Medical Affairs Best Practices
Best Practices, LLC has conducted extensive research in the field of Medical Affairs. Browse through and sample our published Medical Affairs research in the topics below:
| |  | Risk Mitigation Excellence: Structure and Roles that Support REMS Programs  
Non-members: Click here to review a complimentary excerpt from "Risk Mitigation Excellence: Structure and Roles that Support REMS Programs"
STUDY OVERVIEW
New regulatory requirements have created ever greater compliance hurdles for pharmaceutical organizations. One of the outgrowths of these new regulations is that pharmaceutical companies need to develop innovative Risk Evaluation & Mitigation (REMS) program strategies to help achieve both
compliance and commercial objectives.
Best Practices, LLC conducted this research study to identify the most suitable structure and roles to support REMS programs. In addition to exploring how pharmaceutical organizations approach issues around the structure and roles for supporting REMS programs, this study evaluates the role of market research in supporting REMs programs.
Biopharmaceutical leaders who are involved with REMS programs can use this study to compare their structure and roles for supporting REMS programs with the approach used by other leading organizations.
KEY TOPICS
REMS Programs: Structure & Responsibilities
Industry Experience in Developing & Deploying Successful REMS Plans
Role of Market Research Groups in Supporting REMS Programs
REMS Approaches for New Products
SAMPLE KEY METRICS
Functional groups that lead REMS program
Sub-functional group associated with leading the REMS program
Job title level leading the REMS programs
Levels at which the market research groups supports REMS programs
Number of products on which REMS programs were implemented since 2007
Type of activities managed by REMS Program in association with drafting a communication plan
Type of activities managed by REMS Program in association with drafting an Elements to Assure Safe Use (ETASU) plan
Areas of REMS supported by market research function
Activities and research types managed by market research function in support of the development and distribution of communication plans
Activities and research types managed by market research function in support of the development and distribution of ETASU plans
Stage of the new product development process at which REMS planning begins
SAMPLE KEY FINDINGS
Companies Have Little Longitudinal Experience with REMS Products: Most companies 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 plan for 3.33 products since the advent of REMS. The most total REMS products managed by one company was nine.
“Good Medicine is Good Business” Defines Approach to Balancing Risk Communication & Commercial Impact of Deploying REMS Programs: Most study respondents stressed the fact that a REMS plan that clearly communicates all the risks associated with a product is not only necessary but also in keeping with good business practices over the long-term. As one interviewed executive told us: “You have to understand how the components of REMS either aid or inhibit the brand and set expectations accordingly. A disjointed forecast will only lead to problems later."
METHODOLOGY
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.
Risk Mitigation Excellence: Resources & Trends for REMS & RMP Programs
Non-members: Click here to review a complimentary excerpt from "Risk Mitigation Excellence: Resources & Trends for REMS & RMP Programs"
STUDY OVERVIEW
With regulators focused on the safety of new products, pharmaceutical organizations face ever increasing regulatory requirements for their new products. To meet these new standards, pharmaceutical organizations are relying on internal and external resources to support their risk-mitigation programs and meet compliance goals.
This new research study from Best Practices, LLC, examines the internal and external resources that leading organizations use to support Risk Evaluation & Mitigation Strategy (REMS) programs. In addition, the study reviews the challenges of implementing communication plans and trends in the European market for implementing Risk Minimization Plans (RMPs).
Best Practices, LLC conducted this research to help REMS leaders understand current trends in dealing with risk mitigation plans.
KEY TOPICS
Leveraging Resources for REMS Efficiency & Excellence (Internal & External)
REMS Communication Plans: Current Challenges
RMP: Key Trends in Risk Management Plans for Succeeding in the European Market
Appendix: Voices From The Field
SAMPLE KEY METRICS
Percentage of REMS research that is conducted internally versus outsourced to external vendors
Resources used by REMS function to utilize REMS Plans (Data) from other companies
Resources used by REMS function to utilize internal research completed by brand teams and franchise units
[Have you] collaborated with other companies with similar treatments in developing any facets of your REMS plan components
Current challenges 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 used to measure 'acceptable' vs. 'unacceptable' risk(s) of a particular product
Vehicle(s) and techniques used to communicate risk of a particular product
Resources and activities used to determine Communication-of-Risk levels for a given product
Effectiveness rating of Communication-of-Risk plans once it has been implemented
Use of Market Research to support Risk Minimization Plan
Biggest challenges with RMPs
SAMPLE KEY FINDINGS
35% have Collaborated with Other Companies on REMS Development : Companies mainly collaborate with other organizations that support similar products or therapeutic areas. The most common REMS areas on which to collaborate are around either ETASUs (67% of collaborating companies) or with respect to FDA interactions to help ensure compliance or learn about specific therapeutic area standards – a phenomenon which also happens at 67% of companies.
Companies Look to Benchmark Drug Class to Determine “Acceptable” Risk Levels: Although companies actively work to communicate and mitigate all the risks associated with product treatment, they also recognize the importance of focusing their efforts to do the most possible good. To do so, 60% of firms use a drug’s class as a useful benchmark, with another 47% employ risk matrices. Only 13% currently use third-party analysis.
METHODOLOGY
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.
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