Discovery Research From The Editor

  1. More Gene Therapy Outsourcing – Can It Be Quantified? 10/9/2023

    According to ISR Reports inaugural Gene Therapy CDMO Benchmarking survey, well over half the respondents confirmed a complete manufacturing reliance on external partners. Outsourcing has sure come a long way ... more details within.

  2. 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.

  3. “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.”

  4. 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.

  5. “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.

  6. 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.

  7. The FDA's Sway On AI 6/29/2023

    The FDA’s CDER published a paper titled “Artificial Intelligence in Drug Manufacturing" to facilitate input from outside the agency. Here's some of that input from Chief Editor Louis Garguilo.

  8. 3 Updated Fundamentals Of Outsourcing 6/26/2023

    Here are three newly updated key factors for increasing your chances of personal, programmatic, and organizational success, as you pursue the activities known collectively as drug development and manufacturing outsourcing.

  9. Economical Outsourcing: Should I Stay Or Should I Go? 6/19/2023

    I doubt The Clash contemplated drug development and manufacturing when they penned their classic song, “Should I Stay of Should I Go.” But they could have. The question of staying internal with your programs or going to service providers - around the world - can be difficult to answer.

  10. Considerations For Licensing Platforms From Universities 6/16/2023

    Even the best platforms and technologies don’t come out of universities IND-ready. Just ask Coeptis Therapeutics, which recently licensed the novel CAR-T platform, SNAP-CAR, from the University of Pittsburgh. Coeptis’ Dave Mehalick, and Dan Yerace discuss the licensing agreement and the growing pains to expect when preparing a new platform for an IND.