Dr. Robert Hariri is a fascinating figure in the stem cell industry, because he was the earliest pioneer to recognize the regenerative potential of the human placenta. In August 2017, Hariri brought his latest company, Celularity, into the spotlight by announcing a successful Series A financing with contributions from influential investors, including United Therapeutics Corporation, Celgene, Sorrento Therapeutics, and Human Longevity, Inc. (HLI).
Today, Celularity’s investor contributions have reached an astounding $250 million, including contributions from the Genting Group, Dreyfus Family Office and Tony Robbins, among other notable investors.
Celularity, a spin-out company from global biopharmaceutical giant Celgene, announced this morning that it has raised $250 million to support development of revolutionary placental-derived products, including T-cells that will be immune advantaged because of their derivation from the placenta. This is a massive accomplishment, because it dwarfs the $225 million in Series A financing raised by BlueRock Therapeutics in December 2016 that was previously a landmark accomplishment within the stem cell industry.
With the Celgene snagging Juno Therapeutics for a shocking $9 billion in January 2018 and Gilead picking up Kite Pharma for an astounding $11.9 billion in August 2017, Celularity is also joining the ranks of powerful immunotherapy companies that could be a target for merger or acquisition.
If that wasn’t enough, Celularity is looking to burst a major bottleneck in the industry by deriving T-cells from a single (allogeneic) cell line, potentially positioning itself to slash the price point for CAR-T treatments. Currently, Gilead and subsidiary Kite Pharma have a CAR-T cell therapy on the market (Yescarta) with a price point of $373,000 per patient and Novartis has a genetically modified autologous CAR-T therapy (Kymriah) priced at $475,000 per treatment.
At its core, 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 am honored to have had the opportunity to interview 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 this interview, we discuss Celularity’s formation, its leadership in living medicines, and the critical importance of industry collaboration. We also explore the company’s mission and long-term strategic goals.
Outside the office, Dr. Hariri is a jet-rated commercial pilot, produces feature films and documentaries on global societal issues, and shares my love of rugby (he played during medical school), making this a uniquely exciting interview.
Below is Part 1 of a two-part interview. Read Part 2 here.
Interview with Dr. Robert Hariri, CEO of Celularity, Inc.
Cade Hildreth: What was your inspiration for creating Celularity?
Dr. Robert Hariri: Cellular medicine is a great field to be in. There is so much promise. What we are trying to do is tie together a lot of efforts to deliver real products and therapeutics for patients. As I am sure you have seen this, many transformational technologies and cellular medicines have been around quite a while, but the delivery of treatments has been limited. I think that is in part, because it is such a fragmented industry.
Part of the motivation for creating Cellularity was to create a focal point to pull together intellectual assets, human capital and financial resources so that breakthroughs could be approached with the intensity that is needed to drive them through the regulatory process, the clinical community, and get products to patients.
Cade Hildreth: I believe we are right on the cusp of it. There is so much scientific research and clinical evidence. No matter whether you look at patents, clinical trials, scientific publications, or grants, every metric indicates that cellular medicine is progressing, but we are not yet seeing many products progress through to market.
Dr. Robert Hariri: Exactly. The way I look at it is that one of the most difficult things when dealing with a revolutionary scientific and technical concept is having the skill set necessary to communicate them to the constituents you need to deal with. It can be a challenge for people in the scientific community. If you think about it, cellular medicine is an intuitively logical way to treat disease, yet the systems in place to evaluate these approaches are very much grounded in traditional small molecules and biologics. Even biologics took a lot for the regulatory world to get comfortable with their use.
I am real believer that for us to make the impact we need, to bring cellular medicine into the prime-time, we need to abandon our old approaches and talk about these products and the science in a very different way.
I am personally very convinced that we have not done a good job as an industry in redefining what cellular medicine means, how it differs from traditional approaches, and how it must be looked at through a different lens. The FDA has a tough job, because operating systems have been put in place, but the introduction of new technologies requires them to suddenly switch gears, assess new technologies, and change instilled expectations.
For example, if you look at most cell therapy clinical trials, they are kind of one-and-done approaches, where you treat minimally upfront and you look for responses way out. That is not the way biology works, so I am convinced that there needs to be some clinical opinion leaders in this field that have a voice with these regulators, so that we can change that mindset and assist the way the regulatory world evaluates these products.
I was very happy that Dr. Gottlieb was confirmed as the head of the FDA, because I have always known him to be an incredibly thoughtful voice for reforming some of the old mindsets that have existed in the regulatory world. I am optimistic about what is going to happen in the future.
Cade Hildreth: I’m excited to discuss your path to becoming one of the world’s leading visionaries for cellular medicine. You have an extremely interesting background. You are a surgeon, a scientist, an aviator, an entrepreneur. You are also involved with numerous scientific advisory boards and foundations and are credited with the discovery of pluripotent stem cells from the placenta.
How would you describe your background and your most important experiences to date?
Dr. Robert Hariri: At heart and on the inside, I am an engineer. I am a tinkerer. I love the challenge of a problem that completely confounds people and looking for solutions that in some cases may take a very, very unusual path.
One thing that aviation has taught me that most people don’t realize is that when you take off from Point A to go to Point B, there are a billion ways to get between these points during the flight plan. However, it is that constant redefining of the path that is so critical to the safe conclusion to a flight. Aviation is one of those areas where the way you are trained is to deal with the unexpected in a very orderly, procedural manner, to basically be willing to change the system in order to get the output that you want.
The same thing should apply in medicine.
I’ll give you an example. Aviation is incredibly safe. It is an industry that over 100 years has a safety record that is remarkable. In part, that is because every time there was a problem in aviation, there was a very intensive analysis to understand the root cause and the contributing causes. What has happened is, when there were failures related to mechanical issues, the industry said, “We are going to not let that happen, because we are going to insist that these things which can fail are going to be pre-emptively addressed.”
I have two interesting lights on my flight dashboard. One is yellow, one is red. They are big flashing lights. What a Master Caution lights does is constantly interrogate the system and warn you about something that may go wrong. That is the yellow light. In contrast, the red flashing light is the Master Warning, and it tells you something has gone wrong.
The beauty of this technology is that if you make the analogy that reading our genome allows you to identify the things which may go wrong, if you address them before they do go wrong, you generally never have a problem. Preventative approaches which we could instill in healthcare could in fact dramatically reduce the severity, intensity and the burden of diseases.
To give you one simple example, we know that cellular medicine is a unique way to replace, restore and renew things which may go wrong. What if you knew that someone has a genome prone to develop multiple myeloma and what if you transplanted them before they ever sick? Would they even get the disease? That approach would be parallel to our approach in aviation.
Cade Hildreth: That’s a powerful analogy and perspective.
Dr. Robert Hariri: Yes, and I do think that we are on the cusp of this. Like you said, we sit here at the threshold knowing that these tools are available. The ability to assess the genome, to look at the complexities of the efficacies of the genome and the microbiome. These technologies are becoming available. We need great alliances integrating the information with high-performance communities, so these groups can help us figure it out.
Again, that master caution and master warning lights on my screen, those things are the product of extensive computational procedures that are interrogating multiple inputs and then giving me a “caution” or “warning based upon those inputs. The same thing applies to biological products.
I am waiting for the day when there is an app that basically has your genome at the core analytic foundation and then analyzes other inputs, such as wearable sensors or biological or environmental inputs, to analyze those against the genome and give you the “master caution light.” A technology like this could say, “Hey, don’t eat that – your metabolome says that if you eat that you are going to create a state of inflammation which is going to damage your blood vessels.” These are the sorts of things I am waiting on.
Cade Hildreth: Agreed, I definitely believe there will be a point in the future where it will seem crazy that we couldn’t predict a heart attack or seizure. At some point we will look back and say, “Wow, we used to be constantly surprised by biological events.”
Dr. Robert Hariri: You’re right. I am a big dog lover. One of the coolest things is that dogs are incredibly intuitive. They are incredibly good at detecting biological events before they happen. There are seizure warning dogs and now dogs that can sniff out cancer. So, the reality is, these tools for preempting and preventing exist. There’s a great term out there that recently has been used to give a label to this approach. It is called “previver.” Have you heard of this term?
Cade Hildreth: I have, from reading your content!
Dr. Robert Hariri: For example, women who take steps if they feel they are at high-risk of getting breast cancer are previvors. The do not need to be a survivor, because they preemptively handle their medical profile. I believe we are going to see people saying, “You know what? My genome tells me there’s a risk of ‘this’, my environmental influences say I have an increased probability of ‘that’. I am going to take steps to prevent this from happening.” I am looking for that day.
I guess I am an optimist, but if we could do anything at Celularity to make those tools available, to give people those choices – that’s what we are all about.
Cade Hildreth: That would be a fundamental shift. I am also in awe of dogs’ intuitive ability. Since I live in a cabin, I have four dogs and seven slightly less intuitive chickens. I am curious, when did your fascination with cell medicine and exponential health begin?
Dr. Robert Hariri: As a kid I loved biology. I thought medicine was very cool. My Mother was a secretary, raising two kids on her own. She was a big believer in education and she showered me with all kinds of cool books. There was a set of books called the Life Science Library (done by Life Magazine). I don’t know if you remember but when were kids, Life Magazine was an amazing resource with really great journalism. These books looked at different technical areas. One of them was on medicine and one was about the cells. It fascinated me.
Although I thought I would spend my life as a pilot, I decided that medicine and surgery satisfied much of my curiosity and my desire to do something meaningful. So, in college I took all life sciences and the one that I really gravitated toward was Biology.
Cade Hildreth: Very interesting. How and when did you become involved in stem cells?
Dr. Robert Hariri: I often credit my oldest daughter for helping me figure this out. You know, I was a young surgeon at Cornell University and I was on call in the ICU. My wife was having the first ultrasound and I went down to the ultrasound suite. I had seen them before, but for the first time, I was standing there looking at this 8, 9, or 12 week old embryo, and it dawned on me that although the embryo was the size of a peanut, the placenta was a giant organ.
In medical school, we were kind of taught that the placenta was the vascular interface between the maternal and the fetal system. If that was true, the placenta would develop at the same rate as the embryo, right? It would not be way bigger. The engineer in me said, “It must govern at least some aspect of the developing embryo, and if that’s the case, why? For it to be this size, it must be supplying something.”
I did my homework and lots of the literature talked about the placenta being an endocrine organ, but that didn’t make complete sense either. When stem cells hit the landscape, I put two-and-two together and said, “You know what, maybe what the placenta is a supply system for these cells?” When I actually went up and got a placenta from the L&D suite and took it down to my lab to take it apart, I was fascinated, because the organ was designed more as a bioreactor than as anything else.
It has a very clear interface between the maternal and the fetal system. The residual placental interface separates the maternal blood stream from the fetal blood stream, but there are areas for small molecules. So, maybe, what this organ really does is cultivate and expands cells for the developing fetus. Armed with that, I decided I was going to explore this further.
Aside from considering how valuable human tissue is, I was also affected by the fact that 4 million times a year we throw away this valuable biological material in a red biohazard waste bag, instead of trying to find out a way to utilize it.
As a surgeon, the first thing that struck me was that the membranes of the placenta – the amniotic sac, if you actually look at it – it looks like a piece of skin. It looks like many of the biological membranes that we surgically try and repair during the course of an operation.
I found it offensive that this really cool, amazing organ with all its cells and all of its tissues, was being thrown away. If somebody told me that the guy next door was throwing away silver or gold into a landfill, wouldn’t I just make it my ambition to go and pick that stuff up?
When I realized the placenta is perhaps the most valuable, never before considered biological resource, I committed that I would find a way to collect and process it into products. Maybe I was destined to be a waste management expert?
Cade Hildreth: Was there anyone else thinking like this at the point in time that you were having these realizations?
Dr. Robert Hariri: I don’t think so. A couple of smart people were working on the amnio front. A scientist named Scheffer Tseng, M.D., Ph.D. was taking it and cryo-preserving it for use in the eye. I really respected the work that he did. I thought, these materials have to be “productized” in a way that they have high biological value, long shelf life and a low cost.
I am another one of these guys like my buddy Peter Diamondis, who says that transformations technology has to be democratized. You should watch his abundance TED talk.
Dr. Robert Hariri: Peter is like my kid brother. We have been best friends for over 15 years. He’s been a great inspiration for me. When he speaks about how great technologies dematerialize and then ultimately democratize, he clarifies the opportunity we have available to democratize biological materials and cells. The goal is to be able to access, produce, and distribute biological products in a very scalable way at a very reasonable cost. Again, that is why I focus on the placenta.
Cade Hildreth: With an abundance of opportunities available to you, what inspired you to found Cellularity?
Dr. Robert Hariri: I was incredibly fortunate. LifeBankUSA was the first company that I created to collect the placentas and the umbilical cord blood and be able to analyze them. Once we discovered placental stem cells, we created Anthrogenesis, because we wanted to turn the company’s attention on exploring the cells of the placental. Early in the life of that business, I came into contact with a remarkable developing biopharmaceutical company called Celgene.
You probably know of stories where entrepreneurs go out and try to start a business and they spend most of their time trying to raise business. I had the good fortune of knowing the current Executive Chairman of the business, Bob Hugin, and the President and CEO of the company. I got to know them, and aside from the fact that they were incredibly talented scientifically and in terms of building a business, they were very comfortable with risk. They are comfortable with technology that requires true investment.
I was incredibly fortunate to be able to work with them scientifically, and later they acquired our company and turned us into their Cell Therapy division. For close to 15 years, they invested in this long-term vision of turning living cells into medicine. That was a fundamental event in our activity, but it also was incredibly educational. I saw the way that a highly successful biotech company operated and was led, and it helped me understand how their focus on delivering products really, really serves patients. It was a core value that we now carry at Cellularity.
Cade Hildreth: What an interesting path. How is Cellularity funded?
Dr. Robert Hariri: We put about $70 million into it, with the capital coming from investors and strategic partners that include United Therapeutics, Celgene, Sorrento, and Human Longevity Inc. (HLI). We also had fantastic lead investors that included the William Louis Dreyfus Family Office. That family office is very focused on technologies and transformational medical approaches to disease. They have been incredible friends and allies.
We were very fortunate, because Tony Robbins is also a very big supporter and investor, and we had a number of other smaller groups come in. We are probably going to continue to raise capital from this very close network of people.
Cade Hildreth: That is a good show of support!
Dr. Robert Hariri: Yes, we are very fortunate.