New endpoints for early-stage cancer are gaining regulatory traction
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The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial. There are some...
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In this article, Regulatory expert, Cecil Nick, looks at the latest MHRA guidance and what the future holds for biosimilar development.
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Learn how all stakeholders benefit when patients and their insights are at the heart of every aspect of clinical development.
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This article explores the nature and manufacturing process of ATMP and how clinical professionals can execute the development and marketing of these therapies.
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Learn how to improve identification, recruitment and retention of rare disease patients.
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Parexel's Oncology Center of Excellence combines our new early advisory core service of medical, regulatory, genomics/biomarkers, and biostatistics experts with an experienced multi-disciplinary team
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Discover three key considerations for crafting a successful genomic biomarker strategy in this article.
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