ARTICLES BY LOUIS

• Big Pharma Advises Biotech On Outsourcing

  9/25/2023

  They say biotech taught pharma how to outsource. So what’s someone who has spent 31 years working in Big Pharma know about outsourcing from the vantage point of smaller organizations? A lot, it turns out.

• AI Beats Back Bad Batches

  9/21/2023

  “I look from a supply-chain perspective,” says AI / supply-chain expert Tingling Dai, “discovery, development, manufacture ... until we put them into clinical use.” And that involves, he says, “keeping track of multiple stakeholders.”

• AI, The Ghost In The Outsourcing Machine

  9/18/2023

  It’s time to get real about artificial intelligence applied specifically to drug development and manufacturing outsourcing; practical supply-chain enhancements to implement right now. Thoughts from an AI supply-chain expert. Part 1.

• In Year 20, “Biopharmaceutical” Remains The Same

  9/15/2023

  Each year, I present some takeaways to Outsourced Pharma readers from BioPlan's important annual survey on bioprocessing. This year, I notice our noisy nomenclature, and present a chart that indicates CDMOs will keep on keeping on.

• Tales Of Outsourcing Woe (Are Good For You)

  9/11/2023

  A global drug development and manufacturing stalwart recently relayed heady outsourcing advice, and tales of what you might call economic woe that provide words of caution to all readers ...

• The Most Difficult Outsourcing Tasks

  9/6/2023

  Hint: According to long-termed Pfizer supply-chain professional Francis Dumont, it is sterile-fill. Learn about that and much more on working effectively with CDMOs to optimize production.

• Ex-Pfizer Pro Tired Of The Word “Strategic”

  8/28/2023

  A few months past the culmination of a 31-year career at Pfizer, Francis Dumont has this seminal thought on drug development and manufacturing outsourcing:  “I’m tired of the word ‘strategic.’”

• When Batches At The CDMO Go Kaput

  8/21/2023

  What do you do when batches are lost at a CDMO, or other negative outcomes arise from your service provider? Here's a real-life example and answer from an experienced biotech CEO. He believes solutions start with relationships on all levels.

• “Intellectual Responsibility” In Drug Development

  8/14/2023

  All outsourced or not, “It's our product," says NervGen CEO Michael Kelly." We have an 'intellectual responsibility' as stewards to make sure we can get this through clinical trials and to patients as quickly as possible.”

• How A CDMO Should Communicate A Form 483

  8/9/2023

  Form 483 – issued at the conclusion of an FDA inspection – is the perfect example to lend to a universal principle: Whatever is going on at a CDMO that might impact customers should be communicated to those customers. Here's a detailed analysis from industry professionals.