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Innovation in Regulatory Science Is Meeting Evolution of Clinical Evidence Generation.

07:00 EST 13th January 2019 | BioPortfolio

Summary of "Innovation in Regulatory Science Is Meeting Evolution of Clinical Evidence Generation."

At the turn of the century, the pharmaceutical industry began a transition toward a focus on oncology, rare diseases, and other areas of high unmet need that required a new, more complex approach to drug development. For many of these disease states and novel approaches to therapy, traditional approaches to clinical trial design fall short and a number of innovative trial designs have emerged. In light of these changes, regulators across the globe are implementing new programs to provide regular development program support, facilitate accelerated access, use real-world data, and use digital tools to improve patients' lives. Emerging market regulators are also focusing on simplifying their regulatory pathways via regional harmonization schemes with varying levels of ambition. These changes in the external environment imply that biopharma regulatory teams need to adapt and evolve, leveraging digital tools, data and analytics, and positioning themselves as strategic advisors during development. This article is protected by copyright. All rights reserved.

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This article was published in the following journal.

Name: Clinical pharmacology and therapeutics
ISSN: 1532-6535
Pages:

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