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 19 results for:
  2. Research and Drug Development
  3. Disease or Translational Resources
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European Medicines Agency. Qualification of Novel Methodologies for Drug Development: Guidance to Applicants (EMA/CHMP/SAWP/72894/2008). 2014.

Published by European Medicines Agency (EMA)

Drug DevelopmentEMAGuidelinePharmaceuticals 

This guidance is for qualification process addresses innovative drug development methods and tools. It will focus on the use of novel methodologies developed by consortia, networks, public/private partnerships, learned societies and pharmaceutical industry for a specific intended use in pharmaceuticals R&D. 

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European Medicines Agency. ICH Topic E15. Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (EMEA/CHMP/ICH/437986/2006). 2007.

Published by European Medicines Agency (EMA)

EMAGenomic DataGuidelinePharmacogenomicsSample Coding

This guideline contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics and genomic data and sample coding categories. 

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EATRIS Matchmaking for lab services

Published by n/a

core facilityEATRISIndustry collaborationtechnology platforms

EATRIS facilitates academic collaborations with industry. It identifIes scientific & medical expertise and find the capacity to provide access to the latest technologies and core facilities from within our technology platforms.It serves as a single point of contact, provides (legal) support and acts as a negotiator to facilitate project initiation and monitor project execution when needed. Its infrastructure consists of 115+ biomedical research institutes in 14 EU countries.

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Biomarker Commercialization Review Tool

Published by Biomarker Commercialization (BIC) consortium

BiomarkerBiomarker Commercialisation (BIC) ConsortiumGuidelineResearch 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

BiomarkerBiomarker CommercialisationBiomarker DiscoveryBiomarker ValidationIVD AssayRegulatory Biomarker DevelopmentResearch and Drug Development

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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