Bettina Donato, DABT

Senior Principal Consultant

Bettina Donato is a board-certified toxicologist and general regulatory affairs professional with more than 20 years of experience in drug development.  Acting as a primate technician and subsequently study toxicologist at a good laboratory practice (GLP) contract research organization (CRO), she then assumed roles as toxicology program coordinator in the biotechnology industry and as a toxicology lead in the consulting environment.  Bettina has broad regulatory and scientific expertise across different therapies, and her experience includes small molecules, peptides, proteins, monoclonals, antibody-drug conjugates (ADCs), and nanoparticle therapies.  She has expertise in designing and executing nonclinical programs to support all phases of clinical development, marketing applications, and post-marketing activities.  Her therapeutic expertise includes but is not limited to gastroenterology, hematology, ophthalmology, autoimmune diseases, infectious diseases, metabolic diseases, and oncology.  In addition, Bettina has substantial experience developing products for pediatric indications, orphan indications, and for serious and life-threatening diseases including design of accelerated nonclinical programs and orphan drug and breakthrough therapy designations.  She is also very skilled and experienced in nonclinical study monitoring including GLP-compliant facility qualification inspections at CROs in North America, Europe, and Asia.  Bettina has a B.S. in Biological Sciences from Florida Atlantic University, and she is a certified Diplomate of the American Board of Toxicology (DABT).