the military biomaterials roadmap: gap analysis and … · the military biomaterials roadmap: gap...

08 November 2006 CeMBR 2nd Military Biomaterials Roadmap Workshop

The Military Biomaterials Roadmap:Gap Analysis and CeMBR

David Devore, Ph.D.COO, Center for Military Biomaterials Research (CeMBR)

Rutgers, the State University of New Jersey145 Bevier Road

Piscataway, NJ 08854


1st Military Biomaterials Roadmap Gap Analysis

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Projected requirements trends (tbd)



1. BIOMATERIALS AND THEIR IMPORTANCE TO MILITARYMEDICINE

• The process of biotechnology adaptation to militaryneeds is inefficient

– military needs not a factor in early stage R&D• A coordinated military vision required

– military support of biomaterials research is decentralized– opportunities for interdisciplinary collaborations missed

Q: How might we influence market forces to improve R&Dfocus on military requirements?

Q: If the military has not yet achieved a coordinated visionfor biomaterials R&D, how might we assist thatprocess?



1. BIOMATERIALS AND THEIR IMPORTANCE TO MILITARYMEDICINE

• The status of biomaterials research and development:– Should focus research on controlling interactions of artificial

materials and tissue– Current approaches based mostly on trial and error– Regulatory processes must balance innovation and safety

Q: How might we control cellular interactions with syntheticpolymeric and ceramic materials?

Q: How can we debottleneck clinical implementation in apredictable fashion to assure patient health and safety?



2. BIOMATERIALS TECHNOLOGY ASSESSMENT

• Areas of major impact on acute, chronic and rehabilitation carein military medicine are:

– Far-forward wound care– Tissue engineering– Drug delivery– Physiological sensors and diagnostics

Q: What are the gaps between current military needs inthese areas and commercially available technology?

Q: How might we define customer-focused productspecifications for future biomaterial-based products?



3. ENABLING BIOMATERIALS DEVELOPMENT

• New materials and processes are needed to transition ideasinto products– Establish design characteristics for materials in product

applications– Develop rapid screening techniques for new materials– Develop techniques for rapid prototyping, micropatterning and

device manufacturing– Predetermine the regulatory approval path

• Establish metrics the measure progress and success

• Q: How can materials design and manufacture be accelerated?• Q: What metrics are in use in the military and which should be

adopted by CeMBR?

08 November 2006 CeMBR 2nd Military Biomaterials Roadmap Workshop3

CeMBR’s Mission

• The Center for Military Biomaterials Research is a network ofacademia, industry and the military that provides pathways foridentification, development and utilization of biomaterial-basedtechnologies and products that specifically target the military’s mosturgent health care needs on and off the battlefield

3 projects

Stage 1: Feasibility Stage 2: Upscale Stage 3: Prototype Stage 4: Validation

12 projects 6 projects 4 projects


CeMBR achievements to date

• CeMBR network in place and growing– USAMRMC (TATRC & medical research institutes), US Navy– Rutgers, UMDNJ, Princeton, Carnegie Mellon, Vanderbilt,

Penn, Thomas Jefferson, Columbia, Cornell, Harvard, MIT– Osteotech, BioCure, Ciba, Corium

• CeMBR has initiated 10 R&D projects– Aligned with each of the Roadmap’s key areas– Over $7 Million in funding to date

• CeMBR “Innovative Organization” structure established

• CeMBR biomaterials education programs under development


Anti-tumor:Rutgersnanosphere breastcancer drugs andnanocomplex anti-sense ODN’s

Connective tissue:UMDNJ kneemeniscus ligamentpolymer blend cellscaffold

Chronic andamputee pain:RU-Penn ceramic-polymer compositefilm + anesthetic

Anti-malarials:UMDNJ combichemdesigned drugs -polymer conjugates

Nerve:Rutgers PolyNSAID-polymer composite+ growth factorsconduit

Hemostasis:TJU cationicpeptide-polymerbandage

Chemical warfare:Rutgers tissueengineered humanskin barrierprotectant test

Biological warfare:RU-Princeton-USAMRIID targetednanosphereneurotoxin inhibitordelivery

Bone:CMU-Vanderbilt-Osteotechresorbable polymer/composite forfracture fixation

Protectivedressing:BioCure one-handapplied sprayflexible hydrogel +silver antimicrobial

Sensors andDiagnostics

ProtectionTissueRegeneration

Wound Care

Current CeMBR projects address all roadmap areas


Military Biomaterials Institute (MBI) funded by the DoDto address critical unmet needs for combat casualty care

• Aligned with roadmap needs

• Focused thrust on therapies for tissue regeneration

• Ultimately regenerate amputated limbs

Transition to the Military Biomaterials Institute


Langer and Vacanti, Scientific American Sept.1995

MBI’s Approach to Limb Regeneration

• Provide the surgeon with a biomaterial-based “regenerativetool kit” of individual tissue systems

• Major challenges that need fundamental progress– resorbable load bearing bone– neural integration– vascular supply– engineering the transition between tissues Pipeline of intermediate therapeutic products


Open network“switchboard”learningorganization

Requirementsand productspecifications

MBI

Implementation

MBI will apply an industrially inspired, customer focused programapproach to field new tissue regeneration technologies for the military

2nd Roadmap WorkshopNovember 8, 2006New Brunswick, NJ


Conclusions

• The Military Biomaterials Roadmap documents significant gapsbetween current capabilities and requirements

• CeMBR has demonstrated the power of an open networkorganization to effectively address the Roadmap’s requirements

• CeMBR will transition into MBI– 2nd Roadmap Workshop essential for strategic planning

• MBI requires substantial funding and collaborative networkpartnerships to achieve these goals


“Aviation is proofthat, given the will,

we have the capacityto achieve theimpossible”

-Edward Vernon Rickenbacker

Leonardo Da Vinci 1505 Wright Brothers 1903

Rickenbacker1918

Apollo 1969


BioCure set GelSprayTM product spec’s with USAISRDesign• Protect minor wounds that threaten the completion of the mission• Self-applied, one hand• Flexible, conforms to irregular surfaces of hand, face, neck, outer ear• Delivery platform for hemostatic, pain and infection control agents

Delivery Device / Packaging• low cube (fit in pocket) low mass (ca 100 grams), field-worthy• shelf life of 6 months

Safety• Sterile and meets FDA guidelines for a wound dressing

Efficacy• Easy to use in the battlefield environment• Rapid application, i.e. set up in < 1 minute• Covers 5in2 of wound surface per package• Operational at 350F-1000F• Adherent and abrasion resistant• Absorbs or transmits exudate

Cost• Initial target cost is $25 per unit


CeMBR network expansion to the MBI

Military ResearchOrganizations

USAISR

USAMRIID

USAMRICD

WRAMC

TATRC

NMRC

ONR

Industry Partners

Osteotech

Biocure

Corium

Ciba

IntegraLifeSciences

Johnson &Johnson

Boston Scientific

Organogenesis

Smith & Nephew

Core Academic andClinical Team

Joachim Kohn,Rutgers

Harold Brem,Columbia P&S

Joseph Vacanti,Harvard

Robert Langer, MIT

Jeffrey Hollinger, CMU

Paul Ducheyne, Penn

Marjiana Tomic-Canic,Weill Cornell

David Devore, Rutgers


Sean McCormick4 yr post implantation

Cell-Seeded Scaffold Anastomosed TE Bladder

MBI focused on translational R&D

Vacanti’s tissue engineered products• Bone

– Repaired congenital completesternum defect with bone andcartilage generated withpolymeric mesh implant

• Skin– Smith & Nephew, Inc.

DermagraftTM human fibroblast-derived dermal substitute

• Urinary Bladder– Tengion, Inc. (Atala, former post-

doc) licensed Vacanti/Langer IPfor urothelial/smooth musclecells-copolymer for autologouspediatric bladder


Wound healing and regeneration productsdeveloped by MBI team members

• Hollinger: BioMimetics Therapeutics’ growth-factor enhanced matrix forperiodontal bone defects– the first FDA-cleared recombinant growth factor containing product for

the periodontal market• Kohn: TyRx Pharma’s hernia repair devices

– combinatorially designed, resorbable polymer• Kohn: Reva/Boston Scientific’s degradable vascular stent

– combinatorially designed radioopaque polymer composition• Ducheyne: Orthovita’s bone regeneration

– FDA-cleared porous nanoparticle tricalcium phosphates• Ducheyne/Devore: Gentis’ spinal disc repair

– injectable emulsion polymer entering human trials• Langer: 500 patents licensed to 187 companies and 22 start-ups are

impacting medical practice in drug delivery and tissue regeneration


Preliminary Workshop Breakout Topics

• Consider the current roadmap: what would make the roadmap more valuableto the military, industry and academia? How do we go about improving it to achievethat? (e.g., is an in depth market study needed of segment values)? How can wedevelop clear product specifications in each roadmap area (wound care, tissueregeneration, soldier protection, sensors & diagnostics)? What kind of organization isneeded to succeed in meeting the technology and business challenges? How do webuild industry participation? How do we fund the R&D needed?

• Consider regeneration of tissue damaged by major combat wounds: what are the major technical challenges and the strengths & weakness of currentresearch paradigms? What radical new concepts can we propose for tissueregeneration that would go beyond the current research thrusts? What kind oforganization is needed to succeed in meeting the technology and businesschallenges?

• Consider soldier protection from chemical and biological agents, oreven from bullets, shrapnel, fire and explosions: what are the majortechnical challenges and the strengths & weakness of current research paradigms?What radical new concepts can we propose for proactive, bioactive biomaterials forprotection rather than for post-exposure therapeutic treatments that would go beyondcurrent thinking and current research thrusts? What kind of organization is needed tomeet the technology and business challenges?

the military biomaterials roadmap: gap analysis and … · the military biomaterials roadmap: gap...

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