Independent REMS strategy and program management services designed to guide safe use and maximize access to your therapy
We’ll help you plan, implement, and manage Risk Evaluation and Mitigation Strategies (REMS) programs with confidence
When you realize your drug may require a REMS program, it can add a significant layer of complication to your commercialization efforts (not to mention cost).
But, with just over 60 REMS programs for currently marketed products, it’s not something that is widely understood. There are only a handful of experts with the experience, resources, and connections to effectively evaluate options around REMS and efficiently manage programs to ensure you support safe use and maximize patient access.
The good news? Shepherd consists of some of the most experienced REMS experts on the planet, and we’re here to help.
With over 30 years of combined experience in REMS across our team, we have supported more than 20 REMS programs, including more than 10 shared REMS consortium groups. Our team has presented at major industry conferences and REMS-specific events and maintains relationships with FDA’s Division of Risk Management (DRM).
Senior Principal, Strategic Consulting & REMS
Melissa brings over 20 years of management consulting experience to Two Labs, 16 in the biopharma industry. Melissa offers clients her expertise in regulatory strategy, program management, and large-scale program operations, with a particular focus on Risk Evaluation and Mitigation Strategies (REMS).
Account Director, Patient Support Services & REMS
Laura has over 25 years of healthcare experience, with 10 years in REMS. As an Account Director at Two Labs, Laura works with pharma companies to design, implement and execute best-in-class REMS and patient support programs with the goal of increasing safe use conditions for patients and commercialization success.
No matter where you are in the process, we’re here to support, advise, and implement key strategies to ensure the success of your product.