CLINICAL SUPPLY PLANNING ARTICLES
The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?
CLINICAL SUPPLY PLANNING RESOURCES
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Explore how clinical and commercial teams should work together for clinical supply packaging, how the COVID-19 pandemic has changed things, and what to consider when looking for a packaging partner.
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For the industry to realize the potential of cell and gene therapies (CGTs), we must develop improved solutions that reliably support the control and transport of critical CGT raw materials and products.
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Have you noticed that it has become increasingly difficult to transport your material into and out of the United States? That’s because it has!
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Do pharma companies underestimate supply chain challenges? Much can go wrong when sending a therapy from A to B, but the right collaborations can mitigate risk.
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Rachel Curran, Head of Sourcing Services and Special Accounts, discusses the requirements, challenges, and solutions to comparator and co-therapy drug sourcing for clinical trials.
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Early collaboration with a clinical supply manager can help proactively negotiate potential pitfalls. Learn efficient resupply practices and execute successful supply chain strategies.
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The RMAT designation gives the sponsor of a new drug access to increased meeting opportunities with FDA, in a manner comparable to those offered to sponsors of breakthrough-designated therapies. In fact the RMAT may be considered as analogous to the breakthrough designation for regenerative medicine drugs.