ARTICLES BY LOUIS

• 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. 

• Emerging Biotechs Judge CDMOs More Harshly

  7/15/2024

  At the 2024 CDMO Leadership Awards, we learned that smaller sponsors do not feel CDMOs are performing to expectations, or provide their programs with requisite attention. Frankly, we'd never seen such a strong divergence in results before. Here's a closer look, and other takeaways from the Awards.

• What's In Your DMF?

  7/8/2024

  Are relevant Drug Master Files (DMFs) at your CDMO in good order or fully under consideration as part of your upcoming new-drug submissions to the FDA or other agencies? “I've lived with this on both sides, as an FDA official and at biopharma organizations,” says Ben Stevens, Director CMC Policy and Advocacy, GSK, and former  Branch Chief / Chemistry Reviewer at FDA. Here's what he advises.

• Select Your CDMO Based On How You Operate

  7/1/2024

  “We tell them up front we will be hands on. That's a good way to pick the right partners. In other words, we select and view our CDMOs based on the way we operate," explains BlueSphere Bio CEO Keir Loiacono. With a background as an attorney, it's an interesting outsourcing operations indeed.