In this Q&A, RHI talks to biomedical engineer and commercialization expert, Dr. Hunter Peckham about his involvement in Praxis 2016 and what some of the biggest challenges are in bringing a product or therapy to market.
Dr. Peckham is a member of RHI's Commercialization and Praxis advisory committees. |
What is your background?
I have a PhD in biomedical engineering. In a broad sense I work in rehabilitation engineering and more specifically, I work on restoring physical function in people with SCI by using and developing devices called neural prostheses.
Neural prosthesis (a type of functional electrical stimulation or FES) is a medical device, usually implanted, that uses either electrical activation or inhibition of the central nervous system to restore function. Activation can be in the form of sensation or movement, and inhibitors limit neural activity that we don't want such as pain and spasticity.
I have been working with the SCI population since 1972 and founded the Cleveland FES Center in 1991. Based in Ohio, USA, the FES Center's vision is to merge cutting edge research and creative engineering into the clinical environment to create comprehensive options for patients and their families, and the clinicians who care for them.
What interested you about becoming involved in Praxis 2016?
I was interested in participating because Praxis tackles the challenges that are also the focus of the work that I do right now.
Our work in neural prostheses has proven to restore movements in areas such as standing, hand function, bladder and breathing. So we know we have something that works. The ultimate challenge for us then becomes how we can create a sustainable enterprise that will enable people with SCI to have function restored. I am almost entirely focused on that issue right now and it's one of the issues that Praxis is tackling head on.
Whether it's a cellular or biological therapy or a medical device, making that initial discovery is the first step, but all too often we see various stages of development halted or even aborted because of lack of feasibility, money, resources etc. Praxis really gets to the heart of what we are all trying to achieve – and that's getting our discoveries into the hands of people with SCI.
How do you think Praxis 2016 will be different from other SCI-related conferences?
"If your original findings are promising, you begin to collect the evidence for a broader human clinical trial, but even once your research has been through those clinical trials, that doesn't mean it's on a sustainable delivery platform or commercially viable."
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Praxis really focuses on the end game. Once you have made a discovery and have proven it to be safe in animals, it needs to be translated into treatments for people with SCI – and that's a major challenge.
If your original findings are promising, you begin to collect the evidence for a broader human clinical trial, but even once your research has been through those clinical trials, that doesn't mean it's on a sustainable delivery platform or commercially viable.
Praxis will help gain perspective on the areas that people should be thinking about as they develop their work – whether it is in designing their research, developing a product or establishing a therapy.
Right now, the Praxis committee is in the midst of developing a program and speaker lineup that will address each stage and how they can be approached in a sustainable fashion. That is a very important and unique focus.
What do you think attendees will get out of attending Praxis 2016?
There is a lot of very interesting and good science related to discovery in SCI. Overall, attendees will learn what this process is about and what they have to think about through the various stages of development. For scientists, whatever stage they may be in, they'll learn about the things they should be doing in order to get more translatable results that will move their discovery into a clinical situation. It will help them to understand more about the entire process and potentially aid them in improving the design of their research.
"In order to reach your destination, the final available product must be reimbursable, sustainable, economical, and ultimately, be able to make a positive impact on people living with SCI."
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In your experience, what has been the biggest barrier to moving a technological or therapeutic treatment from development to implementation or commercialization?
I'll give you an analogy. You're out for a hike without knowing the final destination. You start climbing and once you reach the first peak, you realize that the first peak was only the beginning. You wonder how many more peaks you'll encounter before you reach the top. If you saw how many peaks there were from the beginning, it may have discouraged you from starting on your hike in the first place. But when you can tackle one peak at a time, it changes your perspective. It allows you to focus on the immediate challenge ahead. But not matter where you are in your journey, as much as you need to think about that first peak, you also need to think about what comes after that and how you will make it to the top. Moving discoveries through the healthcare continuum is very similar to that. There are multiple peaks to summit, all with varying degrees of difficulty. The biggest barrier depends on your perspective and where you are in your journey. But, if you're able to get to that last peak – or successfully move your discovery into the last stage which is the healthcare system – you're faced with a whole set of challenges and you need to be prepared. Were you doing the things along the way that you needed to do in order to reach your final destination?
My point is, every step associated with moving a treatment from development to implementation has its unique set of challenges, but one must always be thinking about the big picture. In order to reach your destination, the final available product must be reimbursable, sustainable, economical, and ultimately, be able to make a positive impact on people living with SCI. Those challenges will be there no matter what stage of development you are in and it our intention to cover all of them at Praxis 2016.
Dr. Hunter Peckham is Founding Director of the Cleveland FES Center; Distinguished University Professor and Donnell Institute Professor of Biomedical Engineering, and Professor of Orthopaedics; Founder, Institute for Functional Restoration, School of Medicine, Case Western Reserve University; and Senior Research Career Scientist, and Co-Director of the MetroHealth Rehabilitation Institute at MetroHealth Medical Center in Cleveland, Ohio. He is also a member of the Rick Hansen Institute's Commercialization Advisory Committee and Praxis Advisory Committee. To learn more about Dr. Peckham's work, visit www.fescenter.org.