Precision for Medicine Webinars and Videos

1. The 3 FDA Oncology Approvals That Will Have The Biggest Impact In 2025 7/25/2025

   The FDA wrapped up 2024 with 3 notable approvals. Harpreet Singh, MD and CMO, provides a recap.

2. The FDA's New Guidance May Be Shaking Up Biotech 7/25/2025

   The FDA’s recent draft guidance on accelerated approval outlines tougher standards for confirmatory trials and introduces a faster process for withdrawing approvals.

3. Precision In, Precision Out: Elevated Kitting Strategies For Clinical Trials 6/17/2025

   As biomarker-driven clinical trials become increasingly complex, the design and management of clinical trial kits play a pivotal role in ensuring operational success and scientific integrity.

4. Achieving Regulatory Compliance With A Unified Immunogenicity Strategy 5/10/2025

   This presentation equips viewers with the knowledge and tools needed to navigate the intricacies of designing immunogenicity assays that comply with both European IVDR and US FDA regulations.

5. Future-Proofing Gene Therapy Assays: Validation Strategies For Long-Term Success 5/10/2025

   In this presentation, viewers engaged in early assay development or optimizing assays for later-phase trials will benefit from expert insight into the development of gene therapy immunogenicity assays.

6. Illuminating IHC: Right-Sizing Your Validation And Regulatory Strategy 5/2/2025

   In this presentation, expert speakers provide an in-depth exploration of the essential validation and regulatory strategies for Immunohistochemistry (IHC).

7. Key Success Factors In Conducting A Translational Clinical Study 5/2/2025

   As precision medicine and biomarker-driven trials become central to clinical development, managing the clinical sample lifecycle has never been more critical.