national institute of allergy and infectious diseases karl a. western, md, dtph asst. director for...
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National Institute of National Institute of Allergy and Infectious Allergy and Infectious
Diseases Diseases
Karl A. Western, MD, DTPHAsst. Director for International Research
Director, Office of Global Affairs
U.S. Department of Health and Human Services
Administration forChildren and Families
(ACF)
Food and DrugAdministration
(FDA)
Health Resourcesand Services
Administration(HRSA)
TheSecretary
Deputy Secretary
Administration onAging(AoA)
Centers for Medicare and
Medicaid Services (CMS)
Indian HealthServices
(IHS)
Centers for Disease Controland Prevention
(CDC)
Substance Abuse andMental Health Services
Administration(SAMHSA)
Program SupportCenter(PSC)
Agency for ToxicSubstances andDisease Registry
(ATSDR)
Agency for Health Care Policy
and Research(AHCPR)
National Institutesof Health
(NIH)
Office of the Director
National Instituteon Alcohol Abuseand Alcoholism
National Instituteof Arthritis andMusculoskeletal
and Skin Diseases
National CancerInstitute
National Instituteof Diabetes andDigestive and
Kidney Diseases
National Instituteof Dental andCraniofacial
Research
National Instituteon Drug Abuse
National Instituteof Environmental Health Sciences
National Instituteon Aging
National Instituteof Child Health
and HumanDevelopment
National Institute onDeafness and Other
CommunicationDisorders
National EyeInstitute
National HumanGenome Research
Institute
National Heart,Lung, and Blood
Institute
National Instituteof Mental Health
National Instituteof NeurologicalDisorders and
Stroke
National Instituteof General
Medical Sciences
National Instituteof Nursing Research
National Libraryof Medicine
Center for InformationTechnology
Center for Scientific Review
National Centerfor Complementary
and AlternativeMedicine
National Instituteof Allergy and
Infectious Diseases
National Centerfor ResearchResources
Clinical Center
National Center on Minority Health andHealth Disparities
National Institute of Biomedical Imagingand Bioengineering
FogartyInternational
Center
National Institutes of Health
NIH fulfills its mission by:NIH fulfills its mission by:NIH fulfills its mission by:NIH fulfills its mission by: INTRAMURAL: Conducting research in its
own laboratories. EXTRAMURAL: Supporting the research of
non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the USA and abroad.
Supporting the training of research investigators.
Fostering communication of medicaland health sciences information.
NIH Roadmap StrategyNIH Roadmap Strategy
Bench Bedside Practice
Building Blocks PathwaysMolecular LibrariesBioinformaticsComputational Biology
TranslationalResearchInitiatives
Clinical ResearchInformatics
Integrated ResearchNetworks
Clinical outcomes
Training
NIH Clinical ResearchAssociates
Interdisciplinary ResearchInnovator Award Nanomedicine
Public PrivatePartnerships
The NIAID MissionThe NIAID Mission
NIAID strives to understand, treat, and ultimately prevent infectious,
immunological, and allergic diseases that threaten hundreds of
millions of people worldwide.
Major Areas of NIAID Major Areas of NIAID InvestigationInvestigation
Acquired Immunodeficiency Syndrome (AIDS)
Asthma and Allergic Diseases Biodefense Emerging Diseases Enteric Diseases Genetics and Transplantation Immunologic Diseases Malaria and Other Tropical Diseases Sexually Transmitted Diseases Vaccine Development
Office of the Director
Board of Scientific Counselors
Office of Global Affairs
Office of Management for New Initiatives
Office of Equal Employment
Opportunities
Office of Clinical Research
Associate Director forManagement & Operations
National Advisory Allergy & Infectious Disease Counselors
Office of Financial
Management
Office ofAdministrative
Services
Office of Ethics
Office ofHuman Resources
Management
Division ofIntramuralResearch
Division ofMicrobiology &
Infectious Diseases
Division ofExtramuralActivities
Office ofPolicy Analysis
Dale & BettyBumpers VaccineResearch Center
Division of Allergy,
Immunology &Transplantation
Office of Technology Information
Systems
NIAID Divisions and Offices (simplified)
Office ofTechnology
Development
Office ofCommunications &
Public Relations
Division of AcquiredImmunodeficiency
Syndrome
Office of Biodefense Research
Guiding Principles of NIAID Global Guiding Principles of NIAID Global Health Research PlanHealth Research Plan
Guiding Principles of NIAID Global Guiding Principles of NIAID Global Health Research PlanHealth Research Plan
Target research efforts to the needs of developing countries
Develop multidisciplinary research programs Build and sustain research capacity in-
country Stimulate scientific collaboration and global,
multi-sector partnerships Develop training, communication and
outreach programs
Intramural- Research Training- Collaboration
Foreign Awards- Investigator Initiated- Clinical/Vaccine Trials
Domestic Awards with Foreign Component- Funding- No Funding
How NIAID Supports How NIAID Supports International Research (1)International Research (1)
Bilateral Programs- Science and Technology- Health
Multilateral Programs- WHO- UNAIDS- European Union
Interagency Agreements- CDC- Army, Navy- USAID- State
How NIAID Supports How NIAID Supports International Research (2)International Research (2)
Research Training- NIAID: Domestic Training- FIC: International Training
International Partnerships Increase Pool of Investigators
- Program Announcements (PAs)- Contracts- Reagents and Repositories
NIAID Strategy to Develop NIAID Strategy to Develop International Programs (1)International Programs (1)
Develop Domestic Multidisciplinary Centers of excellence- Requests for Applications (RFAs)
Develop Linkage Programs- Requests for Applications (RFAs)- Request for Proposals (RFPs)
Direct Support to International Sites- Requests for Applications (RFAs)- Request for Proposals (RFPs)
NIAID Strategy to Develop NIAID Strategy to Develop International Programs (2)International Programs (2)
Intramural Research Training Intramural Research Training and Collaborative Researchand Collaborative Research
Provides opportunities for foreign scientists to train and conduct collaborative research at NIH.
Open to scientists at all career levels. Appointment must be requested by a
senior NIH intramural scientist on behalf of the foreign scientist.
Intramural OpportunitiesIntramural Opportunities
Two paid positions for foreign scientists through the NIH visiting program:
1. Visiting fellow– Open to applicants with a doctoral degree or
equivalent and 5 years or less of research experience
2. Visiting scientist– Open to applicants with a doctoral degree or
equivalent and at least 6 years of research experience
Appointments through NIH senior scientists in same research field as applicant
International Centers for Tropical Disease Research- International Collaboration in Infectious Disease Research- Tropical Medicine Research Centers- Tropical Disease Research Units- Intramural Center for International Disease Research
Tuberculosis Research Unit HIV Vaccine Trials Network, HIV Prevention Trials
Network Multilateral Initiative on Malaria International Training and Research in Emerging
Infectious Diseases Comprehensive international Program for Research on
AIDS (CIPRA)
Major NIAID Programs in Major NIAID Programs in International HealthInternational Health
CIPRACIPRA(Comprehensive International Program of (Comprehensive International Program of
Research on AIDS)Research on AIDS)
CIPRACIPRA(Comprehensive International Program of (Comprehensive International Program of
Research on AIDS)Research on AIDS)
Planning and Organizational (R03): up to $50,000 per year for one or two years
Exploratory/Developmental Research (U01): up to $500,000 per year for up to five years
2 Funding stages:
IRIDIRID(International Research in Infectious Diseases) (1)(International Research in Infectious Diseases) (1)
IRIDIRID(International Research in Infectious Diseases) (1)(International Research in Infectious Diseases) (1)
• Aims– Advance development of local scientific
expertise– Increase collaborative research partnerships at
NIAID international sites– Lead to submission of applications for
independent research funding • Preliminary or pilot studies• Direct funding to investigators who do not
currently have NIAID funded grant awards for research projects
IRIDIRID(International Research in Infectious Diseases) (2)(International Research in Infectious Diseases) (2)
• Topics of interest– Tuberculosis; Malaria; HIV/AIDS; Sexually
transmitted diseases; Diarrheal, respiratory, and enteric diseases; Viral hemorrhagic fevers; Viral encephalitides; Parasitic diseases; and Vector-borne diseases
• Mechanism of support– Up to $50,000 annual direct costs for up to 3
years
NIH Extramural NIH Extramural ProgramProgram
Grant Patron (assistance, encouragement)
Cooperative PartnerAgreement (assistance but substantial program involvement)
Contract Purchaser (procurement)
WORLD CLASS PEER REVIEW SYSTEM
Ideas fromIndividualScientists
NIH receives ~43,000
research project grant
Applications each year
Scientific
Review
Group of ScientistsEvaluate
Scientific Merit
NIHGrantee
s
~30 percent of NIH applications
succeed in gaining research
funding
InstituteNational Advisory
Councils
•Access programs•Approve applications•Public Members•Provide policy advice
PEER REVIEW: PEER REVIEW: Center for Scientific Center for Scientific
ReviewReview• CSR Study Sections are managed by a
Scientific Review Administrator (SRA) who is a professional, usually at the Ph.D. level, whose scientific background is close to the expertise of the study section
• Each CSR standing study section has 12 - 24 members who are primarily from academia
• Generally 60 - 100 applications are reviewed at each study section meeting
Dual Review System for Grant Dual Review System for Grant ApplicationsApplications
Second Level of ReviewCouncil Assesses Quality of SRG Review of Grant
Applications Makes Recommendation to Institute Staff
on Funding Evaluates Program Priorities and
Relevance Advises on Policy
First Level of ReviewScientific Review Group (SRG)
Provides Initial Scientific Merit Review of Grant Applications Rates Applications and Makes
Recommendations for Appropriate Level of Support and Duration of Award
SCIENTIFIC REVIEW SCIENTIFIC REVIEW ADMINISTRATORADMINISTRATOR
• Performing administrative and technical review of applications to ensure completeness and accuracy
• Selecting reviewers based on broad input• Managing study section meetings• Preparing summary statements• Providing any requested information about study
section recommendations to Institutes and National Advisory Councils/Boards
Designated Federal official with overall responsibility
for the review process, including:
REVIEWREVIEW CRITERIACRITERIA
• SIGNIFICANCE: Does the study address an important problem? How will scientific knowledge be advanced?
• APPROACH: Are design and methods well-developed and appropriate? Are problem areas addressed?
• INNOVATION: Are there novel concepts or approaches? Are the aims original and innovative?
• INVESTIGATOR: Is the investigator appropriately trained?
• ENVIRONMENT: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment?
ADDITIONAL ADDITIONAL IMPORTANT IMPORTANT
CONSIDERATIONSCONSIDERATIONS• Research involving human subjects
– Protection from risks– Inclusion of women, minorities, children
• Animal Welfare
• Biohazards
• Data Sharing Plans
• Appropriateness of Budget
RESULTS OF REVIEWRESULTS OF REVIEW
• Unscored (approximately bottom half) or priority score
• Score (generally between 100 and 300)• Percentile ranking (if scored)• Deferral (very rare)• Not Recommended for Further
Consideration (very rare; serious concerns)• Notification of Principal Investigator• Summary Statement
AWARD AWARD DETERMINATIONSDETERMINATIONS
• Scientific merit
• Program considerations, priorities, special initiatives
• Availability of funds
SUMMARY STATEMENTSUMMARY STATEMENT• Study Section Recommendation• Resume and Summary of Discussion (if scored)• Description (Abstract)• Essentially unedited comments of reviewers
– Organized by review criteria
• Administrative notes• Budget Recommendations• Coding for human subjects, animals, gender,
minorities, children• Institute/Center contact information – Program
Director
COMMON PROBLEMSCOMMON PROBLEMS• Lack of new or original ideas• Absence of an acceptable scientific rationale• Lack of experience in the essential methodology• Questionable reasoning in experimental approach• Uncritical approach• Diffuse, superficial, or unfocused research plan• Lack of sufficient experimental detail• Lack of knowledge of published relevant work• Unrealistically large amount of work• Uncertainty concerning future directions
COUNCIL REVIEW AND COUNCIL REVIEW AND FUNDING DECISIONSFUNDING DECISIONS
• Handled by the Institutes and Centers
• Second Level Review by Council– Concurrence with study section– Modification (budget, time)– Deferral for rereview
• Consider IC priorities, national health needs
NIH Internet ResourcesNIH Internet Resources • National Institutes of Health (http://www.nih.gov)
– Office of Extramural Research (http://www.nih.gov/grants/oer.htm)
– Grants Policy (http://www.nih.gov/grants/policy/policy.htm)
• Center for Scientific Review (http://www.csr.nih.gov)
– Referral and Review (http://www.csr.nih.gov/refrev.htm)– Overview of Peer Review Process (http://www.
csr.nih.gov/review/peerrev.htm)
– CSR Study Section Rosters (http://www.csr.nih.gov/committees/rosterindex.asp)
– NIH Peer Review Notes (http://www.csr.nih.gov/prnotes/prnotes.htm)
NIH Research Grants (RO1s)NIH Research Grants (RO1s)
A foreign scientist is eligible to apply
as principal investigator (P.I.) or
co-investigator
to pursue research in any area normally funded by NIH.
NIH Research Grants (RO1s)NIH Research Grants (RO1s)
The foreign P.I. must demonstrate a special opportunity to further health research not readily available in the U.S. Special opportunities include: expertise or access to equipment, resources, or populations not available in the U.S.
Requests for Applications (RFA)Requests for Applications (RFA)
• Announcement describing an institute initiative in a well-defined scientific area
• Invitation to the field to submit research grant applications for a one-time time competition
• Set-aside of funds for a certain number of awards
• Applications generally reviewed within the issuing institute
Program AnnouncementProgram Announcement
• Invites grant applications in a given research area
• May describe new or expanded interest in a particular extramural program
• May be a reminder of a continuing interest in a particular extramural program
• Generally has no funds set aside• Applications reviewed in CSR along with
unsolicited grant applications
NIH/NIAID Grants and Funding Opportunities
NIH/NIAID Grants and Funding Opportunities
http://grants1.nih.gov/grants/
http://www.niaid.nih.gov/ncn/
NIAID International Grants and Contracts
http://www.niaid.nih.gov/ncn/grants/int/default.htm
“Technology TransferTechnology Transfer is the process by which technology developed by the Government or Academic Sector is transferred to the Private Sector.”
“Technology TransferTechnology Transfer is the process by which technology developed by the Government or Academic Sector is transferred to the Private Sector.”
Two Major Mechanisms Two Major Mechanisms to Transfer Technologyto Transfer Technology
• Patenting and Licensing of new inventions
• Developed Technology
• Research Collaborations
• Formal • Informal
• Early stage technology that needs cooperation to develop
Informal Research Informal Research CollaborationsCollaborations
• Exchange of Materials• Scientist to scientist contact,
– Long Stays– Short term visits– Presentation at international meetings
• Publication (peer recognition)• International grants and programs• Mostly with Academic Institutions
Formal Research Formal Research CollaborationsCollaborations
• Mostly with Industry• Pre-agreed research goals• Timelines• Financial terms• Responsibilities of parties• Legal contract
Formal (Industry) Collaborations:Formal (Industry) Collaborations:Advantages Advantages & & ChallengesChallenges
• Confidentiality
• Contract negotiation on IP
• Accessibility of cross-licensed technology
• Direct way of transferring technology /knowledge
• Joint Learning and problem solving experience
• Motivation: long term relationships, alliances, joint ownership of IP, recruitment and placement
Intramural NIH Technology Intramural NIH Technology TransferTransfer
• Over 300 new invention reports/yr.
• Over 2,000 patents
• Over 1,500 active licenses
• Nearly 200 technologies in the market
• $ 54 million royalty income FY2000
• Over 84% licenses are non-exclusive
• About 14% licenses with non-US firms
• Over 52% licenses with small companies
Further Questions?Further Questions?Contact information:
Karl A. Western, MD, DTPH
Director, Office of Global Affairs (OGA)
E-mail: [email protected]
Telephone: (301) 496-6721
NIAID WebsiteNIAID Websitewww.niaid.nih.govwww.niaid.nih.govhttp: //www.niaid.nih.gov