Building Pharmaceutical Scientific Capacity in the Developing World

Tackling diseases of the developing world requires not only innovation in drug products, but also innovation in the organizational structures, training, and education to yield advances in R&D. Collaborative models, which bring together scientists from pharmaceutical companies, universities, and other research institutes, are important ways to marry external and internal activities, and several companies are advancing these approaches.

In June 2011, external researchers from six medical research organizations began work in the GlaxoSmithKline (GSK) “open lab” in Spain as part of GSK’s experiment to stimulate collaboration in the search for new medicines against diseases of the developing world, such as malaria and drug-resistant tuberculosis (TB). In total, eight scientists from six organizations from four countries, including the United States and South Africa, will work on their own research projects in association with GSK scientists at the Tres Cantos research campus. The Tres Cantos Open Lab Foundation provides funding and support for scientists, academics, and institutions to develop and advance new ideas that could lead to new medicines to treat diseases of the developing world. The researchers are the first external researchers to take up the open-lab placements since GSK announced that it was seeking to be more collaborative in this area of research.

GSK had first stated its intention to open the research campus outside of Madrid in 2010 with the plan of allowing GSK researchers to work more collaboratively with scientists from universities, not-for-profit partnerships, and other research institutes to address diseases of the developing world. The facility has made capacity available to independent researchers to allow them to work alongside approximately 120 GSK scientists and access their expertise and the facilities.

Half of this first wave of research projects are being supported by the Tres Cantos Open Lab Foundation, through a £5-million ($8-million) donation in seed funding from GSK to support suitable research projects. Among the projects underway are research to identify and optimize compounds that could be tested in humans against multidrug-resistant TB, three separate projects for malaria, including one that investigates potential compounds from the GSK chemical library, and a new approach against the parasites that can cause leishmaniasis. The specific projects and partners are outlined below:

• Themba Pharmaceuticals—A six-month project to identify potential new compounds for treating TB, specifically multidrug, extremely drug-resistant TB and co-infection with HIV-AIDS

• The Barcelona Center for International Health Research—A two-year project to create a continuous laboratory-based supply of the P. vivax malaria parasite in the blood stage.

• CICbioGUNE—An 18-month project to characterize the ubiquitylation profiles of cells infected by multiple drug-resistant TB and the malaria parasite P. falciparum

• Durham University—A nine-month project to identify compounds that can inhibit a new target in kinetoplastid protozoan parasites

• Weill Cornell Medical College—A 24-month project to identify compounds that can affect both drug-sensitive, multidrug-, and extensively drug-resistant TB in the nonreplicating phase

• Imperial College London, Drug Discovery Center and The Wellcome Trust Sanger Institute—A two-month project aimed to identify calcium-dependent protein kinases inhibitors from the 13,500 compounds identified by GSK in 2010 as inhibiting P. falciparum growth.

Collaborative research models also are the focus of other companies’ efforts. For example, Sanofi recently formed several partnerships to advance research for diseases in the developing world. Earlier this year, the company formed a collaboration with the Drugs for Neglected Diseases initiative (DNDi), a nonprofit product-development partnership, for a three-year project for researching new treatments for nine neglected tropical diseases listed by the World Health Organization. The diseases are kinetoplastid diseases (i.e., leishmaniases, Chagas disease, and human African trypanosomiasis), helminth infections (i.e.,lymphatic filariasis, onchocerciasis, and soil-transmitted helminthiasis), and dracunculiasis, fascioliasis, and schistosomiasis. Under the agreement, Sanofi will initially bring molecules from its libraries into the partnership, and DNDi will collaborate in research activities on innovative molecular scaffolds.

Sanofi also partnered with the Medicines for Malaria Venture, a nonprofit public–private partnership, through an alliance agreement to research malaria treatments and agreed to the first research project agreement within the framework of the alliance. As part of an agreement, signed earlier this year, both parties will work together to identify, characterize, and optimize new candidate compounds to treat malaria and conduct early-development programs to demonstrate proof of concept. The three-year research project, “Orthology Malaria,” seeks to develop drug candidates from a sent of Sanofi compounds that have been selected for their potential activity against malaria parasites.

And in June 2011, Sanofi entered into a research collaboration with Weill Cornell Medical College to identify new anti-infectives that shorten the course of TB treatment and provide therapies against drug-susceptible and drug-resistant strains of TB. Sanofi will prove 80,000 chemical compounds to Weill Cornell, where the compounds will be screened to assess their ability to inhibit growth of Mycobacterium tuberculosis. Weill Cornell has obtained funding from the Bill and Melinda Gates Foundation for screening activities. Sanofi and Weill Cornell will jointly determine if any compounds screened through the collaboration should be optimized for potential development.

Collaborative models also may involve building pharmaceutical scientific capacity. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), for example, facilitated setting up a Clinical Research Career Development program, which is coordinated by the UN Children’s Fund (UNICEF)–UN Development Program (UNDP)–World Bank–WHO Special Program for Research and Training in Tropical Diseases (1). The aim of the program is to provide practical clinical experience for promising researchers from low- and middle-income countries and encourage high-quality clinical R&D on medicines, vaccines, and diagnostics. After a 12-month fellowship with a research-based pharmaceutical company, the researchers return to their home countries and institutes to become a resource for R&D for infectious diseases. In 2009, 12 fellows were placed in training programs with seven IFPMA member companies: Eisai, GSK, Johnson & Johnson, Novartis, Pfizer, Roche, and Sanofi. This year, some of those companies are taking second fellows, and additional fellows are being placed with the IFPMA member companies of Astellas, Boehringer Ingelheim, Merck & Co., and Sigma-tau (1).

Reference

1. P. Van Arum, “IFPMA Outlines Global Health Initiatives,” online, Sourcing and Management 6 (7), June 2011.