Regulatory Videos

  1. Clinical Trials And Business Continuity In The Age Of COVID-19 12/8/2020

    In this webinar we are joined by Rahul Chaturvedi, an expert in clinical development with 10+ years of experience, who discusses some of the ways clinical trials are being disrupted and how to shift your mindset to take advantage of this time to strengthen your clinical program.

  2. How To Stay Ahead Of Disruptive Trends In Clinical Trials 12/8/2020

    Clinical trials are evolving. Whether it’s disruptive technology, changing regulations, or external factors. The pace of change is only increasing - along with the complexity of ensuring your trial data is secure and compliant. This session will provide best practices and insight into how to keep pace with the changes and be better prepared for what’s still to come.

  3. 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. 

  4. 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.

  5. Challenges Associated With In-Use Simulated Administration Of Biologics

    Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

  6. 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.

  7. 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.

  8. Effective Technology Transfer For Mammalian Derived Biopharmaceuticals

    Gain the knowledge and tools necessary to facilitate successful technology transfer and accelerate the translation of your projects from bench to market.

  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. 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.