Discovery Research From The Editor

  1. 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?

  2. BIOSECURE Act Passes House. How Will It Impact Your Outsourcing? 9/10/2024

    The U.S. House of Representatives was hell-bent on sending a message to China – and all of us in the biopharma industry. Congress hopes that message – and real-life consequences – will be accomplished via its successfully passing the BIOSECURE Act in a House vote. Breaking analysis from Chief Editor Louis Garguilo. 

  3. 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.”

  4. 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.

  5. 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?

  6. 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."

  7. 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.

  8. 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.

  9. 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.

  10. 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.