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Best Practices, LLC Strategic Benchmarking Research
REMS Excellence:
Models & Trends in Supporting REMS Program Success
Table of Contents
 Executive Summary pg. 3
 Research Overview pg. 4
 Participating Companies pg. 5
 Abbreviations Used...
Page | 3
REMS Benchmark Research: Objectives, Methodology & Topics
New regulatory requirements, such as those outlined in ...
Page | 4
Benchmark Class and Representative Job Titles of Participants:
This study engaged 19 healthcare executives and le...
Page | 5
The following acronyms are used frequently in this research. Definitions are provided below.
Acronyms Used in thi...
Page | 6
Key Findings & Insights
Few of the key findings and insights that emerged from this study:
 Pharmacovigilance & ...
Page | 7
Pharmacovigil
ance, 42%
Medical
Affairs, 26%
Epidemiology,
11%
Other, 21%
Q. What functional group leads the REMS...
Page | 8
Q. Which of the following REMS Plans does your organization have experience in supporting?
% RespondentsN=18
Wher...
Page | 9
Q. What resources does your REMS function use to leverage internal research completed by brand teams and franchis...
Page | 10
Best Practices®, LLC is an internationally recognized thought leader in the field of best practice
benchmarking®...
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Models & Trends in REMS Program Success

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Given the stringent regulatory requirements in the health care industry, it is important for bio-pharmal companies to develop innovative Risk Evaluation and Mitigation Strategies (REMS) plans during the commercialization of certain products to ensure an acceptable risk-to-benefit ratio.

This benchmark study published by Best Practices, LLC examines how companies develop and execute successful Risk Evaluation and Mitigation Strategies (REMS) plans for newly-approved drugs in the U.S. market. This study can help bio-pharma companies in creating successful REMS programs.

Download Full Report: http://bit.ly/2aOt5Id

Published in: Healthcare
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Models & Trends in REMS Program Success

  1. 1. Best Practices, LLC Strategic Benchmarking Research REMS Excellence: Models & Trends in Supporting REMS Program Success
  2. 2. Table of Contents  Executive Summary pg. 3  Research Overview pg. 4  Participating Companies pg. 5  Abbreviations Used pg. 6  Key Recommendations pg. 7  Key Findings & Insights pgs. 8-10  Benchmark Class Profile pgs. 11-12  REMS Program: Structure & Responsibilities pgs. 13-17  Industry Experience in Developing & Deploying pgs. 18-22 Successful REMS Plans  REMS Approaches for New Products pgs. 23-26  Leveraging Resources for REMS Efficiency & Excellence pgs. 27-31  REMS Communication Plans: Current Challenges pgs. 32-36  About Best Practices, LLC pgs. 37-38
  3. 3. Page | 3 REMS Benchmark Research: Objectives, Methodology & Topics New regulatory requirements, such as those outlined in the Food and Drug Administration’s Amendments Act of 2007, create compliance hurdles for pharmaceutical organizations. As a result, pharmaceutical companies must develop effective REMS program strategies to help achieve both compliance and commercial objectives. Topics Covered: Research Methodology Research Overview  Structure of Risk Evaluation & Mitigation Strategy (REMS) teams  Key activities across functions  Regulatory imperatives and commercial objectives associated with REMS products  How Market Research teams are used to support and benefit REMS programs Best Practices, LLC engaged 20 leaders from 17 biopharmaceutical & medical device companies for this project. This benchmark study examines how companies develop and execute successful Risk Evaluation and Mitigation Strategies (REMS) plans for newly-approved drugs in the U.S. market.
  4. 4. Page | 4 Benchmark Class and Representative Job Titles of Participants: This study engaged 19 healthcare executives and leaders supporting REMS programs at 17 leading life sciences and medical device companies. More than 50% of research participants work at the level of director or senior director. Roughly one-fifth of participants serve either as president or CEO. Universe Of Learning: 17 Companies Participated in Study  Associate Director Phase IV Clinical Trials  Chief Medical Officer  Deputy General Manager  Director, Director of Epidemiology Field Studies  Epidemiologist  Founder and CEO  Global Medical Director  Local Safety Manager  Medical Director  President  Risk Management Consultant  Senior Medical Director  Senior Director Benefit-risk
  5. 5. Page | 5 The following acronyms are used frequently in this research. Definitions are provided below. Acronyms Used in this Study REMS: "Risk Evaluation and Mitigation Strategy" - A set of plans and activities required by the FDA (per the Food and Drug Administration Amendments Act of 2007) and undertaken by a drug manufacturer to educate patients and physicians on the risks associated with certain newly- approved products in the United States. ETASU: "Elements to Assure Safe Use" - A component of certain REMS plans, often for drugs with potentially serious risks. For example, ETASUs can require prescriber training or certification, certification of dispensers, the restriction of drug administration certain healthcare settings, and other steps on the part of the manufacturer. Abbreviations Used:
  6. 6. Page | 6 Key Findings & Insights Few of the key findings and insights that emerged from this study:  Pharmacovigilance & Medical Affairs Functions Lead REMS: According to this research study, REMS programs are mainly led by Pharmacovigilance (at 42% of benchmark companies) and Medical Affairs (26%). Additional support functions such as Regulatory Affairs, Clinical, and Commercial also support overall REMS activities at some organizations. Market Research also serves a limited role in REMS at many participating companies.  Internal Databases and Past Internal REMS Plans Serve as Most-Used Internal Resource: Most companies closely study previous internal REMS programs undertaken within the company, both for drugs in a different therapeutic area (65%) or same therapeutic area (53%). Almost half of companies also refer to internal research repositories / databases to gain further insights.
  7. 7. Page | 7 Pharmacovigil ance, 42% Medical Affairs, 26% Epidemiology, 11% Other, 21% Q. What functional group leads the REMS program at your organization? % Respondents N=19 Ultimate responsibility for REMS programs tends to reside within either the Pharmacovigilance (42% of benchmark companies) or Medical Affairs (26%) function. Regulatory/Compliance, Medical Affairs, Commercial/Clinical, and PV/Safety are functions that provide a secondary support role with REMS programs at 44% of participating companies. Pharmacovigilance, Medical Affairs Typically Lead REMS *Other: Multidisciplinary but Safety (PV) has largest role, Finance/BCP/Compliance, CRO * Functional Home: N=16 *Other: Risk Management, Epidemiology, Development, IT 25% 25% 44% 44% 44% 44% Other Marketing/Market research Pharmacovigilance/Safety Clinical/Commercial Medical Affairs Regulatory/Compliance Other Lead Functions: * Q. List any function or group who have a secondary leading role for the REMS program at your organization. Research
  8. 8. Page | 8 Q. Which of the following REMS Plans does your organization have experience in supporting? % RespondentsN=18 Where REMS plans are required, the benchmark class has the most experience in developing Medication Guides and Communication Plans to support physicians and patients. Slightly less prevalent are “Elements to Assure Safe Use” components (e.g., diagnostic tests, physician training) and Implementation Plans, such as physician or distributor certifications. 89% Have Experience with REMS Medication Guides REMS Plan Experience Areas: 72% 78% 83% 89% ETASU (e.g., diagnostic tests, physician training) Implementation Plans (e.g., certifying physicians, distributors; patient registries) Communication Plans Medication Guides
  9. 9. Page | 9 Q. What resources does your REMS function use to leverage internal research completed by brand teams and franchise units? % Respondents N=17 Instead of trying to “re-invent the wheel” for each new REMS product, 65% of companies capitalize both on past internal REMS data for drugs within different therapeutic areas, while another 53% of companies use past REMS program for drugs within same therapeutic areas is such experience is available within the organization. Companies Draw on Past REMS Product Experience if Available Internal REMS Plans Data Used: 6% 35% 47% 53% 65% Other A centralized knowledge-sharing or Center of Excellence function Internal research repositories / databases Past internal REMS programs for other drugs within the same therapeutic area Past internal REMS programs for other drugs across different therapeutic areas
  10. 10. Page | 10 Best Practices®, LLC is an internationally recognized thought leader in the field of best practice benchmarking®. We are a research, consulting, benchmark database, publishing and advisory firm that conducts work 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. 6350 Quadrangle Drive, Suite 200 Chapel Hill, NC 27517 (Phone): 919-403-0251 www.best-in-class.com Learn More About Our Company:

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