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FDA included Consumer Safety Officer, as well as participant of policy and Office of Pharmaceutical Quality’s OPQlevel draft guidance document writing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