Transparency Life Sciences (TLS), the first drug development company based on open innovation, has officially launched, with the introduction of a prototype of its crowdsourced web platform that allows patients, physicians, researchers and other stakeholders to contribute to the design of clinical studies.
TLS’ goal 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 unprecedented 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,” said Tomasz Sablinski, M.D., Ph.D., founding CEO of TLS. “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.”
Transparency’s approach is based on three principles. First, collaborative intelligence, also known as crowdsourcing, will be employed for the clinical protocol design phase, with the participation of medical experts, front-line physicians, patients and others, resulting in protocols that are focused on parameters most relevant to clinical decision-making and practice.
Second, Transparency is leveraging contemporary health information and communications technologies to implement patient-centric clinical trials that will reduce burdens on subjects and sponsors and enhance data quality. Third, TLS intends to be a leader in demonstrating how transparency throughout the clinical trial process can enhance drug development.
“Drug development has reached a crisis point, with clinical studies too often designed to meet commercial rather than patient needs, which we believe is one key factor underlying their unsustainable cost structure,” said Sablinski. “We expect to achieve much greater efficiency in our patient-centric trials by harnessing the power of crowdsourcing, advances in telemedicine and full data transparency. We think our approach is very much in line with current FDA thinking, and we are encouraged by the enthusiastic response we have received to date from a broad range of drug development experts.”
“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,” he said. “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.
“We’ve reached a tipping point in the biopharmaceutical industry, in which gains in productivity can only be achieved through completely new approaches to clinical drug development,” said David Nicholson, Ph.D., formerly senior vice president and head of worldwide licensing and knowledge management at Merck. “Transparency is addressing a critical point in the drug pipeline with breakthrough innovation that has great promise.”
“Our research at the Tufts Center highlights the urgent need to remove bottlenecks and inefficiencies in clinical development and to reduce the high and rising cost of R&D,” added Kenneth Getz, a senior research fellow and research assistant professor at the Tufts Center for the Study of Drug Development. “Bold new approaches are needed to upend the long-outdated pharmaceutical R&D paradigm. Virtual and open innovation strategies, like that proposed by Transparency Life Sciences, hold great promise in bringing drug development into the 21st century.”
TLS’ founding team is composed of experienced executives from the pharmaceutical, biotechnology and high-technology industries. The company has assembled an advisory board with expertise in crowdsourcing, technology and online media.