Catalyzing research into neglected tropical diseases

By Catherine Jewell, Communications Division, WIPO

The WIPO Re:Search initiative is an open innovation platform that seeks to catalyze research into the development of diagnostic tools, vaccines and drugs to treat neglected tropical diseases (NTDs), malaria and tuberculosis (TB). Since its launch in October 2011, WIPO Re:Search has more than doubled its membership and secured 11 research agreements, with many more in the pipeline. In this article, WIPO Magazine hears from WIPO Re:Search partners about why the initiative is creating such interest.

Dimensions of the challenge

NTDs, malaria and TB are complex diseases that impact millions of the world’s most disadvantaged people. A lack of market-driven innovation, resulting from poor patient purchasing power, has thwarted efforts to develop safer, more effective treatments for these diseases. WIPO Re:Search, a voluntary consortium led by WIPO in collaboration with BIO Ventures for Global Health (BVGH), brings together leading pharmaceutical companies, research institutes and academia to speed up research and development (R&D) into more effective therapies to treat these diseases.

Through WIPO Re:Search, members share their valuable intellectual property (IP) know-how and knowledge with the global health community to support NTD R&D programs, under minimal licensing terms. “In order to share research, data and developments, enterprises need a secure framework within which that sharing can take place. The IP system provides that framework and assists in the development of multiple collaborations across industry, universities and research institutes,” notes WIPO Director General Francis Gurry.

Key drivers

With 11 research collaboration agreements already in place and several others in view, the prospects for making a real difference in treating these diseases are promising. BVGH, which administers WIPO Re:Search’s Partnership Hub, plays a key role in identifying partnership opportunities, matching available assets with research needs and connecting potential partners. “Our role is to provide a framework for industry participation that fits with their priorities as a business,” explains BVGH President Jennifer Dent. “In any other environment, it would be extremely difficult to engage private industry in investing in research for products to prevent or treat these diseases, simply because they are not commercially attractive.”

As growth rates of traditional pharmaceutical markets in North America and Europe stall, pharmaceutical companies are looking to expand into developing markets with higher growth potential. “This provides us with an opportunity to engage companies in social initiatives like WIPO Re:Search. These companies want to move into these markets with a head-start in building consumer confidence as a trusted partner,” Ms. Dent observes. “WIPO Re:Search provides them with an easy platform and a managed opportunity to participate.”

The IP angle

WIPO Re:Search makes it possible for companies to share their IP assets for non-commercial research purposes while protecting their commercial interests. “AstraZeneca, like other pharmaceutical companies, has large quantities of assets that we are not currently commercially exploiting,” explains Kevin Pritchard, Science Policy Enablement Lead at AstraZeneca. “We have understood how valuable these are to external researchers, and we make them available to good quality projects under appropriate agreements. The WIPO Re:Search guiding principles give us a sound basis for doing that.”

AstraZeneca has made its entire patent portfolio accessible via WIPO Re:Search. “While much of our IP relates to materials which we want to commercialize, other material may not be currently under development. We are, however, constantly reviewing past projects and looking to revisit assets. Through these partnerships we need to retain a degree of control so that we know that we can continue to use these assets for commercial purposes if we wish, while giving others the freedom to work on them for non-commercial purposes,” says Dr. Pritchard.

Re-purposing IP assets

Neglected tropical diseases (NTDs), malaria and tuberculosis (TB) impact millions
of the world’s most disadvantaged people. A lack of market-driven innovation has
thwarted efforts to develop safer, more effective treatments for these diseases.
(Photo: iscockphoto. Sean Warren)

WIPO Re:Search creates an opportunity to repurpose IP assets. Many of the compounds and associated research made available through the platform might not have been screened for use in treating NTDs, malaria and TB, and may offer solutions that can advance scientists’ work on these diseases.

Partnerships are absolutely crucial to moving this field forward and spreading the cost of non-commercial research is essential,” Dr. Pritchard stresses. “WIPO Re:Search is a way in which we can use our IP and our general pharmaceutical skills to support the development of new medicines for NTDs – even though they would not become part of our commercial pipeline. That, for us, is a strong motivator.”

Royalty-free licensing

Under the WIPO Re:Search Guiding Principles (a standard blueprint for licensing IP assets that helps reduce transaction costs) members agree to make IP assets and know-how available to qualified researchers of NTDs, malaria and TB with no licensing fee and on a royalty-free basis. Any products resulting from this research will also be royalty-free for sales in least developed countries. “The flexibility of this approach has great scope for enabling multiple types of fruitful partnerships,” notes Dr. Pritchard.

An all-round win

“WIPO Re:Search is a win-win for everybody,” declares Dr. Dennis Liotta, Professor of Chemistry at Emory University, author of multiple patents and inventor of two frontline HIV/AIDS drugs. It’s a win for global health in that the partnerships that it creates promise to accelerate research in these disease areas. “With these partnering opportunities come efficiencies in moving potential drugs, vaccines or diagnostics forward,” he notes.

From an industry perspective it’s a win, because it offers an opportunity to develop in-house expertise around NTDs, malaria and TB which, as the geography of disease evolves, may one day become commercially interesting. “Commercial opportunities around some of the NTDs will remain poor, but several of them may well become commercially viable, as diseases such as dengue, which we thought were localized in developing countries become endemic in developed countries,” suggests Dr. Liotta.

“Companies that participate in WIPO Re:Search can position themselves to take advantage of those opportunities as they will have access to the scientific know-how to develop therapies in these areas,.” he explains. Irrespective of any eventual commercial advantage, participation in WIPO Re:Search offers a number of indirect reputational benefits in terms of business and scientific excellence. It is also “extremely motivational” for participating industry scientists “who feel they can make a direct personal difference,” Dr. Pritchard notes.

WIPO Re:Search is also a win for researchers. “There is some great science to be done here,” Dr. Liotta explains. “Researchers can often only take their NTD research so far, and then it dies because there is no way to go forward. But if you have high-quality international partners to work with then, suddenly, what looked like a limited opportunity starts to become attractive.”

The partnering opportunities fostered by WIPO Re:Search are taking NTD research to new levels thanks to the invaluable in-kind support provided by pharmaceutical companies. “Literally, no amount of money could get you access to these resources unless [pharmaceutical companies] were your partner,” says Dr. Liotta. “While academic institutions are fabulous places for doing discovery research, pharmaceutical companies really bring something special to the table when it comes to drug development,” he explains.

“These days in science, no one person or research group has sufficient expertise to do it all. If you want to do big things that are going to positively affect the health of the public, you had better find some good partners,” he said. In terms of catalyzing partnerships, WIPO Re:Search is unique. “I don’t see anyone else doing it on as comprehensive a scale as WIPO Re:Search,” Dr. Liotta notes.

Opportunities for skills exchange

WIPO Re:Search also offers interesting capacity-building opportunities. “WIPO Re:Search is an incredible opportunity for skills exchange, knowledge transfer and sharing and networking in a globalized world,” notes Dr. Ellis Owusu-Dabo, Scientific Director of the Kumasi Center for Collaborative Research (KCCR) in Tropical Medicine at Kwame Nkrumah University in Ghana. Facilitated access to a global network of scientists will help “avoid the over-duplication that we see all over the place,” he says.

KCCR, a center for the development of cheap diagnostic tools at the point of care for rural communities in Ghana, joined WIPO Re:Search in April 2012 and has already established three collaboration agreements via the platform. “Joining WIPO Re:Search has presented some incredible opportunities to showcase what we can do to a larger forum, and to enhance the capacities of our young scientists,” Dr. Owusu-Dabo notes. In January 2013, one of KCCR’s young scientists will be hosted by the University of San Francisco and funded by the Australian Government to advance his work on soil transmitted helminths (parasitic worms). KCCR has also sealed agreements with PATH and Stanford University to develop cheap diagnostic tools for onchocerciasis and schistosomiasis, respectively. “While every institution has its own focus, I would urge research institutions, especially younger institutions, to get on board to explore the opportunities,” Dr. Owusu-Dabo says.

The training courses and support services available under WIPO Re:Search, especially in IP negotiation and licensing, are also helping improve the capacity of researchers to better understand and more effectively use IP to leverage their research strengths. This is a key benefit for Dr. Owusu-Dabo, for whom IP awareness is a priority. “Demystifying intellectual property among African scientists is extremely important,” he notes. “We need to present IP as something that can benefit science and humanity and that can support scientists in achieving their research goals.”

Building confidence

The strong commitment by BVGH to identify meaningful partnership opportunities has been pivotal in instilling confidence in WIPO Re:Search. “We have adopted a very hands-on approach to identifying the right partnership opportunities for members and presenting concrete opportunities that both leverage what the provider (a pharmaceutical company) wants to share and provide a real opportunity for a user (a research institute or academia) to fill a research gap,” BVGH’s Jennifer Dent explains.

Building networks

By bringing together groups that would not normally know or interact with each other, WIPO Re:Search is catalyzing research into NTDs. As the consortium’s membership expands, so too will opportunities to match up the complementary expertise of different groups. “Bringing those people together creates new momentum in an area where research typically proceeded at a glacial pace,” explains Dr. Liotta. “I am convinced that we will look back in five years and will say that WIPO Re:Search was the ultimate multiplier, and created something much greater than the sum of its parts.”

Measures of success

(Photo: istockhphoto @ emre ogan)

Amid all the optimism about the potential of WIPO Re:Search, when can we expect to see concrete results? All too familiar with the lengthy timelines and challenges associated with vaccine and drug development, members are cautious but optimistic.

Many of the collaboration agreements relate to early-stage research, explains Dr. Pritchard and marrying scientists who have “a deep understanding of disease biology” with the chemical and drug development expertise of pharmaceutical companies “could take many years off the drug R&D process,” he suggests. “We see an enormous amount of scientific capability, and putting together the right sorts of partnerships can really speed things up,” he adds.

While Dr. Liotta agrees that the development of a drug “is not something that we should expect realistically from WIPO Re:Search in the next couple of years,” he notes that “we can see milestones along the way. If we have a drug that reaches early-stage clinical development where you see safety and efficacy, you have done proof of concept, and that is a mark of success. If WIPO Re:Search can achieve several proofs of concept, then I think it will be doing very well,” says Dr. Liotta.

What next?

Building on its initial success, WIPO Re:Search will continue to develop well-targeted collaborations. “Our focus is going to be very much on building collaborations with the existing group of high-quality members,” notes Jennifer Dent. The consortium will also work to expand membership in all regions and to spread the word about WIPO Re:Search.

WIPO Re:Search represents a huge opportunity to make a difference to the lives of the 1.5 billion people living with diseases that, for economic reasons, have been inadequately addressed. The new research collaborations it is creating promise to foster new scientific understanding, revealing new opportunities to alleviate the burden of these diseases. As Francis Gurry notes, WIPO Re:Search is a clear demonstration “that the intellectual property system can work and does work to the benefit of countries at all levels of development.” It will be interesting to see how this exciting initiative evolves.