Marian Glynn, PhD, DABT, RAC
Industry Experience
Dr. Glynn substantively has advanced the development of over 75 new medicines in collaboration with virtual, small private, mid-sized public, and large public pharmaceutical companies over the past 20 years. By building regulatory strategies; designing and interpreting scientific studies; engaging with regulatory authorities and preparing regulatory submissions, Dr. Glynn has facilitated the characterization, communication, and understanding of the benefits and risks of new drug products. In recent years, her focus has been on guiding project teams through the preclinical to clinical-stage transition, enabling opening INDs for First-in-Human clinical studies of over 15 unique drug products.
Dr. Glynn’s experience spans diverse therapeutic areas including neurology (opioid use disorder, depression), ophthalmology (blepharitis, cataracts, macular degeneration), oncology (solid tumors and hematologic cancers), dermatology (wound healing, carcinomas, psoriasis, head lice infestation), hematology (hemophilia A, B, acquired), and metabolic diseases (enzyme replacement). It spans diverse drug classes including antibiotics and antifungals as well as diverse modalities including small molecules, recombinant proteins, antibodies, oligonucleotides, cell therapies, and gene therapies.
Community Engagement
Dr. Glynn is an active member of the American College of Toxicology, serving currently on the Communication Committee and historically on the Education and Program Committees. She also is an active member of the Society of Toxicologic Pathology; the Society of Toxicology and its Northern California Regional Chapter; and the Regulatory Affairs Professional Society.
Dr. Glynn served as Co-Chair and Instructor of the 2019 American College of Toxicology Continuing Education Course ”Leading as the Toxicologist in Pharma: Advancing the Project with a Cross-Functional Team”. In this forum, she taught concepts of nonclinical development strategy, risk communication, and project management.
Educational Foundations
Dr. Glynn is board-certified in general toxicology (DABT) by the American Board of Toxicology. She also is credentialed in regulatory affairs as pertains to drugs (RAC) by the Regulatory Affairs Professional Society.
Dr. Glynn earned her Ph.D. in Pharmacology and Toxicology at the University of California, Davis. The focus of her dissertation research was neuroimmunology and, under the leadership of Dr. A. Kimberly McAllister, she contributed to the understanding of how activation of the immune system modifies development of the brain. Dr. Glynn was a Trainee of the National Institute of Environmental Health Sciences, the Center for Environmental Health Sciences, and the University of California Toxic Substances Research and Training Program. The federal and state training grant programs were instrumental in her pursuit of science education.
Dr. Glynn earned her B.S. in Biology cum laude and completed the degree requirements for a B.A. in Environmental Science and Policy with a minor in chemistry at Duke University. The interdisciplinary program of study at the liberal arts school set the foundations for integrated analysis and science communication so critical to the practice of regulatory toxicology.
Early mentors Dr. Glynn credits with informing her scientific rigor, integrity, and purpose include Dr. Linda Mutter, Dr. A. Kimberly McAllister, Dr. Alan Buckpitt, Dr. Marion Miller, Dr. Jerold Last, Dr. Patricia McClellan-Green, and Dr. Marie Lynn Miranda.