The Military Biomaterials Roadmap: Gap Analysis and CeMBR

Transcription

1 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 Jersey 145 Bevier Road Piscataway, NJ 08854

2 1 st Military Biomaterials Roadmap Gap Analysis Low TECHNOLOGY CHALLENGE High Requirements Technology gap Capabilities 2004 Today New strategic plan Current capabilities trend Projected requirements trends ( tbd) forces] COMMERCIALIZATION CHALLENGE = f [TIME; $; market

3 1 st Military Biomaterials Roadmap Gap Analysis 1. BIOMATERIALS AND THEIR IMPORTANCE TO MILITARY MEDICINE The process of biotechnology adaptation to military needs 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&D focus on military requirements? Q: If the military has not yet achieved a coordinated vision for biomaterials R&D, how might we assist that process?

4 1 st Military Biomaterials Roadmap Gap Analysis 1. BIOMATERIALS AND THEIR IMPORTANCE TO MILITARY MEDICINE 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 synthetic polymeric and ceramic materials? Q: How can we debottleneck clinical implementation in a predictable fashion to assure patient health and safety?

5 1 st Military Biomaterials Roadmap Gap Analysis 2. BIOMATERIALS TECHNOLOGY ASSESSMENT Areas of major impact on acute, chronic and rehabilitation care in military medicine are: Far-forward wound care Tissue engineering Drug delivery Physiological sensors and diagnostics Q: What are the gaps between current military needs in these areas and commercially available technology? Q: How might we define customer-focused product specifications for future biomaterial-based products?

6 1 st Military Biomaterials Roadmap Gap Analysis 3. ENABLING BIOMATERIALS DEVELOPMENT New materials and processes are needed to transition ideas into 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?

7 CeMBR s Mission The Center for Military Biomaterials Research is a network of academia, industry and the military that provides pathways for identification, development and utilization of biomaterial-based technologies and products that specifically target the military s most urgent health care needs on and off the battlefield Stage 1: Feasibility Stage 2: Upscale Stage 3: Prototype Stage 4: Validation 12 projects 6 projects 4 projects 3 projects 3

8 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

9 Current CeMBR projects address all roadmap areas Wound Care Tissue Regeneration Protection Sensors and Diagnostics Protective dressing: BioCure one-hand applied spray flexible hydrogel + silver antimicrobial Bone: CMU-Vanderbilt- Osteotech resorbable polymer/ composite for fracture fixation Biological warfare: RU-Princeton- USAMRIID targeted nanosphere neurotoxin inhibitor delivery Chemical warfare: Rutgers tissue engineered human skin barrier protectant test Hemostasis: TJU cationic peptide-polymer bandage Nerve: Rutgers PolyNSAID -polymer composite + growth factors conduit Anti-malarials: UMDNJ combichem designed drugs - polymer conjugates Chronic and amputee pain: RU-Penn ceramicpolymer composite film + anesthetic Connective tissue: UMDNJ knee meniscus ligament polymer blend cell scaffold Anti-tumor: Rutgers nanosphere breast cancer drugs and nanocomplex antisense ODN s

10 Transition to the Military Biomaterials Institute Military Biomaterials Institute (MBI) funded by the DoD to address critical unmet needs for combat casualty care Aligned with roadmap needs Focused thrust on therapies for tissue regeneration Ultimately regenerate amputated limbs

11 MBI s Approach to Limb Regeneration Provide the surgeon with a biomaterial-based regenerative tool kit of individual tissue systems Langer and Vacanti, Scientific American Sept.1995 Major challenges that need fundamental progress resorbable load bearing bone neural integration vascular supply engineering the transition between tissues Pipeline of intermediate therapeutic products

12 Implementation MBI will apply an industrially inspired, customer focused program approach to field new tissue regeneration technologies for the military 2 nd Roadmap Workshop November 8, 2006 New Brunswick, NJ MBI Open network switchboard learning organization Requirements and product specifications

13 Conclusions The Military Biomaterials Roadmap documents significant gaps between current capabilities and requirements CeMBR has demonstrated the power of an open network organization to effectively address the Roadmap s requirements CeMBR will transition into MBI 2 nd Roadmap Workshop essential for strategic planning MBI requires substantial funding and collaborative network partnerships to achieve these goals

14 Aviation is proof that, given the will, we have the capacity to achieve the impossible -Edward Vernon Rickenbacker Apollo 1969 Rickenbacker 1918 Leonardo Da Vinci 1505 Wright Brothers 1903

15 BioCure set GelSpray TM product spec s with USAISR Design 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 5in 2 of wound surface per package Operational at 35 0 F F Adherent and abrasion resistant Absorbs or transmits exudate Cost Initial target cost is $25 per unit

16 CeMBR network expansion to the MBI Military Research Organizations USAISR USAMRIID USAMRICD WRAMC TATRC NMRC ONR Core Academic and Clinical 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 Industry Partners Osteotech Biocure Corium Ciba Integra LifeSciences Johnson & Johnson Boston Scientific Organogenesis Smith & Nephew

17 MBI focused on translational R&D Cell-Seeded Scaffold Sean McCormick 4 yr post implantation Anastomosed TE Bladder Vacanti s tissue engineered products Bone Skin Repaired congenital complete sternum defect with bone and cartilage generated with polymeric mesh implant Smith & Nephew, Inc. Dermagraft TM human fibroblastderived dermal substitute Urinary Bladder Tengion, Inc. (Atala, former postdoc) licensed Vacanti/Langer IP for urothelial/smooth muscle cells-copolymer for autologous pediatric bladder

18 Wound healing and regeneration products developed by MBI team members Hollinger: BioMimetics Therapeutics growth-factor enhanced matrix for periodontal 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

19 Preliminary Workshop Breakout Topics Consider the current roadmap: what would make the roadmap more valuable to the military, industry and academia? How do we go about improving it to achieve that? (e.g., is an in depth market study needed of segment values)? How can we develop clear product specifications in each roadmap area (wound care, tissue regeneration, soldier protection, sensors & diagnostics)? What kind of organization is needed to succeed in meeting the technology and business challenges? How do we build 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 current research paradigms? What radical new concepts can we propose for tissue regeneration that would go beyond the current research thrusts? What kind of organization is needed to succeed in meeting the technology and business challenges? Consider soldier protection from chemical and biological agents, or even from bullets, shrapnel, fire and explosions: what are the major technical challenges and the strengths & weakness of current research paradigms? What radical new concepts can we propose for proactive, bioactive biomaterials for protection rather than for post-exposure therapeutic treatments that would go beyond current thinking and current research thrusts? What kind of organization is needed to meet the technology and business challenges?