TATRC

TTELEMEDICINEELEMEDICINE && A ADVANCEDDVANCED T TECHNOLOGYECHNOLOGY R RESEARCHESEARCH C CENTERENTER

(TATRC)(TATRC)

U.S. Army Medical Research and Materiel CommandU.S. Army Medical Research and Materiel Command

Rapid Prototyping & Technology TransferRapid Prototyping & Technology Transfer

Strategy for Fiscal Year 2004Strategy for Fiscal Year 2004

31 March 200431 March 2004

TATRC The TATRC Technology Transfer Imperative

• Patent and Trademark Law Amendment Act (Bayh-Dole Act) of

1980

– Option to retain rights to inventions

• Must disclose invention to government (within 2 months)

• Must file patent

• Must pursue commercialization

• Must give preference to small business for licensing

• Must ensure products manufactured in US

• Must provide government a “non-exclusive, non-transferrable, irrevocable paid-

up license” to use federally funded inventions.

TATRC The TATRC Technology Transfer Imperative

Federal Technology Transfer Act passed in 1986 (PL 99-502)

• Requires Federal Labs to transfer tech

• Chartered Federal Laboratory Consortium (FLC) to promote tech transfer

• Specifies following tech transfer activities:

– Tech Assistance – Request from company, university, or government to a Federal Lab.

– Authorizes laboratories to assign or license inventions

– Cooperative Research and Development Agreements (CRADAs) – Agreement between Federal

Lab and industry, non-profit or government to collaborate on project of mutual interest.

– Educational Partnerships – May loan equipment, donate surplus, provide lab personnel

– Cooperative Agreements – Provides funding to support research of interest to Fed Lab. –

– Grants – Same as CA, but does not involve govt involvement.

• TATRC granted laboratory authority in 4th Quarter, FY 03

TATRC

Telemedicine and Advanced Medical Technology Program

Mission Apply physiological and medical knowledge, advanced

diagnostics, simulations, and effector systems integrated with information and telecommunications for the purposes of enhancing operational and medical decision-making, improving medical training, and delivering medical treatment across all barriers.

The program scope is to identify, explore, and demonstrate key technologies and biomedical principles required to overcome technology barriers that are both medically and militarily unique.

Telemedicine & Advanced Technology Research Center Cutting Edge Medical Technology

Department of Defense,Joint Warfighting Science and Technology Plan, Chapter IX, Joint Readiness and Logistics, 1999

TATRC 5 P’s of Precision HealthcareScope of TATRC Functional Objectives

Predictive - Leverage Emerging Developments in Genetics, Bio-Informatics & Multi-Modality Imaging

Preventive - Act Proactively to Prevent Disease

Point of Care - Utilize Mobile Communications, Ubiquitous Computing and Local intelligence – Pinpoint therpeutics

Parametric - Analyze Multi-Parametric Information Referenced to Patient Baseline and Standard Model

Personalized - Individualize Therapeutics to Each Patient

SATAVA 7 July, 1999DARPA

6

TATRC

BIOLOGICALDOMAIN(science)

PHYSICALDOMAIN

(engineering)

INFORMATIONDOMAIN

(computers)

FUTURERoboticsMEMS/NanotechMicroarrayMolecular Imaging

GenomicsProteomicsBioinformaticsBiocomputation

BiosensorsBiomaterialsBiomimetic

Richard M. Satava, MD

U of Washington/TATRC/DARPA

5Ps Transition to Bio Intelligence!

TATRC Core Research Leads to ….Transformational

TechnologiesDecade of the 1950’s

ProgrammableSystems

ENIACTransistor

Lasers

DNAAtomic Clock

?

This DecadeRobotics

Nanotechnology

Immersive VREnvironments

Directed Energy

Biotechnology

TATRC

TATRC TECHNICAL AREAS & SYSTEMS

InformaticsMAJ RAPP

IM/ITCARL HENDRICKS

Bio-SurveillanceMARY PARKER

Bio-InformaticsJAQUES REIFMAN

Mobile Med TechTOMMY MORRIS

HOMELAND SECURITY/DISASTER RELIEF SYSTEMS INT: M. PARKER

FWRD DEPLOYED DIGITAL MED TMNT FAC SYS INT: G. GILBERT

BATTLEFIELD SYSTEMS INT: T. MORRIS

OPERATING ROOM OF THE FUTURE SYS INT: G. MOSES

CLINICAL SYSTEMS INTEGRATOR: R. POROPATICH

TRAINING SYSTEMS INTEGRATOR: C. PUGH

OPERATIONAL T’MED SYS INTEGRATOR: T. MORRIS

TATRC

TATRC TECHNICAL AREAS & SYSTEMS

Bio-SensorsKEN CURLEY

Med Mod & SimGERRY MOSES

RoboticsGARY GILBERT

Adv. ImagingGREG MOGEL

Adv Surg TechGERRY MOSES

HOMELAND SECURITY/DISASTER RELIEF SYSTEMS INT: M. PARKER

FWRD DEPLOYED DIGITAL MED TMNT FAC SYS INT: G. GILBERT

BATTLEFIELD SYSTEMS INT: T. MORRIS

OPERATING ROOM OF THE FUTURE SYS INT: G. MOSES

CLINICAL SYSTEMS INTEGRATOR: R. POROPATICH

TRAINING SYSTEMS INTEGRATOR: C. PUGH

OPERATIONAL T’MED SYS INTEGRATOR: T. MORRIS

TATRC

TATRC TECHNICAL AREAS & SYSTEMS

Cell/Molecular BioKEN CURLEY

Nano-MedicineGARY GILBERT

Comp & Alt MedKEN CURLEY

Chronic DiseaseR. POROPATICH

Ther & Clincal TechDEAN CALCAGNI

HOMELAND SECURITY/DISASTER RELIEF SYSTEMS INT: M. PARKER

FWRD DEPLOYED DIGITAL MED TMNT FAC SYS INT: G. GILBERT

BATTLEFIELD SYSTEMS INT: T. MORRIS

OPERATING ROOM OF THE FUTURE SYS INT: G. MOSES

CLINICAL SYSTEMS INTEGRATOR: R. POROPATICH

TRAINING SYSTEMS INTEGRATOR: C. PUGH

OPERATIONAL T’MED SYS INTEGRATOR: T. MORRIS

TATRC

TATRC TECHNICAL AREAS & SYSTEMS

Digital Mission PlanDOUG FLETCHER

Bio-MaterialsCONRAD CLYBURN

OpthalmologyBILL FLYNN

Adv Dist LearningCARLA PUGH

HOMELAND SECURITY/DISASTER RELIEF SYSTEMS INT: M. PARKER

FWRD DEPLOYED DIGITAL MED TMNT FAC SYS INT: G. GILBERT

BATTLEFIELD SYSTEMS INT: T. MORRIS

OPERATING ROOM OF THE FUTURE SYS INT: G. MOSES

CLINICAL SYSTEMS INTEGRATOR: R. POROPATICH

TRAINING SYSTEMS INTEGRATOR: C. PUGH

OPERATIONAL T’MED SYS INTEGRATOR: T. MORRIS

TATRC

BMIS-T Chest Tube Simulator Digital X-ray

Dreams Digital Ambulance Smallpox Inoculation Retinal ImagingTraining Unit

STAT-CARE

Examples of Commercialized Products over the Last 12 Months

Life Cycle Management Framework

I C M E O

TATRC

TATRC Core Business ProcessesCore Business Processes

II CC MM EE OO

Functional

Scientific

Review

&

Prioritization

Proposals

&

Taskers

RDT&E, Congressional

Defense Health DUST - SBIRSTTR- ACT IICEP - ACTDWRAP - AWEInteragencyPartnerships

Project

Management

Regulatory

Compliance

Technology

Review

Prototypes

Patents

Royalties

Articles

Products

Demos

IInputsnputsCControlsontrols MMechanismsechanisms EExecutionxecution OOutputsutputs

Advanced Technology WatchAdvanced Technology Watch

TATRCTATRC

TATRC

TATRC manages projects through professional business

processes

• Integrated Research Team (IRT)• Program level• Periodic, as required• Broad strategic planning and oversight

• Milestone Reviews• Project Level• Pre-Award• Establish performance metrics, deliverables and milestones

• Integrated Product Team (IPT)• Project level • More frequent, scheduled• Project-specific guidance

• Product Line Review (PLR)• Assessments of research by outside experts• One research category per month; annual cycle

T A T R CT A T R C

TATRC

S U P P O R T I N G B U S I N E S S P R ACTICESS U P P O R T I N G B U S I N E S S P R ACTICES

TATRC

I C M E O Improvements Needed to Support Technology Transfer

InputsModify TATRC Pre-Proposals to include projected market healthcare market data

> Leverage templates developed by National Medical Technology TestBed (NMTB)

Quality ControlsEnsure Proposal Review Board (PRB) fully evaluates projected impact on healthcare market

> Leverage iPIP Matrix developed by Center for Integration of Medicine and Innovative Technology, (CIMIT)

Funding MechanismsLeverage full range of funding mechanisms to support of life cycle management/advanced

development:CSI, P6, P8, SBIR, STTR, DEPSCOR, ATD, ACTD, etc.Develop capabilities to locate/secure private sector 2d round funding for advanced development/commercialization.

ExecutionStreamline/Enhance Regulatory Compliance strategy to optimally address FDA/CMS requirementsEnhance PLR system to assess:

Potential market sizeExpected market sharePotential profit marginsExpected useful life of the technologyAnticipated production time to marketabilityProjected cost of marketingPotential technology development hurdlesPotential regulatory hurdlesIntellectual property protection issues Leverage In Progress Review Process and Business consulting capabilities developed by NMTB Establish Technology Transfer Committee

Outputs Develop management controls and performance metrics for tracking, forecasting and reporting of:

PrototypesIntellectual Property: Patents, Royalties, Peer Reviewed Scientific Articles and FindingsDual Use Commercialized ProductsProof of Concept Demonstration and Validations

TATRC

Total Funding

$0

$50,000,000

$100,000,000

$150,000,000FY98

FY99

FY00

FY01

FY02

FY03

FY04(Proj)Dollars are in Millions

Telemedicine & Advanced Technology Research Center Cutting Edge Medical Technology

Projected FY04 TOTAL = $200m

FY99 TOTAL = $67m

FY00 TOTAL = $85 m

FY98 TOTAL = $61m

FY01 TOTAL = $116 .6m

FY04 TOTAL = $200m

FY03 TOTAL = $114m

FY02 TOTAL = $114m

TATRC TATRC Funding Analysis

$2,750 $6,975$200

$664

$4,418

$98,099

$782

RDTE, Army = $782k

DHP, Army = $6,975k

CSI = $98,099K

SOCOM = $200k

PEO, JMIS = $664k

SBIR/STTR = $3,210k

DARPA = $2,750k

FY03 TOTAL $112,825 ($000)

• $ 782K Army Core provided by RAD 1,2,3,4 for Bioinformatics Cell/Etc..  • $ 98,099K CSI based on congressionals less the DA withholds. • 33 FY03 Congressional Special Interest Budgets • $ 6,975 DHP is PT III and 5,000 RFS• Overhead =10% of portfolio managed

TATRC can draw from a network of existing advanced medical technology R&D public – private partnerships.

               

  

                            

TATRC

Leverages Academic Partnerships…For Basic and Applied Research

• Georgetown University (CA-Medical Vangaurd)

• Howard University (CRDA-Urban Telemed)

• Harvard University (CA-CIMIT)

• Mass Institute of Technology (CA-CIMIT)

• University of Maryland (IPA/CA – ORF)

• University of Utah (Contract-Teleopth)

• Saint Francis University (CRDA-CERMUSA)

• Loma Linda University (CA-NMTB/Proton Beam)

• University of Tex - Houston HSC (CA-DREAMS)

• University South Florida (CA-Telerad/Adv Cancer Detect)

• University of Hawaii (CA-Telemed Curric’lm)

• University of Pittsburgh (Contract-GGTS)

• Stanford University (Contract-Affiliates Prog)

• Yale University (IPA-Adv Tech Watch)

• Texas A & M (CA-DREAMS)

• Johns Hopkins University (CA-Periscopic MIS)

• University of Southern Calfornia (CA-NGI)

Telemedicine & Advanced Technology Research Center Cutting Edge Medical Technology

TATRC

Uses DoD & Federal Partnerships for Non-Medical and Supporting Technologies

* Distributed, Synchronized Databases

* Advanced, Adaptive Multilevel Security

* Data Mining of Disparate Databases

* Secure Global Positioning System

* Network Management Tools

* Info Warfare Surveillance & Defense Tools

* Artificial Intelligence - Expert Systems

* Fault Avoidance and Recovery Systems

* Hands Free, Wireless Telecom

* Wireless Networking

* Data Compression

* High Bandwidth Datalinks

* Low Power Electronics

* Multi-platform, Interoperable Software

* Complex Modeling and Simulation

R&D Panels and Commands “Partnerships”

• U.S. Army Research Laboratory

• Los Alamos National Laboratory

• Sandia National Laboratory

• U.S. Army, Signal Battle Laboratory

• Commo & Electronic Command

• Oak Ridge National Laboratory

• Veterans Administration

• NASA

• DARPA

• National Library of Medicine (NIH)

• Agency for Health Research & Quality (HHS)

Telemedicine & Advanced Technology Research Center Cutting Edge Medical Technology

TATRCLeverages… International Partnerships to Accelerate Development

• US/Norway Telemedicine (Wireless, Handheld)

• European Union Collaboration

• NATO – Telemedicine Standardization Committee

• South African Military Health Service (Peacekeeping)

• International Global Satellite System: Poland (CME)

• Landmine Victim Assistance: Central America > Afghanistan

• Partnership for Peace – Romanian Needs Assessment

• Pakistani Exchange Program

• Yuma Proving Ground - Panama Telemedicine

• South Korean Exchange Program

• ATA Symposiums: EU (2001) – Africa (2002) - Latin America (2003)

Examples of TATRC Partnerships with Significant

Technology Transfer Capabilities

TATRC

TATRC National Medical National Medical Technology TestbedTechnology TestbedNational Medical National Medical Technology TestbedTechnology Testbed

§ Program objectives:Program objectives: Revitalize the economyRevitalize the economy through conversion of defense technologythrough conversion of defense technology Improve military and civilian healthcareImprove military and civilian healthcare through technology research and developmentthrough technology research and development Become self-sustaining through royaltiesBecome self-sustaining through royalties

§ Managed by Loma Linda University Medical Center Managed by Loma Linda University Medical Center

§ Cooperative agreement signed in 1997 Cooperative agreement signed in 1997

§ Funds commercialization of dual use medical productsFunds commercialization of dual use medical products

§ Received first royalties in FY 2003Received first royalties in FY 2003

§ Developed systems for:Developed systems for:-Market analysisMarket analysis-Business developmentBusiness development-IP developmentIP development

§ TATRC CommercializationTATRC Commercialization Subject Matter ExpertsSubject Matter Experts

TATRC

PROBLEM RICH ENVIRONMENT

SOLUTION RICH ENVIRONMENT

CIMIT

Center for Integration of Medicine and Innovative Technology

TATRC CIMIT Assumptions re: Health Care

1) Major advances in next 10-15 years- Devices, Minimally Invasive Procedures, Imaging, Drug Delivery Systems

2) Good News –- Enabling technology already exists

3) Bad News –- Major barriers to “capturing” technology: Clinical Insertion

Economic /RegulatoryIndustrial Involvement

4) These barriers can be rapidly overcome by:- Systematic Culture Blending- Committed Experts- Individualized Facilitation

Dr John ParrishInstitute of MedicineDirector, CIMIT

TATRCCIMIT

Industry Liaison Group

• General Electric Medical Systems• Johnson & Johnson

– Cordis– Ethicon Endosurgery– COSAT

• Karl Storz Endoscopy• Omnicell, Inc• Pentax Precision Instrument Corp• Radianse, Inc• 10 Blade, Inc• Ascension Technology, Corp• AstraZeneca• Baxter Healthcare, Corp• B-K Medical Systems, Inc.• Boston Scientific, Corp• Olympus America, Inc.• OmniGuide Communications, Inc.• Pharmacia, Inc.• Physical Sciences, Inc.• Welch Allyn, Inc.

• Medtronic, Inc.

• Bristol Myers Squibb Co.

• Terumo Medical Corp

• Draeger Medical, Inc.

• Foster-Miller, Inc.

• Foxfire Interactive Corp

• Getinge-Castle, Inc.

• Harvard Clinical Technologies, Inc

• HydroCision, Inc.

• IDEO

• Instrumentarium, Corp

• Granite Peak Technology

• Hewlett Packard Company

• Guidant Corporation

• Mobile Aspects, Inc.

• Motorola, Inc.

• Percadia, Inc.

• Pfizer, Inc.

• TYCO

• TissueLink Medical, Inc.

TATRCCIMIT

Charles Stark Draper Research Laboratory

Navigator Technology Ventures (NTV)

• The NTV is the Venture Capital subsidiary of The Charles Stark Draper Laboratory, Inc. of Cambridge, Mass.– Founded in 2000, – Focuses on early stage investments. – Identifies technologies with attractive commercial potential– Helps set up start up companies– Provides seed financing– Arranges later-stage funding partners. – NTV concentrates on intense engineered technologies:

• Electronics• Software• MEMS• Optics• RF• Material• Across industries such as energy, biotech, telecom, IT, wireless and

Internet.

– NTV currently has investments in Polychromix Inc. and Sionex Corp.

TATRC

CeMBR The Center for

Military Biomaterials Research

Biomaterials Solutions to Acute Trauma

Bringing the Full Power of Materials Science

to Combat Casualty Care

A University and Industry-Sponsored

Research Centernjbiomaterials.org

TATRC

Initial Technical Focus Areas

TATRC CEMBR Industrial Members 2003A Diverse Group of Synergistic Companies

Medical Device Start-ups

– Advanced Materials Design

– BioCure– REVA Medical– Vectramed– Vyteris

Midsize Medical Device Companies

– Enzon– Integra Lifesciences– Hydro Med

Sciences– LifeCell– Osteotech– Stratec

Major Corporations– Avon Products– Boston Scientific– Cordis, a J&J

Company– Dupont– Medtronic– Unilever

Associated Research Centers

– Center for Biomaterials & Advanced Technologies, Medical Products Group (Ethicon, Inc.)

Production and Fabrication

– The MedTech Group

– Corium

Supporting Law Firm

– Norris, McLaughlin and Marcus

Participating Venture Capital Groups

– The Vertical Group

TATRC Cleveland Clinic FoundationComputer Assisted Minimally Invasive Surgery

(CAMIS)

TATRC

Pamela Bailey President, AdvaMedJohn Brown CEO, StrykerSamuel Colella Director, Versant VenturesArt Collins CEO, MedtronicBrian Dovey Partner, Domain AssociatesTom Fogarty, M.D. Cofounder, Three Arch PartnersMike Hildreth Partner, E&YGeorge Hatsopoulos, Ph.D. CEO, PharosCarl Kohrt, Ph.D. CEO, BattelleCaroline Kovac, Ph.D. IBM Life SciencesJouko Karvinen President and CEO Philips Medical SystemsHarry Kraemer CEO, Baxter

Edward Ludwig CEO, BDDane Miller, Ph.D. CEO, BiometMal Mixon CEO, InvacareMichael Mussallem CEO,  Edwards LifesciencesHarry Rein Foundation Medical PartnersErich Reinhardt, D.Eng. CEO,  Siemens Medical SolutionsTim Ring CEO, C.R.BardBill Sanford Chairman, BioEnterpriseLes Vinney CEO, STERISJohn Wareham CEO, Beckman CoulterRaymond Warrell, M.D. CEO, GentaBill Weldon CEO, Johnson & JohnsonMiles White CEO, Abbott LaboratoriesJack Lasersohn General Partner, The Vertical Group

Cleveland Clinic Foundation (CCF) Innovations>New Technology Transfer Center<

“2003 Medical Innovation Summit Participants”

TATRC NASA Commercial Space Centers (CSCs)

• TATRC has funded relationships with two CSCs that focus on medical technology:

– Medical Informatics and Technology Applications Consortium (MEDITAC), Virginia Commonwealth University

• Microsoft• Virginia Biotechnology Research Park• USSC• TeleVital• Olympus• Compaq• QRS• Immersion• Spacelab

– Stanford/NASA Ames Commercial Space Center• Medical Technology• Information Technology• Materials Sciences

TATRC

– GE Medical Systems

– Intel Corp

– Medweb

– Nortel Networks

– AT&T

– Johnson & Johnson

– Trestle Corp

– Eastman Kodak

– SBC Communications, Inc

– Verizon Communications

– ScottCare Corp

– Computerized Screening

– AMD Telemedicine

– Polycom

– iMetrikus

– IBM Life Sciences

– Siemens

– Tandberg, LLC

– American Telecare, Inc.

– Vitelnet, Inc.

– Samsung Electronics Co.

– SMS

– Health Hero Network

– HomMed

– PhoneDoctorx

– Healthcare Vision & Healthcare Computer

Corp.

– Biosign

– Viterion Teleheathcare

Industry Advisory Group

TATRC has long-standing relationship with ATA

…Funds Annual Advanced Briefing for Industry & Academia (ABFI&A), partially funds ATA Annual Conference

TATRC

• RTI Tech Transfer provides a range of services:

– Develop marketing materials

– Identify and target relevant companies outside your core business to solicit

licensing interest

– Project the value of technology

– Evaluates offers

– Assists in negotiating sales, licensing, or donation agreements.

TATRC has long standing relationship with RTI - funds various dual use simulators

TATRC

Other PotentialTATRC Technology Transfer

Partnerships

TATRCPotential Partnerships… Requiring Further Exploration and Development

• Government Affiliated– Federal Laboratory Consortia– Rossetex (Sarnoff – SRI Joint Venture)– In-Q-Tel (CIA Affiliate)– Mohawk, Inc. (DOE Affiliate)– Pacific Telehealth HUI (DOD/VA)

• Academic– Columbia University (CIE)– Drexel University (CIMERC)– Uniformed Services University of Health Sciences (USUHS)

• Henry Jackson Foundation

– University of Maryland (OR of Future)– University of South Florida (National Functional Genomics Center)– University of Pittsburgh (Various Congressionals)– University of California, Los Angeles (CASIT)– Indiana University (Emerging Technologies Center – Business Incubator)

• Commercial or Non-Profit– Vesalius Venture Capital– The Global Telemedicine Group– Battelle Memorial Institute

TATRC

• Technology Transfer Partnerships– TATRC has numerous potential partners– TATRC should form partners into a nationwide,

distributed network of Technology Transfer Centers of Excellence

– Facilitate the commercialization of government funded advanced medical technology Intellectual Property

TATRC Tech Transfer

TATRC TATRC Changes in FY 04

• Implement internal I C M E O changes

• Create a distributed network of Best of Breed partners, for example: CEMBR = Biomateriels CIMIT = Biosensors, Simulation, Etc. NMTB = Market Analysis, Individualized Facilitation, Review ATA = Telemedicine DREAMS = Cardiology, Trauma Care Cleveland Clinic = Ultrasound, Robotics, Etc..

Objective: Streamline COTS development and raise the percentage of government IP commercialized.

Convene > Organize > Execute > Evaluate

TATRC

Designed to Accelerate the “Flash to Bang” …from Basic Research to Tech Transfer

Forward Deployed Digital SystemsMedical Modeling & SimulationOperating Room of the FutureWireless Medical Enterprises

IM/IT SystemsHomeland Security SystemsDisease Surveillance Systems

Telemedicine

NanomedicineBioTechnology

Molecular GeneticsBiomaterielsBioSensors

Basic Research Assured ConnectivityMedical Informatics

Med Training TechnologiesRobotics

Therapeutics

Applied ResearchAdvanced Technology

DevelopmentEarly Prototyping

Engineering ManufacturingDevelopment,

Procurement,Operations & Maintenance

Demonstration & Validation

Program Managers forArmy (PM, MC4), Navy, Air Force, DOD, Industry

Technology

Transfer