ePRO Consortium Announces Open Access Article

 

 

In collaboration with the DIA Study Endpoints Community, C-Path’s ePRO Consortium is pleased to announce the open access article “Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials” is available online in the April 1, 2020 issue of Contemporary Clinical Trials. This article provides recommendations for the structure and content of an evidence dossier aimed at supporting a clinical trial endpoint derived from mobile sensor data as fit-for-purpose in regulatory decision making.

Link to article: https://www.contemporaryclinicaltrials.com/article/S1551-7144(20)30040-9/fulltext

 

 

Collaborating for Cures Leveraging Global Public-Private Partnerships to Accelerate Biopharmaceuticals Development

Event Date: 03/07/2013

Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) and Critical Path Institute (C-Path) held a joint event in Brussels, Belgium on the challenges and opportunities of public-private partnerships (PPPs). More than 120 participants attended the conference and many more followed the live webcast.

This first ever public conference co-sponsored by IMI and C-Path featured cross-sector participants discussing challenges and opportunities in the rapidly-evolving PPP space. The lively discussion focused on identifying mechanisms for enhancing the productivity of PPPs, coordinating individual PPP efforts to avoid duplication, and adopting best practices on data sharing, intellectual property, patient involvement in research, and other cross-cutting issues in order to streamline biopharmaceuticals development world-wide.

  • Download the agenda
  • Watch the entire conference online here
  • Read the highlights of the event on twitter at #CollaboratingForCures

 

Presentations

Innovative solutions to shared challenges

Introduction: Collaborating for Cures – Leveraging Global Public-Private Partnerships to Accelerate Biopharmaceuticals Development
Michel Goldman, Executive Director, IMI Martha Brumfield, President and CEO, C-Path

Harnessing the Discovery Engine of NIH to Maximize Translation
Maria Freire, President, Foundation for the National Institutes of Health (FNIH)

How Technology Transfer and other IP Agreements can Spur Bench to Bedside Translation
Tania Bubela, Associate Professor, School of Public Health, University of Alberta

How patients supply more than a voice in Accelerating Medical Product development
Alastair Benbow, Chief Executive, The Age of the Brain

How FDA Promotes Partnerships to Accelerate Medical Product Development
ShaAvhree Buckman-Garner, Director, Office of Translational Sciences, CDER, FDA

 

IMI and C-Path collaboration on Alzheimer’s disease

Prediction and Faster Assessment of Functional Properties of New Drug Candidates for Alzheimer’s Disease in Early Clinical Development: The IMI PharmaCog project
Jill Richardson, EFPIA coordinator IMI PharmaCog / Director, External Alliances and Development, GSK R&D China

European Medical Informatics Framework (EMIF)
Simon Lovestone, Director Biomedical Research Centre for Mental Health and Dementia, King’s College London

Coalition Against Major Diseases: Regulatory Science can Accelerate Drug Development for Neurodegeneration
Diane Stephenson, Executive Director, Coalition Against Major Diseases, Critical Path Institute

The Regulator’s View
Maria Isaac, Scientific Advisor, European Medicines Agency

 

IMI and C-Path collaboration on tuberculosis

PreDiCT-TB Model-based preclinical development of antituberculosis drug combinations
Gerry Davies, Senior Lecturer in Infection pharmacology, University of Liverpool

CPTR Mission, Structure & Goals for Innovation
Debra Hanna, Executive Director, Critical Path to TB Drug Regimens