First Person Experience with the Kauffman FastTrac® Course

Cherry Wongtrakool is an associate professor of pulmonary medicine and a medical director at the Atlanta VA. She recently completed the Kauffman FastTrac® course and shares her experience.

Tell me about your background/research interests. Were you always interested in research that had commercial potential?

I am a pulmonologist and I take care of patients. The reason why I enjoy research is because I want to be able to add to the body of knowledge that translates directly into helping my patients. I will say that I probably did not go into research with the thought that I would be doing something along the lines of commercialization, but everybody considers their research to be translational in some way. For many clinicians, the reason we do research is to find out how to better serve and better help our patients, so anything we do serves to achieve that ultimate goal.

How did you first decide you were interested in forming a startup?

Well, we haven’t formed a startup yet. We’re still in what would be considered the “preclinical stages” or the “discovery stages” where we’re doing a lot of in vitro and in vivo work to create a body of data that we can use to show to investors once the startup is formed. If you don’t have the data to support your startup idea, you might as well not form the startup. If your data is not very convincing, you won’t be able to attract investor funding, so the quality of your body of work is essential.

We are looking at a nanoparticle-based delivery of oligonucleotides to regulate a specific gene in Type II inflammation in asthma with Khalid Salaita from the Chemistry department. We collaborate where he’s the chemistry arm and I’m the physiology arm. Because our commercialization would fall under the umbrella of drug development, it’s hard to advance without any in vivo data in this pre-clinical, pre-discovery phase. It’s very difficult to do only test tube or cell culture work and then expect to take it through to full drug development because seeing something in a test tube or cell culture is insufficient.  That limited approach doesn’t give any information about possible toxicities, for instance.

What was the rationale for forming a startup as opposed to licensing the technology to an established company?

At this stage, it’s still quite early to think about licensing, although I suppose theoretically it could happen. We feel we need a startup to attract funding to do the really heavy preclinical work needed to apply for an investigational new drug application with the FDA. That work typically includes toxicity and pharmacokinetic studies, with large studies involving two different types of animal species. Drug development has its own unique pathway to commercialization compared to a medical app or a medical device.

Had you previously had interests in entrepreneurship or developing commercial applications for your own research?

This is my first foray into the world of startups. I never really thought about our research in this way before or in this much detail. I didn’t study business or anything like that as an undergraduate. I think that our technology has a lot of potential for growth with different applications. We’re obviously targeting a very specific disease, asthma, and a very specific subset of that disease, but based on our technology, it potentially could have significant impact in other diseases too. From that perspective, it would be nice to see everything come to fruition.

What initially interested you in signing up for the Kauffman course?

As part of this whole venture, we were funded by the Coulter Translational Fund, which is a jointly administered between Georgia Tech and Emory. Getting funded by Coulter involves meeting regularly with their advisors and investors. A lot of what they were saying was relatively new to me. One of the questions as an academic is if you do form a startup, what is your role in it? Are you a CEO? Are you a CFO? Are you a CSO? Are you a CMO?  I didn’t know what to look for in a CEO, because an academic job and the CEO of a startup requires a different skill set.

I didn’t know what I was looking for in a CEO or what do they needed to do. Kevin was unable to attend, but this year, I thought “Okay, since we are potentially getting close to eventually forming a startup company with our data set growing stronger, it would be good for me to learn a little bit more about this.”

What were the most important lessons during the Kauffman sessions?

The biggest lesson I learned was that there is a completely different vocabulary to understand. Otherwise, what was really helpful was the way the course was designed. They invited people who were local to talk about different aspects of having a startup. One speaker gave a great talk about company valuation. There was a talk on IP, which is always helpful. The speakers were very supportive of the Kauffman course, so they were quick to say, “If you have any questions, please reach out to us, just email us directly.” Having that connection as a potential resource, even though you may not necessarily reach out to each person, was really wonderful. Kauffman also gave us a “toolbox,” which had a lot of information and examples of agreements with different companies and different investors, and spreadsheets for different budgetary projections. The course was very informational.

Was there anything you wish had been taught during the Kauffman course or you felt like could have been done differently?

One thing that is always good to learn more about is intellectual property as it relates to drug development. It’s a very specific area, so having a one-on-one with someone who does IP would have been nice, but obviously that may not be feasible in this crash course on entrepreneurship. A lot of drug development startups rest very heavily on their IP. Without proper IP protections, you are not in a strong position to compete for investor dollars. An investor will likely say “If I invest in you, someone might come in with the same thing, then how do I know I will get a return?”

What do you see as your next step after completing the Kauffman course?

I feel like I’m better equipped to search for a CEO because I know the things we need our CEO to have experience with.  Somebody who was a CEO in non-pharmaceutical industries may be good with people skills and management skills, but they may not be the right person simply because they might not have the right contacts in the biomedical space to bring in investor dollars. I think I’m also more able to participate in ongoing conversations about what the needs of our investors are and how to structure milestones for the startup.

You mentioned that you had received Coulter funding and I know you also got funding from the GRA — how is that type of funding helpful?

Coulter funded us at the very beginning. Coulter is a stakeholder and investor in this process and they’ve provided us with ongoing consultancy. They’re very aware of what’s going on in the local market and they meet frequently with GRA (Georgia Research Alliance). There’s important cross talk between the two because GRA’s goal is to advance biomedical research in Georgia whereas Coulter is specific to Emory and Georgia Tech, so they have a very symbiotic relationship. We had GRA Phase I funding to help us do third-party validation studies. We don’t have GRA Phase II funding yet, but we are applying for it.

Both the Coulter and GRA funding have been immensely supportive and crucial to our project.  Without either of them, we would certainly be years away from where we are. That’s because traditional funding mechanisms such as the NIH or the NSF do not typically fund these types of efforts for individual investigators. They don’t fund repetitive third-party validations, so we really are dependent on the Coulter and the GRA funds to move our research down the commercialization path. It’s different once you’re a startup company because then the company can apply for NIH Small Business grants, but if you haven’t formed a company yet, your options are limited.



Monte Eaves’ a Kauffman Success Story

Monte Eaves is a professor of surgery at Emory University and Medical Director at Emory Aesthetic Center. He is also the man behind EMRGE, a company developing products that are revolutionizing the wound closure industry. EMRGE challenges the traditional needle and thread wound closure procedure with noninvasive and cost-effective technology that promotes healing and minimizes scarring. For this, Eaves was recently awarded the Office of Technology Transfer (OTT) award for 2017 Startup of The Year, one of many achievements. Shortly after, we got to talk with him about how he got there and the role OTT and Emory’s Kauffman Foundation FastTrac® TechVenture™ course for entrepreneurs played in helping him along the way.

Monte Eaves

Tell me a little about the origins of your startup company.

So I was a resident here at Emory in the ‘90s. I worked with one of the surgeons named Alan Lumsden and we were co-inventors of the first endoscopic vein harvesting system. Through the OTT we licensed that to Endosurgery Johnson & Johnson, and that product is still made today, more than 20 years later. It was eventually sold to Sorin, and it’s called ClearGlide®. That technology and its derivative products are now used in about 70 percent of heart bypasses. It’s really cool that one product could make such a difference, and that’s what gave me the bug.

Then I left Emory for about 15 years from 1997 to 2013. I had six additional patents that were licensed, but what I found was very frequently this intellectual property (IP) had a hard time actually getting significant and ultimately are just mothballed. I began developing the wound closure technology in 2010, but I was at a loss about how to move it forward until I came back to Emory where OTT really helped me get started and connected me to people in the community. They helped me sign up for the Kauffman course which was quite helpful, and got me into a southeast bio business plan competition. That’s what got me moving toward creating a company.

How did you realize there was this niche opportunity for you in the medical marketplace? What was your thinking process when first developing your products?

Our technology addresses a pretty well recognized need. I actually worked for two years with Johnson and Johnson in the field; I had an inventor’s agreement with them to try and develop new wound closure technology. They were always looking for things that would be faster, less invasive, and would improve scars. And yet, if you look at the majority of the way we close wounds it’s the same way we closed wounds 5,000 years ago; a needle and thread.

I’ve been aware that this was an area in need for a while now. As I was exploring the possibilities I probably tried 50 different technologies, trying to do it internally or trying to do it on the surface. Then one night I was thinking “Okay, I’ve really got to think outside the box. Well… what is the box?” I had to first figure out what box I had put myself in.

I started thinking, the box was that it had to be flat to the surface, or it had to be underneath. I kept examining, “If I can’t be underneath and I can’t be on top, what’s left?” Then I started thinking about Breathe Right® nasal strips and how they bend and flex. We took that concept but reversed it. This creates the forces that can push, turn, and twist tissues, but do it externally.

It’s a dynamic device that has two arcs of rotation, one opens it up and one pushes down this little footplate that’s like a strut, and between those two they create the right action to bring it all together. The process was, for me, a very interesting learning experience; when we’re trying to be creative and original we have to figure out what box we’ve put ourselves into.

Was there any other specific event or experience that got you thinking about creating your own startup?

After a certain point of getting IP mothballed and having projects that just don’t take off, you realize that sometimes you’re just going to have to do it yourself. I think the world has changed from 20 years ago when companies would frequently use internal product development and had the right researchers and engineers inside the company itself. Now, they want to go buy innovation. These days if you want to develop technology you might have to do it yourself.

The other thing that got me interested was being president of the American Society for Plastic Surgery. I think the experience of helping to run an organization made me realize how much I enjoy building teams, having projects, bringing people and concepts together, and figuring out how to pay for it. That’s exactly what you do with a startup.

Did the Kauffman course help you decide on a direction, or did you already know exactly what you wanted to do by the time you took the course?

Before I showed up here in 2013 I spent three years thinking through the technology, filing the original patent, and building what I could with models, but I didn’t have connections to any resources. When I came to Emory I knew I needed to move this forward, I just had no idea how. The Kauffman course was eye-opening in helping me know how to take the first steps.

Was there a specific moment in the course where you realized a startup was actually something you could do, or a particular session where something clicked?

Before the Kauffman course I knew I needed to do this, I just didn’t know how. Even just looking at the course material and its sections gave me an idea of what path to take. I went there knowing I was going to do this, I just needed guidance.

Were there any sessions that continue to provide guidance?

I think the most illuminating sessions were on regulatory processes. That, and understanding finances: what are your options, what are you going to do; that starts you thinking about what your best path is to get there.

Tell me about networking for your startup.

Networking isn’t just something that happens when you go to an event and walk around. That can certainly be helpful, but really what you have to do is just be hungry for it. And it’s amazing, when you start to cold call people asking if they know anyone who could help with a particular thing, if you do it enough you’ll eventually end up talking to the same people again. You get to know people, and then you become a resource for them as well. It’s a two-way street.

It’s amazing, one of my biggest lessons during this process was realizing how many people will help if you approach them with humility, and often after that it starts clicking. You just have to make that call or send that email.

Did any particular speakers from the Kauffman Course stand out to you?

Tom Calloway, he gave the talk on funding. There were a couple of things he said that stuck in my mind. Like, “Time is the enemy, money is the weapon.” I thought through that several different ways, and think it is a very important truism.

When you look back, do you see anything missing from the Kauffman course?

I think one thing that could be helpful is having someone who has gone through the process like me, talking about how to do this and still balance it with other responsibilities. It’s very much a learning curve, you can get so overwhelmed with clinical responsibilities or other research activities. You have to make decisions about priorities. That’s something that would be helpful: information on how to manage it, how to make connections and get the right contacts, how to be a good partner to your manufacturers, things like that.

The Kauffmann course tells you the steps, finances, regulatory, the legal details. It tells you what to do, but if I were teaching a course, I’d talk about how to do it.

Have your experiences in business given you insight into its relationship with medicine, and how the marketplace affects the evolution of the medical world?

Both fields are definitely mutually beneficial. Part of it for me was being the director of the Emory Aesthetic Center, which is a retail medical department, so it’s a business. You have a product, you have to manage people, you only have a certain amount of resources, there are barriers to overcome. There is a lot of beneficial crossover, particularly because I’m in a management position at the center.