Risk Mitigation Excellence: Innovative Models & Trends in Supporting REMS & RMP Programs

Industries Profiled:
Medical Device; Pharmaceutical; Biotech; Chemical; Consumer Products; Diagnostic; Health Care


Companies Profiled:
Baxter International; Genericon Pharma; Actelion; MannKind Corporation; Bristol-Myers Squibb; Genentech; Roche; Bayer Healthcare; Cephalon; AstraZeneca; Inc.; Johnson & Johnson; Pfizer; Covidien; Amylin; Abbott; Upsher-Smith; Merz Pharma; Teva Pharmaceutical Industries Ltd; Ipsen

Study Snapshot

Research participants included 22 executives and managers from 19 leading pharmaceutical, biotech, and medical device companies.

All study participants contributed data through a field survey and representatives from several leading benchmark organizations also provided additional insights through deep-dive interviews.

Sample Key Findings

Pharmacovigilance & Regulatory Affairs Functions Lead REMS: According to the study, REMS programs are mainly led by Pharmacovigilance (at 41% of benchmark companies) and Regulatory Affairs (36%). Additional core functions such as Medical Affairs, and sub-functions such as Epidemiology, also lead overall REMS activities at some organizations. Market Research does not serve as a lead function for REMS at any participating companies.

Medication Guides & Communication Plans Are Primary REMS Components: Some 89% of companies boast experience in developing and disseminating Medication Guides for REMS products, and almost 3/4s of organizations have also deployed Communication Plans. In contrast, the use of other, often more onerous, REMS plan components such as ETASU (“Elements to Assure Safe Use” of a product, undertaken so far at only 37% of companies) and Implementation Plans (32%) is less common.

Collaboration on RMP and REMS Is Becoming More Frequent: Collaboration between RMP teams in Europe and REMS teams in the U.S. enables companies to increase efficiency and share both process and therapeutic-area knowledge. Though 53% do not currently collaborate on this front, a trend toward growing interaction and alignment between these similar teams was observable in this study.

• Study background------------------------------------------------------------------------------------------ 07
• Participating companies----------------------------------------------------------------------------------- 10
• Role of market research groups in supporting REMS programs------------------------------------ 17
• Industry experience in developing & deploying successful REMS plans-------------------------- 23
• REMS approaches for new products-------------------------------------------------------------------- 28
• Leveraging resources for REMS efficiency & excellence (internal & external) ------------------ 33
• REMS communication plans: current challenges------------------------------------------------------ 41
• RMP: key trends in risk management plans for succeeding in the European market---------- 46
• Appendix: voices from the field--------------------------------------------------------------------------- 58
• About Best Practices, LLC---------------------------------------------------------------------------------- 63

• Leadership role for REMS plan components
• Levels of REMS program led in the function
• Support groups of REMS plan components
• Levels of market research group support REMS programs
• REMS plan implementation limited to only a few products
• REMS plans center on med guides, communication plans
• Activities managed in organization’s REMS Program in association with drafting a Communication Plan
• Activities managed in organization’s REMS Program in association with drafting a ETASU Plan
• REMS market research function support areas
• Market research function activities and research types manage in support of the development and distribution of Communication Plans
• Market research function activities and research types manage in support of the development and distribution of ETASU Plans
• New product development process in organization to begin REMS planning
• Activities in market research function conduct at each phase
• Percentage of research associated with REMS Plans are conducted internally versus outsourced to external vendors
• Additional activities or research types conducted to support REMS programs in your organization
• REMS function use to leverage external approved REMS Plans (Data) from other companies
• REMS function use to leverage internal research completed by brand teams and franchise units
• Collaboration with other companies with similar treatments in developing any facets of your REMS plan components
• Facets of REMS planning collaborated with other components
• Current challenge associated with communication plan research
• Most effective sources for identifying risks to be addressed by the safety specification element of a drug’s RMP
• Techniques or tools leveraging to measure ‘acceptable’ vs. 'unacceptable' risk(s) of a particular product
• Vehicle(s) and techniques experienced with in communicating risk of a particular product
• Resources and activities to determine the communication-of-risk levels required for a given product
• Effective measures of communication-of-risk plans once implemented
• Market research to support your risk minimization plan
• Organization to ensure proper cross-functional support, alignment, and completion of periodic safety update reviews (PSURs) on drug launch
• Measuring RMP plan success
• RMP and REMS functions collaborated together to share lessons learned and best practices or streamline processes