I am honored to release this interview with Doug Oliver, Founder of the Regenerative Outcomes Foundation. Doug has an incredible story of being a stem cell patient, turned renowned advocate and consultant within the field of regenerative medicine. In this interview, we explore what inspired him to establish the Regenerative Outcomes Foundation, his awards and accolades within the field, the critical importance of advocacy work, and so much more. Enjoy!
Interview with Doug Oliver, Regenerative Outcomes Foundation
Cade Hildreth: Doug, you have an incredible patient story that has been featured by dozens of major news outlets worldwide over the years. For our readers who are not familiar with you, what is your background and how did you become involved with regenerative medicine?
Doug Oliver: I was introduced to regenerative medicine when I started researching potential therapies for my macular degeneration. My retinal specialist here in Nashville suggested I search clinicaltrials.gov from time to time to keep abreast of what was being done in the field. There wasn’t much expectation of a hopeful intervention, but it kept me busy and ended up being vital to what happened to me and what my life has been like since my treatment.
As you know, I was treated in 2015 with a bone marrow derived stem cell injection, which was hugely successful and restored my sight. It caught the attention of lawmakers and national policy makers, who asked me to come to DC to help craft and refine the 21st Century Cures Act. The journey since then has been very exciting, and life changing for me, to be sure.
Cade Hildreth: When was the Regenerative Outcomes Foundation established and what motivated you to create it?
Doug Oliver: I created the Foundation in early 2017, after learning about what other regenerative medicine patients and were telling each other about their own experiences, with their treatment, their physicians, their primary care docs, their expectations, disappointments and celebrations. They also shared changes in their relationships and families that came after they received their treatment.
Not all, but many of them had not been told much about the procedure they were undergoing, its chances for success in their case, or the potential need for a second treatment in order to maintain any gains. Some, like me, who experienced success, faced adjustments, almost like winning a lottery. Disruptive, and not only in a good way. Then others, whose expectations had expanded because of lack of information, were let down. This happened to friends of mine, who are now ex-friends of mine.
I found that at the point we were at in the industry, providers were new to what patients needed, as new as the patients were. We were all learning, but someone had to provide a means of education and advocacy, inspiring others and bringing some structure to the patient experience, if possible. That would be the only way access to these therapies would remain safe, and patients would behave in a manner that supported outcomes.
So, that’s why I created the Regenerative Outcomes Foundation, to explore ways to help patients receiving the benefit of this brave new technology to thrive and have positive personal outcomes.
Cade Hildreth: You were recently awarded the 2019 Stem Cell and Regenerative Medicine “Action Award” for Inspiration at the World Stem Cell Summit in Miami, FL. This event is one of the largest and more significant events within the field of regenerative medicine, and the award is prestigious in its own right. Vice President Joe and Dr. Jill Biden, Michael J. Fox, and others like them have been recipients. I was in attendance and you received a standing ovation both approaching and leaving stage.
What was this experience like and what did it mean to you to receive this honor?
Doug Oliver: It was humbling to receive this award from people I feel I should honor. So the feeling, whether those in attendance were aware of it or not, was more than mutual.
Part of my commitment to patient access to regenerative therapies is to remind those in industrial medicine that they are, or will be, patients seeking regenerative medicine for themselves, their mothers, daughters, friends, or loved ones.
I think people were standing and clapping for me, yes, but also for themselves. It was a realization that EVERYONE in the room wants this regenerative medicine thing to work. They all want stories, narratives like mine. Dr. Francis Collins, early on in our friendship, shared with me a truth that has kept me going full tilt after nearly 10 years of retirement due to blindness. It’s the common humanity and shared basis for goals that helps us put aside differences. The satisfaction of having helped us all realize that together is very fulfilling. Being recognized for it is extra special.
Cade Hildreth: You also received a Champion Award from the Interventional Orthopedics Foundation (IOF), another highly regarded organization. What was the significance of this award and why were you chosen as a recipient?
Doug Oliver: The award is in recognition of my work to advance and support awareness in the field of interventional orthobiologics. I had featured a well-known company at the World Stem Cell Summit as one of our RMAT case studies, so when the outgoing president of IOF called to invited me to receive the award in Denver, I was happy to accept the honor, and happy to help symbolize with them their new direction under new leadership.
I wish them and their new president the best success as they find their way to new goals for helping patients.
Cade Hildreth: In addition to creating the Regenerative Outcomes Foundation, you’ve also now entered the field privately, forming a Regenerative Outcomes consulting group specializing in helping biotechs with getting their innovations navigated through FDA, particularly with the RMAT designation in mind.
You’re going strong, Doug, and you’ve made a huge difference within the lives of regenerative medicine patients worldwide. Do you feel that way as well about your impact in the industry and its future? If so, in what ways?
Doug Oliver: Yeah, we initially began helping providers and biotechs directly under the auspices of the Foundation, but very soon on began to realize the need was so great, that there were so many treatments about to be introduced for patients to be able to access, that I formed the private company so we could get the top scientists and regulatory folks, pay them well, and begin preparing companies and provider groups for compliance with FDA and their cell therapy and device guidances.
If there are no therapies, there are no treatments. No treatments, no hope. It’s all about getting as many therapies as possible to as many patients as possible as quickly as possible and as safely as possible. Now I hope the work has impact on a much larger scale. We’re very busy already!
Cade Hildreth: How do you see the role of the FDA and policy makers within the evolution of the regenerative medicine industry?
Doug Oliver: I always love speculation! I am often wrong, but I love it anyway. In this case, however, I suspect I’ll be close in my predictions for regenerative medicine and the FDA in the near future.
I think FDA, and CBER in particular, have done an amazing job steering a behemoth organization toward a flexible, more nimble model for trialing regenerative and other biologic medicine and device solutions. However, they are still a huge bureaucracy with many forces acting upon them. Staffing, workload, politics, market pressures, and corporate demands. Their job is very difficult, and it is clear to me (and them) that they risk failure maintaining an accelerated pathway for regenerative medicine. They’ll need help.
If they don’t get adequate help, I suspect the market and patient demand will create a vacuum in policy, and it will shift more aggressively to the states. Patients need to be active in recognizing this and start educating state legislators on the needs of patients.
Think of it in terms of economic power (not statutory). Who has control of university policy? Hospitals? Medical Boards? Insurance regulations? Business tax incentives? Who wants to coax biotech industry to develop and thrive in their area? The FDA has the law, which can and will be changed, like recent precedent with the cannabis movement has shown.
I believe it’s vital that we recognize this power dynamic openly, and plan for the future, especially when it comes to scientific rigor or safety for patients.
Cade Hildreth: You’ve enjoyed several pivotal accomplishments, including established the Regenerative Outcomes Foundation, advancing a registry, launching a “Pioneers of Hope” interview series, and contributing to stem cell and ethics policy. What have these accomplishments meant to you and why did you choose to undertake them?
Doug Oliver: Thank you. Most of the opportunities were laid before me. This journey has largely consisted of these events, followed by me simply saying “yes”.
Only over time have I finally realized that they are, in fact, real accomplishments that could be seen as pivotal. But I don’t spend a great deal of time reflecting on them. In fact, I’m stepping back from a few of them and finally letting others help me. It’s a hard lesson to learn sometimes, that we can’t, and shouldn’t try to do everything ourselves. The Foundation, and day-to-day operations of the consulting firm are soon to become examples of that.
Cade Hildreth: With the creation of the Regenerative Medicine Advanced Therapy (RMAT) designation, sponsors of cell and gene therapies can now obtain an RMAT designation if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs. Unfortunately, obtaining an RMAT can be a very complex and confusing process. What RMAT consultancy services do you offer to companies pursuing this designation and how can you help them?
Doug Oliver: Yes, the RMAT is complex, but the secret in approaching it is to remember that it’s as much about strategy and indication as it is about where you put the needle. Not everybody is going to win the race to a holy grail of a major disease. Conversely, remember, that if we all go after the big ticket items, many, many, many patients will be left out, or made to wait while less than half of the those contenders make grade in time to get the designation.
Our Regenerative Outcomes, LLC offers an array of services we call “RMAT Spectrum Services”. It provides everything from initial education, to indication research, expert regulatory guidance on all aspects of preparing an Investigational New Drug application, and ultimately, clinical trial design and RMAT designation.
Of course, while I know a great deal about the process and strategy involved, the firm procures the services from a distributed network, worldwide actually, of top scientists, researchers, translational manufacturing experts, and others, that provide that custom service. RMAT Spectrum Services is successful because it caters to newcomers who are not yet familiar with regulatory engagement. It uses a truly unique clinical services coordination model that brings the referrals, information, and resources to bear, to get a company to an RMAT designation. We have three companies finishing up their CMC (manufacturing) sections, and about to assemble their trial, ready for application to the FDA. It’s exciting!
Cade Hildreth: You’ve recently stepped away from the day to day with the Foundation. Who is running it now and will you still be continuing advocacy work?
Doug Oliver: Yes, that’s correct. Our Treasurer, Theresa Taylor, a patient and experienced business owner who has accompanied me in Washington, and even at the World Stem Cell Summit, is filling in as Acting Director until the Board selects my replacement. I’ll remain on in Board leadership, maybe more, as we transition. We’ll review our mission, and hire a CEO who can make the vision their own.
In terms of advocacy, absolutely! That’s the heartbeat of why we’re here. The National Registry Effort, Patient Rights, The Pioneers of Hope Interview Series, will remain, and maybe the state-to-state initiatives. We’ll see. We began the transition last October, and expect we’ll have completed it by the end of summer.
Cade Hildreth: On a very personal note, Doug, you shared with me that your vision is beginning to decline slightly. Can you describe what this is like? Are you going to seek another treatment and has anything changed in the way you’re approaching this decision?
Doug Oliver: Yes, that’s true. It feels like the decline has accelerated since we spoke, in fact.
This is very hard to talk about, as you might imagine. I have mixed emotions. Hope is definitely the strongest. I’ve seen again after being told I never would. I’ve experienced my grandchildren’s eyes looking directly at me, and their faces no longer looking like melted candle wax. I’ve been driving around like a fiend (and gained 15 lbs. in the process!). Ann has told me since my miracle, that it’s like I’ve “come alive”.
So, yeah, the number one thing I feel is hope. There is no doubt I will need intervention soon, but the good news is that I’ve already received benefit from one approach, which is repeatable. We’re not sure, of course, that my second rodeo will be as exciting.
Another feeling that I have though is what I call anticipatory grief, which is beginning to feel the possibility of a loss that you know may be on its way. I experienced it going blind the first time. I don’t want to experience it again. For your readers who are familiar with “Flowers for Algernon” by Daniel Keyes, it is a short story about a scientist who reverses dementia in his dad, sparking a miraculous cognitive restoration, but later succumbing to decline when the treatment wears off. I don’t want to be an Algernon.
I’m not driving as much now, finding it more difficult to read…things are clouding up a bit, but it’s having an impact.
So, my plans are to raise money, and go get another treatment. Only this time, I’m in talks with a scientist at an undisclosed major university, who will likely map my live retinas photoreceptor by photoreceptor, so that we may catch some data suggesting a mechanism of action as to what is making this therapy work. It’s all about the science!
Cade Hildreth: Tell us: what is the next chapter in Doug Oliver’s life?
Doug Oliver: I want to help as many companies get their therapies in front of the FDA as I can. I want to pass a regenerative medicine patient rights provision in Federal Law. Most of all, I want to have more time to spend with my family, and to deepen some of the wonderful relationships I’ve formed with people, like you, who I hope will become friends.
Cade Hildreth: Finally and most importantly, how can our readers get in touch with you to learn more about the services and support offered by your organization?
Doug Oliver: Well, as the Foundation spends the next months reevaluating the scope of its mission and refining its organization, Theresa would be a great person to speak with. She or I could also refer anybody to a board member. I could be reached through LinkedIn at: https://www.linkedin.com/in/regeneratvieoutcomesfoundation.
Regenerative Outcomes, LLC, the consulting firm is booming. We welcome inquiries from those interested in engaging FDA, and always looking for companies and physician groups we can help create pathways to their success.