' “This is a new paradigm and a new business model,” says Julio Martin, Ph.D., head of Parasite Chemotherapy at GSK. “Open innovation will become the model across the pharmaceutical industry. Together, we can contribute to innovation in a precompetitive way and provide a return on benefit for society.” ''Open access and crowdsourcing scientific information to accelerate research and development requires a new way of thinking about how clinical research is conducted and breaking down competitive barriers for the greater good.
Crowdsourcing is the process of getting work or funding, usually online, from a crowd of people. This mainstream social experiment, which has been popularized by such funding sites as indiegogo and Kickstarter, is now being implemented in the traditionally siloed framework of clinical research. Social networks, such as PatientsLikeMe, are connecting patients to share healthcare and treatment information and networks for physicians such as Sermo are bringing together physicians in virtual online meeting places that facilitate discussions, online learning, and medical information sharing. And in academia, crowdsourcing has been used for more than a decade for data mining, to solve issues related to computational problems, and to screen for therapeutic effect of compounds against targets.
For pharmaceutical companies, crowdsourcing has taken the form of “open innovation.” Companies such as AstraZeneca, Lilly, GSK, Janssen, Merck, Pfizer, Sanofi, TransCelerate, and others have launched initiatives to enable scientific innovation to cross boundaries between companies, academia, government, and nonprofit organizations.
Additionally, these and other companies have developed challenges or competitions for researchers to apply for grants for new research projects.'
..
“This is a new paradigm and a new business model,” says Julio Martin, Ph.D., head of Parasite Chemotherapy at GSK. “Open innovation will become the model across the pharmaceutical industry. Together, we can contribute to innovation in a precompetitive way and provide a return on benefit for society.”
..
Foldit, a protein folding game with more than half a million registered players, has dramatically improved protein folding algorithms. Foldit’s goal is to predict the structure of a protein through puzzle-solving scenarios, which would aid the creation of designing new proteins to combat disease-related proteins found in HIV/AIDS, cancer, or Alzheimer’s, for example.
..
Crowdsourcing efforts in drug discovery aim to use the power of the crowd to look for potential hits and screen molecules against targets. One such effort is
World Community Grid, which was conceived and is managed by IBM.
Hosted on IBM’s SoftLayer cloud technology, World Community Grid provides free computing power to scientists by harnessing the unused, surplus cycle time of a number of volunteers’ computers and mobile devices from all over the globe. World Community Grid software receives, completes, and returns small computational assignments to scientists.
..
It has enabled multiple breakthroughs, such as helping the Chiba Cancer Center in Japan discover seven new drug candidates to fight childhood neuroblastoma.
..
Tomasz Sablinski, M.D., Ph.D., founder and CEO of Transparency Life Sciences, believed there had to be a better way .. That’s why he founded Transparency Life Sciences in 2011 as a new type of company that develops therapies in a transparent way through a crowdsourced Web platform, which allows patients, physicians, researchers, and other stakeholders to contribute to the design of clinical studies, along with the use of digital and telemedicine technologies for patient data collection.
“I started this company based on three principles, all of which are contrary to how the system operates today,” he says. “The first is transparency. Everything we do is open to the extent that is possible by legal, privacy, and other constraints. That includes design of the experiments, conduct of the clinical trials, publishing results, and being completely open about what happens at the front and at the back end.
“The second principle is truly engaging end users and stakeholders — including patients, prescribing physicians, researchers, and scientists — in designing trials done through structured crowdsourcing,” he continues. “The third significant element of the model is moving trials to where patients are instead of moving patients to the clinical trial sites. We are doing this via increasingly available services of telehealth or telemedicine, wearable devices, and video visits.”
Dr. Sablinski says he expects this model will have several positive results: easier recruitment of patients in trials, more relevant data, a public that is more engaged with research, and savings of about 80% over today’s current practices.
“Bits and pieces of this model are being incorporated, but I believe there needs to be a comprehensive solution rather than point solutions,” he says. “We are pioneering just such a comprehensive solution.”
The company’s core business model is to acquire intellectual property of stalled drug candidates. Through the company’s Protocol Builder tool on its website, patients, researchers, physicians, statisticians, and others can provide feedback on trial protocols.
“We ask specific questions regarding the study protocol,” he says. “Some questions require a binary ‘yes’ or ‘no’ answer, and some are more elaborate. All questions have a box for a narrative response. The aim is to come to a consensus on endpoints, inclusion-exclusion criteria, monitoring systems, and other devices patients and physicians would use to collect data, as well as the best way to measure outcomes.”
Dr. Sablinski points out that traditional key performance indicators — time to recruiting all patients, number of queries, quality of data — are artificial and sometimes unreliable.
“These are very crude measurements of success in clinical development,” he says. “We believe our model increases the likelihood of either quickly killing a drug that generally doesn’t have positive benefit risk ratio or quickly advancing it in development with high quality and lower budget.”
Dr. Sablinski says the Protocol Builder process has resulted in tremendous feedback. In the case of the company’s multiple sclerosis trial, the process resulted in switching primary and secondary endpoints.
He says to have patients and other stakeholders be truly engaged in clinical research requires more than the feedback of a token patient on an advisory board.'
- Denise Myshko,
R&D Moves Slowly Toward Open Source, October 2015
Context(Open Source) - '..where business rivals work hand-in-hand with code.'(Teal)(Reinventing Organizations) - 'Planting the seeds of new possibilities..'(Open Source) - ' “A New World’s Manifesto.” Linux and FOSS are an important part and enabler of this transformation.'(Haptopraxeology) - '..We have lost three centuries as a result of ignoring our scholars!'(In The Electric Universe) Open Source Infrastructure, beginning of the Enterprise Nervous System (ENS)BOINC (Open-source software for volunteer computing)