Dara FitzGerald PhD Enterprise Ireland – Life sciences & Food Commercialisation

1. US Federal Agencies Focus on Funding & Collaboration- Sept ‘09This presentation contains condensed and selected information relating to research, funding that is freely available through public US Federal resources. Dara FitzGerald PhD Enterprise Ireland – Life sciences & Food Commercialisation

2. US Federal Agencies Grants • Where to find Federal grants • Eligibility • How to apply • Specific agencies • NIH • DOD Collaborations • Types • USDA | DOE | NIH

3. Where to Find US Federal Grants - Grants.gov • Grants.gov is a central storehouse for information on over 1,000 grant programs and provides access to approximately $500 billion in annual awards. • Registration is a one-time process, register so you or your organization can apply for grants from the 26 federal grant-making agencies. • Search for grants – open calls • Check eligibility for “non-US applicants” • Investigator initiated grant applications

4. Eligibility • The majority of US Federal grant calls are not eligible to non-US lead investigators. • Some DO allow non-US lead investigators. • Some DO allow non-US Partners. • Many DO allow non-US sub-partners and sub-contractors. If the eligibility section of the grant does not specify non-US involvement then you should contact the agency to clarify. Do not presume that eligibility standards for the same grant types are the same. Each specific call can have different eligibility even if the grant code is the same, e.g. R01.

5. Institutional Registration Register on Grants.gov • Apply for DUNS number http://fedgov.dnb.com/webform • Register with Central Contractor Registration http://www.ccr.gov • Registrants located outside of the U.S. are required to include an NATO Commercial and Governmental Entity (NCAGE) Code on CCR registration http://www.dlis.dla.mil/Forms/Form_AC135.asp • Complete your AOR (Authorized Organization Representative) profile on Grants.gov and create a username and password. • Confirm you’re an Authorized Organization Representative (AOR)

6. Applying for Federal Grants • Identify an appropriate grant (if solicited) • Identify relevant US partner(s) (preferred route) • Download grant application package • Assess grant requirements, constraints and budget • Contact relevant grant point-of-contact • Liaise with your Institute’s research office

7. National Institutes of Health – nih.gov NIH is the steward of medical and behavioral research for the US Mission: to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability… from the rarest genetic disorder to the common cold • Many NIH grants ARE eligible for non-US applicants • Grants are funded by 1 or more of the 27 Institutes and Centres • Funding is aligned to the Center(s) core values • Grants are solicited or unsolicited (investigator initiated) • 100% project costs covered in $US. • 8% overheads to non-US applicants • Explain why work cannot be carried out in the US • IP and Inventions • All IP belongs to the grantee institution • All Inventions must be reported to the NIH • The US federal government reserves the right to use any inventions for non-commercial research – much like any US patent! It’s all about the science! – as applied to a disease/condition

8. EI in NIH Mission Enterprise Ireland mission in the US National Institutes of Health: • Promote collaborative relationships • Identify synergistic in-licensing from NIH to Ireland • Promote export sales into NIH • Identify leading-edge & pipeline R&D at the NIH • Aid in securing NIH research funding • Cement long-term links with NIH

9. National Institutes of Health • Support research by non-Federal scientists across U.S. and abroad • Help train research investigators • Conduct research in NIH labs • Foster communication of medical and health sciences information 2009 Budget = US$30.5 Billion

10. National Institutes of Health Report.govThe Research Portfolio Online Reporting Tool provides access to reports, data, and analyses of NIH research activities, including information on NIH expenditures and the results of NIH-supported research.RCDC Reports the amount of funding in 215 historically reported categories of disease, condition, or research area.

11. Funding Activities Funding Activities: The NIH uses numerous funding activities to support unsolicited and solicited (RFA or PA) research. Abridged breakdown of relevant Grant Types • Research Projects Grants (R01) • Small Research Grants (R03) • Exploratory/Developmental Grants (R21) • International Training Planning Grants (D71) • International Research Training Cooperative Agreements (U2R) • Cooperative Agreements (U01) • International Training Grants (D43) • Educational Projects (R25) • Research Scientist Development Awards (K01) • Resource-Related Research Projects (R24) • Project Grants (P01) • Details for all Activity Codes can be found at http://grants1.nih.gov/grants/funding/ac.pdf

12. National Institutes of Health If investigator initiated, i.e. no suitable call is open • Review similar, previously funded grants e.g. http://crisp.cit.nih.gov/ • Review Institutes core interests http://grants.nih.gov/grants/new_investigators/resources.htm#policies and http://www.nih.gov/icd/index.html • …then as 2-6 on Applying for Federal Grants

13. Department of Defense • Individuals, regardless of ethnicity, citizenship status, may apply for DARPA grants as long as they are employed by, or affiliated with, an eligible institution and meet the specific Program Announcement/Funding Opportunity requirements. • Varied calls for grants applications • Unsolicited applications are also welcome • Focus on “lateral” solutions to existing problems

14. DARPA www.darpa.mil is the central research & development organisation of the DOD. Fund High-risk, High reward research. From Basic and fundamental research to Prototype in Biology, Medicine, Computer science, chemistry, physics, engineering, mathematics, material science, social science, neurosciences… Research is available to US military and defense contractors. Each DARPA office maintains a list of current programs and research thrusts. It publishes solicitations on www.fbo.gov and www.grants.gov Department of Defense

15. Some Other Funding Agencies • Department of Energy • Food & Drug Administration • National Science Foundation • National Institute of Standards and Technology • …possibly the Dept Agriculture – watch this space.

16. COLLABORATION

17. Co-operative Research • US Federal Agencies carry a range of collaborative mechanisms. • CRADA - Cooperative Research & Development Agreements (IP involved) • CA - Cooperative Agreement (no IP involved) • MTA - Materials Transfer Agreement • WFO - Work For Others • MOU - Memorandum Of Understanding

18. Co-operative Research • The VALUE of US Federal collaboration to Irish researchers can include • Access to top class facilities and equipment • Access to expensively funded internal research • US branding of excellence • Links to US academic institutions • Reach through from US partners to Foundation funds

19. Department of Agriculture USDA • Agricultural Research Service. The in-house research arm of the USDA. • Likely to form partnerships with industry and academia (or both) • Has access to massive resources throughout the USDA • Highly divergent research • Focus on crossover research • Basic and applied research • Validation and trials opportunities

20. USDA Human Nutrition Research Center • The HNRC is the largest of USDA's human nutrition research facilities and the home of the first human nutrition research conducted by USDA, dating back to the late 1890's.  Its current program spans the human nutrition and health continuum, from investigating the role of nutrients and food components at the cellular level, to examining the impact of dietary interventions on health in animal and human research, to conducting mission critical surveys to find out what people are eating while supporting an expanded understanding of what's in food. • www.ars.usda.gov/ba/bhnrc

21. Department of Energy • www.energy.gov • Science research carried out in 17 National Laboratories • Primary focus on renewable energy and energy management/efficiency. • Other focuses include Fundamental Biology • Hugely expensive facilities • Traditionally carry out contract research (WFO) • Opportunities to influence new strategies

22. National Institutes of Health • Increased focus of collaboration through the 27 Institutes and Centers. • Nutrition and Disease research is primarily carried out by: • National Cancer Institute • National Institute of Diabetes, Digestive and Kidney Disorders • Office of Dietary Supplements • National Center for Complementary and Alternative Medicine

23. Take home messages • Review www.grants.gov • More information at www.biotechnologyireland.com • Contact Enterprise Ireland: dara.fitzgerald@enterprise-ireland.com

24. www.enterprise-ireland.com dara.fitzgerald@enterprise-ireland.com EastPoint, Dublin.