Beverly D. Smolich

Beverly D. Smolich, PhD, Executive Director and Senior Director, Clinical Research and Regulatory Affairs, is a drug development scientist with expertise in preclinical through clinical research, translational medicine, biomarker development, and regulatory affairs. Dr. Smolich manages scientific and regulatory review and reporting for NIH- and private-client sponsored programs, and directs and is the point of contact for FDA for regulatory submissions, including Investigational New Drug applications (INDs), Clinical Trial Agreements, and Investigator’s Brochures. Dr. Smolich has developed clinical trial materials for physicians and patients, and she has worked extensively with private biotechnology and pharmaceutical clients on regulatory and clinical development projects. Dr. Smolich holds a PhD in biology.