Louis Garguilo's Articles

  1. A Supply-Chain Woman Of Iran 9/23/2024

    Arezou Mehrabi has a spellbinding supply-chain case study. It transpired, of all places, in Iran. It includes major challenges in outsourcing manufacturing to a partner CDMO for a top-ten pharma (Sanofi, to be exact). Our protagonist is a woman who took leadership within a male-dominated workplace, country, and entire region. 

  2. When Should You Select Your Supply Partner? 9/19/2024

    In this part two, James Doherty, President and Chief Development Officer, provides readers with a window into the contracting strategy of Acumen Pharmaceuticals, a biotech developing a novel therapeutic for the treatment of Alzheimer’s disease (AD). Acumen has announced it entered a CDMO contract for both clinical and any future commercial supply.

  3. If The CDMO Shoe Fits, Wear It Now 9/16/2024

    Acumen Pharmaceuticals, a clinical-stage biopharmaceutical developing a novel therapeutic for the treatment of Alzheimer’s, selected its manufacturing partner early on, and told the world about it. Chief Editor Louis Garguilo asked the chief development officer about that strategy.

  4. 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. 

  5. Warning To U.S.-Based CDMOs: Don't Get Complacent 9/9/2024

    How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO  of his eponymous consulting company. His response did not disappoint.

  6. 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?

  7. 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.”

  8. 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.

  9. 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.

  10. 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?