Client Successes

Supplying the Nation with H1N1 Vaccine

In response to the significant demand last year for live H1N1 vaccines, Foley Hoag assisted leading biotechnology companies with securing contracts with the U.S. Department of Health and Human Services (HHS) to supply the H1N1 vaccine. These vaccines were approved by the U.S. Food and Drug Administration (FDA) and provided to health care facilities in advance and during the 2009 influenza season. Lawyers in the firm’s Life Sciences and Government Strategies practice, working as part of a specialized team focused on biodefense and pandemic issues, provide regulatory counsel from early product development to FDA approval, and through the Federal government procurement process.

Protecting the Nation Against Bioterrrorism

Foley Hoag lawyers in the Biodefense and Pandemic Preparedness practice regularly counsel clients on government affairs and business strategy in the development and distribution of products focused on medical countermeasures to terrorism and pandemics. Recently, the firm assisted a client, one of the Nation’s leading developers of effective countermeasures against biological and chemical weapons, in securing research and development funding for a second generation recombinant protective antigen (rPA) anthrax vaccine. The company may also be eligible to sell these critical products to the Federal Government under Project BioShield and authorities created as part of BARDA in 2008. Foley Hoag lawyers provide strategic government counseling and advocacy to secure support for these important biodefense countermeasures.

Promoting Advanced Technology to Improve Security, Public Health

A leading global medical device company asked lawyers in Foley Hoag’s Biodefense and Pandemic Preparedness practice to help secure funding and FDA approval for its next-generation biosurveillance system. The system is a novel technology platform that can identify H1N1 and other emerging infectious diseases, counter bioterrorist attacks more quickly, and help prevent the spread of foodborne illness, more quickly and comprehensively than competing technologies. The system has significant potential applications in academic laboratories, military facilities, numerous government agencies, and in health care settings, such as hospitals and clinical laboratories. Foley Hoag lawyers provide regulatory counsel and government strategy development to secure government and congressional support for new devices in the biodefense space.

Accelerating Innovation Against Emerging Threats

Foley Hoag’s Biodefense and Pandemic Preparedness practice was successful in securing funding in Department of Defense appropriations for research on the efficacy of combination influenza antivirals. The funds were allocated to a small biotechnology company through an agreement with the United States Naval Health Research Center. The public-private collaboration betweenCongress and the U.S. Navy with private and nonprofit researchers significantly advanced the company’s efforts to develop antiviral therapy in response to the influenza pandemic. Foley Hoag lawyers provide strategic guidance and help educate Congress and the Administration on the critical importance of promoting the development of new medical countermeasures against serious public health and security threats.

Enacting Legislation: the Biomedical Advanced Research and Development Authority (BARDA)

In a move that created enormous opportunities for early-stage life sciences companies, the U.S. Congress revitalized the federal government’s program supporting the development of medical countermeasures critical to protecting the nation against bioterrorism and pandemic threats. The resulting legislation created an agency within the Department of Health and Human Services (HHS), the Biomedical Advanced Research and Development Authority (BARDA). BARDA will inject more than $1 billion into research, development, and procurement of vaccines, antivirals and diagnostics. BARDA enhances coordination between government and emerging companies through support of advanced research and development, the vital phase that occurs in between basic research and commercialization. On behalf of a leading venture capital firm Foley Hoag worked with the HHS, Congressional members, and staff to craft legislation strengthening the nation’s response to pandemic outbreaks and bioterrorism. The key financing aspect of the legislation provides much-needed funding to allow early stage companies to traverse the "valley of death" before product commercialization. The legislation authorizes the Secretary of HHS to expedite contracts and grants, and the Director of BARDA to identify areas of unmet need, spurring further innovation and investment. BARDA institutionalizes the important partnership between the federal government and the life sciences industry, critical to safety, innovation and economic vitality.
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