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.

1. Risk Mitigation Excellence:
Innovative Models & Trends in Supporting
REMS & RMP Programs
Best Practices, LLC Strategic Benchmarking Research
REPORT SUMMARY

2. Table of Contents
EXECUTIVE BRIEF
STUDY BACKGROUND
BENCHMARK 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
Market
APPENDIX: VOICES FROM THE FIELD
About Best Practices, LLC

3. Research Objectives & Methodology
New regulatory requirements, such as those outlined in the Food and Drug Administrations
Amendments Act of 2007, create ever greater compliance hurdles for pharmaceutical organizations.
As a result, pharmaceutical companies must develop innovative REMS program strategies to help
achieve 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
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4. 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:
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5. Most Participants Serve at Director Level or Above
Research data and insights were contributed by a veteran class of respondents, the vast
majority 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 of
functions 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
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6. Section Summary: Industry Experience with REMS Plans
Key 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.
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7. 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)
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8. 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)
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9. 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)
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10. 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)
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11. 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
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