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

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FDA included Consumer Safety Officer, as well as participant of policy and Office of Pharmaceutical Quality’s OPQlevel draft guidance document writing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

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

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