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FDA released the final guideline paper in March for first-in-human trial models that include both dosage escalation and various expansion cohorts to assess safety, anti-tumor efficacy, pharmacokinetics (PK), and other features of therapeutic cancer candidates all within a single protocol. The principle is simple: after the optimal Phase 2 dosage has been established during the …

Expansion Cohorts In Clinical Trials Of Oncology Drugs: FDA Issues Guidance Read More »

Research on genomic medicine is growing rapidly, which raises challenges concerning the design of clinical trials, regulatory channels, manufacturing processes, and price structures. Sandy Macrae, Chief Executive Officer of Sangamo Therapeutics, Inc., will explain the new wave of medicine and the hurdles that need to be overcome in order to revolutionize the treatment of genetic …

Navigating Genomic Therapy Development Read More »