Disease or Translational Resources

In this section you will have the opportunity to explore information regarding:
Patient registries,
Natural history,
Patients’ information as organizations, toolkits for patients, new-born screening programs, undiagnosed diseases programs (UDPs), EU planned cross-border treatment
Target Patient Value Profile
Databases/Tools (ODDG)
Networks
Biobanks
Biomarkers (Development, guidelines, validation, qualification, genomic, cancer, pain therapeutics)

  1. Showing 49 results for:
  2. Research and Drug Development
  3. Disease or Translational Resources
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Biobanking in health care: evolution and future directions

Published by J Transl Med.

Biobank

The aim of the present review is to discuss how the promising field of biobanking can support health care research strategies. As the concept has evolved over time, biobanks have grown from simple biological sample repositories to complex and dynamic units belonging to large infrastructure networks, such as the Pan-European Biobanking and Biomolecular Resources Research Infrastructure (BBMRI)

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Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities

Published by Nature Reviews Neurology

Research and Drug Development Disease or Translational Resource BiomarkerBiomarker DiscoveryPain Therapeutic BiomarkerChronic PainBiomarker ValidationRegulatory Issue

This article outlined the NIH initiative, Helping to End Addiction Long-term (HEAL). A trans-agency effort to provide scientific solutions to stem the opioid crisis. One component of the initiative is to provide guidance on biomarker discovery and rigorous validation to accelerate high-quality clinical research into neurotherapeutics and pain.

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Preclinical biomarker qualification

Published by the Society for Experimental Biology and Medicine

PreclinicalResearch and Drug DevelopmentBiomarkerDrug Development ToolQualification BiomarkerRegulatory Qualification

An overview of the biomarker qualification process that provides information on current evidentiary considerations. It also provides new information on the evolution of the role that preclinical qualification plays in clinical qualification of biomarkers and the novel approaches that are being utilized to improve the process

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Biomarker Commercialization Review Tool

Published by Biomarker Commercialization (BIC) consortium

Biomarker Commercialisation (BIC) ConsortiumGuidelineBiomarkerResearch and Drug Development

The BIC Review Tool is designed to improve communication, it allows an “inventors interview”-type of approach, in addition to being a checklist for Technology Transfer Offices and Researchers. It is designed to improve communication between the stakeholders involved in the commercialization process and to facilitate collaboration. The tool is therefore in a completely different format than the Biomarker Commercialization (BIC) Guide. All introductions and explanations are missing by intention since they can already be found in the BIC Guide, Best & Pitfall Practices handbook or the Regulatory Guide. 

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Biomarker Commercialization Guide

Published by Biomarker Commercialization (BIC) consortium

Research and Drug DevelopmentBiomarkerBiomarker DiscoveryBiomarker ValidationRegulatory Biomarker DevelopmentIVD AssayBiomarker Commercialisation

The Biomarker Commercialization (BIC) Guide supports academic researchers and SMEs when developing an in-vitro diagnostic biomarker invention to a commercial product. It provides guidance through the technology readiness levels (TRL) and covers the clinical, regulatory, and business aspects of the commercialization process. The tasks are described and partially supported by useful, downloadable documents.

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FDA Qualification process – Drug Development Tools

Published by IRDiRC

Regulatory AffairsClinical DevelopmentEndpointBiomarkerCenter for Drug Evaluation and ResearchAnimal ModelQualification ProcessDrug Development ToolResearch and Drug Development

This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.

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