Partnering with the New Players

Institutions are not just comprised of bricks and mortar; there is the human capital required to deliver a return on those basic infrastructure assets. It follows that in reviewing new business models for pharma development and production, of which the best example is Brazil's state-owned health enterprise, the Oswaldo Cruz Foundation (Fiocruz), we also highlight the contributions of individual leaders who successfully execute around that model. Carlos Morel, the Foundation's Director for Technological Development in Health, is a fitting example.

Morel, a molecular biologist, has been closely associated with the Foundation from the start of his career and now holds a pivotal role in creating a new infrastructure to support translational research on diseases critical to Brazil and other emerging country markets. "If there is a single word that defines where Fiocruz is going, it is partnership. We don't intend to be seen just as a procurement outlet for low-cost drugs and vaccines reimbursed through the government health system—our aspirations are global."

As a medical researcher, Morel has been prominently associated with the search for new drug treatments for TB, which to this day relies on an armamentarium that dates back to the early 1950s. His work has helped prioritize the development of new diagnostic tools for TB, including a pathogen test that delivers results in a matter of hours compared to the previous processing standard of several weeks, even months. "Despite modern technology, there are today more active cases of TB in all countries than at any time in history. We cannot begin to attack TB without the ability to initiate treatment among a highly contagious patient population the minute they are diagnosed. So progress in diagnostics is essential."

Because so many global health interventions are vertically imposed on national health systems by foreign-based aid donors, the integrative partnering model championed by Fiocruz stands out. Certainly it has scale and reach, with 11,000 employees administering an annual bud- get of $1.25 billion funded mainly through the Ministry of Health. Functions span the equivalent of the FDA, NIH, and the CDC and include managing a network of hospitals, research facilities, and academic/public health training facilities to the manufacturing of drugs (including eight anti-retrovirals for AIDS) and vaccines at plants located throughout the country.

The key objective on the partnership side is the transfer of technology rights to Brazil in return for drug makers' access to the Brazilian market, which puts Fiocruz at the forefront of how emerging country governments are using industrial policy controls to build local innovative capacity in pharmaceuticals and biotech. Fiocruz has agreements in place with Novartis; with Roche on flu vaccine; with GSK on pneumococcal vaccine production and the development of new treatments for dengue fever; and has long cooperated with Genzyme (now part of Sanofi) on applying the orphan drug disease model to yield more research in this area, appropriate to developing countries. Finally, it works with the Gates Foundation as an adviser on medicines manufacturing and distribution, where Fiocruz is on target to make vaccines for Gates for the global market.

Abroad, Fiocruz is building a footprint in Africa with a focus on the Portuguese-speaking countries. A Fiocruz branch has been set up in Maputo, Mozambique. The Foundation is committed to building a regional production factory there for antiviral drugs.

Morel is optimistic that science will provide more than enough opportunity for all players in drug development. "We are in a new world, one that is destined to yield new breakthroughs in how we discover and develop drugs. The issue is how we deploy this biology revolution on the origins of disease to accelerate approval and access to medicines that promote the public health goals of developing countries." Morel believes Fiocruz is best positioned of any institution outside the US and Europe to do that, with some 20 partnerships with private-sector developers now in place—and more to come. – William Looney