national institute of allergy and infectious diseases karl a. western, md, dtph asst. director for...

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: KW18Q@NIH.GOV

Telephone: (301) 496-6721

NIAID WebsiteNIAID Websitewww.niaid.nih.govwww.niaid.nih.govhttp: //www.niaid.nih.gov