Kathryn Bibeau

Vice President, Medical Writing

Mississauga, Ontario

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Phone: +1 905-364-7800
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Kathryn Bibeau is the Vice President of Medical Writing at Intrinsik Corp. With over 25 years of experience in the biotechnology, pharmaceutical & healthcare industry, Kathryn is a seasoned board-certified toxicologist and certified regulatory affairs professional. Her expertise spans a wide spectrum of development and regulatory activities, culminating in clinical trials and successful product registrations. Kathryn’s primary focus lies in medical writing and content generation for regulatory submissions. With her Regulatory Affairs Certification and an in-depth understanding of the ever-evolving regulatory landscape, Kathryn and her team meticulously craft documents that pave the way for product approvals. As the leader of the Medical Writing group at Intrinsik, she oversees the creation and review of clinical and nonclinical CTD sections, including comprehensive ISSs and ISEs. Whether it is literature reviews for 505(b)(2) or SRTD submissions, clinical study reports or protocols, Kathryn ensures precision and clarity. In her earlier career, Kathryn focussed on nonclinical program development. She orchestrated the design, implementation, and monitoring of a multitude of nonclinical studies – ranging from toxicology and safety pharmacology to genotoxicity, reproductive toxicity, and carcinogenicity. Fostering collaboration, Kathryn’s adaptability ensures strong client relationships and high-quality regulatory documents that uphold accuracy, compliance, and scientific rigor.

Experience Highlights

• Provides operational guidance for efficient document authoring, review, and quality control processes.
• Authors and reviews scientific content for regulatory submissions across diverse therapies and therapeutic areas.
• Prepares CTD-compliant Module 2 summaries (2.4, 2.5, 2.6, 2.7) and Module 5 documents (CSRs, ISSs, and ISEs) ensuring that essential information is presented consistently and comprehensively.
• Advises on strategies for literature-based regulatory submissions (505(b)(2) and SRTD submissions).
• Guides regulatory decisions based on analysis and interpretation of complex clinical and toxicological data.
• Conducts in-depth clinical and nonclinical data gap analyses for pharmaceuticals and biologics.

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

Professional Affiliations

• Regulatory Affairs Professionals Society
• Safety Pharmacology Society
• Society of Toxicology
• Royal Society of Biology