Chris Colwell Email & Phone Number

Rockville, Maryland, United States

Singapore, Singapore

Washington, Dc / Philadelphia

Singapore

Washington, Dc / New York City Metro Area

Washington, Dc

Consultant to biotech and vaccine companies with a focus on providing analysis of funding, regulatory and policy impact on business strategies. Clients included both start-ups and large pharma / vaccine companies.

Washington, Dc

Established and developed new policy and advocacy programs at BIO, the world’s largest biotechnology trade organization. Through collaboration and effective stakeholder management quickly established BIO as the leading industry policy and advocacy organization for both vaccine and pandemic influenza / biodefense issues. Established BIO's advocacy platform for research tools and molecular diagnostics. Founding Coordinating Body Member of Rx Response, a private sector initiative that was established in collaboration with NGOs and public health organizations to maintain the supply chain of critical medicines during severe public health emergencies

Rockville, Md

Advised U.S. FDA leadership on policy related to the development and use of medical countermeasures against pandemics and bioterrorist threats. Supported the implementation of new FDA authorities, including stakeholder engagement, communications plans, and the development of guidance documents. Entrusted with national secret security clearance by the U.S. Department of State.

Washington, Dc

Analyzed peer-reviewed articles on health economics and clinical outcomes and created a library of evidence-based talking points and presentations to convey key points. Content was used in the development of white papers, external presentations and media relations

West Point, Pennsylvania (Philadelphia Metro Area)

Managed vaccine manufacturing operations at Merck, including overall responsibility for a bacterial vaccine production facility with staff of over 40 personnel (PedvaxHIB®); start-up of the purification suite of a USD 80 million polysaccharide vaccine facility (Pneumovax®23); and shift operations for a live virus vaccine facility (Varivax®). Managed annual operating budgets and developed long-range operating plans, including planning and executing a large departmental reorganization.Ensured manufacturing regulatory compliance and managed inspections by domestic and foreign regulatory bodies. Prepared documentation, led facility inspections and testified before agencies. Lead Project Engineer responsible for several biotechnology facility projects ranging from USD 9-30M

Master’S Degree, Public Policy Analysis

Emphasis on health policy and health economics.

Bachelor’S Degree, Chemical Engineering