Transparency Life Sciences launched with the introduction of a prototype of a crowdsourced web platform that allows patients, physicians, researchers and other stakeholders to contribute to the design of clinical studies. The goal of the new company is to develop therapies for significant unmet medical needs by acquiring promising drug compounds and testing them in clinical trials that leverage 21st century information technology to achieve productivity.
“The communications and information revolutions have transformed nearly everything around us, yet the design and execution of clinical trials have changed little in the past 40 years,” noted Dr. Sablinski. “Transparency Life Sciences intends to use its own pipeline of compounds to demonstrate that an open innovation approach to drug development can deliver high quality results that facilitate regulatory review and are more patient-centric. And we believe that our approach can accomplish this faster and at a much lower cost than conventional clinical studies.
“Our strategy is first to demonstrate the value of our innovative platform with repurposed off-patent compounds to take advantage of their extensive safety records” Sablinski added. “Once having demonstrated the feasibility of our approach, we expect to access the many opportunities that exist to develop distressed drug assets that have been stalled primarily for non-scientific reasons.”
Clinical protocols for Transparency’s first three repurposed compounds are now available for collaborative input on the TLS crowdsourced web platform. The first is for the widely used anti-hypertensive drug lisinopril, which animal studies suggest may have efficacy in treating multiple sclerosis (MS). Transparency is in late-stage negotiations for an exclusive option to license lisinopril for development as a new treatment for MS. Second is the Phase II protocol design for sulodexide, a heparin-like compound that has demonstrated potential in animal models of peripheral vascular disease. The third protocol is for a Phase Il trial of low-dose naltrexone as a potential treatment for inflammatory bowel disease.
In 2008, the pharmaceutical and biotech industry spent an estimated $35 billion on clinical trials, according to the Tufts Center for the Study of Drug Development, NIH and other sources. Annual compound growth in expenditures exceeded 9% between 2004 and 2008, making clinical trials the fastest growing cost-related barrier to getting new drugs to market.