Scientific start-ups can benefit from open science to reduce costs and accelerate development
The Trump administration recently announced cuts to federally funded science and science infrastructure – a decision that has a resounding impact around the world. Here in Canada, it’s driving Canadian science-based SMEs to rethink how they grow and enter markets around the globe. When re-evaluating this approach, patents – or lack thereof – should be a key consideration.
While many scientific innovations and therapies have found their way to market through the patent process, it is not essential for growth and success. In fact, in many cases patents are unnecessary, and get in the way at the start-up level. Add to this, they are expensive to enforce – upwards of US$3 million – and are found valid only just over half the time.
Open science, an approach where companies and researchers share data and discoveries, offers SMEs and researchers a different approach to traditional drug development models that require patents. An open science approach gives them an opportunity to accelerate drug development while avoiding duplication, increasing efficiency, and reducing overall costs.
Open science is not new but adopting a truly collaborative approach still is. There are concrete examples that showcase the possibilities.
M4K Pharma, a virtual biotech company focused on developing affordable therapies for underserved pediatric conditions, has made headway through its use of regulatory data exclusivities – exclusive rights enforced by governments over the use of preclinical, manufacturing, and clinical data for biopharmaceuticals – rather than patents. In addition to regulatory exclusivities, M4K Pharma also uses priority vouchers and philanthropic funding to advance novel drugs aimed at underserved pediatric diseases, including brain cancer. M4K’s business model is based on sharing not only its results but also its business strategy as a way to prevent others from patenting around its drugs, as well as to engage and support patient and research communities. It encompasses building partnerships without the burden of having to keep secrets and with the advantage of crowdsourcing solutions from researchers, patients, governments, and philanthropies.
Similarly, established with financing from Canada’s Strategic Innovation Fund, Conscience, a Canadian non-profit, helps fund SMEs that engage in open science and teamwork to develop drugs for rare diseases, infectious diseases, and complex diseases. By providing matching funds to those engaging in preclinical research, Conscience offers firms the opportunity to explore non-patent options for those drugs in their portfolios that would otherwise lie fallow due to lack of traditional funding. The organization has three main programs: DMOS (Developing Medicines through Open Science), CACHE (Critical Assessment of Computation Hit-finding Experiments) Challenges, and OSSS (Open Science Support Services). The DMOS program recently announced funding for three projects, each of which involves at least one Canadian SME, to conduct preclinical work towards developing drug candidates in areas where market solutions are limited. CACHE Challenges are open competitions to encourage and accelerate early-stage drug discovery. Biotech companies, researchers, software developers, and pharmaceutical firms have all taken part in CACHE challenges. OSSS provides firms and consortia with support in adopting and implementing open science practices and putting together regulatory strategies. As an extra incentive, Canadian SMEs and academic participants in CACHE and OSSS can have up to 50 per cent or 100 per cent of their costs covered, respectively.
STEMCELL Technologies is another established example. Founded by Allen Eaves in the 1980s, a spin-out of the British Columbia Cancer Agency (now BC Cancer). While at BC Cancer, Eaves started preparing high-quality tissue culture media for researchers. As demand rose, he and his wife, Connie Eaves, spun out STEMCELL Technologies without any patent. They obtained federal funding, built manufacturing facilities and grew. Thirty years later, STEMCELL remains in Vancouver but has facilities around the globe and employs 1,500 people. Over time, it developed its own products, some of which it patented and licensed.
Each of these organizations recognizes the power of open science and true collaboration, and that patents, in many cases, can be more of a burden than a benefit in early phases of development. These case studies demonstrate that there are lower cost and lower risk alternatives that exist, particularly in regulated industries such as drug development.
Even SMEs that pursue patents and copyrights benefit from open science. For example, collaborating openly to build large datasets to train and validate artificial intelligence models brings significant benefit to firms. As no one firm, even a large one, can realistically create these datasets, open sharing is critical.
Open science is not a panacea but is a valuable quiver in the SME toolkit. And while the open science model is not for everyone, given that over half of drug approvals are now for orphan drugs, it is a model to seriously consider. This consideration becomes increasingly important given the challenges that science and science-based SMEs are facing in light of the Trump administration’s gutting of science infrastructure, funding, and programs – not to mention tariffs and trade.
Now is the time for SMEs to open their approach to growth.
