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Advisory Committee for Therapeutics (ACT) toolkit

Published by UNEW

AdviceClinical DevelopmentPreclinical ResearchResearch and Drug DevelopmentToolkits for patientsTranslational ResearchTREAT-NMD

The Advisory Committee for Therapeutics (ACT) toolkit provides procedural advice and guidance to replicate the successful TREAT-NMD Advisory Committee for Therapeutics (TACT) model in other rare disease communities. An ACT can provide independent and objective advice to industry and academia, on a real-life therapeutic pathway of drug development programmes. An ACT review can help an applicant to position a candidate compound along a realistic and well-informed pathway to clinical trial and eventual
registration.

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Information to principal investigators

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AdviceTranslational Research

The aim of the mentoring is to increase the impact and patient benefit of the excellent science funded in ERDERA. With this mentoring support, applicants will receive project-specific feedback from a panel of drug development, biomarker validation, methodological and regulatory experts tasked with optimizing the translational feasibility of the study. There are no costs or obligations to you.

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