When he was appointed BioEntrepreneur-in-Residence (B-EIR) by the Center for Biotechnology in June of 2013, Joe Scaduto was finally able to make the transition from biotech start-up advisor, advocate and enthusiast to actual entrepreneur. For Scaduto, it was the fulfillment of a life-long aspiration. I have always wanted to create and build something, to leverage my formal education in science and business, tap my inner entrepreneurial spirit, and follow a deep desire to determine my own destiny and career success, he says. The Center for Biotechnology’s B-EIR program provided the financial support and practical resources that I needed to do that. Without that program I would not have been in a position to start Traverse.
Still, Scaduto was in a better position than most novice entrepreneurs to maneuver through the complicated terrain of biotech commercialization. Prior to his appointment, Scaduto spent over seven years as Assistant Director of Business Development at the Center for Biotechnology where he played a critical role in introducing and implementing programs (B-EIR among them) that expanded the Center’s footprint as an invaluable resource for biotech commercialization and entrepreneurship on Long Island. In many ways, working with those early stage companies did prepare me for stepping into the entrepreneurial role, he says, quickly adding, Of course, it’s different when you’re in the hot seat.?
For the first six months, Scaduto was figuring out what technology Traverse was going to focus on. It took that long to sift through the top options, he says. In November of 2013, we finally decided on veterinary medicine and identified canine periodontal disease as our first indication, he says. Early in the process, Scaduto recognized that he had a platform technology with multiple applications both for human and veterinary needs. He started talking to clinicians and the big players in the pharmaceutical and animal health industries. And the feedback we received from veterinarians, veterinary dentists and those big players was much more enthusiastic and quickly validated the unmet need in that area, he explains.
In February of 2014, Traverse successfully negotiated an exclusive option to license a proprietary library of polyenolic zinc-binding agents from the Research Foundation of SUNY. The agents were developed by Drs. Lorne Golub (Department of Oral Biology and Pathology, School of Dental Medicine, Stony Brook University) and Francis Johnson (Departments of Chemistry and Pharmacology; President, Chem-Master International, Inc.). Two months later, the company received $100,000 in seed funding from The Accelerate Long Island (ALI) Seed Fund and the Long Island Emerging Technologies Fund (LIETF).
Now that he’s a client of the Center, Scaduto meets with the staff on a regular basis for help with grant proposals, investor presentations, market and competitive analyses and much more. It’s all the stuff I was doing before and the programs I helped create,? he says.
Scaduto admits that entrepreneurship is sometimes a grind and always strenuous and demanding. I think one of the biggest challenges I previously didn’t recognize is how quickly time passes, during which a start-up company is burning cash and the intellectual property clock is ticking, he says. Everything seems to take longer than anticipated, from business strategy, market and competitive analyses, to introductions, meetings and follow-ups with prospective investors and so on.
An optimist at heart, Scaduto is also realistic. That is why the most difficult aspect of the transition was fully accepting that failure is not only an option, but that it is a highly likely outcome of any entrepreneurial venture, especially one based on technology, and even more so in the life sciences, he says. I try to manage this hard reality by mentally separating business failure from personal failure, and by relying on my wife and family for unconditional love, support and encouragement.
After emerging from academia, molecular biologist Piraye Yurttas Beim, one of a handful of experts in the genetics and molecular biology of female mammalian infertility, set out to apply her substantial scientific skills to improving the treatment of female infertility by developing innovative diagnostic tools, technologies and methods. I wanted to take some of the guesswork out of achieving a viable pregnancy and ultimately transform how we approach infertility, she says.
In May of 2009, Beim and neuroscientist Laura Toward Bandak, co-founded their biotech baby and named it, Celmatix, Inc.
While the pairs combined scientific scholarship was formidable, their entrepreneurial expertise was less robust. The training you get as a scientific researcher doesn’t necessarily overlap with the knowledge base you need to be a successful entrepreneur,? says Beim. As academics evolving into entrepreneurs, they needed help to nurture their start-up.
And that’s how we came to the Center for Biotechnology, says Beim. The Center is so important in helping scientists like us, who have an entrepreneurial idea and want to create a company, to turn the research into a product that has commercial potential.
Beginning in September 2009, Celmatix took part in various Center programs starting with the BioStrategy Sessions. In those sessions, we gained critical insights that helped us refine our business plan and retool our initial investor’s pitch deck, says Beim.
During the Technology Commercialization Clinic (TCC) program, Celmatix interacted with business and law students studying intellectual property and other relevant law. They helped us focus on the competitive landscape around the technological approach that we were using to optimize fertility treatment and care, says Beim. And the market research they gathered furthered our understanding of the reproductive technology landscape, what existed and how our approach and technology fit into the terrain, she adds. In addition, the TCC helped us appreciate certain aspects of the competitive landscape that hadn’t been obvious to us.
In March of 2010, Celmatix participated in the 2 day Long Island Innovation Boot Camp/Pre-Seed Workshop where they had the valuable opportunity to pitch their business model to a panel of judges including advisors and investors who offered constructive feedback. One of those investors was Steve Winick, a partner at Topspin, a Long Island-based private equity firm. After Celmatix pitched the panel, Winick approached Beim and told her to contact him when the company was ready to raise funding. About a year later in February of 2012, Topspin Partners led the company’s Series A round funding that raised 8.5 million in capital. The infusion of funds enabled Celmatix to expand its research efforts and continue its development of its lead product, FertilArray ?, a non-invasive diagnostic for assessing female egg quality and genetic indicators of female infertility.
Looking back, Beim says the Center was critically helpful. We learned how to translate scientific work into investor friendly terminology, honed our presentation skills and became fluent in the language of venture capital coming to understand and explain a value proposition and how the vision of what we had fit into the framework of a commercial enterprise, she says. And all those pieces ultimately helped us have the conversations we needed to raise funds The Center was one of our early supporters; they believed in what we were doing, adds Beim.They helped Celmatix go from start up to success story.
After research stints at Rockefeller University and Wyeth Pharmaceuticals, Paul Sheiffele decided to carve out his own entrepreneurial niche in the biotech industry. Fifteen years later, inGenious Targeting Laboratory (iTL), the company he started with two partners, is a 10 million dollar company and a global leader in providing gene targeted custom mouse models to researchers in academic and medical institutes, government research centers, and pharmaceutical and biotechnology companies.
According to Sheiffele, the company’s growth and success is in no small part due to its association with the Long Island High Technology Incubator (LIHTI), the Center for Biotechnology and with Stony Brook University.
Back in 1999, when Sheiffele and his two partner founded iTL, the start-up needed much more than affordable office space. They needed academic partners and support and access to a top notch animal care facility for their growing mouse population. One of the founding partners suggested the Long Island High Tech Incubator at Stony Brook. It turned out to be a match made in entrepreneurial heaven. Along with securing a spot and space in the Incubator, iTL was able to utilize Division of Laboratory Animal Resources (DLAR) to house and care for the mice. “Having a functioning, well-run facility in place to work with was a vital component,” explains Sheiffele, “because if we didn’t have ‘clean’ mice, we would have developed a bad reputation. Without that very successful, well run facility we never would have been successful,” he says emphatically.
iTL also reached out to the Center for Biotechnology. “They guided us through the process of building initial faculty advisors and facilitated meetings with academic researchers,” says Sheiffele. “They also helped us apply for and secure grant funding. Their support allowed “us to focus on development, sales and marketing and R & D,” he adds.
At the Technology Commercialization Clinic (TCC), Sheiffele who describes himself as “relatively naive about intellectual property” got well-schooled in the “importance of IP” and the art of writing and applying for patents. “Those sessions put you on the road to really understanding the patent process, what to look for and what to look out for and how to break down the important aspects of a patent,” says Sheiffele.
In 2011, after 12 years at LIHTI, iTL moved into a 20,000 square foot facility on Long Island. But the move didn’t end the company’s association with the Center and Stony Brook. In fact, the Center helped iTL navigate local politics, taxes and zoning to secure their new Suffolk County facility. And though iTL left the premises, some 2,000 iTL mice still call the DLAR home. And just a few months ago, when Sheiffele needed a sales person, he called on the Center for a recommendation and ended up hiring that person.
Sheiffele’s advice for business starting up or scaling up is simple: “I would recommend connecting with the Center to anyone starting or scaling up a business. They can help you in so many ways. And if they can’t they’ll put you in touch with people who can.”
In most medical specialties, treatment is trending away from surgery towards less invasive interventions to treat diseases. But for orphan diseases those that affect only a small percentage of the population-and therefore have a limited market – identifying and developing such alternatives is more difficult. One example: Dupuytren’s Contracture, a disorder in which excess collagen accumulation in the palm and fingers causes thick, inflexible cords to form triggering a progressive and permanent curling up of the fingers.
Historically, the standard of care has been surgery to cut the cords. But now, thanks to the investigational research begun in the mid ’90s by Drs. Badalamente and Hurst, a non-surgical treatment received FDA approval in 2010. The treatment, known by the brand name Xiaflex, consists of injections of Clostridial collagenase – a highly purified form of a common bacterium – into the affected cords. Collagenase breaks up the cords and relieves the flexion.
In 2013, Xiaflex was also approved by the FDA for the treatment of Peyronie’s disease in which fibrous scar tissue develops inside the penis that causes a significant bend or pain. In addition, Edward Wang, M.D., Associate Professor of Orthopedics at Stony Brook, Dr. Badalamente is studying injectable collagenase as a treatment for frozen shoulder (adhesive capsulitis), a condition in which scar tissue forms around the shoulder joint, restricting movement. Licensed to Malvern, Pa.-based Auxilium Pharmaceuticals, Inc., this application is in clinical trials.
And in a lighter vein, Clostridial collagenase just may turn out to be a silver bullet for a condition that is the scourge of women everywhere: cellulite. In 2006, Dr. Badalamente and a colleague conducted a small study. The results, she says, were very promising.
In the laboratory as in life, a minor makeover can make a big difference. While at Stony Brook University in the early 90’s, Glenn Prestwich and his research team found a way to transform hyaluronic acid, or HA (perhaps best known today as a cosmetic facial filler or injectable for arthritis), from a shapeless “goo” into a functional, customizable biomaterial with a multitude of applications.
HA is a naturally occurring, gel-like substance found throughout the body that acts as a joint lubricant, a protective agent and helps maintain the shape of the eye.
For researchers, the problem is that HA is rapidly turned over; in the body, it degrades and is remade all the time, says Dr. Prestwich. At Stony Brook we found a way to modify the chemistry of HA, to make it last longer and to give it shape we controlled the composition and the stiffness of the gel and then a whole range of commercial opportunities became evident.
Since then, the applications of HA have blossomed to include products for preventing post-surgical adhesions, in ophthalmic surgery, to promote wound healing and tissue repair. Within the past several years, we’ve been investigating HA as a cellular scaffold for tissue engineering, in other words, going beyond just repairing tissues to actually growing new tissues, says Dr Prestwich.
What started at Stony Brook has now been commercialized by five companies-Clear Solutions Biotech, Sentrx Surgical, Carbylan Biosurgery, Glycosan BioSystems and Sentrx Animal Care
The lifespan of human platelets is fleeting about ten days, on average. But during their brief sojourn in the human body, these cells play a critical role. They patrol the vascular system looking for any tear or leak in a blood vessel in need of repair. The first platelets on scene stick to the vessel wall to stem the bleeding. When reinforcements arrive, the platelets crowd together creating a kind of cellular superglue in a process called aggregation.
At least, that’s how it should work. For reasons that are not always clear, platelets can overreact, forming clots in blood vessels constricted and damaged by atherosclerosis (plaque build-up). These clots can block the flow of blood leading to a heart attack or stroke.
In the 1970s and 80s, while researching the cellular mechanism of aggregation at Stony Brook University, Dr. Coller developed a monoclonal antibody that inhibits the action of a key protein receptor involved in platelet aggregation. His discovery and his subsequent collaboration with scientists at Centocor led to the creation of abciximab, a drug that effectively prevents platelets from closing off blood vessels.
In 1994, the drug, marketed as ReoPro® won FDA approval to prevent platelets from sticking together and causing blood clots following coronary angioplasty. The drug, which has been administered to an estimated 3 million people worldwide, has the distinction of being the first drug ever developed by a SUNY institution that was approved for sale by the FDA.
Candies, chocolates and cookies that prevent cavities? No, you’re not dreaming. In the not-too-distant future, sweet treats may become a delectable part of daily dental care for kids, and happily, for adults. The tooth-friendly treats are actually sugarless confections infused with CaviStat®, a novel anti-cavity agent developed by Dr. Kleinberg and his research team. The technology mimics the natural protective action of saliva by neutralizing harmful acid-producing oral bacteria while protecting the teeth against destructive acid demineralization. It is available in a commercial product called BasicMint®.
Two clinical studies have confirmed CaviStat® efficacy. In one with 200 children, those who received twice daily doses of BasicMint®, had up to 75% reduction in dental caries compared to their controls. In another study with 726 children, CaviStat® incorporated into toothpaste cut cavities by more than half compared to a fluoride dentifrice.
CaviStat® technology should mean substantial reduction in cavities and big reduction in treatment costs, says Dr. Kleinberg. And, if CaviStat® is applied to teeth before caries is visibly detectable, such pre-caries lesions can be repaired by re-mineralization treatment, thereby avoiding dreaded drilling and filling.
Dr. Kleinberg’s lab is a fertile breeding ground of ideas and inventions. His team is currently involved in 16 projects in various development and marketing stages. Besides CaviStat® for dental caries, these include two products that reduce dentinal sensitivity: DenClude® for home use and ProClude® for professional use. Both resulted from licensing to Ortek Therapeutics on Long Island and sub-licensing subsequently to one of the world’s largest dental consumer companies for world-wide marketing. A mouthwash that eliminates halitosis has also been developed and is being marketed by another start-up company. An electronic caries explorer, yet unnamed, has reached the manufacturing stage. It is capable of detecting cavities long before they are present visually.
Based on his decades of research into the complex oral ecosystem, Dr. Kleinberg is now examining the metabolisms of the under-arm, between-toes, vaginal, nares (nose) and colon microbial communities. These investigations have given us a broad understanding of how mixed bacteria become unbalanced and cause disease, says Dr. Kleinberg. We now know how to correct microbial community imbalances and are building a significant pipeline of novel health care products and treatments based thereon.
In the last year of my PhD program in chemistry I heard about the Fundamentals of the Bioscience Industry Program. I hadn’t had any exposure to opportunities beyond bench work and I knew that when I completed my degree, I wanted to work outside of the lab. To say the program was eye-opening is an understatement. Not only did I gain insight into the various functions within the bioscience industry that I can leverage my scientific background, the skills I learned participating in the program’s real-world technology project provided me with the foundation upon which I’m building my career.
The opportunity to network with course directors and diverse guest speakers that are involved in the program is incredibly beneficial. I secured a coveted internship with a prominent New York City venture capital firm because of my interactions with a guest speaker. That internship, and the skills I learned in the program, afforded me the opportunity to become a Technology Commercialization Fellow with the Center for Biotechnology and ultimately, led me to my current position. I thoroughly enjoy the work that I’m doing with start-up companies and early-stage technologies, and I don’t think I would have even known about this type of work had it not been for the program. I can’t say enough how important the Fundamentals Program is to young life scientists looking to build a multi-dimensional career.