Discovery Research From The Editor
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Small Molecules And The Arc Of Time
5/15/2023
“I've been trained, and doing the same stuff since I was 25. The same experiments for 50 some years, a long time. I guess you could call what I am describing as the arc of time for small molecules,” says Kintara Therapeutics cofounder and CSO Dennis Brown.
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Large Balloons Over America, Small Molecules In China
5/8/2023
Coinciding with U.S. and China relations continuing to deflate, but with no premeditated intention, my discussion with President and CEO of Kintara Therapeutics, Robert E. Hoffman, and CSO Dennis Brown, focused on the role of China-based CDMOs.
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A Mother Picks A CDMO To Advance Treatment For Her Daughter
3/20/2023
Until her daughter was diagnosed with Infantile Neuroaxonal Dystrophy (INAD) in 2016, Leena Panwala had been content with her life as a new mom, and selling real estate as a profession. Today, she’s co-founder and president of INADcure Foundation, and outsourcing a novel gene therapy.
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A Third Model For Outsourcing Development And Manufacturing
3/8/2023
Biopharma organizations are often counseled to consider the strategy of “mirroring” your outsourcing activities. But what if this were the other way around – your CDMO effectively mirrored your organization? It’s an idea come to life via a partnership development management organization (PDMO) in Aguadilla, Puerto Rico.
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A Bridge To Capacity For The Cell & Gene Industry
2/8/2023
Bridge facilities have been built for cell and gene therapy (CGT) sponsors – and CDMOs – to access here-and-now available, fully outfitted GxP capacity. But bring your own skilled workers. Here's how it works.
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Solving The Equation For A Cell Therapy Development Strategy
2/3/2023
Nowadays, “biotechs” emerge with unique business models, are hybrids of one kind or another, and operate as developers, platform/technology creators and service providers rolled up into one glorious organization. I found another one at Umoja Biopharma, Inc., a Seattle, Washington-based cell-therapy company.
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Multiplying Forces Of Clinical Supply Outsourcing
1/30/2023
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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The Best CDMOs Are Redundant
1/16/2023
The top CDMO-selection criteria for Perry Calias, Chief Operations Officer, Revolo Biotherapeutics, and a veteran outsourcer, is redundancy. Redundancy laced with relationships, that is. Here's how it can work for you.
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A Historic Outlook For 2023
1/9/2023
You might say John Koleng has been living in the drug development and outsourcing future throughout his decades-long career. That career began in 1996 when as a grad student he helped cofound a CDMO. Today, as a VP at TFF Pharmaceuticals, he's as visionary as ever.
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An Industrialization Strategy For Cell Therapies
12/29/2022
If cell therapy is the art of engineering, the industrialization of these therapies – many of which are stymied by an inability to scale up or produce at various locations –is fully contingent upon the application of engineering concepts and practices. Part two of our look into "cell therapy industrialization."