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Risk Evaluation and Mitigation Strategy Excellence: Innovative Trends in Supporting REMS & RMP Programs
 

Risk Evaluation and Mitigation Strategy Excellence: Innovative Trends in Supporting REMS & RMP Programs

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This study examines how leading organizations build and execute successful Risk Evaluation and Mitigation Strategy (REMS) programs for products in the U.S. marketplace. It also provides key insights ...

This study examines how leading organizations build and execute successful Risk Evaluation and Mitigation Strategy (REMS) programs for products in the U.S. marketplace. It 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.

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    Risk Evaluation and Mitigation Strategy Excellence: Innovative Trends in Supporting REMS & RMP Programs Risk Evaluation and Mitigation Strategy Excellence: Innovative Trends in Supporting REMS & RMP Programs Presentation Transcript

    • Risk Mitigation Excellence:Innovative Models & Trends in Supporting REMS & RMP Programs Best Practices, LLC Strategic Benchmarking Research REPORT SUMMARY
    • Table of ContentsEXECUTIVE BRIEFSTUDY BACKGROUNDBENCHMARK STUDY FINDINGS I. REMS Programs: Structures & Responsibilities II. Industry Experience in Developing & Deploying Successful REMS Plans III. Role of Market Research Groups in Supporting REMS Programs IV. REMS Approaches for New Products V. Leveraging Resources for REMS Efficiency & Excellence (Internal & External) VI. REMS Communication Plans: Current Challenges VII. RMP: Key Trends in Risk Management Plans for Succeeding in the European MarketAPPENDIX: VOICES FROM THE FIELDAbout Best Practices, LLC
    • Research Objectives & MethodologyNew regulatory requirements, such as those outlined in the Food and Drug AdministrationsAmendments Act of 2007, create ever greater compliance hurdles for pharmaceutical organizations.As a result, pharmaceutical companies must develop innovative REMS program strategies to helpachieve both compliance and commercial objectives. Objectives: • Examine how leading healthcare organizations: – Structure their Risk Evaluation & Mitigation Strategy (REMS) teams – Delegate key activities across functions – Balance regulatory imperatives and commercial objectives associated with REMS products – Use Market Research teams for maximum support and benefit – Analyze Risk Management Plan (RMP) lessons from the European market to find collaborative opportunities and efficiencies between RMP and REMS operations Field Research & Insight Development: Objective: 1. Provide Critical Insights into the Engaged 22 executives and managers from 19 Quickly Evolving REMS Landscape companies in a performance benchmark 2. Highlight Opportunities for Key Support Functions to Deliver Analyzed quantitative and qualitative findings from Leading Support to REMS Product several deep-dive interviews Teams 3 BEST PRACTICES, ® LLC
    • Universe of Learning: Companies Participating in Study 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. Representatives from several benchmark organizations also provided additional insights through deep-dive interviews. Participating Companies: 4 BEST PRACTICES, ® LLC
    • Most Participants Serve at Director Level or AboveResearch data and insights were contributed by a veteran class of respondents, the vastmajority of who serve at the director level or higher. Throughout the healthcare industry,a wide range of functions support REMS programs, a fact reflected in the diverse set offunctions from which study participants responded. Research Participant Job Titles Include: • Senior VP, Chief Medical • Chief Medical Officer Officer (Regulatory / Safety) • Deputy Director, Medical Affairs • VP, Clinical Neurology & Drug Safety (R&D) • Associate Director, Market Research • Head, Early Stage Commercialization (New • Associate Director, Medical Education Products Marketing) • Associate Director, Commercial Regulatory • Senior Director, Global Product Strategy Affairs • Senior Director, Market Research • Assistant Director, Global • Director, Risk Evaluation & Mitigation Pharmacovigilance & Risk Management Strategy (U.S. Medical) • Senior Manager, Regulatory Affairs • Director, Market Research • Manager, Market Research • Director, Global Pharmacovigilance • Manager, Regulatory Affairs • Director, Global Strategic Analytics • Manager, Regulatory Affairs (QA / QC) • Medical Director, Risk Management (PV) • Manager, Medical Affairs 5 BEST PRACTICES, ® LLC
    • Section Summary: Industry Experience with REMS PlansKey data findings and insights from this section include: SAMPLE INSIGHT: SAMPLE INSIGHT: Companies Have Little Longitudinal Experience with REMS Products:: Most companies Companies Have Little Longitudinal Experience with REMS Products Most companies have relatively limited experience in implementing a REMS plan or executing a REMS throughout 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 plans the entire product lifecycle. On average, benchmark companies have only deployed REMS plans for 3.33 products since the advent of REMS several years ago. The most total REMS products for 3.33 products since the advent of REMS several years ago. The most total REMS products managed by one company was nine. managed by one company was nine. 6 BEST PRACTICES, ® LLC
    • SAMPLE DATA SLIDE:“Specific Leadership Roles Vary Drastically per Activity” The chart below distills two critical insights into the nature of REMS management. First, a handful of different functions all help to lead REMS development and execution. Second, this lead function varies greatly depending on the activity. For example, while Regulatory Affairs often leads Medication Guide activities, it is not uncommon for a commercial group (e.g., Marketing / Brand Teams) to take the lead for Communication Plans. Q5. What group has the primary leadership role for each of the following REMS plan components? (Check all that apply) Regulatory Medical Clinical Marketing Market PV Affairs Affairs Affairs / Brands Research Other Medication Guides 14% 48% 38% 0% 0% 0% 0% Communication Plans 24% 10% 24% 0% 33% 0% 10% ETASU (e.g., diagnostic tests, physician training) 14% 19% 43% 14% 5% 0% 5% Implementation Plans (e.g., certifying physicians, distributors; patient registries) 29% 14% 19% 14% 14% 0% 10% Please indicate the group to which you belong: 14% 29% 19% 5% 5% 19% 10% (n=21) 7 BEST PRACTICES, ® LLC
    • SAMPLE DATA SLIDE:“REMS Collaboration with Other Organizations Limited” Though not prevalent, collaboration between healthcare organizations – especially those with similar therapies – in the development of certain REMS Plan components is not unheard of. Thirty-five percent of companies report some level of such collaboration. Q23. Have you (either as an organization or as a market research group) collaborated with other companies with similar treatments in developing any facets of your REMS plan components? Yes 35% 65% No (n=17) 8 BEST PRACTICES, ® LLC
    • SAMPLE DATA SLIDE:“Internal Research Drives Most REMS Preparation” Across all REMS Plan components, research is mostly done internally, with approximately 84% of Medication Guide research, 77% of Communication Plan research, and 73% of Implementation Plan research managed from within the organization. The most frequently outsourced research type is ETASU; roughly 30% of ETASU research is managed by external vendors. Q15. What percentage of research associated with the following REMS Plans are conducted internally versus outsourced to external vendors? Internal Research (%) External Research (%) Medication Guides 83.9% 16.1% Communication Plans 76.9% 23.1% ETASU (e.g., diagnostic tests, physician training) 69.6% 30.4% Implementation Plans (e.g., certifying physicians, distributors; patient registries) 72.9% 27.1% (n=18) 9 BEST PRACTICES, ® LLC
    • SAMPLE DATA SLIDE:“MR Groups Test Educational Material for RMPs” A majority (54%) of benchmark Market Research groups support RMPs by testing new labeling. The most common activity for Market Research teams is testing educational material, practiced at 62% of companies. A full 23% of study participants selected “N/A,” indicating a lack of MR involvement in the company’s RMP program. Q36. How are you using Market Research to support your Risk Minimization Plan? Testing educational material 62% Testing new labeling 54% Testing packaging communication of risk 46% N/A 23% Other 8% (n=13) 10 BEST PRACTICES, ® LLC
    • Learn More About Our Company Our company is an internationally recognized thought leader in the field of best practice benchmarking®. We conduct research and consulting based on the simple yet profound principle that organizations can chart a course to superior economic performance by leveraging the best business practices, operating tactics and winning strategies of world-class companies. Best Practices, LLC 6350 Quadrangle Drive, Suite 200 Chapel Hill, NC 27517 919-403-0251 best@best-in-class.com www.best-in-class.com 11