BIO2009 Federal Science and Opportunities Track   Hot Federal Biotechnologies Available for Collaboration and Licensing   ...
Technology Transfer at National Institutes of Health (NIH)  Food and Drug Administration (FDA)  Centers for Disease Contro...
http://ott.od.nih.gov/policy/research_tool.html Peptides/Proteins Nucleic Acids/Vectors Assays Small Molecules Animal Mode...
<ul><li>Genotoxin-Detecting Cell Lines  – Myung (NHGRI), HHS Ref. No. E-108-2008/0 </li></ul><ul><li>Cell lines expressing...
There are many more available nucleic acids and vectors! In Stock: Nucleic Acids and Vectors Recombineering Shuttle Vector...
In Stock: Mouse Models <ul><li>Interferon-alpha Mouse Model  - Kottilil et al. (NIAID/NCI/NIHCC),  </li></ul><ul><li>HHS R...
There are many more available antibodies! In Stock: Antibodies <ul><li>Tuberculosis Monoclonal Antibody  – Parra et al. (F...
Generation and validation of a highly selective and versatile rabbit  monoclonal antibody against the receptor tyrosine ki...
To obtain copies of these slides, please visit: http://ttc.nci.nih.gov   Or http://www.ott.nih.gov/BIO2009   Or http:// ww...
BIO2009 Federal Science and Opportunities Track   Hot Federal Biotechnologies Available for Collaboration and Licensing Me...
<ul><li>Easy detection by RT-PCR or immunostaining </li></ul><ul><li>Specific for cancer tissues of different origin </li>...
Novel thermostable Y-family DNA polymerases: applications for the PCR  amplification of damaged or ancient DNAs R. Woodgat...
Jeff Duyn,   Alan Koretsky, and Afonso Silva Lab of Functional and Molecular Imaging, National Institute of Neurological D...
Alan Koretsky, John Moreland, Steve Dodd, and Gary Zabow National Institute of Neurological Disorders and Stroke National ...
<ul><li>The model can be used to measure the  </li></ul><ul><li>performance of imaging procedures designed to  </li></ul><...
CYCLIZED NGR PEPTIDE  B.J. Wood et al.  Clinical Center Radiology and Imaging Sciences, Interventional Radiology Research ...
Encapsulated Nanoparticles for Computed Tomography Imaging Ronald M. Summers et al.  Clinical Center Virtual Endoscopy and...
Automated Identification of Ileocecal Valve Ronald M. Summers et al.  Clinical Center Virtual Endoscopy and Computer-Aided...
Virtual Colonoscopy via Wavelets Ronald M. Summers et al.  Clinical Center Virtual Endoscopy and Computer-Aided Diagnosis ...
Nanoparticles for Imaging and Treatment of Brain Tumors   H. Sarin National Institute of Biomedical Imaging and Bioenginee...
Christy Ludlow Laryngeal and Speech Section,   National Institute of Neurological Disorders and Stroke Patents:  PCT/US200...
Selective Killing of Cancer Cells Wenge Zhu & Melvin L. DePamphilis Program on Genomics of Differentiation National Instit...
Therapeutic Use of E-selectin For Treatment of Multiple Sclerosis and Prevention of Secondary Stroke Hallenbeck, Shukaliak...
Jill Heemskerk a , Jacquie Shukaliak b , and Gene Major c National Institute of Neurological Disorders and Stroke Referenc...
Technology: Razoxane and other bisdioxopiperazines reduce amyloid-beta peptide levels, reduce aggregation of alpha-synucle...
Method of Treating or Preventing Oxidative Stress-related Diseases Nigel H. Greig et al. Drug Design and Development Secti...
Technology:  N ovel inhibitors of p53 and methods of using these inhibitors for the prevention or treatment of the stress ...
Novel Benztropine Analogs for Treatment of Cocaine Abuse  and Other Mental Disorders   Amy H. Newman, Mu-fa Zou, Jonathan ...
Inhibitors of CD25 to Treat Autoimmune Diseases and Tumors   Bibiana Bielekova National Institute of Neurological Disorder...
A Novel & Efficient Technology for Targeted Delivery of siRNA Arya Biragyn, Ph.D,  et al. National Institute on Aging (NIA...
Technology:  Methods of using cytochrome P450 inhibitors to treat or prevent cocaine-induced fetal brain injury, as well a...
Ron McKay Laboratory of Molecular Biology, National Institute of Neurological Disorders and Stroke Reference #:  E-001-200...
Zscan4:  A Gene Critical for Early Embryonic Development Minoru S.H. Ko, M.D., Ph.D.,  et al . National Institute on Aging...
The Neuregulin/ErbB Signaling Pathway as a Novel Drug Target  to Treat Schizophrenia and Bipolar Disorder   Andres Buonann...
The various pharmaceutical compositions and methods for the treatment of Schistosomiasis in mammals are based on a number ...
<ul><li>Low nM inhibition of PDE4 Isozymes. </li></ul><ul><li>Low nM inhibition in cells. </li></ul><ul><li>High selectivi...
<ul><li>novel triazine and purine compounds for the  </li></ul><ul><li>treatment and prevention of: </li></ul>notable inhi...
Melissa Maderia, Ph.D. [email_address] 301-451-3943 To obtain copies of these slides, please visit:  http:// ttc.nci.nih.g...
BIO2009 Federal Science and Opportunities Track   Hot Federal Biotechnologies Available for Collaboration and Licensing Ro...
<ul><li>Epitope-Transplant Scaffolds and Their Use </li></ul><ul><li>Epitopes are removed from whole antigen </li></ul><ul...
<ul><li>HIV Vaccine Immunogens and Immunization Strategies to Elicit Broadly Neutralizing Anti-HIV-1 Against the Membrane-...
<ul><li>Use of Virus-Like Particles (VLPs) as Vaccine against Chikungunya Virus </li></ul><ul><li>Structural Proteins (cor...
<ul><li>Polymorphic Membrane Protein D (PmpD) as vaccine candidate </li></ul><ul><li>>99% Sequence identity between serova...
<ul><li>Sialostatin L2 Mediation Controls Blood Feeding Success  </li></ul><ul><li>of  Ixodes scapularis </li></ul><ul><li...
<ul><li>Phenol-soluble modulin (PSM) polypeptides </li></ul><ul><li>Secreted peptides that recruit, activate and lyse huma...
<ul><li>Aegyptin, a collagen binding protein </li></ul><ul><li>Selectively inhibits collagen platelet aggregation </li></u...
<ul><li>MAOi(s)  prevent HSV infection and may prevent periodic reactivation from latency </li></ul><ul><li>Herpes viruses...
<ul><li>Device/method for microwave assisted cryo-sample processing </li></ul><ul><li>Reduced time required for freeze sub...
For information on these and other opportunities, please contact Rosemary C. Walsh, Ph.D.  Phone:301-451-3528 Email:rcwals...
at the National Cancer Institute John D. Hewes, Ph.D. Technology Transfer Specialist Technology Transfer Center Tel. (301)...
Why Collaborate ? BUSINESS MODELS BASED ON COLLABORATION From PriceWaterHouseCoopers “Pharma 2020: Challenging Business Mo...
Why Collaborate with NCI? TTC maintains an e-mail service to notify you of new technology opportunities. Register at http:...
NCI has produced important drugs and technologies through collaborations and licensing with the private sector. Abbott/Oth...
Chemical programming of antibodies through selenocysteine Christoph Rader, Ph.D. Experimental Transplantation and Immunolo...
Nitric Oxide-releasing Polymers Larry K. Keefer, Ph.D. Laboratory of Comparative Carcinogenesis   <ul><li>Technology: NO-r...
Prognostic for Prostate Cancer Treatment  William D. Figg, Pharm. D. Medical Oncology Branch <ul><li>Technology:  Cancer B...
Methods for Diagnosis and Prognosis of Lymphomas <ul><li>Technology: Microarray diagnostics </li></ul><ul><li>Novel microa...
Development of Novel Anti-HIV Compounds Robert  Shoemaker, Ph.D. and Alan Rein, Ph.D. Developmental Therapeutics Program, ...
HIV-1 Integrase Inhibitors for the  Treatment of Retroviral Infections Technology:  HIV Therapeutics Novel HIV-1 integrase...
Technology: HIV Therapeutics Novel antibody-based technologies for the treatment of HIV/AIDs, including the first anti-HIV...
Assay to detect Plk1 levels and activity Kyung Lee, Ph.D. Laboratory of Metabolism <ul><li>Technology:  Cancer Diagnostic ...
Martin W. Brechbiel, Ph.D. Radiation Oncology Branch <ul><li>Technology: Imaging/Contract Agents </li></ul><ul><li>Silica-...
Sriram Subramaniam, Ph.D. NCI CCR Laboratory of Cell Biology, Biophysics Section Technology: Imaging Strategies are being ...
<ul><li>Technology: Cancer Therapeutics </li></ul><ul><li>New strategy for treating cancers that over-express MDR1 </li></...
John D. Hewes, Ph.D. [email_address] 301-435-3121 To obtain copies of these slides, please visit:  http:// ttc.nci.nih.gov...
Centers for Disease Control and Prevention Technology Transfer Office Suzanne Seavello Shope, J.D. Technology Licensing an...
Centers for Disease Control and Prevention <ul><ul><li>A source of credible health information </li></ul></ul><ul><ul><li>...
CDC Research Areas <ul><li>All Infectious Diseases </li></ul><ul><li>Occupational Health </li></ul><ul><li>Toxic Chemicals...
Examples of Non-patented Technologies <ul><li>Cell lines </li></ul><ul><li>Nucleic acids and vectors </li></ul><ul><li>Ant...
Sampling  of Technologies filed with the USPTO <ul><li>Vaccines: </li></ul><ul><li>I-015-07     M. Tuberculosis  Proteins ...
Identification of  M. Tuberculosis  Proteins as Mucosal Vaccine Candidate Against TB Suraj Sable, Tom Shinnick, Bonnie B. ...
Development of a HIV-1 Multi-Clade, Multivalent (HIV-1MCMV) Recombinant Vaccine Construct Renu B. Lal, Michele Owen,  NCHH...
Development of Rift Valley Fever Virus Vaccines Utilizing Reverse Genetics   Brian H. Bird, Stuart T. Nichol, Cesar G. Alb...
Peptide Vaccine Candidate Against Group A Streptococci Bernard W. Beall, George M. Carlone, Jacquelyn S. Sampson, Edwin W....
Recombinant Multivalent Malarial Vaccine against  Plasmodium falciparum Ya Ping Shi, Altaf A. Lal, Seyed E. Hasnain  Divis...
Peptide from Streptococcus Pneumoniae Surface Adhesion A (PsaA) Protein Associated with Adherence   Edwin W. Ades, Jacquel...
Development of Real-time PCR Assay for Detection of  Pneumococcal DNA and Diagnosis of Pneumococcal Disease Edwin Ades ( D...
Immunological Immobilization of Cardiolipin Antigen  to a Solid Support Arnold Castro, Robert W. George, Victoria Pope  DS...
Diagnostic Antigens for the Identification of Latent Human Tuberculosis Kristin A. Birkness, Fred D. Quinn, David S. Beall...
Rabies Virus Immuno-Contraceptive Vaccine Candidates Charles Rupprecht, Xianfu Wu Rabies program/PRB, DVRD, NCZVED, CCID <...
Centers for Disease Control and Prevention Technology Transfer Office Visit us at the Georgia Pavilion Suzanne Seavello Sh...
Unique Opportunity to Learn about  Federal Science in Bio-Imaging
To obtain copies of these slides, please visit: http://ttc.nci.nih.gov   Or http://www.ott.nih.gov/BIO2009   Or http:// ww...
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  1. 1. BIO2009 Federal Science and Opportunities Track Hot Federal Biotechnologies Available for Collaboration and Licensing Tuesday, May 19, 2009 10:00AM – 11:30AM You will hear about the innovative, cutting-edge research being conducted at Federal laboratories in the field of Biotechnology Session Chair Vio Conley (National Cancer Institute, NIH) Presenters Melissa Maderia (National Cancer Institute, NIH) Rosemary Walsh (National Institute of Allergy and Infectious Diseases, NIH) John Hewes (National Cancer Institute, NIH) Suzanne Seavello Shope (Center for Disease Control)
  2. 2. Technology Transfer at National Institutes of Health (NIH) Food and Drug Administration (FDA) Centers for Disease Control (CDC) <ul><ul><li>Work with Investigators on IP issues </li></ul></ul><ul><ul><li>Employee Invention Reports (EIR) </li></ul></ul><ul><ul><li>Transactional Agreements (CDA, MTA, CTA, CRADA) </li></ul></ul><ul><ul><li>Patent prosecution </li></ul></ul><ul><ul><li>Licensing/Enforcement </li></ul></ul><ul><ul><li>Policy </li></ul></ul><ul><ul><li>Marketing </li></ul></ul>
  3. 3. http://ott.od.nih.gov/policy/research_tool.html Peptides/Proteins Nucleic Acids/Vectors Assays Small Molecules Animal Models Antibodies Cell Lines Libraries … and more! Peptides/Proteins Nucleic Acids/Vectors Assays Small Molecules Animal Models Antibodies Cell Lines Libraries Peptides/Proteins Nucleic Acids/Vectors Assays Small Molecules Animal Models Antibodies Cell Lines Libraries … and more! Many technologies are not patented, but are instead classified as Research Tools Research Tools Available from the Public Health Service <ul><ul><li>Research Tools may include: </li></ul></ul><ul><ul><li>Not usually advertised or marketed </li></ul></ul><ul><ul><li>Described in investigator’s publication </li></ul></ul><ul><li>Freely available to non-profits and academia </li></ul><ul><li>Available via license to for-profit entities </li></ul><ul><ul><li>NIH Research Tools Policy </li></ul></ul>
  4. 4. <ul><li>Genotoxin-Detecting Cell Lines – Myung (NHGRI), HHS Ref. No. E-108-2008/0 </li></ul><ul><li>Cell lines expressing fluorescent ELG1, involved in DNA repair; useful as a screening tool to detect genotoxic agents. </li></ul><ul><li>BRCA2 Cell Lines – Sharan et al. (NCI), HHS Ref. No. E-261-2007/0 </li></ul><ul><li>Eleven murine cell lines expressing wild-type or mutant BRCA2 </li></ul><ul><li>PAM212 Epidermal Keratinocyte Cell line - Yuspa (NCI), HHS Ref. No. B-003-1999/0 </li></ul><ul><ul><li>For studies of inflammation and cancer </li></ul></ul><ul><li>TNF-Sensitive Leukemia Cell Lines - Chan et al. (NIAID), HHS Ref. No. E-289 2003 </li></ul><ul><li>For screening of drugs that inhibit TNF-induced cell death </li></ul>There are many more available cell lines! In Stock: Cell Lines
  5. 5. There are many more available nucleic acids and vectors! In Stock: Nucleic Acids and Vectors Recombineering Shuttle Vector – Casellas et al. (NIAMS), HHS. Ref. No. E-026-2009/0 Highly efficient vector for modifying Bacterial Artificial Chromosomes (BACs) Bitter Taste Receptor Haplotypes – Drayna (NIDCD), HHS Ref. Nos. E-222-2003/2 and E-169-2001/0 22 receptors and >100 different haplotypes High-Throughput E. coli Expression Vectors – Waugh (NCI), HHS Ref. No. E-041-2006/0 Vectors for producing maltose binding protein and hexahistidine-double tagged fusion proteins, to facilitate protein stability and purification Thermostable Y-Family Polymerases – Woodgate et al. (NICHD), HHS Ref. No. E-166-2004/2 For amplification of damaged DNA
  6. 6. In Stock: Mouse Models <ul><li>Interferon-alpha Mouse Model - Kottilil et al. (NIAID/NCI/NIHCC), </li></ul><ul><li>HHS Ref. No. E-106-2009/0 </li></ul><ul><li>Overexpresses Interferon-Alpha Receptor 2; model for hepatitis, as well as other diseases where type-1 interferon plays a role </li></ul><ul><li>T Cell Receptor Mouse Model – Restifo et al. (NCI), HHS Ref. No. E-187-2008/0 </li></ul><ul><li>Expresses a class II-restricted T cell receptor (TCR) recognizing TRP-1 (Tyrosinase Related Protein-1) ; useful for the development of new tumor immunotherapies </li></ul><ul><li>Proadrenomedullin Mouse Model - Cuttitta (NCI), HHS Ref. No. E-099-2004/0 </li></ul><ul><li>Floxed (conditional knockout) mouse model for cancer, hypertension, and diabetes </li></ul><ul><li>ARNT Mouse Model – Gonzalez (NCI), HHS Ref. No. E-047-2007/0 </li></ul><ul><li>Floxed (conditional knockout) mouse model for cancer, diabetes, and inflammation </li></ul><ul><li>Conditional LRRK2 transgenic Mouse Model – Cai (NIA), HHS Ref. No. E-015-2009/0 </li></ul><ul><li>Tet-responsive model for Parkinson’s disease and other inherited diseases caused by LRRK2 mutations. </li></ul>There are more mouse models for a variety of diseases and conditions!
  7. 7. There are many more available antibodies! In Stock: Antibodies <ul><li>Tuberculosis Monoclonal Antibody – Parra et al. (FDA), HHS Ref. No. E-103-2008/0  </li></ul><ul><li>Recognizes PE-PGRS proteins from M. tuberculosis; useful for research, or as a diagnostic tool. </li></ul><ul><li>Monoclonal Antibodies for Chromosomal Segregation Monitoring – Jeang (NIAID), HHS Ref. No. E-119-2003/0 </li></ul><ul><li>Recognize MAD1,a human spindle assembly checkpoint protein involved in chromosomal segregation </li></ul><ul><li>Natural Killer Cell Monoclonal Antibodies – Ortaldo et al. (NCI), HHS Ref. No. B-015-1997/0 </li></ul><ul><li>Useful for studies of Natural Killer cell activation and signal transduction; clones 12A8 (Ly49A/D), 4D11(Ly49G2),and 4E5 (Ly49D) </li></ul><ul><li>Tetanus Toxin Monoclonal Antibodies – Shapiro et al. (FDA), HHS Ref. No. E-061-2009/0 </li></ul><ul><li>Recognize Tetanus Toxin Heavy Chain Fragment C </li></ul><ul><li>Arf GAP Polyclonal Antibodies – Randazzo et al. (NCI), HHS Ref. No. E-220-2008/0 (and others) </li></ul><ul><li>Arf GAP proteins are involved in cancer cell invasion into normal tissues; antisera against several family members available. </li></ul><ul><li>Kidney Transporter Polyclonal Antibodies – Knepper (NHLBI), HHS Ref. No. E-253-2008/0, </li></ul><ul><li>E-254-2008/0, E-255-2008/0 and E-268-2008/0 </li></ul><ul><li>Polyclonal antisera against kidney proteins NHE3, NCC, NKCC2, UTA1, involved in water homeostasis </li></ul>
  8. 8. Generation and validation of a highly selective and versatile rabbit monoclonal antibody against the receptor tyrosine kinase ErbB4 Detlef Vullhorst and Andres Buonanno Section of Molecular Neurobiology, National Institute of Child Health and Human Development <ul><li>A monoclonal antibody (Ab-10) was derived from </li></ul><ul><li>rabbits immunized with a fragment of the intracellular </li></ul><ul><li>domain of ErbB4 of mouse origin fused to GST </li></ul><ul><li>Ab-10 selectively reacts with ErbB4 of human, rat and </li></ul><ul><li>mouse origin in Western blots, immunoprecipitation, </li></ul><ul><li>immunofluorescence, immunohistology and ELISA </li></ul>Figure : Ab-10 in Western blotting ( A ) and immuno-histology ( B,C ).Adult mouse hippocampal sections isolated from wildtype ( WT ) and ErbB4 knockout ( KO ) mice. Value Proposition: Technology : R&D Status: completed; available for licensing/collaboration <ul><li>ErbB4 is of broad interest to scientists in the fields of </li></ul><ul><li>cancer biology and neuroscience, and is emerging as a risk </li></ul><ul><li>gene for psychiatric disorders (schizophrenia and BiP disorder) </li></ul>Reference #: E-171-2009/0 Collaboration Contact Information: [email_address] Licensing Contact Information: Mojdeh.Bahar@nih.gov <ul><li>There is a scarcity of commercially available and well-characterized antibodies selective for ErbB4 </li></ul><ul><li>that perform in a variety of different immunological applications </li></ul>
  9. 9. To obtain copies of these slides, please visit: http://ttc.nci.nih.gov Or http://www.ott.nih.gov/BIO2009 Or http:// www.cdc.gov/tto keyword: BIO
  10. 10. BIO2009 Federal Science and Opportunities Track Hot Federal Biotechnologies Available for Collaboration and Licensing Melissa Maderia, Ph.D. Technology Transfer Specialist Technology Transfer Center National Cancer Institute Competitive Service Center in support of National Institute of Neurological Disorders and Stroke [email_address] http://ttc.nci.nih.gov/ http://tto.ninds.nih.gov/
  11. 11. <ul><li>Easy detection by RT-PCR or immunostaining </li></ul><ul><li>Specific for cancer tissues of different origin </li></ul><ul><li>Prediction with higher prognostic significance than other biomarkers for metastasis </li></ul>Value Proposition <ul><li>R&D Status </li></ul><ul><li>Detection of CPE-∆N by RT-PCR in patient blood underway for early diagnosis of cancer </li></ul><ul><li>Prediction of metastasis in patients with various other cancers underway </li></ul><ul><li>Available for licensing/collaboration. </li></ul><ul><li>Biomarker for metastasis in various cancers: Liver, colon, prostate breast, head and neck </li></ul><ul><li>High CPE-∆N levels in primary tumors able to predict future metastasis/recurrence in liver and </li></ul><ul><li>colon cancer patients </li></ul><ul><li>Suppression of CPE-∆N expression inhibits tumor growth and metastasis </li></ul>IP Status : U.S. provisional patent application No.61/080,508 filed 2008 Reference #: E-234-2008 Collaboration Contact Information: Y. Peng Loh, PhD. lohp@mail.nih.gov Licensing Contact Information: Jennifer Wong. B.A. wongje@mail.nih.gov CPE splice variant CPE-∆N predicts metastasis in various human cancers A Splice Isoform of Carboxypeptidase E (CPE) Promotes and Predicts Metastasis in Human Cancers Y Peng Loh et al. SCN, National Institute of Child Health and Human Development
  12. 12. Novel thermostable Y-family DNA polymerases: applications for the PCR amplification of damaged or ancient DNAs R. Woodgate, J.P. McDonald and W. Yang Laboratory of Genomic Integrity, National Institute of Child Health and Human Development <ul><li>Thermostable lesion-bypassing </li></ul><ul><li>DNA polymerases </li></ul><ul><li>Easily expressed and purified </li></ul><ul><li>Augment recovery of forensic </li></ul><ul><li>and ancient DNAs </li></ul><ul><li>Optimized chimeric enzymes </li></ul>PCR amplification by Y-family DNA Polymerases Value Proposition R&D Status: Expression and purification of enzymes and amplification of lesion-containing DNA demonstrated. Available for licensing/collaboration. <ul><li>Y-family DNA polymerases synthesize DNA through a variety of replication-blocking DNA lesions </li></ul><ul><li>Thermostable Y-family DNA polymerases substitute for Taq DNA polymerase in PCR DNA amplification reaction </li></ul><ul><li>Inclusion of Y-family DNA polymerases in standard PCR reactions augments recovery of lesion-containing DNA </li></ul><ul><li>samples, such as those commonly found in forensic or ancient DNA molecular applications </li></ul><ul><li>Y-family DNA polymerases can incorporate labeled dNTPs including fluorescent labels </li></ul><ul><li>Y-family DNA polymerases can be used in mutagenic PCR applications </li></ul>IP Status : PTC application filed May 2005 United States Patent Application #: 20080193925, Reference #: E- Collaboration Contact Information : Dr. Roger Woodgate, woodgate@nih.gov Licensing Contact Information : Enhanced PCR recovery of Alu sequences from UV lesion-containing human genomic DNA samples utilizing a blend of Taq and Y-family DNA polymerases
  13. 13. Jeff Duyn, Alan Koretsky, and Afonso Silva Lab of Functional and Molecular Imaging, National Institute of Neurological Disorders and Stroke <ul><li>Improvement of neuroimaging through basic development </li></ul><ul><li>New techniques for the acquisition and analysis </li></ul><ul><li>of MRI images </li></ul><ul><li>Improved MRI images that provide anatomical and functional contrast </li></ul><ul><li>Improved signal to noise and shorter acquisition times </li></ul>Technology R&D Status <ul><li>Passive circuitry control to improve homogeneity </li></ul><ul><li>Novel RF coil designs provide improve signal to noise </li></ul><ul><li>Motion Detection for improved MR Imaging </li></ul>Reference #: E-020-2007; E-099-2006; E-144-2008 For Collaboration , please contact Melissa Maderia, Ph.D 301-451-3943 or maderiam@mail.nih.gov For Licensing , please contact John Stansberry, Ph.D. 301-435-5236 or [email_address] MRI Techniques Providing Solutions in NeuroImaging Multi-channel and birdcage coils arrays can be used to obtain improved homogeneity. before after Inductively matched approach for decoupling MRI coil arrays. (GND1) Zp1 1 C4 T1 L2 C3 A C1 L1 M C2 n preamplifier
  14. 14. Alan Koretsky, John Moreland, Steve Dodd, and Gary Zabow National Institute of Neurological Disorders and Stroke National Institute of Standards and Technology Technology R&D Status <ul><li>New imaging modality based on magnetic geometry rather than chemical structure </li></ul><ul><li>Engineered to appear as different effective colors when resolved using MRI as opposed to strictly grey-scale contrast of existing MRI agents </li></ul><ul><li>Enable in vivo labeling and tracking of multiple different types of cells simultaneously </li></ul><ul><li>Act as radio-frequency probes of various physiological conditions </li></ul>IP Status: PCT application claiming priority to provisional application filed 17 April 2008 Reference #: E-081-2008 For Collaboration , please contact Melissa Maderia, Ph.D 301-451-3943 or maderiam@mail.nih.gov For Licensing , please contact John Stansberry, Ph.D. 301-435-5236 or [email_address] Microfabricated Magnetic Nanostructures <ul><li>Applications: </li></ul><ul><li>Magnetic Resonance Imaging </li></ul><ul><li>Cancer </li></ul><ul><li>Cardiovascular diseases imaging </li></ul><ul><li>Drug development </li></ul><ul><li>Drug candidate distribution tracking </li></ul><ul><li>Diagnostics </li></ul><ul><li>Microfluidics </li></ul>Chemical shift imaging (CSI) of demonstration 1.25 mm-diameter particles magnetized by B0 . <ul><li>Several geometries have been microfabricated with varying materials of different properties </li></ul><ul><li>Biological compatibility and uptake in cells in progress </li></ul>
  15. 15. <ul><li>The model can be used to measure the </li></ul><ul><li>performance of imaging procedures designed to </li></ul><ul><li>measure the true intensity of spots on microarrays. </li></ul><ul><li>The simulation procedure can be incorporated into </li></ul><ul><li>hardware/software for ease of use. </li></ul>Value Proposition: The current invention describes a simulation procedure in which several parameters can be used to model microarray image formation. <ul><li>Efficient and accurate microarray signal analysis </li></ul><ul><li>Improved detection of weak targets and improved </li></ul><ul><li>local background estimation for microarray spots </li></ul>R&D Status: Late stage microarray imaging and evaluation of gene expression. Available for exclusive or non-exclusive licensing. Publication: Y Balagurunathan, ER Dougherty, Y Chen, ML Bittner, JM Trent. Simulation of cDNA microarrays via a parameterized random signal model. J Biomed Opt. 2002 Jul;7(3):507–523. IP Status: U.S. Patent No. 7,363,169 issued April 22, 2008 Reference #: E-089-2003/0 Contact: Jeffrey A. James, Ph.D.; 301-435-5474; [email_address] Classification error surfaces from simulated intensity and ratio data plotted to demonstrate the domains where expression ratio or expression intensity data performs better than the other (Attoor, S., et al, Bioinformatics , 20(16) p.2513-2520, 2004). A Parameterized Model for Simulating Microarrays Yidong Chen et al. Cancer Genetics Branch, NCI
  16. 16. CYCLIZED NGR PEPTIDE B.J. Wood et al. Clinical Center Radiology and Imaging Sciences, Interventional Radiology Research Laboratory Design and synthesis of novel cyclic NGR (cNGR) ligands for targeting angiogenic tumor vasculature <ul><li>Value Proposition: </li></ul><ul><li>Able to be attached to nano </li></ul><ul><li>delivery systems without disulfide </li></ul><ul><li>bridge formation on surface </li></ul><ul><li>Greater affinity as a monomer </li></ul><ul><li>and on the surface of liposome </li></ul><ul><li>than common linear forms of NGR </li></ul>cNGR Targeted liposome Improved avidity <ul><li>Advantages: </li></ul><ul><li>Easily attached to nano drug </li></ul><ul><li>delivery vehicles such as liposomes </li></ul><ul><li>Permanently cyclized </li></ul><ul><li>Avoid disulfide bridge </li></ul><ul><li>Greater affinity than linear versions </li></ul><ul><li>Molecular imaging applications </li></ul><ul><li>Retains drug release properties from temperature </li></ul><ul><li>sensitive liposomes (TSL) </li></ul><ul><li>Opens a local-regional therapy (TSL) to a more whole </li></ul><ul><li>body treatment with metastasis targeting </li></ul>R&D Status: Synthesis and characterization demonstrated. Animal studies are underway. IP Status: U.S. Provisional Application filed June 2008 Reference #: E-147-2008 Contact: Michael Shmilovich; [email_address] , 301-435-5019 Antibody cNGR Good binding cNGR liposome Linear NGR liposome
  17. 17. Encapsulated Nanoparticles for Computed Tomography Imaging Ronald M. Summers et al. Clinical Center Virtual Endoscopy and Computer-Aided Diagnosis Laboratory, Radiology and Imaging Sciences <ul><li>Characterize polyps’ mucinous layer using UEA-1 lectin. </li></ul><ul><li>Fabricate polymerized liposomes with </li></ul><ul><li>conjugated UEA-1 targeting moiety. </li></ul><ul><li>Utilize polymerized liposomes to detect </li></ul><ul><li>polyps in APCMin/+ mouse tissue with </li></ul><ul><li>optical and CT imaging. </li></ul>Optical Imaging of UEA-1 conjugated polymerized liposomes (targeted) binding the surface of a polyp found in APC Min/+ tissue. Value Proposition: Technology: R&D Status: Discovery. <ul><li>Potential to improve detection of polyps at </li></ul><ul><li>optical and virtual colonoscopy. </li></ul><ul><li>Potential to enable noninvasive histopathologic assessment of polyps to determine </li></ul><ul><li>which need to be removed. Majority of polyps do not need to be removed but </li></ul><ul><li>currently no way to tell which do. </li></ul>IP Status: US Application #61/064,086 filed 15 February 2008 Reference #: E-254-2007 Polyp Polyp Normal Cells Contact: Michael Shmilovich; [email_address] ; 301-435-5019
  18. 18. Automated Identification of Ileocecal Valve Ronald M. Summers et al. Clinical Center Virtual Endoscopy and Computer-Aided Diagnosis Laboratory, Radiology and Imaging Sciences A method for automated identification of ileocecal valve in CT colonography images <ul><li>Improve specificity of computer- </li></ul><ul><li>aided detection of polyps by including this technique as </li></ul><ul><li>part of a CAD system for </li></ul><ul><li>analyzing virtual colons. </li></ul>Ileocecal valve of a 51 y.o. male detected by this method. Average Attenuation: -131 HU Volume: 2.7 cc. (Left) Transaxial CTC images. (Middle) Lung window settings showing the ICV. (Right) Marked CTC image showing computer generated boundary of ICV. Value Proposition: R&D Status: Licensed. <ul><li>Increase physician attention to </li></ul><ul><li>polyp candidates in the cecum. </li></ul>IP Status: US Applications #60/510,640 (10/10/2003); #7,440,601 (10/21/2008) Reference #: E-174-2003 Contact: Jeffrey James; [email_address] , 301-594-7219
  19. 19. Virtual Colonoscopy via Wavelets Ronald M. Summers et al. Clinical Center Virtual Endoscopy and Computer-Aided Diagnosis Laboratory, Radiology and Imaging Sciences Wavelet-based technologies that reduce false positive detections in computer-aided detection (CAD) of polyps in CT colonography (CTC). <ul><li>Significantly reduce false positives by 41.5% </li></ul><ul><li>in a CTC CAD system for detecting 6-9 mm </li></ul><ul><li>polyps. </li></ul>The search path to efficiently locate a good viewpoint. The dotted line represents the colon centerline, C is the polyp centroid, D is the nearest centerline point to C , and PN is the average normal of the polyp surface. Value Proposition: R&D Status: Ready for Implementation in CAD Software. <ul><li>Potential to improve specificity of CTC and </li></ul><ul><li>reduce unnecessary colonoscopies. </li></ul>IP Status: US Application #11/685,127 (3/12/2007) Reference #: E-314-2006 Contact: Jeffrey James; [email_address] , 301-594-7219
  20. 20. Nanoparticles for Imaging and Treatment of Brain Tumors H. Sarin National Institute of Biomedical Imaging and Bioengineering, Clinical Center Nanoparticles selectively cross the blood-brain tumor barrier (BBTB) of brain tumors but not the normal brain-brain barrier (BBB) IP Status: U.S. Provisional Application No. 61/055,328 filed 22 May 2008 Reference # : E-063-2008 Contact: Surekha Vathyam, Ph.D.; [email_address] , 301-435-4076 <ul><li>Advantages: </li></ul><ul><li>Particle Size : Adjustable to achieve </li></ul><ul><li>the desired particle blood half-life </li></ul><ul><li>Particle size: Only increases </li></ul><ul><li>1 to 2 nanometers per generation (G) </li></ul><ul><li>Particle Exterior : Wide variety of </li></ul><ul><li>small agents can be attached to the </li></ul><ul><li>functional groups on the nanoparticle </li></ul><ul><li>exterior </li></ul><ul><li>Multifunctional : Same particle can be </li></ul><ul><li>used for both imaging and drug </li></ul><ul><li>delivery </li></ul><ul><li>R&D Status: </li></ul><ul><li>Discovery </li></ul><ul><li>Animal brain tumor regression studies </li></ul><ul><li>underway </li></ul>
  21. 21. Christy Ludlow Laryngeal and Speech Section, National Institute of Neurological Disorders and Stroke Patents: PCT/US2007/007993 (device) filed 30 March 2007 PCT/US2006/025535 (method) filed 30 June 2006 Reference #: E-194-2006; E-251-2005 For Licensing and Collaborative Opportunities contact Heather Gunas 301-451-3944 guansh@mail.nih.gov Non-Invasive Device and Methods for Swallowing Recovery Treatment and Training for Volitional Swallowing <ul><li>Indications and Uses </li></ul><ul><li>initiation and retraining of swallowing </li></ul><ul><li>for these indications: </li></ul><ul><li>post-stroke </li></ul><ul><li>post-extubation </li></ul><ul><li>neurologically impaired </li></ul><ul><li>throat cancer </li></ul><ul><li>prevention of aspiration pneumonia </li></ul><ul><li>Advantages of Technology </li></ul><ul><li>button press to initiate sensory stimulation and coordinate </li></ul><ul><li>muscular movement to permit volitional swallowing </li></ul><ul><li>sensor for monitoring pressure on the patient’s larynx and a </li></ul><ul><li>swallowing motion detector </li></ul><ul><li>methods to produce vibratory stimulation, pressure stimulation, </li></ul><ul><li>auditory stimulation, temperature stimulation, visual stimulation, </li></ul><ul><li>olfactory stimulation, taste stimulation, or a combination of these </li></ul><ul><li>Current State of Development </li></ul><ul><li>Two on-going clinical trials at the NIH to test device in </li></ul><ul><li>dysphagic patients </li></ul><ul><li>Future Development Needed </li></ul><ul><li>Manufacture, market, and distribute device </li></ul><ul><li>Technological improvements based on current clinical trial results </li></ul>Prototype of device currently being tested in patients Device consists of -- Device controller (including circuit and battery) Motor (vibrator) Adjustable, flexible keel Patient-controlled switch
  22. 22. Selective Killing of Cancer Cells Wenge Zhu & Melvin L. DePamphilis Program on Genomics of Differentiation National Institute of Child Health and Human Development <ul><li>Value Proposition </li></ul><ul><li>Simple, target specific designer drug </li></ul><ul><li>Effective against wide range of </li></ul><ul><li>cancer cells </li></ul><ul><li>R&D Status </li></ul><ul><li>Animal study in progress </li></ul><ul><li>Available for licensing </li></ul><ul><li>IP Status: U.S. Provisional Application No: 61/106,465 </li></ul><ul><li>Collaboration Contact Information : depamphm@mail.nih.gov </li></ul><ul><li>Licensing Contact Information: Betty Tong (tongb@mail.nih.gov) </li></ul><ul><li>Technology </li></ul><ul><li>Small interfering RNA (siRNA) targeted against Geminin, a key regulator of DNA replication </li></ul><ul><li>Induces unscheduled DNA re-replication in human cancer cells </li></ul><ul><li>DNA re-replication spontaneously triggers apoptosis (cell death) </li></ul><ul><li>NO effect on normal cells </li></ul>Colon Cancer Cells Normal Colon Cells Nuclei FACS
  23. 23. Therapeutic Use of E-selectin For Treatment of Multiple Sclerosis and Prevention of Secondary Stroke Hallenbeck, Shukaliak and Takeda National Institute of Neurological Disorders and Stroke E-selectin over-expression is a necessary component of many inflammation-associated autoimmune disorders, and suppression of this pro-inflammatory signal has shown beneficial effects in mouse models for Multiple Sclerosis (MS) and Secondary Stroke. Value Proposition: <ul><li>R&D Status </li></ul><ul><li>In vivo and in vitro data are available </li></ul><ul><li>Collaborative opportunity – NINDS is actively seeking partners for further research, </li></ul><ul><li>development, and commercialization </li></ul><ul><li>Multi market therapeutic platform based on nasal delivery with a tolerization dosing regimen. </li></ul><ul><li>Safety and efficacy trials may be conducted in collaboration with NINDS </li></ul>IP Status: National stage, with three issued patents in Secondary Stroke Reference #: E-153-2005 (MS) and E-237-1999 (secondary stroke) Collaboration Contact Information: Laurie Arrants, [email_address] , 301-435-3112 Licensing Contact Information: Dr. Norbert Pontzer,pontzern@mail.nih.gov , 301-435-5502. Intranasal delivery of E-selectin
  24. 24. Jill Heemskerk a , Jacquie Shukaliak b , and Gene Major c National Institute of Neurological Disorders and Stroke Reference #: E-133-2006; E-187-2007; E-290-2007; E-179-2007 For Collaboration or Licensing , please contact Melissa Maderia 301-451-3943 maderiam@mail.nih.gov Drug Treatment for Neurological Disorders <ul><li>Compounds for the Treatment of Stop Codon Diseases a </li></ul><ul><li>A library of compounds for the treatment of various neurological disorders, such as Spinal </li></ul><ul><li>Muscular Atrophy Muscular Dystrophy, and Cystic Fibrosis. </li></ul><ul><li>Operate via translational read-through of non-sense stop codons to produce full length protein </li></ul><ul><li>Pass through the blood-brain barrier </li></ul><ul><li>Method of Treating Disease Involving Myelin and/or Axonal Loss b </li></ul><ul><li>Use of Tempol for treatment of Multiple Sclerosis (MS), and other neurodegenerative diseases </li></ul><ul><li>Use of Tempol to modulate the generation and limit the damage caused by autoimmune T cells </li></ul><ul><li>Tranilast as an Effective Inhibitor of JC Virus and BK Virus Infection c </li></ul><ul><li>Use in treatment and prevention of polyomavirus infection in immunocompromised patients </li></ul><ul><li>Used for prevention of PML in treatment therapies for MS patients </li></ul>Analogs based on Indoprofen Template Tempol CH 3 CH 3 H 3 C H 3 C O · OH N
  25. 25. Technology: Razoxane and other bisdioxopiperazines reduce amyloid-beta peptide levels, reduce aggregation of alpha-synuclein and tau protein, and reduce abnormal protein folding or aggregation for the treatment of Alzheimer’s Disease (AD) and related diseases with protein aggregation pathology. Value Proposition: Razoxane has been approved for human use and could be more quickly developed as a treatment for Alzheimer’s Disease, Parkinson’s Disease and other diseases. R&D Status: Clinical safety data and pre-clinical efficacy data for treatment of AD. Available for licensing. IP Status: PCT Application No. PCT/US2007/013607 filed 08 Jun 2007. Reference # E-216-2007/0 Licensing Contact: Norbert J. Pontzer, Ph.D., J.D. [email_address] Use of Razoxane for the Treatment of Alzheimer's Disease Nigel H. Greig Drug Design and Development Section, Laboratory of Neurosciences NATIONAL INSTITUTE ON AGING
  26. 26. Method of Treating or Preventing Oxidative Stress-related Diseases Nigel H. Greig et al. Drug Design and Development Section Laboratory of Neurosciences, NATIONAL INSTITUTE ON AGING Technology: Uric acid analogs with improved anti-oxidative and solubility properties for use as free radical scavengers or antioxidants. Novel uric acid analogs for use as antioxidants to help reduce the risk of stroke, neurological diseases and assisting with wound repair. Value Proposition: A number of diseases are associated with oxidative stress including Alzheimer's disease, ischemic stroke, heart disease, cancer, hepatitis, and autoimmune disease. (stroke and neurodegenerative diseases, wound healing and cardiovascular diseases) R&D Status: Pre-clinical IP Status: PCT Application No. PCT/US2007/076597 filed 23 Aug 2007 Reference # No. E-059-2006/0 Collaboration Contact: John Hewes, Ph.D. , [email_address] Licensing Contact: Norbert J. Pontzer, Ph.D., J.D., [email_address]
  27. 27. Technology: N ovel inhibitors of p53 and methods of using these inhibitors for the prevention or treatment of the stress related tissue degeneration observed in Alzheimer's disease, myocardial infarction and stroke. Value Proposition: In vitro and ex vivo studies demonstrated that p53 inhibition protected nerve cells from toxic insults that otherwise induced programmed cell death. In a rat model of stroke, p53 inhibition produced a 50% reduction in stroke volume. R&D Status: Pre-clinical IP Status: PCT/US01/21504 filed 06 Jul 2001 Reference # No. E-222-2000/0 Contact: Norbert Pontzer, Ph.D., J.D. Email: [email_address] Drug Design and Development Section, Laboratory of Neurosciences, NATIONAL INSTITUTE ON AGING Novel Inhibitors of p53 for Treatment of Neurodegenerative Disorders, Myocardial Infarction and Other Tissue Insults Nigel H. Greig et al.
  28. 28. Novel Benztropine Analogs for Treatment of Cocaine Abuse and Other Mental Disorders Amy H. Newman, Mu-fa Zou, Jonathan L. Katz The Medicinal Chemistry and Psychobiology Sections, National Institute on Drug Abuse Technology: Novel benztropine analogs and methods of using these analogs for treatment of mental and conduct disorders such as cocaine abuse, narcolepsy, ADHD, obesity and nicotine abuse. Value Proposition: Drug leads for treatment of cocaine abuse, ADHD, nicotine abuse, obesity, and other dopamine-related disorders R&D Status: Pre-clinical IP Status: U.S. Patent Application No. 12/063,072 filed 06 Feb 2008 Reference # E-234-2005/1 Licensing Contact: Charlene A. Sydnor, Ph.D. for licensing. Email: [email_address]
  29. 29. Inhibitors of CD25 to Treat Autoimmune Diseases and Tumors Bibiana Bielekova National Institute of Neurological Disorders and Stroke Patent Status: U.S. Provisional Application No. 61/201,589 filed 12 Dec 2008 Reference #: E-007-2009 For Collaboration , please contact Martha Lubet, Ph.D, 301-4435-3120; lubetm@mail.nih.gov For Licensing , please contact Suryanarayana (Sury) Vepa, Ph.D., J.D.; 301-435-5020; [email_address] <ul><li>Description of Technology: </li></ul><ul><li>Therapeutics treatment of Multiple Sclerosis, uveitis, and certain cancers </li></ul><ul><li>Provides methods and compositions for selectively blocking CD25 on T cells or dendritic cells </li></ul><ul><li>Ability to exhibit superior specificity and minimal side-effects </li></ul><ul><li>Applications: </li></ul><ul><li>Therapeutics for autoimmune diseases </li></ul><ul><li>Therapeutics for tumors </li></ul><ul><li>Development Status: </li></ul><ul><li>Early stage </li></ul><ul><li>Scientific Findings: </li></ul><ul><li>Mature dendritic cells (mDC) use CD25 for trans-presentation of IL-2 </li></ul><ul><li>Blockade of CD25 on the surface of mDCs abrogates T cell proliferation </li></ul><ul><li>CD25 expression on T cells is dispensable for their proliferation </li></ul><ul><li>CD 25 expression limits effector T cell survival </li></ul>Dendritic Cell CD25 Antagonists T-cell Inhibition 
  30. 30. A Novel & Efficient Technology for Targeted Delivery of siRNA Arya Biragyn, Ph.D, et al. National Institute on Aging (NIA), Laboratory of Immunology <ul><li>Cell surface receptor targeting ligand, such as a chemokine or </li></ul><ul><li>cytokine, fused to a domain that binds an inhibitory oligonucleotide </li></ul><ul><li>Inhibitory oligonucleotide is efficiently delivered to the cell </li></ul><ul><li>expressing the cell surface receptor targeting ligand </li></ul>Figure caption Value Proposition: Novel compositions and methods for delivering inhibitory oligonucleotides to cells in a targeted and efficient manner R&D Status: Animal studies in progress. The NIA is currently seeking licensing partners and/or collaborative partners for further development. <ul><li>In vivo targeted delivery of inhibitory RNAs instead of </li></ul><ul><li>systemic delivery </li></ul><ul><li>Long term repression of target gene expression </li></ul><ul><li>Treatment of cancers and autoimmune diseases </li></ul>IP Status: PCT application; claiming priority to provisional application filed 15 April 2008 Reference #: E-051-2008 Collaboration Contact Information: Nicole Darack Guyton, Ph.D., darackn@mail.nih.gov Licensing Contact Information: Surekha Vathyam, Ph.D.; vathyams@mail.nih.gov Eradication of CEM tumors established in NOD-SCID mice using novel siRNA delivery method. A and B , Macroscopic appearance of tumors treated with control ( A ) or TARC-PE38 ( B ) at day 27 posttumor challenge. C and D , Microscopic appearance (H&E-stained slides, original magnification, x200) of tumors treated with control ( C ) and TARC-PE38 ( D , margin of necrotic area) at day 27 posttumor challenge.. Representative data from two independent experiments with comparable data with eight mice per group.
  31. 31. Technology: Methods of using cytochrome P450 inhibitors to treat or prevent cocaine-induced fetal brain injury, as well as methods for screening for inhibitory drugs to treat or prevent cocaine-induced fetal brain injury. Value Proposition: Useful in diagnosing and treating fetal brain injury caused by cocaine exposure. It is estimated that one percent of pregnant women use cocaine at some point in their pregnancies. R&D Status: Pre-clinical IP Status: PCT Application No. PCT/US2008/055998 filed 06 Mar 2008 Reference # No. E-025-2007/0 Licensing Contact: Charlene A. Sydnor, Ph.D. Email: [email_address] Treatment of Cocaine-Induced Fetal Brain Injury Chun-Ting Lee and William J. Freed Cellular Neurobiology Research Branch National Institute on Drug Abuse
  32. 32. Ron McKay Laboratory of Molecular Biology, National Institute of Neurological Disorders and Stroke Reference #: E-001-2003; E-182-2007; E-239-2005 For Collaboration , please contact Martha Lubet, Ph.D, 301-4435-3120; lubetm@mail.nih.gov For Licensing , please contact Fatima Sayyid, M.H.P.M., 301-435-4521; [email_address] Targets for Treatment of Neurological Disorders Stem Cell Proliferation and Survival Stem cell survival and proliferation has been demonstrated in vitro and in neuronal precursor cells in vivo via several targets, including the Notch ligand, growth factors (FGF-2 or insulin), as well as a population of stem cells expressing STAT3 phosphorylated at serine 727. <ul><li>Applications </li></ul><ul><li>Increased generation of stem cells in vitro for treatment of neurological disorders </li></ul><ul><li>Treatment of neurodegenerative disorders, such as Parkinson’s disease, stroke, and </li></ul><ul><li>spinal cord injury </li></ul><ul><li>Development Status </li></ul><ul><li>In vitro method described in Nature 2006 Aug 17;442(7104):823-826. </li></ul><ul><li>In vivo method validated in rodent models of Parkinson’s disease and stroke. </li></ul>Stroke Parkinson Spinal Cord Injury CNS Neural Stem Cells HES 3 Shh NOTCH ligand STAT3/Ser727
  33. 33. Zscan4: A Gene Critical for Early Embryonic Development Minoru S.H. Ko, M.D., Ph.D., et al . National Institute on Aging (NIA), Laboratory of Genetics <ul><li>Inhibition of Zscan4 expression </li></ul><ul><li>using siRNA delays progression </li></ul><ul><li>from the 2-cell to the 4-cell </li></ul><ul><li>stage of embryogenesis and </li></ul><ul><li>produces blastocysts that fail to </li></ul><ul><li>implant in the mouse embryo. </li></ul><ul><li>Invention discloses methods of </li></ul><ul><li>promoting blastocyst </li></ul><ul><li>outgrowth of ES cells and </li></ul><ul><li>methods of identifying ES cells </li></ul><ul><li>expressing Zscan4. </li></ul>Figure caption Value Proposition: Zscan4 plays an essential role in early embryonic development, with potential applications for the development of stem cell therapeutics and assisted reproduction technologies. R&D Status: Early stage development. Technology is available for licensing. <ul><li>Development of stem cell therapeutics </li></ul><ul><li>Assisted reproduction technologies and </li></ul><ul><li>studies of early embryonic development </li></ul>IP Status: PCT application; claiming priority to provisional application filed 26 March 2007 Reference #: E-088-2007 Contact: Tara Kirby, Ph.D.; tarak@mail.nih.gov Insert figure here A schematic illustration of Zscan4 expression patterns.
  34. 34. The Neuregulin/ErbB Signaling Pathway as a Novel Drug Target to Treat Schizophrenia and Bipolar Disorder Andres Buonanno Section of Molecular Neurobiology, National Institute of Child Health and Human Development <ul><li>Identification of novel drug targets in the NRG-ErbB signaling </li></ul><ul><li>pathway to treat cognitive deficits associated with schizophrenia </li></ul><ul><li>(Scz) and bipolar (BiP) disorder, such as working memory. </li></ul><ul><li>Develop novel markers to diagnose and classify distinct types and </li></ul><ul><li>phases Scz and BiP disorder. </li></ul><ul><li>Use of novel knockout mice and lentivirus-targeted shRNAs to </li></ul><ul><li>identify and test novel drugs. </li></ul>Figure : Effects of Neuregulin (NRG) and a small molecule antagonist on dopamine release (A) and long-term potentiation(LTP), a form of memory ( B,C ). A) NRG causes dramatic dopamine release [  ], which is blocked by antagonist [  ]. B) NRG reverses LTP (  ,blue ), as compared to control (  ,black). C) LTP reversal by NRG is prevented by small molecule inhibitor (  ,blue ). Value Proposition: Technology : R&D Status: in progress, searching collaborations <ul><li>Neuregulin, and its receptor ErbB4, are the most reproducibly </li></ul><ul><li>known “at risk genes” for Scz and BiP disorder. </li></ul>IP Status: PCT/US2007/75724 Reference #: E-304-2005/0-PCT-02 Collaboration Contact Information: [email_address] Licensing Contact Information: [email_address] <ul><li>All drugs presently used are D2-type dopamine receptor antagonist that </li></ul><ul><li>treat “positive symptoms” (i.e., hallucinations) but fail to treat the most </li></ul><ul><li>debilitating aspects of the disease, such as deficits in executive functions. </li></ul>A. B. C.
  35. 35. The various pharmaceutical compositions and methods for the treatment of Schistosomiasis in mammals are based on a number of compounds derived from 1,2,5-oxadiazole that are potent inhibitors of thioredoxin glutathione reductase (TGR), a critical parasite redox protein. Value Proposition: R&D Status: To date, the general oxidiazole-2-oxide chemotype described here has shown efficacy in animal models. Available for licensing. Publications: Sayed, A. A.; Simeonov, A.; Thomas, C. J.; Inglese, J.; Austin, C. P.; Williams, D. L . Identification of oxadiazoles as new drug leads for the control of schistosomiasis. (2008) Nature Med. 14 , 407-412 . IP Status: U.S. Provisional Application No. 61/088,970 filed August 14, 2008 Reference #: E-162-2008/0 Contact: Cristina Thalhammer-Reyero , Ph.D., MBA; 301-435-4507; [email_address] <ul><li>selected oxidiazole-2-oxides are being evaluated in advanced ADME/T assays and are being formulated for oral dosing experiments. </li></ul><ul><li>TGR as an appropriate molecular target for </li></ul><ul><li>pharmacological intervention </li></ul><ul><li>TGR potential chemotherapy for schistosomiasis </li></ul>Technology: Treatment of Schistosomiasis Using Substituted Oxadiazole 2-Oxides C.J. Thomas et al. NIH Chemical Genomics Center
  36. 36. <ul><li>Low nM inhibition of PDE4 Isozymes. </li></ul><ul><li>Low nM inhibition in cells. </li></ul><ul><li>High selectivity for PDE4. </li></ul><ul><li>Extensive SAR investigations. </li></ul><ul><li>Known DMPK data. </li></ul><ul><li>Value Proposition: </li></ul><ul><li>Easily scalable synthesis for gram </li></ul><ul><li>scale production. </li></ul><ul><li>Excellent SAR understanding will </li></ul><ul><li>provide room for modulation of </li></ul><ul><li>bioavailability properties. </li></ul><ul><li>Physiologically proven target for </li></ul><ul><li>drug discovery programs including </li></ul><ul><li>from asthma, chronic obstructive pulmonary disease (COPD) and memory enhancement. </li></ul><ul><li>R&D Status: Synthesis, SAR, biochemical and cell based activity demonstrated. Animal studies are underway. </li></ul><ul><li>Publication: AP Skoumbourdis et al . Identification of a potent new chemotype for the selective inhibition of PDE4. </li></ul><ul><li>Bioorg Med Chem Lett. 2008 Feb 15;18(4):1297–1303. </li></ul><ul><li>IP Status : U.S. Patent Application filed January 8, 2009. Application No. PCT/US/2009/000105 </li></ul><ul><li>Contact: Fatima Sayyid, M.H.P.M.; 301-435-4521; [email_address] </li></ul>Design and synthesis of novel Triazolothiadiazines and Triazolopyridazines as PDE4 Inhibitors Substituted Triazolothiadiazines and Triazolopyridazines C.J. Thomas et al. NIH Chemical Genomics Center L o g [ 1 0 ] , M % A c t i v i t y S N N N N O M e M e O M e O O O P D E 4 A 1 A P D E 4 B I C 5 0 ( n M ) 0 . 2 6 2 . 3 P D E i s o f o r m P D E 4 D 1 . 9 P D E 4 B 1 . 6
  37. 37. <ul><li>novel triazine and purine compounds for the </li></ul><ul><li>treatment and prevention of: </li></ul>notable inhibitors of cruzain Value Proposition: Parasitic protozoa are responsible for a wide variety of infections in both humans and animals. R&D Status: In vitro and in vivo data are available upon request and upon execution of an appropriate confidentiality agreement. IP Status: U.S. Provisional Application No. 61/199,763 filed Nov 19, 2008 Reference #: E-267-2008 Contact: Kevin W. Chang, Ph.D.; 301-435-5018; [email_address] <ul><li>Novel compounds against the cysteine proteases, cruzain and rhodesain </li></ul><ul><li>Compounds possess low nanomolar inhibitory potential against cruzain and rhodesain </li></ul><ul><li>mammalian protozoal diseases </li></ul><ul><li>(including African trypanosomiasis) </li></ul><ul><li>Chagas disease </li></ul><ul><li>opportunistic infections </li></ul>Substituted Triazine and Purine Compounds, Methods of Inhibiting Cruzain and Rhodesain, and Methods of Treating Chagas Disease and African Trypanosomiasis C.J. Thomas et al. NIH Chemical Genomics Center
  38. 38. Melissa Maderia, Ph.D. [email_address] 301-451-3943 To obtain copies of these slides, please visit: http:// ttc.nci.nih.gov or http:// ott.od.nih.gov or http:// www.cdc.gov/tto keyword: BIO Contact Info
  39. 39. BIO2009 Federal Science and Opportunities Track Hot Federal Biotechnologies Available for Collaboration and Licensing Rosemary C. Walsh, Ph.D. Technology Development Associate Office of Technology Development National Institute of Allergy and Infectious Diseases [email_address]
  40. 40. <ul><li>Epitope-Transplant Scaffolds and Their Use </li></ul><ul><li>Epitopes are removed from whole antigen </li></ul><ul><li>and placed on a protein “scaffold” </li></ul><ul><li>Epitopes retain their 3-D structure even when missing </li></ul><ul><li>some of the surrounding original antigen sequence </li></ul><ul><li>Model system utilizes one or more </li></ul><ul><li>gp120 epitopes from HIV-1 </li></ul><ul><li>Value Proposition: </li></ul><ul><li>Novel, structure-based approach for vaccine design </li></ul><ul><li>may succeed in maximizing generation of neutralizing antibodies </li></ul><ul><li>Method can be generalized to non-HIV vaccines </li></ul><ul><li>R&D Status: Pre-clinical </li></ul><ul><li>IP Status: Filed US & EP WO 2008/025015 </li></ul><ul><li>Reference # E-302-2006/1 </li></ul><ul><li>Collaboration Contact: Marguerite Miller; millermarg@niaid.nih.gov </li></ul><ul><li>Licensing Contact: Cristina Thalhammer-Reyero; [email_address] </li></ul>Peter D. Kwong, et al. National Institute of Allergy and Infectious Diseases Novel Approach to Vaccine Design Conserved neutralization epitope on HIV-1 gp120
  41. 41. <ul><li>HIV Vaccine Immunogens and Immunization Strategies to Elicit Broadly Neutralizing Anti-HIV-1 Against the Membrane-Proximal Ectodomain of HIV gp41 </li></ul><ul><li>Generate an immune response against HIV-1 gp41. </li></ul><ul><li>Binds to the broadly neutralizing antibodies 2F5, 4E10, and Z13. </li></ul><ul><li>IP Status: Filed US, WO 2005/111079 Reference # E-218-2004/0 </li></ul><ul><li>Conformationally Stabilized HIV Envelope Immunogens, and Triggering HIV-1 to Reveal Cryptic V3-Loop Epitopes </li></ul><ul><li>Stabilizing HIV envelope gp120 improves its immunogenicity </li></ul><ul><li>Stabilization is accomplished by non-naturally occurring disulfide bonds </li></ul><ul><li>IP Status: Filed US, WO 2007/030518 Reference # E-324-2005/3 </li></ul><ul><li>HIV gp120 Crystal Structure and its Use to Identify Immunogens </li></ul><ul><li>Immunogens present HIV-1 epitopes that bind neutralizing antibodies </li></ul><ul><li>Do not induce other antibodies that might interfere with epitope binding </li></ul><ul><li>IP Status: Filed US& EP, WO 2007/030637 Reference # E-280-2006/1 </li></ul><ul><li>R&D Status: Pre-clinical </li></ul><ul><li>Collaboration Contact: Marguerite Miller, MBA; millermarg@niaid.nih.gov </li></ul><ul><li>Licensing Contact: Cristina Thalhammer-Reyero; thalhamc@mail.nih.gov </li></ul>Peter D. Kwong, et al. National Institute of Allergy and Infectious Diseases Potential HIV Vaccine Immunogens
  42. 42. <ul><li>Use of Virus-Like Particles (VLPs) as Vaccine against Chikungunya Virus </li></ul><ul><li>Structural Proteins (core, E1 and E2) were expressed in 293 producer cells as VLPs </li></ul><ul><li>Immunization of mice with VLPs </li></ul><ul><ul><li>Generates neutralizing antibodies against both homologous and heterologous virus strains </li></ul></ul><ul><ul><li>Ab titer is 2 orders of magnitude greater than that achieved with DNA vaccines </li></ul></ul><ul><li>Value Proposition: </li></ul><ul><li>Efficient method of developing vaccines against Chikungunya virus </li></ul><ul><li>Strategy amenable to developing vaccines against other pathogens </li></ul><ul><li>R&D Status: Animal (mouse and non-human primate) data available </li></ul><ul><li>IP Status: Filed US Provisional Pat. Application #61/201,118 on12/5/2008 </li></ul><ul><li>Reference # E-004-2009 </li></ul><ul><li>Collaboration Contact: Marguerite Miller; millermarg@niaid.nih.gov </li></ul><ul><li>Licensing Contact: Cristina Thalhammer-Reyero; thalhamc@mail.nih.gov </li></ul>G. Nable National Institute of Allergy and Infectious Diseases Chikungunya Vaccine
  43. 43. <ul><li>Polymorphic Membrane Protein D (PmpD) as vaccine candidate </li></ul><ul><li>>99% Sequence identity between serovariants </li></ul><ul><li>Surface located antigen </li></ul><ul><li>Antibodies neutralize all 15 serotypes in vitro </li></ul><ul><li>Can be expressed in E.coli and Modified </li></ul><ul><li>Vaccinia Ankara (MVA) </li></ul><ul><li>Value Proposition: </li></ul><ul><li>Antigen common to all serotypes </li></ul><ul><li>Vaccination preferable to antibiotic intervention which can compromise development of immunity </li></ul><ul><li>R&D Status: preclinical </li></ul><ul><li>IP Status: Filed PCT application (WO 2008/048348) on1/9/07, priority date:1/9/06 </li></ul><ul><li>Reference # E—031-2006 </li></ul><ul><li>Collaboration Contact: Anna Amar; aamar@niaid.nih.gov </li></ul><ul><li>Licensing Contact: Peter Soukas: soukasp@mail.nih.gov </li></ul>H. D. Caldwell National Institute of Allergy and Infectious Diseases Chlamydial Vaccine
  44. 44. <ul><li>Sialostatin L2 Mediation Controls Blood Feeding Success </li></ul><ul><li>of Ixodes scapularis </li></ul><ul><li>I. scapularis main vector of Lyme’s Disease </li></ul><ul><li>Salivary secretions crucial for pathogen transmission </li></ul><ul><li>Use of Sialostatin 2 as vaccine in guinea pigs </li></ul><ul><ul><li>Decrease in feeding ability of tick nymphs </li></ul></ul><ul><ul><li>Increase in rejection rate of nymphs </li></ul></ul><ul><ul><li>Increase in inflammation of guinea pigs </li></ul></ul><ul><li>Value Proposition: </li></ul><ul><li>Use of Sialostatin L2 as anti-tick vaccine will confer protection from tick nymphs and pathogens transmitted by tick bites </li></ul><ul><li>Potential as part of a multi-component vaccine </li></ul><ul><li>Environmentally friendly alternative to acaricides(pesticides ) </li></ul><ul><li>R&D Status: Animal (Guinea Pig) data available </li></ul><ul><li>IP Status: Filed PCT (WO 2009/017689) on 7/25/2008, priority date: 8/2/2007 </li></ul><ul><li>Reference # E-289-2007 </li></ul><ul><li>Collaboration Contact: S. Dana Hsu: dhsu@niaid.nih.gov </li></ul><ul><li>Licensing Contact: RC Tang; tangrc@mail.nih.gov </li></ul>M. Kotsyfakis, J.M.C Ribeiro, J.G. Valenzuela, J. Anderson, J. Andersen National Institute of Allergy and Infectious Diseases S. Karim, T.N. Mather at the University of Rhode Island Anti-tick Vaccine
  45. 45. <ul><li>Phenol-soluble modulin (PSM) polypeptides </li></ul><ul><li>Secreted peptides that recruit, activate and lyse human neutrophils </li></ul><ul><li>Eliminate main cellular defense against S. aureus infection </li></ul><ul><li>High PSM expression gives methicillin resistant S. aureus infections contracted in community settings greater virulence that MRSA found in health care settings </li></ul><ul><li>Deletion of encoding gene cluster (psm  ) in Staphlycocci is associated with reduced capacity to form lesions and kill mice </li></ul><ul><li>Application: </li></ul><ul><li>Target for development of new classes of antibiotics and vaccines against MRSA </li></ul><ul><li>R&D Status: Animal data available </li></ul><ul><li>IP Status: Filed International application on 5/8/2008; priority date:6/6/2007 </li></ul><ul><li>Reference # E-239-2007/2-PCT-01 </li></ul><ul><li>Collaboration Contact: Johanna Schneider; schneiderjs@niaid.nih.gov </li></ul><ul><li>Licensing Contact: Cristina Thalhammer-Reyero; thalhamc@mail.nih.gov </li></ul>M. Otto National Institute of Allergy and Infectious Diseases Novel Targets Against Staphlycocci Bacterial Infections
  46. 46. <ul><li>Aegyptin, a collagen binding protein </li></ul><ul><li>Selectively inhibits collagen platelet aggregation </li></ul><ul><li>Blocks interaction of collagen with its major ligands </li></ul><ul><ul><li>Willebrand factor </li></ul></ul><ul><ul><li>Glycoprotein VI (GPVI) </li></ul></ul><ul><ul><li>Integrin a2 β 1 </li></ul></ul><ul><li>Applications: </li></ul><ul><li>Adjuvant to “clot busting” therapeutics </li></ul><ul><li>Prevention/treatment of cardiovascular/thrombotic disease </li></ul><ul><li>Treatment for patients undergoing invasive cardio procedures </li></ul><ul><li>May play role in treatment of pancreatic carcinoma </li></ul><ul><li>R&D Status: Pre-clinical development </li></ul><ul><li>IP Status: Filed US Provisional Applications: 60/198,629 on 7/9/2007 and </li></ul><ul><li> 60/982,241 on 10/24/2007 </li></ul><ul><li>Reference # E-172—2007/1 </li></ul><ul><li>Collaboration Contact: S. Dana Hsu: dhsu@niaid.nih.gov </li></ul><ul><li>Licensing Contact: Jennifer Wong; wongje@mail.nih.gov </li></ul>E. Calvos, et al. National Institute of Allergy and Infectious Diseases Platelet Aggregation Inhibitor Platelet GpIb-V-IX Exposed Collagen Endothelium vWF Aggregation Adhesion Shape change Release of granules content GPVI α 2 β 1 Multiple receptors mediate platelet adhesion to collagen: GPVI, integrin alpha2beta1 and GPIb/vWF
  47. 47. <ul><li>MAOi(s) prevent HSV infection and may prevent periodic reactivation from latency </li></ul><ul><li>Herpes viruses are repressed by host chromatin structures that wrap the viral genome </li></ul><ul><li>Enzymes (LSD1) are recruited to halt repression </li></ul><ul><li>LSD1 is inhibited by MAOi(s); expression of viral genes is inhibited </li></ul><ul><li>Application: </li></ul><ul><li>May also prevent significant lytic replication of other herpes viruses </li></ul><ul><li>May reduce viral infection during transplant </li></ul><ul><li>Other more specific drugs targeted to LSD1 may prevent other viral infections </li></ul><ul><li>R&D Status: Pre-clinical </li></ul><ul><li>IP Status: Filed US Provisional 61/111,109 on 11/4/2008 </li></ul><ul><li>Reference # E275-2008 </li></ul><ul><li>Collaboration Contact: Christopher Freeman; freemanch@niaid.nih.gov </li></ul><ul><li>Licensing Contact: Cristina Thalhammer-Reyero; thalhamc@mail.nih.gov </li></ul>T. Kristie, et al. National Institute of Allergy and Infectious Diseases Mono-amine oxidase inhibitors (MAOi) for treatment of herpes simplex infection
  48. 48. <ul><li>Device/method for microwave assisted cryo-sample processing </li></ul><ul><li>Reduced time required for freeze substitution fixation from 2-6 days to 2-3 hours </li></ul><ul><li>Equivalent preservation of morphology when compared to traditional freeze substitution fixation </li></ul><ul><li>Superior preservation of morphology when compared to conventional fixation techniques using passive diffusion </li></ul><ul><li>Value Proposition: </li></ul><ul><li>Enables microscopic examination of samples within hours of collection (eg. during surgery) </li></ul><ul><li>Enables analysis of hydrogels not well preserved by traditional X-linking reagents </li></ul><ul><ul><li>Biological-cartilage, synovial fluid, extracellular matrices, biofilm </li></ul></ul><ul><ul><li>Commercial-contact lenses, prosthetic devices </li></ul></ul><ul><li>R&D Status: Looking for partner to develop device prototypes </li></ul><ul><li>IP Status: Filed US Provisional Pat. Application #61/112,575 on 11/7/2009 </li></ul><ul><li>Reference # E-238-2008 </li></ul><ul><li>Collaboration Contact: Christopher Freeman; freemanch@niaid.nih.gov </li></ul><ul><li>Licensing Contact: RC Tang; [email_address] </li></ul>D. Dorward, V. Nair, E. Fischer National Institute of Allergy and Infectious Diseases Faster Cryo-Sample Processing
  49. 49. For information on these and other opportunities, please contact Rosemary C. Walsh, Ph.D. Phone:301-451-3528 Email:rcwalsh@niaid.nih.gov To obtain copies of these slides, please visit: http:// ttc.nci.nih.gov or http:// ott.od.nih.gov keyword: BIO
  50. 50. at the National Cancer Institute John D. Hewes, Ph.D. Technology Transfer Specialist Technology Transfer Center Tel. (301) 435-3121 email: [email_address] http://ttc.nci.nih.gov
  51. 51. Why Collaborate ? BUSINESS MODELS BASED ON COLLABORATION From PriceWaterHouseCoopers “Pharma 2020: Challenging Business Models,” retrieved from www.pwc.com/pharma STRATEGIC TRENDS IN PHARMACEUTIC INDUTRY <ul><li>Markets </li></ul><ul><li>Patients more informed </li></ul><ul><li>Patients paying more </li></ul><ul><li>Personalized medicine </li></ul><ul><li>Patient outcomes </li></ul><ul><li>Emerging markets </li></ul><ul><li>Health/Healthcare </li></ul><ul><li>Cost of chronic diseases </li></ul><ul><li>Payers establishing protocols </li></ul><ul><li>Pay-for-performance </li></ul><ul><li>Financial constraints of payers </li></ul><ul><li>Science/Technology </li></ul><ul><li>R&D becoming virtualized </li></ul><ul><li>R&D shifting to Asia </li></ul><ul><li>Remote monitoring </li></ul><ul><li>Data warehousing/sharing </li></ul>IMPLICATIONS TO PHARMACEUTICAL INDUSTRY <ul><li>Pharma goes beyond medicine </li></ul><ul><li>Outcomes, not products, become drivers </li></ul><ul><li>Prevention vs. cure </li></ul><ul><li>Flexible pricing pressure </li></ul><ul><li>R&D goes beyond the Lab </li></ul><ul><li>Data universe is growing </li></ul><ul><li>Virtual lab space is growing </li></ul><ul><li>Multi-disciplinary </li></ul><ul><li>Geographic expansion (Asia) </li></ul><ul><li>Bottom-line results </li></ul><ul><li>Value chains of Pharma & Healthcare more interlinked </li></ul><ul><li>Work with Regulators </li></ul><ul><li>Work with providers for trials </li></ul><ul><li>Dispersed services to coordinate </li></ul>
  52. 52. Why Collaborate with NCI? TTC maintains an e-mail service to notify you of new technology opportunities. Register at http://ttc.nci.nih.gov <ul><li>Value Proposition </li></ul><ul><li>IRP researchers can efficiently translate world-class discoveries into clinical applications using a broad infrastructure, such as that provided by NIH Clinical Center (world’s largest clinical research hospital). </li></ul><ul><li>Accessible to industry through research collaborations and licensing </li></ul><ul><li>Leverage the NCI's expertise, resources, and broad network of clinical researchers and sites </li></ul><ul><li>Trials at the Clinical Center allows investigators from other NIH institutes to participate </li></ul><ul><li>NIH can recruit patients from around the country, trials performed at the Clinical Center are more likely to enroll enough patients with rare diseases to provide the statistical power needed to produce meaningful results. </li></ul>Intramural Research Program (IRP) ($718M in FY08) 10% of the NCI budget supports projects conducted by nearly 400 scientists in its own laboratories, most of whom are on the NIH campus in Bethesda or NCI-Frederick (MD).
  53. 53. NCI has produced important drugs and technologies through collaborations and licensing with the private sector. Abbott/Others AIDS Test Kits Schering AG/Berlex Fludara® BMS Videx ® (ddI) BMS Taxol ® (paclitaxel)* Roche Hivid ® (ddC) Millennium Velcade® * Cell Therapeutics Zevalin® Amgen Kepivance ® 20/20 GeneSystems Multi-Replica Blotting Kit* Molecular Devices PixCell® Laser Capture Microdissection* Merck Gardasil® Medimmune Oncology NeuTrexin® Monogram Biosciences PhenoSenseTM HIV phenotype tests Isis Vitravene® Ortho Biotech Prezista® Biovest/Accentia BiovaxID™ Squirrel Free Products Squirrel-free capsaicin-treated birdseed *Developed under NCI CRADA Marketed NCI-Licensed Technologies
  54. 54. Chemical programming of antibodies through selenocysteine Christoph Rader, Ph.D. Experimental Transplantation and Immunology Branch Technology: Cancer Therapeutics (immunoconjugate/antibody-drug conjugate) An engineered selenocysteine near the C-terminus of an antibody, or antibody fragment, covalently links the antibody and a small synthetic molecule to produce hybrid molecules. Value Proposition: Combines advantages of small synthetic molecules with monoclonal antibodies Small synthetic molecules Monoclonal antibodies Unlimited structural diversity Prolonged and predictable in vivo half life Reach recessed sites on macromolecules Potent interference with macromolecular Straightforward manufacturing interactions Adjustable valence and effector activity R&D Status: Pre-clinical in vivo (mouse) toxicity, administration routes, and pharmacokinetics IP Status: PCT/US2008/059135 (4/2/08); U.S. Patent Application 60/909,665 (4/2/07) Reference # E-146-2007 Collaboration Contact: John D. Hewes, Ph.D., hewesj@mail.nih.gov, 301-435-3121 Licensing Contact: Jennifer Wong, wongje@mail.nih.gov, 301-435-463
  55. 55. Nitric Oxide-releasing Polymers Larry K. Keefer, Ph.D. Laboratory of Comparative Carcinogenesis <ul><li>Technology: NO-releasing Biomaterials Polymers containing the X-N 2 O 2 - functional group (NONOates, diazeniumdiolates) spontaneously generate bioactive NO at their surfaces on contact with physiological media for up to a month or more. NIH inventors have now produced and tested polymers in which the NO-releasing group is attached directly to the carbon backbone of many of the important workhorse industrial materials used in medicine to produce </li></ul><ul><li>Polyacrylonitriles and Polyurethanes (tubing, textiles, vascular grafts, hemofilters, ECMO, antithrombotics, inhibition of neointimal hyperplasia) </li></ul><ul><li>Polydiazeniumdiolated cyclic polyamines (multiphasic NO release) </li></ul><ul><li>Polysaccharides (Cotton for bandages, surgical fabric, wound healing, tissue repair) </li></ul><ul><li>Imidoester- and amidine-derived diazeniumdiolates (Antibacterial additives, platelet storage) </li></ul><ul><li>Value Proposition: Attaching NO-releasing groups onto biomaterials, which deliver NO to specific sites without systemic exposure to NO or its potentially toxic by-products </li></ul><ul><li>R&D Status: Pre-clinical proof-of-concept </li></ul><ul><li>IP Status: U.S. Patents issued, U.S. and foreign patent applications </li></ul><ul><li>Reference # E-189-2002, E-276-2002, E-188-2004, E-248-2005, E-279-2005 </li></ul><ul><li>Collaboration Contact: John D. Hewes, [email_address] , 301-435-3121 </li></ul><ul><li>Licensing Contact: Steve Standley, 301-435-4074, [email_address] </li></ul>
  56. 56. Prognostic for Prostate Cancer Treatment William D. Figg, Pharm. D. Medical Oncology Branch <ul><li>Technology: Cancer Biomarkers for androgen-independent prostate cancer (AIPC) </li></ul><ul><li>a. CYP1B1*3 A genetic marker called CYP1B1*3 can predict survival in patients with prostate cancer prior to treatment with docetaxel. This genetic marker can be measured in DNA obtained from a blood sample. This technology can be potentially used to predict the patient's propensity to respond to docetaxel treatment when being treated for AIPC, which remains the second leading cause of cancer death in men in developed nations, </li></ul><ul><li>b. SLCO1B3 Two polymorphic genetic markers in the SLCO1B3 gene, measured in genomic DNA obtained from a blood sample, can provide a correlation between clinical outcome of SLCOlB3 genotype with median survival of androgen independent prostate cancer. The genotype can also predict testosterone uptake, which is useful in clinical decisions regarding anti-androgen therapy. </li></ul><ul><li>Value Proposition: </li></ul><ul><li>Potential to improve clinical diagnosis and prognosis for individual AIPC patients </li></ul><ul><li>R&D Status: Pre-clinical in vitro analysis of patient samples </li></ul><ul><li>IP Status: a. U.S.11/991,878 filed 03/11/2008; b. PCT/US2008/000310 filed 01/08/2008 </li></ul><ul><li>Reference # a. E-307-2005; b. E-083-2007 </li></ul><ul><li>Collaboration Contact: John D. Hewes, Ph.D., hewesj@mail.nih.gov, 301-435-3121 </li></ul><ul><li>Licensing Contact: Sabarni K. Chatterjee, Ph.D., chatterjeesa@mail.nih.gov, 301-435-5587 </li></ul>
  57. 57. Methods for Diagnosis and Prognosis of Lymphomas <ul><li>Technology: Microarray diagnostics </li></ul><ul><li>Novel microarray for obtaining gene expression profile data for identifying lymphoma types and predicting survival in a lymphoma patient </li></ul><ul><li>Established using a human genome gene chip set measuring the expression of over 27,000 genes in more than 500 lymphoproliferative tumor samples </li></ul><ul><li>Describes a variety of methods for analyzing gene expression data obtained from a lymphoma sample, and specific algorithms for predicting survival and clinical outcome </li></ul><ul><li>Value Proposition: </li></ul><ul><li>Allows clinicians to tailor drug treatments to an individual’s unique lymphoma phenotype </li></ul><ul><li>Enables the diagnosis of lymphoma subtypes that are indistinguishable by current methods but that are clinically distinct </li></ul><ul><li>Designed to provide an all-in-one method for the diagnosis of all lymphomas </li></ul><ul><li>R&D Status: Pre-clinical proof-of-concept with human tissue samples </li></ul><ul><li>IP Status: PCT Application No. PCT/US2004/029041 (9/3/2004) </li></ul><ul><li>Reference # E-234-2003 </li></ul><ul><li>Collaboration Contact: John D. Hewes, Ph.D., hewesj@mail.nih.gov, 301-435-3121 </li></ul><ul><li>Licensing Contact: Sabarni K. Chatterjee, Ph.D., chatterjeesa@mail.nih.gov, 301-435-5587 </li></ul>Louis M. Staudt, M.D., Ph.D. Metabolism Branch
  58. 58. Development of Novel Anti-HIV Compounds Robert Shoemaker, Ph.D. and Alan Rein, Ph.D. Developmental Therapeutics Program, HIV DRP Retroviral Replication Laboratory <ul><li>Value Proposition: </li></ul><ul><li>The mechanism of anti-HIV action of Stibavirin is different from current approved drugs. </li></ul><ul><li>This suggests addition of Stibavirin to HAART regimen, in combination treatment of patients with AIDS, particularly those who have become resistant to other drugs. Well tolerated in vivo. </li></ul><ul><li>R&D Status: Pre-clinical in vivo , incl. efficacy, pharmacokinetics, preliminary tox studies. </li></ul><ul><li>IP Status: U.S. application 10/528,747 filed 3/22/2005 </li></ul><ul><li>Reference # E-121-2002 </li></ul><ul><li>Collaboration Contact: John D. Hewes, Ph.D., hewesj@mail.nih.gov, 301-435-3121 </li></ul><ul><li>Licensing Contact: Sally Hu, Ph.D., MBA, hus@mail.nih.gov, 301-435-5606 </li></ul>Technology: HIV Therapeutic Active anti-viral compound Stibavirin comprises aromatic, antimony-containing compound that was shown to inhibit viral particle assembly and inhibit the binding of nucleocapsid protein to nucleic acid. Also demonstrated was the capability of blocking HIV-1 viral entry into CD4+ cells through binding to CD4 and inhibiting gp120-CD4 interaction.
  59. 59. HIV-1 Integrase Inhibitors for the Treatment of Retroviral Infections Technology: HIV Therapeutics Novel HIV-1 integrase inhibitors that inhibit strand transfer (ST) of HIV viral DNA into the host genome <ul><li>Value Proposition: </li></ul><ul><li>Potential therapeutic and preventative value for AIDS and other retroviral infections </li></ul><ul><li>Potential benefit for patients exhibiting resistance to current therapy regimes </li></ul><ul><li>R&D Status: Pre-clinical in vitro </li></ul><ul><li>IP Status: U.S. Provisional Application No 60/956,636 (08/17/2007) </li></ul><ul><li>Reference # E-237-2007 </li></ul><ul><li>Collaboration Contact: John D. Hewes, Ph.D., hewesj@mail.nih.gov, 301-435-3121 </li></ul><ul><li>Licensing Contact: Sally Hu, Ph.D., MBA, hus@mail.nih.gov, 301-435-5606 </li></ul>Terrence R. Burke Jr., Ph.D., Yves Pommier, M.D., Ph.D., et al. Laboratory of Medicinal Chemistry HIV-1 Integrase Strand Transfer (ST) Inhibitory Potency (IC 50 ) in the Presence of Mg2+ and Antiviral Inhibitory Potency (EC 50 ) in HIV-1 Infected Cells
  60. 60. Technology: HIV Therapeutics Novel antibody-based technologies for the treatment of HIV/AIDs, including the first anti-HIV human domain antibody (m36), which can potentially be used alone or synergistically with other anti-HIV antibodies and antiretroviral drugs. Also included in this platform is a fusion construct that may elicit broad neutralizing antibodies and an HIV vaccine that is able to elicit a desired antibody against a target antigen. Antibody-based HIV treatment and prevention <ul><li>Applications: </li></ul><ul><li>HIV treatment and prevention </li></ul><ul><li>Ability to neutralize HIV isolates from different clades </li></ul><ul><li>R&D Status: Pre-clinical in vitro and in vivo </li></ul><ul><li>IP Status: US Patent Applications filed </li></ul><ul><li>Reference # E-043-2008, E-072-2008, E-322-2008 </li></ul><ul><li>Collaboration Contact: John D. Hewes, Ph.D., hewesj@mail.nih.gov, 301-435-3121 </li></ul><ul><li>Licensing Contact: Sally Hu, Ph.D., MBA, hus@mail.nih.gov, 301-435-5606 </li></ul>Dimiter S. Dimitrov, Ph.D. NCI CCR Nanobiology Program
  61. 61. Assay to detect Plk1 levels and activity Kyung Lee, Ph.D. Laboratory of Metabolism <ul><li>Technology: Cancer Diagnostic </li></ul><ul><li>Mammalian polo-like kinase 1 (Plk1), a critical mitotic kinase, is upregulated in ~ 80% of human cancers. A growing body of evidence suggests that Plk1 plays a critical role in numerous mitotic events and cellular proliferation. Plk1 has been suggested as a biomarker for several types of human cancers and is considered an important potential target for anti-cancer therapy. </li></ul><ul><li>Value Proposition: </li></ul><ul><li>Rapid and highly-sensitive ELISA that allows quantification of Plk1 activity with only several microgram of unpurified total lysates from cells and tissues. </li></ul><ul><li>Provide broad clinical applications including prognosis of Plk1-associated cancers and assessment of early therapy response following anti-proliferative chemotherapy. </li></ul><ul><li>R&D Status: Pre-clinical in vitro analysis of patient samples </li></ul><ul><li>IP Status: U.S. Provisional Application No. 61/054,032 filed 16 May 2008 </li></ul><ul><li>Reference # E-091-2008 </li></ul><ul><li>Collaboration Contact: John D. Hewes, [email_address] , 301-435-3121 </li></ul><ul><li>Licensing Contact: Jennifer Wong, 301/435-4633, [email_address] </li></ul>
  62. 62. Martin W. Brechbiel, Ph.D. Radiation Oncology Branch <ul><li>Technology: Imaging/Contract Agents </li></ul><ul><li>Silica-encased, ultrasmall super-paramagnetic iron oxide (USPIONs) that can be detected through MRI, SPECT/PET and fluorescence simultaneously. </li></ul><ul><li>Bifunctional chelate to sequester radiometals and conjugated to the mAb for targeted imaging or drug delivery. </li></ul><ul><li>Novel method to embed fluorescent dyes in an ultrasmall particle, allowing better delivery in vivo . </li></ul>Value Proposition: Lab and clinical labeling at the cellular level for diagnostics and drug delivery. R&D Status: Pre-clinical in vitro and in vivo IP Status: U.S. and foreign patent applications Reference # E-157-2007 Collaboration Contact: John D. Hewes, Ph.D., hewesj@mail.nih.gov, 301-435-3121 Licensing Contact: John Stansberry, Ph.D., stansbej@mail.nih.gov, 301-435-5236 New Agents for Lab and Clinical Imaging
  63. 63. Sriram Subramaniam, Ph.D. NCI CCR Laboratory of Cell Biology, Biophysics Section Technology: Imaging Strategies are being developed for automated, 3D visualization of cellular organelles using ion abrasion scanning electron microscopy (IA-SEM) combined with high resolution mass spectrometry to detect spatial distribution of proteins, metabolites and ions inside cells. <ul><li>Potential applications: </li></ul><ul><li>Spatial mapping of drug distribution and drug targets in mammalian cells within organelles </li></ul><ul><li>Determination of metabolite and ion gradients </li></ul><ul><li>R&D Status: Pre-clinical prototype </li></ul><ul><li>Pilot experiments are underway for development and optimization of the technology using commercially available components and custom-designed technologies. </li></ul><ul><li>IP Status: US Patent Application # 60/906,166 (03/9/2007) </li></ul><ul><li>Reference # E-313-2007 </li></ul><ul><li>Collaboration Contact: John D. Hewes, Ph.D., hewesj@mail.nih.gov, 301-435-3121 </li></ul><ul><li>Licensing Contact: Michael Shmilovich, J.D., shmilovm@mail.nih.gov, 301-435-5019 </li></ul>3D Mapping of Cells at Nanometer Resolution
  64. 64. <ul><li>Technology: Cancer Therapeutics </li></ul><ul><li>New strategy for treating cancers that over-express MDR1 </li></ul><ul><li>Unlike most methods, this approach does not inhibit MDR1 function </li></ul><ul><li>The anticancer effects of these novel agents depend on the overexpression of MDR1 </li></ul><ul><li>These agents also appear to down-regulate MDR1 expression </li></ul><ul><li>Value Proposition : </li></ul><ul><li>Capitalizes on the most common defense mechanism that cancer cells employ </li></ul><ul><li>Correlation of effectiveness to level of expression increases specificity to cancer cells </li></ul><ul><li>May avoid side effects seen with attempts to inhibit MDR1 function </li></ul><ul><li>May re-sensitize cells to chemotherapeutics, allowing additional effective treatment </li></ul><ul><li>R&D Status : Pre-clinical in vitro </li></ul><ul><li>IP Status : PCT/US2009/000861(2/10 /09); US 61/027,712 (f/10/08) </li></ul><ul><li>Reference : E-017-2008 </li></ul><ul><li>Collaboration Contact: John D. Hewes, Ph.D., hewesj@mail.nih.gov, 301-435-3121 </li></ul><ul><li>Licensing Contact : David Lambertson, Ph.D., lambertsond@mail.nih.gov; 301-435-4632 </li></ul>Matthew D. Hall, Ph.D. et al. Laboratory of Cell Biology New Strategy and Compositions for Treating Multidrug Resistant Cancer
  65. 65. John D. Hewes, Ph.D. [email_address] 301-435-3121 To obtain copies of these slides, please visit: http:// ttc.nci.nih.gov or http:// ott.od.nih.gov or http:// www.cdc.gov/tto keyword: BIO TTC maintains an e-mail service to notify you of new technology opportunities. Register at http://ttc.nci.nih.gov Contact Info
  66. 66. Centers for Disease Control and Prevention Technology Transfer Office Suzanne Seavello Shope, J.D. Technology Licensing and Marketing Scientist
  67. 67. Centers for Disease Control and Prevention <ul><ul><li>A source of credible health information </li></ul></ul><ul><ul><li>Response to disease and disaster outbreaks </li></ul></ul><ul><ul><li>Source of national and international health statistics </li></ul></ul><ul><ul><li>Development of new diagnostic and vaccine technologies </li></ul></ul>
  68. 68. CDC Research Areas <ul><li>All Infectious Diseases </li></ul><ul><li>Occupational Health </li></ul><ul><li>Toxic Chemicals at work, home and school </li></ul><ul><li>Injury prevention </li></ul><ul><li>Chronic Diseases </li></ul><ul><li>Health Statistics </li></ul><ul><li>Birth Defects </li></ul>
  69. 69. Examples of Non-patented Technologies <ul><li>Cell lines </li></ul><ul><li>Nucleic acids and vectors </li></ul><ul><li>Antibodies </li></ul><ul><li>PCR probe pairs </li></ul>
  70. 70. Sampling of Technologies filed with the USPTO <ul><li>Vaccines: </li></ul><ul><li>I-015-07    M. Tuberculosis Proteins as Mucosal Vaccine Candidate Against TB    </li></ul><ul><li>I-013-03    HIV-1 Multi-Clade, Multivalent (HIV-1MCMV) Recombinant Vaccine Construct   </li></ul><ul><li>I-008-08    Development of Rift Valley Fever Virus Vaccines Utilizing Reverse Genetics </li></ul><ul><li>I-039-00    Peptide Vaccine Candidate Against Group A Streptococci </li></ul><ul><li>I-004-98    Recombinant Multivalent Malarial Vaccine Candidate against Plasmodium falciparum </li></ul><ul><li>Therapeutic: </li></ul><ul><li>I-030-04 Peptide from Streptococcus Pneumoniae Surface Adhesion A (PsaA) Protein Associated with Adherence </li></ul><ul><li>Diagnostics: </li></ul><ul><li>I-001-05    Development of Real-time PCR Assay for Detection of Pneumococcal DNA and Diagnosis of Pneumococcal Disease </li></ul><ul><li>I-010-05 Immunological Immobilization of Cardiolipin Antigen to a Solid Support </li></ul><ul><li>I-018-99 Diagnostic Antigens for the Identification of Latent Human Tuberculosis </li></ul><ul><li>Animal: </li></ul><ul><li>I-025-06 Rabies Virus Recombinant Immuno-Contraceptive Vaccine Candidate </li></ul>
  71. 71. Identification of M. Tuberculosis Proteins as Mucosal Vaccine Candidate Against TB Suraj Sable, Tom Shinnick, Bonnie B. Plikaytis, and Mani Cheruvu NCHHSTP, CCID <ul><li>Technology: Effective mucosal vaccine for TB : </li></ul><ul><li>Strong cell mediated immune cytokine response </li></ul><ul><li>Intranasal delivery of a single moderate dose of the BCG or a multi-component subunit vaccine induced a stronger and more sustained Mycobacterium Tuberculosis- specific T cell response in lung parenchyma and cervical lymph nodes than vaccines delivered subcutaneously </li></ul><ul><li>The alanine protein rich antigen (APA, Rv1680) was highly antigenic following intranasal vaccination </li></ul><ul><li>Value Proposition: </li></ul><ul><li>Strong need for new tuberculosis (TB) vaccines </li></ul><ul><li>There is currently only one approved vaccine and it is not considered to be very effective </li></ul><ul><li>Estimated market size to be $300 million (India is expected to account for 23% sales) </li></ul><ul><li>A group of countries committed $1.5 billion for vaccines for diseases including TB (2007) </li></ul><ul><li>The Gates Foundation has pledged $900 million to fight TB with the goal of eradicating it by 2015 </li></ul><ul><li>R&D Status: Looking for a licensee or collaborating partner for animal studies/human trials </li></ul><ul><li>IP Status: PCT Patent Application was filed in January 2009 </li></ul><ul><li>CDC Reference # I-015-07; contact CDC Technology Transfer Office 770-488-8600 </li></ul>
  72. 72. Development of a HIV-1 Multi-Clade, Multivalent (HIV-1MCMV) Recombinant Vaccine Construct Renu B. Lal, Michele Owen, NCHHSTP, CCID <ul><li>Value Proposition: </li></ul><ul><li>A successful vaccine has huge potential throughout the world </li></ul><ul><li>This candidate overcomes some past challenges </li></ul><ul><li>Expanded funding opportunities from private foundations and federal government </li></ul><ul><li>R&D Status: Looking for a licensee or collaborating partner for animal studies </li></ul><ul><li>IP Status: Patents issued in US (7,425,611) and India, pending in Canada, Australia and Europe </li></ul><ul><li>CDC Reference # I-013-03; contact CDC Technology Transfer Office 770-488-8600 </li></ul><ul><li>Technology: </li></ul><ul><li>Multiple conserved epitopes provide broad immune responses less subject to subtype variations </li></ul><ul><li>Carefully fabricated strings of T- and B- cell epitopes designed with appropriate spacers and armed with cellular targeting sequences for inducing both T- and B- cell immune responses </li></ul><ul><li>Constructed to allow easy addition, substitution or deletion of epitopes for optimization of antigen recognition and processing </li></ul><ul><li>Designed for use as a DNA vaccine and as an expression construct for recombinant antigens </li></ul>B-cell Epitopes Tat Env CCR5 T-helper Epitopes Gag Vpr Rev +/- Lysosomal Targeting Pol Env CTL-Epitopes Nef +/- Proteosome Targeting Gag Pol Env = Unique restriction site for cloning into vectors
  73. 73. Development of Rift Valley Fever Virus Vaccines Utilizing Reverse Genetics Brian H. Bird, Stuart T. Nichol, Cesar G. Albarino, and Thomas G. Ksiazek Special Pathogens Branch, DVRD, NCZVED, CCID <ul><li>Technology: Rift Valley Fever (RVF) Vaccine </li></ul><ul><li>Single vaccine dose generates robust protective immune response (strong neutralizing antibody response) </li></ul><ul><li>Survival of vaccinated rats after lethal virus challenge </li></ul><ul><li>Ability to discriminate natural infection and vaccines </li></ul><ul><li>Defined attenuated vaccine constructs </li></ul><ul><li>Potential for use to prevent and control RVF infections </li></ul><ul><li>Value Proposition: </li></ul><ul><li>Rift Valley Fever is prevalent in Africa and occasional outbreaks have occurred in the Middle East </li></ul><ul><li>Highly contagious nature, healthcare burden, impact on veterinary and meat industry and potential as a biological threat agent </li></ul><ul><li>Potential for the virus to spread to Europe, Asia, North America and other parts of the world </li></ul><ul><li>Commercial potential in Europe, the Middle East and in the US (USDA, Homeland Security stockpile) </li></ul><ul><li>R&D Status: Large animal studies are underway; looking for a licensee. </li></ul><ul><li>IP Status: PCT Patent Application was filed in Dec 2008 </li></ul><ul><li>CDC Reference # I-008-08; contact CDC Technology Transfer Office 770-488-8600 </li></ul>Countries with endemic disease and substantial outbreaks of RVF Countries known to have some cases, periodic isolation of virus, or serologic evidence of RVF
  74. 74. Peptide Vaccine Candidate Against Group A Streptococci Bernard W. Beall, George M. Carlone, Jacquelyn S. Sampson, Edwin W. Ades Meningitis And Vaccine Preventable Diseases Branch, DBD, NCIRD, CCID <ul><li>Technology: Synthetic Group A streptococci </li></ul><ul><li>Immunoreactive peptides of the M proteins of the most prevalent group A strep serotypes in the US </li></ul><ul><li>Potential multi-antigenic peptide vaccine that has the ability to protect against 10 most common strains of Group A streptococci </li></ul><ul><li>Synthetic peptide strategy circumvents previous problems </li></ul><ul><li>Functional antibody response shown in mice which decrease the amount of nasopharyngeal colonization </li></ul><ul><li>Value Proposition: </li></ul><ul><li>>9500 cases per year in the US with approximately 1300 deaths </li></ul><ul><li>Difficulties with producing vaccine in the past include >80 serological M types and some M proteins cross-react with human tissue </li></ul><ul><li>Simple vaccine design strategy could result in inexpensive vaccines, with versatility for altered formulations applicable for use in developed and undeveloped countries. </li></ul><ul><li>R&D Status: Requesting a CRADA partner to develop vaccine components and do animal studies </li></ul><ul><li>IP Status: Patent issued in US (7,407,664), pending in Canada, Australia and Europe </li></ul><ul><li>CDC Reference # I-039-00; contact CDC Technology Transfer Office 770-488-8600 </li></ul>
  75. 75. Recombinant Multivalent Malarial Vaccine against Plasmodium falciparum Ya Ping Shi, Altaf A. Lal, Seyed E. Hasnain Division of Parasitic Diseases, NCZVED, CCID <ul><li>Technology: Multivalent Malaria Vaccine </li></ul><ul><li>Recombinant, multi-valent and multi-stage malaria vaccine antigen more specifically useful for preventing or treating P. falciparum malarial infections in all three stages </li></ul><ul><li>Effective in inhibiting reproductive growth of the parasite after initial infection </li></ul><ul><li>Includes antibodies against a recombinant protein containing antigenic epitopes useful as research or diagnostic reagents </li></ul><ul><li>Value Proposition: </li></ul><ul><li>There are 350-500 million cases of malaria worldwide each year and >1 million deaths </li></ul><ul><li>Extensive potential for safe and effective vaccine, particularly in India (private market healthcare) </li></ul><ul><li>In addition to the local population in the endemic areas, governments, travelers and military are potential large scale customer base </li></ul><ul><li>Gates Foundation supports substantial founding and targets reduction in death by 2015 </li></ul><ul><li>R&D Status: Stability at large scale preparation has been shown; need a partner for animal studies and clinical trials </li></ul><ul><li>IP Status: Patents issued in US (6,828,416), India and Australia, pending in Canada and Europe </li></ul><ul><li>CDC Reference # I-004-98 (and I-019-03, I-021-03) ; contact CDC Tech Transfer Office 770-488-8600 </li></ul>
  76. 76. Peptide from Streptococcus Pneumoniae Surface Adhesion A (PsaA) Protein Associated with Adherence Edwin W. Ades, Jacquelyn S. Sampson, Sandra Steiner, George M. Carlone, Joseph J. Caba, and Gowrisankar Rajam Meningitis And Vaccine Preventable Diseases Branch, DBD, NCIRD, CCID <ul><li>Technology: P4 peptide from PsaA used for therapeutic intervention through augmented passive immunotherapy </li></ul><ul><li>Multilineage cell activator in vitro </li></ul><ul><li>Hypothesize P4-mediated activation of phagocytic cells could rapidly and substantially increase opsonophagocytosis of bacteria to decrease fatal pneumococcal infection </li></ul><ul><li>Value Proposition: </li></ul><ul><li>Animal studies show 100% remission of bacteremia and rescued 80% of mouse models </li></ul><ul><li>R&D Status: Have animal study data, need a partner for clinical trials and to make the material as GMP </li></ul><ul><li>IP Status: Patents pending in the US, Canada, Australia, Hong Kong and Europe </li></ul><ul><li>CDC Reference # I-030-04; contact CDC Technology Transfer Office 770-488-8600 </li></ul>
  77. 77. Development of Real-time PCR Assay for Detection of Pneumococcal DNA and Diagnosis of Pneumococcal Disease Edwin Ades ( DBD, NCIRD, CCID ), Nadine Rouphael (CDC, Emory), and Harry Keyserling (Emory) <ul><li>Technology: Pneumococcal disease detection </li></ul><ul><li>Unique primers and probes (PsaA) for a real-time PCR assay for detection of pneumococcal DNA </li></ul><ul><li>Great tool for routine diagnostics as well as to test the efficacy of new pneumococcal vaccines </li></ul><ul><li>Value Proposition: </li></ul><ul><li>Detection of pneumococcal pneumonia is limited by the lack of a sensitive, specific, and accurate laboratory assays </li></ul><ul><li>Strong need for sensitive, real-time assays for pneumococcal infections </li></ul><ul><li>Roughly 21-33 instances annually of S. Pneumoniae for every 100,000 members of the population. </li></ul><ul><li>Assuming that each of these required a diagnosis, market projection is between 600,000-1,000,000 tests annually </li></ul><ul><li>Real time PCR becoming common in hospitals and clinical labs, hence adoption of this technique rather easy </li></ul><ul><li>R&D Status: assays in mouse model have been completed, available for licensing to produce and distribute a kit </li></ul><ul><li>IP Status: Patent issued in US (7,476,733), pending in Canada, Australia, Brazil, Japan and Europe </li></ul><ul><li>CDC Reference # I-001-05; contact CDC Technology Transfer Office 770-488-8600 </li></ul>
  78. 78. Immunological Immobilization of Cardiolipin Antigen to a Solid Support Arnold Castro, Robert W. George, Victoria Pope DSTDP, NCHHSTP, CCID <ul><li>Technology: Sensitive dual detection of syphilis infection </li></ul><ul><li>Ability to detect treponemal antibodies and anti-lipoidal antibodies to differentiate previous and new infections </li></ul><ul><li>Opportunity to treat the new infection and prevent further spread </li></ul><ul><li>Easy-to-read Color Band Signal with Built-in Test Control </li></ul><ul><li>Immobilizing these antigens onto solid support media such as nitrocellulose make it an inexpensive assay tool   </li></ul><ul><li>Value Proposition: </li></ul><ul><li>Rates of syphilis - once on the verge of elimination -- rose for the seventh consecutive year </li></ul><ul><li>Demand for more sensitive tests expected to increase as more and more cases are reported </li></ul><ul><li>Need to differentiate previous and new infections to treat the new infection to prevent further spread </li></ul><ul><li>Simultaneous screening and confirmatory test (currently a two-stage process) </li></ul><ul><li>Potential to develop as a point of care, visually inferable test </li></ul><ul><li>R&D Status: Ready to license, have one non-exclusive licensee, looking for additional licensees </li></ul><ul><li>IP Status: Pending in US (2), Brazil, India, ARIPO regional, China, Canada, Australia and Europe </li></ul><ul><li>CDC Reference # I-010-05; contact CDC Technology Transfer Office 770-488-8600 </li></ul>
  79. 79. Diagnostic Antigens for the Identification of Latent Human Tuberculosis Kristin A. Birkness, Fred D. Quinn, David S. Beall, Manon Deslauriers, Peter King Mycobacteriology Laboratory Branch, DTE, NCHHSTP, CCID <ul><li>Technology: Detection of proteins expressed by  M. tuberculosis : </li></ul><ul><li>This invention focuses on the detection of proteins expressed by  M. tuberculosis only while in a non-replicating state and therefore would serve as an indicator of latent infection </li></ul><ul><li>Detection of these proteins can be  adapted to standard diagnostic methods for clinical use </li></ul><ul><li>Value Proposition: </li></ul><ul><li>Ability to distinguish between active or latent TB infections </li></ul><ul><li>Ability to determine BCG vaccine exposure and TB infection </li></ul><ul><li>Ability to distinguish non tuberculosis mycobacteria infections </li></ul><ul><li>Need to positively identify  M. tuberculosis infections in immunosuppressed individuals </li></ul><ul><li>R&D Status: Ready to license, have one non-exclusive licensee, looking for additional licensees </li></ul><ul><li>IP Status: Patents issued in US (7,425,611), JP and Australia, pending in Canada, Australia and Europe </li></ul><ul><li>CDC Reference # I-018-99; contact CDC Technology Transfer Office 770-488-8600 </li></ul>
  80. 80. Rabies Virus Immuno-Contraceptive Vaccine Candidates Charles Rupprecht, Xianfu Wu Rabies program/PRB, DVRD, NCZVED, CCID <ul><li>Technology: Effective contraceptive vaccine for rabies : </li></ul><ul><li>By incorporating a main immunocontraceptive gene into the rabies virus ERA genome, this invention provides a recombinant immuno-contraception vaccine for population management and rabies protection. </li></ul><ul><li>Value Proposition: </li></ul><ul><li>More than 55,000 people die of rabies each year. About 95% of these occur in Asia and Africa </li></ul><ul><li>More than 90% of human rabies are caused by rabid dog biting. Once the signs and symptoms of rabies start to appear, the disease is almost always fatal. </li></ul><ul><li>Globally, the most cost-effective strategy for preventing human rabies is by eliminating rabies in dogs through animal vaccinations. http://www.who.int/mediacentre/factsheets/fs099/en </li></ul><ul><li>This vaccine can prevent rabies and simultaneously control animal populations </li></ul><ul><li>The vaccine is inexpensive and can be used on many animals including dogs, cats, raccoons, and other wild animals that spread rabies </li></ul><ul><li>R&D Status: Animal study data is available; technology is available for licensing or collaboration </li></ul><ul><li>IP Status: Provisional Patent Application filed September 2008 </li></ul><ul><li>CDC Reference # I-025-06; contact CDC Technology Transfer Office 770-488-8600 </li></ul>
  81. 81. Centers for Disease Control and Prevention Technology Transfer Office Visit us at the Georgia Pavilion Suzanne Seavello Shope, J.D. Technology Licensing and Marketing Scientist Sources: www.who.int www.cdc.gov Internal marketing reports
  82. 82. Unique Opportunity to Learn about Federal Science in Bio-Imaging
  83. 83. To obtain copies of these slides, please visit: http://ttc.nci.nih.gov Or http://www.ott.nih.gov/BIO2009 Or http:// www.cdc.gov/tto keyword: BIO

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