1. National Institute of Allergy and Infectious Diseases Karl A. Western, MD, DTPH Asst. Director for International Research Director, Office of Global Affairs

2. U.S. Department of Health and Human Services Administration for Children and Families (ACF) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) The Secretary Deputy Secretary Administration on Aging (AoA) Centers for Medicare and Medicaid Services (CMS) Indian Health Services (IHS) Centers for Disease Control and Prevention (CDC) Substance Abuse and Mental Health Services Administration (SAMHSA) Program Support Center (PSC) Agency for Toxic Substances and Disease Registry (ATSDR) Agency for Health Care Policy and Research (AHCPR) National Institutes of Health (NIH)

3. Office of the Director National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Dental and Craniofacial Research National Institute on Drug Abuse National Institute of Environmental Health Sciences National Institute on Aging National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Eye Institute National Human Genome Research Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of General Medical Sciences National Institute of Nursing Research National Library of Medicine Center for Information Technology Center for Scientific Review National Center for Complementary and Alternative Medicine National Institute of Allergy and Infectious Diseases National Center for Research Resources Clinical Center National Center on Minority Health and Health Disparities National Institute of Biomedical Imaging and Bioengineering Fogarty International Center National Institutes of Health

4. 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 medical and health sciences information.

5. NIH Roadmap Strategy BenchBedsidePractice Building Blocks Pathways Molecular Libraries Bioinformatics Computational Biology Translational Research Initiatives Clinical Research Informatics Integrated Research Networks Clinical outcomes Training NIH Clinical Research Associates Interdisciplinary Research Innovator Award Nanomedicine Public Private Partnerships

6. The NIAID Mission NIAID strives to understand, treat, and ultimately prevent infectious, immunological, and allergic diseases that threaten hundreds of millions of people worldwide.

7. Major Areas of NIAID Investigation  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

8. 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 for Management & Operations National Advisory Allergy & Infectious Disease Counselors Office of Financial Management Office of Administrative Services Office of Ethics Office of Human Resources Management Division of Intramural Research Division of Microbiology & Infectious Diseases Division of Extramural Activities Office of Policy Analysis Dale & Betty Bumpers Vaccine Research Center Division of Allergy, Immunology & Transplantation Office of Technology Information Systems NIAID Divisions and Offices (simplified) Office of Technology Development Office of Communications & Public Relations Division of Acquired Immunodeficiency Syndrome Office of Biodefense Research

15. Guiding Principles of NIAID Global Health 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

16.  Intramural - Research Training - Collaboration  Foreign Awards - Investigator Initiated - Clinical/Vaccine Trials  Domestic Awards with Foreign Component - Funding - No Funding How NIAID Supports International Research (1)

17.  Bilateral Programs - Science and Technology - Health  Multilateral Programs - WHO - UNAIDS - European Union  Interagency Agreements - CDC - Army, Navy - USAID - State How NIAID Supports International Research (2)

18.  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 International Programs (1)

19.  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 International Programs (2)

20. Intramural Research Training and 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.

21. Intramural 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

22.  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 International Health

23. CIPRA (Comprehensive International Program of 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:

24. IRID (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

25. IRID (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

26. NIH Extramural Program GrantPatron (assistance, encouragement) CooperativePartner Agreement(assistance but substantial program involvement) ContractPurchaser (procurement)

27. WORLD CLASS PEER REVIEW SYSTEM Ideas from Individual Scientists NIH receives ~ 43,000 research project grant Applications each year Scientific Review Group of Scientists Evaluate Scientific Merit NIH Grantees ~ 30 percent of NIH applications succeed in gaining research funding Institute National Advisory Councils Access programs Approve applications Public Members Provide policy advice

28. PEER REVIEW: Center for Scientific Review 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

29. Dual Review System for Grant Applications Second Level of Review Council  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 Review Scientific 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

30. SCIENTIFIC REVIEW ADMINISTRATOR 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:

31. REVIEW CRITERIA 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?

32. ADDITIONAL IMPORTANT CONSIDERATIONS Research involving human subjects –Protection from risks –Inclusion of women, minorities, children Animal Welfare Biohazards Data Sharing Plans Appropriateness of Budget

33. RESULTS 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

34. AWARD DETERMINATIONS Scientific merit Program considerations, priorities, special initiatives Availability of funds

35. SUMMARY 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

36. COMMON 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

37. COUNCIL REVIEW AND FUNDING 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

38. NIH Internet Resources NIH 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)

39. 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.

40. 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.

41. 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

42. Program 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

43. 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/def ault.htm

44. Technology Transfer “Technology Transfer is the process by which technology developed by the Government or Academic Sector is transferred to the Private Sector.”

45. Two Major Mechanisms to Transfer Technology Patenting and Licensing of new inventions Developed Technology Research Collaborations Formal Informal Early stage technology that needs cooperation to develop

46. Informal Research Collaborations 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

47. Formal Research Collaborations Mostly with Industry Pre-agreed research goals Timelines Financial terms Responsibilities of parties Legal contract

48. Formal (Industry) Collaborations: Advantages & Challenges 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

49. Intramural NIH Technology Transfer 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

50. Further Questions? Contact information: Karl A. Western, MD, DTPH Director, Office of Global Affairs (OGA) E-mail:KW18Q@NIH.GOV Telephone:(301) 496-6721

51. http: //www.niaid.nih.gov