Updated: Dec 5, 2022
Back on July 1st I penned a blog post in this space entitled “From Studying to Intervening: Advancing Social Pharmaceutical Innovation” where I outlined the two pronged strategy of the social pharmaceutical innovation project (SPIN), which included both studying SPIN and also trying to support them.
Since then our project has been involved with three recent events in support of social pharmaceutical innovation in Canada. The first was mentioned in that July 1st posting, which was a panel that I co-organized and chaired along with translational medicine expert Dr. Douglas Mahoney entitled “What’s the endgame for cancer immunotherapy in Canada?” at the Summit for Cancer Immunotherapy on Monday the 21st of November in Montreal. In that panel we brought together a range of experts from across the research, development and deployment lifecycle of treatments to explore how exciting new CAR-T immunotherapies developed entirely in Canada and entirely within the public system[i] could move from clinical trial to more routinized modes of access and clinical practice.
The idea of the panel was to inspire the Canadian immunotherapy community to think beyond the conventional model for treatment development and instead consider the practical implications of what it would take to innovate in ways akin to SPIN. To facilitate this thinking we brought in Kathy Brodeur-Robb Executive Director at the C17 Council (“an organisation composed of the institutionally appointed heads of the sixteen paediatric hematology, oncology, and stem cell transplant programs across Canada”) to talk about how single patient studies (which offer real potential for treatment innovation in rare diseases) can actually be carried out from a regulatory perspective.
We also heard from international evidence based health policy consultant Karen Facey about the role and feasibility of the production and collection of real-world evidence to enable access to emerging treatments; and then Nicole Mittmann ( Chief Scientist and Vice-President of Evidence Standards at Canada’s Drug and Health Technology Agency [CADTH]) responded in terms of how these innovative approaches can be viewed and advanced from an institutional/regulatory perspective. It was important for us to show that these kinds of alternative modes of treatment development are not pie-in-the-sky, and so we had Julie Douville (Senior Director of Pre-clinical Development at the n-Lorem Foundation) show us how the n-Lorem Foundation operates (at this moment primarily in the US) as a non-profit model for translating advanced therapeutics to nano-rare patients. Overall, the idea was to get the scientific community to think about the system requirements of bringing their research through the lab, clinical trial, and into patients in ways that don’t require $2 billion dollars, spin-off, or acquisition from a major bio/pharmaceutical company.
The second event in question took place the next day, on November 22nd at the fall conference of the Canadian Organization for Rare Disorders in Toronto where I presented the framework of SPIN to a diverse group of patients (and their advocates), industry representatives, and researchers. Here the idea was to explore SPIN as framework for “investment in Canadian research and development in innovative therapies for rare diseases” and how SPIN could inform Made-in-Canada alternatives for “sustainable, cost-effective access to specialized therapies” for the emerging national rare disease strategy. There my presentation was proceeded by a panel on “innovative pathways to optimize access to innovative medicines” where Canadian scientists (including those at -and affiliated with the- BioCanRx and the CAR-T research) discussed what is Canada doing well and how can we improve?
In the weeks prior to all of this the President & CEO of BioCanRx - Dr. Stephanie Michaud - organised a panel at the Canadian Science Policy Conference dedicated entirely to social pharmaceutical innovation, again bringing together researchers from Canadian and American institutions to not only discuss scientific advances in alternative modes of R&D but also the policy requirements necessary to move these advances forward.
Much more can and should be said about these events, but this isn’t really the format. Perhaps another blog post on each to give the panelists and discussions the credit they deserved.
Nevertheless, our consortium has always seen SPIN “as a ‘working concept’, both in terms of the work it carries out as a heuristic device that aids in framing research and asking pertinent questions concerning transformations in pharmaceutical R&D, and in terms of being a concept ‘in work’ in terms of its evolving nature” (Douglas, Aith, Boon, et al. 2022). These three recent events show that SPIN is ‘at work’ in Canada. Its interdisciplinary approach is providing a framework that is proving to be of interest and value to the scientific, patient and policy audiences that we started off studying. For us in the Canadian team there is no greater honour than contributing to advancing these initiatives, and there is no great sign of ‘working’ nature of SPIN than this kind of impact.
We look forward to doing whatever else we can in contributing to the safe, effective and fair development of treatments, drugs and systems to benefit rare disease patients.
[i] This is amazing work supported Canada’s immunotherapy network (BioCanRx https://biocanrx.com/ ) and specifically the team being led by Dr. Natasha Kekre (https://biocanrx.com/ct8-kekre ). They are in phase III clinical trials and treating over 60 patients.
Written by: Dr Conor Douglas (PhD)