Regenerative Outcomes, LLC, Achieves Rapid Growth, as Demand for RMAT Consultancy Expands – Intervie
I am honored to release this interview with Megan Moneypenny, CEO of Regenerative Outcomes, LLC, a rapidly growing consulting firm within the emerging field of Regenerative Medicine, with a specialty in RMAT consulting. Regenerative Outcomes is an organization that was spun out from the Regenerative Outcomes Foundation, a non-profit group founded by Doug Oliver. Doug has an incredible story of being a stem cell patient, turned renowned advocate and consultant within the field of regenerative medicine.
Since January 1, 2019, the group’s consulting services have been offered through Regenerative Outcomes, LLC, of which Megan Moneypenny is at the helm as CEO. In this interview, we explore what inspired Ms. Moneypenny to become involved with Regenerative Medicine, the swift growth of their consulting services, and the group’s strategic approach to guiding clients toward FDA IND application approvals and attaining RMAT designations. Enjoy!
Interview with Megan Moneypenny, CEO of Regenerative Outcomes, LLC
Cade Hildreth: What is your personal/professional background?
Megan Moneypenny: I suppose, like so many people I’ve encountered in the world of Regenerative Medicine, that my passion was sparked by losing someone very close to me.
When I was 24 years old, my mother was diagnosed with Liver and Lung cancer. Not being a smoker or a drinker, this came as a shock to my entire family. One month later, she was given 3 weeks left to live. Thankfully, I was able to be with her and take care of her during her final weeks. But to hear the strongest woman I have ever known pray every night for healing, so she could live long enough to see her children walk down the aisle, I not only felt that she died too soon, but I also saw her express real hope for the future. Her commitment to hope inspired me, and still does every day.
I have adopted it as my own and now look forward to seeing a cure for the terrible disease that took her, and so many others. So, the future of Regenerative Medicine is the perfect symbol to me of all that would have helped my mother.
The notion that I could personally be in a position to help create opportunities for healing for patients by making regenerative medicine my career came from the outside, when I was introduced to Doug Oliver at a conference a couple of years ago. We shared our stories, and something he said hit home, sort of brought it all together for me, to where I am now. “Did you know that it’s possible a cure for the kind of cancer your mother had could actually be on the horizon? Maybe even soon… maybe even 5 years…”
That conversation continued for over two hours. Doug asked me about my background in Political Science and Education, and before the afternoon was up, we had committed to another conversation to discuss possibly working on a counseling and education program for The Regenerative Outcomes Foundation.
A few months later, I joined as Clinical Curriculum Advisor and it wasn’t long before it became clear there was a place for me to help build the organization. Before we knew it, I was moving from Boston to Nashville to join the Foundation full time as Operations Coordinator, which soon turned to Director of Operations.
Around that time, the Foundation began offering regulatory consulting services and the pace at which things ramped up from there was phenomenal!
Cade Hildreth: So, you started out working for The Regenerative Outcomes Foundation, a non-profit entity. How did you become involved in Regenerative Outcomes, LLC, a for-profit consulting firm?
Megan Moneypenny: Soon after our regulatory consulting services began at the Foundation word about it spread like wildfire. We were getting calls weekly from Regenerative Medicine providers and biotechs seeking our help, and because the Foundation only had resources to serve up to five clients at the time, we had to start turning them away. Both Doug and I saw this as an obstacle to our main mission, which is helping patients to gain access to healing innovations.
One morning I came into the office and Doug said to me, “How would you like to go into business together?” I gave the same answer I had given to every opportunity he had provided me up to that point – “yes!” The transition started shortly after, and as of January 1, 2019, our consulting services officially moved from the non-profit to the for-profit consulting firm.
Cade Hildreth: Doug Oliver, the Founder of both the Foundation and the consulting firm, has this amazing story of recovering his sight with a stem cell treatment. What is the importance of you stepping into a top role as CEO? Will you be a hands-on leader?
Megan Moneypenny: We both realized early on that it was vital to share leadership at the top of this organization, especially when we’re getting started and expecting to grow quickly. While Doug leads at the 30,000-foot view, developing the vision, mission and values for our business, I lead closer to ground level, managing the day-to-day operations.
So, yes, I am and will remain a sleeves up, hands-on leader! I want to be able to propel Doug’s vision as the business grows and be prepared to act quickly when changes arise.
Cade Hildreth: With Regenerative Outcomes now providing specialized consulting services to small biotechs and cellular therapy providers, can you tell us more about the consulting and what types of companies and organizations you serve?
Megan Moneypenny: Only about 20% of the folks that come to us know about the current FDA regulations in regenerative medicine, and of those, even fewer are aware of the RMAT pathway. Consequently, we often start at the very beginning – educating clients and providing them with a tactical roadmap that outlines the most efficient and least costly path for them to getting their innovations to market. Once we have a roadmap established, we begin with strategic indication research, which leverages that curious mix of health and social policy, choosing one that we believe will be RMAT eligible.
From there, with the help of our world class team of scientists and researchers, we take them through benchmarks, with the primary objective of getting their FDA IND application approved and allowing them to attain a RMAT designation as soon as possible.
We mainly serve small to medium sized biotech companies, as well as large physician groups within the Regenerative Medicine (RM) and Gene Therapy (GT) space. We also have global consultants and are developing partnerships with CROs around the world so when we have clients where an international focus makes sense, we have the ability to take them to several different countries to conduct earlier trials, usually with FDA approval as the final goal.
I’m happy to say that after just two months of starting the consulting firm, we have 10 clients and two are in the process of preparing for their IND and RMAT submission.
Cade Hildreth: With your boutique specialty in regulatory affairs and compliance consulting, especially related to the RMAT designation, your firm has an unusual ability to provide niche services within this brand-new and accelerated pathway the FDA has created.
Could you explain how Doug Oliver’s involvement came to be, and why it remains important to patients?
Megan Moneypenny: After a 25-year career in regulatory heath compliance and social policy and after just recovering his eyesight, Doug assisted Senator Lamar Alexander and Bill Frist in writing the 21st Century Cures Act and the new RMAT designation in order to advance safe and effective regenerative medicine and gene therapies to patients in need.
Having been so intimately involved with FDA and key policy makers, and factoring in his patient advocacy, Doug and our boutique consulting firm enjoy the support of top leaders in all areas of this rapidly evolving field. It’s not just our experience and knowledge that makes us successful, but our relationships that allow us to speed these therapies to market.
We, like our clients, are a very flexible and nimble company, with a specialty in these niche services, but personally, I believe that the reason our relationships are strong is because we do all of this from a patient perspective and for the right reasons.
Cade Hildreth: Are there any additional services being planned for the coming year?
Megan Moneypenny: Actually, we have quite a few things in the works!
I’m very excited that we are in the process of designing a “Compliance Check-Up” program for small physician groups. We envision a medical practice bringing in Regenerative Outcomes to conduct a two-day site visit with a thorough evaluation of all aspects of their practice including the therapies being administered, informed consent, patient messaging and advertising and all the things that the FDA is focused on.
After the compliance evaluation, we will then share what needs to be modified in order to be in compliance with FDA regulations. That particular provider or group would then have us back for a follow-up visit to ensure that all recommendations have been addressed.
The end goal would be to award a kind of “Regenerative Outcomes Stamp of Approval.” This certification is a service we very much look forward to executing so that patients will have the knowledge of which providers are interested in paying extra attention to the needs and rights of patients, as well as working towards FDA compliance. It will give them the confidence that they will receive a treatment that mirrors industry best practices.
Second, we hope to develop several patient-driven programs, inspired by the work Doug began at the Foundation. Among those would be the development of a patient coordinator curriculum as well as a variety of training courses for both patient coordinators and physicians.
Cade Hildreth: In your opinion, what trends are we seeing within the Regenerative Medicine sector and how is Regenerative Outcomes rising to meet them?
Megan Moneypenny: I have noticed a growing trend, which basically equates to a race to the finish line for biotechs and large physician groups seeking to get their innovations to market first, and some of these folks attempt to take others down along the way.
Doug put it eloquently in his latest article, stating: “Isn’t it time to learn how to play nice in the sandbox of opportunity that awaits our participation? After all, it’s a huge sandbox and deep, with plenty of room for all serious players to learn, experiment, grow, and ultimately prosper.” I believe we all want cures for diseases patients are currently suffering from and what we ourselves may suffer from in the future. If we stop fighting and realize we all have something to offer, this will be possible.
Regenerative Outcomes is poised to help facilitate such a shift. An advantage we have over large companies with top heavy processes is that we are a small company that is fast and adaptable, and we have the ability to create a sense of community among small and medium sized companies, which in turn models for and empowers them to do likewise with each other to achieve optimum benefits. Who wins is not what motivates us. Making sure as many people as possible make it to the end of the race is what matters.
Cade Hildreth: It must be fulfilling to look forward and see the potential impact that you as a young female executive can have in the narrative of this movement. Tell us, on a personal note as we close, what does it mean for you – for Megan to consider this?
Megan Moneypenny: It means everything to me. I love what I do and do not consider it work. I feel so blessed to be a part of something so important that can make such a positive impact on the lives of so many patients for years to come. Sometimes it feels surreal and there are so many occasions that arise that make me realize just how much of an impact I can actually, personally make.
I was recently invited to be part of a panel for Woman in Advanced Therapies at the World Stem Cell Summit, and to be sitting with other woman, so incredibly accomplished each in their own way, and addressing such a talented audience working in this field was yet another very rewarding experience. And, it is only the beginning. I can hardly wait!