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JUNE 2015 Research Alert

This month we added four new studies to the Best Practice Database, the research repository for Best Practices, LLC. One of the new documents is a case study of Tecfidera's launch and the strategy Biogen utilized to guide the MS therapy to blockbuster status even though it was the third oral drug for relapse remitting multiple sclerosis on the market. The remaining three studies deal with key activities performed by the quality function at medical device organizations: compliance and product support; inspection and production; and nonconforming activities.

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: Tecfidera Case Study: Using Safety as a Springboard for Blockbuster Status (ID 5360)
This case study examines how Biogen used safety and pricing to differentiate Tecfidera from competitors and catapult the MS drug to blockbuster status.

Benchmanrking Medical Device Quality: Staffing and Budget AllocationsDownload: Benchmarking Medical Device Quality 2014-15: Compliance and Product Support (ID 5359)
Best Practices, LLC conducted this benchmarking study to understand the role of quality in the funding and management of key compliance and product support activities at medical device companies. This study also examines how much companies are utilizing low-wage markets for quality assurance and product support activities.
Download - Benchmarking Advisory Board Management at Large Pharmaceutical & Medical Device Organizations: Structure and OperationsDownload: Benchmarking Medical Device Quality 2014-15: Inspection and Production Activities (ID 5364)
Best Practices, LLC undertook this study to help quality leaders better understand compliance and inspection activities within the quality function. Research findings provide evidence-based benchmarks around these issues so quality leaders can compare their efforts with industry peers.
Benchmarking Advisory Board Management at Large Pharmaceutica & Medical Device Organizations: Cost and ChallengesDownload: Benchmarking Medical Device Quality 2014-15: Nonconforming Activities (ID 5365)
This study helps quality leaders better understand the role of the the quality function regarding managing/funding key nonconforming activities. The study also addresses the level of Quality nonconforming activities conducted in low-wage markets, CAPA and NCEs ratios, and additional Quality metrics.

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