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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 Investigatorā€™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.