Claire T. Driscoll Director, Technology Transfer Office

1. NIH as a Research Partner: How to Collaborate with NIH Scientists & Gain Access to Funding and other Resources University of Queensland, Oct 24, 2008 Claire T. Driscoll Director, Technology Transfer Office National Human Genome Research Institute (NHGRI) National Institutes of Health (NIH) U.S. Department of Health & Human Services (DHHS)

2. National Institutes of Health • Largest financial backer of basic biomedical research in the world • Mission: Uncover new knowledge that will lead to improved public health by conducting and supporting research

3. Getting to Know the National Institutes of Health • Top biomedical research institution in U.S. • U.S. federal government research agency • 2008 budget: $28.8 Billion • An extremely information-rich web site www.nih.gov • Increasing trend for joint, collaborative endeavors and public-private partnerships • NIH Roadmap Initiative http://nihroadmap.nih.gov

4. The NIH is BIG, COMPLEX & INTIMIDATING…. • A HUGE number of grant & contract programs • Valuable research & clinical services and research resources available to scientific community • A lot of MONEY to “give away” each year (~$25B) • 100s of inventions available for licensing; 1,000s of top-notch potential collaborators

5. Getting to Know the National Institutes of Healthcontinued • FAIR • open, unbiased competition for grants, contracts & licenses • TRANSPARENT • all evaluation and eligibility criteria, standard forms, policy documents, etc. are publicly available and are posted on our web site • SERVE MANY STAKEHOLDERS—U.S. taxpayers, U.S. Congress, academia, the global biopharma industry, etc.

6. 82% of the U.S. Government’s Annual ~$28B Investment in Biomedical Research Goes to the NIH

7. Institutes: Understanding the NIH Structure • Each NIH Institute (IC) has a unique mission & is semi-autonomous • All the diseases/disorders/research areas covered by an Institute may not be reflected in its name • ICs are structured by disease (Cancer; Diabetes), organ systems (Heart, Lung & Blood; Musculoskeletal), life stage (Aging; Infants & Children) and disciplines (Neurological; Infectious Disease)

8. The 27 Institutes and Centers of the National Institutes of Health (www.nih.gov)

9. NHGRI: Building on the Success of the HGP….we’re just one of 27 ICs • Human Genome Project (HGP) • The SNP Consortium • The Pharmacogenetics Research Network • The Mammalian Gene Collection (MGC) • Haplotype Map Project (HapMap) • ENCODE Project (Encyclopedia of DNA Elements) • Knockout Mouse Project (KOMP) • Molecular Libraries project • Cancer Genome Atlas Project (CGAP) • Genetic Associations Information Network (GAIN) • The Cancer Genome Atlas

10. Why Bother with the NIH? • Access to funds (~$25B/yr) to conduct research in the form of grants and contracts • Access to drug screening services, databases, clinical trial testing networks, repositories of research reagents & natural products, etc. • Access to 1,000s of potential top notch collaborators and customers • 100s of inventions & technologies available for licensing

11. NIH’s “On Campus” Intramural Research Program • Intramural budget $3B (=~10% of total) • Bethesda, Maryland main campus (plus some satellite locations)—just outside Washington DC • Intramural (on site) = 18,000 employees; 6,000 MDs/PhDs; 2000+ intramural R&D projects • Many research collaborations w/ both public and private sectors scientists • Intramural-developed technologies & inventions are available for licensing http://ott.od.nih.gov/techabs.html

12. Extramural NIH (off site) • Extramural = universities, hospitals, non-profit research institutions worldwide plus some companies (ex. 2.5% of all grant money goes to Small Business Innovation Research (SBIR) grantees) that receive NIH funding of some kind • *SBIR funds limited to small 51% indiv-owned U.S. companies • Extramural = 60,000 awards to 3,000 organiz./year • Grantees/contractors control their own inventions even if made using government money • There are many non-U.S. grantees and contractors

13. ….now on to Grants Part II: Not so Secret Secrets for Successfully Securing NIH Grant $

14. Distribution of Research Funds • The majority of allocated research $ for a given NIH Institute is directed to the extramural research community. • Extramural research $ are utilized using Grant and Contract mechanisms—the Grants Program is the predominant form of research funding. • Most of the extramural research budget is committed dollars. We depend on increases in funding above current levels and a release of commitment from grants and contracts already funded to fund new research every year.

15. NIH GUIDE for Grants and ContractsU.S. Department of Health and Human Services • Lists all new NIH Scientific Initiatives • Is the official publication for NIH medical and behavioral research grant policies, guidelines and funding opportunities • Updates to the NIH Guide with new grant & contract opportunities are also distributed to interested individuals via a LISTSERV • http://grants.nih.gov/grants/guide/index.html

16. NIH Grant Info • Historically ~5% of NIH grant $ goes to non-U.S. entities (each type of grant or fellowship has specific eligibility criteria—some are for U.S. entities or U.S. citizens only; some for academic entities, etc.) • Intense, difficult ‘ordeal’ but the process is transparent (detailed info posted on web) http://grants.nih.gov/grants/ • Cornerstone of process is PEER REVIEW • If you meet the eligibility criteria, include all requested info and score high enough you get funded. Period. End of Story.

17. http://grants.nih.gov/grants/oer.htm

18. Summary of NIH Extramural Funding Vehicles GRANTS NIH as a Patron (R_s, RFAs, PAs) (assistance, encouragement) COOPERATIVE NIH as a Partner AGREEMENTS (assistance; substantial NIH (U_s, RFAs, PAs) scientific/admin involvement) CONTRACTS NIH as a Buyer (RFPs) (procurement/fee for service)

19. Types of NIH Grants ($ Range: $25,000-$25Million!) • R Series—Investigator Initiated Research (RO1, R03, R21, R13 etc.) (*R43, 44 small business) • U Series—Cooperative Agreements (U01, U19, U54, U13 etc.) • P Series—Program Projects/Research Centers (P01, P50, P30, etc.) • F Series—Fellowship Training Grants (F31, F32, F33, etc.) • K Series—Clinician Scientists Training Grants (K08, K02, K23, K24, etc.) • T —Training (Institutional Grants) (T32, T34, T37, etc.) *SBIR and STTR; limited to small 51% indiv-owned U.S. companies

20. How do NIH Institutes Communicate & Interact with the Global Scientific Community? • Issuance of Solicitations in The NIH Guide: • “Regular” investigator initiated Grants (3 deadlines/year) • Program Announcements (PAs) • Request for Applications (RFAs-Grants) • Request for Proposals (RFPs-Contracts) • NIH program staff work with the community to ensure that new cutting edge and/or public health priority areas are explored and funded • Sponsorship and attendance at conferences

21. NIH Portfolio: Balancing Blue Sky Research vs. Practical Needs Investigator- Initiated Scientific Concepts Programmatic Direction to Guide Research and Development Let the scientists decide/ Bottom up approach Let the leaders decide/ Top down approach

22. #1 Johns Hopkins University $555M/year #2 Univ of Washington #3 UPenn #4 UCSF #5 Washington Univ #6 Univ of Michigan $362M #7 Univ of Pittsburgh #8 UCLA #9 Duke Univ #10 Yale Univ #11 Harvard Univ #12 Boston Univ $292M # 64 MIT $94M #100 NY State Psychiatric Institute $50M Top University Recipients of NIH Grant Funding in 2003

23. Non-U.S. Entity Eligibility for Competing for NIH Funding • Grants and contracts to foreign institutions and companies possible under many but not all mechanisms and initiatives • Support of collaborations with foreign institutions through subgrants, subcontracts or consortium agreements from U.S. recipients of NIH funding • Some fellowships for foreign scientists

24. Grant Opportunities for Non-US Entities • Most research funded by NIH is via traditional investigator-initiated grants (R01). • Foreign institutions are eligible for most types of investigator-initiated research projects (example R01, R03 & R21) • Read Program Announcements (PAs) and RFAs eligibility criteria carefully

25. Definition A substantial foreign componentof a grant to a U.S. institution is defined as: The use of grant funds to provide support to any significant scientific element or segment of the project which is to be performed outside of the U.S. either by the grantee project staff or by a researcher employed by a foreign institution.

26. Other Possibilities • Collaborations with US Scientists Can be done as subcontracts to grants to U.S. institutions—the NIH grant applic and review process is complex & highly competitive (work & learn from those who already know the system!) • Select Individual Postdoctoral Fellowships • Some special programs managed by the Fogarty International Center (FIC)

27. Why Does NIH give $ to non-US Entities? • We are committed to supporting the best biomedical research regardless of location • Special resources, expertise and/or populations exist outside the U.S. • The interdisciplinary nature of modern biology demands extensive collaborations • Disease knows no boundaries • We’re just nice folks!

28. Special Requirements of Foreign Applicants? Yes • The following will be assessed in addition to the usual evaluation & scoring using standard NIH review criteria • Does the project present special opportunities for furthering research programs through the use of unusual talent, resources, populations or environmental conditions that are not readily accessible in the U.S. or that augment existing U.S. resources? • Does the proposed project have specific relevance to the mission and objectives of the Institute and have the potential for significantly advancing health sciences?

29. Non-US Recipients of NIH Grant by Country (cum. avg ’02-’05) • Australia $85.2M/year • Canada $46.6M/year • UK $40.7M/year • China $ 4.3M/year • France $ 3.8M/year • Germany $ 2.0M/year • Netherlands $ 2.0M/year • Korea $ 0.3M/year Avg total NIH grant $ to non-US/yr = $200M-350M

30. NIH Grants are Harder to Obtain These Days Zerhouni, I. (2006) Science314: 1088-1090

32. Study Section Review • Reviewers: Usually at least 3 scientists are assigned to a grant application: Primary, Secondary, and 1 or more ‘readers’ • Review Criteria- Four critical areas Significance Approach Innovation Investigators • Scoring 1.0 (highest priority)-5.0 (lowest priority)/percentile ranking UN (unscored) triage process that CSR put in place for efficiency-to eliminate from the review discussion those grants deemed to be in the lower half. NR (Not Recommended For Further Consideration) Remember: a poor score does not necessarily mean poor science will be done.

38. Ways NIH Institutes Communicate & Interact • Mission Statement available on Web site • Support of Scientific Meetings • Issuance of Solicitations in the NIH Guide: http://grants.nih.gov/grants/guide/index.html -Program Announcements (PAs) -Request for Applications (RFA-Grants) -Request for Proposals (RFP-Contracts) • NIH program staff working with the science community to see areas of research focus developed

39. Maximizing Interactions with NIH to Effect Positive Outcomes • Making the Connection: -Contact Public Relation Liaison at the NIH Institute(s) if you do not know who the program staff assigned for your research area is (are). -Contact extramural NIH program staff -Attend the Institute Advisory Meetings—the first day is public and the institute’s funding policies, training, and scientific issues are discussed.

40. A Few Tips • Think small…try for workshop or fellowship funding 1st (as opposed to submitting a 5yr $500K ROI grant right off the bat) • Collaborate w/ a NIH grantee (sub-grantee) to learn more & gain expertise • Encourage univ. faculty to join NIH peer review study sections • Read the latest & greatest grant , cooperative research and contract funding announcements put out regularly by NIH • Try, try again (incorporate reviewer comments)…no one gets funded the 1st time

41. Criteria for Selection of Peer Reviewers Active & Productive Researchers Meet Internal Administrative Considerations • Geography Doctoral or Equivalent Degree Research Capability • Institutional Interest in Serving • Affiliation • Non-Federal • Employment Non-Research • Gender & Expertise in Discipline of Review Group and Specialization Needed Ethnic Status Non-Doctoral Scientific Community Active and Productive Researchers

42. Not so Secret Secrets: How to Partner with NIH Researchers

43. Why Bother with the NIH? • Access to funds (~$25B/yr) to conduct research in the form of grants and contracts • Access to drug screening services, databases, clinical trial testing networks, repositories of research reagents & natural products, etc. • Access to 1,000s of potential top notch collaborators and customers • 100s of inventions & technologies available for licensing

44. Top 5 Legal & Policy Issues (universal) • Intellectual Property (IP) considerations • Licensing provisions • Confidentiality terms • Data Ownership, Access and Use terms • Publication/Public Disclosure terms

45. Top 10 Issues in Transactional Agreements (in order of importance/time spent negotiating) • Intellectual Property/Patent Rights (if any) • Licensing terms (if any) • Confidentiality terms • Data Ownership, Access and Use terms • Publication rights (& pre-publication sharing) • Indemnification/Liability terms • Choice of Law and/or Jurisdiction • Conflict Resolution and termination terms • Financial/budget aspects • Scientific/technical issues and/or “division of labor”

46. We do A LOT of deals at the NIH • Whether a small deal or a big one the fundamentals are the same • Reach a common understanding (this is the hard part!) • Preserve that understanding in writing (not so easy) • Use the right legal instrument (getting easier) • Maintain urgency but don’t unduly rush • The devil is in the details…sweat the details! • Obtain expert help (legal, business development/commercialization, scientific, etc.) • A clearly written agreement will serve you well in the future (minimize use of “legalese”) ….really!

47. NIH Extensive scientific expertise and regulatory at Company Access to proprietary materials No ability to commercialize Access to additional funds Technology transfer is a responsibility of all Federal labs Company Opportunity to collaborate with top research and clinical scientists Access to unique technologies and materials May be able to license NIH inventions Signing an Agreement may help Company to leverage funds (prestige of working with NIH) Why Collaborate with the NIH? NIH and Company Perspectives:

48. NIH/Univ. Basic & Innovative Science-based Publication oriented Shares materials U.S. government funded Potential Conflicts of Interest Private Industry Applied Product oriented Patents/Ownership Controls materials Wary of gov. “march in”* & gov. use rights Consulting/scientific advisors/board of directors NIH-Industry Collaborations: Contrasting Environments *has never occurred

49. How do I find the “right” person at NIH to talk to about Collaboration Opportunities? • NIH Staff directory—search by name • http://ned.nih.gov/search/search.aspx • Each Institute has a TDC (Technology Development Coordinator)—”point” person & liaison for all tech transfer matters • http://ott.od.nih.gov/nih_staff/tdc.html • List of IC tech transfer offices’ web sites • http://ott.od.nih.gov/nih_staff/tdc.html • Published Federal Register advertisements • http://www.gpoaccess.gov/fr/index.html

50. Getting Started…Do Your Homework before Contacting Anyone! • CRISP at http://crisp.cit.nih.gov/ - a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other research institutions & NIH intramural • Search by topic, name or other terms to find NIH-funded researchers working in extramural community • Search by “Z” number (under “Activity” to find descriptions of Intramural research projects • PubMed/Medline – search by scientist name (once have found the experts in areas of interest); retrieve papers • http://www.ncbi.nlm.nih.gov/sites/entrez?db=PubMed