Session 1: Product Development and Delivery-Challenges and Solutions in Device, Drug and Cellular Therapies

Chair: Graham Creasey, Professor of Spinal Cord Injury Medicine, Stanford University

The development and delivery of new medical devices, drugs and cellular therapies is fraught with obstacles and barriers beyond the demonstration of effectiveness. Through the sharing of lessons learned from accomplished speakers and thought-provoking questions posed to participants about potential solutions, Session 1 outlines insightful lessons learned and provides participants with an opportunity to recommend strategies for enabling successful product development and delivery throughout Valley 1.

Lessons Learned Panel:

  1. Lessons Learned from a Medical Device Perspective in SCI
    P. Hunter Peckham, Donnell Institute Professor of Biomedical Engineering
  2. Drug Development in SCI
    Andrew Blight, Chief Scientific Officer, Acorda Therapeutics
  3. The Geron Story: Lessons From a Commercial Stem Cell Study
    Edward Wirth, Chief Medical Officer, Asterias Biotherapeutics
  4. New Commercialization Strategies for SCI
    Megan Moynahan, Executive Director, Institute for Functional Restoration

Session 2: Pre-clinical and Clinical Trials of Regeneration and Repair in SCI

Chair: Naomi Kleitman, Senior Vice President for Grants & Research, Craig H. Neilsen Foundation

Session 2 continues to primarily address Valley 1 challenges. Although several SCI clinical trials have been undertaken for protecting the spinal cord from secondary damage after injury or for promoting restoration of spinal nerve circuitry, few have proceeded past the stage of safety and early efficacy studies and no effective treatment to restore function has been demonstrated.

The eminent researchers in this session’s case study panel will provide a candid brief overview of the challenges they have experienced when conducting trials and will expand on what has contributed to their success. Participants will work with colleagues and associates in table discussions to learn from one another and generate a plan for a successful way forward with respect to future SCI trials.

Case Study Experiences Panel:

  1. Funder’s Perspective : Why Clinical Trials Fail
    Lyn Jakeman, Program Director, National Institute of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS)
  2. Clinician Researcher Perspective: Can Pre-clinical Data Predict Success of Clinical Studies? Retrospective Review of Past and Current Neuroprotection Studies
    Brian Kwon, Canada Research Chair in Spinal Cord Injury, University of British Columbia
  3. An Administrator/Researcher Perspective: Challenges in Recruitment in SCI clinical trials: A View from the Trenches
    Michele (Shelly) Towle, Assistant Director, SCI Program, DP Clinical

Session 3: Bringing Knowledge into Clinical Practices

Chair: Catherine Truchon, Senior Advisor, Trauma Team, Institut National d'Excellence en Santé et Services Sociaux

Session 3 focuses primarily on Valley 2 where implementation of best practices for standardization of care is a significant challenge in SCI. Although efficient rehabilitation interventions, standards of practice, guidelines, various clinical tools, protocols, and approved therapies exist for SCI care, their adoption is often inefficient and inequitable across facilities and regions.

Learn from outstanding Canadian leaders about the successful implementation of leading practices in areas such as stroke rehabilitation. Discuss what works and what doesn’t with other conference participants. Recommend approaches for the future in collaboration with experts from a range of sectors.

Perspective Panel: Using What We Know

  1. Research into Practice Perspective: Challenges and Opportunities in Research in Rehabilitation Care after SCI (in clinical settings)
    Anthony Burns, Physiatrist, UHN-Toronto Rehabilitation Institute
  2. Research into Practice Perspective: Challenges and Opportunities in Research in Rehabilitation Care after SCI (in clinical settings)
    Mark Bayley, Medical Director, Brain & Spinal Cord Rehab Program, UHN-Toronto Rehabilitation Institute
  3. Front-Line Care Perspective: Making real changes
    Cathy Craven, Medical Lead, Brain & Spinal Cord Rehab Program, Toronto Rehabilitation Institute
    Associate Professor, Dept of Medicine, University of Toronto

Session 4: Financial Viability – Uncertain Markets
Investors, Industry, IP and Insurance-Product Development and Reimbursement

Chair: Lisa McKerracher, Founder and CEO, BioAxone BioSciences

One barrier to clinical studies and commercialization of SCI-related innovations is limited financial resources for first-in-man and placebo-controlled studies for novel drugs or cell-based therapies. Early stage investors and industry, the not-for-profit sector, advocacy groups and governments can play various critical roles in translating innovative ideas into commercial products, but products related to SCI are often not considered attractive for investment for a variety of reasons, including a lack of understanding of SCI and related reimbursement opportunities, Intellectual Property considerations, and a limited target market.

Session 4 speakers will share their extensive and sometimes difficult experiences in a lessons learned format. They will interact with each other and conference participants who will then engage in multi-sector table discussions to identify solutions for attracting investment and corporate partnerships while maximizing the role of all sectors including not-for-profits and patient advocacy groups.

Experiences-in-Action Panel

  1. Support for Early Stage Research: What Companies Look For
    Phil Tinmouth, Vice President & Head, Business Development & Alliance Management, Vertex Pharmaceuticals Inc
  2. Intellectual Property and Technology Transfer
    Kathleen Marsman, Patent Agent, Borden Ladner Gervais LLP
  3. Business and Regulatory Challenges: a Solutions Perspective
    Dennis Choi, Professor and Chair, Department of Neurology, Stony Brook Medicine
  4. Commercialization
    Ron Podraza, Co-Founder and CEO, Reimbursement Principles, Inc.