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Could you give our readers a bit of background about yourself, your career path, and what led you to become CEO of Emulate?
My career has always been about commercializing life science diagnostics and medical technology. I started my career with Abbott Diagnostics, where I got a great foundation in the industry.
I got the urge to do my first startup, which was in the medical imaging space. I was with that company for about seven years, where we did breast cancer detection work.
Then, I moved on to my second startup, which was in the stem cell space, for a company called ViaCell. That company was then acquired by PerkinElmer.
I did not think I would stay long, but I ended up staying for about 11 years and ran every division across PerkinElmer, which is a very diverse global life science company.
Then, I was offered the role of CEO at Emulate. If I look back at my career: about 60 percent of it was with two large companies, which provided me with a great foundation, and I have also led three startups, with Emulate being my third.
Could you give us an overview of what you are working on at Emulate, and how it is benefiting patients?
Of course. We develop Organ-on-a-Chip technology, which is ideally utilized to reduce animal testing in medical research.
We create a chip that recreates the microenvironment of a particular organ of interest, by placing live human cells onto those chips.
Then, the researcher can test their compound and look for safety or efficacy signals utilizing that format.
Can we deep delve into the science behind Organ-on-a-Chip technology? How exactly does that work, and what organs are you able to emulate?
The chip itself is about the size of a computer thumb drive. It has two microfluidic channels, and, with those channels, we can create a dynamic culture environment.
Because they are independent channels, we can flow media through them, just like all your organs have blood flowing to them. We can recreate that in the chip, which is very important to recreate the in vivo environment.
We take the cells, which could be a primary cell, an organoid, or an induced pluripotent stem cell (iPSC) cell, and place them on that chip and recreate a portion of that organ.
Now, we have an organ that is being nourished, taking away the debris. If it is appropriate, like for the lung or the intestine, we can apply mechanical forces to that, which affects the biology.
At that point, you can flow your compound in there, and take the effects of the downstream analysis, to figure out what is going on.
So, we have a Liver-Chip; a Kidney-Chip; a Colon-Chip; a Duodenum-Chip; and a Brain-Chip, all of which we market on a regular basis.
Could you give us an example, such as an end-to-end run-through of a particular organ that you might be emulating? What data are you feeding it? What might the output be? Why is it useful?
Sure, but let me just add one more thing: those are the models that we sell, but our system is open.
We sell a blank chip - we call it a ‘Basic Research Kit’ - and a researcher can build their own models. Our customer base has published on more than 30 different models that they are developing: things that I do not have the time, or rather the ability, to explain.
The open platform makes it really interesting for the marketplace.
Regarding your other question, in our Liver-Chip, for instance, that would be a model where we place four different cell types into the chip itself. We culture that up. That would be on the instrument for a period of seven days. We would do microscopy on an every-other-day basis, QC-ing the chips.
At day one, three, and then again, at seven, we would do endpoint analysis for certain measures that are indicative of liver failure. Things such as alanine aminotransferase (ALT), albumin - those types of measurements would be done downstream.
That allows the scientist to interpret, for example, whether the compound that they are putting on this ‘liver’ is causing drug-induced injury, or is it safe and clean?
There has been a massive surge in computational power, and the quality of data analytics, over the past couple of years. How have you been utilizing that to improve your models?
We use a variety of analytical tools. Many of them are organ- and endpoint-specific.
By automating that, in a fashion, it allows us to have more reproducibility with each of our models.
I also mentioned we use microscopy throughout the process. We are now starting to apply AI to morphology scoring to get greater consistency in how the scientist is interpreting what they are seeing via the microscope.
Could you talk a bit about the Brain-Chip, and how it is influencing your work in brain and blood-brain barrier research?
Yes, this is actually our second-generation model. What we learned when we went to market with the first-generation model was that customers want a complete neurovascular unit. That is what we are now able to offer.
There are five cell types in this particular model. But, most importantly, they are isogenic, meaning they are from the same donor.
This is an iPSC-derived cell type, and so the researcher can build the most comprehensive neurovascular unit and study the blood-brain barrier with the greatest clarity possible.
Could you talk about the wider Organ-on-Chip sector? What does that landscape look like, and how are you positioning yourself?
It’s a field that is relatively new into the marketplace. Many of my direct competitors are academic spinouts—as were we, out of Harvard, many years ago.
The industry is obviously trying to move the medical research community away from animals by providing more predictive tools than they currently utilize today. So, it is early days.
I tell my employees, if there is a nine-inning baseball game here in the US, we are in the first inning.
I would suggest that we are leading the industry from an Organ-on-Chip perspective, but there is a ton of innovation that must continue to happen, and of which we really need to remain at the forefront.
The industry has been testing on animals for 80 years. So, there are going to be decades of innovation that have to occur to make this pivot complete. It will take time, and I am all for more regulatory oversight in this area.
Looking toward human-relevant in vitro data, what kind of regulatory hurdles and expectations are you going to face?
We are actually the first Organ-Chip company that has been accepted into the FDA ISTAND program. We submitted our Liver-Chip for a context-of-use claim focused on identifying drug-induced liver injury.
I believe the clearer the advice that we can get for regulatory qualification of these tools, the faster that the ambiguity in the marketplace goes away for our customers.
We are looking forward to submitting other models into the FDA ISTAND program, once we complete the required validation work for the Liver-Chip.
Who would your ideal client base be, and how is that shaping your go-to-market strategy?
Our fastest-growing market right now is pharma and biopharma. They are adopting this technology and finding ways to utilize it as much as possible.
The second biggest market is the academic market. As I mentioned earlier, this is an open platform. So, there are academics using our platform who are developing models and publishing on all different types of organs. They are utilizing it across many application areas, including cancer- and infectious disease research.
The third would be the government. We work with a lot of government agencies, doing a variety of testing.
If we are focusing on one Organ-Chip, what are the costs and how does it scale up?
The cost depends on how you think about an experiment.
Typically, they will do a dose-ranging study and multiple replicates to try and understand what the particular outcome was.
But, an average chip, to give you an example, costs about $650.
When you are making the economic case to biopharma clients, compared to traditional animal studies, what are you measuring, and how does it size up?
We have done that in collaboration with our very good customers, Moderna, who did an analysis examining how they use LNPs as part of the delivery vehicle for their therapeutics or vaccines.
As LNPs can cause toxicity, they have implemented a program where they screen their LNPs on our Liver-Chip, because most of the effects are liver related. They only progress the best ones into an actual non-human primate study.
On our website, we have a cost calculator that shows how you can reduce your need for LNP work in non-human primates.
It is all published through the collaboration with Moderna, and there are significant cost savings in this particular example.
As demand increases, along with the complexity of chips, and regulatory validation requirements growing, how are you approaching pricing going forward?
We are actually trying to drive down our prices in the marketplace, through innovation.
We just launched a next-generation platform. The design of that chip allows us to manufacture it with greater ease and at lower cost. Those savings are being passed onto customers.
I believe if we can drive down the cost of consumables, adoption will go faster, and we will be able to get into workflows on a more consistent basis.
Of course, there is regulatory complexity, but if you use innovation to drive design with lower manufacturing costs, those savings can be passed on to the customer. That is exactly what we have done with the next-generation platform.
What would success look like for you at Emulate two years from now?
Two years is pretty close. In a two-year time frame, we are looking to get our ISTAND approval through the FDA. Ideally, we can have that done in the next year. Under that program, we will be looking to submit other organ models, too.
As we have just launched our new platform, over the next 24 months, it would be great to see a hundred of these systems in the marketplace.
We are really excited to help bring about more biological innovation. Having mentioned the brain earlier, we have other applications on that Brain-Chip that we want to bring to market.
The whole area of immunology is very exciting to us—things like lymph node models that we are really eager to bring out, for instance. So, within 24 months, we are trying to get a lot done. It’s a very exciting time for us!
What would you say is the ‘secret sauce’ to being a leader who can drive people toward ambitious goals?
People have a real passion to do things that have meaning.
I have the good fortune of being in an industry where we have the opportunity to reduce the number of animals being tested in medical research, which, I think, hits anyone’s heart.
We have the ability to bring down the cost of drugs, because we can reduce failures going into the clinic, and, ideally, we can bring drugs to patients quicker. That mission is very important to my employees.
If you can create a working environment where there’s a high level of trust, a lot of intellectual stimulation, and you hold people accountable, then you’ve got a really good chance of fostering a culture that works well.
