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Biopharma companies seeking to bring cell and gene therapies (CGTs) to market in the European Union face multiple challenges, not least of which are the differing regulatory requirements and product definitions. Understanding these nuances is imperative for regulatory approval and market access. Learn about five current and emerging challenges facing companies planning a European CGT launch and practical recommendations on navigating approval.
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Based on a recently conducted survey of 19 formulary decision-makers, this report provides payer trends on market access, formulary evaluations, innovative payment models, and the future of CGTs. Its insights can inform the payer engagement and reimbursement strategies of CGT manufacturers to help improve patient access for advanced therapies.
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Cencora’s specialty distribution and third-party logistics (3PL) experts share their insights, drawn from direct experience supporting several CGTs approved by the U.S. Food and Drug Administration (FDA). Based on this experience, they pose questions CGT manufacturers should be considering and share examples to illustrate several best practices for meeting the complex, highly individualized distribution and logistics needs of CGTs.
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In a recent discussion with a trade director for a CGT manufacturer and a chief commercial officer (CCO) of a specialty pharmacy, Cencora explored the qualities manufacturers should prioritize in their distribution partnerships. Learn the distribution decisions that helped succeed — and why they matter for your launch.
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