Regulatory Videos

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. The FDA Modernization Act is Signed Into Law. Now What? 4/22/2024

    Scientists worldwide celebrated the signing of the FDA Modernization Act into law. Gain expert insights into what to anticipate regarding using New Approach Methods (NAMs) in novel IND submissions.

  6. Gain Support For Your Regulatory Submission Process 3/27/2024

    Join us in this video as we delve into invaluable tips, cutting-edge tools, and unwavering support that Cytiva offers to facilitate your documentation progress.

  7. A Regulatory Perspective: How Government Funding Spurs Scientific Innovation 3/25/2024

    Review the different ways the United States government supports alternative, innovative approaches for more reliable readouts of toxicity and efficacy.

  8. What Indications Can, And Will, mRNA Therapeutics Address? 12/5/2023

    During our Bioprocess Online Live event, mRNA Update: Beyond Prophylactic Vaccines, we asked an audience of several hundred biopharma professionals what indications they’re addressing in mRNA therapeutic development. Here, our panelists address their responses and offer final thoughts on unfolding mRNA regulatory frameworks.

  9. Safety & CQAs: Do mRNA Therapeutic Regulators Know What They Want? 12/5/2023

    In this segment, Combined Therapeutics CSO Thomas Van Cott, Ph.D. and Omega Therapeutics Executive Director, Process Development and Analytical Sciences Jeff Atkinson, Ph.D. address regulators’ likely safety and CQA concerns as well as audience questions regarding variable and changing RNA constructs.

  10. Facing NASH Therapeutic Skepticism With 89bio's Rohan Palekar 8/9/2023

    The non-alcoholic steatohepatitis (NASH) therapeutics market has proven to be an 11/10 on the difficulty scale. Despite billions of big biopharma dollars invested in therapeutic development, and a few close calls, no therapeutics has yet reached the finish line.