ARTICLES BY LOUIS GARGUILO
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When Should You Select Your Supply Partner?9/19/2024
In this part two, James Doherty, President and Chief Development Officer, provides readers with a window into the contracting strategy of Acumen Pharmaceuticals, a biotech developing a novel therapeutic for the treatment of Alzheimer’s disease (AD). Acumen has announced it entered a CDMO contract for both clinical and any future commercial supply.
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If The CDMO Shoe Fits, Wear It Now9/16/2024
Acumen Pharmaceuticals, a clinical-stage biopharmaceutical developing a novel therapeutic for the treatment of Alzheimer’s, selected its manufacturing partner early on, and told the world about it. Chief Editor Louis Garguilo asked the chief development officer about that strategy.
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Warning To U.S.-Based CDMOs: Don't Get Complacent9/9/2024
How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO of his eponymous consulting company. His response did not disappoint.
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The Most Difficult Outsourcing Tasks9/6/2023
Hint: According to long-termed Pfizer supply-chain professional Francis Dumont, it is sterile-fill. Learn about that and much more on working effectively with CDMOs to optimize production.
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Multiplying Forces Of Clinical Supply Outsourcing1/30/2023
There are a number of varying and converging forces baring down on sponsors looking for CROs/CDMOs who can provide a full slate of services around their clinical-trial material. Both CDMOs and sponsors need to add or subtract from their strategies to adjust.
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Beware The Manufacturing Bottleneck: Lessons From Inside6/6/2022
Steven Kelly, President & CEO, Carisma, a biotech with a CAR M therapy in phase one, is a repeat-CEO. “I’ve had a varied experience, and different functional responsibilities,” he says, "but when I think about manufacturing, two experiences stand out for me.”