Global healthcare company GlaxoSmithKline has announced new measures to further advance its commitment towards greater openness, transparency and collaboration, designed to help develop new solutions for the world’s most serious health challenges.
Over the past few years, GSK has been making fundamental changes to its business model to become more open to sharing its intellectual property and knowledge, and to forming partnerships to help stimulate more R&D into diseases that most affect the world’s poorest people. Building on that progress, GSK is setting out new measures to help develop new and faster-acting treatments for tuberculosis (TB), a huge global health need where R&D has been at an impasse, and to support independent research into diseases of the developing world.
GSK also outline new commitments to share detailed clinical trial data to enable additional scientific inquiry and analyses to further scientific knowledge and help bring benefit to patients.
“As a truly global healthcare company, I believe we have a responsibility to do all we can at GSK to use our resources, knowledge and expertise to help tackle serious global health challenges. However, the complexity of the science and the scale of the challenge mean that we cannot solve these problems alone,” said Andrew Witty, CEO of GSK. “We need to take a different approach—one focused on partnership, collaboration and openness. By being more open with our clinical trial data, we also hope to help further scientific understanding. I am pleased with the progress we have made so far to evolve our business model but we recognize there is more we can do.”
GSK will be making their TB ‘compound library’ freely available. GSK scientists have screened the company’s entire pharmaceutical compound library of more than two million compounds for any that may inhibit TB bacteria and will publish in a scientific journal the results of this process—about 200 promising hits that could act as new starting points for the discovery of new medicines for TB.
This is the first time a pharmaceutical company will have made public its own proprietary compounds which have demonstrated signs of activity against TB. It is hoped this will encourage others to pursue a fully open approach to research in to a disease that causes around 1.5 million deaths around the world every year.
This builds on a similar work carried out by GSK in 2009 to place all of its malaria compounds in the public domain. Since the publication of this data in 2010, GSK’s anti-malarial dataset has been shared with research institutions around the world, resulting in a number of promising research projects now underway.
In a further move to foster the sharing of scientific knowledge, GSK will double its funding for its Open Lab at Tres Cantos, Spain, awarding it an additional $8 million. The Open Lab was established in 2010 to allow independent researchers access to GSK facilities, resources and knowledge to help them advance their own research projects into diseases of the developing world. Two years since the Open Lab was established, there are now 16 research projects in the portfolio.
For example, iThemba, a company supported by the South African government, has worked on a project at the Open Lab to identify potential new compounds against TB, specifically multidrug, extremely drug resistant TB and co-infection with HIV-AIDS. There are further projects underway at Tres Cantos looking at TB, malaria, Chagas disease, leishmaniasis and sleeping sickness.
The majority of these projects are supported by the Tres Cantos Open Lab Foundation, an independent, not-for-profit organization established with $8 million in funding from GSK. Overseen by a board of leading scientists, the Foundation provides funding and support to researchers to help them develop and advance new ideas that could lead to new medicines to treat diseases of the developing world. Researchers supported by the Foundation are encouraged to share their work to ensure their discoveries are also accessible to other researchers.
In addition, GSK shares detailed data from its clinical trials. The company posts summary information about each trial it begins and shares the summary results of all of its clinical trials—whether positive or negative—on a website accessible to all. The website currently includes almost 4,500 clinical trial result summaries and receives an average of almost 10,000 visitors each month. GSK has also committed to seek publication of the results of all of its clinical trials that evaluate its medicines—regardless of what the results say—to peer-reviewed scientific journals.
Expanding further on its commitments to openness and transparency, GSK also plans to create a system that will enable researchers to access the detailed anonymized patient-level data that sit behind the results of clinical trials of its approved medicines and discontinued investigational medicines. To ensure that this information will be used for valid scientific endeavor, researchers will submit requests which will be reviewed for scientific merit by an independent panel of experts and, where approved, access will be granted via a secure web site. This will enable researchers to examine the data more closely or to combine data from different studies in order to conduct further research, to learn more about how medicines work in different patient populations and to help optimize the use of medicines with the aim of improving patient care.
This initiative is a step towards the ultimate aim of the clinical research community developing a broader system where researchers will be able to access data from clinical trials conducted by different sponsors. GSK hopes the experience gained through this initiative will be of value in developing and catalyzing this wider approach.