Discovery Research From The Editor

  1. Legal And IP Protection For New Biotechs 10/31/2023

    Want to ensure you've got your biotech legal, IP, and patent bases covered? Join Business of Biotech host Matt Pillar and BlueSphere Bio CEO and biotech legal expert Keir LoIacono on 11/13 for the live, interactive, and FREE digital event Legal And IP Protection For New Biotechs. 

  2. Oh, Oligonucleotides! Everybody Wants In 10/23/2023

    “We’re working on oligonucleotides,” says the bubbling biotech. “We can do oligos!” cries the eager CDMO. So it’s a deal? Hang on, says Tony Sampognaro, Director, CMC Project Management, at oligo-focused Stoke Therapeutics.

  3. Outsourcing Needs More MBAs (Yes, You Read That Correctly) 10/16/2023

    Tony Sampognaro of Stoke Therapeutics recently received his MBA. He thinks many others in our industry should do so as well. He believes its what we need to outsource more efficiently, and work better with CDMOs.

  4. 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.

  5. 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.

  6. “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.”

  7. 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.

  8. “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.

  9. 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.

  10. 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.