Praxis 2016, hosted by the Rick Hansen Institute (RHI), assembled leaders and stakeholders in the field of spinal cord injury (SCI) for a landmark conference to develop practical solutions for overcoming challenges to translating research into improved outcomes for people living with SCI.
Designed to change the mold of a traditional scientific meeting by focusing on action and engaging a diverse group of participants, Praxis convened consumers, researchers, clinicians, and representatives of funding organizations, regulators, policy makers and industry. Through the sharing of hard-won experience and challenging small group conversations, participants agreed that a paradigm shift is required to accelerate research through two translational “Valleys of Death”: from basic research to clinical research (Bench to Bedside) and from initial implementation to dissemination to the entire SCI community (Bedside to Worldwide).
In his opening address Bill Barrable, CEO of RHI, said: “We hope that you look back on this meeting in the future as a milestone on our journey toward a world without SCI and secondary complications. We have a lot of collective work to do, and the true value of this meeting will be apparent many months down the line.”
Graham Creasey (Stanford School of Medicine) illustrated the need for SCI stakeholders to bridge gaps and establish effective communication between researchers, clinicians, policy makers, funders, regulators, industry and consumers. Eric Marcotte (Canadian Institutes of Health Research) highlighted CIHR’s focus on patient oriented research in moving research into practice and further underlined the essential role of collaboration. Rick Hansen (Rick Hansen Foundation) stated, “I hope we can look back at this moment of time and say we really turned the dial and elevated the trajectory towards the cure for SCI.” Emphasizing the repercussions on consumers, Jennifer French (Neurotech Network) urged participants to consider the following questions with respect to bringing change: “If not now, when? And if not me, who?” Kim Anderson-Erisman (Miami Project to Cure Paralysis) related the importance of stakeholders coming together as equals to address the barriers to effective translation of research to the sessions throughout the conference.
Keynote speaker Francesco Marincola (Sidra Medical and Research Centre) shared insights and experience gleaned from cancer for guiding research from basic science to clinical application. Quoting Jonas Salk, he noted that the focus should be on asking the right questions. Dr. Marincola added that stakeholders need to learn from their mistakes since translational medicine is a two-way road: basic science informs clinical practice but clinical experiences should be used to inform and better design the questions targeted by basic scientists. Dr. Marincola concluded by urging Praxis participants to dare themselves to push beyond traditional “no entry” signs in scientific research, pointing to the benefit of diverse opinions and new ways of thinking that drive innovation in research and application.
A distinguishing feature of Praxis 2016 was active participant engagement. The format of the sessions consisted of short presentations by subject matter experts discussing their experience with challenges in translational research followed by group discussions to identify practical solutions based on individual experience and knowledge.
SESSION 1: Product Development and Delivery – Challenges and Solutions in Device, Drug and Cellular Therapies
“Lessons Learned” Panel members:
- P. Hunter Peckham (Case Western Reserve University),
- Andrew Blight (Acorda Therapeutics),
- Edward Wirth (Asterias Biotherapeutics), and
- Megan Moynahan (Institute for Functional Restoration)
Panel members outlined challenges in the development and delivery of new medical devices, drugs and cellular therapies that go beyond demonstrating efficacy, and proposing practical strategies and business models to get products into clinical use and commercial viability.
SESSION 2: Pre-Clinical and Clinical Trials of Regeneration and Repair in SCI
“Case Study Experiences” Panel members:
- Lyn Jakeman (National Institute of Health/National Institute of Neurological Disorders and Stroke)
- Brian Kwon (University of British Columbia), and
- Michele (Shelly) Towle (DP Clinical)
Highlights of the session included panel members sharing their perspectives on issues contributing to the failure or suspension of SCI clinical trials. Despite challenges related to limited funding, low recruitment rates, and the use of pre-clinical data to predict success of clinical studies, the SCI field can learn from past experiences in order to ask better research questions in the future and to ensure success of future clinical studies.
SESSION 3: Bringing Knowledge into Clinical Practices
“Perspectives” Panel members:
- Anthony Burns (UHN-Toronto Rehabilitation Institute and University of Toronto),
- Mark Bayley (UHN-Toronto Rehabilitation Institute), and
- Cathy Craven (UHN-Toronto Rehabilitation Institute and University of Toronto)
Drawing from their experience, including examples from stroke rehabilitation, panel members illustrated the fact that implementation is often inefficient and uneven despite the best rehabilitation interventions, standards of practice, guidelines, various clinical tools and protocols and approved technologies. Solutions discussed ranged from new funding strategies to policy and behaviour change.
SESSION 4: Financial Viability – Uncertain Markets: Investors, Industry, IP and Insurance – Product Development and Reimbursement
“Experience-in-Action” Panel members:
- Kathleen Marsman (Borden Ladner Gervais LLP),
- Dennis Choi (Stony Brook Medicine), and
- Ron Podraza (Reimbursement Principles, Inc.)
Panel members highlighted the critical role early stage investors and industry play in translating ideas into commercial products. Products for SCI are often not considered attractive due to a lack of understanding of the potential to improve patient quality of life, unknown revenue potential, and uncertainty related to product reimbursement by health care payers and insurers. Some of the solutions proposed included early education of researchers about commercial viability of products, cost-effectiveness research and the need to build a reimbursement path.
Session Chairs (Graham Creasey from Stanford School of Medicine, Naomi Kleitman from Craig H. Neilsen Foundation, Catherine Truchon from Institut National d’Excellence en Santé et Services Sociaux, and Lisa McKerracher from BioAxone BioSciences) highlighted insights from the conference and offered recommendations on next steps. Participants also committed to take action through communicating, advocating, sharing information and engaging to accelerate the pace of translation of SCI research. Graham Creasey wrapped up the conference by saying, “We’ve paused together in our journey, discussed experiences, shared stories, and come to recommendations for how we can do better. Now, it is time for us to strike out again together, with an adventurous and collaborative spirit, to press forward in improving the lives of people living with SCI”.
An Action Committee was convened to lead the work of prioritizing and sharing actions by Praxis 2016 participants. Led by Graham Creasey and Catherine Truchon, who volunteered to serve as the primary initial contacts, and supported administratively through a secretariat at the Rick Hansen Institute, the Action Committee will serve as a bridge between the work of Praxis 2016 participants and the implementation of change in the SCI research and consumer communities.
A comprehensive Praxis 2016 report will be disseminated to conference delegates and other key stakeholders in the fall. Peer-reviewed publications will also be produced in relation to the conference. Visit www.rickhanseninstitute.org for updates.
Program Advisory Committee
Graham Creasey, MD, FRCSEd (Chair)
Kim Anderson-Erisman, PhD
Naomi Kleitman, PhD
Brian K. Kwon, MD, PhD, FRCSC
Lisa McKerracher, PhD
Hunter Peckham, PhD
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