ARTICLES BY LOUIS

• 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.

• “Hiring” A CDMO For A Peptide To Repair Nerve Damage

  8/7/2023

  Things are moving relatively quickly at NervGen, but CEO Michael Kelly took time to speak about his outsourcing experiences and best practices for "hiring" external partners such as CDMOs.

• Japan's Global Lessons In Outsourcing

  8/2/2023

  Chief Editor Louis Garguilo's first experiences in outsourcing involved Japan, when Japan Pharma considered offshore CDMOs as too risky. He recently took a trip to Tokyo to report on the state of the biopharma-CDMO market there today.

• Geo-partnering With Global Suppliers

  7/24/2023

  Andrew Trigwell of Paradigm BioPharmaceuticals in Australia, deals in distances. He can teach you how long-distance outsourcing can work, and how to meet the challenges of a global supply chain.