ARTICLES BY LOUIS

• Who Handles Maintenance At Your CDMO? You Should Know

  10/7/2024

  Computerized Maintenance Management Systems (CMMS); Integrated Facilities Management (IFM); Mechanical / Electrical Systems (M&E); and pest control (!) ... who handles maintenance at your CDMO? Here's what you should know from someone who has been doing it for decades.

• Sanofi, Sanctions, And Supply-Chain Challenges

  10/1/2024

  After learning about Arezou Mehrabi in part one, we now get the details to her case study of a supply chain challenged by trade sanctions, and how Big Pharma (Sanofi) collaborated with a CMO to keep delivering essential medicines. Set in Iran, circa 2018, it's a lesson for all outsourcers provided by the woman who led the charge to get manufacturing back on track.

• 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. 

• 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.

• 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.

• 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. 

• 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.

• 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.