Innovative Technologies

History

The National Center for Toxicological Research has established a Center for Innovative Technologies within the Division of Systems Toxicology to invent, develop, and promote technologies that support FDA’s regulatory responsibilities. The Center is currently focused on five novel technologies important for public health and safety that can significantly improve food protection, biodefense, drug-toxicity screening, cancer therapy, and noninvasive tumor diagnostics. These technologies were developed over a decade of research by the Center’s co-directors, Dr. Jon Wilkes and Dr. Dan Buzatu who realized that to bring these technologies to public use, publication in peer-reviewed literature was not sufficient in many cases. Therefore, when appropriate, the Center works to patent, license, and commercialize technologies to promote their use by industry. This aspect makes the Center for Innovative Technologies unique compared to NCTR’s other Centers of Excellence in the way it executes its mission.

Authority for a technology-transfer mission within federal government laboratories resides in the Baye-Dohl and Stevenson-Wydler Technology Innovation Acts of 1980, the latter amended in 1986 to include the Federal Technology Transfer Act (FTTA). These laws extended eligibility of patent protection to universities and R&D (research and development) labs that receive public funding; fostered collaboration between government, industry, and universities to support technology innovation; and made technology transfer the responsibility of every Federal laboratory scientist and engineer. The FTTA required federal laboratories to seek opportunities to transfer technology to industry, universities, and state and local governments. It also chartered the Federal Laboratory Consortium (FLC) to promote technology transfer using the following methods:

• technical assistance
• patent licensing
• Cooperative Research and Development Agreements (CRADAs)
• educational partnerships
• grants
• consortia or alliances

Mission

The mission of NCTR’s Center for Innovative Technologies is to:

• discover and develop technologies that advance the FDA and DHHS missions, thereby contributing to the American  public’s health and well being
• bring these technologies from publication in the scientific literature to commercial and/or regulatory adoption
• transfer technologies to appropriate partners by producing patents, establishing CRADAs, and licensing discoveries

Current Projects

• OMNIPrint—combination mass spectrometry/computational system for rapid, cost-effective screening and strain-level identification of pathogenic agents and hoax materials for the protection of the public, particularly the food and feed supply. OMNIPrint can distinguish and characterize microbiological or organic chemical samples in as few as 15 seconds, at a cost of $2 per sample. This technology will be used to create a comprehensive spectral database, i.e., a repository of spectra for typical bacteria and drug-formulation ingredients. The database can be consulted for near-instant identification of pathogens or hoax materials in disease or illness outbreaks. NCTR patents on OMNIPrint have been licensed by LITMUS, LLC, of Little Rock, AR and a CRADA is in place between NCTR and LITMUS.
• QSDAR—spectrum-based method with an accuracy rate of 80-99% for predicting a novel, organic compound’s biological, chemical, or physical properties. The NCTR patents on QSDAR have been licensed for use in pharmaceutical drug discovery. NCTR’s Center for Innovative Technologies research will focus on using this technology to build a fleet of pattern recognition models for the prediction of toxicological properties of chemicals—whether the contaminants are in pharmaceuticals, are in cosmetics, are the new drugs themselves, or are environmental pollutants.
• BNNT—novel cancer therapy utilizing biopolymer-coated and antibody- bound boron nitride nanotubes (BNNTs) as an immunotargetable reagent for boron neutron capture therapy. In vitro proof-of-concept experiments demonstrated the efficacy and targeting aspects of the technology. NCTR’s Center for Innovative Technologies is collaborating with academic groups and a company that has licensed the patent, to complete in vivo proof-of-concepts studies in animals.
• RAPID-B—flow-cytometric detector of bacteria in food or other complex matrices such as human sputum. For use in detecting bacterial contamination in food, it has been shown to count from 1 to 100,000 cells of a targeted species in 2-5 minutes in a small sample of rinsed or pulverized food. In collaborative work with the Arkansas Department of Health and the University of Arkansas for Medical Sciences, similar analytical speed and specificity has been obtained for pathogens like Mycobacterium tuberculosis in patient sputum. RAPID-B was co-developed with a CRADA partner and is being commercialized for use in multiple settings to ensure food safety, accurate diagnoses of infectious diseases, and recognition of bioterror agents. Current Center for Innovative Technologies research is focused on extending the number of bacterial pathogens that can be targeted for RAPID-B.
• MRS—automated classification of brain-cancer types based on pattern recognition of low-resolution magnetic resonance scans (MRS). Most medical centers utilize low-resolution scans from 1.5 Tesla MRIs making classification of tumor types difficult. As a result, the current clinical standard is to diagnose the disease using brain tissue obtained by needle biopsy. Typical morbidity and death rates associated with brain lesion needle biopsies approach 4%. By utilizing methods developed by NCTR’s Center for Innovative Technologies, doctors can obtain the same diagnostic accuracy using the scans alone, potentially rendering diagnosis painless and non-invasive. Identified as a research priority in the DHHS 2007-2012 Performance Plan, NCTR plans to expand its research on brain scans by 1) collecting more patient MRS brain scans to develop models capable of predicting not only the type of tumor, but also to detect its early onset or other brain anomalies; and 2) pursuing the development of MRS-based predictive models for other types of organ cancers (e.g., pancreas, ovary, prostate, etc).

Patents

• “Production of Nanostructures by Curie Point Induction Heating” Jon G. Wilkes, Dan A. Buzatu, Dwight W. Miller, Alexandru Sorin Biris, Alexandru Radu Biris, Dan Lupu, and Jerry A. Darsey. US Patent Number 7,365,289, issued April 29, 2008 with 17 claims. Based on Utility Patent Application No. 11/302,986, filed December 14, 2005.
• Buzatu DA, Wilkes JG, Moskal TA, Nevius B, Taylor JT, Tucker RK, Miller M, and Ramsaroop S. “Flow-cytometry-based systems and Methods for Detecting Microbes.” USPTO Provisional Patent Application 61/089,387, filed August 15, 2008 with 50 claims.
• "Food Quality Indicator Device." D. Miller, J. Wilkes, E. Conte, US Patent # 7014816, issued March 21, 2006 with 15 claims. Israeli patent # 129002 issued April, 2005; Australia (#782088 issued August 1, 2002 with 28 claims). Submitted as US Utility Patent Application No. 09/116,152 July 16, 1998, and international patent application number WO 99/04256, January 28,1999 (published). Applied for several other country patents in 1999, including Korea, Japan, Canada, Finland, New Zealand, Mexico, Norway, etc.
• "Drift Compensation Method for Fingerprint Spectra." J. Wilkes, F. Rafii, K. Glover, M. Holcomb, X. Cao, and J. Sutherland. US Patent No. 6,996,472, issued February 7, 2006. 25 Claims. Licensed exclusively [March 8, 2006, by Litmus LLC under PHS CRADA FDA 7803; License Application Number: A-017-2006]
• "Methods for Predicting the Biological, Chemical, and Physical Properties of Molecules from Their Spectral Properties" Dwight W. Miller, R. Beger, J. Wilkes, J. Lay, Jr., and J. Freeman. US Patent No. 6,898,533 issued May 24, 2005 with 74 claims. Pending Canadian Patent Application 2399967. Licensed exclusively March 8, 2006, by Litmus LLC under PHS CRADA FDA 7803; License Application Number: A-017-2006.
• "Methods for Predicting Properties of Molecules" R. Beger and J. Wilkes, Patent Application 10/383,602 filed with USPTO March 07, 2003. Based on PHS Employee Invention Report, 04/24/01. Licensed exclusively March 8, 2006, by Litmus LLC under PHS CRADA FDA 7803; License Application Number: A-017-2006.

Contact Information

Dr. Jon Wilkes and Dr. Dan Buzatu co-direct the CIT and are supported by Dr. Randal Tucker and Pierre Alusta.

Dr. Jon Wilkes: 870-543-7108 or jon.wilkes@fda.hhs.gov

Dr. Dan Buzatu: 870-543-7287 or dan.buzatu@fda.hhs.gov