A Message from the Board

September 2022 

Kevin Holman Headshot

In this Together: Patient Safety and Risk Management

I’m thrilled to address our members for the first time in the RIC Newsletter! Thank you for your willingness to get involved and help drive the future of REMS for our industry!

As we know, REMS programs exist at the intersection of safety, regulation, and operations that help ensure that the benefits of a medication outweigh its risks. REMS have far-reaching implications for patients because they are designed to reinforce medication use behaviors and actions that support the medication’s safe use. This awesome responsibility to our patients and to society at large allows each of us a unique opportunity to help advance the science of patient safety and risk management.

For those of you I haven’t yet had the pleasure of meeting yet, I lead a team of incredible experts within the REMS & Risk Management Center of Excellence at Janssen Pharmaceuticals, Inc., and like each of you, we work every day to design, implement, manage, and assess REMS programs in the U.S. and risk management programs across North America. Throughout my career, I’ve worked with many of you and contributed to more than half of the currently approved shared REMS programs and nearly one third of single-product REMS programs across therapeutic areas.

I’m passionate about contributing to better outcomes for patients. When we started planning the RIC nearly 3 years ago, it was clear that companies were struggling with common challenges. From operational design, all the way through evaluating the effectiveness of a REMS program, the issues we encounter are similar. With that perspective, the RIC Mission to foster collaboration and innovation to advance patient safety, appropriate access, and best practices in REMS-related drug and biologic risk management began to take shape.

As we gain momentum this year and looking to 2023, our priorities as the Board of Directors have shifted from building the RIC organization to collaborating across companies with the FDA to address common challenges including effectively operationalizing complex REMS programs and developing best practices that will be the benchmark for our industry in the years to come.

Our Vision is to improve patient safety and medication access through REMS innovation. To that end, our Working Groups are busy creating educational content for newcomers to the REMS space, engaging with FDA to help drive innovation and consistency in REMS, and exploring capabilities and technology needed to effectively build and operationalize REMS programs. Our goal is to improve the ability of appropriate patients to access treatment safely while minimizing complexity.

Finally, I want to sincerely thank each of our Board members for their time, effort, and collective dedication to enabling the RIC’s goals. As we move towards the end of 2022, keep an eye out for regular information from the RIC for our new educational and operational resources, and particularly for the details on our first ever REMS Industry Consortium Annual Meeting to take place in the first half of 2023!

I look forward to communicating additional updates and information via this Newsletter, put together by Manuel Collazo and the team at Association Headquarters. With the leadership of the Board, supported by our partners at Buchanan, Ingersoll, & Rooney and the team at Association Headquarters, we’ll continue to build momentum and advance the science of safety for our patients!

Please reach out if you have any comments, questions, or suggestions, please email info@remsconsortium.org.

All the best,

Kevin Holman, MBA, RAC

Board Chair