Defense Related Vision Research Opportunities Association for …€¦ · Stephen Rose Foundation...

Robert Read/MCMR-TT (301) 619-4207 (DSN 343) [email protected] UNCLASSIFIED 5/11/2012 12:23 PMSlide 1 of (30)

Defense Related Vision Research Opportunities

Association for Research In Vision and OphthalmologyFort Lauderdale, Florida

Robert C. ReadDepartment of the Army Civilian

Telemedicine & Advanced Technology Research Center

U.S. Army Medical Research & Materiel Command

May 7, 2012


Commanding General

Medical Research and Technology Laboratory CommandsContractingDirectorate

Operational Medical LogisticsCommands

Strategic Medical LogisticsCommand

Medical Advanced DevelopmentCommands

Principal Assistant for Research and Technology

• Dir, Infectious Diseases Res Prog• Dir, Combat Casualty Care Res Prog• Dir, Military Operational Medicine Res Prog• Dir, Clinical & Rehabilitative Medicine Res Prog• Dir, Partnership Support Office• Dir, Blast Injury Coordinating Office• Prog Dir, Armed Forces Institute of Regenerative

Medicine

Deputy Commander

Command Sergeant

Major

Chief of Staff

Chief of Staff Special Staff• Dir, Materiel• Dir, Surety, Safety, &

Environment• Equal Opportunity Advisor• Protocol Officer• Public Affairs Officer• Reenlistment Officer• Staff Judge Advocate• Strategic Partnerships Office

Deputy Chiefs of Staff• DCS, Personnel (G1)• DCS, Operations (G3)• DCS, Logistics (G4)• DCS, Resource Management

(G8)• DCS, Info Mgmt / Info Tech

• Secretary of the General Staff

Principal Assistant for Acquisition

Congressional Programs• Congressionally Directed Medical

Research Programs (CDMRP)• Telemedicine and Advanced

Technology Research Center (TATRC)

Deputy Commander Special Staff• Dir, Office of Research Protections• Dir, Plans, Programs, Analysis, &

Eval• Dir, Quality Management• International Affairs Officer

• Proj Mgr, Pharmaceutical Systems• Proj Mgr, Medical Support Systems• Proj Mgr, Medical Devices• Proj Mgr, Integrated Clinical Systems• Proj Mgr, USAMRMC Enterprise IM/IT• Proj Mgr, Theater-Wide Enterprise Logistics

System

US Army AeromedicalResearch Laboratory (USAARL)

US Army Institute of Surgical Research (USAISR)

US Army Medical Research Institute for Chemical Defense (USAMRICD)

US Army Medical Research Institute of Infectious Diseases (USAMRIID)

Walter Reed Army Institute of Research (WRAIR)

US Army Research Institute of Environ-mental Medicine (USARIEM)

US Army Medical Materiel Development Activity (USAMMDA)

US Army Medical Materiel Agency (USAMMA)

US Army Medical Materiel Center, Europe (USAMMCE)

US Army Medical Materiel Center, Korea (USAMMCK)

US Army Medical Research Acquisition Activity (USAMRAA)

Commanding General Special Staff• Dir, Office of Small Business Programs• Dir, Med Systems Office, ASAALT• Inspector General• Internal Review• Principal Ass’t Resp for Contracting• Staff Judge Advocate

USAMRMC Actual Personnel – 30 Apr 2010

MILITARY CIVILIAN CONTRACTOR TOTAL

994 2,519 2,543 6,056

16.41% 41.60% 41.99% 100.00%

USAMRMCOrganization Chart


TATRC Vision Program Plus

• Manage a total of 22 projects (eight CSI; two augmentation and 12 VRP) totaling $36,122,568 for FY09 and 10 awards

• FY09/10 CSI peer reviewed Vision Research Program (VRP) 12 Investigators funded $11,014,931 ($206K to $1.997M; Mean $~918K)

• FY11/12 CSI peer reviewed Vision Trauma Research Program (VTRP)

Results pending

• Other USAMRMC agencies awarded 12 vision grants totaling $13,671,732 (FY10 – 12)


Funding Sources

• Congressional Special Interest (CSI) Projects

• Peer Reviewed Programs

– TATRC Vision Research Program

– Congressionally Directed Medical Research Program (CDMRP)

• Augmentation Funds

• AMEDD Advanced Medical Technology Initiative

• Small Business Innovation Research (SBIR)

• Small Business Technology Transfer (STTR)


Congressional Special Interest (CSI) Medical Programs

Congressional liaison Congressional liaison offices provide

feedback loop to help ascertain “intent of

Congress”


Current TATRC Vision CSI Projects

Schepens Eye Research Institute Boston, MA

FY00,01,04,06,07,08,09, 10 Ends OCT2012

St John’s Research Institute Springfield, MO

FY09 Ends OCT2012

U. of N. Texas Health Science Center Ft Worth , TX

FY09 and 10 Ends FEB2013

University of Southern California Los Angeles, CA

FY10 Ends FEB2013

Wills Eye Hospital Philadelphia, PA

FY04, 05, 06, 07, 08, 09 and 10 Ends OCT2013

Bascom Palmer Eye Institute Miami, FL

FY08, 09 and 10 Ends OCT2013*

University of Iowa Iowa City, IO

FY 10 Ends OCT2014

National Neurovision Research Institute Columbia, MD

FY06, 07, 08, 09 and 10 Ends OCT2014


CSI Principal Investigators

Byron LamBascom Palmer

Stephen RoseFoundation Fighting

Blindness

Thomas YorioU.N.T.H.S.C.

Schachar TauberSt. John’s Health

System

Darlene DarttSchepens Shuliang Jiao

U.S.C.

Robert SergottWills Eye

Randy KardonU. of Iowa


2009/10 Peer Reviewed Vision Research Program


• 120 Pre-proposals Received

• 51 Selected for Full Proposal Submission

• 49 Submitted Full Proposals

• 12 Investigators Selected for Funding

• $11,014,931 ($206K to $1.997M; Mean $~918K)

Submissions and Selections


Investigator Title

Nguyen Computational Model of the Eye for Primary and Secondary Blast Trauma

Kardon Objective Methods to Test Visual Dysfunction in the Presence of Cognitive Impairment

Weiland Wearable Visual Aid as Treatment for TBI Associated Visual Dysfunction

Doherty Evaluation of an Acute RNAi-Mediated Therapeutic for Visual Dysfunction Associated with Traumatic Brain Injury

Brecha A Novel Approach to Alleviating Aberrant Calcium Signaling Causing Retinal Cell Loss in Traumatic Optic Neuropathy

Choi Ultrahigh Resolution Retinal Imaging with Adaptive Optics for Early Diagnosis of TBI

Rex Treatment of Traumatic Vision Loss in a New Mouse Model of Blast Injury

Regueiro Simulation of Blast Loading on an Ultrastructurally-Based Computation Model of the Ocular Lens

Schultz Reduction of Corneal Scarring Following Blast and Burn Injuries to Cornea Using siRNAs Targeting TGF Beta and CTGF

Ciuffreda Treatment of TBI Induced Oculomotor Dysfunctions Associated Reading Problems

Petrov Oculomotor Reflexes as a Text of Visual Dysfunctions in Cognitively Impaired

Polat Behavioral Treatment TBI Associated Visual Dysfunction on Cortical Plasticity

Selected Proposals


VRP Principal Investigators

Nicholas BrechaU.C.L.A.

Stacey ChoiNew England College of Optometry

Colin DohertySt. James (U.K.)

Randy KardonU. of Iowa

Thao NguyenJohns Hopkins U.

Richard RegueiroU. of Colorado

Gregory SchultzU. of Florida

Tonia RexU. of Tennessee

James WeilandU.S.C.

Uri PolatU. Of Tel Aviv

Kenneth CiuffredaS.U.N.Y

Yury PetrovNortheastern U.


Congressionally Directed Medical Research Program (CDMRP)

• Funded through the Department of Defense (DoD)

• Via annual Congressional legislation known as the Defense Appropriations Act

• For most programs, the DoD sends a multi-year budget request to Congress in the form of the President's Budget.

• Dollars for the CDMRP are not considered part of the DoD's core mission, and are therefore not included in the DoD's requested budget.

• Rather, the dollars to fund CDMRP are added every year during the budget approval cycle by members of the House or Senate, in response to requests by consumer advocates and disease survivors.


CDMRP Funding Process

• Vision Setting: Identifies programmatic priorities for the year.

• Release of Program Announcement (posted on website).

• Proposal Receipt: Submitted electronically to CDMRP.

• Peer review: Reviews science and budget…

• Programmatic review: Considers military relevance…

• CG approval/Negotiations/Award Execution


FY 10 – 12 $15,946,353

• Larry Benowitz Children’s Hospital Boston DMRDP Restoring Vision After Optic Nerve Injury

• Christopher Tyler Smith Kettlewell DMRDP Human Oculomotor Function and its Deficits in TBI

• Eliezer Peli Schepens DMRDP Rehabilitation of Visual and Perceptual Dysfunction after Severe TBI

• Gang Lou Schepens DMRDP Development of a Vision Assistive Device for Veterans with TBI

• Shigeo Tamiya U. of Louisville DMRDP Novel Use of Clinical Drugs to Prevent Major Eye Injury Associated Complication

• Ricardo Carvalho Targeted Therapy Tech LLC DMRDP Episcleral Therapy for IED Related Ophthalmic Injury

Other Than TATRC Funded Projects


• Gregory Liou Medical College of Georgia DMRDP Role of Adenosine Receptor A2a in Traumatic Optic Neuropathies

• Aimee Arnoldussen Wicab Inc DMRDP Visual Information Restoration and Rehabilitation via Sensory Sunstitution Technology

• Benjamin Rollins Bombyx Technologies DMRDP Preventing Vision Loss from Blast Injuries with Regenerative Biomaterial

• Heuy-Ching Hetty Wang USAMRD ISR CRMRP Regeneration of Retinal elements by Exogenous and Endogenous Stem Cells to Restore Vision

• Jose Capo-Aponte USAARL, FT Rucker, AL MOMRP The Effects of Controlled Repetitive Blasts on the Visual System

• Thomas Harding USAARL, FT Rucker, AL MOMRP Primary Blast Waves Effects on Ocular Components and Protective Optical Surfaces

Other Than TATRC Funded Projects


• Addresses issues of relevance to mission and portfolio.

• Funds range of projects from basic research to technology insertion.

• Funding approximately $200,000.

• Funding must be approved by Proposal Review Board (PRB).

TATRC Augmentation Funds


Other TATRC Vision Projects

Florida Institute for Human and Machine Cognition Pensacola, FL FY09 Ends FEB2012

Henry Jackson Foundation & Johns Hopkins UniversityRockville, MD FY10 Ends OCT2013


Augmentation Principal Investigators

Denise RyanHJF & Johns Hopkins

Anil RajFLA Inst for

Human & Machine Cognition


AMEDD Advanced Medical Technology Initiative (AAMTI)

• An OTSG-funded program initiated in 1999. Each year $4,600,000 in P8 funds are MIPRed/FADed to AMEDD facilities to enable technology demonstrations.

• Key objectives

1.Demonstrate Advanced Medical Technologies and their Impact on Cost, Access and Quality of Care

2.Provide Senior AMEDD Leadership with Medical Tech-Watch Capability

3.Encourage Medical Technology Entrepreneurship by Funding AMEDD Technology Innovators


AMEDD Advanced Medical Technology Initiative (AAMTI)

• Open to AMEDD Personnel with Collaboration from Industry and Academia Designed to Foster “Medical Technology Entrepreneurship”

• Demonstrates Technology’s Impact on Cost, Access, Quality of Care

• Typical Award is $175-$225K; Period of Performance is 18 Months

• Proposals Submitted Via the Web Once per Fiscal Year

• url: www.tatrc.org. and click on the AAMTI Link


What is SBIR and STTR?

A congressionally mandated program…Across Federal Government (DoD, DoE, DHS, DoT, etc…)

2.5% (SBIR) and 0.3% (STTR) of Extramural RDT&E (gradual increase)

Increase small business participation in federally funded R&D

Three-phased process encompassing technology feasibility, demonstration, and transition

Transition Federal R&D into:

Government Programs

Industry Initiatives


CommercializationTransition to Federal Govtor Private Program

No SBIR Funds

Feasibility Study$150K, 6 Months

(Army SBIR: 100K + 50K option)

~10% of proposals submitted selected

Phase I

Phase II

DoD SolicitationSBIR YY.1, YY.2, and YY.3

Topics

Phase III

Phase I + Phase II = $1,150,000

Prototype Development$1.0M, 2 Years

~50% invitedproposals selected

Commercialization Pilot Program (CPP)

Three Phased Process


SBIR: Participation Requirements

U.S. small Business of 500 or fewer employees (exceptions)

Principal Investigator’s primary employment (more than 50% of time spent) must be with the proposing firm

During Phase I, a minimum of 2/3 effort must be performed by the proposing firm

During Phase II, a minimum of ½ of the effort must be performed by the proposing firm

Work must be performed in the U.S.

SBIR participationrequirements include:


STTR: Participation Requirements

U.S. small business of 500 or fewer employees (exceptions); no size limit on research institution.

Research institution is a FFRDC, college or university, or non-profit research institution.

Small business must perform a minimum of 40% of the work; research institution a minimum of 30%.

Small business must manage and control the STTR funding agreement.

Principal Investigator may be at the small business or research institution.

Work must be performed in the U.S.

SBIR participationrequirements include:


Funding Levels

The SBA raised the funding ceilings for the SBIR program.

– $150K Phase I

– $1.0M Phase II

Army and OSD are implementing these new levels in FY11.

Army is implementing this as $100K Phase I; $50K Phase I Option, $1.0M Phase II

STTR has not adjusted their funding levels


1. Most preliminary research proposals fail because the writing is ambiguous. There is a lack of detail: the deliverable, plans, and methods are not clear and, as a result, the value to the government is not clear.

2. Overarching strategy: Tone and tenor-write the proposal as if it were your money being requested. What information and clarity would YOU expect/want before deciding if you had any further interest.

3. Executing the strategy: Writing style- Use actions verbs/language: we will, we intend to, the technology will, this study will result in…..etc. Do not use passive language when describing the expected results of the study/research.

Keys to Success


4. Executing the strategy: Identify key elements of the proposed work: Deliverable-what is the end product of the research (publications, furthering the state of knowledge, prototype, platform, treatment protocol, research tool, etc.)? Major Milestones: what are the critical milestones that must be met in order for you to reach the deliverable? This could be access to patient population or data, legal agreements, early results, etc. Metrics to be used to demonstrate success: How do you define success, what are the metrics you will apply? For clinical studies identify the potential impact across Cost, Access, and/or Quality of care.

5. Demonstrate topic area knowledge through strong literature search; provide supporting data; provide details of previous research; provide alternate or back-up plans in case a key element of the work is not successful/feasible; where appropriate, compare your approach to other historical or extant work-how is it better/improvement, etc.

Keys to Success


U. S. Army Medical Research and Materiel Command

https://mrmc.amedd.army.mil/

Telemedicine and Advanced Technology Research Center

http://www.tatrc.org

http://www.tatrc.org/?p=funding_aamti

Congressionally Directed Medical Research Program

http://cdmrp.army.mil/

Broad Agency Announcement

http://www.usamraa.army.mil/pages/Baa_Paa/mrmcbaalist.cfm

Grants.Gov

http://www.grants.gov/

SBIR

http://www.acq.osd.mil/osbp/sbir/

Important Web Sites


Eye Guys

COL Donald GaglianoDirector, DoD / VA VCE

Robert ReadProgram Coordinator

Marc MitchellGOR & Project Officer

LTC Michael MinesGOR & Medical Consultant

Dr. Francis McVeighGOR & Sr. Clinical Consultant

Robert MazzoliDOD/VA VCE

Defense Related Vision Research Opportunities Association for …€¦ · Stephen Rose Foundation...

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