Three Princeton graduates launched a nonprofit organization in Sept. 2013 that collects stool samples and provides hospitals with screened, filtered and frozen material for clinical use.
Mark Smith ’09, James Burgess ’09 and Carolyn Edelstein ’10 created OpenBiome, which has already been featured in The New York Times.
Edelstein explained that fecal transplants have been proven effective in fighting harmful intestinal bacteria, noting that while antibiotic treatments for the infection are approximately 80 percent effective, fecal matter transplantations, also known as FMTs, are around 89-92 percent effective.
Smith explained that the process of an FMT starts far before one heads into the surgical room, noting that an FMT is an extremely complicated process that first requires finding a donor to undergo a very rigorous set of screenings, come in and produce fecal material to be processed. The methods of transplantation are generally limited to colonoscopy, enema or through the nasogastric tube.
With OpenBiome, Smith, Burgess and Edelstein aim to centralize and facilitate the FMT process, and make it faster and easier for both doctors and patients, Smith said.
The actual FMT process at OpenBiome ensures complete sanitation by involving a double-screening process in which the donor is tested for parasites or dangerous microorganisms at both the beginning and end of a 60-day contribution period, Edelstein said.
“It’s just much more effective than hiring a bunch of different donors,” she added.
Smith said that for the past five years he had been working on the microbiome, the community of microorganisms that live in the gastrointestinal tract as well as several other places. He explained that looking at the composition of a microbiome can help identify causal relationships between what the microbiome looks like and what diseases a person can be predisposed to.
“What’s really cool about FMT is that we can go in and manipulate the system in a defined way and see how it responds. That was very interesting to me,” Smith said.
However, Smith explained that launching OpenBiome was also a personal endeavor, since his family friend had been suffering from Clostridium difficile for nearly a year and a half. C. difficile refers to a specific bacterial species that causes chronic and severe diarrhea, as well as abdominal pain and bloating, and kills approximately 14,000 Americans annually. C. difficile, like colitis and irritable bowel syndrome, is one of various diseases that can be remedied through FMTs.
“There weren’t any doctors nearby who provided the treatment,” Smith said. “Doctors are used to taking medicine off the shelf and giving it to the patient. If a patient needs blood, there’s a blood bank. This is exactly the same kind of approach.”
Smith noted that for many people, the concept of FMTs may seem foreign, if not gross and unnecessary.
“For people on the outside of this world, there’s definitely a ‘yuck factor,’ ” he explained, referring to those outside the medical and scientific world. “But for patients who are suffering, if you tell them there’s a treatment, they are happy to do anything to get rid of the symptom.”
Smith noted that some in the scientific community are worried that a relatively low-cost nonprofit organization providing this specific service may undermine commercial efforts. However, he also noted that he and his company are now collaborating with various biotechnology and pharmaceutical companies that are interested in developing the next generation of treatment. He added that an existing solution, however crude people may consider it, should not be withheld from patients simply because of potentially refined solutions in the future.
Eric Alm, associate professor of biological engineering at MIT and an OpenBiome team member, said that, in his opinion, OpenBiome is a business with good ethical values actually trying to solve a problem, rather than a business that charges a lot of money for problems that are easy to solve.
“I am really immensely proud of these guys and what they’ve accomplished, and what they’re doing,” Alm said.
Smith first began brainstorming with Burgess and Edelstein in the beginning of 2012. Noting that talking to lawyers and working through Federal Excise Tax regulations took nearly a year and a half, Smith said, “It’s a very unusual treatment. Is it a drug? Is it a tissue? It was all very unclear at the time.”
Although the Food and Drug Administration originally decided to regulate fecal matter used for medical purposes as a drug, protests led to a subsequent announcement allowing treatment for patients with C. difficile infections without the burdensome Investigational New Drug process otherwise required.
“One of the things you need to do with a drug that you can’t do with a stool is being able to identify active ingredients,” Edelstein said. “They’re regulated like drugs unless you’re using them for those people with recurrent C. diff infections.”
Burgess noted that the company had not always been geared toward becoming a nonprofit organization, but explained that he and the other founders thought it could have a greater impact without generating profit.
“We had a lot of difficulty structuring it as a commercial venture, especially because this was started by a group of people who didn’t have strong pharma or biotech experience,” he said.
OpenBiome has been providing fecal material and offering services since October 2013. Smith explained that clinical interest has grown tremendously since that time, noting that the company now works with 13 hospitals and has been contacted by another 15 to 20 in the last few weeks.
Smith explained that due to several generous donations, OpenBiome was able to hire two full-time staff members in order to run day-to-day operations, which consist of processing the materials and working with hospitals.
Burgess, currently the director of OpenBiome, first met Smith during his freshman year in 2005. While at the University, they worked together in various ways, from starting a student-run seminar on climate change to starting a business recycling refrigerators and reselling them to freshman students. Burgess noted that wanting to make a positive impact in people’s lives was what drew Smith and him together.
“We’ve had a lot of discussions about our values and interests,” Burgess said. “We overlap a lot in our approach to solve problems, and we rely on each other to make the right decisions and do things in the right way.”
Smith graduated with a degree in ecology and evolutionary biology and pursued certificates in environmental studies and engineering biology.
Edelstein, who concentrated in the Wilson School and is currently an MPA candidate at the Wilson School, first met Smith while he was running a meeting for Greening Princeton, an organization that successfully petitioned for the creation of the Office of Sustainability, which now exists. Before working at OpenBiome, Edelstein worked on promoting more cost-efficient policy solutions with the U.S. Agency for International Development for two years. Although Edelstein herself never expected to be involved in such a unique field, she is still following through with her interest in policy and desire to help people. “I just didn’t think it’d involve so much poop,” she said.
Smith said that his ambitions for OpenBiome are grand, noting that he and his coworkers hope to provide 1,000 treatments to hospitals and clinics within the next six months. Smith also noted the desire to increase the number of FMT providers throughout the nation so that every populated town would be within a 50-mile radius of a provider.
Most doctors do not currently want to provide FMTs because FMTs are extremely complicated processes, Smith said. However, Smith added that the OpenBiome team is working as quickly as possible to save lives.
“I just got contacted the other day by a woman whose mother just passed away from C. diff at a hospital that we were in the process of getting set up with,” he explained. “We take that stuff very seriously. There are people’s family members who are dying for this super treatable thing.”
The existence of a connected network of doctors and local proximity to FMTs are critical to the success of the field, Smith said. He noted that many Americans who suffer from Clostridium difficile, such as his family friend, often attempt home solutions, an incredibly dangerous process that should happen with the help of doctors rather than YouTube videos.
Carol Capps, a retired resident in North Carolina, was one patient who did successfully receive FMT treatment. She explained that after various episodes and months of unsuccessful antibiotic treatment, she was desperate for a permanent solution and underwent treatment by colonoscopy in December 2013.
“It was a miracle, thanks to the donor,” Capps said. “I am just better. I am a different person.”
The deeply personal nature of OpenBiome, on multiple levels, has not always been easy for Smith and Burgess.
“Frankly, I wouldn’t be well cut out to be a doctor myself because doctors have to deal with patients dying all the time. It’s been hard. The good news is that we hear a lot of exciting and uplifting stories, where we do make it in time,” Smith said.