Kassa Ayalew

Experience

• 

  FDA

  Jul 2000 - Jul 2013

  Responsible for the GCP review and evaluation of clinical trial data submitted in support of NDAs and BLAs Responsible for planning and conduct of clinical inspections of regulated entities using risk-based approach Lead the team of medical officers to review of the design of the protocol(s) for their ability to test the clinical hypothesis (Phase I- IV) established for the product and procedures data that can be useful in determination of the product’s safety and effectiveness. Reviewed the design of the Phase I-IV protocol(s) for their ability to test the clinical hypothesis established for the product and procedures data that can be useful in determination of the product’s safety and effectiveness. Reviewed, evaluated, and provided comprehensive written reviews of initial safety submissions of Investigational New Drug (IND) applications, and clinical review of data submitted in new drug applications (NDAs). Worked on broad range of issues relating to the regulation of biological, antibacterial and immunosuppressant agents, within the context of BLAs, IND review, pre-IND and pre-BLA review

  • Medical Officer, CDER, Office of Scientific Investigations

    Jul 2009 - Jul 2013

  • Team Leader, CDER, Division of Medical Imaging and Hematologic Products

    Apr 2008 - Jun 2009

  • Medical Officer, CDER, Division of Special Pathogens and Antimicrobial Products

    Oct 2003 - Mar 2008

  • Medical Officer, CBER, Division of Clinical Trial Design and Analysis

    Jul 2000 - Sept 2003
• 

  FDA

  Jul 2021 - now

  Lead the FDA’s Good Clinical Practice (GCP) oversight programs for CDER-regulated drug and biologic products.Oversee the coordination of onsite and remote regulatory inspections of clinical investigators, sponsors, monitors, and contract research organizations for CDER-regulated drug and biologic products. Responsible for scientific oversight of CDER assigned GCP inspections of clinical investigators, sponsors, contract research organizations and institutional review boards including recommendations regarding data integrity to Office of New Drugs for regulatory decision making. Lead the FDA’s Good Clinical Practice (GCP) oversight programs for CDER-regulated drug and biologic products.Oversee the coordination of onsite and remote regulatory inspections of clinical investigators, sponsors, monitors, and contract research organizations for CDER-regulated drug and biologic products.

  • Division Director

    Nov 2021 - now

  • Branch Chief/Acting Branch Chief

    Jul 2013 - Jul 2022

  • Acting Division Director, Division of Clinical Compliance Evaluation

    Jul 2021 - Nov 2021