The Office of Program and Strategic Analysis (OPSA) provides a range of analytical services, project management support, and strategic and operational planning for CDER offices to improve the effectiveness and efficiency of regulatory functions.
Director: Andrew Kish, MSPPM
Deputy Director: Michael Rappel, PhD
OPSA has a diverse team of professionals including economists, data scientists, LEAN experts, change facilitators, decision scientists, performance appraisers, and crowdsourcing experts.
- Analytics and Data Services Staff
- Decision Support and Analysis Staff
- Economics Staff
- LEAN Management Staff
- Program Evaluation and Implementation Staff
- Resource Capacity Planning Staff
Analytics and Data Services Staff (ADSS)
The Analytics and Data Services Staff (ADSS) serves as the Center’s technical experts in the development of specialized and informative management and performance reports from corporate databases
Decision Support and Analysis Staff
The Decision Support and Analysis Staff (DSAS) serves as subject matter experts for developing and incorporating decision analysis approaches, tools, and methods to structure, inform, and effectively communicate the Center’s drug regulatory decision-making.
The Economics Staff serves as the Center’s experts in understanding the business and economics of drug development, the pharmaceutical industry, and the economic implications of potential agency actions and events which may impact the agency.
Lean Management Staff
The Lean Management Staff (LMS) serves as the Center coordinator and focal point to drive cross-organizational operational improvements.
Program Evaluation and Implementation Staff
The Program Evaluation and Implementation Staff implements, evaluates, and supports efforts related to the Center’s drug programs, policies, and regulations. Our staff helps CDER learn what practices work and how to implement those practices.
Resource Capacity Planning Staff
The Resource Capacity Planning Staff (RCPS) serves as the coordinator and focal point for resource capacity planning and its interfaces with budget planning, execution, and relevant financial analyses for medical product user fee programs that impact CDER.