K. Shawn Davison

WORK HISTORY

EDUCATION

ABOUT K. SHAWN DAVISON

In 2024 and 2025, as sole regulatory expert at AbCellera- led and submitted AbCellera\'s first 2 CTAs in different therapeutic areas precisely on schedule and within 2 weeks of one another in April 2025 - led cross-functional team of 80+ scientists in all regulatory submissions, successfully securing regulatory approval to initiate clinical trials from Health Canada - sole internal authority across regulatory affairs, regulatory intelligence, regulatory CMC, regulatory nonclinical, regulatory clinical, and regulatory writing/publishing domains - member of core team and clinical development team for all clinical candidate and clincal molecules - numerous CTA-A, CTA-N, and protocol clarification letters to maintain ongoing clinical trials - designed, tested, and implemented regulatory infrastructure - successfully held meetings with regulatory authority, both virtually and in-person Regulatory and Medical Writing Expertise- authored CSRs, clinical protocols, Investigator\'s Brochures, clinical overviews, clinical summaries, and study narratives across all trial phases (P1, P2, and P3) with regulatory approval success for submission to Health Canada, FDA, and EMA - complete Module 3 quality documentation, Module 4 nonclinical study reports, and Module 2 quality and nonclinical overviews - directly worked with over 10 of top 20 pharma - numerous P3 trials that achieved FDA and EMA marketing approval-> 30 years of experience as clinical research scientist and medical writer Scientific Communications- extensive portfolio including primary research, guidelines, abstracts, white papers, CME materials, posters, and slide presentations. Thought Leadership- Co-Director of world\'s largest randomly-selected osteoporosis study (CaMOS)- led teams of 1 to 65 experts across pharmaceutical companies, biotech, regulatory authorities, universities, and non-profits- delivered 100+ CMEs - served on national advisory boards as recognized key opinion leader