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.
Annette Stemhagen, DrPH, FISPE is an epidemiologist with more than 35 years of public health research experience, including epidemiologic research and safety surveillance of pharmaceutical and biotechnology products, vaccines, and medical devices. She provides strategic consultative services with a focus on risk evaluation and mitigation strategies (REMS) and developing real-world evidence to meet regulatory and commercial objectives regarding product safety and value.
Dr. Stemhagen has specific expertise in the design, implementation, and analysis of epidemiologic studies, both observational and pragmatic, for products in Phase IIIb and post-approval. She has designed and evaluated risk assessment studies, including more than 60 regulatory-mandated, long-term global safety studies. She has also designed global risk minimization programs and risk management evaluation studies and developed REMS 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. Dr. Stemhagen was appointed as the first Industry Representative to the FDA Drug Safety and Risk Management Advisory Committee. In addition to providing consultative services, Dr. Stemhagen has held positions within the government, academia, and the pharmaceutical industry focused on patient safety.
Chief Science Officer
Natalie O’Donnell, BSN, RN, is the Senior Vice President responsible for UBC’s Safety & Risk Management services. She is a highly experienced and dedicated Registered Nurse (RN) with a passion for patient safety and public health. As the Head of Safety and Risk Management at UBC, Natalie plays a critical role in ensuring the safe and effective use of pharmaceutical products. This includes pharmacovigilance, REMS, RMPs, and Safety & Epidemiology consulting.
Mrs. O’Donnell’s background includes more than 20 years of healthcare and clinical research experience and she has worked in risk management for the last 12 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 also spent 2 years as an 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.
Prior to joining UBC, Natalie held key positions in pharmaceutical services, where she honed her expertise in adverse event reporting, risk assessment, and REMS. Her contributions have been instrumental in shaping industry best practices.
In her current role at UBC, Natalie leads a team of talented professionals and oversees the design and implementation of robust pharmacovigilance and risk management strategies. 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
With a passion for patient-centric healthcare, Natalie continues to drive excellence and ensure that patient safety remains at the heart of UBC’s mission.
Mrs. O’Donnell received her Bachelor of Science in Nursing from 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