Vice President, Medical Writing & Regulatory Affairs
Phone: +1 905-364-7800
Kathryn Bibeau is the of Vice President of Medical Writing at Intrinsik Corp. Kathryn is a board-certified toxicologist and certified regulatory affairs professional with over 19 years of experience in the biotechnology, pharmaceutical & healthcare industry. She has been involved in a broad range of development and regulatory activities leading to clinical trials and product registration. Kathryn’s focus is on medical writing and content generation for regulatory submissions. With her Regulatory Affairs Certification and experience in the current regulatory field in the United States and Canada, Kathryn manages the scientific aspects of product development programs including authorship and content review for numerous successful INDs, CTAs, NDAs, and NDSs. Kathryn oversees the Medical Writing group at Intrinsik, which is responsible for managing, authoring, and reviewing clinical and nonclinical CTD sections, literature reviews for 505(b)(2) and SRTD submissions, clinical study reports, as well as ISSs and ISEs. Earlier in her career, Kathryn’s focus was on nonclinical program development. She has been involved in the design, implementation, and monitoring of hundreds of nonclinical studies (toxicology, safety pharmacology, genotoxicity, reproductive and developmental toxicity, carcinogenicity) in support of regulatory applications. Kathryn has also been responsible for literature-based human health safety assessments of excipients, contaminants, degradants, and impurities, often eliminating the need to conduct toxicology studies. She also monitored nonclinical studies at international CROs for quality and compliance with GLPs, and has been an invited speaker on GLP regulations and implementation.
- Provides strategic operational guidance for efficient authoring/review/QC processes
- Provides strategic regulatory guidance based on analysis and interpretation of complex clinical and toxicological data
- Authors and reviews content for regulatory submissions (pre-IND, IND, pre-CTA, CTA, IB, NDA, NDS, MAA, ODD, DSUR) for broad range of therapies and therapeutic areas (g., cardiovascular, oncology, pain, CNS disorders, metabolic disorders, orphan indications)
- Authors and reviews CTD-compliant Module 2 summaries (2.4, 2.5, 2.6, 2.7) and Module 5 documents (CSRs, ISSs, and ISEs)
- Authors and reviews literature-based regulatory documents (g., 505(b)(2) and SRTD submissions)
- Prepares and implements nonclinical testing strategies and data gap analyses for pharmaceuticals and biologics covering a broad range of therapeutic areas.
- Specializes in impurity qualification assessments for pharmaceuticals (including genotoxic impurities).
- Toxicology expert for regulatory submissions and meetings.
Education and Professional Qualifications
- B.Sc. (Honours), Biomedical Toxicology, University of Guelph
- DABT, Diplomate of the American Board of Toxicology
- ERT, European Registered Toxicologist
- RAC, Regulatory Affairs Certification (U.S.)
- Regulatory Affairs Professionals Society
- Safety Pharmacology Society
- Society of Toxicology