Current Regulatory Guidelines for Human Biospecimens & Patient Consent in Clinical Research

Lorrie Divers, President, QRCP Solutions

Lorrie D. Divers has thirty years of experience in clinical research and development, including monitoring, clinical project management, regulatory compliance, training, auditing, quality assurance, and quality management in the pharmaceutical, biologics, vaccines, medical device and central service provider sectors. 

Prior to establishing QRCP Solutions, Inc. in 2017, Lorrie held director and executive director level positions in a global central laboratory and was responsible for all quality assurance and regulatory compliance activities for global clinical trials and commercial laboratory operations. She has previously worked in GCP quality assurance, procedural compliance and training roles for Bausch + Lomb and Wyeth Vaccines, as well as other clinical research roles for Bristol Myers Squibb, the University of Rochester, and Roswell Park Cancer Institute. 

Lorrie has successfully managed numerous regulatory authority inspections at sponsor facilities, investigator/study sites, and the clinical laboratory. She has presented at local and national conferences on a range of GCP and quality management topics and previously served as a member of the AIDS/Oncology IRB for a large academic medical center.

Mark Engelhart, Chief Commercial Officer, BioFortis

Mark Engelhart has more than 25 years’ experience within the pharmaceutical and drug development industries, with extensive experience in sales, marketing, strategy, and global commercial operations. He has held commercial and general management roles across the continuum of drug development and commercialization, from pre-clinical and clinical development through post-approval marketing and sales. Mr. Engelhart is currently the Chief Commercial Officer at BioFortis, the leading provider of Biospecimen Lifecycle Management technology and services in the clinical research and development domains.