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» Products & Services » » Quality, Compliance and Regulatory » Deployment

REMS Excellence: Models & Trends in Supporting REMS Program Success

Download FREE Excerpt

ID: POP-270

Features:

13 Info Graphics

15 Data Graphics

180+ Metrics

Pages: 38

Published: 2016

Delivery Format: Shipped

 

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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
Considering the stringent regulatory requirements in the health care industry, it is important for biopharmaceutical 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.


Given the complexity of balancing regulatory requirements and commercial objectives, Best Practices, LLC undertook benchmarking research to examine how leading life sciences and medical device companies develop and execute successful REMS plans for newly-approved drugs in the U.S. market.

In particular, the study provides insights around the structure and responsibilities of REMS teams, use of internal and external resources to support REMS programs, physician/ distributor compliance on ETASU, current challenges in REMS communication plans and innovative REMS approaches for new products.


Industries Profiled:
Pharmaceutical; Consulting; Manufacturing; Biotech; Consumer Products; Diagnostic; Medical Device; Health Care; Biopharmaceutical; Clinical Research; Laboratories


Companies Profiled:
Abbvie; Oxon Epidemiology; Arthur F. Morelli and Associates; Baxter BioScience; Bayer; Cadila Pharmaceuticals; Eisai; Gilead Sciences; Hospira; Lilly; MedicinesOracle; Novartis; Pfizer; Reliance Life Sciences; Sanofi; Scientific Advantage; UCB Pharma


Study Snapshot

Best Practices, LLC engaged 20 leaders from 17 leading biopharmaceutical and medical device companies through a benchmarking survey. More than 50% of participants are at the level of director/ senior director and around 20% of participants are CEO/president.

Key Findings

·Pharmacovigilance & Medical Affairs Functions Lead REMS: According to the study, REMS programs are mainly led by Pharmacovigilance (at 42% of benchmark companies) and Medical Affairs (26%). Additional support functions such as regulatory affairs, and sub-functions such as clinical and commercial also support overall REMS activities at some organizations. Market Research serves very limited role in REMS at any participating companies.

·“Internal Database and Past Internal REMS Plans Serve as Most Used Internal Resource: Most companies use past internal REMS programs, for drugs in different therapeutic area (65%) or same therapeutic area (53%). Almost half of the companies also refer internal research repositories/database.


Table of Contents

· Executive Summary, pgs. 3-10
· 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 Successful REMS Plans, pgs. 18-22
· 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

List of Charts & Exhibits

· Functional group leading REMS program at benchmarked organizations
· Level of lead job title
· Groups holding primary leadership role for listed REMS plan components
· Groups supporting listed REMS plan components
· Number of products for which REMS plan has been implemented at benchmarked companies
· REMS plan experience of participating organizations
· Communication activities managed by REMS organization
· Effectiveness of ETASU activities managed by REMS organization
· Stage of new product development process at which REMS planning begins
· Strategies adopted for inducing physician and/or distributor compliance for drugs requiring an ETASU REMS plan
· Percentage of research associated with REMS plans conducted internally versus outsourced to external vendors
· Resources used by REMS function to leverage external approved REMS plans (data) from other companies
· Resources used by REMS function to leverage internal research completed by brand teams and franchise units
· Collaboration with other organizations
· Balancing REMS communication strategy and messaging to not only inform physicians of treatment risk but to also instill greater confidence in treatment
· Balancing risk (from the clinical perspective) vs. commercial impact (from the marketing perspective) in the context of REMS program deployment for new products
· Integration of REMS support functions within benchmarked companies
· Effective policies for integrating REMS support functions

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