Regulatory Videos

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Solutions For Sustainable Chemistry And Supply Chain 7/31/2023

    Examine how a CRDMO committed to delivering innovative solutions can help meet the unique needs and requirements of clients in the pharmaceutical, biotechnology, and other industries.

  10. Dissecting Spesolimab's Approval With Boehringer Ingelheim's Carine Boustany 1/2/2023

    Join Matt Pillar for a conversation with Carine Boustany, PharmD, Ph.D. and SVP, US Research Site Head and Global Head of Immunology and Respiratory Diseases at Boehringer Ingelheim. On this episode of the Business of Biotech, we walk through the story leading up to the recent approval of spesolimab. In September 2022, spesolimab was approved in the USA for the treatment of generalized pustular psoriasis (GPP) flares in adults. Dr. Boustany shares the antibody's fortuitous discovery, the challenges her team faced on the path to approval, and how those challenges were overcome.