by Nicholas McKeehan
July 2015 – cucumbers were suspected to have caused a salmonella outbreak. It affected 27 states, killed one person, and sickened at least 285 others. April 2013 – cucumbers again were suspect in a salmonella outbreak. This one affected 18 states and sickened 84 people. Late 2011 – cantaloupes were suspected to have caused a listeria outbreak that affected 28 states and killed nearly three-dozen people. These preventable incidents are an unfortunate reminder that current regulations for the testing of disease causing microbes in food are relatively lax. Even for proactive farmers and distributors, routine testing is time consuming and expensive. Contamination, therefore, often goes unnoticed until consumers get sick, prompting investigations and recalls. In response to these issues, new Federal regulations aim to shift the model from response to prevention. The Food Safety Modernization Act (FSMA) will require adherence to more periodic and frequent testing, and Dr. Noel Goddard, CEO of Goddard Labs and April’s 1st Pitch Life Science “Best in Show” winner, is developing a new device that will make testing faster and more cost effective.
Although Dr. Goddard’s early career followed the standard academic track – PhD, post-doc, faculty position – she was first exposed to entrepreneurship during her PhD studies at Rockefeller University. A chance collaboration with a neuroendocrinologist resulted in the development of a novel high throughput screening technology, which the collaborator decided to commercialize. “I was fortunate to participate in the process of technology transfer discussions, team recruitment, business plan writing, and fund raising meetings. Unfortunately, the company did not come to fruition, but the exposure to the process was very valuable.”
Following her PhD, she took a postdoc position in Dr. George Church’s laboratory at Harvard Medical School. “I was involved in a number of projects that were driving towards commercialization,” Dr. Goddard says. “We had frequent meetings with venture capitalists, which is the norm in tech-heavy Boston. By the mid to late 2000s, the Church lab probably had more alumni going into startups than academics.” Despite this exposure to the life science entrepreneurial world, when she was offered an opportunity to build a new biophysics program at Hunter College, part of the City University of New York (CUNY) system, she took it and served in the physics department from 2007-2013.
However, as those of us in academia know, the budget for federal funding for research (through the NIH, NSF, etc) has been through a significant decline, and Dr. Goddard found it increasingly difficult to acquire grant funding for her research. As an academic, she was constrained to writing grant proposals in her specific field that she thought the government would want to fund. As an entrepreneur, however, she felt she would be able chase the problems that she was interested in. In 2011, she started to think about making the transition from academia into entrepreneurship.
Dr. Goddard’s initial interest was human polymicrobial infection diagnostics. A friend had been hospitalized for late-stage lung cancer. The doctors suspected an infection in his lungs. The gold standard for detecting infections is to grow organisms in culture in order to identify them, and it took nearly two weeks for the test results to be confirmed. “In the meantime, my friend was lying in the pulmonary ICU, and the infection was growing inside his lungs. It was a powerful reminder that even routine medical diagnostics needed an overhaul.” So Dr. Goddard started to think about how to make a low-cost, easy-to-use, method to isolate pathogenic cells from everything else. She quickly realized, however, that the healthcare diagnostic field is highly competitive and dominated by a few huge global companies. She was starting a venture from scratch – as a lone, first-time entrepreneur – and it would be incredibly difficult to compete.
“When you start your company, you pick your goal and want to be in a space where you are not going to be plowed over in five minutes.” So she decided to investigate the possibilities that lay in food safety diagnostics – a smaller, more opportune market that would allow her some breathing room in her R&D niche. Similar to the healthcare industry, much of the food industry’s pathogen testing was constrained to culture-based diagnostics, imposing the same time lag. If farmers could perform quicker testing, they could prevent contaminated produce from entering the distribution chains. If farmers could perform cheaper, more frequent testing, they would only have to discard smaller lots if contamination was found. Dr. Goddard decided to focus on building a technology to eliminate culturing from the diagnostic pipeline.
Her solution is HARVEST, an easy-to-use, hand-held, sample preparation device. Wash water or produce slurry is collected in a bottle with a special substrate column attached to the bottom. Using a vacuum, the water or slurry is pulled through the substrate, capturing bacteria. Then the live bacteria can be released from the substrate with a special buffer, collected into a small tube, and then sent to a lab for molecular diagnostic testing. Using the HARVEST technology, samples can be tested for contamination in a matter of hours rather than the days required for culturing.
The HARVEST technology was entirely developed at Goddard Labs. However, Dr. Goddard started to think about the direction of her startup while still a faculty member at Hunter College. “Most faculty contracts have a consulting clause allowing a certain percentage of time to devote towards those endeavors. So I decided that I would use my consulting time to establish an independent facility to decide what I wanted to do.” She looked at a number of the New York City incubators, including the Audubon Business and Technology Center, SUNY Downstate Biotechnology Incubator and the Alexandria Center, to find a place outside of Hunter to do her research. However, laboratory rent prices in New York City at that time were prohibitive if you were self-funding a company on a faculty salary. So she looked east, to Long Island, and discovered the Stony Brook University’s Calverton Business Incubator.
She began to build out her Stony Brook lab in 2012. “The initial buildout took me quite a bit of time because you are bargain shopping. You have only a limited floor plan you can put things in to. You are looking at used equipment websites, and if you type in ‘refrigerator’, you get 5,000 types of refrigerators you can choose from, none of which have the space specs for what you need. Shipping costs can also become prohibitive depending on where you are getting it from.”
In 2013, the New York Economic Development Corporation helped to fund an affordable startup incubator, Harlem Biospace, which has much of the equipment a biotech startup might need already built in. “I really applaud the efforts to create these core facilities like the Biospace, because people don’t think about how much money is involved in just getting a basic molecular biology lab together.” (A new NYC life science incubator, BioLabs New York, has recently announced it will be opening in 2016).
Dr. Goddard’s professional transition from academic to entrepreneur was accompanied with a similar mindset transition. “Doing (academic) research is different, because if you are in a laboratory and an experiment doesn’t work, you get together, discuss, and decide a new direction and try it. And it’s not the end of the world. You find another interesting question and you move forward. In a company, each one of those decisions takes time, and time is money. You become really aware of that when you are self-funded.”
In trying to get her company going, Dr. Goddard made a few early missteps. Her early attempts at getting NIH SBIR/STTR grants did not work out. “The NIH SBIR/STTR route is much easier if you have an active partnership with an academic lab. If you don’t, you’d better have some publications. That is literally where I screwed myself. I never really thought of doing food safety research before I started writing SBIR applications. I started to get dinged because I didn’t have the right academic qualifications, no matter how good the idea was. I think a common academic misconception is the perceived ease of acquiring SBIR funding, versus standard research grant pathways. The time involved in the application and review process is similar to any NIH or NSF grant. You need to apply at least a year before you anticipate needing the funds.”
Fortunately, Long Island has been actively building its entrepreneurial ecosystem, and she was able to find assistance in the community. At Stony Brook’s Long Island Innovation Boot Camp, she was teamed up with a legal advisor, tech transfer officer, graduate and business students interested in entrepreneurship. They became her team for the duration of the bootcamp. Stony Brook invited an expert to lecture on assembling a successful pitch deck. Dr. Goddard’s team hashed out what details should be on each slide, and at the completion of the bootcamp, she presented the deck in front of a panel of investors for feedback. She also joined the Accelerate Long Island (ALI) Accelerate Assist program. The program teamed her with legal and MBA student interns. Her MBA students conducted a market research study for Goddard Labs.
“It (marketing research) is one of the hardest things to do for your own company because you are always biased. And there is a bandwidth thing. If you have five people searching the internet, you have a better chance of finding something.” Her team discovered one particular insight that significantly impacted the direction of the R&D prototype development. “One of the big surprises from the report lay in the details of the new regulatory situation. Farmers and distributors will go through external auditors for sample collection. So that means my customer isn’t the farmer, it’s the laboratory.”
In addition to programming for Long Island companies, Accelerate Long Island provides funding. The Accelerate Long Island Seed Fund teamed up with the Long Island Emerging Technologies Fund (LIETF) (a partnership between Topspin Partners and Jove Equity Partners) to provide seed funding for Long Island-based biotech and clean energy companies. Last year Dr. Goddard received $100,000 in seed funding from ALI and LIETF which she used to buy an expensive piece of equipment she needed.
Dr. Goddard is currently raising money to manufacture and distribute a HARVEST prototype to test with local partners. Additionally, she is considering hiring her first technician so that she can spend more time raising money and working with partners and less time in the lab. You will be able to see Goddard Labs present at our upcoming “Best of the Best” event on December 7th.