Last week Transparency Life Sciences launched as the world’s first drug development company that is based on Open Innovation. Crowdsourcing.org takes a look at Open Innovation in the scientific community to see how this could work in the world of medicine.

OPEN INNOVATION – THE LOWDOWN

Open Innovation has gained traction over the past few years – Henry Chesbrough coined the term with the publication of his book “Open Innovation: The New Imperative for Creating and Profiting from Technology”. Chesbrough is the Executive Director of the Center for Open Innovation at the Haas School of Business, University of California. The Center focuses on conducting research, publishing articles and developing teaching materials around Open Innovation and encourages outsiders to engage in several ways.

The argument for Closed Innovation is obvious – companies like to have full control of their ideas, right down to production, marketing and distribution of any products and services. This level of protection guarantees a maximum level of return on investment which is what business is all about. This is why organizations spend so much on research and development and why the R&D departments are seen as the most secretive part of any company.

Several factors have combined in recent years to pave the way for a less secretive attitude towards developing new products and services, resulting in the growing popularity of Open Innovation. The open source software movement led the way for Open Innovation and widespread use of the internet is speeding up the process – allowing anybody with a computer and an internet connection to get involved.

THE SCIENCE COMMUNITY OPENS UP

The science community seems to be the last bastion of closedness – this is understandable in many ways as organizations need to protect their investments. However, science is striving to become more open where appropriate.

A year ago Crowdsourcing.org posted an article on Matthew Todd, an organic chemist from the University of Sydney’s School of Chemistry. He’d used a Google Tech Talk to persuade the scientific community to become more open and share knowledge and research results.

In September of last year the global science community was abuzz with the unprecedented news that researchers at CERN in Switzerland published the results of some of their work online, inviting scientists worldwide to look for any systematic errors.

Bringing the story right up to date is Michael Nielsen, formerly a researcher in quantum information and computation and currently one of the chief advocates of open science and “the development of new tools for scientific collaboration and publication”. Recently, Nielsen featured in a TEDtalk titled “The difficulties in opening science: Q&A with Michael Nielsen”. In his new book, “Reinventing Discovery”, Nielsen claims that we’re about to see some of the most dramatic changes in science in more than 300 years – changes driven by new cognitive tools and made possible by the internet.

TRANSPARENCY LIFE SCIENCES

This brings us neatly back to the news about Transparency Life Sciences, which aims to cut costs, improve success rates in clinical trials and boost patient involvement with its Open Innovation approach. The company’s Crowdsourced web platform enables researchers, physicians and patients to have a say in the design of clinical studies so that therapies can be developed for medical needs that have not yet been met.

Tomasz Sablinski, MD, PhD, the founder and CEO of Transparency Life Sciences claims that there is a crisis in drug development with clinical studies being done to meet commercial needs rather than patient needs. TLS says it aims to demonstrate more efficiency in patient-centric trials using the power of Crowdsourcing, full data transparency and advances in telemedicine (using information technology to provide healthcare at a distance).

Transparency Life Sciences plans to demonstrate the value of this innovative platform with “repurposed off-patent compounds” that already have established safety records. Sablinski reckons that once this approach has been demonstrated to be effective, the organization will begin to develop “distressed drug assets” that have been halted for non-scientific reasons.

(Polish born Sablinksi (in his former role as MD of Celtic Therapeutics) spoke to Marc Dresner of Partnerships TV about the inefficiencies in clinical trial procedures and possible solutions in this 13 minute video. In another (much longer) video, he spoke at the Open Science Summit of 2011 on Crowdsourcing Clinical Drug Development and his talk “Leverage Crowdsourcing, Telemedecine and Transparency to Conduct Patient-Centric Trials” was presented at the Patient Centricity in Clinical Trials Conference recently in Philadelphia.)

Transparency Life Sciences has made a plea to drug developers, researchers and patients to join them in a bid to deliver safe drugs to patients who need them via “dramatically lower-cost clinical trials”. So far, TLS' website has a list of three active projects, each of which has a Project Dashboard from which patients may take a survey, share their experience and join the forum discussion. Researchers and physicians are encouraged to sign up to participate in the process by sharing their expertise.

TLS has no plans to take part in product commercialization, but hopes to partner its products to third parties (including biotech and pharmaceutical companies) after the mid-stage development. 

A WARM WELCOME FOR OPEN INNOVATION?

This spirit of Open Innovation is being welcomed by many in the science community with a growing consensus among industry analysts that big pharma companies need to change to remain productive and relevant. Jean-Pierre Garnier, former CEO of GlaxoSmithKline (GSK) revealed in 2008 that “leaders of major corporations including pharmaceuticals have incorrectly assumed that R&D was scalable, could be industrialized, and could be driven by metrics and automation. The grand result: a loss of personal accountability, transparency, and the passion of scientists in discovery and development.”

Eli Lilly helped to create or spin out three Open Innovation projects, namely InnoCentive, Your Encore and PD2. InnoCentive was the first web-based problem solving platform “designed to connect companies with research challenges with external solution providers who receive prize money if successful." YourEncore has gathered a network of veteran and retired scientists to act as paid advisors to companies at various stages of drug discovery and Lilly’s PD2 provides a confidential and secure platform for the evaluation of promising compounds.

GSK says it is committed to removing Intellectual Property and patents as barriers to new drug discovery and has released more than 800 compound and process patents into the public domain. Both GSK and Lilly have voiced support for Open Innovation in the field of pharmaceutical R&D and are partners in the Collaborative Drug Discovery initiative that created a software platform for sharing collaborative drug discovery data.

THE CHALLENGES WE FACE

There are still challenges facing the future of Open Innovation in the pharmaceutical field, however. Open Innovation is likely to raise the regulatory requirements associated with drug development due to the increased number of contributors to the process. Then there’s the problem of who will own the patents and IP generated during the process. And what about the reward system involved with Open Innovation – where will the initial capital investment come from and how will any income be disbursed among contributors of a successful project? And last, but not least, with the big pharma companies becoming increasingly risk-averse, what percentage of the risk will they agree to shoulder in Open Innovation drug development projects?

Although the future of Open Innovation in drug development is in its infancy, it’s forecast to have great potential in a variety of fields. Transparency Life Sciences, with its pioneering attitude, is at the forefront of this new revolution.