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Feb 24, 2012

Drug Developer Pursues an Open-Source Approach in Designing Clinical Trials

    Biopharma leaders have long needed greater transparency in the industry, though usually in the context of activity by government regulators and necessarily by companies themselves. Now, two industry veterans are testing the value of offering such transparency through an open innovation model for drug development.

    Tomasz Sablinski, M.D., Ph.D., and Marc Foster, and launched Transparency Life Sciences (TLS) along with a beta version of a virtual community of physicians, scientists, and patients. Transparency is seeking input over the next 35 days from patients, physicians, and drug developers to help design clinical studies for three drugs.

    • the heparinoid Sulodexide for peripheral vasular disease
    • the ACE inhibitor Lisinopril, now used as a treatment for hypertension, for multiple sclerosis (MS)
    • a low dose of the opiate receptor antagonist Naltrexone (LDN) for Crohn disease

    “Since there is considerable unmet medical need in Crohn’s Disease, and since there is a well-defined regulatory path for the approval of medicines for this disease, we have made the study of LDN in Crohn’s disease one of TLS’ highest priority projects,” Transparency states.

    All three treatments in Transparency’s pipeline are repurposed generic drugs, though long-term plans call for the company to develop its own drugs, MedCity News reported. Transparency plans over time to either divest itself of those drugs or find development partners once it has “substantially increased their value through mid-stage development,” the company told Pharma Times, adding that it expects to grow by accessing “the many opportunities that exist to develop distressed drug assets that have been stalled primarily for nonscientific reasons."

    Sablinski told Xconomy he got the idea for an open-source drug development company from an article about Linux, the open-source operating system that marked its 20th year on the market last October: “If computer coders can do open source, so can drug developers,” he said, adding: “You have to add patients to the mix, because they’re really the reason you’re doing drug development.”

    About 30 patients have joined Transparency, registering as users, then sharing comments about their experiences and making suggestions for the planned clinical trials. According to Xconomy, Sablinski hopes to multiply that population by having his company begin reaching out to patient advocacy groups in its disease areas of MS, peripheral vascular disease, and inflammatory bowel disease. Transparency asks users to answer sets of questions that vary depending on their status as patients or physicians. Patients can also make use of a forum for questions on diseases and treatments as well as the company’s Facebook and Twitter pages.

    Sablinski, who is also the head of development at Celtic Therapeutics, co-founded Transparency and is its CEO, while Foster is the company’s COO, and was previously an executive at FoldRx Pharmaceuticals before its acquisition by Pfizer. The company employs a handful of staffers in New York City and Boston to manage its site.

    As MedCity News noted, Transparency is one of several companies that are pursuing crowdsourcing to carrying out clinical trials. InnoCentive has offered a $30,000 prize for developing a protocol for the efficient recovery of bacterial spores (Bacillus subtilis/Bacillus atrophaeus) from prewetted surface sampling tools with handle. The winner won’t have to transfer their exclusive IP rights to the company but will instead grant a nonexclusive license to practice that protocol.

    Foster also sees potential in using telemedicine for clinical trials, as Pfizer did last year, when it launched its first ever investigational drug trial with remote patient participation. The trial, known as REMOTE  (research on electronic monitoring of OAB treatment experience), is designed to assess the safety and efficacy of Detrol LA (tolterodine tartrate), a treatment for overactive bladder.

    --
    To read the story from Xconomy, click here.

    For Pharma Times' article, click here.

    And to check out MedCityNews' coverage, click here.


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