DH 3. Working with the US Military Medical Community
|
|
- Roy Francis
- 8 years ago
- Views:
Transcription
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 9
10 Combat Casualty Care 10
11 Combat Casualty Care 11
12 Institute of Surgical Research 12
13 Infectious Diseases 13
14 Infectious Diseases 14
15 USAMRIID 15
16 Operational Medicine 16
17 Medical Chemical Biological Defense Research 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 26
27 Clinical and Rehabilitative Medicine 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 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
CTC Technology Readiness Levels
CTC Technology Readiness Levels Readiness: Software Development (Adapted from CECOM s Software Technology Readiness Levels) Level 1: Basic principles observed and reported. Lowest level of software readiness.
More informationNew Significant Funding Opportunity for Mesothelioma Research Investigators DOD Peer Reviewed Medical Research Program
New Significant Funding Opportunity for Mesothelioma Research Investigators DOD Peer Reviewed Medical Research Program The Mesothelioma Applied Research Foundation () is pleased to provide background information
More informationOverview of Drug Development: the Regulatory Process
Overview of Drug Development: the Regulatory Process Roger D. Nolan, PhD Director, Project Operations Calvert Research Institute November, 2006 Adapted from course taught by Cato Research Background: Roger
More informationexactly. The need for efficiency in developing effective new therapeutics has never been greater.
exactly. The need for efficiency in developing effective new therapeutics has never been greater. As demands on the global healthcare system increase and treating disease becomes more complex, the research,
More informationCHEMICAL AND BIOLOGICAL DEFENSE PROGRAM 15.C Small Business Technology Transfer (STTR) Proposal Submission Instructions
CHEMICAL AND BIOLOGICAL DEFENSE PROGRAM 15.C Small Business Technology Transfer (STTR) Proposal Submission Instructions The approved FY15.C topic included in the Chemical and Biological Defense (CBD) Small
More informationBIOTECHNOLOGY OPERATIONS
BIOTECHNOLOGY OPERATIONS Principles and Practices Michael J. Roy TECHNISCHE INFORMATION SBIBLIOTHEK UNIVERSITATSBIBLIOTHEK HANNOVER CRC Press TaylorStFrancis Croup Boca Raton London New York CRC Press
More informationDiagnostic Tests. Brad Spring Director, Regulatory Affairs
Regulatory Challenges in the Development of Diagnostic Tests Industry Perspective Brad Spring Director, Regulatory Affairs September 28, 2011 Balancing Evidence of Safety & Effectiveness and Time to Market
More informationGuidance for Industry
Guidance for Industry Codevelopment of Two or More New Investigational Drugs for Use in Combination U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation
More informationAchieving Regulatory Success: Areas of focus for biotechnology companies. Michael J. Schlosser, PhD, DABT April 21, 2013
Achieving Regulatory Success: Areas of focus for biotechnology companies Michael J. Schlosser, PhD, DABT April 21, 2013 Regulatory Success Outline Regulatory Initiatives Regulatory Science Pre-Regulatory
More informationPOLICY AND PROCEDURES OFFICE OF NEW DRUGS. Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics.
POLICY AND PROCEDURES OFFICE OF NEW DRUGS Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics Table of Contents PURPOSE...1 BACKGROUND...2 POLICY...3 ROLES AND RESPONSIBILITIES...4
More informationJ D R F R E Q U E S T S E X P R E S S I O N S O F I N T E R E S T F O R : C O M B I N AT I O N T H E R AP I E S I N T Y P E 1 D I A B E T E S
J D R F R E Q U E S T S E X P R E S S I O N S O F I N T E R E S T F O R : C O M B I N AT I O N T H E R AP I E S I N T Y P E 1 D I A B E T E S PURPOSE JDRF, the world s leading non-profit organization with
More informationOverview of Phase 1 Oncology Trials of Biologic Therapeutics
Overview of Phase 1 Oncology Trials of Biologic Therapeutics Susan Jerian, MD ONCORD, Inc. February 28, 2008 February 28, 2008 Phase 1 1 Assumptions and Ground Rules The goal is regulatory approval of
More informationThe Application Readiness Level Metric
The Application Readiness Level Metric NASA Application Readiness Levels (ARLs) The NASA Applied Sciences Program has instituted a nine-step Application Readiness Level (ARL) index to track and manage
More informationNot All Clinical Trials Are Created Equal Understanding the Different Phases
Not All Clinical Trials Are Created Equal Understanding the Different Phases This chapter will help you understand the differences between the various clinical trial phases and how these differences impact
More informationFormal FDA Meeting Request: Guidance and Template
Formal FDA Meeting Request: Guidance and Template ICTR Navigators July 23, 2011 Version 2.0 Page 1 of 20 1.0 Table of Contents Section Page 1.0 Table of Contents 2 2.0 Abbreviations 2 3.0 FDA Regulations
More informationFAST TRACK DEVELOPMENT OF EBOLA VACCINES: FDA REGULATORY PERSPECTIVE
FAST TRACK DEVELOPMENT OF EBOLA VACCINES: FDA REGULATORY PERSPECTIVE Marion Gruber, Ph.D. Director Office of Vaccines Research & Review Center for Biologics Evaluation and Research US Food and Drug Administration
More informationThe Clinical Trials Process an educated patient s guide
The Clinical Trials Process an educated patient s guide Gwen L. Nichols, MD Site Head, Oncology Roche TCRC, Translational and Clinical Research Center New York DISCLAIMER I am an employee of Hoffmann-
More informationDoing Business with USAMRMC
Doing Business with USAMRMC Laurie E. Hovermale US Army Medical Research Acquisition Activity (USAMRAA) US Army Medical Research and Materiel Command 23 March 2015 UNCLASSIFIED Cheryl Miles US Army Medical
More informationCareers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA
PharmaSUG 2014 Paper CP07 Careers in Biostatistics and Clinical SAS Programming An Overview for the Uninitiated Justina M. Flavin, Independent Consultant, San Diego, CA ABSTRACT In the biopharmaceutical
More informationRegulatory Pathways for Licensure and Use of Ebola Virus Vaccines During the Current Outbreak FDA Perspective
Regulatory Pathways for Licensure and Use of Ebola Virus Vaccines During the Current Outbreak FDA Perspective Office of Vaccines Research and Review Center for Biologics Evaluation and Research U.S. Food
More informationJ D R F R E Q U E S T S L E T T E R S O F I N T E N T F O R : B I O M AR K E R S O F P AN C R E A T I C B E T A C E L L S T R E S S AN D H E AL T H
J D R F R E Q U E S T S L E T T E R S O F I N T E N T F O R : B I O M AR K E R S O F P AN C R E A T I C B E T A C E L L S T R E S S AN D H E AL T H PURPOSE JDRF, the world s leading non-profit organization
More informationMovember Clinical Trial Award (CTA)
Movember Clinical Trial Awards Part 1: Overview Participating Organisation (s) Funding Category Description The Movember Foundation and Prostate Cancer Foundation of Australia Movember Clinical Trial Award
More informationPA 14-01: CIRM Accelerated Development Pathway
PA 14-01: CIRM Accelerated Development Pathway I. Purpose Through the Disease Team (Disease Team Research or Therapy Development) and Strategic Partnership Award programs, the California Institute for
More informationQuality by Design Concept
3rd Jerusalem Conference on Quality and Pharma Sciences 6-7 June, 2012 QbD in Clinical Research - Where Can QbD Impact Clinical Research Practices? Dr. Yafit Stark Vice President, TEVA Pharmaceutical Industries,
More informationRare Diseases: Common Issues in Drug Development Guidance for Industry
Rare Diseases: Common Issues in Drug Development Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft
More information298.015) UC 6:30 8:20 PM
Course Description: This course is an in depth review of the history, authorizing statute and regulatory authority of US FDA and the influence and impact of FDA on science and health policy. Drug development,
More informationHealth Solutions. Mission-Critical Support Across the Health Spectrum
Health Solutions Mission-Critical Support Across the Health Spectrum IT Experts Who Know Health, Health Experts Who Know IT Today s healthcare challenges are formidable: an aging population, lack of interoperability
More information2 Divisions, 1 Purpose: Regulatory Support for fielding Medical Products for the Warfighter
2 Divisions, 1 Purpose: Regulatory Support for fielding Medical Products for the Warfighter UNCLASSIFIED LTC Lela C. King; Director (CSSD) Tracy Ulderich; Chief, Regulatory Operations (DRAC) USAMMDA US
More informationZoonotic Disease Symposium US Army Veterinary Service
Zoonotic Disease Symposium US Army Veterinary Service COL Bob E. Walters Director, Department of Defense Veterinary Service Activity 24 September 2010 US Army Veterinary Service FORCE PROTECTION F O O
More informationDepartment of Defense Biological Defense Program Needs for Strategic Biotechnology Development
Department of Defense Biological Defense Program Needs for Strategic Biotechnology Development Anna Johnson-Winegar, Ph.D. Deputy Assistant to the Secretary of Defense for Chemical and Biological Defense
More informationAST Transplantation and Immunology Research Network (TIRN) 2016 Allied Health Professional Research Grant
AST Transplantation and Immunology Research Network (TIRN) 2016 Allied Health Professional Research Grant If you have any questions, please email TIRN@myAST.org. The application deadline is 11:59 pm Pacific
More informationOffice of Acquisitions & Grants Services (OAGS) FDA Small Business Outreach Vendor Fair. February 19, 2014
Office of Acquisitions & Grants Services (OAGS) FDA Small Business Outreach Vendor Fair February 19, 2014 FDA Mission FDA is responsible for: Protecting the public health by assuring that foods are safe,
More informationBrain Health and Fitness Overview
Brain Health and Fitness Overview UNCLASSIFIED CAPT C. Douglas Forcino Director, Military Operational Medicine Research Program Chair, Joint Program Committee 5 for Military Operational Medicine US Army
More informationGeneral Services Administration Federal Supply Service Authorized Federal Supply Schedule Price List
General Services Administration Federal Supply Service Authorized Federal Supply Schedule Price List GSA Schedule 66 Scientific Equipment and Services SIN 66-1000 Professional Scientific Services IHRC,
More informationNon-clinical development of biologics
Aurigon Life Science GmbH Non-clinical development of biologics Requirements, challenges and case studies Committed to Life. Sigrid Messemer vet. med. M4 Seminar March 10 th 2014 Aurigon - your full service
More informationDrug Development Process
Drug Development Process Original Arthur: Addie D. Anderson CRB Consulting Engineers, Inc. Overview Important milestones establishing our current system of regulations Step-by-step overview of the drug
More informationProgram Announcement. Military Burn Research Program
Program Announcement for the Department of Defense Congressionally Directed Medical Research Programs Military Burn Research Program Burn Injuries Research Award Funding Opportunity Number: W81XWH-15-MBRP-BIRA
More informationRegulatory Issues in Genetic Testing and Targeted Drug Development
Regulatory Issues in Genetic Testing and Targeted Drug Development Janet Woodcock, M.D. Deputy Commissioner for Operations Food and Drug Administration October 12, 2006 Genetic and Genomic Tests are Types
More informationNATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997
NATIONAL HEALTH COUNCIL RESOLUTION Nº 251, DATED 7 AUGUST 1997 Plenary of the National Health Council in its 15 th Special Meeting, held on 5 August 1997, in the exercise of its competencies, as set forth
More informationProgram Announcement. Multiple Sclerosis Research Program
Program Announcement for the Department of Defense Defense Health Program Congressionally Directed Medical Research Programs Multiple Sclerosis Research Program Pilot Clinical Trial Award Funding Opportunity
More informationAlberta/Novartis Translational Research Fund Opportunity. Program Guide 2014/2015
OBJECTIVES Program Guide 2014/2015 Alberta Innovates - Health Solutions (AIHS), Novartis Pharmaceuticals Canada Inc. (Novartis), and the Government of Alberta have partnered to create the Alberta/Novartis
More informationCommercial Solutions Opening (CSO) Office of the Secretary of Defense Defense Innovation Unit (Experimental)
SECTION 1 - INTRODUCTION 1.1 Background and Authority Commercial Solutions Opening (CSO) Office of the Secretary of Defense Defense Innovation Unit (Experimental) The 2014 Quadrennial Defense Review (QDR)
More informationGuidance for Industry
Guidance for Industry End-of-Phase 2A Meetings U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) September 2009 Procedural Guidance
More informationEthics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015
Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Clinical Trials at HKU Phase 1 Phase II Phase III Phase IV Conducted on patient
More informationFebruary 2006 Procedural
Guidance for Industry Reports on the Status of Postmarketing Study Commitments Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 U.S. Department of Health and
More informationRE AP QUE PLIC FOR IONS. Compa CPRIT RFA C 12 FORM 2. Company. p.1/17
RE AP QUE ST PLIC AT RFA C 12 FORM 2 FOR IONS Compa any Formation Awards FY 2012 Fiscal Year Award Period September 1, 2011 Augustt 31, 2012 CPRIT RFA C 12 FORM 2 (Rev 6/ /30/11) Company Formation Awards
More informationVertex Investigator-Initiated Studies Program Overview
Vertex Investigator-Initiated Studies Program Overview Our Goal To support independent, investigator-initiated research designed to advance scientific knowledge of disease states, patient populations,
More informationProgram Announcement. Autism Research Program
Program Announcement for the Defense Health Program Department of Defense Congressionally Directed Medical Research Programs Autism Research Program Pilot Award Funding Opportunity Number: W81XWH-13-ARP-PA
More informationPharmacology skills for drug discovery. Why is pharmacology important?
skills for drug discovery Why is pharmacology important?, the science underlying the interaction between chemicals and living systems, emerged as a distinct discipline allied to medicine in the mid-19th
More informationSubject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure
703 1 of 11 POLICY The Beaumont Research Coordinating Center (BRCC) will provide advice to clinical trial investigators on protocol development, content and format. Upon request, the BRCC will review a
More informationDepartment of Defense INSTRUCTION
Department of Defense INSTRUCTION NUMBER 6200.02 February 27, 2008 SUBJECT: Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs USD(P&R) References:
More informationRoles & Responsibilities of the Sponsor
Roles & Responsibilities of the Sponsor Developed by Center for Cancer Research, National Cancer Institute, NIH Endorsed by the CTN SIG Leadership Group Objectives Funding for clinical research comes from
More informationGENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GENERAL CONSIDERATIONS FOR CLINICAL TRIALS E8 Current
More informationCombination Products Regulation in the United States
Combination Products Regulation in the United States Presenter: Scott Sardeson RAC US/EU 3M Health Care St. Paul, MN USA 1 Presentation Outline Combination products Definitions and Regulations Jurisdiction
More informationGuidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products
Guidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation
More informationApply with Resume to: www.rjrt.com Submenu Path Company/Careers/Current Openings/Job Type: Science
Position: Biostatistician Required Experience: At least 5 years This position is responsible for providing broad statistical support in general and biostatistical support specifically, including study
More informationProgram Announcement. Clinical and Rehabilitative Medicine Research Program
Program Announcement for the Department of Defense Congressionally Directed Medical Research Programs Clinical and Rehabilitative Medicine Research Program Vision Prosthesis Pilot Study Award Funding Opportunity
More informationTeam Redstone Small Business
Team Redstone Small Business March 30, 2015 Ms. Pamela Monroe Assistant to the Director, Subcontracting and Mentor Protégé Program Manager Mission Advise the Secretary of the Army and the Army leadership
More informationA Cost Effective Way to De Risk Biomarker Clinical Trials: Early Development Considerations
A Cost Effective Way to De Risk Biomarker Clinical Trials: Early Development Considerations Ce3, Inc. and Insight Genetics, Inc. Oncology Forum July 15, 2015 Agenda Introductions Definitions Regulations
More informationThe Johns Hopkins Hospital and The Johns Hopkins University Health, Safety and Environment Manual Biological Safety:
Page 1 of 7 Keywords: Table of Contents Page Number I. POLICY 1 II. SUMMARY 1 III. REVIEW CYCLE 7 Appendix A: Process for Institutional Review of Life Sciences Research within the Scope of the Click Here
More informationData Standards in Clinical Trials, A Regulatory Perspec9ve
Data Standards in Clinical Trials, A Regulatory Perspec9ve NIH Data Standards Forum: Maximizing Innova8on by Standardizing Mary Ann Slack Center for Drug Evalua9on and Research (CDER) U.S. Food and Drug
More informationGuidance for Industry
Guidance for Industry S9 Nonclinical Evaluation for Anticancer Pharmaceuticals U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center
More informationGuidance for Industry
Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products Center for
More informationProgram Announcement. Multiple Sclerosis Research Program
Program Announcement for the Defense Health Program Defense Medical Research and Development Program Department of Defense Congressionally Directed Medical Research Programs Multiple Sclerosis Research
More informationGeneral Guidelines for Awards Funded by the Department of Defense (DoD)
General Guidelines for Awards Funded by the Department of Defense (DoD) All awards issued by the DoD are subject to the regulatory policies and procedures of the DoD Grant and Agreement Regulations (DODGARs),
More informationOffice of Acquisitions & Grants Services (OAGS) FDA Small Business Outreach Vendor Fair. March 3, 2015
Office of Acquisitions & Grants Services (OAGS) FDA Small Business Outreach Vendor Fair March 3, 2015 Agenda Who we are What we buy Goals and statistics Partnering with OAGS 2 FDA Mission FDA is responsible
More informationGregory Milman National Institute of Allergy and Infectious Diseases gmilman@niaid.nih.gov May 7, 2012
Secrets of NIH Small Business Grant Applications Gregory Milman National Institute of Allergy and Infectious Diseases gmilman@niaid.nih.gov May 7, 2012 Particularly Important Information Is Highlighted
More informationRegulatory Submission: Applying GLP in Surgical Efficacy Studies
Regulatory Submission: Applying GLP in Surgical Efficacy Studies Curtis Schondelmeyer, DVM Director Preclinical Veterinary Services and Efficacy and Surgical Research Services Welcome to Toxikon 2 CONFIDENTIAL
More informationTechnology Program Management Model (TPMM) A Systems-Engineering Approach to Technology Development Program Management
UNCLASSIFIED Technology Program Management Model (TPMM) A Systems-Engineering Approach to Technology Development Program Management 10-26-2006 Mike Ellis TPMM Development Manager Dynetics, Inc. Mike.Ellis@Dynetics.com
More informationGuideline for Industry
Guideline for Industry The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Longterm Treatment of Non-Life- Threatening Conditions ICH-E1A March 1995 GUIDELINE FOR INDUSTRY
More information4.1 Objectives of Clinical Trial Assessment
L1 4.1 Objectives of Clinical Trial Assessment Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office of Clinical
More informationFunding Opportunities
Funding Opportunities Expanding the Boundaries of Health Informatics using AI (HIAI 14): Making Personalized and Participatory Medicine A Reality Saturday November 15 th US Government Small Business Innovative
More informationIssues. Does the academe have as a goal or an obligation, the development of its discoveries for human benefit?
ELLEN PURÉ, Ph.D. Issues Does the academe have as a goal or an obligation, the development of its discoveries for human benefit? Can the academic review process support individual career development in
More informationUS Perspective on the Regulatory Assessment of Benefit-Risk of Vaccines
US Perspective on the Regulatory Assessment of Benefit-Risk of Vaccines Norman W. Baylor Biologics Consulting Group, Inc. 23-25 June 2014 Foundation Merieux Conference Center OUTLINE OF PRESENTATION Introduction
More informationA clinical research organization
A clinical research organization About Us State of art facility. All clinical trials carried out in accordance with ICH GCP guidelines. Quality services within stipulated time period. Team of experienced
More informationFACILITY SAFETY PLAN INSTRUCTIONS
FACILITY SAFETY PLAN INSTRUCTIONS Approval of the Facility Safety Plan is granted on an institution basis rather than on a proposal basis. Facility Safety Plan approvals are granted for a 5-year period
More informationGuidance for Clinical Investigators, Sponsors, and IRBs
Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs Improving Human Subject Protection U.S. Department of Health and Human Services Office of the Commissioner (OC) Center
More informationGuidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes
Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes U.S. Department of Health and Human Services Food and Drug Administration Center
More informationAnnex 7 Guidelines for the preparation of a contract research organization master file
World Health Organization WHO Technical Report Series, No. 957, 2010 Annex 7 Guidelines for the preparation of a contract research organization master file Background 1. General information 2. Quality
More informationDZIF-Product Development Unit (PDU)
November 29, 2013 7 th International VPM Days DZIF-Product Development Unit (PDU) - DZIF-TPMO at HZI - DZIF-OSRA at PEI Thomas Hesterkamp, Helmholtz Zentrum für Infektionsforschung Support from TPMO &
More informationMedical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules?
Medical Device Directive 2007/47/EC What is New? Are we moving towards Drug Rules? CEMO Congress, Paris, February 3rd, 2011 Dr. Martine Dehlinger-Kremer Vice President Global Regulatory Affairs Agenda
More informationICH Topic E 8 General Considerations for Clinical Trials. Step 5 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS (CPMP/ICH/291/95)
European Medicines Agency March 1998 CPMP/ICH/291/95 ICH Topic E 8 General Considerations for Clinical Trials Step 5 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS (CPMP/ICH/291/95) TRANSMISSION
More informationUse of Electronic Health Record Data in Clinical Investigations
Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding
More informationMicromyx. Micromyx. A Microbiology Services Company. Lab Services Research - Consulting -
A Microbiology Services Company Lab Services Research - Consulting - Regulatory Company description is a microbiology services company specializing in antiinfective discovery and development for the pharmaceutical,
More informationA FDA Perspective on Nanomedicine Current Initiatives in the US
A FDA Perspective on Nanomedicine Current Initiatives in the US Carlos Peña, PhD Office of the Commissioner FDA September 3, 2010 Outline Context Nanotechnology Task Force report summary Identification
More informationPDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2013 THROUGH 2017
PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2013 THROUGH 2017 I. REVIEW PERFORMANCE GOALS A. NDA/BLA Submissions and Resubmissions B. Original Efficacy Supplements C. Resubmitted
More informationStrategies to Prepare for Meetings with the FDA. Kim Colangelo Associate Director for Regulatory Affairs Office of New Drugs, CDER, FDA
Strategies to Prepare for Meetings with the FDA Kim Colangelo Associate Director for Regulatory Affairs Office of New Drugs, CDER, FDA Topics for Discussion Who Are We? How Do We Interact Internally? Why
More informationSMALL BUSINESS INNOVATION RESEARCH (SBIR) SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES PHS 2015-2 OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH, CENTERS FOR DISEASE CONTROL AND PREVENTION, FOOD AND DRUG ADMINISTRATION, AND ADMINISTRATION
More informationA leader in the development and application of information technology to prevent and treat disease.
A leader in the development and application of information technology to prevent and treat disease. About MOLECULAR HEALTH Molecular Health was founded in 2004 with the vision of changing healthcare. Today
More informationPRIORITY RESEARCH TOPICS
PRIORITY RESEARCH TOPICS Understanding all the issues associated with antimicrobial resistance is probably impossible, but it is clear that there are a number of key issues about which we need more information.
More informationCLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD
CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD Gwen L. Nichols, M.D., is currently the Oncology Site Head of the Roche Translational Clinical Research Center at Hoffman- LaRoche. In this
More informationApplication Guide. 2015 Global Awards in Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) Research
Application Guide 2015 Global Awards in Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) Research A Competitive Grants Program Supported by Pfizer www.aspireresearch.org Table of Contents THE ASPIRE
More informationCord Blood Licensure. Session 2C: Advanced Cell Therapies April 11, 2013
Cord Blood Licensure Session 2C: Advanced Cell Therapies April 11, 2013 Objectives Describe rationale for cord blood licensure Cite licensure regulations Illustrate a case study of one program s pathway
More informationComparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP
Comparison Chart of FDA and EPA Good Laboratory Practice (GLP) Regulations and the OECD Principles of GLP Document issued on: June 2004 U.S. Department of Health and Human Services Food and Drug Administration
More informationCarolina KickStart Commercialization Award Program
Carolina KickStart Commercialization Award Program Request for Applications Description The Carolina KickStart Commercialization Award Program will provide up to $50K in non-dilutive funding to UNC faculty-led
More informationCall 2014: High throughput screening of therapeutic molecules and rare diseases
Call 2014: High throughput screening of therapeutic molecules and rare diseases The second call High throughput screening of therapeutic molecules and rare diseases launched by the French Foundation for
More informationTERM SHEET EXAMPLE. 1 P age
1 P age TERM SHEET EXAMPLE BIOTECHCO Overview & Business Strategy BIOTECHCO (the licensor), located in North Dakota, has a proprietary technology called ZIP that can generate fully human antibodies with
More informationThe Telemedicine Response to Homeland Safety and Security Developing a National Network for Rapid and Effective Response for Emergency Medical Care
The Telemedicine Response to Homeland Safety and Security Developing a National Network for Rapid and Effective Response for Emergency Medical Care The unprecedented and growing threats to the safety and
More informationCollege of Pharmacy. Pharmacy Practice and Science
520 SPECIAL TOPICS IN PHARMACY LAW. (2) Discussion of the legal framework and special legal issues in pharmacy practice. Topics will include application of antitrust laws to pharmacy, patent and trademark
More information