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Advisory Committee for Therapeutics (ACT) Toolkit

Published by Newcastle University

Clinical TrialExpert AdviceNetworkNeuromuscularResearch and Translational Resource

The TREAT-NMD Advisory Committee for Therapeutics (TACT) is a unique multi-disciplinary model centred upon an international group of academic and industry drug development experts, including patient representatives. TACT gives advice on the translational and development pathway of therapeutic programs in rare Neuromuscular Diseases. Due to its success in the neuromuscular field, a toolkit to replicate the TACT model has been produced. The Advisory Committee for Therapeutics (ACT) toolkit is intended to support rare disease communities outside of Neuromuscular to establish their own ACT, by providing them with step-by-step guidance and template documentation.

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Stakeholders interactions – Patients Affairs Staff

Published by IRDiRC

Clinical DevelopmentEarly Access SupportFDA Regulatory AdvicePatient AdvicePatient Affairs StaffPatient EngagementPatient SupportRegulatory AffairsResearch and Drug Development

At the FDA, the Patient Affairs Staff (PAS) is devoted to supporting cross-cutting patient engagement activities across the FDA. Its mission is to coordinate and support patient engagement activities across FDA to facilitate awareness and collaboration with patients, their advocates and the FDA

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Decentralized trials 

Published by IRDiRC

Adaptative PathwayClinical DevelopmentClinical Trial DesignDecentralised TrialDigital EndpointPatient DataRegulatory SciencesResearch and Drug Development

Decentralized trials aim to improve patient access to trials by enabling patient follow-up from home or community care, increase the participation of more diverse populations, and enhancing data collection by combining the adoption of digital endpoints and telemedicine as applied to trials, decentralized trials aim

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The Assay Guidance Manual

Published by NIH

Drug Discovery GuidelineDrug RepurposingNCATSNIHResearch and Drug DevelopmentSmall MoleculeTarget Validation Drug Development

This manual is a comprehensive resource for early drug discovery, providing guidelines for developing therapeutic hypotheses, validating targets and pathways, and establishing proof of concept criteria. It includes analyses of costs at various stages of drug development. The content encompasses critical decision-making points in New Chemical Entity (NCE) development, exploratory Investigational New Drug (IND) processes, and orphan drug designation. Furthermore, it delves into Drug Repurposing and drug delivery technologies, making it an invaluable guide for professionals initiating new drug discovery and development programs.

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