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Fulfilling FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) requirements for new and existing products isn’t something most sponsors have deep knowledge and experience with.
Having a trusted partner to design your REMS, guide regulatory interactions, oversee program execution, and manage the ongoing operations and evaluation of a REMS is critical. REMS programs also require unique technical experience and prowess to efficiently integrate into the healthcare system.
With experience on more than 120 risk management programs for products in a variety of therapeutic areas, UBC leads the market in providing integrated, comprehensive REMS services. Led by our team of epidemiologists, safety scientists, data analysts, software developers, psychometricians, and project managers, UBC has established a reputation among sponsors and the FDA as the leader in full-service REMS delivery.
Whether you believe a REMS is on your horizon or it has already been discussed with the FDA, we offer consulting on all aspects of your program and FDA interactions. We begin partnering at any time to review product benefit and risk, provide REMS design options, and ensure you are ready for REMS discussions as you move through approval.
UBC is dedicated to the design, development, and deployment of technologically driven REMS services. We combine highly experienced leadership and best-in-class technology, to create, implement, and assess the effectiveness of REMS programs.
When a multi-sponsor REMS consortium is considered, it is important to broker consensus on key topics among the sponsors in the single shared system REMS. By utilizing both UBC’s deep REMS experience and our PMO experience, sponsors have a single source of accountability, eliminating intermediary services and functions, and placing UBC’s experts in closer proximity to the work.
Dr. Annette Stemhagen is an epidemiologist with more than 30 years of public health research experience, including 20 years in safety surveillance of pharmaceutical, biotechnology, and vaccine products. She is the Senior Vice President of Safety, Epidemiology, Registries and Risk Management within United BioSource, where she provides strategic consultative services to pharmaceutical, biotech, and medical device clients.
Dr. Stemhagen has specific expertise in safety surveillance and design, implementation, and analysis of epidemiologic studies, registries, large streamlined safety studies, and actual use and observational studies for products in Phase IIIb and post approval. She has designed and evaluated risk assessment studies, including more than 50 regulatory-mandated, long-term global safety studies. She has designed risk intervention programs, risk management evaluation studies, Risk Minimization Action Plans (RiskMAPs), Risk Evaluation and Mitigation Strategies (REMS), and risk minimization programs for EU Risk Management Plans for more than 120 products.
Dr. Stemhagen is active in the International Society for Pharmacoepidemiology and the Drug Information Association. She served on the Board of Directors for each of these organizations. Dr. Stemhagen has held adjunct faculty appointments at the University of Pennsylvania Center for Epidemiology and Biostatistics in the School of Medicine, the Temple University School of Pharmacy, and the Drexel University School of Public Health. In 2004, Dr. Stemhagen was appointed as the first Industry Representative to the FDA Drug Safety and Risk Management Advisory Committee.
Chief Science Officer
Mrs. O’Donnell leads the UBC’s Safety & Risk Management services that oversees product safety and risk minimization activities for pharma and biotech. This includes pharmacovigilance, REMS, RMPs, and the Safety & Epidemiology consulting team.
Mrs. O’Donnell’s background includes more than 20 years of healthcare and clinical research experience and has worked in the area of Risk Management for the last 10 years. Her career began as a registered nurse in the hospital setting where she was responsible for medical surgical patients, pediatric patients, and was a certified oncology nurse. Mrs. O’Donnell’s also spent 2 years as Acute Dialysis nurse, providing renal care to the critically ill. She began in clinical research as a drug safety associate focusing on medical and legal review of medical charts. Then she spent several years in Strategic Research & Marketing where she researched and evaluated the drug development pipeline for major pharmaceutical and biotech companies for a large contract research organization, assisted in the writing and coordination of government proposals, and was responsible for global information requests.
During her tenure, she was awarded the Strategic Research and Marketing award.
During her time at UBC Mrs. O’Donnell has overseen pregnancy registries, investigator-initiated studies, and minority-focused phase IV trials. While in Program Management, she provided support and direction to UBC project teams conducting late stage studies, including regulatory-mandated programs and observational studies.
As the Senior Vice President for Safety & Risk Management, she is responsible for UBC Pharmacovigilance, designs REMS, REMS Supporting Documents, REMS tools, and oversees the team responsible for REMS effectiveness assessments as well as REM’s FDA Assessment Reports. She ensures quality and performance expectations are being met, including responsibility for detailed timeline development and maintenance, budget management, regulatory requirements, and study start-up and operations
Mrs. O’Donnell received her Bachelor’s of Science in Nursing from the former College Misericordia (currently Misericordia University) in northeastern Pennsylvania followed by her Program Management Certificate from Villanova University, also in Pennsylvania.
Head of Safety & Risk Management
VP, Data Intelligence & Program Analytics
Jason Leedy is an entrepreneur, technologist, and business executive with over 15 years of experience in REMS. He is the founder and former president of Gigamoto, LLC, and Examoto, LLC. UBC acquired Examoto, which focuses on innovation to maximize the benefits and safe use of prescription drugs while reducing the burden on patients, healthcare providers, and the healthcare delivery system, in August 2022.
Corporate VP, Technology Strategic Design & Innovation