North Carolina Federal Advanced Technologies SymposiumMay 9, 2013Biotechnologies PanelHosted by:Office of Senator Richard BurrNC Military Business CenterNC Military FoundationInstitute for Defense & BusinessUniversity of North Carolina SystemReception Sponsor:Bronze Sponsor:
Portable Nanodevice for mTBI You simply need a drop of blood to diagnosis mTBICollaborators:Dr. Ralf LenigkGE Global ResearchSenior Microfluidic SpecialistDr. Hiram BrownellBoston College University
Protein Normal Values Cut-off Valuesfound in TBITime Course BiomarkerindicationS100B 0.2 ng/ml 1.13ng/mL;~1fmol/µL6 hours after injury(Savola et al., 2004)Breakdown ofblood-brain barrierGFAP 0.49 μg/L 1.5 ng/mL;~27 amol/µL24 hours after injury(Vos et al., 2004)Damage to glial cellsNSE <12.5 ng/mL(Mondello et al.,2011)21.7 ng/mL;265 amol/µL6 hours after injury(Berger et al., 2007a)Breakdown ofblood-brain barrierUCH-L1 2.7 ng/mL(Papa etal., 2010)44.2 ng/mL (+/-7.9) in severe TBIgroup; ~1.8fmol/µL6 hours after injury (Svetlov etal., 2010)Cell deathC-TauProteinsUndetectable (< 12pg/mL) (Berger etal., 2007b)1600ng/mL;~140fmol/µL6 hours after injury(Liliang et al., 2010)NeuronaldegenerationC-ReactiveProtein< 1 µg/ml 50 µg/ml; ~ 33pmol/µL24 hours after injury(Hergenroeder et al.,2008)InflammationBlood-Based Biomarkers for TBI
Enhanced SPRi Detection of ssDNAto 1fM ConcentrationMalic, L.; Sandros, MG; Tabrizian M Anal Chem 2011, 83, 5222–5229.* HDFT- Heptadecafluoro-1-decanethiol
A brief primer on aptamersSELEX↓MiSeq sequencing↓Analysis of sequencesobtainedhttp://www.nanotemper-technologies.com/applications/list-all-applications/article/aptamer-interaction-with-thrombin/
Nanoparticles SPRi SignalEnhancement16 Fold Signal Enhancementfor 500 ng/ml of CRP
EnvironmentalBiotechnologyA safe, effective and lower cost cleanup for persistent organicchemical pollutants in soil, sediment and groundwaterExceeds mandates of Executive Order 13423 Strengthening Federal Environmental, Energy, and Transportation Management
Why do some chemical pollutantsdegrade naturally while otherchemical pollutants persist fordecades or longer?
The Answer Persistent chemical pollutants prevent bacterial genes fromexpressing messenger proteins (genetic impairment) Messenger proteins are essential for bacterial enzymesecretion Bacteria secrete enzymes to reduce all organic material as afood source for growth & reproduction Impaired genes → no messenger proteins →no enzymesecretion →no enzymatic reduction in target pollutants
Environmental Gene Signaling Gene signaling is the capacity to manipulate geneperformance (enzyme secretion) through the insertion ofdeficient proteins Analog proteins restore gene function and restore thenatural bacteria’s capacity to secrete reductive enzymes Environmental cleanup can be completed for a fraction ofconventional cleanup costs Environmental biotech can reduce DODs $100 billionenvironmental liability by 50% to 70%
Lifespan: Reproduce as often as every 20 minutes. Up to 1,000 trillion per squaremeter (5 billion in one tablespoon of soil).
The Factor Biotechnology is not genetic engineering or creating aSuper-bug. Treatments simply restore an innate function that isdisrupted in the presence of these man-made chemical compounds
U.S. Army Research, Development andEngineering CommandDr. Stephanie McElhinnyProgram Manager, BiochemistryArmy Research Officestephanie.email@example.comBiotechnology Research Opportunitiesin the Department of DefenseUNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
Utilize the vast intellectual capital of our nation to: Create and Exploit Scientific Opportunities forRevolutionary New Army Capabilities Drive Science to Develop Solutions toExisting Army Technology Needs Accelerate Transition of Basic Research Leverage S&T From Outside Sources Create and Strengthen University, Industry,Government Partnerships Unbiased expert assessments for HQs Educate and Train the Future S&EWorkforce for the Army Prevent Technological Surprise Chemistry Computing andInfo Science Electronics Environmental Life Sciences Materials Mathematics Mechanics Network Science PhysicsResearch Domains• 270+ Institutes of Higher Learning• 1,121 individual Investigators• 47 Research CentersResearch Fundingby StateMore FundingLess FundingArmy Research OfficeGoalswww.aro.army.milUNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
Biotechnology Researchat the Army Research Officewww.aro.army.milBiotic/Abiotic interface betweennanostructures and biomolecules togenerate advanced materialsReactive Chemical SystemsGenetics, genomics, epigenetics,systems biology to optimizeperformance and enhance protectionGeneticsBiomolecular assembly, biomolecularspecificity and regulation, biologicalfibers, adhesives, compositesBiochemistryMechanisms of microbial adaptationand survival, systems and syntheticbiology of microbesMicrobiologyNeural codes of human perceptionand behavior, neuronal computation,optimized human-machine interfacesNeuroscienceSurface and interface engineering(e.g., bio/organic/semiconductor) toprovide multifunctional capabilitiesMaterials DesignBio-inspired mathematical methodsunderlying automated sensing andtarget trackingInformation Processing & FusionForce-activated materials, lightweightballistic protection, adhesives,nondestructive material evaluationMechanical Behavior of MaterialsUNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
Department of DefenseBiotechnology Funding Agencieswww.onr.navy.milwww.afosr.af.mil• Synthetic Biology of living organisms• Biomaterials – protein-based materials,biomimetic materials, adhesives• Bionanotechnology – biomimetic systems,bio-directed synthesis/patterning ofnanomaterials• Bioenergy Harvesting – Microbial Fuel Cells• Metabolic Engineering for chemicalbiosynthesis• Marine Anti-Biofouling/Fouling ReleaseCoatings• Autonomous In Vivo Medical Devices• Biomimetics – mimic and control organismsensors and sensor denial systems(camouflage), natural chromophores andphotoluminescent materials• Biomaterials – using organisms tosynthesize materials, mimicking naturalmaterials, using existingmaterials/organisms as novel materials• Biotic/Abiotic Interfaces – bio-directedassembly to create new catalysts andtemplates for optical or electronic materialsOffice of Naval Research Air Force Office ofScientific ResearchUNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
Department of DefenseBiotechnology Funding Agencieswww.darpa.mil• Biowarfare defense – advanced diagnostics,decontamination, medical therapies• Tactical Biomedical Technologies – mobiletrauma stabilization, novel therapeutics,generation and storage of blood products• Restorative Biomedical Technologies – restorecomplex tissues after traumatic injury, neural-controlled prostheses• Bio-inspired Platforms and Systems – mimiclocomotion and chemical/visual/aural sensing• Microphysiological Systems – organs-on-chip tomimic human physiological systems• In Vivo Nanoplatforms for diagnostics andtherapeutics• Living Foundries – create engineeringframework for synthetic biologywww.dtra.mil• Reduce, eliminate, counter, mitigateweapons of mass destruction• WMD sensing and recognition• Threat containment, filtering, shielding• Decontamination• Forensics• Neutralization of CBRNE materialsDefense AdvancedResearch Projects AgencyDefense ThreatReduction AgencyUNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
SBIR STTRPhase I:Project feasibilityup to 10 monthsup to $150,0006 monthsup to $150,000Phase II:Project developmentto Prototype2 yearsup to $1,000,0002 yearsup to $1,000,000Phase III:CommercializationCommercialize, with non-SBIR/non-STTR funds, the technology inmilitary and/or private sector marketswww.armysbir.army.milwww.acq.osd.mil/osbp/sbirDoD and ArmySBIR/STTR ProgramsDoD FY13 SBIR/STTR Solicitation ScheduleSolicitation Pre-Release Open CloseDoD SBIR 2013.2 24 Apr 2013 24 May 2013 26 Jun 2013DoD SBIR 2013.3 26 Jul 2013 26 Aug 2013 25 Sep 2013DoD STTR 2013.B 26 Jul 2013 26 Aug 2013 25 Sep 2013UNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
32NC Federal Advanced Technology Symposium5/15/2013Jay Strum, PhDPresidentDevelopment of G1T28-1 as a Radiomitigant forthe Treatment of Acute Radiation Sickness
G1’s PHARMACOQUIESCENCE™ (PQ™) Approach5/15/2013PharmacoQuiescence™MechanismInhibition of CDK4/6 tomodulate the cell cyclefor multiple uses:Chemo-protectionRenal-protectionRadiomitigationNiche antineoplasticSG2G0G1MSpecifically, cell cycletraversal from G1 to S isarrested.33
G1T28-1 protects hematopoietic stem and progenitor cells (HSPC)5/15/201334UNMETUNMET*StemCellMulti-potentProgenitorsCommonMyeloidProgenitorCommonLymphoidProgenitorGranulocyte/MonocyteProgenitorMegakaryocyte/ErythroidProgenitorErythrocytes Platelets Granulocytes Macrophages T-cells B-cellsCDK4/6 dependent HSPC’sCDK4/6 independent cellsQuadrilineage protection of blood cells from radiation exposure
Radiomitigation (Federally funded)5/15/2013Radiomitigationo Phase II SBIR grantfunding through NIAIDo Lead molecule G1T28-1o $0.5B+ mkt. opportunityGrants $Amount StatusNIAIDPhase I$600K CompleteNIAIDPhase II$3M OngoingBARDAPOC$4.5MUnderreviewA single, oral dose of G1T28-1 12 hours after ionizingradiation significantly improves survivalDevelopment funded by grants (BARDA app. to be submitted May 29)35
RADIOMITIGATION PATH MAY SPEED APPROVAL5/15/201336• Acute Radiation Sickness (Hematologic Syndrome)• U.S. Government stockpile• 200,000+ doses of radiation mitigant, $500 million market• Other markets: Japan, Israel, etc.• U.S. military for soldiers• Civilian Populations• Significant US government financing (NIAID, BARDA)1. KNOWN MECHANISMOF ACTION2. NON-HUMAN PRIMATEEFFICACY STUDYPerformed ingovernment-sponsoredfacility3. PHASE 1 SAFETYIn this case, CDK4/6inhibitionTimeline to approval: 24+ monthsApproval Based on FDA Animal Rule – 3 Criterion:Use existing trial orconduct new trial
N O R T H C A R O L I N A B I O T E C H N O L O G Y C E N T E RBio Technology Panel SessionModerator: Mary Beth Thomas, PhD
N O R T H C A R O L I N A B I O T E C H N O L O G Y C E N T E RNorth CarolinaBiotechnology CenterSupporting biotechnology research, business andeducation statewide since 1984
N O R T H C A R O L I N A B I O T E C H N O L O G Y C E N T E R
Purpose of the conference:- To address the future advanced technology needs ofthe Dept. of Defense and other federal agencies.- Projects that are:• Mission-driven• Solution-oriented• Application-focusedN O R T H C A R O L I N A B I O T E C H N O L O G Y C E N T E RWhy Biotech?Biotech can deliver this across a highly diversespectrum of interest areas.
• “The Need” – Dr. Stephanie McElhinny,Army Research Office (ARO)• “The Idea” – Dr. Vince Henrich, UNC-Greensboro/JointSchool for Nanosci & NanoEngineering• “The Development Engine” – Industry partners– Brandon Conover Bennett Aerospace– David Ellis SmartGene– Christopher Young Biotech Restorations– Dr. Jay Strum G1 TherapeuticsN O R T H C A R O L I N A B I O T E C H N O L O G Y C E N T E RBiotech Panelists:
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