Use of Biomarkers in Orphan Drug Development

Published by IRDiRC

Biomarker Development Clinical Development Endpoint EndpoInternationalBiomarker Orphan Drug Regulatory Sciences Research and Drug Development

Biomarkers can be utilized as primary surrogate endpoInternationalas a basis for accelerated approval (US), and as secondary or exploratory endpoints for drug mechanism of action or aspects of Safety monitoring.

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Decentralized trials

Published by IRDiRC

Adaptative Pathway Clinical Development Clinical Trial Design Decentralised Trial Digital Endpoint Patient Data Regulatory Sciences Research 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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TREAT-NMD Advisory Committee for Therapeutics

Published by IRDiRC

Advisory Committee for Therapeutics TREAT-NMD

Established in 2009, the TREAT-NMD Advisory Committee for Therapeutics (TACT) is a unique multi-disciplinary international group of internationally recognized academic and industry drug development experts as well as representatives of patient foundations and regulatory experts

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How to Plan and Manage a Project

Published by ANU Press

Project Management Research and Drug Development Translational Research

This Research management manual describes the rules and procedures that are required to successfully conduct translational research programmes . Depending on the nature and the complexity of a given project an increasingly complex and thorough project planning is required.

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Regulatory Guide for Translational Research

Published by EATRIS

Early Access Support Regulatory Sciences Research and Drug Development Scientific Guidelines Regulations

Regulatory Database

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The Assay Guidance Manual

Published by NIH

Drug Discovery Guideline Drug Repurposing NCATS NIH Research and Drug Development Small Molecule Target 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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Drug repositioning: a brief overview

Published by JPP

Drug Discovery Drug Repurposing Generic Research and Drug Development

Overview of the drug repositioning benefits both its public health benefits and its commercial value.

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Challenges and opportunities with Drug Repurposing: finding strategies to find alternative uses of therapeutics

Published by Expert Opinion on Drug Discovery

Big Data Crowdfunding Drug Discovery Drug Repurposing Intellectual Property Neglected Disease Precision Medicine Rare Disease Research and Drug Development

Article that cover the most significant challenges and opportunities in Drug Repurposing.

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Exploring the new horizons of Drug Repurposing: A vital tool for turning hard work into smart work

Published by European Journal of Medicinal Chemistry

Clinical Trial Drug Discovery Drug Repurposing Lead Molecule Research and Drug Development

This review provides different approaches for Drug Repurposing and addresses recent developments and future scope of drug repositioning strategies. In addition provides a list of repurposed drugs and repurposing resources.

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The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

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