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| Join Cell & Gene's Chief Editor, Erin Harris, for this timely Cell & Gene Live offering an in-depth regulatory outlook with two of the field's most trusted experts, Wilson Bryan, M.D., former director of FDA's Office of Tissues and Advanced Therapies (OTAT), and Daniela Drago, Ph.D., RAC, Partner at NDA Partners. Learn More! |
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Some raw materials simply aren't available in GMP. Experts Yan Zhi and Lawrence Thompson describe risk assessment approaches that inform sourcing decisions in this segment from Cell & Gene Live "Viability On The Line." Some investigational therapies require many unique raw materials, and controlling them appropriately gets tricky. |
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| Don't Let Distribution Derail Your CGT Launch | Article | Cencora | Overcoming distribution challenges is critical for the success of cell and gene therapies. Learn how to build a flexible, robust strategy to optimize patient access. |
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| Gene Therapy & CDx: Smarter Development | e-book | By T. Harrison, Ph.D., K. Daniels, Ph.D., and D. Phippard, Ph.D., Precision for Medicine | Gene therapy success depends on optimized vectors, robust trials, biomarker-driven strategies, and coordinated regulatory planning for companion diagnostics and FDA engagement. |
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| Targeted Indication Selection Using Adaptive Design | Case Study | Veristat, Inc. | What is a Simon 2-stage design, and how was it used to enable each tumor-specific cohort in a Phase 2, multi-cohort oncology trial to be independently assessed for objective response rates? |
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