The Rick Hansen Institute RHI is a Canadabased notforprofit organisation committed to accelerating the translation of discoveries and best practices into improved treatments for people with spinal cord injuries SCI RHI is developing innovative partnerships and programmes to support the commercialisation of therapeutics and medical devices with application to SCI
Spinal Cord Injury (SCI) is one of the greatest survivable catastrophes experienced by a human being. Regardless of cause or age at injury, SCI has a devastating impact on an injured person’s health and well-being, and far reaching consequences for individuals, their families and the healthcare system. There is currently no approved treatment for paralysis following SCI beyond surgery and rehabilitation. Furthermore, required care is highly specialised and complex—including costs for acute, rehabilitative, emergency, primary, mental health, home and long term care and adaptive equipment—resulting in substantial financial costs for governments. The worldwide annual incidence and prevalence of SCI is conservatively estimated at 130,000 and 2,500,000, respectively. In Canada alone, a country with a population of approximately 35 million people, the cost of care for people with traumatic SCI is now estimated at approximately US$2.7 billion a year.
Today RHI is a Canada-based not-for-profit organisation committed to accelerating the translation of discoveries and best practices into improved treatments for people with spinal cord injuries. It does this by leading the collaboration of researchers, healthcare professionals and service providers across Canada and internationally. RHI has matched leadership and research collaboration with government funding to facilitate one of the largest interdisciplinary spinal cord injury research programmes in the world.
At its core, RHI is essentially a network. The network is formed through a variety of partnerships with governments, researchers, clinicians, granting agencies, corporations, research and healthcare organisations and accreditation agencies. RHI considers people who have suffered an SCI, SCI patients and consumers, to also be effective partners in achieving its mission. Therefore, the innovation in RHI’s partnership model is not necessarily represented by a specific partnership; however, the innovation in the partnership model is derived more from the breadth and variety of the partnerships. This partnership model allows RHI and its network to provide a total value that is greater than the sum of its individual parts.
Scarcity of research funding
In this economic climate, research funding is scarce. There are more researchers and organisations searching for funding than there are funds available. It is a function of competition over scarce resources. This aspect of competition should be familiar to all those involved in just about any aspect of research and development. Researchers compete for grant funding; charities, foundations and not-for-profit organisations compete for donations and government funding; early-stage and emerging companies compete for investment funding; and more mature companies with approved products compete for actual customers. Therefore, in order to facilitate the implementation of new therapeutics and medical devices into the delivery of healthcare for people with SCI, there is a need to secure more funding into the space. Specifically, there is a need to draw more investment capital into the commercialisation of innovations with application to SCI. However, in order to do so, the investment must be sufficiently de-risked so that it becomes an attractive investment opportunity.
In terms of partnership models to de-risk early-stage investment into research, this is often represented by a not-for-profit organisation providing resources towards the development or commercialisation of a technology relevant to its mission. The recipient uses these resources to advance the commercialisation process of the technology to the point in which it can reach a tangible commercialisation outcome, such as an investment or licensing event. The implication is that through providing resources the not-for-profit assumes some of the risks involved in the development and the investment is effectively de-risked for a third party, such as an investor or commercial partner. RHI is in a unique position to perform a similar de-risking for investment into therapeutics and medical devices with application to SCI under development by an early-stage or emerging company. Ideally this will result in increased investment into technologies with application to SCI and thus increase investor and industry participation in the space. Successfully commercialised therapeutics and medical devices will improve outcomes or decrease the cost of outcomes for people with SCI and the various stakeholders, ideally both.
However, RHI’s core programmes have largely focused on initiatives within the public healthcare system and research-based institutions. Although RHI has provided grant funding to a few projects associated with the commercialisation of a technology, it has not specifically targeted the commercialisation process within the activities of its core programmes. In other words, RHI has lacked specific mechanisms to support the commercialisation of innovations with the potential to improve outcomes for people with SCI that are under development by early-stage and emerging companies.This represents a proverbial hole in RHI’s portfolio of activities as translating research into products requires risk-taking and the entrepreneurs that run these companies are typically more likely to take the necessary risks. RHI is addressing this need with the development of its Commercialisation Strategy (CS).
The overall goal of RHI’s CS is to facilitate the development of innovative pre-commercial therapeutics and medical devices that will improve the lives of those living with SCI. However, the capital required in order to shepherd a new therapeutic or medical device all the way through the commercialisation pathway from idea to regulatory approval is well beyond the resources of RHI. The CS must account for these limitations and seek innovative ways of partnering with organisations in order to leverage available resources. Thus, the goals of the strategy include:
RHI’s CS aims to address a common challenge for an early-stage or emerging company in the life sciences and biotechnology field–securing bridge funding to test an idea through proof of concept to the point in which it is able to secure the investment necessary to continue its development. This is often described as the commercial ‘Valley of Death’ and is an even larger challenge for companies developing therapeutics and medical devices for SCI for a variety of reasons, including:
Partnerships will be critical to the success of RHI’s CS. Ideally, the partnerships will leverage RHI’s domain expertise in SCI research and care with the commercialisation process expertise and resource of other organisations. Therefore, RHI will seek to partner with pharmaceutical, biotechnology and medical device companies that have the resources to invest and continue the commercialisation of technologies to regulatory approval and implementation into the delivery of healthcare.
The first step for RHI’s CS has been to pilot the RHI SCI Global Investment Forum. The Forum is intended to facilitate connections between early-stage and emerging companies, developing therapeutics and medical devices with application to SCI and the secondary complications, to investors and partners. This is done by providing these companies the opportunity to pitch their company and SCI-related technology at an event that is attended by potential investors and partners from the biotechnology and life sciences community. RHI has hosted two forums to date. The first was held at the Interdependence 2012 Global SCI Conference in May 2012 in Vancouverand the second was held at Biotech Showcase™ 2013 in January in San Francisco.
RHI acknowledges that the RHI SCI Global Investment Forum alone will be insufficient to accomplish the goals of its commercialisation strategy. RHI must implement mechanisms that actually de-risk investment into early-stage and emerging companies in the SCI space. Therefore, RHI is in the process of developing other opportunities for early-stage and emerging companies that are commercialising an innovative therapeutic or medical device for SCI.
De-risking early-stage investment and translating research into products is challenging in life sciences, particularly for a complex and costly condition such as SCI. Innovative partnerships are required in order to be able to accomplish these goals. RHI’s innovative partnership model is evidenced in its network that includes a variety of different stakeholders involved in the SCI research and development continuum from both the public and private sectors. Governments, researchers, clinicians, granting agencies, corporations, research and healthcare organisations, accreditation agencies, and SCI patients and consumers are all critical in translating research into products that improve outcomes and decrease the cost of outcomes for people with SCI.
Twenty five years ago, Canadian Rick Hansen—paralysed from the waist down in an accident at the age of 15—had a dream: to make the world more accessible and inclusive and to find a cure for paralysis after SCI. Inspired by a deep-seated belief that anything is possible, Rick’s ‘big dream’ took shape in the form of the Man In Motion World Tour. For 26 months, he and his team wheeled more than 40,000 km through 34 countries, raising awareness of the potential of people with disabilities. Following the tour, Rick established the Rick Hansen Foundation (RHF) to continue his quest for an accessible and inclusive society and a cure for paralysis after SCI.
Under Rick’s leadership RHF functions as a social innovator, finding collaborative solutions to challenges in the community and the resources necessary to implement those solutions. Rick Hansen has also nurtured a dream of true collaboration across the SCI community. In 2003 his dream began to be realised when the SCI Network was established with funding from the federal government (Western Economic Diversification) invested through RHF. Three initiatives evolved—the SCI Solutions Alliance, the Rick Hansen SCI Registry, and the SCI Translational Research Network, which was funded by a US$30 million investment from Health Canada. In April 2008, a decision was made to combine these three entities into a single organisation, which is more effectively and efficiently addressing priority needs and generating solutions for people with SCI. The Rick Hansen Institute (RHI) became incorporated in March, 2009. RHI received charitable status from Canada Revenue Agency (CRA) in January, 2010 and now operates as an independent charitable organisation.
John Barclay is responsible for the development, implementation and management of RHI’s commercialisation strategy. John has over eight years of experience in the life sciences industry in both profit and non-profit sectors with a focus on strategic relationship management in order to connect innovative ideas to the resources that will help advance them.
RHI operates three interconnected core programme areas that represent a unique model in which to translate research into products and best practices for people who have suffered an SCI
RHI’s TR programme focuses on applying discoveries generated during laboratory research and preclinical studies to the development of trials and studies in humans, and, where success has been determined, preparing that knowledge for implementation into clinical practice. Projects supported through the TR programme are carefully selected through strategic investment or calls for proposals, based on their potential impact against three objectives: reduce the incidence and severity of paralysis after SCI; improve healthcare outcomes in the treatment of people with SCI and reduce long-term costs in the care of people with SCI. Examples of projects sponsored through RHI’s TR programme include an acute-phase multi-centre clinical trial for the use of minocycline as a neuro-protective therapeutic treatment for traumatic SCI, and a clinical study that monitors Cerebrospinal Fluid (CSF) pressure and will validate biomarkers with the intent of limiting secondary damage to the spinal cord by developing a procedure to help drain the CSF and stratify injury severity and predict neurological recovery based on the presence of specific biomarkers.
Through its BPI programme, RHI works translate knowledge from its TR programme in order to affect the changes in clinical practices necessary to achieve the best possible health outcomes for people with SCI, from acute care to community integration. RHI is committed to improving the development, validation, dissemination and adoption of best practices in spinal cord injury care. Examples of projects supported through RHI’s BPI programme include an initiative with Accreditation Canada that will create standards for hospitals that provide acute and rehabilitation care services for individuals with SCI, and another initiative with the Canadian Medical Association that is developing incentive mechanisms for Canada’s more than 50,000 family physicians to adopt evidence-based best practices for care of individuals with SCI.
RHSCIR is an unprecedented, nation-wide project that is collecting critical information on SCI at 31 major Canadian acute care and rehabilitation hospitals. RHSCIR was established in Vancouver, BC in 2004 and since has expanded to 31 facilities across Canada, effectively creating a clinical research network. The network includes governments, granting bodies, corporations, research and healthcare organisations, and accreditation agencies. Among this network are many key opinion leaders in SCI research and care. This collaboration—largely due to the need to increase the number of participants available for clinical trials, and to enable interactions between researchers world-wide—is now expanding internationally.
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