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
