1. Preparation of NIH Grant Applications Karl Salzwedel NIH Grantsmanship Workshop Kuala Lumpur, Malaysia July 2, 2013

2. Find Answers and Plan Your Approach www.niaid.nih.gov

3. The NIH Grant Application Lifecycle www.niaid.nih.gov/researchfunding/grant

4. Where to Start Some things to consider: To which grants are you eligible to apply ?To which grants are you eligible to apply ? What is the best grant mechanism for your situation?What is the best grant mechanism for your situation? How much preliminary data do you have?How much preliminary data do you have? What is the potential impact of your research to the field?What is the potential impact of your research to the field? How novel is your idea?How novel is your idea? Is this something that the NIH is looking to fund (solicited vs. unsolicited)?Is this something that the NIH is looking to fund (solicited vs. unsolicited)? Is it best to apply as a principal investigator, co-investigator or collaborator?Is it best to apply as a principal investigator, co-investigator or collaborator? Researching the best fit for you is critical

5. Which grant mechanism is right for you? K22 R01 Ph.D. Career Development Awards K22- Research Scholar Development Award K99/R00- Pathway to Independence Award R21R03 K99/ R00 M.D. Career Development Awards K08- Mentored Clinical Scientist Development Award K23- Mentored Patient-Oriented Research Career Development Award Independent Research Grants R03- Small Grant R21- Exploratory/Developmental Research Grant R01- Research grant Ph.D. M.D.M.D. TrainingTraining Faculty position Independent PI K08K23 www.grants.nih.gov/grants/guide/parent_announcements

6. Career Award Selection www.grants.nih.gov/training/kwizard K22 K23 K08 K99 K01

7. K22 and the K99/R00 Award Features K22 2 yr award No mentored phase Awardee gets funds at the time of becoming asst. professor $150K (year 1) direct costs + $100K (year 2) direct costs + 8% F&A Must have less than 5 years postdoctoral experienceK99/R00 3 year award only Up to 1 yr mentored phase ($90K/yr) Awardee becomes asst. professor- No peer review 2 yr independent R phase ($249K/yr TC) Citizenship and green card not required- unique to this K mechanism Must have less than 5 years postdoctoral experience http://grants.nih.gov/training/careerdevelopmentawards.htm

8. K08 and the K23 Award Features K08 Up to 5 year award Mentored clinical research Minimum 75% effort required Allows other support in last 2 years* Up to $75K salary + fringe benefits+ $25K research costs Does not support new clinical trialsK23 Up to 5 year award Mentored patient-oriented research Minimum 75% effort required Allows other support in last 2 years* Up to $75K salary + fringe benefits+ $25K research costs Does not support new clinical trials http://funding.niaid.nih.gov/researchfunding/tool/pages/traincareercomp.aspx

9. International Applicants  Most K-awards require U.S. citizenship (exception:K99)  Eligible for R03, R21, R01 research grants  Opportunities specific to international scientists (RFAs) www.niaid.nih.gov/researchfunding/int

10. What does the NIH currently fund? www.projectreporter.nih.gov

11. Specific Aims  The most critical page in the application  A one page summary of the application –Why is this problem significant? –What is the exciting preliminary data? –What are the hypotheses supported by the data? –How will this project significantly impact the field? –Make sure to emphasize important points that you absolutely want the reviewer to know –Make them want to keep reading –Avoid simply listing things you are going to do

12. Common Pitfalls  Proposed project is not novel or innovative  Even if project is successful will have questionable impact to the field  Failure to convince reviewers of scientific rationale for proposed studies  Research is mainly descriptive or correlative –’looking at’ bad, testing good  Lack of clear, testable hypothesis – ‘fishing expedition’  Inadequate preliminary data to support a large investment  Unfocused research plan  Lack of experience in the proposed methodology  Insufficient publication record  Uncertainty concerning the future directions  Failure to consider potential pitfalls/alternative approaches  Unrealistically large amount of work  Lack of statistical considerations

13. Things to keep in mind  Don’t work in a vacuum - actively seek out advice, collaborators/consultants to strengthen your proposal  Follow instructions - page limits, font size, margins  Be concise and clear - tables, figures clearly numbered with legends/footnotes  Letters of collaboration should clearly state what the collaborators/consultants have to offer  Allow sufficient time for honest feedback on draft proposal from colleagues/peers  Reviewers’ have zero tolerance for typos and bad grammar

14. Strong significance to an important problem in public health: IMPACT is high  High degree of novelty and innovation Strong track record by a well qualified applicant and collaborators Clear rationale Relevant and supportive preliminary data Clear and focused approach that provides unambiguous results Careful attention to details  Presentation, readability, clarity of data, graphics, error bars, spelling, etc Summary: Hallmarks of an Outstanding Grant Application

15. www.niaid.nih.gov/researchfunding/ann/pages/opps

16. “I’m from the government and I’m here to help”  PO - Program Officer –Responsible for directing and evaluating research programs and scientific administration of your grant  SRO - Scientific Review Officer –Responsible for peer review of your application  GMS - Grants Management Specialist –Responsible for the fiscal and federal policy administration of your grant

17. NIAID Funding Opportunities in HIV/AIDS Research Karl Salzwedel Division of AIDS, NIAID, NIH July 2, 2013

18. NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.

19. The Division of AIDS (DAIDS) Scientific Programs Basic Sciences Program Therapeutics Research Program Prevention Sciences Program Vaccine Research Program

20. Steps Along the HIV Cure Pathway Basic Research Translational Research Pilot Clinical Studies Phase I- IV Clinical Trials Delivering Therapeutics to Residual Active HIV Reservoirs RFA (R01) Martin Delaney Collaboratory: Towards an HIV-1 Cure (U19) Beyond HAART: Innovative Therapies to Control HIV-1 (P01) Targeting Persistent HIV Reservoirs (TaPHIR) PAR (R21/R33) Clinical Trials Networks: Cure Agenda (UM1) FY11 FY14 FY13 FY12 FY14

21. Basic Research Translational Research Pilot Clinical Studies Phase I- IV Clinical Trials Targeting Latently Infected Cells Without Reactivation (R01) Beyond HAART II Innovative Therapies to Control HIV (U19) Pilot Clinical Trials to Eliminate the Latent Reservoir (U01) Quantitative Viral Outgrowth Assay (Q-VOA) Service Resource (N01) Innovative Assays to Quantify the Latent HIV Reservoir (R21, R01) Delivering Therapeutics to Residual Active HIV Reservoirs RFA (R01) Martin Delaney Collaboratory: Towards an HIV-1 Cure (U19) Beyond HAART: Innovative Therapies to Control HIV-1 (P01) Targeting Persistent HIV Reservoirs (TaPHIR) PAR (R21/R33) Clinical Trials Networks: Cure Agenda (UM1) New New Funding Initiatives for 2015

22. NIH AIDS Reagent Program Viruses Cell lines, hybridomas Monoclonal and polyclonal antibodies DNA clones, DNA libraries, expression vectors Recombinant proteins, synthetic peptides Reference panels for: –PCR –HIV subtyping –Drug resistant viruses –Neutralizing antibodies and sera Antiviral drug standards http://www.aidsreagents.org Provides standardized reagents and new technologies to the AIDS research community

23. U.S. institutions with funding to provide shared infrastructure support for HIV research CFARs support a multidisciplinary, collaborative environment that promotes basic, clinical, behavioral, and translational research in the prevention, detection, and treatment of HIV infection and AIDS. Web site: www.niaid.nih.gov/LabsAndResources/resources/cfar

24. CFAR One mission of the CFAR is to strengthen capacity for HIV/AIDS research in developing countries. CFARs accomplish this through a variety of ways including: Establishment of Cores abroad which provide training, services and expertise to local investigators Provide funding for pilot projects with an international component through the CFAR Developmental Core Offer training/mentorship in-country or in US Access to databases, repositories, computer-based training

25. CFARs are a Trans-NIH Program Co-funded by nine NIH Institutes: National Institute of Allergy and Infectious Diseases (NIAID) National Cancer Institute (NCI) National Institute of Child Health and Human Development (NICHD) National Heart, Lung and Blood Institute (NHLBI) National Institute on Drug Abuse (NIDA) National Institute on Mental Health (NIMH) National Institute on Aging (NIA) National Institute of General Medical Sciences (NIGMS) National Institute of Nursing Research (NINR) Co-managed by the NIH Institutes above, and by: Office of AIDS Research (OAR) Fogarty International Center (FIC)

26. CENTERS FOR AIDS RESEARCH

27. CFAR projects funded 2009-2012 India (5) China (4) Peru (3) Brazil (1) Tanzania (11) South Africa (20) Zambia (5) CFAR-Funded International HIV/AIDS Research Malawi (8) Kenya (26) Cameroon (1) Uganda (12) Botswana (10) Mexico (4) Updated June 2012 Cambodia (1) Zimbabwe (2) Mozambique (4) Namibia (2) Rwanda (4) Russia (1) Canada (1) Democratic Republic of Congo (1) Ethiopia (1) Ghana (2) Guatemala (1) Haiti (1) Romania (1) Australia (2)

28. www.cnihr.org Creative and Novel Ideas in HIV Research (CNIHR) Encouraging Innovation in HIV Research  Goal: to attract both international and U.S.- based early stage investigators from outside the field of HIV research  Up to 2 yrs, $150k per year Direct Costs  Concept sheets (2 pages) will be submitted by October 16, 2013

29. These are U01, collaborative grants, which establish international regional centers Foster collaboration on HIV research on regional and global level Advance methodology for collection and harmonization of data Address research questions using data sets

30. Region 1: North America Region 2: Latin America & Caribbean (CCASAnet) Region 5: Australia, China, India, Pakistan, Asia (excluding Central Asia) Region 10: East AfricaRegion 11: South AfricaRegion 9: Central AfricaRegion 8: West Africa 7 Funded Regions

31. International Research in Infectious Diseases including AIDS (IRIDA) Program (R01 ) Objective: to advance the development of local scientific expertise, build local research infrastructure, and to increase collaborative research partnerships at resource limited eligible foreign countries that propose research related to infectious diseases that are of interest to that country Application Receipt Date for AIDS Applications: August 23, 2013 Contact (for HIV/AIDS Research ): Opendra Sharma, Ph.D. Telephone: (301) 496-9041 Email: osharma@niaid.nih.gov http://grants.nih.gov/grants/guide/pa-files/PAR-11-145.html PAR-11-145

32. In Summary There are many opportunities − researching the best fit for what you wish to do is critical.  Karl Salzwedel, salzwedelkd@niaid.nih.gov  Diana Finzi, dfinzi@niaid.nih.gov  Ann Namkung Lee, anamkung@niaid.nih.gov