helping patients by safely and effectively testing potential new drugs
Cardiovascular diseases are the leading cause of death in the United States. Researchers are constantly looking for new therapeutics to treat these deadly diseases, and safety testing is critical. But because they are potentially cardiotoxic, many promising drugs are removed from further development and never reach patients.
The University of Michigan has designed a platform for cardiotoxicity testing using human-stem-cell-derived cardiac muscle cells that can be cryopreserved, thawed, and cultured.The derived cells display all the physiologic hallmarks of cardiac muscle cells, and can accurately predict eventual cardiotoxicity in humans. This new platform streamlines the drug development process and promotes the release of safe new drugs to market.
Significant Need
This new testing platform more accurately predicts eventual cardiotoxicity in humans, limits the need for animal testing, and enables drugs to move to market faster to treat a myriad of diseases.
Competitive Advantage
This in-vitro testing platform is faster, cheaper, and more accurate than the current methods that often involve unreliable animal testing and result in false positive cardiotoxicity results.
Commercialization Path
- Intellectual Property – Patent application filed. Full patent will be filed after the initial characterization is complete showing the predictability of the system. Another invention disclosure/patent will likely be issued for the high throughput 96 well format optical mapping.
- Commercialization Strategy – Two possible commercial paths; a license to large pharma to use human cardiac cells in safety studies, and a license to companies providing drug safety screening services.
- Regulatory Pathway – Approvals from the FDA will be required for commercialization.
- Engage Investors – Non-disclosure agreement established with major biotech company.
- Product Launch Strategy – To be determined by licensee.
Milestones
- Complete the development of the dual calcium and membrane voltage measurements in 96 well format
- Non-disclosure agreement established with major biotech company
- Complete preservation development
- Human-stem-cell-derived cardiac muscle cells preserved in 96 well plates
- Explore potential investors and interested commercial entities
- Obtain FDA approvals
- Seek additional sources of private or public funding
- License the technology
- Q316 Update: CardioTox (startup)
