A simple, safe and cost effective blood test for diagnosing ovarian cancer before its too late and too far gone to cure.
What is the critical gap in cancer treatment that you are addressing?
The key to surviving cancer is to find it early, before the disease has had a chance to spread to multiple places of the affected organ or to distant sites in the body. We know that earlier diagnosis of cancer can dramatically improve treatment options, clinical outcomes and survival.
The quest for an early detection test for ovarian cancer has consumed cancer researchers and patient advocacy communities for decades. This is because ovarian cancer is one of the deadliest disease for women worldwide with an overall mortality rate of 75%. However, in 90% of cases, ovarian cancer can be cured if diagnosed while the disease is still limited to the ovaries.
Regrettably, a robust, wide-use early detection test for ovarian cancer has been out of reach. Given the low prevalence of ovarian cancer in the general population, a general screening strategy must be highly sensitive (>75%) and highly specific (99.6%) before it can be implemented. This has yet to be achieved and as a result, 35,000 women worldwide each year, do not survive ovarian cancer beyond 2 months of their diagnosis.
IES Life Sciences (IES) is a Maryland based biotechnology company with a unique diagnostic technology that combines the detection of “interferons,” a set of 21 proteins launched in the blood stream during an immune response, with machine learning and artificial intelligence analysis. Our technology is a simple blood test designed to generate a unique interferon “signature” that indicates the presence of disease, before the appearance of classical symptoms. We believe the exquisite sensitivity our test will enable clinicians to detect stage 0/1 ovarian cancer, when the disease is still curable.
What is the key product development milestone you seek to fund?
Our next critical step is to obtain and test high quality blood samples from women with ovarian cancer and a panel of control samples (without ovarian cancer). The blood samples are expected to yield an ovarian cancer blood “signature” of detected interferons. The identification of this specific and sensitive signature represents the earliest key product development milestone.
Once we have identified an ovarian cancer interferon signature, we can proceed with the development of a diagnostic kit designed to test multiple samples at once from affected and non affected women. From there, we will use of artificial intelligence and machine learning to increase the sensitivity and specificity of our test for ovarian cancer.
If successful, IES will file for worldwide patent protection, will offer the test as a Lab Developed Test (LDT) to start producing revenue and will apply for FDA approval.
How will funds be used?
|Use of Funds||Cost||Number||Total US Dollars ($)|
|Ovarian Cancer and Control Blood Samples||$500||100||50,000|
|Test Components, Calibrators and Controls||$220||125||27,500|
|Development of Diagnostic Kit||$300||400||120,000|
|Machine Learning and Artificial Intelligence Analysis||150,000|
|Worldwide Patent Protection||100,000|
|Apply for FDA Approval||250,000|
What key resources have/will you acquire to facilitate the accomplishment of the above R&D milestone?
IES has developed a number of key relationships that will facilitate our goals for developing a diagnostic tests for ovarian cancer and other unmet diagnostic needs. The original discovery was born through a research agreement with the US FDA and Public Health Services. (A Materials Collaborative Research and Development Agreement.) To date, IES enjoys continued technical support with our FDA co-inventors and the FDA Laboratory of Immunobiology.
Other strategic alliances include The School of Pharmacy and Health Professions at the University of Maryland Eastern Shore (UMES). IES and UMES share resources, equipment (qPCR/ddPCR) and clinical and scientific expertise through a collaborative research agreement and a grant funded through the University System of Maryland (USM), Maryland Industrial Partnerships (MIPS) Program.
The Pathology and Laboratory Department at Beebe Healthcare is also an important collaborator. They help us access patients blood samples and provide clinical and pathology expertise.
Our contracted services with Vertex Laboratories is crucial for enabling machine learning and artificial intelligence automation help us identify the ovarian cancer diagnostic signature.
Support from the Maryland technology community, including the Maryland Technical Council, Startup Maryland and Startup Health have been vital to our process and will be instrumental for our future success.
If your technology were to disappear in the “Valley of Death” funding gap, how might this impact society?
Ovarian cancer is a death sentence. Most women do not survive because diagnosis of their disease is too late and too far gone for modern day treatments to work. The only hope for women is to find ovarian cancer early, but the development of early diagnostics tools has yet to come to fruition.
Compounding the issue, the incidence of ovarian cancer worldwide is increasing annually from 239,000 in 2012 to over 371,000 by 2035. Without an early diagnostic test by 2035, the world will endure the deaths of 254,000 women from ovarian cancer.
IES has a unique opportunity to change these dire statistical predictions. With the combination of artificial intelligence and machine learning algorithms, the IES test can identify the unique signatures of interferons in the blood that signify the presence of disease before symptoms arise.
Hence, the loss of the IES ovarian cancer test due to lack of funding would inevitably perpetuate a failed practice of diagnosing early stage ovarian cancer. However, if the IES technology can be faithfully developed, the concept of ovarian cancer being a treatable and curable condition is within our foreseeable future.
Mr. Spiegel is an Entrepreneur, CEO and Consultant with more than 30 years of experience in executive management, leadership and finance. He is experienced in all aspects of business formation from conception to go-to market. Mr. Spiegel is an effective communicator with the ability to leverage opportunities to achieve funding and organizational goals. Mr. Spiegel has worked with Fortune 100 companies in the arenas of Marketing, Logistics and Finance.
During his tenure at IES Life Sciences as one of the founding partners he has worked to bring the vision from concept to an operational company. He has worked with a team of scientists that developed cutting edge technology in molecular diagnostics and worked with legal counsel to patent, both in the US and internationally, a unique technology using the human immune system to diagnose diseases. Mr. Spiegel has presented this technology for usage in real world scenarios to both the US Department of Defense, Homeland Security and a large hospital group. He has also interacted with legislators and helped to modify existing tax incentive legislation in Maryland to meet the needs of and attract the biotechnology industry. Upon completion of the tax incentive legislation he relocated both the corporate office and laboratory from Pennsylvania to Maryland, including a laboratory partnership with the University of Maryland.
Mr. Spiegel holds a BS in Electrical Engineering from the University of Bridgeport and obtained his MBA in International Finance from the Wharton School at the University of Pennsylvania.
After law school Mr. Manoff clerked in the Pennsylvania Court of Common Pleas. Following his clerkship, Mr. Manoff joined the corporate department of a prominent regional law firm. After becoming a partner, he left the firm to form his own practice focusing on start-up, early stage and high growth companies. Over the next several years Mr. Manoff helped guide numerous firms to significant success. In 2005, Mr. Manoff was asked to join the management team of one of his clients, an innovative environmental company. After serving as General Counsel for a year, he was asked by the company Board to assume the role of President and CEO to lead the company through its entry into the public market. After steering the company through a successful entry into the public marketplace Mr. Manoff left to form his own management and financial consulting firm focusing on helping high growth companies with the management, legal and financial needs. In 2014, Manoff closed his consulting practice to focus all of efforts of IES Life Sciences.
Mr. Manoff holds a BS in Political Science from Albright College and a JD from The National Law Center at George Washington University.
Dr. Jubin is a visionary veteran biotech executive with more than a 27-year track record in R & D with therapeutic and diagnostic expertise. He has a proven ability to synthesize new scientific breakthroughs into cogent discovery programs with a proof of concept design approach strategy to drive and reach go/no go decision points. He demonstrates an adroit set of leadership skills across the continuum of drug development. From the washroom to boardroom, real life experience provides for comprehensive project development with accurate and achievable development milestones. Dr. Jubin has an expertise in a broad range of therapeutic areas including, autoimmunity, hematology, immuno-oncology and viral immunology and a strong business acumen with success in cost-effective budget planning, effective outsourcing and establishing high-value collaborations, strategic alliances and partnerships
Dr. Jubin holds a BS in Biology from Kean College, an MS in Microbiology from Seton Hall University and a PhD in Microbiology and Molecular Genetics from Rutgers Medical School
With over 30 years of experience as an Accountant, Controller and Chief Financial Officer Mr. Andrews has experience in all aspects of financial management in both Private and Public companies.
He has extensive experience with S.E.C. Filings, identifying public shell organizations and facilitating the reverse merger process. Mr. Andrews has prepared quarterly and annual earnings announcements along with required 10-Q and 10-K filings. He has coordinated the preparation of S-1 and S-4 S.E.C. reports, and has directed S-18 filings, M & A financial statements and financial disclosure documents. Mr. Andrews has raised $21,000,000 in equity and up to $25,000,000 in Bank Credit Lines for public and private entities and negotiated the sale and lease-back of assets.
Mr. Andrews has led teams of investment bankers in preparation for “offer memorandums.” He has been the primary contact for Wall Street analysts and investors. He has directed pricing and due diligence activities for acquisitions. He was the director for the reorganization of accounting divisions and the implementation of the conversion of accounting computer software from ACCPAC to Great Plains.
Mr. Andrews earned a BS in Accounting from Villanova University.
Mr. Figliozzi is a freshly trained doctoral human disease research scientist raised by entrepreneurs who faced a devastating road through diagnostics at a young age. Inspired by countless experiences with exploratory tests and procedures he is determined to the development of diagnostics for elusive diseases. In addition to strong heart Mr. Figliozzi brings a learned mind to the laboratory. He holds a B.S. in Chemistry from Salisbury University and is an all but defense Ph.D. in Toxicology from the University of Maryland Eastern Shore. He has co-authored numerous grants and peer reviewed research papers on human diseases and immunology. His research and entrepreneurial activities have been funded by all levels of support from the NIH and University System of Maryland funds to his friends and family. He has directed and mentored dozens of student and professional scientists within several labs at the academic, municipal and commercial level. In addition, Mr. Figliozzi has experiences founding, consulting, growing, volunteering and working for a dozen startups including healthcare facilities, diagnostics labs, biotech research organizations.
Mr. Figliozzi was honored by the University System of Maryland for his efforts as a student entrepreneur scientist and has served on economic development and commercialization advisory panels for the USM Board of Regents and a consultant to some of its investment funds. His academic and professional network united to form a grant funded diagnostic research campaign between IES Life Sciences, UMES and Beebe Healthcare.
Mr. Bell is a serial entrepreneur, CEO, and investor with more than 12 years of experience in building and leading technology start-ups. He has founded and funded eight technology companies. All of which have built cutting edge technologies, developing solutions that have set world records. He is the Founder and CEO of Vertex Labs, a custom Artificial Intelligence solutions provider which specializes in Machine Learning, Deep Learning and Automation. Mr. Bell is an expert in building teams and strategies to solve complex and impactful problems. His experience in business strategy, marketing, operations, and sales have lead to successful partnerships with industry and academic leaders. In addition to his role at Vertex, he serves as a board member and adviser to several Philadelphia-based start-ups as well as a non-profit organization.
Mr. Bell holds a BS in Business Administration and Entrepreneurship from the Lebow School of Business at Drexel University.