Public Health Preparedness
The research and development of medical and non-medical countermeasures is an essential aspect of the Nation’s preparedness. It also presents a unique opportunity for pharmaceutical and biotechnology companies to capture funding that furthers their commercial objectives, while, at the same time, helping to keep the Nation safe. Biodefense commonly consists of defensive measures against chemical, biological, radiological, nuclear and explosive (CBRNE) threats, including emerging infectious diseases and engineered threats.
One of the U.S. government’s critical national priorities is to strengthen the nation’s defenses against biological weapons. Our team, in support of the Federal Government’s goal to strengthen the national stockpile (SNS), assisted in the creation and implementation of such programs as Project BioShield, bolstered research funding at the National Institutes of Health (NIH) and helped create the Biomedical Advanced Research and Development Authority (BARDA). These programs provide critical funding for comprehensive solutions and assistance to clients working to develop countermeasures such as vaccines, antivirals, antibodies, antibiotics, detection devices and diagnostics. In terms of procurement with the Federal Government, our recognized proficiency and success in assisting our clients both in securing government contracts and managing relationships for peak performance at the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DoD), makes Tiber Creek Partners the proven “go-to” firm in this critical sector of the bio-pharma industry.
Pandemic Influenza Preparedness
As a result of our representation of more than two dozen companies targeting public health preparedness, we have been at the forefront of the Federal Government initiatives for pandemic influenza planning. Members of our team have testified on numerous occasions before Senate committees as authorities on liability mitigation during a pandemic and the need for policy changes to prepare the nation for an influenza pandemic. Our team members are active participants in the U.S. Chamber of Commerce’s pandemic preparedness working group, serve on the Chamber’s Homeland Security Task Force and have testified on behalf of the Chamber before the U.S. House of Representatives on the issue of liability reform and risk mitigation. Members of our team also assisted in the drafting of the SAFETY Act, the first federal tort reform law providing risk mitigation to providers of homeland security goods and services, and provided legislative strategy and legal support to assure its inclusion in the Homeland Security Act of 2002. Our team played a significant role in the design and passage of the 2006 Pandemic and All-Hazards Preparedness Act, which expands funding and coverage to include the advance development of early stage products against emerging infectious diseases. The Act also establishes the Biomedical Advanced Research and Development Authority (BARDA) to issue contracts and grants for advanced research and development in an effort to guide promising countermeasures between applied research and advanced development. Additionally, we helped lead the effort to pass of the Public Readiness and Emergency Preparedness Act (PREP Act), which was signed by President George W. Bush on December 30, 2005. The PREP Act provides broad protection for those involved in the research and development, manufacturing, and administration of medical countermeasures for not only bioterrorism, but also emerging infectious disease. The PREP Act proved absolutely essential to the Nation’s robust response to the 2009 H1N1 influenza pandemic, garnering bi-partisan support in allowing critical vaccines, antivirals, and protective equipment to quickly get to the American people without needless delay caused by fears of legal liability.