Regulatory Videos

  1. The FDA's Progressive Appeal ft. Allan Shaw 2/16/2021

    Allan Shaw rejoins the Business of Biotech with candid and deep commentary on the unprecedented pace of biopharma innovation, and how the FDA is doing in its equally unprecedented effort to keep pace. In particular, Shaw shares his take on the advance of cell and gene therapies, his observation on the outsized approval rate for orphan disease and oncology therapies, and much, much more. *Editor's note: the review of Biogen's Aducanumab, referenced here as taking place in the March timeframe, was extended shortly after this episode was recorded.

  2. Using Egnyte For Life Sciences As GxP Repository 1/6/2021

    Transitioning from the research phase to the clinical trial phase is a big step for any company, but it also means challenges, not the least of which means your electronic records need to comply with FDA 21 CFR Part 11 and GxP. In this democast, we will review how to deploy and use a GxP-compliant repository using Egnyte’s industry-focused platform, Egnyte for Life Sciences, without sacrificing usability or security, and without creating administrative overhead.

  3. IND Best Practices: 5 Tips For A Successful Filing 1/6/2021

    There are many steps that need to be performed in order to assemble an Investigational New Drug (IND) Application. Whether it be consulting with the FDA, using a GxP compliant collaboration platform, or finding a partner, this process is often complex. Despite the numerous steps, it does not have to be an insurmountable goal. This webinar reviews 5 key best practices for assembling your IND and identifies specific tips that you can integrate into your workflow today.

  4. GxP Audit Trails For FDA Compliance 12/8/2020

    Many companies struggle with ensuring a strong compliance envelope as they transition from an R&D culture to a more-structured, regulated one. In this video we will cover Egnyte for Life Sciences platform overview focusing on audit trails, versioning, and reporting capabilities that can help you overcome your compliance challenges.

  5. 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.

  6. 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.

  7. 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. 

  8. 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.

  9. 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.

  10. 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.