Improving Cost Estimates in a Medical Acquisition Environment
Methods and Models II Track
Estimating costs for drug development has proven difficult over the years. Difficulties stem from the overlapping of the Department of Defense (DoD) acquisition process and the Food and Drug Administration’s (FDA’s) review process, small data pool, industry close hold of cost data, the inherent difficulties in the drug development process, and the lack of using best practices in cost estimating. Over the past couple of years the medical cost community has been working towards improving their cost estimates. These efforts included the establishment of a standard drug development work breakdown structure to ensure that data could be collected and compared in a standard way. A medical cost model was then created in order to use the available data to develop program estimates. Additional efforts have begun to join with agencies outside of the DoD to increase the size of the data pool. This presentation will detail the difficulties of estimating the cost of drug development activities and review the efforts that have begun to improve cost estimates.
Kalman and Company Inc.
Mr. Russo has been working as a cost estimator for the past 5 years. Previously, Mr. Russo has worked supporting the Marine Corps on their Global Combat Support System Marine Corps (GCSS-MC), Autonomic Logistics (AL), and Family of Target Acquisition Systems (FTAS) programs. He also worked with the Advanced Development Manufacturing Medical Countermeasures (ADM MCM) under the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) in the development of their Independent Government Cost Estimate. Currently, Mr. Russo supports the Joint Project Manager for Transformational Technologies (JPM-TMT) in the development of multiple cost estimates. Under JPM-TMT he also supports the development of the Small Molecule Integrated Cost Model (SMICM) and the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) interagency cost model.
Dr. Kimberly Wallace
Kimberly Wallace is a subject matter expert in bacterial pathogenesis and molecular microbiology. She received her BS in Molecular Biosciences and Biotechnology from Arizona State University and a Ph.D in Microbiology and Immunology from Dartmouth College. Kimberly currently works for Joint Project Manager Transformational Medical Technologies (JPM-TMT) as the Deputy Product Manager for the Advanced Bacterial Countermeasures Program, and also serves as the lead for the JPM-TMT cost model and Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Interagency Cost Model initiative.