Evolving Benefit-Risk Management: A New Approach to Benefit-Risk Assessments

Dr. Stella Blackburn leads risk management efforts in North America, Europe and Asia-Pacific for the Quintiles real-world and late phase research group. In her role, Dr. Blackburn develops multidisciplinary benefit risk management services, reviews and assists customers with interpretation of pharmacovigilance legislation, and ensures compliance with regulations and best practices in the conduct of pharmacovigilance and risk management activities for the company’s real-world and late phase research efforts.

With more than two decades of experience in the pharmacovigilance and pharmacoepidemiology fields, Dr. Blackburn joined Quintiles from the European Medicines Agency (EMA) where she served for more than 16 years in various roles, most recently as the EMA Risk Management Development and Scientific Lead. In this role, Dr. Blackburn was responsible for designing and implementing risk management public policy and processes used throughout Europe. Dr. Blackburn also worked with biopharmaceutical companies, government bodies and industry consortia to advance risk management and real-world research, including registry projects and public-private partnerships.

Before joining the EMA, Dr. Blackburn worked in hospital medicine and also spent more than 11 years in the pharmaceutical industry in a variety of leadership roles. Throughout her career, Dr. Blackburn has lectured and written several textbooks on pharmacovigilance, risk management and industry-related guides.

Mary Mease, RPH, MPH, is a Senior Benefit-Risk Management Director in the Safety Knowledge and Reporting team of the Clinical Design and Reporting unit at Quintiles.  She has 17 years of experience in signal detection and validation, risk management, and benefit-risk communication.  

Ms. Mease has served as a Benefit-Risk Analyst at Quintiles for 6 years.  Since joining Quintiles, Ms. Mease has completed projects including post-marketing surveillance, signal detection and verification, portfolio-wide benefit-risk assessments, Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and specialized risk management commitments and she serves as an internal consultant for signal detection services, REMS, RMPs, post-marketing regulatory safety concerns, and a breadth of regulatory compliance.

Ms. Mease completed her undergraduate degrees at Virginia Tech and University of Maryland School of Pharmacy and her Master’s in Public Health at Johns Hopkins University.

Prior to joining Quintiles, Ms. Mease was employed by CDER/FDA for 11 years where she authored many postmarketing signal detection and analyses reports based on FAERS and epidemiology data; authored benefit-risk communications for the public and healthcare professionals; contributed content to Congressional testimonies and CDER Center Director briefings on high-profile safety issues; served on CDER’s Drug Safety and Oversight Board; and conducted inspections and evaluated inspection results of investigators, sponsors, and IRBs.  Prior to joining CDER, Ms Mease was a Senior Analyst in the Department of Army’s Medical Research Command where she was an active member of the Army’s IRB, consulted with investigators on protocol development and feasibility, and inspected clinical sites. Ms. Mease also has 8 years of experience in drug development, manufacturing, and execution of all phases of clinical trials.    

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