Transparency Life Sciences (TLS), a biopharmaceutical development company based in the US, has marked its official launch by unveiling a prototype of the crowdsourced web platform it will use to design clinical trial protocols more in tune with the needs of patients, physicians, medical experts and other stakeholders.
It would be a stretch to call TLS entirely “new”: the LinkedIn entry for founding chief executive officer Dr Tomasz Sablinski – who is also managing director of drug development enterprise Celtic Therapeutics – lists him as having set up Transparency Life Sciences in 2010.
Nonetheless, the company is raising its public profile as a unique proposition that will harness 21st century information and communications technologies to improve the productivity of clinical development and the regulatory viability of resulting compounds, while significantly reducing timelines and costs.
Open innovation base
TLS calls itself “the world’s first drug development company based on open innovation”.
It will use this strategy to develop medicines for significant unmet medical needs, with an initial focus on acquiring and repositioning compounds that have shown efficacy and a clean safety profile but have been left ‘on the shelf’ due to poor alignment with the owner’s corporate strategy, unsuitable properties for current indications of interest or for financial reasons.
The company will look to divest or partner these products once it has “substantially increased their value through mid-stage development”.
In the near term it does not intend to get involved in product commercialisation, although in some cases (e.g., orphan indications or where the cost of incremental development is low), TLS may consider advancing compounds into later development stages and registration activities.
Its “game-changing” approach is based on three core principles:
• Collaborative intelligence, or crowdsourcing, will be employed in the design of clinical protocols, with participation from medical experts, front-line physicians, patients, researchers and others. The aim is to come up with protocols “focused on parameters most relevant to clinical decision-making and practice”.
• TLS will leverage contemporary health information and communications technologies to implement “patient-centric clinical trials that will reduce burdens on subjects and sponsors”, as well as enhancing data quality.
• As its name suggests, TLS wants to take a leading role in demonstrating “how transparency throughout the clinical trial process can enhance drug development”.
The strategy is first to demonstrate the value of this platform using repurposed off-patent compounds with extensive safety records. TLS then expects to “access the many opportunities that exist to develop distressed drug assets that have been stalled primarily for non-scientific reasons”.
Clinical protocols for the company’s first three repurposed compounds are now available for collaborative input on the TLS crowdsourced web platform.
The first protocol is for the widely used antihypertensive lisinopril. Animal studies have suggested that the compound may have potential efficacy in multiple sclerosis (MS), TLS notes. It is in late-stage negotiations over an exclusive option to lisinopril for development as a new MS treatment for MS.
The second protocol is for a Phase II trial of sulodexide, a heparin-like compound that has shown potential in animal models of peripheral vascular disease. The third is for a Phase Il trial of low-dose naltrexone as a potential treatment for inflammatory bowel disease. Changed little
“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,” Dr Sablinski commented.
“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.”
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”, Sablinski added.
The CEO’s previous career includes stints as vice president, clinical development and medical affairs, and in other executive positions at Novartis; and as medical director at Parexel.