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DTSTART;TZID=America/Los_Angeles:20260820T110000
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SUMMARY:FDA Engagement Strategies And Best Practices Amid Agency Changes
DESCRIPTION:How can life sciences companies developing new medicines engage the FDA successfully during a period of rapid changes in agency personnel and policies? \nShould companies adjust their agency communication strategies or ask new questions during meetings? Our deeply experienced panelists will discuss key changes at the FDA\, how companies can get the most out of agency interactions\, and strategies to lower risks and avoid regulatory surprises. \nRegister for free today and secure your spot for this important virtual event.
URL:https://thebiocalendar.com/event/fda-engagement-strategies-and-best-practices-amid-agency-changes/
LOCATION:Online webinar
CATEGORIES:Webinar
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SUMMARY:CAR-T for Relapsed/Refractory AML: From Discovery to First-in-Human Active Phase 1 Evaluation
DESCRIPTION:Join Dr. Marco Davila to explore a novel anti-CD83 CAR-T design for relapsed/refractory AML that overcomes myelosuppression barriers. Register for the live session. \nDeveloping effective Chimeric Antigen Receptor (CAR) T-cell therapies for Acute Myeloid Leukemia (AML) remains one of the most formidable frontiers in cellular immunotherapy. Unlike lymphoid malignancies where lineage-specific targets like CD19 or BCMA offer a clear therapeutic window\, AML presents a severe biological bottleneck. The vast majority of well-characterized myeloid antigens (such as CD33 or CD123) are shared with healthy hematopoietic stem and progenitor cells (HSPCs). Consequently\, conventional CAR-T approaches frequently induce prolonged\, life-threatening myelosuppression and bone marrow aplasia severely limiting their clinical utility. This webinar by Dr. Marco Davila will explore a paradigm-shifting strategy developed at Roswell Park Comprehensive Cancer Center that addresses this exact barrier: a novel CAR-T design targeting the CD83 antigen. \nOur discussion will center on the unique biology of CD83\, a protein highly expressed on malignant AML blasts but distinctively regulated in healthy tissues\, offering a pathway to selectively suppress leukemia cells while sparing critical progenitor stem cells. Moving from bench to bedside\, we will detail the rigorous process development and GMP manufacturing frameworks involved in generating this CAR-T cell therapy to be tested in clinic. Finally\, we will share insights into the initiation and objectives of the first-of-its-kind\, active Phase 1 clinical trial evaluating autologous anti-CD83 CAR-T cell infusions in patients with relapsed or refractory AML. Join us to discover how this dual-action architecture reshapes safety\, efficacy\, and translation benchmarks in the myeloid cell therapy space.
URL:https://thebiocalendar.com/event/car-t-for-relapsed-refractory-aml-from-discovery-to-first-in-human-active-phase-1-evaluation/
LOCATION:Online webinar
CATEGORIES:Webinar
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