Company

HISTORY

Convergence of Artificial Intelligence (AI), Machine Learning and Proteins Active in the Tumor Microenvironment

OTraces was founded in 2008 by CEO Keith Lingenfelter, several years after the successful sale of IGEN International to Roche in order to take in vitro blood testing technology to a much larger platform. This could be done by addressing what Mr. Lingenfelter perceived as unmet needs in proteomics based disease detection technology and large scale opportunities that included the following:

  • to improve the accuracy of disease detection testing by applying OTraces’ unique AI methods with proteins, cytokines, active in the war between the tumor and the immune system;
  • to provide a long-awaited breakthrough in blood-based cancer screening tests, wherein the only significant approved product has been the Prostate Specific Antigen (PSA) assay which was cleared by the U.S. FDA in 1986;
  • to apply these AI based computational techniques from physics to biological testing which has never been done before;
  • to address global market of healthy adults presently not being tested for cancer as part of their routine annual physical exams — a vast market of recurring revenues and reagent sales that rivals an important breakthrough in the drug filed and would be equally profitable.

MANAGEMENT TEAM

Keith Lingenfelter

Founder, Chief Executive Officer and Member of the Board of Directors

  • Former VP and General Manager, Diagnostics for IGEN International where he managed the development of a breakthrough luminescent immunoassay technology for measuring the concentration of proteins and DNA in biological fluids.
  • Licensed to Boehringer Mannheim (now Roche Diagnostics), Eisai Inc., Akzo Pharmaceuticals (Organon Technika) and ABI/Perkin Elmer. These marketing and development partnerships positioned IGEN for an IPO and eventual sale to Roche for $1.5 billion.
  • Prior to IGEN, Mr. Lingenfelter held a number of management positions at Abbott Laboratories where he was primarily involved in strategic marketing and management of large R&D programs that developed chemistry instrumentation and reagents for clinical assays for the in-vitro diagnostic market.
  • Mr. Lingenfelter has a Master’s degree in engineering from California State University.

Alain Cappeluti

Founder, Chief Financial Officer and Chairman of the Board of Directors

  • More than 30 years experience in finance and public accounting for private and public companies, and has participated directly in approximately $4 billion of corporate financing transactions.
  • Management experience in the biotech industry includes BioReliance, Human Genome Sciences (HGS), and CoGenesys. He joined HGS in 1992 at its founding and served for many years as VP of Finance. He was part of the team that spun Cogenesys out from HGS in 2006 and was its’ CFO until it was sold to Teva Pharmaceuticals in 2008.
  • Mr. Cappeluti serves on the OTraces Board of Directors and is currently the company’s largest shareholder. It is the Company’s intention to recruit a full-time CFO in the future as warranted by business activity.

Suzana Radulovich, M.D., PhD

Vice President and CLIA Lab Director

  • MD, PhD. Certified in Clinical Pathology, Immunology.
  • Numerous CLIA Laboratory Licenses.
  • Founded the ALDT Laboratory for 20/20 Gene Systems’ proteomic based Advanced Laboratory Developed Test (ALDT) for lung cancer.
  • Regulatory knowledge and experience (CLIA, COLA, FDA)
  • Broad scientific background in the fields of immunoassays (ELISA); nucleic acids, PCR, qPCR and RT-PCR, isothermal amplification technologies, DNA/RNA sample preparation technologies
  • Institutional services (University of Maryland, School of Medicine) and National services (NIH/NIAID; MIDRP, American College of Physician, CRDF/International Science and Technology reviews)
  • Editorial boards: Infection and Immunity, Journal of Infectious Diseases, Vaccine, FEMS Microbiology, Journal of Immunology, Emerging Infectious Diseases, American Journal of Tropical Medicine & Hygiene, Journal of Immunology, Vector-borne and Zoonotic Diseases, Journal of ASTMH.

Brian Leyland-Jones M.D. Ph.D.

Chief Medical Officer

  • Dr. Leyland-Jones is the Vice President of Molecular and Experimental Research at the Avera Cancer Institute and the Director of the Darwin Foundation;
  • lead major changes in breast cancer clinical trials and treatments, as well as his ongoing focus on how genomics plays a vital role in the fight against breast cancer;
  • As the Director of the Darwin Foundation (formerly the Consortium for Clinical Diagnostics), Dr. Leyland-Jones is partnering with scientists at research institutions and biopharmaceutical companies who are dedicated to facilitating genomic research and diagnostics.

Richard Saul Ph.D.

Vice President, Research and Product Development

  • In-depth experience in the research, development and technical support of diagnostic products in the areas of clinical chemistry and rapid microbiology.
  • Founder of Axo Diagnostics.
  • Vice President of Product Development at Celsis-Lumac plc
  • Director of Assay Development at IGEN International
  • Director – Chemistry R&D, Dade Stratus, Baxter Diagnostics.
  • Dr. Saul has broad experience in both large and startup organizations, in both the management and hands-on laboratory level, in assay development using various detection technologies, systems development for both unit-dose devices and high throughput instruments, as well as directing the technical and manufacturing support of finished products

SCIENTIFIC ADVISORY BOARD

Kenneth J. Pienta, M.D.,

  • Dr. Pienta is the Donald S. Coffey professor of urology and professor of oncology and pharmacology and molecular sciences at the Johns Hopkins University School of Medicine, and also serves as the director of research at the Brady Urological Institute;
  • widely recognized for his expertise and leadership in prostate cancer research including the development of novel chemotherapeutic programs in prostate cancer;
  • leading authority in translational research and has studied the role of the tumor microenvironment extensively.

Donald Berry Ph.D.

  • Professor, Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX
  • Adjunct Professor, Department of Department of Statistics, Rice University, Houston, TX
  • Has extensive cancer research and policy experience;
  • opinion leader in Bayesian biostatistics and adaptive clinical trial design;
  • Has championed adaptive trials in clinical research and worked closely with the FDA Center for Devices and Radiological Health to set high scientific and quality standards for a Bayesian approach, which led to adaptive designs gaining favor with both U.S. and international regulatory agencies;
  • Championed the application of Bayesian methods in early cancer detection and the exploration of biomarkers that may signal the onset of tumor formation — especially for non-small cell lung cancer (NSCLC)

Suresh Mohla Ph.D.

  • Dr. Mohla was in the senior ranks of cancer research at the National Cancer Institute for 26 years, specializing primarily in the tumor microenvironment and various aspects thereof including inflammation, stem cells, angiogenesis, lymphangiogenesis, exosomes, metastasis, tumor dormancy and mechanisms of hormone refractory cancers;
  • actively promoted transdisciplinary research in emerging scientific areas such as these;
  • successful creation of the new NCI Network on Tumor Microenvironment, and he served as the Program Director for the Tumor Microenvironment Network (TMEN) Consortium for 10 years;
  • served as associate editor of J Cellular Biochemistry and Cancer Microenvironment;
  • He was a member of the Federal working Group on Bone Diseases – a transdisciplinary group. He was actively involved in scientific program committees of several national and international symposia including Skeletal Complications of Malignancy, and Chaired the International Symposium on Hormonal Oncogenesis. He was a member of the Steering Committee of the AACR Working Group on Tumor Microenvironment and is a member Emeritus of the AACR.

Brian Leyland-Jones M.D.

  • Dr. Leyland-Jones is the Vice President of Molecular and Experimental Research at the Avera Cancer Institute and the Director of the Darwin Foundation;
  • lead major changes in breast cancer clinical trials and treatments, as well as his ongoing focus on how genomics plays a vital role in the fight against breast cancer;
  • As the Director of the Darwin Foundation (formerly the Consortium for Clinical Diagnostics), Dr. Leyland-Jones is partnering with scientists at research institutions and biopharmaceutical companies who are dedicated to facilitating genomic research and diagnostics.

Company Representative, Richard Saul Ph.D.

See Biography Above Under Management Team

ADDITIONAL MANAGEMENT

The Company has been operating with a group of long time business associates who are acting in a consulting capacity, performing functions such as engineering, software development, immunoassay development, clinical laboratory product development, regulatory affairs coordination, business development, patent consultation and manufacturing operations. All of these people have worked with Mr. Lingenfelter in the past on successful endeavors and are highly experienced. The CRO consultants have already connected with the Canadian Regulatory Apparatus and have completed plans for clinical trials. All of these people would be qualified to serve as OTraces employees if financial circumstances permit.

The Hamilton company

U.S. based Hamilton Company has been a leading manufacturer of medical instrumentation and devices for more than 60 years, with U.S. and branches and subsidiary offices throughout the world. Hamilton manufactures, maintains and services OTraces’ CDX instrument to company specifications.

Maxim BioMedical

Maxim Biomedical, located in the Rockville, MD, manufactures and supplies reagents and test kits used in the CDx instruments and has extensive global experience serving the needs of a number of leading diagnostics companies. Maxim operates a 30,000 sq. ft. GMP and ISO 13485 certified facility which is equipped to meet OEM manufacturing needs for the pharmaceutical and in vitro diagnostic product industry.

BioIT Solutions

Bio-IT Solutions, based in Maryland, was formed in 2006 to manage the demanding IT requirements of genomic research and bioinformatics for the biotech and pharmaceutical industry. Chief Executive Officer Michael Fannon was formerly the Chief Information Officer of Human Genome Sciences, Inc. from 1994 through September 2005 where he managed the design and implementation of computerized systems to support HGS’s high-volume laboratory data collection, biological research, clinical data management, product development, manufacturing and business operations.