Biomarker Commercialization Guide

Published by Biomarker Commercialization (BIC) consortium

Biomarker Biomarker Commercialisation Biomarker Discovery Biomarker Validation IVD Assay Regulatory Biomarker Development Research 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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In vitro diagnostics BIC Regulatory Guide

Published by Biomarker Commercialization (BIC) consortium

Biomarker IVD Biomarker Assay Development Regulatory Research and Drug Development

The BIC In Vitro Diagnostics Regulatory Guide introduces researchers and entrepreneurs to basic understanding of the regulatory process for CE mark of IVD diagnostics, along with the development of the project toward a clinical product

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EU planned cross-border treatments

Published by IRDiRC

Early Access Support EU Planned Cross-Border Treatment Orphan Drug Patient Information Research and Drug Development

Different ways to access the health care structures and professionals of the foreign EU Country National Health System (NHS) for people insured in the EU countries.

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BBMRI-ERIC – European research infrastructure for biobanking.

Published by IRDiRC

Biobank European Union Infrastructure Research and Drug Development

BBMRI-ERIC is a European research infrastructure for biobanking. We bring together all the main players from the biobanking field – researchers, biobankers, industry, and patients – to boost biomedical research

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Core Outcome Measures in Effectiveness Trials

Published by IRDiRC

Clinical Development Clinical Trial Design Effectiveness Trial Endpoint COMET Outcome Measure Research and Drug Development

The COMET (Core Outcome Measures in Effectiveness Trials) Initiative brings together people interested in the development and application of agreed standardised sets of outcomes, known as ‘core outcome sets’ (COS). These sets represent the minimum that should be measured and reported in all clinical trials of a specific condition, and are also suitable for use in clinical audit or research other than randomised trials.

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EURORDIS Open Academy

Published by IRDiRC

Open Academy Orphan Drug Patient Information Research and Drug Development Toolkit for EURORDIS Training Programme

The training aims to provide participants with the knowledge and skills needed to become experts in medicines research and development. Over 20 EURORDIS Summer School trainers provide the training each year.

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Advisory Committee for Therapeutics (ACT) Toolkit

Published by Newcastle University

Clinical Trial Expert Advice Network Neuromuscular Research 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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Connect 4 Children (C4C) – Paediatric Clinical Research Networks

Published by IRDiRC

C4C Clinical Research Network Network Orphan Drug Research and Drug Development

c4c (connect4children) is a large collaborative European network that aims to facilitate the development of new drugs and other therapies for the entire paediatric population.

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Genetherapy.net

Published by GeneTherapy.net

Advanced Therapy Cell Therapy Drug Discovery EMA Gene Editing Tool Gene Therapy Non-Viral Vector Regulation Affairs Research and Drug Development

Web resource for basic and clinical research in Gene Therapy, cell therapy, and genetic vaccines. In addition, it provides an overview of the different international regulations and guidelines associated with clinical Gene Therapy trials.

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European Patients’ Academy (EUPATI) toolbox

Published by IRDiRC

EUPATI Orphan Drug Patient Information Patient Training Research and Drug Development Toolbox Toolkit for Patient

The EUPATI Academy is the only in-depth training program for patient experts so far in EU that lasts 14months.
It includes an on online training program supported with two weeks of F2F training. The Academy is still operated by EPF, providing high quality training in drug development to patient from EMEA.

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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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