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  1. Center for Drug Evaluation and Research | CDER

Office of Program and Strategic Analysis (OPSA)


The Office of Program and Strategic Analysis (OPSA) provides analytical, project management, evaluation, and process improvement services, and strategic and operational planning for CDER offices to improve the effectiveness and efficiency of regulatory functions.

 

Office Leadership

  • Andrew Kish, MSPPM, Office Director
  • Adam Kroetsch, MSPPM, Deputy Office Director
  • Pujita Vaidya, MPH, Decision Support and Analysis Team Director (Acting)
  • Andreas Schick, PhD, Economics Staff Director
  • Michael Rappel, PhD, LEAN Management Staff, Director (Acting)
  • Reza Kazemi-Tabriz, PhD, Performance Analysis and Data Services Staff Director
  • Kimberly Taylor, (MBA, MPH), Program Evaluation and Implementation Staff Director

Description of Organizational Units

Immediate Office

Decision Support and Analysis Team

Assists CDER in its efforts to structure and communicate its regulatory decision making. Develops and implements tools, methods, and processes to support internal deliberation on complex drug review issues, facilitate the incorporation of patient input into regulatory decision making, and foster clear communication of CDER’s decision-making to the public.

Leads and supports efforts to meet CDER commitments under PDUFA and 21st Century Cures Act, such as the Benefit Risk Framework and Patient-Focused Drug Development.

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.

Conducts quantitative and qualitative data analysis consulting.  Applies operations research, statistical analysis, econometric analysis, health economics and outcomes research, machine learning techniques, and cost-benefit analysis, to support senior management decisions in offices throughout the Center and Agency.

Publishes and reviews research to communicate and comment, to the public, on topics which are of concern to the Center and Agency, with a particular focus on pharmaceutical drug development, manufacturing, and other issues relevant to the regulation of pharmaceutical products.

Lean Management Staff

Serves as the Center coordinator and focal point for Lean Management and provides consultation on application of Lean Management concepts to Center operations. Conducts lean management analyses on identified cross-cutting internal processes, recommending business process improvements as appropriate to improve efficiency of Center operations.

Performance Analysis and Data Services Staff (PADSS)

Serves as the Center’s technical experts in the development of specialized and informative management reports from corporate databases.

Supports senior management through centralized program reporting for branded drugs and biologics, generics, and biosimilars. Determines Center reporting requirements as regulations, policies, and program needs change. Provides data for Congressional reports, including but not limited, to annual user fee program performance reports.

Coordinates data and information requests from other government agencies and the public (e.g. Press Inquiries, Freedom of Information (FOIs) requests, Congressional inquiries and reports, General Accounting Office (GAO) studies, and Office of Inspector General (OIG) studies).

Provides expertise in data analytics and sciences to other CDER offices for their specific projects.

Program Evaluation and Implementation Staff

Conducts program evaluation studies and special operational analyses to assess the impact of Center initiatives to improve effectiveness and efficiency. Provides project management and other technical services to direct or coordinate implementation of significant Center initiatives and to improve the efficiency and effectiveness of Center resources and key business processes.

Conducts a wide range of qualitative and quantitative analyses to answer key questions of Center operations, informing internal strategy and decision-making, as well as Center strategy with respect to the external stakeholder environment.

Leads and coordinates Center-wide development of strategic and operational plans.

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