Regulatory Videos

  1. Gap Analysis With Dr. Pablo Valenzuela & Cristián Hernández-Cuevas 9/30/2020

    On the season finale of the Business of Biotech, we're joined by biopharma pioneer Dr. Pablo Valenzuela and a rising star in Chile's biotech scene in Cristián Hernández-Cuevas for a candid discussion on biopharma's compute power revolution, the influence of technology on gap analyses and next steps for emerging biopharma, and what's driving biotech growth in South America.

  2. CMC Considerations For In-Human Studies With Drs. Edith Perez And Nathan Ihle 9/23/2020

    Bolt Biotherapeutics CMO Dr. Edith Perez and VP of CMC & Quality Dr. Nathan Ihle bring a unique combination of patient and production process expertise to the table for an enlightening conversation on preparing chemistry, manufacturing, and controls for an IND and ensuing first in-human studies.

  3. Commitment To GMP With Dr. Shabbir Anik 9/13/2020

    Sutro Biopharma Chief Technical Operations Officer Shabbir Anik has contributed to 15 INDs and 10 NDA’s over the course of his distinguished career, making him a great choice to sit down for a chat about the mechanics of GMP and CMC strategy in new and emerging biopharma enterprises. Here, Dr. Anik shares stories from the front lines of Sutro's effort to move its antibody conjugate, bispecific antibody, and cytokine derivative candidates forward.

  4. Data Quality & Master Files With Dr. Robert Hariri 9/6/2020

    If ever a biotech unwittingly begged for FDA scrutiny by virtue of its business model, it was Celularity. The company is working on a host of biologic therapies, the development of which is dependent on the large-scale collection of stem cells harvested from afterbirth in maternity wards across the globe. That's an approach that simply begs for FDA oversight, which is why Celularity founder Dr. Robert Hariri makes for an excellent discussion on the importance of data quality and complete master files for FDA submissions. 

  5. Taking ADCs Across The Finish Line 8/13/2020

    While Immunomedics CMO Loretta Itri, M.D. is no stranger to taking drugs across the commercial finish line in big pharma environments, her most recent win with TRODELVY was very, very different. On this episode, Dr. Itri shares insight on her small biopharma's first commercial launch, the manufacturing and regulatory approval challenges that were overcome to get there, and why antibody drug conjugates are coming of age.

  6. Filling The Need For Integrated Bioconjugate Solutions

    Explore how the ADC landscape is being reshaped by new drug product capabilities that enable end-to-end development and manufacturing of cytotoxic bioconjugates.

  7. Embrace Molecule Complexity With Optimized Expression Technologies

    Explore the needs of more complex candidates, through case studies that demonstrate the range of expression capabilities across mammalian and microbial-derived molecules.

  8. Inclusion Bodies: Mother Nature's Help Or Hindrance?

    Explore strategies to improve the performance of IB processes as well as the pros and cons of soluble and insoluble processes: isolating, solubilizing, and properly refolding.

  9. Achieving Biologics License Application Success Using A Structured Approach

    This webinar focuses on the critical CMC elements of a product’s life cycle and the regulatory submissions support and strategy necessary for a successful BLA application.

  10. Drug Product Process Characterization For Liquid And Lyophilized DP

    Consider these important initial steps that should be implemented during the process design phase as a pre-requisite to a successful PPQ campaign and readiness for commercial manufacturing.