Investors, including private equity and venture capital firms, are increasingly aware of the fact that government policies and funding efforts established in the US and the EU directly influence the value of their investments. Mr. Clerici’s practice centers on working with new entrants to the government marketplace and assisting existing participants in government-focused efforts in development of effective business strategies for selling goods and services to the federal, state and local governments, particularly in the biotechnology, pharmaceutical, and public-private partnership arena. These efforts involve all aspects of strategy development and tactical execution, including consideration of legislative and regulatory solutions and impact, public relations strategies, legal advice regarding appropriate contract actions, and suggesting corporate structures to maximize commercial value to his clients. Mr. Clerici, through providing counsel on strategic positioning, has contributed to clients securing more than US$10 billion in funding, including over US$4 billion in the life sciences area as well as assisting clients in entering into novel public-private partnerships on more than 50 Department of Defense installations throughout the United States.
Mr. Clerici has represented a number of large pharmaceutical and biotechnology clients to impact significantly the legislation implementing Project BioShield, the US Government’s initiative to promote and fund the development of biomedical countermeasures. He has negotiated the numerous contracts for clients selling stockpiles of countermeasures to the federal government, including the majority of the awards made under Project Bioshield. In 2005, Mr. Clerici played a substantial role in the drafting and passage of the Public Readiness and Emergency Preparedness Act (PREP Act), landmark legislation that provides substantial liability protections for makers and distributors of pandemic, epidemic, and bio-terrorism countermeasures. He testified as an expert in support of this legislation on four occasions before the US Senate Appropriations Committee, the HELP Committee, and the Judiciary Committee. In 2006, Mr. Clerici was instrumental in the passage of legislation creating the Biomedical Advanced Research and Development Agency (BARDA), which builds upon and improves Project BioShield.
Mr. Clerici has extensive experience advising clients engaged in public-private partnerships with the federal government, including representing one of the largest and most successful military housing privatization contractors in the Nation.
He's played a significant role in developing the legislative strategy and drafting key provisions of the SAFETY Act, a major component of the Homeland Security Act of 2002. Mr. Clerici has testified on behalf of the US Chamber of Commerce before the U.S. House of Representatives on the SAFETY Act's implementation and has represented a number of entities that have successfully received SAFETY Act certification. His political involvement spans more than two decades, having worked on campaigns for the US Senate, House of Representatives, and State offices. In 2001, Mr. Clerici was a candidate for the Virginia House of Delegates.
Prior to joining the firm, Mr. Clerici was a judge advocate with the US Air Force where, among other assignments, he advised the Air Force Research Laboratory on the procurement of technology from research institutions throughout the United States, Europe and Asia.
- "Public Health Funding Opportunities From the US", co-authored with Jennifer Hannesschlager, MedNous, January 2009
- "Meeting The Challenge Of Avian Flu: A Blueprint For Global Pandemics?", Metropolitan Corporate Counsel, July 2006
- “From BioShield to the PREP Act and Beyond: Developing a Market for Infectious Disease and Bioterror Countermeasures”, co-authored with Dana Perkins, Metropolitan Corporate Counsel, March 2006
- "Congress Enacts Substantial Liability Protections for Public Health Emergencies", co-authored with Doug Farry and Frank Rapoport, Washington Legal Foundation Legal Opinion Letter, February 10, 2006
Activities and Affiliations
Mr. Clerici served as a featured speaker at the following conferences:
- BIO 2009, Atlanta, GA, May 18 - 21, 2009
- NDIA Environment, Energy & Sustainability Symposium, Denver, CO, May 4 - 7, 2009
- Phacilitate Vaccine Forum, Washington, DC, January 26 - 29, 2009
- Genesis 2008, London, England, December 8 - 10, 2008
- AusBiotech 2008, Melbourne, Australia, October 26 - 28, 2008
- Funding and Collaboration Opportunities in Biotechnology, London, England, September 16, 2008
- Pacific Rim Summit on Industrial Biotechnology, Vancouver, BC, September 9 - 10, 2008
- 6th Annual Biodefense Vaccines & Therapeutics Conference, Washington, DC, June 9 - 11, 2008
- World Vaccine Congress 2008, Washington, DC, April 14 - 16, 2008
- AusBiotech 2007, Melbourne, Australia, October 21 - 24, 2007
- 5th Annual Biodefense Vaccines & Therapeutics Policy, Funding & Development, Washington, DC, June 4 -6, 2007
- Phacilitate Vaccine Forum, Munich, Germany, May 28 -30, 2007
- National Association of County and City Health Officials Public Health Preparedness Summit, Washington, DC, February 16, 2007
- Phacilitate Vaccine Forum, Baltimore, MD, January 22 - 24, 2007
- Webinar: The Pandemic and All-Hazards Preparedness Act, Washington, DC, January 16, 2007
- Member, US Chamber of Commerce Homeland Security Task Force
- Director, Aeolus Pharmaceuticals