Author Archives: biosecureblog

http://youtu.be/M9ha3xHlUpg

Luciana Borio, MD

Assistant Commissioner for Counterterrorism Policy and Director, Office of Counterterrorism and Emerging Threats in the Office of the Chief Scientist, US Food and Drug Administration

Description

In this interview, Dr. Borio outlines the evolving role that the Food Drug Administration (FDA) has assumed in the development of medical countermeasures. Under Dr. Borio’s leadership, the FDA has established the Medical Countermeasure Initiative (MCMi), which is an effort to hasten the development of these products, and to improve their odds of achieving FDA approval. The MCMi has made investments in improving the regulatory science that will be necessary for government’s ability to evaluate a new generation of medical products. Here, Dr. Borio discusses some of the successes that the FDA has achieved in this arena, such as the ability to evaluate and approve multiplex diagnostic assays, as well as the challenges that remain.

Video produced by the Center for Biosecurity of UPMC

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http://youtu.be/eFDkRPkn8zY

Phyllis Arthur
Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy, Biotechnology Industry Organization

Description
The timely availability of medical countermeasures—drugs, vaccines and other medical resources needed for a robust response—is a key component of US biosecurity. Ms. Arthur discusses the role of public-private partnerships in drug and vaccine development and production and broadly outlines the roles that Congress, the Administration, and the private sector play regarding US biodefense policy.

As a senior leader at the Biotechnology Industry Organization (BIO), Ms. Arthur has a unique and critical role at the interface between the resources and requirements of the US government and the research, development, manufacturing, and production capabilities of private industry.

Video produced by the Center for Biosecurity of UPMC

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