Regulatory Videos

  1. Obesity Tx End-Around With Skye Bioscience's Punit Dhillon 10/20/2024

    While the trend toward CB1 inhibition for obesity took a small hit with the release of Novo Nordisk's small molecule oral cannabinoid receptor (CB1) inverse agonist monlunabant last month, Skye Bioscience Chairman and CEO Punit Dhillon is shaking it off. He's confident that his company's antibody-based approach to CB1 inhibition will make a moot point of the neuropsychiatric side effects that put a damper on Novo's data. On this episode of the Business of Biotech, we're digging into the uber-hot business of weight loss therapeutics.

  2. Ask The Expert: 21 CFR Part 11 Compliance 9/25/2024

    Hear from a 21 CFR Part 11 expert with nearly 20 years of experience supporting pharmaceutical, diagnostic, and medical device companies with implementing solutions and systems to ensure compliance.

  3. Steering Through Setbacks with AVEO Oncology's Michael Bailey 8/18/2024

    For all the drug commercialization successes he's played a leading hand in during his tenures at GSK, Genentech, and ImClone — Androderm, Augmentin, necitumumab, and Erbitux among them — Michael Bailey concedes that he's likely better known for his failures. After hearing his stories on this episode of the Business of Biotech, I tend to disagree.

  4. Building An Effective Contamination Control Strategy For Final Sterile Filtration 8/13/2024

    Watch to learn about important considerations for final sterile filtration throughout product development and for performing pre-use post-sterilization integrity testing.

  5. Leading From Within with ISCT & Kiji's Miguel Forte, M.D. 8/11/2024

    He's been a big pharma executive. He's a multi-time biotech founder and current biotech CEO. He was once a regulator. He's a physician. He serves on multiple boards. And as of this summer, he's president of one of the most influential global organizations dedicated to the advance of cell and gene therapies (ISCT), and an executive member of another (ARM). Miguel Forte, M.D. simply can't stop finding places to apply his talents and energy to influence the advanced therapies landscape.

  6. Virus Filtration: Regulations And Mechanisms 7/25/2024

    In this presentation, Dr. Nigel Jackson, Principal Engineer in R&D, offers an in-depth discussion on regulatory guidance and recent updates pertaining to virus filtration.

  7. Drug Delivery Differentiators with Syncromune's Eamonn Hobbs 7/7/2024

    Syncromune's Sync-T solid tumor therapeutic platform is, in a word, complex. The company's three phase 1 programs combine T-cell science with a proprietary drug delivery device to target solid tumors, specifically metastatic breast, non-small-cell lung, and castrate-resistant prostate cancers. But, while orchestrating a successful drug/device combination therapy presents unique regulatory challenges and requires a diverse array of in-house skillsets, President and CEO Eamonn Hobbs is confident. Why? He's done it before.

  8. How Can Biotech Industry Leaders Build Public Trust? 5/16/2024

    Allan Shaw explains how and why the biotech industry should take action to build trust with consumers and Wall Street.

  9. Will Direct-To-Consumer Options Solve The Drug Price Problem? 5/16/2024

    Allan Shaw explains how directly engaging consumers could benefit pharmaceutical companies and patients by cutting costs.

  10. Why Does The Pharmaceutical Supply Chain's Last Mile Have Broken Links? 5/16/2024

    Rising drug prices are the "elephant in the room" in the pharmaceutical industry. Expert Allan Shaw explains how this problem started and how it could be solved.