Dr. Genna L. A. Kingon, Senior Director, Regulatory Strategy, oversees regulatory strategy and submissions from pre-IND/CTA to post-approval with more than a decade of experience in regulatory strategy and submission project management and more than 16 years of experience in scientific writing and editing. Her experience includes leading and contributing to multidisciplinary teams for marketing applications to FDA and to various international regulatory authorities, for example: 505(b)(1) programs, one of which was for a BTD product including management of the study-level biometrics and CSR development for the Phase 3 program (4 studies plus 2 with open-label extension portions) through Pre-NDA and NDA submission-readiness; 505(b)(2) NDAs; sNDAs; BLAs; sBLAs; MAA; JNDA. Dr. Kingon’s experience also includes serving as the program director leading multi-disciplinary teams in the regulatory strategy and integrated product development planning, management, and development of multiple INDs/IDEs and associated marketing application activities for a portfolio of related products. She has led or supported >20 INDs/CTAs and >23 marketing applications and numerous meetings with the regulators including serving as US regulatory contact for clients. In addition, Dr. Kingon provides regulatory and program management oversight as an advisor on many programs in a variety of indications. She has led the preparation, review, and coordination of a variety of regulatory and clinical documents, for example, integrated summaries of safety and efficacy, package inserts including annotation, agency meeting request letters and briefing packages, integrated product development and clinical development plans, RMAT designation requests, protocols, investigational plans/brochures, CSRs, gap analyses, CMC sections of INDs, and annual reports.

Dr. Kingon’s integrated product development, regulatory strategy, medical/regulatory writing, and research expertise encompass a broad range of therapeutic areas, including pain and anesthesia, allergy, addiction, dermatology, gastroenterology, genetic diseases, immunology, infectious diseases, musculoskeletal, neurology, oncology, ophthalmology, and otolaryngology.

Dr. Kingon earned her PhD at North Carolina State University in the Department of Chemistry where she studied proteomics and mass spectrometry. She then spent a year at the University of North Carolina in the Gillings School of Global Public Health as a postdoctoral researcher. She was awarded a NIEHS Toxicology Training Fellowship for research in Chemical Toxicology. Dr. Kingon received her Regulatory Affairs Certification from the Regulatory Affairs Professionals Society in 2013.