Jill Wechsler

The need for novel treatments for neglected diseases raises new challenges and opportunities. Hundreds of new drugs are in development to treat cancer, asthma, and other conditions prevalent in western nations, but very few for third-world diseases, commented James Geraghty, Genzyme's senior vice president. He noted that efforts to find new solutions to production and formulation issues can support corporate R&D programs and provide a valuable psychological boost for employees; third-world product development is "not charity," Geraghty said, but "a strategic responsibility" for the industry that is vital for maintaining political support and for regaining public trust and goodwill.

Tadataka (Tachi) Yamada, president of the Global Health Program at the Bill & Melinda Gates Foundation, described his organization's continued support for collaborative R&D programs, noting that the private sector must be more involved in bringing new solutions to this area. Gates also is providing more support to companies developing basic platform technologies, such as vaccine formulations without cold chain requirements, and is looking at "microfinancing" opportunities to support small local ventures.

Much of the discussion about global health at BIO and the International Conference on Global Health in Washington a few weeks later reflected progress in developing, testing, and producing new vaccines to prevent and reduce disease. The Malaria Vaccine Initiative managed by Seattle-based nonprofit organization PATH now has a candidate vaccine from GlaxoSmithKline nearing Phase 3 clinical trials. PATH's Meningitis Vaccine Project is even further along in developing a low-cost (40 cents a dose) vaccine to prevent frequent meningitis epidemics across Africa.

The Aeras Global TB Vaccine Foundation is working with the Dutch biotechnology company Crucell NV to use its advanced vector and large-scale cellular production systems to develop new products. Aeras has established its own vaccine production facility, "It's just as cheap to establish a facility that meets good manufacturing practices (GMPs) as one for clinical supplies," said president Jerald Sadoff.

The big disappointment is lack of a vaccine to prevent or treat AIDS. Models for AIDS treatment alone are unsustainable, Yamada noted; with 45 million people infected with the disease, all ultimately will need second-line treatment, a situation that already is creating tension about access to and patent protection for these more effective therapies. It will be a "great failure of modern medicine," said Yamada, if collaborative efforts do not succeed in this area.

Vaccine research also has benefited from the surge in funding to prepare for disease pandemics and bioterrorist attacks. As part of the national campaign to prepare for disease pandemics, Project BioShield is providing R&D support for new vaccines to prevent anthrax and smallpox, among other plagues. A sign of progress is the recent contract awarded Bavarian Nordic of Denmark to stockpile millions of doses of its new, safer smallpox vaccine. The Biomedical Advanced Research and Development Authority (BARDA), which was established by the Department of Health and Human Services (HHS) in April 2007, is implementing new policies that extend federal support for testing and developing medical countermeasures. Pandemic flu vaccine development should be facilitated by a final guidance from FDA on developing and testing seasonal and pandemic influenza vaccines.