Monica Commerford, Ph.D.

Head of Viral Vector Services Regulatory Affairs
Cambridge, Massachusetts, USA

Key roles and responsibilities

  • Develop, implement, and maintain regulatory submissions including site master files and drug master files
  • Partner with clients to provide chemistry, manufacturing, and controls (CMC) information to support their regulatory submissions for advanced therapy medicinal products and cell and gene therapy products
  • Frequent interaction with regulatory authorities for regulatory inquiries
  • Provide guidance and compliance oversight for any recalls, complaints, and regulatory reporting

Professional highlights

  • FDA Product Quality Microbiology and Biologics Licensing Applications (BLA) reviewer and pre-licensing inspection lead
    • Division of Microbiology Assessment in the Office of Process and Facilities in the Office of Pharmaceutical Quality (OPQ) within the Center for Drug Evaluation and Research
    • Led Type C industry meetings on Product Quality Microbiology and CMC-related topics
  • Additional roles at FDA included Consumer Safety Officer, as well as participant of policy and Office of Pharmaceutical Quality’s OPQlevel draft guidance document writing
  • Post-doctoral work at the National Institutes of Health included investigation of the function and molecular mechanism of a nonessential bacterial molecular chaperon required for virulence in pathogenic bacteria using genetic screens and assays building upon its overexpression phenotype
  • Discovered a new outer membrane lipoprotein bacterial cell wall polymerase cofactor, needed to build bacterial peptidoglycan using synthetic lethal screening while receiving Doctor of Philosophy degree

Education

  • Sallie Rosen Kaplan Post-Doctoral Fellow, National Cancer Institute, National Institutes of Health
  • Doctor of Philosophy in Microbiology and Molecular Genetics from Harvard University
  • Bachelor’s degree in Biochemistry and Molecular Biology from Michigan State University

Scientific expertise

  • Cell and gene therapy CMC expert
  • Microbiology and molecular genetics
  • Microbial control, Product Quality microbiology, and Sterility Assurance for investigational new drug and marketing applications
  • Developing, editing and reviewing regulatory submissions, including reviews as a health authority assessor
  • Regulatory intelligence and interpreting regulatory guidance

Related Sites

Additional Resources