Malcolm J. Bertoni serves as Associate Commissioner for Planning and Director of the Office of Planning in the Office of the Commissioner, a position he has held since August, 2008. Mr. Bertoni joined FDA in July, 2004, as Director of the Planning Staff in the Office of Planning.
The Office of Planning works collaboratively to provide objective planning, analysis, and program evaluation services to improve FDA's policies and performance.
Mr. Bertoni is responsible for directing agency-wide strategic planning, performance management, economic analysis, program evaluation, business process planning, risk communication research and planning, user fee program analysis, and public health outcome measurement and analysis. The Office of Planning works to improve FDA's effectiveness and efficiency through a broad array of initiatives that include:
- Developing a comprehensive, coherent framework of performance metrics and outcome measures that align with FDA and HHS strategic goals and priorities.
- Improving the effectiveness and productivity of agency business processes.
- Enhancing the efficiency and effectiveness of economic analyses.
- Strengthening the agency’s risk communication capacity, research, and best practices.
- Expanding the agency’s program evaluation capabilities.
- Enhancing the analytical tools and features available to program managers and the public in the FDA-TRACK performance management system.
Mr. Bertoni holds a Bachelor of Arts degree from Stanford University's interdisciplinary Program in Human Biology, with a concentration in Public Policy, and a Master of Science in Operations Research from The George Washington University, with a concentration in Management Science. He also is a graduate of the Senior Executive Fellows program at Harvard University's John F. Kennedy School of Government.
Prior to joining FDA, Mr. Bertoni was a Program Director and Senior Research Scientist at RTI International's Washington, DC office, where he managed a contract research program in the areas of quality management systems, decision support, and environmental research planning.