Dr. Genna Kingon, Senior Director, Regulatory Strategy, has participated in and contributed to the regulatory strategy and submission management from pre-IND to post-approval. Her experience includes leading teams for a 505(b)(1) program for a BTD product, including management of the study-level biostatistics and programming activities and CSR development for the Phase 3 program through NDA submission-readiness.  Also, she serves as the program director leading multi-disciplinary teams in the strategy, management, and development of multiple INDs/IDEs and associated marketing application activities for a portfolio of related products. With over a decade of experience in scientific writing and editing clinical and nonclinical documentation, which includes several publications in peer-reviewed scientific journals, Dr. Kingon also serves as lead regulatory author on multiple programs for submissions to FDA and to various international regulatory authorities. She has contributed to the strategy and development of CMC efforts and has authored the CMC section for two IND submissions. Dr. Kingon has led the preparation, review, and coordination of a variety of regulatory and clinical documents, including integrated summaries of safety and efficacy, package inserts with annotation, FDA meeting request letters and briefing packages, protocols, investigational plans/brochures, CSRs, IND/NDA/BLA gap analyses, and annual reports.

Her medical writing and research expertise encompasses a broad range of therapeutic areas, including acute and chronic pain, dermatology, inner ear disorders, gastrointestinal disorders, ADHD, oncology, immunology, musculoskeletal disorders, and drug addiction. 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.