of PathoGenesis Corp. in September 2000, has already demonstrated in vitro activity against both drug-sensitive and multi-drug resistant strains of TB (Stover, C.K. et al. Nature 405: 962-966. 2000). "PA-824 represents a novel class of compounds which is different from traditional TB drugs," Freire explained. "This is the first [new] compound that actually had some activity -- sterilizing as well as bactericidal -- against TB."

Though the TB Alliance will now take responsibility for drug development, the two parties may decide to collaborate in the future. Chiron does not get royalties on eventual drug sales in developing countries, but it does have a grant-back option for manufacturing and commercialization of any resulting products in developed markets.


Like the Global Alliance for TB Drug Development, the Medicines for Malaria Venture is establishing public-private partnerships to speed the progress of R&D on new medicines to treat a neglected disease -- in this case, malaria, which kills 1-2 million people annually, most of them children living in sub-Saharan Africa. Here, too, drugs for treating this disease do exist; but as with TB, resistance is on the rise. Not only is the malarial parasite itself able to quickly develop drug resistance, but also the female mosquito that transmits the parasite to humans readily adapts to insecticides, making it virtually impossible to wipe out. (You can find an in-depth description of the parasite's complex life cycle, and how it's able to evade the human immune system, in the Signals article, "Navy Wages Biotech War On Malaria.")

The Medicines for Malaria Venture (MMV), which was founded by WHO and the International Federation of Pharmaceutical Manufacturers Associations in November 1999, spent about $10 million last year on projects in its R&D pipeline. Like the TB Alliance, the MMV selects these projects from proposals that have been rigorously reviewed by its scientific advisory committee. Typically, MMV partners academic researchers with pharmaceutical companies. (Its collaborators are listed in the table.)

"We focus on financing drug discovery and development programs," explained Christopher Hentschel, MMV's CEO. "The underlying concept is the same as the other PPPs, but the execution is different. We're the only PPP that has established relationships with big pharma partners." In contrast, he continued, "IAVI [the International AIDS Vaccine Initiative] tends to have relationships with small biotech companies, which are more like subcontracts than real partnerships."

Organization	Date Founded	Focus	Funding	Partners
Medicines for Malaria Venture (MMV) (Geneva)	November 1999	Malaria drugs	Gates Foundation ($5M); ExxonMobil ($0.1M); Rockefeller Foundation ($2.3M); WHO-Rollback Malaria & UNDP/World Bank/WHO TDR ($4M); Swiss Government ($0.6M)	GlaxoSmithKline [GSK], Bristol University & the London School of Hygiene and Tropical Medicine (3/01); Jacobus Pharmaceuticals, Texas A&M University & Albert Einstein College of Medicine (3/01); Schering-Plough Research Institute, University of Washington, Seattle & Yale University(3/01); Bayer AG & Hong Kong University of Science and Technology (3/01); Jacobus Pharmaceuticals & WRAIR-U.S. Army (3/01); GSK & University of Liverpool (3/01); WRAIR-U.S. Army (3/01); Shin Poong Pharmaceuticals & WHO/TDR (3/01); GSK & UCSF (10/01)

The core to MMV's R&D partnerships, Hentschel said, is the fact that all parties contribute to the effort. MMV provides the money, academic groups bring intellectual property rights and basic scientific research, and the pharma companies provide the technology, chemical libraries and product development and regulatory expertise. As well, the pharmaceutical company scientists involved in these projects are "completely dedicated" to the project; they don't have to split their time with in-house R&D programs.

In return, MMV gets the intellectual property rights to any drug that's developed for use in disease-endemic countries. "Pharma gets products rights in the travelers' market, which is the largest market for anti-malarial drugs," he continued. Pharma partners also get the rights to "anything non-malarial coming out of R&D." Academic partners get "some financial return, but not necessarily a royalty," the exact terms of which vary from deal to deal, Hentschel said.


Ultimately, MMV intends to create a pipeline that can turn out one new anti-malarial drug every five years. Currently funded projects range from those with short-term goals -- particularly combining derivatives of the Chinese herb-extract artemisinin with known malaria drugs -- to those that explore the utility of new classes of drugs to fight drug-resistant disease.

One of those potential new therapies could well come out of the collaboration that MMV formed with GlaxoSmithKline (GSK) -- a major player in this field (as well as TB and AIDS) -- and the University of California at San Francisco (UCSF) in October 2001. MMV will finance the project; the other partners will provide in-kind contributions. In brief, the collaborators will build on a previous alliance in which researchers at UCSF discovered that inhibiting the digestive enzyme falcipain -- which malarial parasites use to degrade red blood cells -- might provide a new therapeutic approach, while scientists at GSK identified selective inhibitors of this enzyme.

Now, GSK will contribute certain rights under its patents on these inhibitors for use in the treatment and prophylaxis of malaria, as well as laboratory facilities and services to optimize drug candidates. UCSF, for its part, will evaluate the drug candidates in animal models.

Eventually, any product candidates emanating from MMV's projects that qualify for clinical trials will be tested in malaria-endemic countries, where (given the number of patients) trials can be conducted fairly easily. "These drugs have to work incredibly well," Hentschel said. "The benchmark is a cure in three days."


Anti-malarial vaccines, on the other hand, are intended to prevent the disease rather than cure it. For many reasons -- including the parasite's multi-stage life cycle, each stage of which has a different set of antigens -- malaria vaccines have proven extremely difficult to make. (For details, refer again to the Signals article, Navy Wages Biotech War On Malaria.") However, one candidate vaccine is already in clinical trials in Africa.

Developed by GlaxoSmithKline Biologicals, the RTS,S vaccine (a recombinant polypeptide consisting of part of the sporozoite protein fused to hepatitis B surface antigen) has been in development since 1983. It was initially tested in seven U.S. Army volunteers -- six of whom were protected from malaria. Subsequently, GSK tested its vaccine in adult men in The Gambia, West Africa; the product showed an efficacy of 70 percent in providing protection over a short period of time.

In March 2001, GSK joined forces with the Malaria Vaccine Initiative (MVI) at PATH (Program for Appropriate Technology in Health) to help speed this vaccine candidate into clinical trials in children. This is a joint project, with MVI providing the funding ($6.7 million) and participating in the decision-making process for moving the product forward. GSK is contributing its development and manufacturing know-how, scientific expertise and proprietary technology in malaria vaccine R&D. Pending favorable results from the preliminary clinical trials, the agreement also provides a mechanism by which MVI can participate fully in the product's late-stage development -- from Phase III trials to production and distribution.

Organization	Date Founded	Focus	Funding	Partners
Malaria Vaccine Initiative (MVI) at PATH (Seattle)	June 1999	Malaria vaccines	Gates Foundation ($50M)	Apovia (1/01); GlaxoSmithKline Biologicals (3/01); European Malaria Vaccine Initiative & USAID (6/01); Bharat Biotech International & India's International Centre for Genetic Engineering and Biotechnology (7/01); Oxxon Pharmaccines & Oxford University (10/01); Biotech Australia & Australia's Cooperative Research Centre for Vaccine Technology [CRC-VT] (12/01); Progen Industries & Monash University (12/01); Progen Industries & CRC-VT (12/01)

Within a month, the Medical Research Council in The Gambia, West Africa, had initiated Phase I trials of the vaccine in children aged 6-12. And early this year, Mozambique's Centro de Investigacao em Saude de Manhica started Phase I trials in children between the ages of 1 and 5. The Phase II trials will also be conducted in Mozambique, where year-round malaria transmission allows for a more complete evaluation of the vaccine's efficacy.

Without MVI's participation in and support of this program, it may never have gotten so far. "GlaxoSmithKline had stopped its malaria [vaccine] program prior to the time when MVI was created [June 1999]," explained Melinda Moree, MVI's senior program officer, business development. However, she said, the company was more than willing to let its scientists continue to work on the project if they could secure the funds. And they did -- about a year later when MVI stepped into the picture.

The GSK partnership is only one of about eight that MVI has established in its efforts to identify and advance malaria vaccine candidates. (Its collaborators are listed in the table.) And though each partnership is unique (with the exception that product rights revert to MVI if a partner decides to end its malaria project), they share a common vision.

In these deals, MVI brings more than money to the table. Importantly, it sets up relationships with clinical trial sites in Africa, where "understanding how to work clinical trials is not trivial," Moree said. "We all work together with the clinical trial sites," she explained. "It gives everyone a measure of assurance that in the midst of politics and other dynamics MVI is a neutral player." As well, MVI is able to supply vaccine adjuvants, contract consultants, hire outside experts, review INDs and even fund primate studies. In these ways, "MVI adds value to its partnerships," Moree said.

It also helps speed product development. "Our mantra is 'fail fast forward'," she explained. "We use an evidence-based approach. If something's going to fail, we want to find out ASAP." This means designing and conducting studies that provide definitive answers. This is the reason that MVI funds expensive primate studies, for instance: "We want to use enough monkeys to answer the question." As well, MVI tries to pare down the number of potential product candidates to those that have a high probability of success. According to Moree, "Every antigen ever discovered for malaria is still a candidate [for a vaccine]. Nothing's been eliminated yet. We want to take some of those off the list."


It's also been tough for researchers to devise an effective vaccine for AIDS. In the 15 or so years since HIV was first identified as the cause of AIDS, more than 30 vaccine candidates have been tested in Phase I trials. Of those, few have made it as far as Phase III trials. In late February 2002, the National Institutes of Health (NIH) decided not to proceed with a U.S.-based Phase III trial of a two-vaccine combination (one made by Aventis Pasteur, the other by VaxGen Inc.), but a similar trial in Thailand is on schedule. As well, VaxGen's AIDSVAX is being evaluated in two separate Phase III trials in North America, Europe and Thailand.

Given the obvious difficulty of devising an AIDS vaccine -- and the overwhelming need for one (3 million people died from AIDS in 2001) -- the Rockefeller Foundation convened a series of international meetings in the mid-1990s to discuss strategies for moving R&D forward rapidly, and for engaging industry in the effort. The result: The International AIDS Vaccine Initiative (IAVI), the first public-private partnership, headed by Seth Berkley (then the Foundation's associate director of health sciences).

IAVI accomplishes its mission by linking scientists from academia or biotech companies with clinical researchers in developing countries. The goal, once again, is to maximize the number of vaccine candidates in clinical trials, especially products that are tailored to viral strains that predominate in developing countries. Moreover, these vaccines must be inexpensive to manufacture, easy to transport and administer, stable under field conditions and require few inoculations.

Organization	Date Founded	Focus	Funding	Partners
International AIDS Vaccine Initiative (IAVI) (New York)	1996	AIDS vaccines	Gates Foundation ($126M); Rockefeller Foundation; The Starr Foundation; The World Bank (total funding as of 12/01: $227M)	Cobra Pharmaceuticals, IDT, University of Oxford & University of Nairobi (1998); Targeted Genetics, Children's Research Institute [Children's Hospital, Cleveland] & South African AIDS Vaccine Initiative (2/00); AlphaVax Human Vaccines, University of Cape Town, Children's Hospital [Columbus, OH] & University of North Carolina at Chapel Hill (11/00); Maxygen & DBLV (2/01); Therion Biologics, India's Ministry of Health and Family Welfare & the Indian Council for Medical Research (3/01); Berna Biotech, the Institute of Human Virology [University of Maryland] & the Uganda Virus Research Institute (2/02)

"When we set up IAVI, the AIDS field was at a nadir," president and CEO Berkley said. Basic research was making strides, but vaccine candidates weren't making it into the clinic. IAVI's goal was to bridge that gap. It's doing that through multiple partnerships. (IAVI's collaborators are listed in the table.)

For example, IAVI signed a research partnership with Durham, NC-based AlphaVax Human Vaccines Inc. in November 2000 to develop a vaccine based on recombinant Venezuelan equine encephalitis replicon particles (self-replicating RNA molecules). Inserted into this vector are several genes derived from HIV-1 clade C, the major HIV subtype found in South Africa, where the clinical trials will be conducted. "AlphaVax had a concept, which IAVI is financing [$4.6 million] to move it into humans," Berkley explained. "IAVI will help with hiring staff, regulatory issues and fund-raising." Moreover, the clinical trials will be conducted in the U.S. (at the NIH) and in South Africa -- presumably simultaneously, he added. As with all of its partnerships, IAVI negotiated a commercial arrangement that ensures opportunities to market the vaccine in developed countries and to offer it at a reasonable price in developing nations, where the need is greatest. The intellectual property remains "completely with the company," Berkley explained, although IAVI gets the developing-world rights.

Eventually, at least one of the AIDS vaccine candidates being developed under IAVI's partnerships should make it into large-scale Phase III trials. Where will the funds come from to support those trials? "In an ideal world, IAVI wants to partner as much as possible," he said. Financing might come from large pharmaceutical companies, biotech firms, public sector agencies (such as the NIH) or bilateral donors (Sweden or the Netherlands, for instance), he added. "They would have the money, the expertise and the infrastructure."


Indeed, although the various public-private partnerships have all secured substantial "start-up" funds -- primarily from the Gates Foundation -- finding the money to finance large-scale clinical trials -- or even to advance multiple programs into late-stage development -- is a challenge to all.

MVI for instance, initially focused on putting its programs into place and "getting things going," Moree said. But now, it "has to make things happen." And, though the $50 million in start-up funds it received from the Gates Foundation is a handsome endowment, indeed, it's clearly not enough money to support the full clinical development, registration, production and distribution of as many as eight new vaccines.

Where will the next "round" of funding come from? "Many PPPs are struggling with this question," Moree said. Aside from the Rockefeller Foundation, "There aren't many donors like Gates giving money for these kinds of activities."

Would the Gates Foundation give another grant to an organization it's already seeded? "It depends on what they're doing," explained Helene Gayle, the Foundation's director, HIV/AIDS and TB. "We certainly wouldn't shut off funding if the organization is making exciting discoveries."


Related Organizations

Organization	Date Founded	Focus	Funding	Partners
Global Alliance for Vaccines and Immunization (GAVI) (Geneva)	1999	Childhood immunization; provides vaccines and financial support directly to low-income countries	The Vaccine Fund ($750M from the Gates Foundation); governments of Norway, the U.K., the U.S. and the Netherlands (together, more than $250M); total funds $1.2B (2/02)	The Bill & Melinda Gates Children's Vaccine Program; the International Federation of Pharmaceutical Manufacturers; the Rockefeller Foundation; the World Bank Group; the World Health Organization; UNICEF; public health and research institutions; national governments
Global Fund To Fight AIDS, Tuberculosis & Malaria (Geneva)	January 2002	Set up as a financial instrument to disperse additional funds to existing programs	Almost $2B in pledges, including $1.3B from G-8 leaders and $100M from Gates Foundation (3/02)	First funded projects to be announced 4/02
Institute for One World Health (San Francisco)	July 2000	Parasitic diseases	ND	Celera Genomics & NIH (2/02)
Sequella Global Tuberculosis Foundation (Rockville, MD)	1997	TB vaccines	Gates Foundation ($25M)	The University of California Los Angeles (3/02); EpiVax & Intercell AG (3/02); Sequella & Cobra Pharmaceuticals (3/02)

In fact, IAVI has received money from the Gates Foundation more than once. "IAVI started with $2-$3 million from Gates, and shortly thereafter got another $25 million," MVI's Moree said. And in January 2001, IAVI received a $100 million challenge grant from the Gates Foundation, intended to spur increased public sector support for AIDS vaccine development.

Perhaps MVI will look to the Gates Foundation once again, too, but in order to do that it has to go back with results in hand, she added. It's not unlike raising money for a biotech company: "You have to justify the investment and be held accountable."

For, despite its seemingly boundless generosity, the Gates Foundation is run like a business: "They want to see leveraging of their money," explained MMV's Hentschel. Partnering or co-funding are ways to accomplish that: "Both add substantial value," explained Sally Stansfield, the Foundation's acting director, vaccines and infectious diseases. "We want our money to be as catalytic as possible," Gayle added.


While public-private partnerships are making significant progress in their efforts to bring together academics, companies, government agencies and non-profit organizations, there may yet be other ways to speed the development of drugs and vaccines for neglected diseases. And the Biotechnology Foundation (BTF) of the Institute for Global Health (located at UCSF) is looking for them.

Funded by the Rockefeller Foundation, the BTF's goal is to provide academic research projects with technologies owned by biotech or pharmaceutical companies, according to Anne Sunderland, project assistant. In the conceptual model, the BTF serves as a broker between the two parties. Companies agree to provide access to key technologies while licensing arrangements as well as intellectual property and legal issues are managed by the Foundation.

BTF project director Hannah Kettler is now conducting case studies on existing public-private partnerships to test the feasibility of this model. "We want to understand what has and has not worked in these PPPs," she said. "Can you broker the partnership independent of a specific disease?" That's a question she has yet to answer. However, Kettler said that she is impressed with the way the PPPs have handled issues surrounding intellectual property (IP). "They've shown that if there's money available, there are ways to get around IP issues." Moreover, she said, "as these cases add up, we can say that IP is not a major issue anymore."

Although the PPPs are "all versions of the same theme, they start from different places," she continued. Some concentrate on early-stage discovery projects; others focus on getting products into the clinic. But, she said, none has yet to provide the evidence that it can reduce the risk enough for a major pharmaceutical company to take over a project.

Aye, there's the rub. However, especially since the AIDS drug brouhaha in Africa, there's every reason for big pharmas to get involved in the global effort to abolish the AIDS, TB and malaria epidemics. Reportedly, many are currently reviewing their policies in this arena. One -- GlaxoSmithKline -- has gone on record in full support of public health initiatives. With the advent of public-private partnerships, pharmaceutical companies now have a mechanism by which they can participate fully in eradicating today's pandemics.