Louis Garguilo Articles

  1. Do You Know Your QMM? Moderna Might Some Day 6/3/2024

    Don’t panic if you aren’t familiar with the above acronym, which stands for Quality Management Maturity. Chief Editor Louis Garguilo wasn't – until schooled by Jason Kerr, Regulatory Intelligence Senior Manager, Moderna and Adjunct Professor of Quality Systems, Keck Graduate Institute. QMM, it appears, may very well be in your future.

  2. Medicinal Chemist, Meet Your CDMO 5/23/2024

    Ben Stevens of GSK documents his career, and highlights a stage in outsourcing we often overlook –  key interactions between med-chem scientists and research biologists, and contract development and manufacturing providers (CDMOs).

  3. Assassination By Implication? Interview With WuXi AppTec (Part 2) 5/20/2024

    “As you read these accusations, it’s like an attempted death by a thousand implications,” says Rick Connell, former Pfizer supply-chain executive and current WuXi AppTec President, U.S. and Europe. In this part two, he provides a line-by-line analysis of the BIOSECURE Act targeting his company.

  4. 2024 CDMO Leadership Awards Opening Remarks 5/14/2024

    Chief Editor Louis Garguilo opens the 2024 Leadership Awards with an acknowledgement of the vital role CDMOs play, and also an intriquing insight into this year’s data to determine the award winners.

  5. Exclusive Interview: WuXi AppTec Responds To BIOSECURE Act 5/13/2024

    Rick Connell, WuXi AppTec’s President, U.S. and Europe, agreed to an exclusive interview with Chief Editor Louis Garguilo to address accusations in the BIOSECURE Act. To understand Connell is to understand the shock at WuXi AppTec – and  among its customers.

  6. Don't Blame The Molecule; You May Be The Problem 5/6/2024

    Ali Pashazadeh has been a healthcare investment banker for 20 years, surgeon for 30, and biotech CEO. Today he leads Treehill Partners. “I can explain our logic in two minutes,” he says of his approach to developing drugs, and targeting diseases.

  7. A Spy At Moderna 5/1/2024

    Jason Kerr of Moderna is a snoop, a spy, a watcher of all things. More officially, he’s tasked by his employer with monitoring for regulatory changes in the environment. “Some do call it regulatory surveillance,” he says, “Some just regulatory monitoring.” Whichever, you might need to hire a Kerr, too. Here's why.

  8. Nothing To See Here! Just Big Pharma Investments In China 4/22/2024

    WuXi AppTec assists U.S.-based biotechs to develop and supply drugs to U.S. patients. Western-based Pharma assists the development of China's industry, the China Communist Party (CCP) by extension, and patients there. Guess which is under assault? Chief Editor Louis Garguilo tries to figure it all out.

  9. CDMOs Pelted By Slings And Arrows 4/18/2024

    Chief Editor Louis Garguilo thought he was precipitating a frontal assault by canvassing the Outsourced Pharma Editorial Advisory Board with questions such as: When outsourcing development and manufacturing, what are the challenges, and where are your pain points? But before anyone claims “one-sided,” please read on.

  10. A Good Feeling ($$) About Contract Manufacturing 4/15/2024

    Occasionally, we look at revenue numbers assigned to the collective activities we focus on at Outsourced Pharma: drug development and manufacturing outsourcing, and working with CDMOs. And we also can provide some pep talks, too.