Disruption isn’t a word normally associated with clinical drug development, but nevertheless it is coming. We can feel the rumblings of it. New technologies and technology-enabled techniques for productivity in mainstream business applications are slowly making their way into the clinic. There are signals that drug development is starting to catch up with the general trend toward open collaboration and innovation. This trend is enabling tremendous advances in other industries, so why not ours?
In the life sciences, we are typically conservative, but we must innovate to overcome the cost challenges that the pharmaceutical industry and society as a whole are facing. We have to step out of our comfort zone, welcome change and embrace positive transformations. There are a number of innovation initiatives happening as we speak that could accelerate that shift.
Disruptive Business Model Innovation
Transparency Life Sciences (TLS) is a drug development company and a leader in the effort to embrace open innovation in clinical development. Tomasz Sablinski, the company’s CEO and founder, is calling for transparency in clinical trials to improve study design, quality and outcomes while drastically reducing costs. With recent clearance by the FDA of its Investigational New Drug application to assess lisinopril as an adjunct treatment for multiple sclerosis, TLS is embracing the power of disruption. Sablinski’s goals are universal and his success would be revolutionary. TLS aims to cut clinical development costs by 50 percent initially, with an ultimate goal of 80 percent savings, along with designing better trials and producing better outcomes. That’s high-impact, groundbreaking change. (Full disclosure: my company did some consulting work for TLS in 2012)
Excluding private patient information and intellectual property, this is a company driven by principles of transparency and openness. TLS begins with crowdsourcing, engaging a community of interest around a therapeutic concept and encouraging open dialogue. Transparency has developed a technology platform for crowdsourcing study design and clinical trial protocols, its Protocol Builder tool, to obtain input from a global community of stakeholders. For the lisinopril study design, a diverse group of doctors, MS researchers and patients participated in the project. TLS expects that its crowdsourced model will result in clinical protocols that are more relevant to real world medical practice. For example, a mobility parameter was included in the lisinopril study, based on patient input indicating they consider the ability to perform daily activities of paramount importance. Sablinski explains that one can also arrive at insights and well-informed decisions much faster by curating a discussion among a broad spectrum of contributors and perspectives. Based on initial experience, TLS estimates that use of its crowdsourcing model could reduce protocol development times from the industry average of six months to less than six weeks.
A second pillar of TLS’s innovation is maximizing clinical trial productivity. This involves digitizing the clinical process and moving away from established norms of bringing patients to clinical study sites for monitoring/examination. Traditional site visits are expensive and inconvenient for trial participants. By contrast, TLS relies on remote monitoring so that data can be captured on a continuous basis in the patient’s own environment (at rest, before/after meals, etc.) as opposed to a single point in time in an unfamiliar setting. Not only is this approach more cost-efficient, it also provides a much more comprehensive data set upon which to base insights. Remote monitoring technology is advancing at a galloping pace, and will become increasingly feasible over time. The fact that FDA cleared the TLS lisinopril protocol, which primarily relies on telemonitoring, sends a strong signal that regulators are ready to consider this novel methodology in appropriate situations.
TLS’s contributions to positive changes in clinical trials are complemented by the work of a recently formed biopharmaceutical consortium, TransCelerate Biopharma. The formation of TranCelerate, a group of 10 of the world’s largest biopharmaceutical companies, sends another clear signal of a new, open mindset in clinical development. TransCelerate’s mission is to accelerate drug development by first focusing on streamlining the clinical trial process where longstanding challenges exist.
It’s no secret that clinical trial teams, even within the same company, collect and manage data differently; and tend to reinvent the wheel with every development program. TransCelerate has said that one of its first efforts will be to standardize how clinical data is recorded in order to minimize human error, enable the use of data across trials and generally manage data more efficiently. Another program aims to standardize qualification of trial sites and investigator training, all with the goal of increasing efficiency and quality.
While the TransCelerate project is still in its early stages, the promise of its mission is exciting. In a competitive industry where information is held close and rarely shared, this new willingness to communicate and collaborate is a major step forward.
Innovation calls for change, and change calls for different, uncharted circumstances which haven’t been previously encountered or regulated. With the new techniques and technologies presented by innovative groups like TLS and TransCelerate, there is always the question of which methods, technologies and methods will be accepted by regulatory bodies.
Transparency Life Sciences began its journey with a repurposed drug that already had a known safety profile. Still, the regulatory clearance of its crowdsourced protocol and the authorization of remote monitoring technology in the trial is a significant advancement. TLS’s successful filing should encourage others to push the envelope, take the road less traveled, and re-think traditional processes. The very real issues facing pharmaceutical drug development demand no less. The life sciences thrive on progress and innovation, and industry leaders should be ready to capitalize on opportunities to be a trailblazer and catalyze positive change. TLS’s Sablinski is clear and direct when he advises the best approach to introducing new methods and technologies in clinical development: be open to new ideas, seek input from outside your comfort zone, involve regulators early on in the study design process, be bold but reasonable and, of course, be transparent.
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