Azitra Inc. is one of many biotech startups working out of the University of Connecticut Technology Incubation Program (TIP).

Azitra collaborates with scientists from Yale University, The Jackson Laboratory, and the University of Connecticut. The company’s work is supported by National Institutes of Health (NIH) grants, private grants, and investment from Bios Partners, Connecticut Innovations, KdT Ventures, and Breakout Labs.

Innovation Destination Hartford spoke with Azitra CEO Richard Andrews about his involvement with Azitra and what it takes to get a biotech company up and running.

NAN PRICE: This isn’t your first science-related startup.

RICHARD ANDREWS: I’ve been involved in startups since the 1980s. Startups are exciting because they challenge every aspect of your skills. You’re developing teams, finding great science and scientists, forming the business strategy and plans, finding funding, charting milestones, and then patching it all together to help the team build the science.

You have to have great science, of course. But, I’ve always said what makes a successful company isn’t always the science, it’s how hard you’re willing to work and how creatively you can execute your operation and plan. And having a clear plan and a network of advisors to help you is imperative.

NAN: Tell us about your entrepreneurial experience. How many startups have you worked with?

RICHARD: This is my sixth. My background is physical chemistry and chemical engineering. I got a master’s degree from the Massachusetts Institute of Technology (MIT) in the early 1980s and then went into technical consulting at Arthur D Little. That experience helped me understand how to pair up science with effective business strategies. Shortly after that, I became the head of business development at a high-tech bio-materials company because I liked connecting great science and discoveries with practical utility.

I ultimately ended up running a couple biotech divisions. In the 1990s, I worked with a company that came out of the University of Massachusetts to help launch BioSave, a microbiome product that protects fruit and vegetables in a natural way. It’s still on the market. It’s not too different from what Azitra is trying to do, except we are conducting a lot more rigorous science, which is typical today.

Every time you do something like this, you push yourself one step more. When I started, I was a scientist and then I focused on linking the science with practical use. And then the next step is to figure out how to manufacture it.

Each step in that process, you try to push yourself to understand a little more. You don’t become an expert, but eventually you fully understand the impact of all those things—packaging, shipping, manufacturing, and quality.

And, if you’re really smart—and I’m trying to be—you find the people who know how to do those things better than anyone else and you bring them in. I’m not an expert at any one of those steps, but I do know people who are! So, the job of an entrepreneur in the life science industry is to recognize value in science, understand all the things it’s going to take to turn the science into something real, and then bring in all the experts to orchestrate the process. It’s like you’re a conductor. And it’s so much fun!

NAN: When and why did you become involved with Azitra?

RICHARD: I’ve been with Azitra for about a year. The company was started in 2014 by two Yale students who wanted to develop and understand how to use the microbiome on skin to improve skin conditions and treat skin diseases. The founders worked in a small offsite facility in New Haven through 2015. And then, in 2016 they connected with Jackson Labs, which has a world-class research group focused on the microbiome.

NAN: Tell us about Azitra’s involvement with the TIP.

RICHARD: Jackson Labs is across the road from the TIP. In 2015, the founders became engaged with the TIP and opened their first lab here. Then, in 2017, Azitra expanded to two labs.

The TIP helps facilitate the discovery and the creation of the assets and elaborate the science. And it does it a marvelous way. This is one of the best incubation programs I’ve ever been in. You get tremendous support here.

NAN: Let’s talk a little more about Azitra’s evolution.

RICHARD: When the founders created the company’s core technology, things started happening. Networks of people and scientists started paying attention to what they were doing.

When this happens, you get to the first transition in a company, where you say: The science is looking good. How do we translate that to product concepts and definitions so we can take the core discovery and define a development process?

At this point, you’ve still got a lot of research to do. You still have many questions to answer. But you need to have a process. And that’s very different than academic research, where you explore things.

Many times, an academic will conduct every step of the science. Whereas a company like Azitra will focus on the science and then bring in someone like me, who will start subcontracting to contract research organizations (CROs) to accelerate a development plan.

NAN: Is that how and why you became involved, because you have experience?

RICHARD: Yes. I was brought on to help with that first translation to take us from discovery to product focus. In the beginning, Azitra’s founders had an excellent concept and today the company has a very focused product strategy. And that extends from manufacturing all the way through packaging, formulation, targeting, commercial work, and understanding what the customers need. In our case, that involved talking to the dermatologists. You have to address the full spectrum so you can refine and define your product plan.

And then you build a strategy that takes you step-wise through the process. You have to stay disciplined and focused while you’re sustaining the creativity. That’s a balance we’ve been going through for about a year. And we will keep going through that. It never ends.

The next step is manufacturing—knowing we can manufacture the product with Good Manufacturing Practices (GMP) quality that can get through the U.S. Food and Drug Administration (FDA). We already know the dermatologists want it, so there’s a customer need. We know how it’s going to perform. We know its mechanism of action. All those important factors have come together.

So now we say: How do we become a company? And how do we build identity around that? Because now it’s much more than the science. Now it’s a clinical team that’s going to execute clinical trials. It’s a group of people with regulatory expertise that’s going to shepherd us through the FDA. It’s quality assurance people who are writing our technical reports and ensuring every step of the science is perfect.

I have to go through that process with the scientists all the time. How do we take discoveries, make sure they’re in our lab notebooks, and then translate that into technical reports? Because technical reports are real products where we have firmly documented technical success.

Those reports become our property, which must be documented. And that becomes core assets. And from those core assets we build patents. It sounds complicated but understanding how it all flows together is a very structured process.

NAN: Where are you in this process with Azitra?

RICHARD: Right now, we have built most of the foundation. My next job is to convert this from a real, tangible opportunity to a company. Because we’re not trying to build a piece of science I’m going to sell. We’re trying to build a company that has value. Value is created when you follow a fully articulated process from discovery through product manufacturing.

We’re going to move to our next step in the creation of a company as soon as we close the next financing. That will be part of the process, because our evolution will take us from what we have now into the clinic. When we get into the clinic, the company is going to need clinical folks who will also need support with administrative, quality assurance, and regulatory issues. Some of those I will manage through contracts, and some of them I will hire. That’s how you build a company.

The TIP is an invaluable research facility but doesn’t handle that, and it shouldn’t. I’ll continue to build and value that research, but I’m going to take the next step with the clinical as the lead.

Right now, we’re setting up a clinical trial. We’ll need to set up a data safety monitoring board (DSMB), which will be a collection of physicians and biostatisticians who will review the clinical data. I hope to draw from the dermatology group at UConn to help populate the board. They’ll report back to us as to whether the trial should continue, or we need to make adjustments to ensure the patients we treat are always safe.

With regard to Connecticut resources, we have tremendous support financially and for our auditing and there are talented legal teams in Connecticut we can draw from. We just concluded a financing with Connecticut Innovations. We’re very pleased to have them as an investor.

NAN: What types of startup challenges has Azitra encountered?

RICHARD: There are always scientific challenges. Science never works as anticipated, so you always have to look critically at what the science is telling you. You have to let the facts dictate the process.

Sometimes you fall in love with your strategy and don’t pay enough attention to what your science is telling you. And that will bring you down the wrong path. That’s where science advisory board members are so valuable. Their critique is invaluable because they accept nothing based on assumptions. They’re looking for facts. And that keeps you on track.

The other challenge is mapping out a patent strategy. Microbiome is a new space, and many of the people who are focused on the microbiome came to it out of a fervent belief in natural and biological—they didn’t come to it with the background of building a business that’s going to make money.

Belief and passion are good, but then you need to figure out: How do I establish proprietary positions? How do I establish control over the manufacturing, formulation, and ownership structure so that when we make a product we get paid? How do we create value for investors? How do we build a business?

And that requires a real focus on the process. When you do that, you question: How do I own the channel? How do I make scientific discoveries in formulation, delivery, manufacturing, utility, and application that enable me to own it? How do we stake out our own turf that gives us a strong patent position and a proprietary position in our field?

It’s not an unfair competitive advantage, but it’s clearly a competitive advantage. And that is a creative challenge.

That’s my job—to take this nascent science and technology and create robust science that can serve the world. It starts with a great idea. But that great idea is just the first step. It’s a great idea that must be refined and structured and made operational in a way that benefits people worldwide.

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