ARTICLES BY LOUIS

• 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.

• A QR Code For Finding The Right CDMO

  7/19/2023

  Is it getting more difficult to select the best CDMO? Too many choices with similar pitches? If only there were QR codes to scan for help in locating the right CDMOs. Let me explain.

• Is Your “Preferred Provider List” Legacy-Heavy?

  7/17/2023

  Doesn’t an approved/preferred service-provider list facilitate partner selection? Ronald Lewis thinks it depends. "As you evolve as a company,” he says, “it probably makes sense in most cases to trim these down and streamline.”

• Is Your CDMO Relevant? How To Find Out

  7/12/2023

  Ron Lewis, Sr. of MEI Pharma, harkens back two decades to outsourcing gems he’s mined over his career. A most vital question: "Has the CDMO been in the industry for years, do they seem stale, are they still relevant?”