Mimi Yen, PhD - Founder of PhagePro
Company Vision/Mission
We plan to use phage products to help the world’s most vulnerable communities. Our first product is aimed at cholera prevention. It’s targeted towards household members of patients who are suffering from cholera in an effort to stem transmission among the household members as well as to hopefully prevent the transmission to the larger community as well.
How did the idea to create a startup develop?
The Tufts 100k New Ventures Competition. Tufts realized that they weren’t getting too much participation from the Sackler campus, so they held an info session for our campus, which I attended. I thought my thesis project would be applicable, and I decided to enter for fun. I never thought I would be a business person whatsoever, but I do like challenges, so I decided to go for the competition. We were surprised we got past the first round, and the second round was actually a pitch, which I had never done. Surprisingly, we got past that round as well and made it to the final round where we placed second in the life sciences track. That’s when we realized that someone actually believed in our work, so we decided to keep going.
How has the startup been going since the competition?
It’s rough. Biotech in general is a very risky venture, and if you’re looking at the pharmaceutical product side, products usually take an average of 8-10 years to develop. However, it’s still fun. We’re learning a whole lot of stuff you don’t typically learn through a PhD program, such as analyzing the market, where the pain is, how to communicate to different audiences, and how to build value for your company. We’re doing pretty well with the cholera product. We have a contract with a company through the NIH, which has been supportive of our entrepreneurship. Through them, we’re creating a product development plan for cholera. We’re hoping to identify gaps and risks in terms of manufacturing and bringing the cholera product to market.
Could you talk about what the product actually looks like, how it works, etc.?
Phages are specific viruses that target bacterial cells. Ours is a cocktail that targets Vibrio cholerae, which is the causative agent of cholera, so the idea is that it’ll be taken in oral form. The household members, depending on the clinical trials, will be able to drink our product once or twice daily to be immediately protected, as opposed to vaccines which can take 2 weeks to take effect. The treatment is continued for 7 days since there’s a 1-2 day window where the household members can come into contact with cholera via the index patient, so we want to let them take it for 7 days to be on the safe side. The way that it would be delivered to household members would be based out of a diarrheal center in Bangladesh which already exists. Since the household members will likely come in with the patient needing treatment, the household members would receive the treatment while the patient is being treated for cholera. We would also potentially give the family members our products to take home to other family members who may not be present at the center. Once our product clears clinical trials, we’d have to be a little more creative in terms of reaching the people who don’t have access to the center and rural clinics. We would have to figure out who to partner with in terms of the best delivery system, especially in places that have a huge unmet need.
What has the process been like with the FDA?
Our product is a pharmaceutical device that falls under the biologics category. Phages are very different from anything else that the FDA has dealt with. The FDA is open to other ideas given the fact that antibiotic resistance isn’t stopping or slowing down, so figuring out the regulatory pathway there has also been a challenge.
Interactions with the FDA have been pretty casual so far. They have a strict protocol that we’ve followed. Since my PI has been in the field for a while, people at the FDA already know him, so he’s been able to help connect us and move us through the process. The FDA has been very helpful with figuring out the best path forward for our product. There hasn’t been as much pushback as I expected.
How far along are you in the development process?
We did proof of concept experiments during my thesis. Cholera has 2 animal models—one is the infant mouse model for colonization, the other one is the infant rabbit model for symptoms of human cholera. In both, we’ve been able to show that if you give our product up to 24 hours before the actual cholera challenge, the animals will be protected. Moving on from there to the product side, it’s a bit more technical trying to figure out how to large-scale manufacture a phage, which is not something a lot of American companies know how to do. Next, we need to figure out how our company can get money to fund scientists working on both sides of things. However, before we can get any funding, there are certain hoops we need to jump through and be able to move out of Tufts.
Have there been any challenges with the university getting the academic research translated into a commercial venture?
We’ve been in talks with the Tech Transfer Office at Tufts throughout the process. There has been a little bit of a pushback with patenting our product, partially because it’s cholera. One argument was that no one would chase after cholera, so we wouldn’t need a patent. However, we needed a patent, because if we don’t have a patent as a company, then no one would want to invest in us. So, we have an application filed; we did a provisional patent and a PCT in April. It’s Tufts owned, so PhagePro has to license it from Tufts.
The environment at Tufts is actually changing to encourage more entrepreneurial activity. They’re creating an incubator space at the Boston campus for the Tufts Medical and Sackler School right next door. There’s already a beautiful lab space, and ideally, we would move our company there when the space is established. It’s great because now Tufts can cash in on the vibrant ecosystem that we have here.
What do you enjoy the most about your work?
It depends on the day. I think I’ve always been someone who wanted to have a direct impact as a result of my research, and I think when I was in college and even early grad school, I thought that the best way to do that would be by being in the lab, studying, and doing basic research. In some papers, you see statements such as “this research will ultimately lead to X” or “this discovery has the hopes to do Y,” and I thought that was the role that I’d be playing forever. The exciting part of my work now is that I’m able to bring this to a market. I will be able to see it through clinical trials, and if successful, into a pilot study. Ultimately, I hope to see my work saving the lives of people who we as academic researchers often think about, but are so far removed from by being at the bench. So, in terms of passion, that’s what I’m most excited about.
Sometimes as a startup founder, you feel like you’re always pushing a rock up a hill, so it’s important to have that dream in sight. In Boston, the startup ecosystem has people that love to give back. So, having people to bounce your ideas off of or having people with experience in the field mentor you is also very encouraging, especially when you’re down in the trenches and feel like nothing is actually going to work. That’s also a very exciting part of my work.
You mentioned feeling like you were “pushing a rock up a hill” at times. What were some instances when the rock rolled back?
That rock is definitely more like a cube; sometimes it doesn’t even roll! With cholera, it’s not a venture capitalist funded endeavor, or even an angel investor endeavor. Our strategy for funding is to go to foundations, family offices, and the government to find grants for small businesses. Since Tufts owns our patent, we can only apply to a certain fund from the NIH. That type of grant requires 40% of the work to be done by an academic lab. The academic lab in which we need to do our work has a PI who has an affiliation which prevents him from being involved with our work. So now, our biggest source of funding has to wait until the PI’s affiliation appointment runs out, which has put us on ice for the past year or so. Our other approaches to get funding have not been as successful thus far, but there are other routes that are possible. One of our mentors always encourages us to think out of the box about different pathways. There’s always hope; sometimes you just have to breathe, go home for a bit, and come back with a fresh mind to see the light at the end of the tunnel.
Could you talk a little about your academic career path to get you to where you are now?
I studied biological engineering at MIT for my undergrad. I wasn’t a very good engineer which I quickly figured out, but I kept going because I saw that my experiences taught me to think with the mindset of an engineer in terms of constantly applying science. I also worked in a lab all 4 years, which is a great thing about MIT; they let freshmen get involved with research by helping out grad-students. Through that, I was able to work on oral vaccines and delivery, and that's when I became interested in infectious diseases, particularly in low and middle-income countries. Right after college I had the notion that if I want to focus on pathogens, I should probably first learn more about pathogens. So I came to Tufts and did a PhD in microbiology. As part of my PhD thesis, I went to Haiti for a month to collect cholera samples and train technicians in a lab. That experience is what really changed my mind about the role I wanted to play in global health. I didn’t just want to be a bench researcher because I saw that even if you do make a great product, it's actually the infrastructure and the healthcare delivery aspects which really matter to the people in vulnerable communities. Because of this realization, I decided to apply to a part-time master’s program in public health at Boston University. That's what I’m doing now at Boston University while still focusing on my company.
Do you have any advice for future medical or healthcare professionals based on your experience so far and where you see the field going?
I feel like I shouldn’t give advice to medical people since I’m not technically a medical person, but I think for me, the greatest lesson I learned was to always keep in mind what your goal is supposed to be. It doesn’t even have to be a permanent goal, but it’s important to always work towards something. It's okay if that “something” changes, as long as everyday you feel like you’re actually working towards your passion and towards something you really believe in. That way, even if your pathway ends up being something completely different from what you thought it would be, you’ll still feel totally satisfied with your decisions.
From a startup’s perspective, my advice is to always think about the people whom you’re trying to help, and connect with them to ensure that your product will actually be helpful and not just something that's going to be thrown by the wayside.
It's also good to take breaks. They actually do help your mind clear up and that's something I didn’t realize till a few months ago, so it can be a hard lesson to learn.
Has your mission or vision changed at all over the course of your experiences, and are you’re still happy with the direction in which everything is moving?
When we first started, I was very narrow minded and was only focused on cholera. When more business-savvy people told me to branch out and consider products in more commercial areas, I felt, not like I was betraying my global health mission, but a little dirty in that I was supposed to be helping dying people in low/middle income countries, yet here I was, thinking about making money for a company. I have slowly realized that it actually is necessary to think about how you’re supposed to fund your company because without money you can't do anything, and I know that because right now we’re stuck. So, we’ve been thinking about looking into aquaculture and agriculture as alternative routes, and we think that these strategies may be more profitable. However, they will also ultimately help the economy and industry become more sustainable in general. So, the vision has evolved to be broader and maybe more realistic. I’m not the naive, idealistic girl who was just trying to help cholera with no money a year ago. I've had to change, but it's a good change I think.
What impact do you see your work having on the future healthcare landscape?
Phage therapy has always been talked about. It's part of a toolkit in the Eastern European region, Russia, etc. and you can buy it over the counter there. Now that we’re starting to consider the more prudent use of antibiotics in healthcare and agriculture, we’re also at the very beginning stages of that movement. As our company breaks into phage therapy, it will hopefully be a proof of concept which shows that phages can be used successfully as interventions for acute bacterial diseases. It should be considered a strong treatment candidate by doctors in the US for people who are battling sepsis, pseudomonas, and maybe even other bacterial disease that we haven’t really thought about. Sometimes, however, the medical profession can be a little more traditional and resistant to shifting away from the use of antibiotics to a newer therapy. But this makes sense, since they want to save people’s lives and want to make sure that everything is safe.
Additionally, we often think about cancer and heart disease, but there are still a lot of people dying in the hospital due to hospital-acquired infections. Phages could be used as viable alternatives if antibiotics stopped working as they once did. They could also be utilized as a pathway to reduce antibiotic use. So, if our company is successful at marketing and delivering our products safely, then hopefully it will set an example as a good pilot study for phage therapy in general. Phage therapy would also get a little more attention from the media and government so that it starts becoming the norm rather than just something you hear about once in a while.