Regulatory Videos

  1. 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.

  2. 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.

  3. Cell Therapy Process Development Made Easy 3/27/2024

    Explore how Fast Trak™ process development services offered by Cytiva can guide you through achieving GMP compliance in your cell therapy manufacturing process.

  4. 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.

  5. Biotech Down Under with BiomeBank's Dr. Sam Costello 12/20/2023

    Merry Christmas, Business of Biotechers! On this Christmas Day release, we’re taking a trip to the land down under to visit with Dr. Sam Costello, managing director and co-founder at Adelaide, Australia-based BiomeBank. We covered some ground on this one, most notably the unique path BiomeBank took to chalking up the first donor-derived microbiome therapeutic approval of its kind, anywhere in the world. In a segment of biotech that’s been particularly battered of late, that’s a big, big win. 

  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. The Role Of PUPSIT In A Contamination Control Strategy 7/25/2023

    Here, we discuss the relationship between the CCS and PUPSIT, highlight the role of sterilizing grade filtration in the control strategy, and talk about how this can change throughout the product life cycle.