Description
I have 15 years of experience working with big and small sized companies in the biotech, pharmaceutical and chemical industries to address pharmacology/toxicology and regulatory affairs issues. I have more than 30 years of research, consulting and regulatory experience. I have extensive experience interacting with national and international CROs, developing IND-enabling strategies for small and large molecules as well as biologics and gene therapies, developing protocols, study monitoring, reviewing and summarizing both GLP and non-GLP nonclinical pharmacology and toxicology data as well as other published scientific data. I have experience with human health safety assessments. I also have experience interacting with regulatory agencies and regulators. I am an active member of the American College of Toxicology, Society of Toxicology, and American Society of Gene and Cell Therapies. I also am a Diplomate of the American Board of Toxicology (DABT) since 2018.
