CEO Alan Schneyer and COO Elissa Brown were busy today working the Innovation Zone at BIO 2019 in Philadelphia, meeting with potential partners and working to raise investment for future development of their technologies.
Fairbanks was able to display in the Innovation Zone because the company was awarded an SBIR grant in 2018. As BIO describes it, the Zone enables “Small Business Innovation Research (SBIR) funded early-stage biotech companies to showcase their cutting-edge technologies, form long-term partnerships, and begin to raise funds in the private sector.”
There was a time when graduate students entering life science PhD programs set their career goals on an academic research position at a university, a view consistent with the most common advice from mentors and advisors. However, over the past 20 years or so, the number of such jobs has fallen far short of newly minted PhD’s. A recent article in Science reported that the number of new PhD’s entering the private sector was equal to those entering academia for the first time last year. Meanwhile the number of tenure track positions held by PhD’s dropped 10% since 1997 to 23%. All of this leaves mentors pondering what advice to give to new students regarding their most likely career choices as well as what is the proper number of students to accept into PhD programs given these career realities.
My experience starting Fairbanks Pharmaceuticals in 2014, after a long career in academic research, has shown me that another increasingly attractive career choice, for both new and old PhD’s, is to take an entrepreneurial approach to scientific research. While this necessitates focusing on research leading directly to commercially viable products, it is just as rewarding in terms of contributing to overall human health as the more abstract biomedical research found in academia. And, as an added bonus, it is increases the probability that research discoveries become new treatments for patients since it facilitates transfer of academic research discoveries into commercially viable therapeutic opportunities.
To advance this idea, the Endocrine Society, at my urging, held a discussion event at their 2018 annual meeting that was attended by more than thirty members, whose interests included promoting an “entrepreneurial” track and programming at the annual meeting, with the goal of helping members achieve their entrepreneurial goals. This interest led Endo to hold a symposium at the 2019 meeting in March in which three entrepreneurs at different stages of development described their experience, including my experience with Fairbanks. This presentation described how one might get started by using financing from the SBIR program at NIH.
This success has led to suggestions that the Endocrine Society test new programming at next year’s meeting in San Francisco focused specifically on entrepreneurs. Potential ideas have included a pitch competition (similar to ABC’s “Shark Tank”), a networking session with potential partners inside and outside of pharma, SBIR grant proposal training, and practicing how to speak with potential investors. Stay tuned or check with ENDO2020 in the fall of 2019 to see what programming is actually planned, and if your research is in an endocrine field, apply to participate in the competition. If this new programming is successful it might foster other professional societies to help their members enter this career track.
I founded Fairbanks Pharmaceuticals to develop potential novel diabetes therapies based on my National Institutes of Health (NIH)-funded research over a period of 35 years. Fairbanks is currently funded by a Phase II SBIR grant from the National Institute of Diabetes and Digestive Diseases (NIDDK) at NIH.
NIH is the most important agency of the federal government dedicated to funding biomedical research that leads to better health for Americans. Since this research is often lengthy and labor intensive, consistent funding that keeps up with inflation is essential for a vibrant research effort that maximizes the benefit of NIH-funded research.
On March 5th, 2019, I joined two other Massachusetts-based biomedical researchers to visit our congressional representatives as part of the Federation of American Societies for Experimental Biology (FASEB)’s Capitol Hill Day to discuss how critical this funding is for health.
We first met with staff from Representatives Joe Kennedy and Katherine Clark, who were already familiar with, and big supporters of both the NIH and National Science Foundation (NSF). In our meetings we discussed funding increases for NIH and NSF and the specific opportunities and needs based on FASEB analysis.
We also visited the office of Representative Lori Trahan, whose district includes Concord, MA, where Fairbanks is located. Meeting with her staff members we explained our request that Representative Trahan support the recommended budget increases for NIH and NSF. I mentioned that our SBIR grant has helped us create three jobs in Massachusetts while allowing us to further evaluate our diabetes therapy. We were assured of strong support from the entire Massachusetts House delegation.
Our final visits were with staff from the offices of Senators Ed Markey and Elizabeth Warren.. At each office we found the same unwavering support for biomedical and basic science research funded by both NIH and NSF. We were impressed by and appreciative of the expertise on biomedical topics and specifically diseases like diabetes displayed by the staff we met. They were also sympathetic to the need for the continued level support necessary to attract the next generation of scientists into research as well as to continue progress on longer term research efforts.
The opportunity to speak with the Massachusetts delegation about the benefits of biomedical research was both enjoyable and productive. I look forward to continuing this discussion in the home districts over the coming year.
Boehringer Ingelheim (BI) and the BI Venture Fund have awarded Fairbanks Pharmaceuticals the prestigious 2018 Boston Innovation Prize “Golden Ticket.” The prize recognizes the challenge and dedication it takes to successfully build a new company by supporting the innovation process and celebrating life-science entrepreneurs. The award, worth up to $75,000, includes one year of rent at the LabCentral facility in Cambridge, MA. Dr. Clive Wood, Senior Vice President of Discovery Research at BI, presented the award to Dr. Alan Schneyer, Fairbanks’ CEO.
LabCentral is a first-of-its kind shared laboratory space designed as a launchpad for high-potential life sciences and biotech startups. As a testament to its success, in recent years, LabCentral residents and alumni have raised over two billion dollars, with over $750 million dollars in financing in 2017 alone.
Fairbanks Pharmaceuticals was chosen from a field of ten early-stage bioscience organizations that presented their pitches to a panel of judges. “We are honored to have been selected by BI as the best young biotech company and we greatly appreciate the validation of our idea and approach by such a distinguished pharmaceutical company” said Dr. Schneyer. Dr. Schneyer said that he and his team are excited for the opportunity to locate in Lab Central in Cambridge, the center of biotech entrepreneurism. Fairbanks is also looking forward for the opportunity to work more closely with BI scientists to facilitate development of our lead candidates.
With a Phase II SBIR award in hand, Fairbanks Pharmaceuticals CEO Alan Schneyer and team are moving quickly to execute the project plan and achieve the goals of the grant. At a kickoff meeting at the Baystate Research Facility in Springfield, MA, Fairbanks team members worked on planning activities and enjoyed a celebratory lunch that was joined by their scientific and technical colleagues working in the BRF.
The SBIR grant, entitled “Development Of Novel Diabetes Therapies Based On Neutralizing FSTL3 Activity”, provides a total of $1.8M in funding for two years of research. The immediate focus of this research is to test the lead compound in animal models of diabetes for safety and effectiveness. The remaining goals are to identify the mechanism(s) involved in its beneficial effects and engineering the compound to be a more effective therapeutic in humans.
Fairbanks Pharmaceuticals, Inc. has been awarded a Phase II Small Business Innovation Research (SBIR) grant for $1.83M from the National Institutes of Health.The Phase II SBIR is a highly competitive program that encourages domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization.
Fairbanks was awarded the SBIR grant for its proposal “Development Of Novel Diabetes Therapies Based On Neutralizing FSTL3 Activity” following up from the demonstration of feasibility duringits Phase I SBIR grant awarded in 2016. The Phase II award started in June 2018 and will run for two years.During this time Fairbanks will test its lead antibody in vitro and in two mouse models of diabetes for efficacy in treating diabetes.Another arm of the study will analyze whether this antibody treatment induces regeneration of beta cells through transdifferentiation from alpha cells.
It is anticipated that Fairbanks will be in a position to begin human testing around 2020.With preliminary results obtained as a result of pursuing SBIR funding, Fairbanks is currently in discussion with potential partners to help develop this therapy for human use.
On Sunday, June 24th, Fairbanks Pharmaceuticals CEO Dr. Alan Schneyer presented a poster at the American Diabetes Association meeting in Orlando entitled “FSTL3 Inhibition Restores Glucose Responsive Insulin Secretion In Non-Functional Human Islets”.
Theposter describes identification of FSTL3 neutralizing monoclonal antibodies, verification of their specificity and ability to inhibit FSTL3 binding to activin A and B as well as GDF11, and the ability of these antibodies to disrupt pre-formed FSTL3-activin complexes that otherwise are stable.
Also shown was experiments in which human islets that lost their ability to secrete insulin in response to glucose (the most critical contribution of the beta cells) were restored to glucose responsiveness after exposure to Fairbanks’ antibodies.These results support further development of this FSTL3 neutralizing approach as a novel therapy for diabetes.
Fairbanks Pharmaceuticals was selected as a semi-finalist for this year’s Diabetes Challenge competition. The poster pictured above was submitted for display at the May 21st event that will include a pitch competition among the finalists.
The poster first emphasizes that diabetes is caused by inadequate production of the hormone insulin and, critically, that insulin comes only from cells called beta cells. In type 1 diabetes, beta cells are destroyed by a patient’s immune system leaving them without insulin for the rest of their lives. In type 2 diabetes, which affects 95% of diabetic patients, beta cells gradually lose insulin production for a variety of reasons and eventually fail to secrete enough insulin to control blood glucose, leading to a host of associated maladies. Fairbanks Pharmaceuticals is developing a new type of therapy that will restore function to these beta cells and over time, induce regeneration of new beta cells in order to restore natural insulin production.
The next panel shows the scientific evidence that led to this therapeutic strategy. A protein called FSTL3 regulates growth factors in the TGF-beta family known as activin, GDF11, and myostatin. By eliminating FSTL3 in mice we found that their islets were doubled in size and they contained many more beta cells. This allowed them to more easily control blood glucose and were more sensitive to insulin that was produced by these beta cells (red lines on graphs on right side). This suggested that a therapy which could completely block FSTL3 might induce more beta cells and better insulin production, the basis for Fairbanks’ therapy.
On the right side of the poster is our research and development team as well as our scientific advisory board that includes basic scientists who are experts in FSTL3 and the TGF-beta family, diabetes clinicians who are also researchers, and diabetes clinicians who have successfully developed drugs for diabetes.
Below that is a panel showing that Fairbanks has produced at least 1 antibody that can neutralize FSTL3 (FP-101). In one test of its activity, this antibody was used to treat human islets (containing beta cells) that behaved like defective diabetic islets. After 24 hours of treatment, the defective islets regained their ability to secrete insulin in response to elevated glucose, suggesting that the antibody could restore diabetic islet function as proposed. This also indicates that the FSTL3-activin system is functional in human islets.
Finally, the last panel indicates that Fairbanks has applied for a patent and funded its work so far with personal funds, a Phase 1 SBIR grant (completed April 2017) and is awaiting the imminent start of our Phase II grant.
The Endocrine Society held its Annual Meeting in Chicago March 17-20th, 2018. A major focus of endocrinology involves metabolism and diabetes and Fairbanks Pharmaceuticals CEO Alan Schneyer presented the progress achieved by Fairbanks Pharmaceuticals in developing a new diabetes therapy in a poster on Monday March 19th.
In the poster he described the scientific basis for the therapeutic strategy of neutralizing FSTL3, development of antibodies that can achieve this goal, and initial testing showing promise on diabetic mouse islets.
In recognition of its strength and uniqueness, the poster was selected for a new activity where top posters are presented orally to an assembled group of scientists during the poster session. The response to this therapeutic was positive and encouraging and we look forward to continuing the development program with in vivo studies in the near future.