DomesticPreparedness met with Dr. Robert P. Kadlec, Director, Biodefense and Public Health Practice, PTRM Management Consultants. The key architect of the 2006 Pandemic and All-Hazard Preparedness Act, which established the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the Department of Health and Human Services (HHS), provides his insights on homeland-security medical countermeasures implementation, procurement, and organization for advanced research and development.

Overview of ASPR Implementation

The operational imperative behind the 2006 Pandemic and All-Hazard Preparedness Act and the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) strategy and implementation plan.

Overview of Procurement and the Biomedical Advanced Research and Development Authority (BARDA)

How a government market for the biodefense industry parallels the government’s aerospace market – and the differences between the two. The challenge posed by high failure rates in pharmaceutical development. The standup of the Biomedical Advanced Research and Development Authority, the key operational link between basic research and acquisition for the Strategic National Stockpile.

Medical Countermeasures

The importance of a concept of operations (CONOPS) for a medical-countermeasure program. First-responder and health officials’ input into the implementation process. Triage and the requirements for clinical diagnostic assays. Balancing preventive and treatment strategies. The operational implications of the “one bug, one drug” strategy vs. broad-spectrum pharmaceuticals and diagnostics. Investments in non-pharmaceutical medical countermeasures. Squaring medical countermeasure investments against non-medical countermeasures.

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Robert P. Kadlec

Dr. Robert P. Kadlec, a career officer and physician in the U.S. Air Force, served in several senior positions in the Department of Defense and the White House while on active duty. Following retirement he served as staff director of the U.S. Senate Subcommittee on Bioterrorism and Public Health, and in that capacity played a key role in drafting the Pandemic and All-Hazard Preparedness Bill. A graduate of the United States Air Force Academy, he also holds a Doctorate of Medicine and a Master's degree in Tropical Medicine and Hygiene from the Uniformed Services University of the Health Sciences as well as a Master's degree in national security studies from Georgetown University.

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