ARTICLES BY LOUIS

• The CDMO Chase Has Gone Digital. Is It Safe?

  9/3/2024

  Biotechs chasing down CDMOs. CDMOs chasing up new clients. But both sides, at times, passing by each other, or inadvertently chasing each other away.  The problem lies mostly in how we look … and communicate. And where we go to look. Is it time, and safe, for some digital dating?

• The High Life And Times Of A Qualified Person (QP) In Europe

  8/26/2024

  You must be appropriately qualified, trained, accepted by the relevant competent authority in the European Union, and named on a site’s authorization. According to Nolliag Buckley, a Qualified Person (QP) also needs more. “Honest to God, you must be creative. That sort of individual skill is helpful. I'm a troubleshooter. That's what I love.”

• Clinical Trials In China Reboot BIOSECURE Act

  8/21/2024

  Clinical trials are not my beat, but the BIOSECURE Act targeting CDMOs sure is. Now the congressional committee involved with putting that legislation together has found something of perhaps more substance, and better substantiated, to add to the impetus of the Act: clinical trials in China.

• New Study: Biopharmaceutical Manufacturers Vs. CDMOs

  8/19/2024

  Fortuitous to all OusourcedPharma.com readers, BioPlan Associates, Inc., allows Chief Editor Louis Garguilo to relay some salient points from their annual survey.  What caught his attention this year was "data indicates the focus on supply chain security is already abating,” and there's a competition between sponsor and supplier for talent.

• Portals For Productive Communication

  8/12/2024

  At the age of 28, Ammar Badwy began his biopharma-industry journey by creating an online portal that “digitized the sourcing of API.” He’s now expanded to a platform for sponsors to find CDMOs offering all their variated development and manufacturing services. Will it be successful? Is this how we should have been communicating all these years?

• You Want Success With CDMOs? Think In Threes

  8/9/2024

  Twenty-eight years at Gilead, but Reza Oliyai’s new pursuit is no mere second act. He establish Oliyai Consulting Corporation, focused on Chemistry and Manufacturing Controls (CMC), to teach others his series of guiding "triads" to apply to all activities related to drug development and manufacturing outsourcing.

• Need Supply In Europe? Mind Your QPs "Ps And Qs"

  8/5/2024

  No batch of medicinal product can be used for investigational purposes or sold commercially without certification from an EU Qualified Person. So who are these QPs? Who trains them? What exactly do they accomplish? Nollaig Buckley has the answers. She’s been an independent QP and consultant for 22 years.

• A Day In The Life Of A CMC Professional

  8/1/2024

  This CMC (chemistry, manufacturing and control) professional spends a good deal of time thinking about and interacting with his CDMOs. Through his experience, he knows that ineluctably some form of challenge will arise. Just another day at the office?

• In Defense Of The Full-Time Equivalent (FTE)

  7/26/2024

  "Back in the day," says Chief Editor Louis Garguilo, "it proved most optimal for my biopharma clients ... I’m speaking of the full-time equivalent (FTE) model at CDMOs for your drug development (and certain manufacturing) needs. Hooking up to specific professionals at your CDMO still makes good sense."

• Outsourcing At Cerus: Blood, Sweat … and FTEs?

  7/22/2024

  After four decades in the biopharma industry, including at NIH, Elan Pharmaceuticals, and Gilead Sciences, Nils Olsson may be undertaking his most complex role: continue to develop and supply vital technologies and pathogen-reduced blood components to blood centers, hospitals, and patients relying on safe blood supply.