As a consortium our project is focussing on what new social innovation approaches are emerging in the context of pharmaceutical research and development for rare diseases and other unmet medical needs, and what such approaches contribute to improve healthcare provision in terms of availability, accessibility, quality, equity and sustainability?
And for the past two years we have being doing that, we have been studying emerging initiatives - which we term Social Pharmaceutical Innovation - in Brazil, Canada, France and the Netherlands that are seeking to address some of the well known challenges in the rare disease space as they pertain to the research, regulatory, coverage and delivery dynamics. We think that there is space for these initiatives within the pharma innovation landscape, and that these initiative have the potential to address some of those challenges. As a consequence, as a group of interdisciplinary scholars in the social science, law, and public health, we are studying these initiatives, trying to understand what makes these initiatives work, what kind of barriers they face, how they might be supported and/or replicated.
However, from the outset of our project our consortium wanted to not just study Social Pharmaceutical Innovation (SPIN) initiatives, but we established two-pronged goals to drive our project, which included both studying SPIN and also trying to support them. We have always wanted to not just understand how SPINs work but also intervene in SPINs to broaden the innovation landscape in rare diseases and beyond.
After two years of research studying and understanding how SPINs are working from a whole systems perspective we are now entering into a phase in which we can now actually intervene in some of these initiatives to advance specific SPIN projects and Social Pharmaceutical Innovation more generally.
Two examples of this come from the Canadian context. The first example comes from the work we have been doing on a made-in-Canada CAR-T product to treat a rare form of cancer. We have been studying this initiative that is -for the first time in Canada- creating this particular cell therapy entirely within Canada and entirely within the context of publicly funded research system ( https://biocanrx.com/research/made-canada-car-t-therapy-timeline ). 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 patients…some of which might not otherwise be receiving treatment. They are developing a product that could be brought to market, entirely from within the public system. While this is a case that we will report on in more formal academic format to describe and explain it properly, this is a significant developed, and we have been studying it as such. Recently, however, we have moved on from studying this initiative to intervening in it. From the 19th to the 21st of November, 2022 the Summit for Immunotherapy will be held in Montreal (https://cancersummit.ca/program/agenda ), and on the 21st there will be a dedicated session to explore “What’s the endgame for cancer immunotherapy in Canada?”. This is session that I am co-chairing with a translational medicine expert Douglas Mahoney (https://charbonneau.ucalgary.ca/our-members/our-members/dr-mahoney-douglas) from the University of Calgary where we will bring together a range of experts from across the life-cycle of medicinal development to explore what it would really take to bring an immunotherapy to market. Beyond the scientific and technological capacities (which the Kekre team is demonstrating to be in place), what are the evidentiary, regulatory, Health Technology Assessment (HTA), sponsorship, financing and coverage requirements necessary to get these kinds of treatments into patients by way of this alternative pathway.
The immunotherapy community is now in a position where the science is possible, and now as a consortium our SPIN project is now able to intervene in the process and help them to ask critical social, political and economic questions (and possibly develop some strategies or routes) to move these treatments out of trials and into regular clinical practice.
So this is one way in which we are intervening.
And there are others, which I will post about in more detail when the information is public.
The point is, SPIN is possible. It is taking place. What is more, it is critical that we understand the regulatory, economic, institutional, and socio-political dynamics through which they are taking place – because they matter. The scientific community recognises this, and we feel like it is an area where we can contribute to social pharmaceutical innovation.
Photo credit: Ameen Fahmy (2019). Selective Focus Photography of a Lightbulb [Image]. https://unsplash.com/photos/_gEKtyIbRSM
Written by: Dr. Conor Douglas