Richard A. Angelo, PhD

Principal Scientist, Clinical Research

Richard A. Angelo, PhD, is Principal Scientist, Clinical Research, for the Regulatory Sciences group of Cardinal Health Specialty Solutions.

Role responsibilities

Dr. Angelo is responsible for clinical research product development services in areas such as clinical program planning; regulatory strategies toward commercialization; Phase 1 to 4 clinical study design, oversight and management; vendor qualification and management; investigator site qualification and management; regulatory agent services and management of regulatory submissions.

Professional experience

Dr. Angelo has more than 28 years of product development experience in the pharmaceutical, biologic and medical device industries in operational, senior operational, executive leadership and senior consultant roles. His industry tenure includes leadership positions in publicly traded US pharmaceutical corporations as well as full-service contract research organizations. He has led regional, national and international multidisciplinary clinical development teams in various therapeutic areas, including infectious diseases, oncology, analgesia and allergy.
Dr. Angelo’s expertise helps companies ensure compliance with FDA regulations, harmonized international regulations, industry guidance documents, Good Clinical Practices, Good Clinical Laboratory Practices, Good Pharmacovigilance Practices, clinical study protocols and applicable standard operating procedures pertaining to development and commercialization of drugs, biologics and medical devices.
Dr. Angelo was the principal author of chapter 16, “Medical Device Compliance and Postmarketing Activities,” in Fundamentals of US Regulatory Affairs, Seventh Edition, a Regulatory Affairs Professionals Society (RAPS) publication.

Education

Dr. Angelo received a master’s degree in microbiology from the University of Missouri–Kansas City and a doctorate in microbiology from the University of Kansas. He also served as a biochemistry post-doctoral research fellow at Purdue University.

Areas of Expertise


Clinical quality compliance audits

Quality systems audits

Mock pre-approval regulatory agency inspections

Good Clinical Practices

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