DH 3. Working with the US Military Medical Community

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1 Working with the US Military Medical Community Presented for Vancouver Mr. Dave Hood MS, MBA, PMP {Former Senior Advisor to Principal Assistant for Acquisition USAMRMC Former Co-Founder and President of IMS (Co-inventor of Product Line)} President and CEO, DH3 & Associates , 03 March

2 DH3 & Associates Key Personnel Dave D Hood MS, MBA, PMP Dave D Hood is President of DH3 & Associates, a consulting company focusing on performing technology assessments and developing strategies for product development, business development, program management,regulatory strategy and sales. Specializing on medical products for the time critical functions and procedures throughout the continuum from point of injury through patient stabilization including the ER, OR, and ICU environments. Emphasizing the pursuit and capture of non-dilutive funding coupled with institutional and strategic investors. For more than five years, Mr. Hood also served as a Senior Advisor for the Principal Assistant for Acquisitions at the US Army Medical Research and Material Command. Prior to founding DH3 & Associates, Mr Hood was the Co-Founder and President of Integrated Medical Systems where he was also co-inventor of the company s core product line. Prior to being selected to guide this successful spin-out from Northrop Grumman, he served as a Senior Program Manger successfully guiding the development and deployment of various integrated sensor systems for high performance aircraft, missiles, and satellites including the stealth bomber and the Global Positioning Satellites (GPS). He also guided successful projects pioneering intelligent transportation systems and high performance fuel efficient, environmentally friendly engines and brake systems for automobiles and motorcycles. Mr. Hood has worked with the US Congress and European governments to sponsor funding for innovative medical products. He holds 3 patents and has been the stimulus for more than 2 dozen. He has published and presented extensively in the US and Europe. He taught graduate school courses in Project Management, Business Management, Operations Management and Entrepreneurship. He is a certified Project Management Professional and has received executive training from the University of Southern California and the Massachusetts Institute of Technology. He is the former Chairman of the Long Beach Sailing Foundation, a 501c organization that owns a fleet of matched sailboats used for team building experiences as well as amateur and professional racing events including the Congressional Cup. He is the former Head Coach for a club softball team that provided inner city and disadvantaged teenage girls an opportunity to learn the fundamentals of teamwork and sportsmanship. 2

3 Why Why consider working with the US military medical community? Non-dilutive R&D funding Validation, Credibility, Value added technical input Early adopters Significant sales 3

4 Why In recent years the military medical community has invested nearly $2B annually in R&D for combat casualty care, infectious disease, operational medicine, bio/chem medical countermeasures, and clinical rehabilitation. In addition, they have looked at many areas that affect veterans such as cancer, psychological health, regenerative medicine, and orthopedic related concerns. Their advanced technology area has also looked at telemedicine, health IT, and robotics. 4

5 Agenda US Military Medical Community Interests US Military Medical Community How do They Work Research & Development Life Cycle Technology Readiness Levels US Military Medical Community How should YOU work with Them Summary 5

6 Eligibility Eligible organizations include for-profit, nonprofit, public, and private organizations, such as universities, colleges, hospitals, laboratories, and companies. Eligible Investigators Includes all individuals, regardless of ethnicity, nationality, or citizenship status, who are employed by, or affiliated with, an eligible organization. Investigators must meet the specific Program Announcement/Funding Opportunity requirements. Non-domestic (non-u.s.) Entities (Foreign Organizations) The US Army Medical Research and Materiel Command (USAMRMC) uses the Excluded Parties List System (EPLS) to exclude recipients ineligible to receive Federal awards. The EPLS is online at Federal Awardee Performance and Integrity Information System (FAPIIS) to verify that a recipient is not ineligible to receive Federal awards. The FAPIIS is online at Dun & Bradstreet Universal Numbering System (DUNS) Number and Central Contractor Registration (CCR) Meet certain minimum standards pertaining to institutional support, financial resources, prior record of performance, integrity, organization, experience, operational controls, facilities and conformance with safety and environmental statutes and regulations (OMB Circulars at 6

7 Military Medical Community Objective Efficiently deploy needed medical capability to support the war fighter, his family and our veterans. 7

8 USAMRMC Tech Base Core Programs Military Infectious Diseases Research Program (ID) Combat Casualty Care Research Program (CCC) Hemostasis Resuscitation Blast Dental Vaccines Drugs Diagnostics Military Operational Medicine Research Program (MOM) Medical Chemical and Biological Defense Research Program (Chem/Bio) Nutrition Biodynamics Environmental Stressors/hazards Vaccines Drugs 8 Diagnostics

9 MRMC https://mrmc-www.army.mil/index.cfm?pageid=medical_r_and_d.overview 9

10 Combat Casualty Care https://mrmc-www.army.mil/index.cfm?pageid=medical_r_and_d.ccc.overview 10

11 Combat Casualty Care https://ccc.amedd.army.mil/ 11

12 Institute of Surgical Research 12

13 Infectious Diseases https://mrmc-www.army.mil/index.cfm?pageid=medical_r_and_d.midrp.overview 13

14 Infectious Diseases https://midrp.amedd.army.mil/ 14

15 USAMRIID 15

16 Operational Medicine 16

17 Medical Chemical Biological Defense Research https://mrmc-www.army.mil/index.cfm?pageid=medical_r_and_d.medchembio.overview 17

18 Chem Bio Defense Partnership Support Directorate 18

19 Defense Threats Reduction Area 19

20 Defense Threat Reduction Agency 20

21 DTRA Topics of Interest DIAGNOSTICS, DETECTION AND DISEASE SURVEILLANCE DIVISION Diagnosis of Antimicrobial Resistance Markers (AMR) and Multidrug Resistance (MDR) Sample to Sequence (S2S) Next Generation Analytic Capabilities for BSV New and Unique Data Sources for BSV BSVE Data Challenge Micro Gas Analyzer Integration TRANSLATIONAL MEDICINE DIVISION Reinvestigating, reformulating, and/or repurposing antimicrobial drugs or leads: Development of improved dosing, drug delivery, or combination therapy to counter biothreats Targeting Mechanisms of Antimicrobial Resistance (AMR) in Bacillus anthracis, Yersinia pestis, Francisella tularensis and Burkholderia pseudomallei Discovery and development of antitoxin against botulinum neurotoxin Q Fever Clinical Immunology and Vaccine Development Closing the Immunity Onset Gap: Urgent Pre-Exposure, and Post-Exposure Prophylaxis with Single Dose, Rapidly Protective Vaccines in Unvaccinated Warfighters Pre-Exposure or Post-Exposure Immuno-Prophylaxis Against Aerosol Exposure to Bacterial or Viral Threat Agents 21

22 BARDA Strategic Plan 22

23 BARDA Program Divisions 23

24 BARDA BAAs 24

25 BARDA Industry Day 25

26 Clinical Rehabilitative Medicine https://crmrp.amedd.army.mil/ 26

27 Clinical and Rehabilitative Medicine https://crmrp.amedd.army.mil/ 27

28 Health Information Technology 28

29 Regenerative Medicine 29

30 Blast Injury 30

31 Core Medical R&T Supporting Laboratories USAISR U.S. Army Institute of Surgical Research USAARL U.S. Army Aeromedical Research Laboratory USARIEM U.S. Army Research Institute of Environmental Medicine Combat Casualty Care 18.3% Military Infectious Diseases 23.6% Military Operational Medicine 17.1% Medical Chemical Defense 15.5% Medical Biological Defense 25.5% USAMRIID U.S. Army Medical Research Institute of Infectious Diseases U.S. Army Medical Research Unit - Nairobi, Kenya Armed Forces Res Inst of Med Sci, Bangkok, Thailand US Army Medical Research Unit, Heidelberg, Germany US Army Dental and Trauma Research Detachment US Army Medical Research Detachment WRAIR Walter Reed Army Institute of Research USAMRICD U.S. Army Medical Research Institute of Chemical Defense US Army Center for Env Health Med 31

32 CONUS-Based Organizations USADTRD WRAIR Detachment Great Lakes, IL Military Dental Research USAMRD WRAIR Detachment Brooks City-Base, TX Laser Bioeffects USAISR* Fort Sam Houston, TX Combat Casualty Care Burn Trauma USAMITC San Antonio, TX Information Systems USAMRICD APG, MD Medical Chemical Defense USAARL* Fort Rucker, AL Objective Force Safety and Survivability WRAIR* Silver Spring, MD Infectious Diseases Combat Stress Chem/Bio USAHFPA Falls Church, VA Health Care Facility Planning USARIEM* Natick, MA Nutrition and Environmental Injury Prevention HQ,USAMRMC Fort Detrick, MD USAMMA* Medical Materiel Life Cycle Management USAMMDA* Advanced Medical Materiel Development USAMRAA* Contract Support USAMRIID* Medical Biological Defense USACEHR* USAMRICD Detachment Environmental Health Res. 32

33 Department of Defense Congressionally Directed Medical Research Programs Website 33 US Army Medical Research and Materiel Command

34 Department of Defense Congressionally Directed Medical Research Programs CDMRP Funding History 34 US Army Medical Research and Materiel Command

35 Department of Defense Congressionally Directed Medical Research Programs Areas of Interest 35 US Army Medical Research and Materiel Command

36 Department of Defense Congressionally Directed Medical Research Programs How Often Do You Win? 36 US Army Medical Research and Materiel Command

37 Department of Defense Congressionally Directed Medical Research Programs How Often Do You Win? 37 US Army Medical Research and Materiel Command

38 Department of Defense Congressionally Directed Medical Research Programs Awards to Canada 38 US Army Medical Research and Materiel Command

39 Department of Defense Congressionally Directed Medical Research Programs CDMRP Current Funding Opportunities 39 US Army Medical Research and Materiel Command

40 Department of Defense Congressionally Directed Medical Research Programs CDMRP Current Funding Opportunities 40 US Army Medical Research and Materiel Command

41 TATRC 41

42 TATRC 42

43 TATRC Annual Report 43

44 TATRC Funding History 44

45 Program Announcements/Solicitations 45

46 Program Announcement Information 46

47 DARPA 47

48 Neuroscience 48

49 Biology update 49

50 DARPA MTO 50

51 MRMC Tech Transfer https://technologytransfer.amedd.army.mil/ 51

52 Veterans Affairs 52

53 VA Research 53

54 VA R&D Centers for Innovation 54

55 Pathway to Deploy Products A B Program Initiation C IOC FOC DoD Concept Refinement Technology Development System Development & Demonstration Production & Deployment Operations & Support Procurement OMA Devices Research Concept Planning and Definition Evaluation and Verification Design and Implementation Clinical / User Tests File (PMO Only) Launch Lifecycle Management Concept Decision Product Requirement Milestone A Product Specification Milestone B Product Design Milestone C PMA Filing Full Production Rate IPR PMA Clearance, Launch Post Launch Review Commercial TRL TRL TRL TRL TRL TRL TRL TRL TRL Papers to Patents to Products 55

56 Development Lifecycle - Device Detail DoD Concept Refinement A Technology Development B Program Initiation System Development & Demonstration C IOC Production & Deployment FOC Operations & Support Procurement OMA Devices Research Concept Planning and Definition Evaluation and Verification Design and Implementation Clinical / User Tests File (PMO Only) Launch Lifecycle Management Research Core research / technology options War fighter needs Concept Decision TRL 1 Concept Product options Product requirements TRL 2 Product Requirement TRL 3 Planning and Definition Development strategy Detailed product definition Hardware design Software design Product development plan/functional group schedules Proof of concept system TRL 4 Milestone A Product Specification TRL 5 Design and Implementation Detailed design and layout Software implementation Hardware/software integration Verification/Validation and Test design and generation Pre-clinical testing Product/process validation and verification Transfer to manufacturing Build evaluation/clinical units System prototype I Initiate Intellectual Property Commercial TRL 6 Milestone B Product Design TRL 7 Milestone C PMA Filing Full Production Rate IPR Clinical / User Tests File System integration / design readiness review User acceptance tests 510K Clearance Clinical strategy and trial design and conduct Recruitment Data collection and analysis PMA/Regulatory submission compilation Logistics planning Environmental testing System prototype II Complete PMA Obtain FDA clearance IOT&E TRL 8 PMA Clearance, Launch Launch Market release Ramp to volume Post Launch Review Lifecycle Mgmt Maintenance Track/report adverse events Database for next generation improvements Post-marketing studies 56 TRL 9

57 Development Lifecycle - Overview A B Program Initiation C IOC = Initial Operational Capability FOC = Full Operational Capability IOC FOC DoD Concept Refinement Technology Development System Development & Demonstration Production & Deployment Operations & Support Pharmaceutical Procurement OMA Discovery Preclinical Phase I Phase II Phase III File Launch LCM Candidate* Selection Milestone A** First in Human Project Scope Milestone B Proof of Concept*** Commit to Phase III Milestone C NDA/BLA filing NDA/BLA Approval, Launch Post launch review * Based on agreed development plan and back-up strategy, multiple candidates may move through the development process. ** First in Human decision should occur after the FDA pre-ind meeting if being conducted. Not all projects will have a pre-ind meeting. ** If First in Human (FIH) is a small trial, a Milestone A may occur after positive results are obtained to understand if there is a potential materiel solution to a known threat. In this situation, a FIH mtg. with the CG will still be required. *** Proof of Concept occurs when evidence of safety and efficacy provide sufficient confidence to invest in larger studies. This typically falls between Phase IIa and IIb but varies by product 57 Products Lifecycle Gate will be applied to: Drugs and Vaccines Core Programs and Congressional Programs 57

58 Development Lifecycle Vaccine Detail DoD Concept Refinement Project Scope Technology Development Program Initiation A B C System Development & Demonstration IOC Production & Deployment FOC Operations & Support Vaccine Disease requirements Approach Definition Candidate Discovery Candidate Optimization Preclinical Phase I Phase II Phase III File Lifecycle Launch Management Product Requirements Disease Requirements Define product requirements Characterize pathogen (isolate virus, sequence gene/protein, identify factors of virulence) Begin field site development Epidemiology, (study natural immunity, fatality rates, endemic population, prevalence, impacts, size of trials) 58 Vaccine Approach Approach Definition Define correlates of immunity List vaccine platform options Search literature for current vaccine platforms Assess MRMC resources and business risk:reward of approaches Evaluate commercial viability Determine vaccine platform Candidate Discovery Identify candidate vaccine component Understand candidate vaccine components physical and biological properties Identify animal/ simulation models Develop correlates of immunity Candidate Downselect Candidate Optimization Develop assays Assess activity with all targets Optimize vaccine/ adjuvant structure Animal model developed for safety, delivery immunogenicity Challenge model availability Antigen:feasibility of construction Interface of vaccine components Refine correlates of immunity and surrogate / biomarkers Candidate Selection Milestone A First in Human Preclinical Toxicology Immunogenicity Plan clinical studies Dosing ranges Formulation, stability, manufacturing, labeling, packaging Prepare clinical supplies Test/release clinical supplies IND/CTA Commercial Phase I Small dose healthy volunteers Monitor: Adverse event (AE) Toxicology Determine safety and dose ranges for future trials (intervals, amounts) Milestone B Proof of Concept Phase III Phase II Variable dosages target volunteers Monitor: Safety Immunogen -icity Dosage Determine Dose and frequency Whether to proceed Perform challenge studies Milestone C NDA/BLA filing Phase III Many sites Large and diverse patient population Monitor: Safety Immunogenicity Compare to marketed products Determine: Labeling BLA Approval, Launch File Complete BLA Obtain FDA approval Launch Launch product production Post Launch Review Lifecycle Management Phase IV studies to consider product safety and efficacy of product in active use TRL TRL TRL TRL TRL TRL TRL TRL TRL

59 WHERE AND WHEN CAN YOU PLAY Prototype A B Program Initiation C IOC FOC DoD Concept Refinement Technology Development System Development & Demonstration Production & Deployment Operations & Support Procurement OMA Pharmaceutical Discovery Preclinical Phase I Phase II Phase III File Launch LCM Technology Candidate* Selection Milestone A** First in human Compound T&E Milestone B Proof of Concept CRO Commit to Phase III Milestone C NDA/BLA filing NDA/BLA Approval, Launch Continual Market Survey & Analysis Leverage Other People s Money (NIH, Gates, Commercial) R&D Investment based upon need or Congressional dynamics Go to war focus of core program versus Congressional Special Interest 59 Post launch review End Product

60 Technology Readiness Levels (TRLs) TRL 1 NASA/DoD R TRL Definition: Basic principles observed and reported. NASA/DoD R TRL Description Lowest level of technology readiness. Scientific research begins to be translated into technology s basic properties. USAMRMC Equivalent TRL Descriptions Pharmaceutical (Drugs) Pharmaceutical (Biologics, Vaccines) Medical Devices 3 Lowest level of technology readiness. Maintenance of scientific awareness and generation of scientific and bioengineering knowledge base. Scientific findings are reviewed and assessed as a foundation for characterizing new technologies. TRL 1 DECISION CRITERION: Scientific literature reviews and initial Market Surveys are initiated and assessed. Potential scientific application to defined problems is articulated. Medical IM/IT & Medical Informatics HW/SW System technology explored. Basic theories applied to IM/IT field suggesting promise. TRL 1 DECISION CRITERION: Identification of the potential medical solution to mission need. Medical Informatics data and knowledge representation issues are defined. TRL 2 NASA/DoD R TRL Definition: Technology concept and/or application formulated. NASA/DoD R TRL Description Invention begins. Once basic principles are observed, practical applications can be invented. The application is speculative and there is no proof or detailed analysis to support the assumption. Examples are still limited to paper studies. USAMRMC Equivalent TRL Descriptions Pharmaceutical (Drugs) Pharmaceutical (Biologics, Vaccines) Medical Devices 3 Intense intellectual focus on the problem with generation of scientific paper studies that review and generate research ideas, hypothesis, and experimental designs for addressing the related scientific issues. TRL 2 DECISION CRITERION: Hypothesis(es) is generated. Research plans and/or protocols are developed, peer reviewed, and approved. Medical IM/IT & Medical Informatics HW/SW Systems invention begins. Overall system concepts are documented by flowcharting or other system descriptive techniques. TRL 2 DECISION CRITERION: Medical Informatics data and knowledge representation schema are defined. 60

61 Biomedical TRLs TRL 3 NASA/DoD R TRL Definition: Analytical and experimental critical function and/or characteristic proof-of-concept. NASA/DoD R TRL Description USAMRMC Equivalent TRL Descriptions Pharmaceutical (Drugs) Pharmaceutical (Biologics, Vaccines) Medical Devices 3 Medical IM/IT & Medical Informatics Active research and development is initiated. This includes analytical studies and laboratory studies to physically validate analytical predictions of separate elements of the technology. Examples include components that are not yet integrated or representative. Basic research, data collection, and analysis begin in order to test hypothesis, explore alternative concepts, and identify and evaluate technologies supporting drug development. Initial synthesis of countermeasure candidate(s) and identification of their sites and mechanisms of action. Initial characterization of candidates in preclinical studies. Basic research, data collection, and analysis begin in order to test hypothesis, explore alternative concepts, and identify and evaluate critical technologies and components supporting candidate biologic/vaccine constructs research and eventual development of a candidate countermeasure. Agent challenge studies are conducted to support models based on presumed battlefield conditions. Researchscale process initiation and evaluation conducted, as are studies to identify site(s) and mechanism(s) of action, potential correlates of protection for vaccines, and initial physical/chemical characterization of constructs. Basic research, data collection, and analysis begin in order to test hypothesis, explore alternative concepts, and identify and evaluate component technologies. Initial tests of design concept, and evaluation of candidate(s). Study endpoints defined. Animal models (if any) are proposed. Design verification, critical component specifications, and tests (if a system component, or necessary for device T&E) developed. Separate elements of HW/SW System components are investigated and developed but not yet integrated or representative. TRL 3 DECISION CRITERION: Initial proof-of-concept for candidate drug constructs is demonstrated in a limited number of in vitro and in vivo research models. TRL 3 DECISION CRITERION: Initial proof-of-concept for biologic/vaccine constructs is demonstrated in a limited number of in vitro and in vivo research models. TRL 3 DECISION CRITERION: Initial proof-of-concept for device candidates is demonstrated in a limited number of laboratory models (may include animal studies). TRL 3 DECISION CRITERION: Medical Informatics data and knowledge representation schema are modeled. 61

62 Biomedical TRLs TRL 4 NASA/DoD R TRL Definition: Component and/or breadboard validation in laboratory environment. USAMRMC Equivalent TRL Descriptions NASA/DoD R TRL Description Pharmaceutical (Drugs) Pharmaceutical (Biologics, Vaccines) Medical Devices 3 Medical IM/IT & Medical Informatics Basic technological components are integrated to establish that the pieces will work together. This is relatively low fidelity compared to the eventual system. Examples include integration of ad hoc hardware in a laboratory. Non-GLP laboratory research to refine hypothesis and identify relevant parametric data required for technological assessment in a rigorous (worst case) experimental design. Exploratory study of candidate drugs (e.g., formulation, route(s) of administration, method of synthesis, physical/chemical properties, metabolic fate and excretion or elimination, and dose ranging). Candidate drugs are evaluated in animal model(s) to identify and assess potential safety and toxicity problems, adverse events, and side effects. Assays to be used during nonclinical and clinical studies in evaluating candidate drugs are identified. Laboratory research (non-glp) to refine hypothesis and identify relevant parametric data required for technological assessment in a rigorous (worst case) experimental design. Exploratory study of critical technologies for effective integration into candidate biologic/vaccine constructs, for example, environmental milieu (ph, adjuvant, stabilizers and preservatives, buffers, etc.), route(s)/methods of administration, proposed production/ purification methods, further physical/chemical characterization, metabolic fate and excretion or elimination, dose ranging, and agent challenge studies for protection. Candidate biologic/vaccine constructs are evaluated in animal model(s) to identify and assess safety and toxicity, biological effects, adverse effects, and side effects. Assays, surrogate markers, and endpoints to be used during nonclinical and clinical studies to evaluate and characterize candidate biologic/vaccine constructs are identified. Non-GLP laboratory research to refine hypothesis and identify relevant parametric data required for technological assessment in a rigorous (worst case) experimental design. Exploratory study of candidate device(s)/systems (e.g., initial specification of device, system, and subsystems). Candidate devices/systems are evaluated in laboratory and/or animal models to identify and assess potential safety problems, adverse events, and side effects. Procedures and methods to be used during nonclinical and clinical studies in evaluating candidate devices/systems are identified. The design history file, design review, and when required a master device record, are initiated to support either a 510(k) or PMA. Prototype produced. HW/SW System components are integrated to establish that the pieces will work together. This is relatively low fidelity compared to the eventual system. TRL 4 DECISION CRITERION: Proof-of-concept and safety of candidate drug formulation(s) demonstrated in defined laboratory/animal model(s). TRL 4 DECISION CRITERION Proof-of-concept and safety of candidate biologic/vaccine constructs demonstrated in defined laboratory/animal model(s). TRL 4 DECISION CRITERION Proof-of-concept and safety of candidate devices/systems demonstrated in defined laboratory/animal models. TRL 4 DECISION CRITERION: Medical Informatics data and knowledge representation models are instantiated with representative data or knowledge from applicable domain. 62

63 Biomedical TRLs TRL 5 NASA/DoD R TRL Definition: Component and/or breadboard validation in a relevant environment. USAMRMC Equivalent TRL Descriptions NASA/DoD R TRL Description Pharmaceutical (Drugs) Pharmaceutical (Biologics, Vaccines) Medical Devices 3 Medical IM/IT & Medical Informatics Fidelity of breadboard technology increases significantly. The basic technological components are integrated with reasonably realistic supporting elements so that the technology can be tested in a simulated environment. Examples include high fidelity laboratory integration of components. Intense period of nonclinical and preclinical research studies involving parametric data collection and analysis in well-defined systems with pilot lots of candidate pharmaceuticals produced and further development of selected candidate(s). Results of research with pilot lots provide basis for a manufacturing process amenable to cgmp-compliant pilot lot production. Conduct GLP safety and toxicity studies in animal model systems. Identify endpoints of clinical efficacy or its surrogate. Conduct studies to evaluate the pharmacokinetics and pharmacodynamics of candidate drugs. Stability studies initiated. Intense period of nonclinical and preclinical research studies involving parametric data collection and analysis in well-defined systems with pilot lots of candidate biologics/ vaccines produced and further development of selected candidates. Research results support proposing a potency assay, proposing a manufacturing process amenable to cgmp-compliant pilot lot production, identifying and demonstrating proof-of-concept for a surrogate efficacy marker in an animal model(s) applicable to predicting protective immunity in humans, and demonstrating preliminary safety and efficacy against an aerosol challenge in a relevant animal model. Conduct GLP safety and toxicity studies in animal model systems. Identify endpoints of clinical efficacy or its surrogate in animal models that may be applicable to predicting protective immunity in humans. Conduct studies to evaluate immunogenicity, as well as pharmacokinetics and pharmacodynamics when appropriate. Stability studies initiated. Further development of selected candidate(s). Devices compared to existing modalities and indications for use and equivalency demonstrated in model systems. Examples include devices tested through simulation, in tissue or organ models, or animal models if required. All component suppliers/vendors are identified and qualified; vendors for critical components audited for cgmp/qsr compliance. Component tests, component drawings, design history file, design review, and any master device record verified. Product Development Plan drafted. Pre-IDE meeting held with CDRH for proposed Class III devices, and the IDE is prepared and submitted to CDRH. For a 510(k), determine substantially equivalent devices and their classification, validate functioning model, ensure initial testing is complete, and validate data and readiness for cgmp inspection. First technical test of prototype. HW/SW System components are integrated and realistic supporting elements are employed so that the system can be tested in a simulated environment. Actual interfaces to supporting systems are specified and development begins. TRL 5 DECISION CRITERION: A decision point is reached at which it is determined that sufficient data on the candidate drug exist in the draft technical data package to justify proceeding with preparation of an IND application. TRL 5 DECISION CRITERION: A decision point is reached at which it is determined that sufficient data on the candidate biologic/vaccine exist in the draft technical data package to justify proceeding with preparation of an IND application. TRL 5 DECISION CRITERION: IDE review by CDRH results in determination that the investigation may begin. For a 510(k), preliminary findings suggest the device will be substantially equivalent to a predicate device. TRL 5 DECISION CRITERION: Medical Informatics data and knowledge representation models are implemented as data and/or knowledge management systems and tested in a lab environment. 63

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