Risk Mitigation Excellence: Structure and Roles that Support REMS Programs

STUDY OVERVIEW

New regulatory requirements have created ever greater compliance hurdles for pharmaceutical organizations. One of the outgrowths of these new regulations is that pharmaceutical companies need to develop innovative Risk Evaluation & Mitigation (REMS) program strategies to help achieve both
compliance and commercial objectives.

Best Practices, LLC conducted this research study to identify the most suitable structure and roles to support REMS programs. In addition to exploring how pharmaceutical organizations approach issues around the structure and roles for supporting REMS programs, this study evaluates the role of market research in supporting REMs programs.

Biopharmaceutical leaders who are involved with REMS programs can use this study to compare their structure and roles for supporting REMS programs with the approach used by other leading organizations.

KEY TOPICS

• REMS Programs: Structure & Responsibilities
• Industry Experience in Developing & Deploying Successful REMS Plans
• Role of Market Research Groups in Supporting REMS Programs
• REMS Approaches for New Products

• Functional groups that lead REMS program
• Sub-functional group associated with leading the REMS program
• Job title level leading the REMS programs
• Levels at which the market research groups supports REMS programs
• Number of products on which REMS programs were implemented since 2007
• Type of activities managed by REMS Program in association with drafting a communication plan
• Type of activities managed by REMS Program in association with drafting an Elements to Assure Safe Use (ETASU) plan
• Areas of REMS supported by market research function
• Activities and research types managed by market research function in support of the development and distribution of communication plans
• Activities and research types managed by market research function in support of the development and distribution of ETASU plans
• Stage of the new product development process at which REMS planning begins

• Companies Have Little Longitudinal Experience with REMS Products: Most companies have relatively limited experience in implementing a REMS plan or executing a REMS throughout the entire product lifecycle. On average, benchmark companies have only deployed REMS plan for 3.33 products since the advent of REMS. The most total REMS products managed by one company was nine.
• “Good Medicine is Good Business” Defines Approach to Balancing Risk Communication & Commercial Impact of Deploying REMS Programs: Most study respondents stressed the fact that a REMS plan that clearly communicates all the risks associated with a product is not only necessary but also in keeping with good business practices over the long-term. As one interviewed executive told us: “You have to understand how the components of REMS either aid or inhibit the brand and set expectations accordingly. A disjointed forecast will only lead to problems later."

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