Realizing policy objectives in global health initiatives requires cooperation and innovation from the private sector, nongovernmental organizations (NGOs), and national governments. Technology transfer for pharmaceuticals and vaccines plays a crucial role in delivering healthcare solutions on a sustainable basis to low- and middle-income countries. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) recently issued a report, Technology Transfer: A Collaborative Approach to Improve Global Health, to provide insight, best practices, and case studies from the pharmaceutical industry on how to use technology transfer as a vehicle to improve health outcomes in the developing world.
In its report, IFPMA points out that technical transfer is essential for overall economic development for low- and middle-income countries as a way to accelerate the acquisition of knowledge, experience, and equipment related to advanced and innovative industrial products and processes. With regards to healthcare, technology transfer could be one innovative way to bridge the research and development (R&D) and access gap in low- and middle-income countries. In its report, IFPMA points to eight crucial factors for creating a favorable environment for pharmaceutical technical transfer as follows:
• A viable and accessible local market
• Political stability and good economic governance
• Clear development priorities
• Effective regulation
• Availability of skilled workers
• Adequate capital markets
• Strong intellectual property rights and effective enforcement
• Quality of the relationship between industry and government and the extent they are able to work together effectively for long periods of time.
The importance of transferring technology for medicines is recognized in the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property Rights of the World Health Organization (WHO), whose implementation IFPMA is contributing to through issuing its report on technology transfer. Moreover, the IFPMA report points out that technology transfer is more than simply handing over technology. “The transfer of R&D pharmaceuticals is more than a question of bricks and mortar; or providing a toolbox." said the report. “It occurs through many channels, all of which result in improving the economic capabilities of the recipient.” The United Nations identifies the following elements as part of technology-transfer package:
• Technoware, which from a pharmaceutical-industry perspective, would include the transfer of physical objects, such as equipment for use in research laboratories or production equipment for manufacturing pharmaceutical ingredients, formulation development, or manufacturing and packaging of finished drug products
• Humanware, which includes skills and human aspects of technology management and learning, such as a training course for researchers or physicians
• Infoware, which relates to techniques related to knowledge, information. and technology, inclusive of a technology license
• Orgaware, which involves the organizational and procedural knowledge needed to operate a given technology relating to a chemical or biological compound.
Collaboration between Fiocruz and GlaxoSmithKline
The IFPMA report details several examples of successful technology transfer in the pharmaceutical industry. One such example is a long-standing partnership between the Oswaldo Cruz Foundation (Fiocruz) in Rio de Janeiro, Brazil, and GlaxoSmithKline (GSK). Fiocruz was established in 1900 as the research arm of the Brazilian Ministry of Health with a goal to promote health and social development by spreading scientific knowledge. Today, Fiocruz performs basic and applied research, develops new technologies, and produces vaccines and medicines. The Immunobiological Technology Institute or Bio-Manguinhos unit of Fiocruz, which was established in 1976, develops and produces biopharmaceuticals, vaccines, and reagents for diagnostic kits. Fiocruz/Bio-Manguinhos manufactures approximately 10 million biopharmaceutical units per year (with capacity to triple this production), 7 million reactions for diagnostic kits, and 154 million doses of vaccines.
“We use different strategies to make products in-house to be available for our population,” says Antonio de Pádua Barbosa, director of production of Fiocruz’s Bio-Manguinhos. “Besides our own innovation and development, we have partnerships with local and global organizations, and we use technology transfer to accelerate the viability of the products for the population.”
Bio-Manguinhos currently has 35 projects in development: 7 in bacterial vaccines, 14 in viral vaccines, 6 in biopharmaceuticals, and 8 in in vitro diagnostics. “Most of the projects are in clinical development, “ says de Pádua Barbosa. “We have two bacterial-vaccines projects in Phase II, and three viral vaccine products in Phase II/III development,” he adds.
Fiocruz currently has a partnership with GSK for developing a vaccine for Dengue fever. “It is a partnership involving scientists from both organizations, who from time to time, visit, discuss, and implement actions to achieve the goals of the projects,” he says. “The projects are currently in preclinical studies, and we intend to go to Phase I clinical development within a year.”
The project for developing a vaccine for Dengue fever is one of several partnerships that Fiocruz has with GSK. GSK and Fiocruz first partnered in 1998 to develop vaccines, and the organizations recently announced new projects. In November 2010, GSK and Fiocruz formed a R&D agreement to develop new medicines to treat diseases that disproportionately affect people in the developing world. Under the new collaboration, GSK and Fiocruz will share research and expertise for drugs to treat malaria, tuberculosis, and leishmaniasis, with initial research prioritized for drugs to treat Chagas disease and leishmaniasis. The partnership will enable scientists at Fiocruz and GSK’s Tres Cantos facility in Spain to openly share new research, ideas, and know-how. GSK’s Tres Cantos Medicines Development Campus is focused on discovering new medicines to address diseases of the developing world. In January 2010, GSK created the nonprofit Tres Cantos Open Lab Foundation with £5 million ($8 million) in seed funding. The Open Lab Foundation is designed to facilitate collaborations across academia and industry.
GSK also partnered with Fiocruz in 2009 to provide Fiocruz with access to the technology behind GSK’s 10-valent conjugate vaccine for pediatric pneumococcal disease, or Synflorix. Under the agreement, GSK supplied Synflorix to Fiocruz until the technology transfer was completed. The vaccine was incorporated in Brazil’s national immunization program. Other strategic alliances between GSK and Fiocruz involve partnerships for several other vaccines, including vaccines against Haemophilus influenzae Type b, MMR (i.e., measles, mumps, and rubella), and rotavirus.
Eli Lilly’s MDR-TB Partnership
Another example of successful technology transfer is through the Lilly MDR–TB Partnership, a public–private partnership set up in 2003 by Eli Lilly to address the problem of multidrug-resistant tuberculosis (MDR-TB) by increasing access to treatment and focusing global resources on prevention, diagnosis, and treatment of patients with MDR-TB. Eli Lilly set up the partnership with an initial investment of $135 million in cash in 2003. The MDR-TB Partnership seeks to offer a multidimensional program from drug supply to treatment and surveillance to community support. For drug supply, Eli Lilly is engaged in working with partners to produce the active pharmaceutical ingredient and finished drug product for two antibiotics, capreomycin and cycloserine. It has transferred the technology, expertise, formulas, and trademarks to manufacture these drugs to manufacturers in China, India, Russia, and South Africa to serve high-burden MDR-TB areas. Eli Lilly also continues to supply antibiotics at concessionary prices to WHO-approved DOTS programs (Directly Observed Treatment, Short Course) for MDR-TB. These drugs are supplied through WHO’s global drug facility.
“Technology transfer is one component to drug supply,” says Patricia Carlevaro, head of the international aid unit with Eli Lilly. “It also involves providing manufacturing expertise, related technical assistance, and human-resources to support the technology transfer.”
In the case of the Lilly MDR–TB Partnership, Eli Lilly formed several strategic partnerships to meet an objective of increasing access to drugs to treat MDR-TB. For drug supply, it formed partnerships with several pharmaceutical manufacturing companies: Akorn (Lake Forest, Illinois), Aspen Pharmacare (Durban, South Africa), Hisun Pharmaceutical (Taizhou Zhejiang, China), Shasun Chemicals and Drugs (Chennai, India), SIA International (Moscow), and Vianex (Athens). Shasun is producing the API cycloserine, which is an oral drug, and Hisun is producing the API capreomycin, which is an injectable drug. Several manufacturers are producing the finished drug products: Hisun, Vianex, SIA International, Aspen, and Akorn. Purdue University in West Lafeyette, Indiana, is partnered with Eli Lilly to provide GMP training and related expertise to the partner companies in the MDR-TB Partnership. Also, Lilly also provides its partners staff for onsite technical assistance and training as well as financial support for facility upgrades as needed.
“In terms of a technology transfer strategy, our interest in these partnerships was to share Lilly’s specific and general manufacturing knowledge,” says Carlevaro. “We wanted to create self-sustaining centers of manufacturing excellence capable of providing additional products and employment. This involves supporting reliable generic-drug producers to ensure expanded multisource availability and to offer the manufacturing firms in the MDR-TB hot spots in China, India, Russia, and South Africa, the technology to produce the two second-line TB drugs.”
Carlevaro emphasizes that successful technology transfer relies on mutual trust and partnerships between the players and offers a mechanism to create sustainable drug supplies for developing-world markets. “It is a win–win situation for us and our partners,” she says. “We are able to share our technology for drugs that have reached the end of their product lifecycle for the innovator-drug company with companies or other partners that can manufacture and produce these drugs for the developing world.” She added that further facilitation of such arrangements can be helped through regulatory bodies as well by them allowing the mutual-recognition processes for drug approvals. “In the end, we are not just transferring manufacturing technology, but also other forms of acquired expertise: equipment, staff training, and quality.”