Dr. Robert P. Kadlec, Director, Biodefense and Public Health Practice, PTRM Management Consultants

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. 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. 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. 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. Overview of ASPR ImplementationOverview of Procurement and the Biomedical Advanced Research and Development Authority (BARDA)Medical Countermeasures