Translating Research into Medical Products for Service Members - PowerPoint PPT Presentation

Translating Research into Medical Products for Service Members UNCLASSIFIED Dr. Tyler Bennett Deputy for Acquisition United States Army Medical Materiel Agency Ms. Kathleen Berst Deputy for Acquisition United States Army Medical Materiel Development Activity UNCLASSIFIED 1

Agenda » Why does the DoD develop medical products? » Who are we? » What do we do? » How do we do it? » How can we work with you? UNCLASSIFIED 2

Why? USAMRMC: We Save Lives! We save lives by delivering medical solutions that: • Increase warfighter readiness • Improve fitness, health, protection, and resilience • Improve downrange health delivery • Enhance recovery, rehabilitation or reintegration UNCLASSIFIED 3

Why is Army Medicine Involved? We select, modify, and procure commercial medical materiel solutions when appropriate or we partner to develop. We take the lead in R&D when: • The issue is unique to the military • Industry/academia lack interest • Military needs require acceleration of solution • Directed by Congress • Available commercial product cannot be sustained in military environment UNCLASSIFIED 4

This Work is Too Important to Leave to Chance Change Manufacturing Business Science Practice Regulatory Reimbursement Other funding UNCLASSIFIED 5

US Army Medical Research and Materiel Command DoD and Service Medical Requirements Medical Medical Knowledge and Research and Materiel for the Technology Warfighter LIFE CYCLE MEDICAL MATERIEL MANAGEMENT Medical Medical Strategic and Advanced Operational Development Logistics UNCLASSIFIED 6

USAMRMC Actual Personnel – DEC 2016 MILITARY CIVILIAN CONTRACTOR TOTAL USAMRMC Organization Chart 1064 2268 3189 6521 16% 35% 49% 100% Also DHA Director for Commanding General Deputy R&D Chief of Staff Commander Other Organizations • Congressionally Directed Medical Research Programs (CDMRP) Command • Telemedicine and Advanced Technology Research Center (TATRC) Sergeant Major USAMRMC’s Principal Assistant for Research Product Principal Assistant for Acquisition and Technology Development and Regulatory Capability US Army US Army US Army US Army Medical US Army Medical US Army 6 th Medical US Army Research Medical Walter Reed Army US Army US Army Aeromedical Research Institute Research Institute Medical Materiel Logistics Medical Materiel US Army Institute of Institute of Research Institute Medical Materiel Medical Materiel Research of Chemical of Infectious Development Management Center Center, Europe Surgical Research Environmental of Research Agency Center, Korea Acquisition Laboratory (USAISR) Defense Diseases Activity (6MLMC) (USAMMCE) Medicine Activity (WRAIR) (USAMMA) (USAMMCK) (USAARL) (USAMRICD) (USAMRIID) (USAMMDA) (ADCON) (USARIEM) (USAMRAA) Strategic Medical Medical Logistics Commands Advanced Contracting Medical Research and Technology Laboratory Commands Development Activity Operational Medical Logistics Commands Commands UNCLASSIFIED 7

USAMRMC Operational Scope Fielded Medical Fielded Medical Knowledge Materiel Research to produce medical knowledge ACQUISITION & LOGISTICS DEVELOPMENT & ACQUISITION RESEARCH & DEVELOPMENT Medical Advanced Medical Logistics Medical Research & Development Program (6.4-6.7) Program (PROC – O&M) Technology Program (6.1-6.3) FDA Regulatory Support Congressional Special Interest Programs Other Government Agencies Industry, Academia, Other UNCLASSIFIED 8

Product Development Competencies Advanced Development Translates Research Into Fielded Products = Medically Ready Force RESEARCH ADVANCED DEVELOPMENT FIELDED PRODUCT FDA Clinical Regulatory Development Management Medical Force Health Product Protection Development Advanced Development’s Core Competencies Bridging the Valley of Death UNCLASSIFIED 9

Balancing Technology and Requirements TECHNOLOGY REQUIREMENTS PUSH PULL • Strategic Guidance • Intramural and Documents Extramural Partners - T echnology Transition • Joint Capabilities Agreement (TTA) Integration and Development (JCIDs) • Industry and Academia – Documents SBIRs, STTRs, etc. • Congressional Direction • Other Federal Departments/Agencies (i.e. HHS, DHS, DoD) End Goal: FDA approved, safe, effective, militarily relevant, affordable, and sustainable fielded product. UNCLASSIFIED 10

Governing Processes Integration of DoD 5000 and FDA Regulation Process Program MDD A B C Initiation ICD ICD CDD CPD Materiel Tech Eng & Production & Operations & Research Solution Maturation & Manufacturing Deployment Support Analysis Risk Reduction Development DoD Acquisition TRL 1 - 4 TRL 5 - 6 TRL 7 TRL 8 TRL 9 Proof of Preclinical Clinical Marketing & Discovery Concept Sustainment Testing Testing Production Clinical FDA Regulated Development TRL = Technology Marketing FDA IND/IDE Readiness Levels Application Approval “Translate Research Into Products” UNCLASSIFIED 11

Integrated Product Teams IPTs are critical because broad expertise is needed to develop and field medical products Other Regulatory Service Contracting Reps Medical Logistics Advisor/ SME IPT Chair/ ORTA Co- Legal Chair Clinical Combat Operations Developer/ Product User Tech Quality Operations Mgmt UNCLASSIFIED 12

USAMRMC’s Medical Product Portfolio Where Our Products Touch the Lives of Warfighters Prevention Diagnose and Treat Rehabilitate & Restore UNCLASSIFIED 13

USAMRMC Materiel Development Portfolio A B C MDD Technology Engineering & FRP Materiel Production & Maturation Manufacturing Operations & Support Deployment Solution Analysis and Risk Reduction Development • Bacteriophage Treatment for • Alternate Dengue Vaccine • Anti-Malarial IV • Environmental • Adenovirus Vaccine (DHP Bacterial Infections Artesunate Sentinel funding) • Anti-Plaque Chewing Gum • Intra-Compartmental Pressure • Carbon Dioxide Biomonitor • Bacterial Diarrhea • Burn Resuscitation Decision Relief Generator Vaccine(s) • Noise Immune Support System – Mobile • Drug Treatment for Post- • Cryopreserved Platelets • Burn Treatment Skin Repair Stethoscope • Leishmania Rapid Diagnostic Traumatic Stress Disorder • Dengue Tetravalent • Drug Treatment for TBI Device • Extremity Injury Repair Vaccine • Hemorrhagic Fever w/ Renal • Oxygen Generator Field Portable • Improved Flying Vector Trap • Freeze Dried Plasma Syndrome Vaccine • Steam Sterilizer Field Portable • Intrathoracic Pressure • HIV Vaccine (Regional) • HIV Vaccine (Global) • Rigid Wall & Soft Wall Shelters Regulation Therapy • Lab Assay for TBI • Intracavitary Non- • >214 LINs including ~130 • Next Generation Malaria Drugs Compressible Hemorrhage • Malaria Chemo- Medical Equipment and Medical • Non-invasive Neuro- Control Agent Prophylaxis - Tafenoquine Materiel Sets Assessment Device (TBI) • Malaria Vaccines • Topical Anti-Leishmanial • Prehospital e.g., Combat • Platelet Derived Hemostatic Drug • Next Gen Diagnostic System Medic, Air Ambulance Agent Infectious Disease Assays • Whole Blood Pathogen • Combat Support Hospital • Temporary Corneal Repair Reduction Device • Portable Neuromodulation • Chemical Agent Patient • Transfusion Transmitted Stimulator (PoNS) • Battlefield Pain Decontamination Disease Rapid Diagnostic Management - Sufentanil • Rapid Human Diagnostic • Chemical Agent Patient Device Devices Treatment • Transport Telemedicine Programs supporting other Program Executive Offices (PEO) • Ground Ambulance • Junctional Hemorrhage Control Agent - XSTAT (USAF program - Army support) Programs in purple: = • Air Ambulance • Deployable Oxygen Generator System-Small (USAF program - Army support) Army executing DHP • JBAIDS Special Materiel • Improved First Aid Kit (PEO Soldier) funds; Milestone • Entomology, Field • Maxx PRO Plus Ambulance Litter Lift System (PEO CS&CSS) Decision Authority is • Armored Multipurpose Vehicle Ambulance &Treatment Mission Essential Packages (PEO GCS) • Water Quality Analysis the Defense Health • Remote Physiological Status Monitor (PEO Soldier) • CSH 44-Bed Water Distribution Agency Component • Solider Optimization Decision Aids (PEO Soldier) Acquisition Executive and Wastewater Management UNCLASSIFIED 14

Considerations in Development Planning • Begin with the end in mind • Understand the Army need • “Good enough” now is better than perfect later • Avoid losing focus on what is really important • Regulatory strategy • Early research decisions can have significant impact on future regulatory strategies • Focus on the target indication can avoid unnecessary money and time spent on studies not aligned to end goal • Financial planning • DoD funding process starts years in advance of transition • We have already built the Army FY19-23 financial plan and are building the DHP FY19-23 financial plan now • Requirements documents • It takes time to identify and develop the necessary requirements documents • Development and staffing of requirements documents can take 1-2 years – must be done in advance of acquisition decisions • Execution vehicles • Well planned research and development contracts with appropriate options can take ~12-18 months (depending on value) UNCLASSIFIED 15