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

ID: POP-242


4 Info Graphics

32 Data Graphics

217 Metrics

29 Narratives

Pages: 62

Published: Pre-2016

Delivery Format: Shipped


License Options:

Single User: Authorizes use by the person who places the order or for whom the order was placed.

Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.

Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.

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With ever increasing regulatory requirements in place for healthcare companies and their new products, pharmaceutical organizations must develop innovative risk-mitigation programs to support patients and meet compliance goals.

This critical new Best Practices, LLC study examines how leading organizations build and execute successful Risk Evaluation & Mitigation Strategy (REMS) programs for products in the U.S. marketplace.

This study also provides key insights into how market research groups support high-performing REMS teams, while highlighting collaboration opportunities with Risk Management Plan (RMP) teams working on European products.

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.

Table of Contents

Executive brief---------------------------------------------------------------------------------------------- 03
  • 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

List of Charts & Exhibits

Functional group leads the REMS program at organization
  • 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