Dr. Chris Chapman is the founder and CEO of Chapman Pharmaceutical Consulting Inc. He has extensive experience working with biotechnology companies to design clinical trial protocols and conduct clinical trials. He is an expert at helping clients meet or exceed quality and regulatory requirements.
Dr. Chapman received his MD degree from Georgetown University in Washington, D.C. in 1987. He completed his internship in Internal Medicine, a residency in Anesthesiology and a fellowship in Cardiovascular and Obstetric Anesthesiology at Georgetown. Since 1995, Dr. Chapman has been a critical care physician on the staff at Doctor's Community Hospital in Lanham, Maryland. Dr. Chapman has served as Consultant Director of Regulatory and Medical Affairs for several biotechnology companies.
His most recent accomplishments include:
• Worked with Oncology Division of FDA to secure approval of an IND for a product that had been on clinical hold since 1988
• Submitted an Pre-IND package to FDA that satisfied requirements for a unique delivery system
GMP Facility Coordination
• Switzerland: Secured a contract for services including the preparation of the CMC section for IND submission, GMP production of drug substance and drug product for oncology clinical trials
• Netherlands: Secured a contract for services including the preparation of the CMC section for IND submission, GMP production of drug product for clinical trials of the new antifungal formulation via a liposomal-derivative delivery system. Organized and participated in an audit of manufacturer for compliance with GMP guidelines
EMEA: Secured Orphan Medicinal Product Designation for a development-phase product
Dr. Chapman has arranged meetings and provided product presentations before over 20 major public and private corporations on behalf of his worldwide client base.
Dr. Chapman's experience spans international and consumer products, businesses and healthcare. His clients include Astellas Pharmaceutical, Takeda Pharmaceutical and Kissei Pharmaceutical in Japan, Sigma Tau Pharmaceutical in Italy and Symphogen Inc in Denmark. Clients in the United States include Church and Dwight Co., Inc., Akorn Pharmaceutical and McKesson Healthcare.