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APRIL 2016 Research Alert

This month we added five new studies to the Best Practice Database, the research repository for Best Practices, LLC. Three of the new documents are from a new disease state awareness study that examines critical aspects of these important programs including timing of activities, budget and best practices. Another new study provides a current perspective on the 9-year-old REMS law and current trends in program success. The final study tackles priority review vouchers and the research delivers an overview of the voucher program, its benefits, recent developments and criticisms.

The new Best Practices, LLC studies listed below under Newly Added Research explore how leading companies have made their operations more effective across these different areas.
Download: Priority Review Vouchers: An Innovative Approach to Accelerate New Product Reviews by the FDA and Encourage Development of Medicines for Neglected Diseases (ID 5406)
Under the FDA’s 2007 priority review voucher law, developers of medicines for specified neglected or rare pediatric diseases receive a voucher for six-month priority review from the FDA to be redeemed with another product of choice or sold to another organization. This study provides a brief overview of priority review vouchers, its benefits, recent developments and criticisms against the voucher program.
Download: Disease Awareness Program Excellence: Structure, Activities Timing, and Budget (ID 5407)
The study provides insights and benchmarks that illustrate how leading pharma and biotech companies are approaching issues of structure, timing and budget to ensure the effectiveness of their disease awareness program.
Download: Disease Awareness Program Excellence: Utilizing Advocacy Groups and Social Media (ID 5408)
Best Practices, LLC conducted a primary research study that examines what type of disease awareness activities companies perform with advocacy groups, when they start those activities, and which do they consider most important. The study also looks at the use of social media for disease awareness activities.
Download: REMS Excellence: Models & Trends in Supporting REMS Program Success (ID 5410)
This report provides leading insights and benchmarks around the structure and responsibilities of REMS teams, use of market research teams to support and benefit REMS programs, physician/ distributor compliance on ETASU, current challenges in REMS communication plans and innovative REMS approaches for new products.
Disease Awareness Program Excellence: Interview Narratives and Best Practices (ID 5409)
This Best Practices, LLC study presents qualitative insights from study participants about their experiences with disease awareness programs. The study spotlights effective practices and challenges participants have faced.

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