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Go to the Transparency Life Sciences web site and take yourself on a tour of drug development in the future. A future where the 80-80-80 paradigm becomes the 20-20-20 paradigm, and as TLS Founder and CEO Tomasz Sablinski, MD, PhD says, will become a reality by 2020.
Sablinski, who freely admits he operates in triplet, says that clinical trials are 80% too expensive; 80% are trials that no one wants; and they all use technology from the 80s. Sablinski envisions by 2020, trials will be 20% of current legacy costs; only 20% will be trials no one wants; and all will be using technology of the 20s…that is 2013 and onward.
And the key to achieving that is through the triple pillars of TLS: transparency, open crowdsourcing and telemonitoring. All three of which would not, say, come up in the top three keyword search for the clinical research enterprise. But what the three do address is what Sablinski knows is his single largest personal pet peeve, and sees as the biggest detriment to clinical trials…waste.
“Some industries are wasteful, like healthcare, but clinical trials are wasteful and they start with tremendously inefficient processes,” says Sablinski. “It is criminal that we have huge discoveries in research, and new medication, in the past 25 years, but we have the same systems, processes and cultures that persist from 25 to 40 years ago.”
Four years ago, Sablinski left Novartis after fits and starts in clinical study innovation. He moved to Celtic Therapeutics, an innovative and entrepreneurial drug development firm in its own right, and launched TLS January 31, 2012. Less than one year later, the company founded on open innovation had its IND for a Phase II trial of lisinopril as an adjunctive therapy in multiple sclerosis approved.
Sablinski says there was no active marketing outreach from the company, save for the impact of media stories from various outlets, to spur participation in this first protocol. On the professional side, Sablinski said the team relied on its own Rolodex of business contacts and researchers who thought it was a great idea and spread the word. Regarding the patient community, said Sablinski: “When they see something where they can help make a difference, they spread the word.” The company is planning proactive outreach to relevant patient and professional communities going forward.
TLS started with four protocols, of which the approved one and two others in Crohn’s and Parkinson’s are still active. The company made the decision, as a start-up initially with limited funds and manpower, to focus on the MS protocol and not spread themselves too thin through the FDA submission and fundraising processes. A feature of the Protocol Builder process is designating a patient expert and a research expert for the specified indication to help provide guidance for the survey and the input, and these experts are called Curators. The company, with its first FDA win, is confident it will soon be able to move forward on one of the other protocols.
During the MS protocol process, TLS discovered a few things. One is that telemonitoring, a key component of the TLS business model, is very attractive to the MS community. The protocol stipulates a first visit on day zero, and a second site visit at 12 months. “We learned a lot about the patients’ comfort zone regarding participating in trials,” said Sablinski. “It’s very difficult for patients to see the value in the office visits needed in conventional trials. It’s frustrating to wait in the doctor’s office, and there is not any value added in that wait time.” Now while telemonitoring is an ideal solution for many chronic conditions, and avoids that office wait scenario, Sablinski notes that there remains a key quality for the study-patient relationship, and that is direct contact. “There needs to be a link between the site and person, whether it’s a doctor or study nurse, a reference point for a patient. Someone they can always call or push a button on a computer to be able to chat online.”
Through crowdsourcing, they were also able to identify a qualitative scale that has been identified for years by MS experts as a more accurate and effective measure, but that was not logistically achievable. Turns out this superior scale, which provides a more holistic status of the MS patient, is ideal for the telemonitoring environment. TLS’s telemonitoring partner is Advanced Monitored Caregiving (AMC) Health, which provides at-home patient monitoring for healthcare, and which is, by virtue of that environment, more related to the day-to-day clinical care of a patient. AMC Health executives noted in a release that it is looking forward to working with TLS to ensure the success of this patient-centric approach to clinical research.
I’ll be writing more soon about the TLS approach to clinical trials in regard to other efficiency initiatives in clinical development, patient centricity, and a key three pillar--transparency.