Repurposing Medicines Toolkit – Guidance for navigating the process

Published by MRCLife Arc

GuidelineRepurposing

This toolkit aims to provide a guide for researchers, charities and others embarking on repurposing projects. It highlights common activities, issues and considerations at each development stage and signpost to other available resources. The content is mostly styled as questions – what should I be considering at each development stage? It is intended to stimulate thinking and not as a step-by-step guide, which reflects the variable nature of repurposing.

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MDC Connects: A Guide to Drug Discovery

Published by Medicines Discovery Catapult

Drug DiscoveryTarget IdentificationSmall Molecules

This guideline is a summary presentation from the Medicines Discovery Catapult (MDC) webinars. The aim was to create a resource of modern drug discovery knowledge to support small companies who are developing their own medicines. The guideline is focused on preclinical research with an emphasis on small molecules in the following topics:
• What makes, and how to identify, a good target
• Methods to identify the chemical compound which would become the drug
• How to optimise that drug
• How to test it works in models of disease
• And how to demonstrate that it would be safe to dose in humans

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Through a combination of in-house and external partnerships with a range of regulatory experts and groups, EATRIS can provide regulatory support for most types of product including: Expert opinion, Orphan Drug Designation and Scientific Advice application at the EMA, Pre-clinical and clinical plan development, Informal scientific advice with selected national competent authorities, for highly complex projects,
access to EATRIS Regulatory Database (free of charge) that contains information about the regulatory requirements, guidelines and legislations from 27 EU countries (as well as Norway, Switzerland, Turkey and Israel) regarding drug and medical device development derived from the application of European legislation.

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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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Assay Development and Screening Technology (ADST)

Published by NCATS

Small MoleculeNCATSHigh Throughput Screening

One of the first steps in the drug development process is creating test systems — called assays — on which researchers assess the effects of chemical compounds on cellular, molecular or biochemical processes of interest. At NCATS, the experts in the Assay Development and Screening Technology (ADST) program work to optimize assays requested or submitted by the biomedical research community for high-throughput small-molecule screening

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Drug discovery and development: Role of basic biological research

Published by Alzheimers Dement (N Y).

Drug DiscoveryTarget Validation

This article provides a brief overview of the processes of drug discovery and development. The aim is to help scientists whose research may be relevant to drug discovery and/or development to frame their research report in a way that appropriately places their findings within the drug discovery and development process and thereby support effective translation of preclinical research to humans.

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