Thermo Fisher Live Event Shorts

  1. What Bioprocessing Bottlenecks Does Process Intensification Address? 8/27/2024

    Supply chains, consumables, and data are identified as three of the management challenges that intensified processes and process automation technology (PAT) are addressing at AbbVie and AstraZeneca.

  2. Why AstraZeneca and AbbVie Are Intensifying Processes 8/27/2024

    In this segment of the Bioprocess Online Live event Bioprocess Intensification In The Real World, our speakers share the motivation for continued process intensification in their respective organizations.

  3. IND Submission Advice From The Front Lines 2/21/2023

    NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim share parting shots and nuggets of IND submission wisdom, and respond to a few final audience questions, in this final segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray.

  4. Resources For Successful IND Submissions 2/21/2023

    In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim offer several of their go-to resources for guidance when preparing an IND submission.

  5. So, You've Been Put On Clinical Hold… 2/21/2023

    As the frequency of clinical holds increases, so do the chances it’ll happen to you. What’s a biopharma leader to do if it happens? Umoja Biopharma VP of Regulatory Affairs Helen Kim and NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. offer advice on direct engagement with the FDA to expedite the release of a clinical hold.

  6. How To Avoid A Clinical Hold 2/21/2023

    Umoja Biopharma's VP of Regulatory Affairs and an NDA Partners Regulatory Affairs Expert Consultant have come together to dig into how biopharmas can avoid clinical holds from the outset

  7. IND Submissions Are On The Rise 2/21/2023

    During this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, we asked our live audience about their near-term IND submission plans. Our panelists, NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim, reflected on the uptick in submissions to the FDA in recent years and prognosticated on the trend.

  8. The Impact Of The Clinical Hold 2/21/2023

    In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, Umoja Biopharma VP of Regulatory Affairs Helen Kim and NDA Partners Regulatory Affairs Expert Consultant Daniela Drago, Ph.D. discuss the ramifications of a clinical hold on your study progress, investor perception, and timelines.

  9. Why Clinical Holds Happen 2/21/2023

    The volume of clinical holds doled out by the FDA has skyrocketed in recent years. In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, NDA Partners Expert Consultant Daniela Drago, Ph.D. and Umoja Biopharma VP of Regulatory Affairs Helen Kim explain clinical holds and discuss why they happen.

  10. Animal Testing & Tox: What's Required Today? 2/21/2023

    In this segment of the Bioprocess Online Live event IND Success: Navigate Through The Regulatory Gray, Umoja Biopharma VP of Regulatory Affairs Heln Kim entertains audience questions on FDA toxicology and animal study requirements in light of the Reducing Animal Testing Act passed in December, 2022.