Later this month in San Diego at the BIO International Convention, BIO will be partnering with the National Institutes of Health (NIH) and the National Science foundation (NSF) to host the first-ever BIO Innovation Zone. The Zone will feature Small Business Innovation Research (SBIR) funded early-stage biotech companies.
The SBIR/STTR program provides U.S. federal funding to small businesses engaged in research with the potential for commercialization. Companies are rigorously vetted through the NIH and NSF SBIR review process prior to receiving the funding. The majority of participating companies in the Innovation Zone have received SBIR Phase II grants, which provide up to $1 million dollars in funding to engage in R&D that has the potential for commercialization.
Over the new few weeks, we will feature snapshots of a few of the companies who will participate in the Zone. Today, we interviewed Ayla Annac, the president & CEO of Madison, Wisconsin-based InvivoSciences, Inc., a small business supported by NIH’s SBIR program.
What is your company’s lead product or technology?
InvivoSciences, Inc. (IVS) is a leading developer of proprietary human 3D cell/tissue culture models for highly-predictive, multi-parameter phenotypic assays both in pharmacology safety & discovery screening and in personalized and regenerative medicine. Our functional 3D tissue models recapitulate the physiological properties of cardiac, smooth and skeletal muscle and connective tissue, as well those tissues in diseased states, e.g., hereditary cardiac diseases, cardiac fibrosis, cancer and orphan diseases. Our unique combination of tissue engineering technology with assay automation and sample miniaturization offers a rapid and cost effective platform for unprecedented therapeutic discovery.
IVS is addressing a significant, well-recognized but underserved problem with a technology that can effectively fill the gap in the existing large market.
Cardiovascular diseases (CVDs) are the number one cause of death globally. The high failure rate of cardiovascular clinical trials (e.g., 11% of Phase II failure between 2008-11) indicates that there is an unmet need for more focused approaches, including personalized drug discovery for specific patient groups or even for rare genetic diseases, i.e., orphan drug market.
Cardiovascular safety liabilities remain the major cause of costly drug withdrawals (e.g. 52.3 % drug withdrawals were cardiac safety related between 1980-2011). Our engineered heart tissue based phenotypic analyzer enables scientists to address cardiac safety issues and identify their mechanisms and pathways rapidly and efficiently.
Tailored to represent diverse human populations and specific diseased states, our EHTs can offer an exceptional ability to predict potential cardiac safety issues and drug efficacy in clinical studies.
How has the NIH SBIR program helped your company grow?
National Institute of Health (NIH) SBIR program has supported IVS to achieve proof-of-concept studies of cardiac safety applications of our innovative technologies in collaboration with major pharmaceutical companies. NIH’s leadership has recognized our invention and its future value at its present early phase. This enabled IVS’s scientific team to continue critical proof of concept studies to build a strong foundation for commercialization. Strong data led to the establishment of collaborative strategic partnerships. The funds also created new jobs to support the future growth of the industry segment. The National Federation of Independent Businesses estimates that about two-thirds of the new jobs in recent years have been created by small businesses, and that start-ups including technology base account for a large share of these new jobs.
Without NIH support and the entrepreneurial mechanism of its funding structure, IVS would be only “a dream concept “ in the minds of its three founders. It would not have been able to sustain the business structure essential for its growth and hire a technical team to support the creation of solid data that led to a rich globally competitive IP portfolio. Moreover, without this support IVS would not have been able to attract multiple dynamic collaborations with key industry and academic partners that helped IVS create a rich and diverse product/assay and service portfolio that is designed towards unmet needs of drug discovery, development and patient populations with debilitating diseases. We appreciate NIH’s vision for innovation-based growth economies and its ability to prepare entrepreneurs with commercial guidance under the CAP program in collaboration with the Larta Institute. Thanks to the leading efforts of Dr. Lenka Fedorkova, PhD, program manager for NIH SBIR/STTR programs, IVS and hundreds of other biomedical companies can dare to take the path to commercialization of innovative technologies, and we have the opportunity to showcase our cutting edge technologies along with other exciting companies who are working diligently on next generation healthcare solutions at Innovation Zone.
What are the upcoming milestones and long-term priorities for your company?
IVS seeks sufficient private funding to enable and support our global commercial growth plans as well as to scale up and fully-automate manufacturing of human engineered heart tissue production. We also aim to complete proof-of-concept studies for developing disease models of inherited heart failure.
What do you hope to gain out of your participation at the 2014 BIO International Convention?
IVS plans to promote its innovative technologies and its product and service portfolio to potential customers and to establish strategic partnerships with pharmaceutical and biotech companies while connecting with potential private funding partners to share the business opportunity.
Tell us something about your company that investors might not know.
US food and drug administration (FDA) will most likely amend the current preclinical cardiac safety protocol. InvivoSciences, Inc. is an active member of the cardiac safety technical committee organized by HESI (http://www.hesiglobal.org/i4a/pages/index.cfm?pageid=3431) to review new technologies such as applications of human induced pluripotent stem cells (iPSC) derived cardiomyocytes for improving preclinical cardiac safety assays. Other members of the committee include FDA and most of the global pharmaceutical companies.
Visit booth 5449. See our presentation on June 26 at 11 AM in Solana Beach Room. www.invivosciences.com