ARTICLES BY LOUIS

• 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.

• Breaking: BIOSECURE Act Out. Long Live Wuxi Apptec?

  6/25/2024

  The U.S. House Rules Committee did not include the BIOSECURE Act in the final list of amendments for the National Defense Authorization Act (NDAA). Chief Editor Louis Garguilo has been outspoken in defending WuXi Apptec’s right to due process. Readers have responded in spades. Here's the latest.

• Power Of Attorney For Cell Therapy Outsourcing

  6/24/2024

  “I always say I’ve brought a little New Jersey litigator to Pittsburgh biotech,” says BlueSphere Bio CEO Keir Loiacono. And to the CDMOs he works with. Today, his attorney-informed focus is applied to T cell receptor (TCR) technology. Here's part one of his unique insights to outsourcing.

• So You Want To Be An Outsourcing-Industry Entrepreneur?

  6/18/2024

  Secretly, somewhere inside you, is the thought: I’d like to leave this job at my established biopharma company. You wonder: How would I start my own, wait for it: contract service organization? Jeffrey Kiplinger, formerly of Pfizer, did just that. And wrote a book about it.