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North Carolina Federal Advanced Technologies Symposium
May 9, 2013
Biotechnologies Panel
Hosted by:
Office of Senator Richard Burr
NC Military Business Center
NC Military Foundation
Institute for Defense & Business
University of North Carolina System
Reception Sponsor:
Bronze Sponsor:
Portable Nanodevice for mTBI
 You simply need a drop of blood to diagnosis mTBI
Collaborators:
Dr. Ralf Lenigk
GE Global Research
Senior Microfluidic Specialist
Dr. Hiram Brownell
Boston College University
Protein Normal Values Cut-off Values
found in TBI
Time Course Biomarker
indication
S100B 0.2 ng/ml 1.13ng/mL;
~1fmol/µL
6 hours after injury
(Savola et al., 2004)
Breakdown of
blood-brain barrier
GFAP 0.49 μg/L 1.5 ng/mL;
~27 amol/µL
24 hours after injury
(Vos et al., 2004)
Damage to glial cells
NSE <12.5 ng/mL
(Mondello et al.,
2011)
21.7 ng/mL;
265 amol/µL
6 hours after injury
(Berger et al., 2007a)
Breakdown of
blood-brain barrier
UCH-L1 2.7 ng/mL(Papa et
al., 2010)
44.2 ng/mL (+/-
7.9) in severe TBI
group; ~1.8
fmol/µL
6 hours after injury (Svetlov et
al., 2010)
Cell death
C-Tau
Proteins
Undetectable (< 12
pg/mL) (Berger et
al., 2007b)
1600
ng/mL;~140
fmol/µL
6 hours after injury
(Liliang et al., 2010)
Neuronal
degeneration
C-Reactive
Protein
< 1 µg/ml 50 µg/ml; ~ 33
pmol/µL
24 hours after injury
(Hergenroeder et al.,2008)
Inflammation
Blood-Based Biomarkers for TBI
Enhanced SPRi Detection of ssDNA
to 1fM Concentration
Malic, L.; Sandros, MG; Tabrizian M Anal Chem 2011, 83, 5222–5229.* HDFT- Heptadecafluoro-1-decanethiol
A brief primer on aptamers
SELEX
↓
MiSeq sequencing
↓
Analysis of sequences
obtained
http://www.nanotemper-technologies.com/applications/list-all-
applications/article/aptamer-interaction-with-thrombin/
Nanoparticles SPRi Signal
Enhancement
16 Fold Signal Enhancement
for 500 ng/ml of CRP
Environmental
Biotechnology
A safe, effective and lower cost cleanup for persistent organic
chemical pollutants in soil, sediment and groundwater
Exceeds mandates of Executive Order 13423
 Strengthening Federal Environmental, Energy, and Transportation Management
Target Pollutants
 ALDRIN, CAMPHECHLOR, CHLORDANE, DDT, DIBENZOFURANS
(CHLORINATED)
 DIELDRIN, ENDRIN, HEPTACHLOR, HEXACHLOROBENZENE,
MIREX
 POLYCHLORINATED BIPHENYLS (PCBs)
 POLYCHLORINATED DIBENZO-P-DIOXINS
 PETROLEUM HYDROCARBONS
 INDUSTRIAL SOLVENTS AND DEGREASERS
 EXPLOSIVE RESIDUES
 OTHER UNSPECIFIED ORGANIC POLLUTANTS
Why do some chemical pollutants
degrade naturally while other
chemical pollutants persist for
decades or longer?
The Answer
 Persistent chemical pollutants prevent bacterial genes from
expressing messenger proteins (genetic impairment)
 Messenger proteins are essential for bacterial enzyme
secretion
 Bacteria secrete enzymes to reduce all organic material as a
food source for growth & reproduction
 Impaired genes → no messenger proteins →no enzyme
secretion →no enzymatic reduction in target pollutants
Environmental Gene Signaling
 Gene signaling is the capacity to manipulate gene
performance (enzyme secretion) through the insertion of
deficient proteins
 Analog proteins restore gene function and restore the
natural bacteria’s capacity to secrete reductive enzymes
 Environmental cleanup can be completed for a fraction of
conventional cleanup costs
 Environmental biotech can reduce DODs $100 billion
environmental liability by 50% to 70%
Lifespan: Reproduce as often as every 20 minutes. Up to 1,000 trillion per square
meter (5 billion in one tablespoon of soil).
The Factor Biotechnology is not genetic engineering or creating a
Super-bug. Treatments simply restore an innate function that is
disrupted in the presence of these man-made chemical compounds
© SmartGene 2013
Simply managing complex data
2013 North Carolina Federal
Advanced Technology Symposium
May 9th, 2013
David Ellis – President, SmartGene, Inc.
© SmartGene 2013
Who are we?
U.S. Headquarters in Raleigh, NC
Founded in 1998; multi-year market experience,
starting in Infectious Diseases
Customers: Leading academic medical centers,
diagnostic labs, government agencies
What do we do?
Application service provider (ASP)
Software as a Service to facilitate analysis and
management of genetic sequences in routine
SmartGene Overview
© SmartGene 2013
 Bacterial, mycobacterial identification
 Fungal identification
 Virus genotyping and drug-resistance assessment
(e.g. HIV, HCV, HSV, CMV)
 Epidemiological typing of viruses/bacteria by MLST
gene panels (e.g. Influenza, Campylobacter…)
 Human genetics:
 HLA mono-/bi-allelic genotyping
 Human polymorphism analysis
Examples of SmartGene Modules
© SmartGene 2013
 1953 Nature publication on structure of DNA
 1977 Sanger et al. “DNA Sequencing with Chain-
terminating inhibitors” – still in use!
 1987 Applied Biosystems first automated sequencer
 2000 Draft Human Genome announced by Clinton
White House (HGP Consortium and Celera)
 2005 First NextGen platform marketed (Roche 454)
 1.6 million reaction wells per run
 Vs. 96 capillaries on ABI Prisms used in HGP
 2005 - ? Race for highest data output, lowest
cost/sequence …and distributed sequencing
Milestones in Genetic Sequencing
© SmartGene 2013
Growing Challenge of Managing Data
© SmartGene 2013
SmartGene’s role
Bio-informatics are essential for routine use
Application-specific solutions better suited than
general approaches to address challenges
Applications should be sequencer-agnostic
Potential routine applications for NGS?
Microbiome analysis for wound healing
Exquisite typing of healthcare-acquired infections
for transmission, resistance, virulence
Centralized, real-time pathogen surveillance,
regardless of sequencing location
Realizing the promise of sequencing
© SmartGene 2013
Simply managing complex data
dellis@smartgene.com
U.S. Army Research, Development and
Engineering Command
Dr. Stephanie McElhinny
Program Manager, Biochemistry
Army Research Office
stephanie.a.mcelhinny.civ@mail.mil
919-549-4240
Biotechnology Research Opportunities
in the Department of Defense
UNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
Utilize the vast intellectual capital of our nation to:
 Create and Exploit Scientific Opportunities for
Revolutionary New Army Capabilities
 Drive Science to Develop Solutions to
Existing 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&E
Workforce for the Army
 Prevent Technological Surprise  Chemistry
 Computing and
Info Science
 Electronics
 Environmental
 Life Sciences
 Materials
 Mathematics
 Mechanics
 Network Science
 Physics
Research Domains
• 270+ Institutes of Higher Learning
• 1,121 individual Investigators
• 47 Research Centers
Research Funding
by State
More Funding
Less Funding
Army Research Office
Goals
www.aro.army.mil
UNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
Biotechnology Research
at the Army Research Office
www.aro.army.mil
Biotic/Abiotic interface between
nanostructures and biomolecules to
generate advanced materials
Reactive Chemical Systems
Genetics, genomics, epigenetics,
systems biology to optimize
performance and enhance protection
Genetics
Biomolecular assembly, biomolecular
specificity and regulation, biological
fibers, adhesives, composites
Biochemistry
Mechanisms of microbial adaptation
and survival, systems and synthetic
biology of microbes
Microbiology
Neural codes of human perception
and behavior, neuronal computation,
optimized human-machine interfaces
Neuroscience
Surface and interface engineering
(e.g., bio/organic/semiconductor) to
provide multifunctional capabilities
Materials Design
Bio-inspired mathematical methods
underlying automated sensing and
target tracking
Information Processing & Fusion
Force-activated materials, lightweight
ballistic protection, adhesives,
nondestructive material evaluation
Mechanical Behavior of Materials
UNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
Department of Defense
Biotechnology Funding Agencies
www.onr.navy.mil
www.afosr.af.mil• Synthetic Biology of living organisms
• Biomaterials – protein-based materials,
biomimetic materials, adhesives
• Bionanotechnology – biomimetic systems,
bio-directed synthesis/patterning of
nanomaterials
• Bioenergy Harvesting – Microbial Fuel Cells
• Metabolic Engineering for chemical
biosynthesis
• Marine Anti-Biofouling/Fouling Release
Coatings
• Autonomous In Vivo Medical Devices
• Biomimetics – mimic and control organism
sensors and sensor denial systems
(camouflage), natural chromophores and
photoluminescent materials
• Biomaterials – using organisms to
synthesize materials, mimicking natural
materials, using existing
materials/organisms as novel materials
• Biotic/Abiotic Interfaces – bio-directed
assembly to create new catalysts and
templates for optical or electronic materials
Office of Naval Research Air Force Office of
Scientific Research
UNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
Department of Defense
Biotechnology Funding Agencies
www.darpa.mil
• Biowarfare defense – advanced diagnostics,
decontamination, medical therapies
• Tactical Biomedical Technologies – mobile
trauma stabilization, novel therapeutics,
generation and storage of blood products
• Restorative Biomedical Technologies – restore
complex tissues after traumatic injury, neural-
controlled prostheses
• Bio-inspired Platforms and Systems – mimic
locomotion and chemical/visual/aural sensing
• Microphysiological Systems – organs-on-chip to
mimic human physiological systems
• In Vivo Nanoplatforms for diagnostics and
therapeutics
• Living Foundries – create engineering
framework for synthetic biology
www.dtra.mil
• Reduce, eliminate, counter, mitigate
weapons of mass destruction
• WMD sensing and recognition
• Threat containment, filtering, shielding
• Decontamination
• Forensics
• Neutralization of CBRNE materials
Defense Advanced
Research Projects Agency
Defense Threat
Reduction Agency
UNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
SBIR STTR
Phase I:
Project feasibility
up to 10 months
up to $150,000
6 months
up to $150,000
Phase II:
Project development
to Prototype
2 years
up to $1,000,000
2 years
up to $1,000,000
Phase III:
Commercialization
Commercialize, with non-SBIR/non-
STTR funds, the technology in
military and/or private sector markets
www.armysbir.army.mil
www.acq.osd.mil/osbp/sbir
DoD and Army
SBIR/STTR Programs
DoD FY13 SBIR/STTR Solicitation Schedule
Solicitation Pre-Release Open Close
DoD SBIR 2013.2 24 Apr 2013 24 May 2013 26 Jun 2013
DoD SBIR 2013.3 26 Jul 2013 26 Aug 2013 25 Sep 2013
DoD STTR 2013.B 26 Jul 2013 26 Aug 2013 25 Sep 2013
UNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
32
NC Federal Advanced Technology Symposium
5/15/2013
Jay Strum, PhD
President
Development of G1T28-1 as a Radiomitigant for
the Treatment of Acute Radiation Sickness
G1’s PHARMACOQUIESCENCE™ (PQ™) Approach
5/15/2013
PharmacoQuiescence™
Mechanism
Inhibition of CDK4/6 to
modulate the cell cycle
for multiple uses:
Chemo-protection
Renal-protection
Radiomitigation
Niche antineoplastic
S
G2
G0
G1
M
Specifically, cell cycle
traversal from G1 to S is
arrested.
33
G1T28-1 protects hematopoietic stem and progenitor cells (HSPC)
5/15/2013
34
UNMETUNMET*
Stem
Cell
Multi-potent
Progenitors
Common
Myeloid
Progenitor
Common
Lymphoid
Progenitor
Granulocyte/
Monocyte
Progenitor
Megakaryocyte/
Erythroid
Progenitor
Erythrocytes Platelets Granulocytes Macrophages T-cells B-cells
CDK4/6 dependent HSPC’s
CDK4/6 independent cells
Quadrilineage protection of blood cells from radiation exposure
Radiomitigation (Federally funded)
5/15/2013
Radiomitigation
o Phase II SBIR grant
funding through NIAID
o Lead molecule G1T28-1
o $0.5B+ mkt. opportunity
Grants $Amount Status
NIAID
Phase I
$600K Complete
NIAID
Phase II
$3M Ongoing
BARDA
POC
$4.5M
Under
review
A single, oral dose of G1T28-1 12 hours after ionizing
radiation significantly improves survival
Development funded by grants (BARDA app. to be submitted May 29)
35
RADIOMITIGATION PATH MAY SPEED APPROVAL
5/15/2013
36
• 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 MECHANISM
OF ACTION
2. NON-HUMAN PRIMATE
EFFICACY STUDY
Performed in
government-sponsored
facility
3. PHASE 1 SAFETY
In this case, CDK4/6
inhibition
Timeline to approval: 24+ months
Approval Based on FDA Animal Rule – 3 Criterion:
Use existing trial or
conduct new trial
Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved. 1
Advanced Technology Division (ATD)
 R&D arm of the company
 Myriad core capabilities led by
PhD-level S&T Team
Bennett Tech. Services Division (BTS)
 Providing on-site professional services
for the U.S. government
 Leveraging PhD-level S&T Team
Bennett Aerospace Overview
Brandon Conover, PhD
Director – ATD
BConover@BennettAerospace.com
Bennett Aerospace, Inc.
Research Triangle, North Carolina
SDB | WOSB | EDWOSB | VOSB | 8(a)
“Creating New Technologies to
Benefit Society”
Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved.
< Julia Bennett, CEO
< Douglas Bennett, President
Kenneth Land, VP – NASA Programs
Dr. Brandon Conover, PhD, Director – ATD
Dr. Stephen Cunnion, MD, PhD,
Director – Operational Medical Research
Dr. Dave Strube, PhD
Director – Signals and Sensors Center
Sandra Bunn, Director – USAF Programs
Dr. Stefan Schmidt, PhD, Sr Research Engineer
(RF Communications)
Dr. Andrew Thomas, PhD, Sr Research Engineer
(Medical Physics)
Dr. Alderson Neira, PhD, Sr Research Engineer
(Advanced Materials)
2
Team / Locations
 Research Triangle - Cary, NC
 Company Headquarters
 TOP SECRET Facility
 Washington, DC
 Dayton, OH (Wright Pat AFB)
 Houston, TX (NASA JSC)
 Atlanta, GA (Georgia Tech)
Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved.
 Bennett Technical Services:
 Engineering Staffing, incl. SETA and Engineering Admin.
 C5ISR – Information Assurance
 IT & Cyber Security (Compliance to Intrusion Detection)
 RF Communications (including hardware design)
 Medical/Biomedical (from lab assistance to R&D leads)
 Advanced Technology Division :
3
What We Do: BTS & ATD
Physical Sciences/ Engineering
 Modeling, Simulation, Analysis
 Optics/ Lasers/ Displays
 Software/ App Engineering
 Robotics for Field Use
 RF Comms (Radio, Antennas, C5ISR)
 Energy Systems
 Nano-Materials R&D
 Specialized Sensor & Sensor Fusion
Systems
 Embedded Systems, DSP, FPGA
Medical/ Bio Sciences
 Biomedical Sensing – Disease,
Toxin, Pathogen Detection
 Medical Device Design
 Medical Simulation for
Triage and Battlefield Care
 Directed Energy Effects for
Human Protection
 Infectious Assessment and Mitigation
 Medical Physics and Radiology
Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved.
 Small, portable, discreet hand-held unit
 Human-friendly Sensor Bugs™ trained in ~2 minutes to detect
targets of interest in seconds
 Sensor Bugs™ are AS GOOD and sometimes BETTER THAN
dogs: detection in PPB and PPT
 Equivalent of 5 scent-trained dogs on the job
 Can detect the PRESENCE and SOURCE of:
SmartHound™
4
• Explosives
• Toxins (Chem/ Bio)
• Drugs
• Human Remains
• Insects, Rodents
• Mold
• Disease
Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved.
 C/B-DAQ™ System:
Chem/ Bio-Detection And Quantification System
 Low-cost, extremely sensitive, all-in-one TRL-6 sensor
 PPM and PPB sensitivity (1-2 orders more sensitive than ELISA)
 Detect and Quantify chemical and biological threats
 Operates on Vapor and Liquid Phases in one unit
 Simultaneous, Real-Time Detection of multiple targets
 Ideal for field deployment, perimeter sentry monitoring, UAV-
mounted olfactory mapping, water monitoring, and building
monitoring.
 Proven Capabilities (short list):
C/B-DAQ™
5
• Explosives (TNT, RDX)
• Narcotics (Meth)
• Biologicals (E. Coli,
Salmonella, Influenza,
Warfare Agents, DNA)
• Chemical Compounds
(Alcohols, DMAC, DMMP)
• Proteins (Avidin, Ricin)
Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved. 1
Advanced Technology Division (ATD)
 R&D arm of the company
 Myriad core capabilities led by
PhD-level S&T Team
Bennett Tech. Services Division (BTS)
 Providing on-site professional services
for the U.S. government
 Leveraging PhD-level S&T Team
Bennett Aerospace Overview
Brandon Conover, PhD
Director – ATD
BConover@BennettAerospace.com
Bennett Aerospace, Inc.
Research Triangle, North Carolina
SDB | WOSB | EDWOSB | VOSB | 8(a)
“Creating New Technologies to
Benefit Society”
Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved.
< Julia Bennett, CEO
< Douglas Bennett, President
Kenneth Land, VP – NASA Programs
Dr. Brandon Conover, PhD, Director – ATD
Dr. Stephen Cunnion, MD, PhD,
Director – Operational Medical Research
Dr. Dave Strube, PhD
Director – Signals and Sensors Center
Sandra Bunn, Director – USAF Programs
Dr. Stefan Schmidt, PhD, Sr Research Engineer
(RF Communications)
Dr. Andrew Thomas, PhD, Sr Research Engineer
(Medical Physics)
Dr. Alderson Neira, PhD, Sr Research Engineer
(Advanced Materials)
2
Team / Locations
 Research Triangle - Cary, NC
 Company Headquarters
 TOP SECRET Facility
 Washington, DC
 Dayton, OH (Wright Pat AFB)
 Houston, TX (NASA JSC)
 Atlanta, GA (Georgia Tech)
Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved.
 Bennett Technical Services:
 Engineering Staffing, incl. SETA and Engineering Admin.
 C5ISR – Information Assurance
 IT & Cyber Security (Compliance to Intrusion Detection)
 RF Communications (including hardware design)
 Medical/Biomedical (from lab assistance to R&D leads)
 Advanced Technology Division :
3
What We Do: BTS & ATD
Physical Sciences/ Engineering
 Modeling, Simulation, Analysis
 Optics/ Lasers/ Displays
 Software/ App Engineering
 Robotics for Field Use
 RF Comms (Radio, Antennas, C5ISR)
 Energy Systems
 Nano-Materials R&D
 Specialized Sensor & Sensor Fusion
Systems
 Embedded Systems, DSP, FPGA
Medical/ Bio Sciences
 Biomedical Sensing – Disease,
Toxin, Pathogen Detection
 Medical Device Design
 Medical Simulation for
Triage and Battlefield Care
 Directed Energy Effects for
Human Protection
 Infectious Assessment and Mitigation
 Medical Physics and Radiology
Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved.
 Small, portable, discreet hand-held unit
 Human-friendly Sensor Bugs™ trained in ~2 minutes to detect
targets of interest in seconds
 Sensor Bugs™ are AS GOOD and sometimes BETTER THAN
dogs: detection in PPB and PPT
 Equivalent of 5 scent-trained dogs on the job
 Can detect the PRESENCE and SOURCE of:
SmartHound™
4
• Explosives
• Toxins (Chem/ Bio)
• Drugs
• Human Remains
• Insects, Rodents
• Mold
• Disease
Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved.
 C/B-DAQ™ System:
Chem/ Bio-Detection And Quantification System
 Low-cost, extremely sensitive, all-in-one TRL-6 sensor
 PPM and PPB sensitivity (1-2 orders more sensitive than ELISA)
 Detect and Quantify chemical and biological threats
 Operates on Vapor and Liquid Phases in one unit
 Simultaneous, Real-Time Detection of multiple targets
 Ideal for field deployment, perimeter sentry monitoring, UAV-
mounted olfactory mapping, water monitoring, and building
monitoring.
 Proven Capabilities (short list):
C/B-DAQ™
5
• Explosives (TNT, RDX)
• Narcotics (Meth)
• Biologicals (E. Coli,
Salmonella, Influenza,
Warfare Agents, DNA)
• Chemical Compounds
(Alcohols, DMAC, DMMP)
• Proteins (Avidin, Ricin)
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
Bio Technology Panel Session
Moderator: 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 R
North Carolina
Biotechnology Center
Supporting biotechnology research, business and
education 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 of
the Dept. of Defense and other federal agencies.
- Projects that are:
• Mission-driven
• Solution-oriented
• Application-focused
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
Why Biotech?
Biotech can deliver this across a highly diverse
spectrum of interest areas.
• “The Need” – Dr. Stephanie McElhinny,
Army Research Office (ARO)
• “The Idea” – Dr. Vince Henrich, UNC-Greensboro/Joint
School for Nanosci & NanoEngineering
• “The Development Engine” – Industry partners
– Brandon Conover Bennett Aerospace
– David Ellis SmartGene
– Christopher Young Biotech Restorations
– Dr. Jay Strum G1 Therapeutics
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
Biotech Panelists:

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Biotechnologies

  • 1. North Carolina Federal Advanced Technologies Symposium May 9, 2013 Biotechnologies Panel Hosted by: Office of Senator Richard Burr NC Military Business Center NC Military Foundation Institute for Defense & Business University of North Carolina System Reception Sponsor: Bronze Sponsor:
  • 2. Portable Nanodevice for mTBI  You simply need a drop of blood to diagnosis mTBI Collaborators: Dr. Ralf Lenigk GE Global Research Senior Microfluidic Specialist Dr. Hiram Brownell Boston College University
  • 3. Protein Normal Values Cut-off Values found in TBI Time Course Biomarker indication S100B 0.2 ng/ml 1.13ng/mL; ~1fmol/µL 6 hours after injury (Savola et al., 2004) Breakdown of blood-brain barrier GFAP 0.49 μg/L 1.5 ng/mL; ~27 amol/µL 24 hours after injury (Vos et al., 2004) Damage to glial cells NSE <12.5 ng/mL (Mondello et al., 2011) 21.7 ng/mL; 265 amol/µL 6 hours after injury (Berger et al., 2007a) Breakdown of blood-brain barrier UCH-L1 2.7 ng/mL(Papa et al., 2010) 44.2 ng/mL (+/- 7.9) in severe TBI group; ~1.8 fmol/µL 6 hours after injury (Svetlov et al., 2010) Cell death C-Tau Proteins Undetectable (< 12 pg/mL) (Berger et al., 2007b) 1600 ng/mL;~140 fmol/µL 6 hours after injury (Liliang et al., 2010) Neuronal degeneration C-Reactive Protein < 1 µg/ml 50 µg/ml; ~ 33 pmol/µL 24 hours after injury (Hergenroeder et al.,2008) Inflammation Blood-Based Biomarkers for TBI
  • 4. Enhanced SPRi Detection of ssDNA to 1fM Concentration Malic, L.; Sandros, MG; Tabrizian M Anal Chem 2011, 83, 5222–5229.* HDFT- Heptadecafluoro-1-decanethiol
  • 5. A brief primer on aptamers SELEX ↓ MiSeq sequencing ↓ Analysis of sequences obtained http://www.nanotemper-technologies.com/applications/list-all- applications/article/aptamer-interaction-with-thrombin/
  • 6. Nanoparticles SPRi Signal Enhancement 16 Fold Signal Enhancement for 500 ng/ml of CRP
  • 7. Environmental Biotechnology A safe, effective and lower cost cleanup for persistent organic chemical pollutants in soil, sediment and groundwater Exceeds mandates of Executive Order 13423  Strengthening Federal Environmental, Energy, and Transportation Management
  • 8. Target Pollutants  ALDRIN, CAMPHECHLOR, CHLORDANE, DDT, DIBENZOFURANS (CHLORINATED)  DIELDRIN, ENDRIN, HEPTACHLOR, HEXACHLOROBENZENE, MIREX  POLYCHLORINATED BIPHENYLS (PCBs)  POLYCHLORINATED DIBENZO-P-DIOXINS  PETROLEUM HYDROCARBONS  INDUSTRIAL SOLVENTS AND DEGREASERS  EXPLOSIVE RESIDUES  OTHER UNSPECIFIED ORGANIC POLLUTANTS
  • 9. Why do some chemical pollutants degrade naturally while other chemical pollutants persist for decades or longer?
  • 10. The Answer  Persistent chemical pollutants prevent bacterial genes from expressing messenger proteins (genetic impairment)  Messenger proteins are essential for bacterial enzyme secretion  Bacteria secrete enzymes to reduce all organic material as a food source for growth & reproduction  Impaired genes → no messenger proteins →no enzyme secretion →no enzymatic reduction in target pollutants
  • 11. Environmental Gene Signaling  Gene signaling is the capacity to manipulate gene performance (enzyme secretion) through the insertion of deficient proteins  Analog proteins restore gene function and restore the natural bacteria’s capacity to secrete reductive enzymes  Environmental cleanup can be completed for a fraction of conventional cleanup costs  Environmental biotech can reduce DODs $100 billion environmental liability by 50% to 70%
  • 12. Lifespan: Reproduce as often as every 20 minutes. Up to 1,000 trillion per square meter (5 billion in one tablespoon of soil).
  • 13. The Factor Biotechnology is not genetic engineering or creating a Super-bug. Treatments simply restore an innate function that is disrupted in the presence of these man-made chemical compounds
  • 14. © SmartGene 2013 Simply managing complex data 2013 North Carolina Federal Advanced Technology Symposium May 9th, 2013 David Ellis – President, SmartGene, Inc.
  • 15. © SmartGene 2013 Who are we? U.S. Headquarters in Raleigh, NC Founded in 1998; multi-year market experience, starting in Infectious Diseases Customers: Leading academic medical centers, diagnostic labs, government agencies What do we do? Application service provider (ASP) Software as a Service to facilitate analysis and management of genetic sequences in routine SmartGene Overview
  • 16. © SmartGene 2013  Bacterial, mycobacterial identification  Fungal identification  Virus genotyping and drug-resistance assessment (e.g. HIV, HCV, HSV, CMV)  Epidemiological typing of viruses/bacteria by MLST gene panels (e.g. Influenza, Campylobacter…)  Human genetics:  HLA mono-/bi-allelic genotyping  Human polymorphism analysis Examples of SmartGene Modules
  • 17. © SmartGene 2013  1953 Nature publication on structure of DNA  1977 Sanger et al. “DNA Sequencing with Chain- terminating inhibitors” – still in use!  1987 Applied Biosystems first automated sequencer  2000 Draft Human Genome announced by Clinton White House (HGP Consortium and Celera)  2005 First NextGen platform marketed (Roche 454)  1.6 million reaction wells per run  Vs. 96 capillaries on ABI Prisms used in HGP  2005 - ? Race for highest data output, lowest cost/sequence …and distributed sequencing Milestones in Genetic Sequencing
  • 18. © SmartGene 2013 Growing Challenge of Managing Data
  • 19. © SmartGene 2013 SmartGene’s role Bio-informatics are essential for routine use Application-specific solutions better suited than general approaches to address challenges Applications should be sequencer-agnostic Potential routine applications for NGS? Microbiome analysis for wound healing Exquisite typing of healthcare-acquired infections for transmission, resistance, virulence Centralized, real-time pathogen surveillance, regardless of sequencing location Realizing the promise of sequencing
  • 20. © SmartGene 2013 Simply managing complex data dellis@smartgene.com
  • 21. U.S. Army Research, Development and Engineering Command Dr. Stephanie McElhinny Program Manager, Biochemistry Army Research Office stephanie.a.mcelhinny.civ@mail.mil 919-549-4240 Biotechnology Research Opportunities in the Department of Defense UNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
  • 22. Utilize the vast intellectual capital of our nation to:  Create and Exploit Scientific Opportunities for Revolutionary New Army Capabilities  Drive Science to Develop Solutions to Existing 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&E Workforce for the Army  Prevent Technological Surprise  Chemistry  Computing and Info Science  Electronics  Environmental  Life Sciences  Materials  Mathematics  Mechanics  Network Science  Physics Research Domains • 270+ Institutes of Higher Learning • 1,121 individual Investigators • 47 Research Centers Research Funding by State More Funding Less Funding Army Research Office Goals www.aro.army.mil UNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
  • 23. Biotechnology Research at the Army Research Office www.aro.army.mil Biotic/Abiotic interface between nanostructures and biomolecules to generate advanced materials Reactive Chemical Systems Genetics, genomics, epigenetics, systems biology to optimize performance and enhance protection Genetics Biomolecular assembly, biomolecular specificity and regulation, biological fibers, adhesives, composites Biochemistry Mechanisms of microbial adaptation and survival, systems and synthetic biology of microbes Microbiology Neural codes of human perception and behavior, neuronal computation, optimized human-machine interfaces Neuroscience Surface and interface engineering (e.g., bio/organic/semiconductor) to provide multifunctional capabilities Materials Design Bio-inspired mathematical methods underlying automated sensing and target tracking Information Processing & Fusion Force-activated materials, lightweight ballistic protection, adhesives, nondestructive material evaluation Mechanical Behavior of Materials UNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
  • 24. Department of Defense Biotechnology Funding Agencies www.onr.navy.mil www.afosr.af.mil• Synthetic Biology of living organisms • Biomaterials – protein-based materials, biomimetic materials, adhesives • Bionanotechnology – biomimetic systems, bio-directed synthesis/patterning of nanomaterials • Bioenergy Harvesting – Microbial Fuel Cells • Metabolic Engineering for chemical biosynthesis • Marine Anti-Biofouling/Fouling Release Coatings • Autonomous In Vivo Medical Devices • Biomimetics – mimic and control organism sensors and sensor denial systems (camouflage), natural chromophores and photoluminescent materials • Biomaterials – using organisms to synthesize materials, mimicking natural materials, using existing materials/organisms as novel materials • Biotic/Abiotic Interfaces – bio-directed assembly to create new catalysts and templates for optical or electronic materials Office of Naval Research Air Force Office of Scientific Research UNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
  • 25. Department of Defense Biotechnology Funding Agencies www.darpa.mil • Biowarfare defense – advanced diagnostics, decontamination, medical therapies • Tactical Biomedical Technologies – mobile trauma stabilization, novel therapeutics, generation and storage of blood products • Restorative Biomedical Technologies – restore complex tissues after traumatic injury, neural- controlled prostheses • Bio-inspired Platforms and Systems – mimic locomotion and chemical/visual/aural sensing • Microphysiological Systems – organs-on-chip to mimic human physiological systems • In Vivo Nanoplatforms for diagnostics and therapeutics • Living Foundries – create engineering framework for synthetic biology www.dtra.mil • Reduce, eliminate, counter, mitigate weapons of mass destruction • WMD sensing and recognition • Threat containment, filtering, shielding • Decontamination • Forensics • Neutralization of CBRNE materials Defense Advanced Research Projects Agency Defense Threat Reduction Agency UNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
  • 26. SBIR STTR Phase I: Project feasibility up to 10 months up to $150,000 6 months up to $150,000 Phase II: Project development to Prototype 2 years up to $1,000,000 2 years up to $1,000,000 Phase III: Commercialization Commercialize, with non-SBIR/non- STTR funds, the technology in military and/or private sector markets www.armysbir.army.mil www.acq.osd.mil/osbp/sbir DoD and Army SBIR/STTR Programs DoD FY13 SBIR/STTR Solicitation Schedule Solicitation Pre-Release Open Close DoD SBIR 2013.2 24 Apr 2013 24 May 2013 26 Jun 2013 DoD SBIR 2013.3 26 Jul 2013 26 Aug 2013 25 Sep 2013 DoD STTR 2013.B 26 Jul 2013 26 Aug 2013 25 Sep 2013 UNCLASSIFIED // APPROVED FOR PUBLIC RELEASE
  • 27. 32 NC Federal Advanced Technology Symposium 5/15/2013 Jay Strum, PhD President Development of G1T28-1 as a Radiomitigant for the Treatment of Acute Radiation Sickness
  • 28. G1’s PHARMACOQUIESCENCE™ (PQ™) Approach 5/15/2013 PharmacoQuiescence™ Mechanism Inhibition of CDK4/6 to modulate the cell cycle for multiple uses: Chemo-protection Renal-protection Radiomitigation Niche antineoplastic S G2 G0 G1 M Specifically, cell cycle traversal from G1 to S is arrested. 33
  • 29. G1T28-1 protects hematopoietic stem and progenitor cells (HSPC) 5/15/2013 34 UNMETUNMET* Stem Cell Multi-potent Progenitors Common Myeloid Progenitor Common Lymphoid Progenitor Granulocyte/ Monocyte Progenitor Megakaryocyte/ Erythroid Progenitor Erythrocytes Platelets Granulocytes Macrophages T-cells B-cells CDK4/6 dependent HSPC’s CDK4/6 independent cells Quadrilineage protection of blood cells from radiation exposure
  • 30. Radiomitigation (Federally funded) 5/15/2013 Radiomitigation o Phase II SBIR grant funding through NIAID o Lead molecule G1T28-1 o $0.5B+ mkt. opportunity Grants $Amount Status NIAID Phase I $600K Complete NIAID Phase II $3M Ongoing BARDA POC $4.5M Under review A single, oral dose of G1T28-1 12 hours after ionizing radiation significantly improves survival Development funded by grants (BARDA app. to be submitted May 29) 35
  • 31. RADIOMITIGATION PATH MAY SPEED APPROVAL 5/15/2013 36 • 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 MECHANISM OF ACTION 2. NON-HUMAN PRIMATE EFFICACY STUDY Performed in government-sponsored facility 3. PHASE 1 SAFETY In this case, CDK4/6 inhibition Timeline to approval: 24+ months Approval Based on FDA Animal Rule – 3 Criterion: Use existing trial or conduct new trial
  • 32. Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved. 1 Advanced Technology Division (ATD)  R&D arm of the company  Myriad core capabilities led by PhD-level S&T Team Bennett Tech. Services Division (BTS)  Providing on-site professional services for the U.S. government  Leveraging PhD-level S&T Team Bennett Aerospace Overview Brandon Conover, PhD Director – ATD BConover@BennettAerospace.com Bennett Aerospace, Inc. Research Triangle, North Carolina SDB | WOSB | EDWOSB | VOSB | 8(a) “Creating New Technologies to Benefit Society”
  • 33. Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved. < Julia Bennett, CEO < Douglas Bennett, President Kenneth Land, VP – NASA Programs Dr. Brandon Conover, PhD, Director – ATD Dr. Stephen Cunnion, MD, PhD, Director – Operational Medical Research Dr. Dave Strube, PhD Director – Signals and Sensors Center Sandra Bunn, Director – USAF Programs Dr. Stefan Schmidt, PhD, Sr Research Engineer (RF Communications) Dr. Andrew Thomas, PhD, Sr Research Engineer (Medical Physics) Dr. Alderson Neira, PhD, Sr Research Engineer (Advanced Materials) 2 Team / Locations  Research Triangle - Cary, NC  Company Headquarters  TOP SECRET Facility  Washington, DC  Dayton, OH (Wright Pat AFB)  Houston, TX (NASA JSC)  Atlanta, GA (Georgia Tech)
  • 34. Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved.  Bennett Technical Services:  Engineering Staffing, incl. SETA and Engineering Admin.  C5ISR – Information Assurance  IT & Cyber Security (Compliance to Intrusion Detection)  RF Communications (including hardware design)  Medical/Biomedical (from lab assistance to R&D leads)  Advanced Technology Division : 3 What We Do: BTS & ATD Physical Sciences/ Engineering  Modeling, Simulation, Analysis  Optics/ Lasers/ Displays  Software/ App Engineering  Robotics for Field Use  RF Comms (Radio, Antennas, C5ISR)  Energy Systems  Nano-Materials R&D  Specialized Sensor & Sensor Fusion Systems  Embedded Systems, DSP, FPGA Medical/ Bio Sciences  Biomedical Sensing – Disease, Toxin, Pathogen Detection  Medical Device Design  Medical Simulation for Triage and Battlefield Care  Directed Energy Effects for Human Protection  Infectious Assessment and Mitigation  Medical Physics and Radiology
  • 35. Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved.  Small, portable, discreet hand-held unit  Human-friendly Sensor Bugs™ trained in ~2 minutes to detect targets of interest in seconds  Sensor Bugs™ are AS GOOD and sometimes BETTER THAN dogs: detection in PPB and PPT  Equivalent of 5 scent-trained dogs on the job  Can detect the PRESENCE and SOURCE of: SmartHound™ 4 • Explosives • Toxins (Chem/ Bio) • Drugs • Human Remains • Insects, Rodents • Mold • Disease
  • 36. Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved.  C/B-DAQ™ System: Chem/ Bio-Detection And Quantification System  Low-cost, extremely sensitive, all-in-one TRL-6 sensor  PPM and PPB sensitivity (1-2 orders more sensitive than ELISA)  Detect and Quantify chemical and biological threats  Operates on Vapor and Liquid Phases in one unit  Simultaneous, Real-Time Detection of multiple targets  Ideal for field deployment, perimeter sentry monitoring, UAV- mounted olfactory mapping, water monitoring, and building monitoring.  Proven Capabilities (short list): C/B-DAQ™ 5 • Explosives (TNT, RDX) • Narcotics (Meth) • Biologicals (E. Coli, Salmonella, Influenza, Warfare Agents, DNA) • Chemical Compounds (Alcohols, DMAC, DMMP) • Proteins (Avidin, Ricin)
  • 37. Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved. 1 Advanced Technology Division (ATD)  R&D arm of the company  Myriad core capabilities led by PhD-level S&T Team Bennett Tech. Services Division (BTS)  Providing on-site professional services for the U.S. government  Leveraging PhD-level S&T Team Bennett Aerospace Overview Brandon Conover, PhD Director – ATD BConover@BennettAerospace.com Bennett Aerospace, Inc. Research Triangle, North Carolina SDB | WOSB | EDWOSB | VOSB | 8(a) “Creating New Technologies to Benefit Society”
  • 38. Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved. < Julia Bennett, CEO < Douglas Bennett, President Kenneth Land, VP – NASA Programs Dr. Brandon Conover, PhD, Director – ATD Dr. Stephen Cunnion, MD, PhD, Director – Operational Medical Research Dr. Dave Strube, PhD Director – Signals and Sensors Center Sandra Bunn, Director – USAF Programs Dr. Stefan Schmidt, PhD, Sr Research Engineer (RF Communications) Dr. Andrew Thomas, PhD, Sr Research Engineer (Medical Physics) Dr. Alderson Neira, PhD, Sr Research Engineer (Advanced Materials) 2 Team / Locations  Research Triangle - Cary, NC  Company Headquarters  TOP SECRET Facility  Washington, DC  Dayton, OH (Wright Pat AFB)  Houston, TX (NASA JSC)  Atlanta, GA (Georgia Tech)
  • 39. Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved.  Bennett Technical Services:  Engineering Staffing, incl. SETA and Engineering Admin.  C5ISR – Information Assurance  IT & Cyber Security (Compliance to Intrusion Detection)  RF Communications (including hardware design)  Medical/Biomedical (from lab assistance to R&D leads)  Advanced Technology Division : 3 What We Do: BTS & ATD Physical Sciences/ Engineering  Modeling, Simulation, Analysis  Optics/ Lasers/ Displays  Software/ App Engineering  Robotics for Field Use  RF Comms (Radio, Antennas, C5ISR)  Energy Systems  Nano-Materials R&D  Specialized Sensor & Sensor Fusion Systems  Embedded Systems, DSP, FPGA Medical/ Bio Sciences  Biomedical Sensing – Disease, Toxin, Pathogen Detection  Medical Device Design  Medical Simulation for Triage and Battlefield Care  Directed Energy Effects for Human Protection  Infectious Assessment and Mitigation  Medical Physics and Radiology
  • 40. Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved.  Small, portable, discreet hand-held unit  Human-friendly Sensor Bugs™ trained in ~2 minutes to detect targets of interest in seconds  Sensor Bugs™ are AS GOOD and sometimes BETTER THAN dogs: detection in PPB and PPT  Equivalent of 5 scent-trained dogs on the job  Can detect the PRESENCE and SOURCE of: SmartHound™ 4 • Explosives • Toxins (Chem/ Bio) • Drugs • Human Remains • Insects, Rodents • Mold • Disease
  • 41. Copyright ©2013 Bennett Aerospace, Inc. All Rights Reserved.  C/B-DAQ™ System: Chem/ Bio-Detection And Quantification System  Low-cost, extremely sensitive, all-in-one TRL-6 sensor  PPM and PPB sensitivity (1-2 orders more sensitive than ELISA)  Detect and Quantify chemical and biological threats  Operates on Vapor and Liquid Phases in one unit  Simultaneous, Real-Time Detection of multiple targets  Ideal for field deployment, perimeter sentry monitoring, UAV- mounted olfactory mapping, water monitoring, and building monitoring.  Proven Capabilities (short list): C/B-DAQ™ 5 • Explosives (TNT, RDX) • Narcotics (Meth) • Biologicals (E. Coli, Salmonella, Influenza, Warfare Agents, DNA) • Chemical Compounds (Alcohols, DMAC, DMMP) • Proteins (Avidin, Ricin)
  • 42. 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 Bio Technology Panel Session Moderator: Mary Beth Thomas, PhD
  • 43. 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 North Carolina Biotechnology Center Supporting biotechnology research, business and education statewide since 1984
  • 44. 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
  • 45. Purpose of the conference: - To address the future advanced technology needs of the Dept. of Defense and other federal agencies. - Projects that are: • Mission-driven • Solution-oriented • Application-focused 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 Why Biotech? Biotech can deliver this across a highly diverse spectrum of interest areas.
  • 46. • “The Need” – Dr. Stephanie McElhinny, Army Research Office (ARO) • “The Idea” – Dr. Vince Henrich, UNC-Greensboro/Joint School for Nanosci & NanoEngineering • “The Development Engine” – Industry partners – Brandon Conover Bennett Aerospace – David Ellis SmartGene – Christopher Young Biotech Restorations – Dr. Jay Strum G1 Therapeutics 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 Biotech Panelists: