Celularity is a biotechnology company that specializes in leveraging biologically active cell populations within the postpartum human placenta. Founded on the pioneering work of Robert Hariri, MD, PhD, in human placenta-derived cellular therapeutics and biomaterials, Celularity is uniquely positioned to harness the potential of most biocreative event on earth: human birth.
I had the honor of interviewing Celularity’s CEO, Dr. Robert Hariri, a pioneer and visionary within the stem cell industry. As a surgeon, biomedical scientist and serial entrepreneur, Dr. Hariri was previously the Founder and CEO of one of the world’s largest human cellular therapeutics companies, Celgene Cellular Therapeutics, a division of Celgene Corporation. In August 2017, Hariri brought Celularity Inc. into the spotlight by announcing a successful Series A financing with contributions from influential investors, including Sorrento Therapeutics, United Therapeutics Corporation, and Human Longevity, Inc. (HLI).
On February 15th, 2018, the company broke even bigger news when it announced that it had raised $250 million in funding, with contributions from the Genting Group, Tony Robbins, and Dreyfus Family Office, among others.
Below is Part 2 of a two-part interview with Celularity’s CEO, Dr. Robert Hariri. Click here to read Part 1.
Cade Hildreth: What’s the core mission of Celularity?
Dr. Robert Hariri: First and foremost, Celularity is a singularity in Cellular Medicine and Functional Regeneration. I divide the two things, because Cellular Medicine is a very broad heading that includes not just stem cells and the traditional things for which stem cells are used, but also immune therapy, using cells that are already programmed to perform immunological functions. Obviously, immunology is such a hot area, and Celularity is very deeply involved with immunological therapy as well.
Functional Regeneration is any tool derived from the placenta that stimulates, facilitates or accelerates the global, functional repair and regeneration of processes that are intended to improve health.
If you think about it, biology is a highly renewable process. Our body is continually being renovated and renewed by a population of stem cells and their byproducts, which in essence, do demolition on the bad parts of our biology and replace it with new biology. When that functions correctly, we are healthy. When it’s done abnormally, we can develop disease. I think that cancer in many ways is demolition followed by abnormal repair. Fibrosis scarring is demolition, followed by abnormal repair. Both of those things lead to a state of disease which I believe we can address by turning back on the normal repair and regeneration process.
If you look at cancer, it is an adversary that invades the immune system, but it is also a highly competitive process where the tumor is out-competing the normal cells. That to me suggests that if we have a healthy repair and regeneration system – what I call the “regenerative engine” – when that’s working well we are protected.
Cade Hildreth: Very interesting. Celularity is focused on placental-derived tissues. What are the advantages to working with the placenta?
The reality is that it is a fascinating organ. It is so rich in cells and materials. I think of it as similar to “biological crude oil.” Have you ever seen crude oil coming out of a well?
Cade Hildreth: No, I haven’t.
Dr. Robert Hariri: Crude oil is horrible. It is this black, disgusting stuff. It smells bad, it really is horrible. Thankfully, the refinery industry decided to go and extract the valuable chemistry and turn it into useful things. We get beautiful plants to make this remarkable fuel oil. I think the placenta is the biological equivalent of crude oil.
Our company gets this ugly looking stuff, but we take it to a lab, extract the remarkable cells from it (not just the stem cells but also the immune cells) and we take those biological materials and turn them into really cool products. I don’t know whether you have seen the functional regeneration products we have, but they look like healthy human tissue. It’s structural and architecturally perfect tissue. We dehydrate it and sterilize it, so it can sit on the shelf for 5 to 10 years. This product looks like cellophane. You take it out and you hydrate it, and it looks like skin. These are the sorts of highly derivatized materials from the placenta that I think are so incredibly valuable.
Now, let’s talk about why the placenta is so important:
#1: It is abundantly available, and it is a material that can be procured under very rigorous controls. You know when a placenta is about to come. It does not sneak up on you. I am a surgeon, and with organ transplantations, they sneak up on you, because you can’t readily predict when a person is going to die. With placentas, you know they are coming. You have a pregnancy, you get to qualify the donors and the parental lineage, and you can be there with a system in place to collect that material at birth.
#2: The placenta is nature’s professional allograft. In the world of stem cell transplantation, matching matters – tissue type matters. The placenta has evolved, so that it is nature’s professional allograft material. What that means, is a mother carries her fetus and a placenta for 9 months. She doesn’t reject it and it doesn’t reject her.
However, the mother is only 50% matched to the DNA of that fetus. Think about a surrogate pregnancy in which a mother carries her fetus and a placenta for 9 months. She does not reject it, and it does not reject her. In fact, she will likely go on to carry some of the cells that trafficked from that placenta into her body for the rest of her lifetime.
Cade Hildreth: Wow. I have a niece and nephew (twins) that were born by surrogacy, so this is intriguing to consider.
Dr. Robert Hariri: It is fascinating, isn’t it? Evolution has created a polarizing system that is designed to allow mammalian evolution to occur. Think about it, right? Mammalian evolution was dependent on the immunological coexistence of multiple organisms in the same litter. If you look at the simple anatomy of a litter, you recognize that these circulations encroach upon one another. That means that during the course of pregnancy, cells are escaping from these litters and finding their way into each other. Every animal who produces offspring in litters actually survives as a chimera.
Chimerism is a fascinating concept that allows multiple genomic systems to co-exist without the threat of immunologic destruction. The placenta has evolved its capability of existing like that and we want to harvest it for clinical use.
To summarize, the placenta is nature’s professional allograft. It is readily available. It is a highly scalable resource, a very valuable material. I also like to say that every placenta that is available to us at birth has come through nature’s quality control process. For an organism to survive pregnancy and be born alive and healthy, it comes with a metaphorical white slip that says, “Inspected by Mother Nature.”
These are some of the reasons why I have been focused on and fascinated by productizing things from the placenta.
Cade Hildreth: I agree, this aspect of mammalian biology is truly fascinating. What intellectual property (IP) does Celularity control and what advantages does this give you as a company?
Dr. Robert Hariri: We have been fortunate, because early on we captured very powerful intellectual property around the cells and tissues from the placenta. Several years ago there was an article that analyzed about 10,000 patents on the stem cell landscape to look at their impact and what the authors believed was their value. They did a top 20 list of all patents in the stem cell space. We were very lucky, because our two core patents were right there at #2 and #8 on the list.
Our IP on the placenta is considered to be the seminal discovery work covering the broad composition of matter around stem cells. Again, one of the great luxuries of being part of Celgene was that Celgene’s IP team was superb. They helped us to create one of the richest IP portfolios on the planet. Today, we have some 1,500 US and international patents covering everything around the composition of matter for placental cells, their methods for derivation, the manufacturing, clinical applications, and more. It is very rich IP portfolio.
Cade Hildreth: In addition to this strong IP portfolio, what other assets are controlled by Celularity?
As a spin-up, we have a rich set of technical infrastructural assets, which were contributed by the combined parties. So, Celularity came out of the gate as a mature operating business with labs, manufacturing know-how, registrations, licenses, etc.
It is also a roll-up of other technologies, including intellectual assets around antibody-CAR constructs which we got from Sorrento, intellectual property and methodologies which we got from Human Longevity, and relationships to whole genome sequence stem cells from Human Longevity. These things combine to create what I believe is the richest set of intellectual and technical resources in cellular medicine.
Cade Hildreth: Wow. How has your involvement with other ventures, such as Celgene Cellular Therapeutics, Human Longevity, and LifebankUSA impacted Celularity? You spoke about this from an IP perspective, but what are the other benefits?
Dr. Robert Hariri: We are very fortunate. The relationships with Celgene, United Therapeutics, Human Longevity and Sorrento are very close strategic relationships. We work as strategic affiliates of those organizations. LifeBank USA is our business arm that provides the banking services around umbilical cord blood and placenta. As a strategic partner to these companies, we get access to internal resources.
For example, with Human Longevity we are working on bringing high performance development tools to the world of cell banking. With Sorrento, we are working to develop immunotherapeutic assets by taking their antibodies and CAR constructs and embedding them in our cells. Those relationships put us in a very unique position in the industry.
Cade Hildreth: How have you leveraged other valuable relationships from across the healthcare to strengthen your position within the marketplace?
Dr. Robert Hariri: This is perhaps more of my personality than anything, but Celularity wants to be the good guys in this industry. I think if you speak to people who know me, they will tell you that I am a collaborative, inclusive person. There is nothing that more important to me than a team effort. In fact, it is one of the reasons why Celularity was even born. I felt that this industry really deserved a team effort to produce technologies for patients.
We have very good relationships with academic institutions, with scientific and clinical leaders, and with the regulatory community, who we hold in very high respect because we know how hard their job is. Those things have resulted from 15-20 years of experience operating as other businesses. Additionally, the vast majority of our scientific and technical teams have worked with me for years in the past. I am fortunate to have a very large number of alumni.
Cade Hildreth: It certainly seems that one of your personal strengths is an ability to identify collaborations, forge relationships, and create synergies as a team. As an outside observer I would completely agree with that.
Dr. Robert Hariri: You know, I grew up in the space era. My biggest hero growing up was Buzz Aldrin. Buzz and I have been very close friends for a long time. I met him when I was 10 years old, and in fact, he is a big inspiration to me in my aviation career. I absolutely love him.
I remember watching the moon program: Mercury, Gemini, Apollo. That was the greatest achievement in human history at the time. Putting a man on the moon. Remember, we did it in 9 years, pretty much from the ground up!
That only happened because it enlisted everybody. Everybody felt a common mission. They said, “We are going to do this.” It didn’t matter what industry you were in. People in the shipping industry had to participate in making it happen. People in raw materials had to participate in that moon program. Like the Manhattan Project, the space program was the prototypical team effort. I am such a fan of that approach. I think we need that in this industry too.
Cellular medicine has the potential to transform everybody’s life. We have discovered that the cells that we harnessed from the placenta might in fact be our key to living longer and healthier, “The Fountain of Youth.” However, it is only going to happen if we as a team enlist the best of the best and we are all growing in the same direction.
What troubles me – and this is a symptom of the biotech industry to some extent – is that there are 700 little companies out there, working in the field of cellular medicine. They are all under-capitalized, under-manned, lacking something. They never talk to each other, or if they do, they talk suspiciously. When I am at a meeting, I am the guy trying to invite everybody out for a drink. The reality is, I want to plan a pathway. Let’s get everyone together, put our heads together, and figure out a solution!
You know that immunotherapy for cancer is a transformational revolution. We take a new cell, we engineer it, we give it back to you and it can hunt down and kill your cancer. Carl June is a good friend. Literally, that is his contribution to mankind. However, it does not end there. The ‘powers that be’ should be thinking, “These guys and their proof of concept transformed how we look at engineering the immune system for good purposes. What is the next step?”
In my mind, the next step is to figure out ways to democratize it. It troubles me when I look and see that the anticipated cost for a therapy is going to be $500,000. That scares the heck out of me. Part of what we are doing is looking at ways to leverage what we have technologically, to address this great breakthrough, so that it can be democratized.
Cade Hildreth: You mentioned “The Fountain of Youth.” There has been substantial life extension over the last 150 years, but it has almost gone unrecognized, because we take it for granted.
What do you predict will be the shift in an average health span over the next 150 years?
Dr. Robert Hariri: You make a really good point. Human life expectancy more than doubled in 125 years. Much of that had to do with fundamental breakthroughs in the areas of sanitation, infectious disease, and so on.
The issue is, the way you statistically increase population lifespan is to eradicate causes of premature death. So, eradicating infectious causes of premature death has been the focus. Now, it needs to be about eradicating causes of cardiovascular and cancer death. The way we do that is to identify great new approaches, like immunotherapy.
If we push life expectancy to 85, for example, we already know that there is a hidden thief that is going to rob us of this great breakthrough, and that is cognitive dysfunctional diseases like Alzheimer’s. While we are doing things to increase life expectancy for the population, one in ten of the population is over 65 and at high risk for Alzheimer’s disease. We will need to predict who is going to get it and intervene to prevent them from getting it, or we’ll need a very powerful tool to treat the disease when it rears its ugly head.
Stem cells are going to play an important role in this. We have done remarkable work in collaboration with Human Longevity. We know a lot about stem cells and how they contribute to the regenerative processes that are necessary to keep us healthy as we age. I am confident that Celularity will be leading the charge there.
Cade Hildreth: What are your five-year goals for Celularity?
We also want to be the company that consolidates and aligns businesses that are creating products for functional regeneration, so that we can give surgeons and doctors more tools to fix what is broken.
The key long-term objective is to wind up identifying and consolidating technical assets that are under-represented, under-funded, under-capitalized companies. Like I said, there are lots of brilliant people out there. I am a big believer in hanging around with smart people, and they will make you smarter. So, the objective is to find a lot of those smart people and to find a way to work with them.
Cade Hildreth: That is an exciting vision for the future. Of course, a key component of that will be how the regulatory agencies accept these new technologies. What is your view on the FDA regulation of human cell and tissue based products (HCT/Ps)?
Dr. Robert Hariri: The FDA has done a masterful job in keeping the peace through the field, while at the same time, observing the spirit of the mission to protect the public interest from products that are not proven or are unsafe. If you remember, when cellular medicine first came out, the FDA was very skeptical about the long-term safety. The concept of putting a cell into a human being, especially when we know some cells go bad, led the regulatory world to fear malignancy. The truth is that in 20 some years of clinical experience with stem cells, what we have really found is these are completely safe products.
Cellular medicine has a safety profile that is enviable.
The FDA has since gotten more comfortable and now they are much more receptive and willing to work with companies like ours to accelerate the development of these clinical programs. I am enormously optimistic about Dr. Gottlieb leading the FDA. I have known him for some time, and I have enormous respect for him. He is brilliant, thoughtful, and deeply knowledgeable of how the regulatory world interacts with industry, academia, etc. I think his experience has led him to create solutions that will serve the public by getting products out there for faster and cheaper.
I am very excited about the FDA during this administration. When I think about what is going to happen over the next 10, 15, 20 years, I am convinced that we have a window of opportunity. I don’t want to get into the political stuff, but I am a libertarian by mindset, and I believe that people need to be given the opportunity to chart their own course and path to their health. I think that the public needs to have at their disposal completely unbiased, unfiltered informational resources, so that they can make well-informed decisions. I am a big believer that the best clients for companies like ours are the most well-educated and well-informed.
I think that we have a perfect storm here of a great regulatory environment, a really powerful set of proofs of concept scientifically, and information and resources that are going to empower people. I am optimistic that the next 10 or 20 years is going to see a flood of new approvals, new products and tools to treat diseases.
Cade Hldreth: I agree and I hope so. I attend more than a dozen stem cell related events each year. Of the exponential medicine and healthcare events that you attend, which one do you enjoy the most?
Dr. Robert Hariri: I like ISSCR, and Exponential Medicine, I love that conference. It combines a lot of different areas together. For example, if we are thinking about bioinformatics, those people all attend and they can look at cellular medicine and say, “Hey, you need to be looking at cell therapy in a very different way.” I don’t know if you saw the article that Dr. Caplan and I wrote about using stem cells to change the fundamental biology of a system, but I created a model where if you look at what a stem cell is, you can create an analogy to a computer. Much of that came from my long collaborations with Dr. Craig Venter, the biological software guy. If you think about what a stem cell is, it can be compared to a boot disk that can be used to reboot a software system.
Much of what we are seeing now – stem cell activity through synthetic secretory behavior – that model actually works. It also is a strong justification for why, if you collect stem cells as early as possible in the life of the donor, it is less likely that the “biological software” has been corrupted by exposure to everything out that that damages our DNA throughout our lifetime. It also supports the stem cell banking industry.
Cade Hildreth: That is an interesting perspective, because MSCs derived from adipose tissue and other readily sourced tissues are being investigated in hundreds of clinical trials, but there are clear advantages to sourcing cells at earlier stages of the human life-cycle. At birth, there are numerous options for storing cord blood, but fewer options for preserving other perinatal tissues that are of immense biological value.
Dr. Robert Hariri: Agreed. One of the reasons why I always focus on the placenta is that I think it is a remarkable resource. I have often said, “Every human being is at their biological best potential at birth. It goes downhill after that.
Cade Hildreth: Haha, agreed. You are an incredible visionary and inspiration to me and to many others. I am curious, who is an inspiration to you?
Dr. Robert Hariri: I am inspired by so many people. We mentioned Peter Diamandis. Craig Ventor is also a very dear friend, and I am very inspired by the work that he has done. I would say that I am a comfortable, willing student and there are so many people out there that have contributed to my personal education. I would simply say I am open to ongoing inspiration from those who share my view that a team effort is necessary to take cellular medicine across the finish line. I want to have an open-door policy so that we talk to them and work with them on an on-going basis.
Cade Hildreth: Makes perfect sense. For our readers, how can they learn more about Celularity?
Dr. Robert Hariri: I would love people to visit the website (Celularity.com) and also use our social media resources to communicate with us (Twitter: @Celularity; LinkedIn: Celularity, Inc.) I am a big believer that people today can be informed about day-to-day breakthroughs at their fingertips. I am a follower of yours on LinkedIn and Twitter, and I am fan of those tools because it is bidirectional communication.
People can also feel very comfortable reaching out to us via email or calling us. I have got people who would be happy to speak to anyone and everyone.
Cade Hildreth: This has been an incredible honor and I have learned an enormous amount. I can’t wait to share your insights with our audience.
Dr. Robert Hariri: Listen, for me this is a real treat. I have been looking forward to getting to know you, and I am a big fan of your work. You and I share a passion for rugby, I understand?
Cade Hildreth: Yes, your passion for aviation is equivalent to my passion for rugby! I have done it for as long as I can remember, all over the world and on every continent except for Antarctica. I represented the U.S. Team for years, trained at the Olympic Training Center, and competed abroad in New Zealand. It is good to have hobbies.
Dr. Robert Hariri: I played football and baseball in school, then I played rugby in medical school and fell in love with it. It is one of those things where you can really get yourself beaten up and you come away thinking, “Wow, I want to do it again next week.”