The Demand

Years of increased R&D expenditure by the pharmaceutical industry and the federal government have actually coincided with a decline in new drugs approved for use. At the same time, the cost of developing drugs continues to increase substantially, $800 million per approved compound by recent estimates. A significant portion of that cost represents failed projects. Lowering the number of failed projects, and shortening the time to identify failures would significantly lower the cost of drug development.

The Goal

The proposal to create a collaborative imaging biomarker center addresses the significant opportunity to accelerate the development of new therapeutics for the treatment of human disease by leveraging the collective R&D capability represented in the region’s life science industry, universities, academic medical centers and hospitals. The project would advance the use of imaging biomarkers for early evidence of therapeutic efficacy before taking candidates into clinical testing as well for use as surrogate endpoints for regulatory approval.

The Role of Imaging Biomarkers

Biomedical imaging is widely viewed as one of the most promising tools to improve the process of drug development and reduce the costs of failure. Advances in imaging technology along with increased understanding of molecular and cellular processes have opened the floodgates for a range of new indicators to be leveraged in pharmaceutical development. These novel indicators – imaging biomarkers – are showing the presence or progress of disease, the reach, effectiveness or toxicity of proposed drugs and the response to therapy at cellular and molecular levels of detail and precision never before possible. Industry, funding agencies and regulators alike see the deployment of these imaging biomarkers and the enabling technology as a important new way to

1. improve the selection of drug candidates to take into expensive clinical trials
2. shorten the trials themselves
3. accelerate regulatory approval

Current project phase - Due Diligence

The working group is beginning the due diligence phase of the project focused on:

1. opportunity validation - developing and testing the model for the center
2. partnership development - both current and new industry and academic partners and sponsors
3. economic impact analysis - for the Massachusetts life sciences cluster
4. business model and business plan definition to proceed to implementation

The Executive Committee of the John Adams Innovation Institute has voted to support the due diligence phase of the Collaborative Imaging Biomarker Center project. Thanks go the University of Massachusetts Medical Center who submitted the CIBC proposal and our partners who provided letters of support highlighting the importance this project.

For more information on the Collaborative Imaging Biomarker Center, email mgreis@massinsight.com.

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