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  1. CDER Offices and Divisions

Office of Computational Science

Who We Are:

The Office of Computational Science (OCS) drives the modernization of CDER’s scientific review process and provides CDER reviewers innovative and reliable solutions that improve and strengthen the scientific review process by integrating data, tools, and training.

What We Do:

  • Build solutions that drive New Drug Modernization, promote access to quality data, and optimize data analysis capabilities.
  • Enhance the accessibility of data, reducing data integrity issues, and supporting robust data governance through improved coordination and prioritization of CDER’s scientific computing plans and activities.
  • Engage stakeholders in developing and delivering effective tools, technologies, services, and training to enhance their ability to meet CDER’s mission.
  • Apply advanced technologies to enhance review transparency, efficiency, consistency, and predictability.
  • Deliver solutions that streamline Bioresearch Monitoring (BIMO) workflow for reviewers and inspectors throughout the inspections process, automate manual tasks to minimize data entry and redundant processes for BIMO stakeholders, and improve the reliability, accessibility, and timeliness of BIMO data.
  • Spearhead the CDER Innovation Board to harness subject matter expertise across FDA and provide a knowledge capture framework to guide and advance innovation projects.
  • Offer cloud-enabled innovation space for tools, technologies, and data exploration, providing a platform for technologists and innovators to prototype, test, and implement solutions to CDER’s pressing business challenges.
  • Collaborate with industry, academia, and other external partners through our work with PHUSE, CDISC and BioCelerate, which enables us to share insights and subject matter expertise and pursue innovative solutions in support of regulatory review.

Office Organization:

Immediate Office (OCS-IO)
Office Director: Lilliam Rosario, Ph.D.    
Deputy Director: Isaac Chang, Ph.D.

Division of Regulatory Review & Research (DRRR)
Division Director: Jose Delgado Donayre, M.D.

Division of Tools Technology & Innovation (DTTI)
Division Director: Sanjay Sahoo, MS, MBA

For more information, contact Office of Computational Science.

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