ARTICLES BY LOUIS

• Fabled Route-Scouters Riding AI Applications

  11/18/2024

  Route scouting professionals – self-effacing hunters of small-molecule simplicity, searching for efficient pathways to commercial success, fearless in pointing out risks, and at times, dead ends. Today they face mounting challenges. Can artificial intelligence (AI) bring more clairvoyance to these battered scientists? “Absolutely,” says Dr. Jürgen Swienty-Busch of Elsevier.

• Is Executive Leadership At Today's CDMOs Up To The Job?

  11/11/2024

  A report from WittKieffer's Global Life Sciences provides a macro analysis of the executives that helm today’s CDMOs. Competent executive leadership should be a main driver of business-to-business confidence. So as a component of your CDMO due diligence, are you adequately assessing the senior executives at that organization? If so, do they inspire confidence that theirs is a well-governed and operated entity?

• Aftershocks: Catalent's Leader Assures The Market

  11/7/2024

  Hard to believe it was back in early February we got the news: Novo Holdings Acquires Catalent. As with any “shake up,” the dust settles and emerging "realities" must be addressed. That’s what has transpired via an "open letter“ from Catalent's executive officer. “I want to correct a few key inaccuracies,” he begins. Analysis from Chief Editor Louis Garguilo.

• Global CDMOs: What's The Right Price And Location?

  11/5/2024

  Jin-an Jiao of Synthekine, a developer of CAR T therapies and biologics, says despite the specifics of his pipeline, plenty of CDMOs are interested in working with him. “However,” he says, “what’s most interesting is there's a huge difference in price estimates for the same work.” Here's his advice on how to handle that.

• I Outsource, Reluctantly

  11/1/2024

  “I’ve worked with CROs and CDMOs since 2000,” says an outwardly jovial Jin-an Jiao, VP, Process and Analytical Development, Synthekine, a developer of CAR T therapies and biologics. His apparent mirth, though, masks a complication: Generally speaking, Jiao is a reluctant outsourcer. Here's how he handles that.

• My Kingdom For A Horse! Or At Least A CDMO

  10/28/2024

  The crown of commercialization depends more than ever on specialized technologies and skilled workmanship, inducing an arduous search throughout the kingdom of development and manufacturing for external partners. Alas, we had thought we’d entered a golden age of outsourcing.

• Were We (Are We) Correct About Oligonucleotides?

  10/25/2024

  In 2023, Chief Editor Louis Garguilo proclaimed it was "the year of oligonucleotides," and 2024 would be an incredible growth year for oligos. How are those proclamations panning out? He takes a detailed look, including the important role in the expected growth played by CDMOs.

• You Still Can't Find Your Providential CDMO?

  10/21/2024

  Why does it remain so problematic for sponsors to select the appropriate external manufacturing partners? Why haven't we got this figured out? Why isn't it easier to connect sponsors and providers? So much more information is out there. Here's a frank discussion of our perennial problem ...

• BIOSECURE Act Starts Dismantling WuXi

  10/16/2024

  Components of the WuXi global organization are for sale. It’s a forced divestiture. WuXi AppTec is marketing some of its U.S. and European operations. The ill-advised BIOSECURE Act targeting several China-based biopharma companies is having its intended effects, even before the legislation is fully passed by the U.S. government. Where do you stand?

• Your CDMO's Maintenance, From Roof To Floor And Ever More

  10/14/2024

  Facility Maintenance –an all-encompassing descriptor. It starts with taking care of an internal ecosphere - everything from roof to floor. It also includes an exosphere – the real estate the facilities sit on, the business parks where they are located, and the communities they reside within. When you are outsourcing, it makes you a part of it all as well. How much do you know about this area of your CDMO’s existence?