ARTICLES BY LOUIS

• You Still Can't Find Your Providential CDMO?

  10/21/2024

  Why does it remain so problematic for sponsors to select the appropriate external manufacturing partners? Why haven't we got this figured out? Why isn't it easier to connect sponsors and providers? So much more information is out there. Here's a frank discussion of our perennial problem ...

• 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?

• Your CDMO's Maintenance, From Roof To Floor And Ever More

  10/14/2024

  Facility Maintenance –an all-encompassing descriptor. It starts with taking care of an internal ecosphere - everything from roof to floor. It also includes an exosphere – the real estate the facilities sit on, the business parks where they are located, and the communities they reside within. When you are outsourcing, it makes you a part of it all as well. How much do you know about this area of your CDMO’s existence?

• 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

  In part one, we met Arezou Mehrabi. Now, she shares a 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.