Louis Garguilo
ARTICLES BY LOUIS
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1/3/2024
I'm a big believer in open-source information as much as possible,” says Nana Collett. “Companies need proprietary information, but I'm a bit radical this way. I believe that as an ecosystem, we're going to get stronger if we can find our way to more data-sharing.”
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12/26/2023
2023, among other potential designations, was the year of oligonucleotides. Accordingly, here’s a question I raised with professionals throughout the year: How do you successfully outsource development and manufacture of an oligo program?
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12/20/2023
Our Advisory Board members describe their outsourcing experiences during 2023, and offer us ideas and questions on how to make 2004 a better environment, specifically for all our advancing platforms.
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12/13/2023
It takes a certain, trained perspicuity to identify the CDMO right for you. If you are a small biotech, says CEO Matthias Schroff, you most likely will not have the weight to ensure an external partner’s “real focus on producing for you.” Here's what he recommends.
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12/7/2023
A strategic switch in focus from a CAR T program closing in on the clinic, to a CAR M program further back in development but generating more excitement, drove the divesting of a manufacturing facility, and a whole lot of change. Part 2 of an investigative series.
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12/4/2023
For months, kept under stealth mode was an emerging cell-therapy company’s plans to spin out its development and manufacturing facility as a CDMO. No, not a stealth biotech. A stealth CDMO. Part 1 of an intriguing investigation.
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11/27/2023
The context and scope of what quality, regulatory, and technical teams – CMC development professionals – need to accomplish has changed dramatically. It’s a different paradigm, and when you add a CDMO to the mix, it's a very interesting conversation.
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11/20/2023
“As unpopular as this may be with your readership ... I think it's important to own, control, have complete oversight and a seamless process at an internal manufacturing facility with your own team.” No worries about being controversial, CEO Brian Culley. Please go on.
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11/16/2023
Is this an example of a therapy developer with “platform technology” ostensibly pursuing its own pipeline, but also offering services as a contract manufacturer? Lineage CEO Brian Culley says no. He has a different model in mind.
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11/13/2023
How would you go about looking for a modest-sized facility in the U.S. to establish your own development and clinical-stage manufacturing platform? How might a CDMO go about it today? We started this path of inquiry in our previous editorial. Today, the actual tour.