SBIR - STTR: Advancing Medicine Through Innovation

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1 Small Business Innovation Small Business Innovation Research Small Business Small Innovation Business Research Small Business Technology Research & Transfer Small Business Programs Technology Transfer Programs Technology Transfer Programs SBIR - STTR: Advancing Medicine Through Innovation The NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs award provide federal The NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs award federal research grants and development to small businesses funding to conducting U.S. Small biomedical Businesses, research. to explore The the purpose feasibility of these of innovation programs technologies is to spur technological have innovation a strong potential and help for the commercialization federal government and meet creating its research medical and solutions. development (R&D) needs, with the ultimate goal research grants to small businesses. The purpose of these programs is to spur technological innovation and help the that federal government meet its research and development (R&D) needs, with the ultimate goal being commercialization of being commercialization of these innovative technologies and improved public health. these innovative technologies and improved public health. Fast Track Register your business. Register your Register your business business Choose Program & Submit Application. Choose program Choose program & submit application submit application Phase Phase I FAST TRACK FAST TRACK Phase Phase II II II Niche Niche Niche CAP CAP CAP Phase Phase III III III NIH s SBIR and STTR Programs Can Help Your Small Business Receive R&D Funding NIH s SBIR and STTR Programs Can Help Your Small Business Receive R&D Funding Follow these steps to find out how to get started on your application: Follow these steps to find out how to get started on your application: Determine which Determine which Funding Opportunity Funding Opportunity is Best Suited for You is Best Suited for You Parent Funding Funding Opportunity Funding Opportunity Opportunity: SBIR Announcements (PA ) and (FOAs): Announcements (FOAs): STTR (PA ) SBIR (PA ) and STTR SBIR (PA ) and STTR (PA ) (PA ) NIH is interested in YOUR NIH is interested in YOUR research NIH is interested ideas - apply in YOUR using research ideas - apply using the research Omnibus ideas solicitation. - apply using the Omnibus solicitation the Omnibus solicitation. Targeted Funding Opportunity FOAs: Announcements Targeted Funding (FOAs): Opportunity Issued by NIH s Institutes and Announcements Issued by NIH s Institutes (FOAs): and Centers (ICs) Centers Issued by (ICs) NIH s Institutes and Centers (ICs) Decide between SBIR Decide between SBIR and STTR Funding and STTR Funding SBIR: SBIR: Principal Investigator: Must be Principal Investigator: Must be employed by the small business. employed by the small business. Research Partner: Research partner Research Partner: Research partner optional, (up total effort 1/3 for up Phase to 33% I and for optional (up to 1/3 for Phase I and 1/2 Phase for I Phase and 50% II) for Phase II 1/2 for Phase II) STTR: STTR: Principal Investigator: Can be Principal Investigator: Can be employed by the small business or employed by the small business or non-profit research institution. a non-profit research institution. Research Partner: Research Partner: Required. Formal collaborative Required. Formal collaborative effort between small business effort between small business (minimum 40%) and research (minimum 40%) and research institution (minimum 30%). institution (minimum 30%). Submit Your Submit Your Application Early Application Early The grants registration process The grants registration process can take 6-8 weeks! can take 6-8 weeks! There are required There are 5 required registrations: registrations: 1. DUNS 4. era Commons 1. DUNS 4. era Commons 2. Sam.gov 5. SBA Registry 2. Sam.gov 5. SBA Registry 3. Grants.gov 3. Grants.gov Standard Grant Due Dates: Standard Grant Due Dates: Phase and Phase II: Phase I and Phase II: April 5, August 5, December April 5, August 5, December 5 AIDs AIDS and AIDs-related: AIDS-related: AIDs and AIDs-related: May 7, September 7, January May 7, September 7, January 7 If you have questions about any of these steps, please contact sbir@od.nih.gov, or the program officer at the NIH IC If you have questions about any of these steps, please contact sbir@od.nih.gov, or the program officer at the NIH IC that s most clearly related to your research topic. Contact information is located in the SBIR/STTR Omnibus solicitations. that s most clearly related to your research topic. Contact information is located in the SBIR/STTR Omnibus solicitations. Stay Connected! Stay Connected! Subscribe to the SBIR/STTR listserv: Subscribe to the SBIR/STTR listserv: listserv@list.nih.gov with this text in the listserv@list.nih.gov with this text in the message body: subscribe SBIR-STTR your name message body: subscribe SBIR-STTR your name Contact Us: Us: Contact Us: sbir@od.nih.gov sbir@od.nih.gov Website: Website: sbir.nih.gov sbir.nih.gov Follow Follow us on us on Twitter: Follow us

2 Follow the Follow below the steps below to get steps started to get on started the application the application process! process! Follow the below steps to get started on the application process! Confirm your small Confirm your small business concern (SBC) business concern (SBC) meets eligibility requirements meets eligibility requirements. Confirm your small Develop an business concern innovative research (SBC) meets eligibility idea for your SBC requirements. Five required registrations: 1. DUNS 4. era Commons 2. SAM.gov 5. SBA Registry CONTACT NIH BEFORE APPLYING 3. CHOOSE Grants.gov ONE FOA SBIR Omnibus (PA ) SBIR Omnibus SBIR Omnibus (PA ) (PA ) STTR Omnibus (PA ) STTR Omnibus STTR Omnibus (PA ) Targeted (PA ) SBIR/STTR FOAs CHOOSE ONE FOA Develop an innovative Develop an innovative research idea for research idea for your SBC your SBC $ Five required registrations: Five required registrations: 1. DUNS 4. era Commons 1. DUNS 4. era Commons 2. SAM.gov 5. SBA Registry 2. SAM.gov 5. SBA Registry 3. Grants.gov 3. Grants.gov Targeted Targeted SBIR/STTR FOAs SBIR/STTR FOAs Awardee conducts research Awardee Awardee conducts conducts research research Funding decisions and awards are made $ NIH Center for Scientific Review evaluates your grant on scientific merit and commercialization potential Submit your SBIR/STTR grant application to NIH electronically Funding decisions NIH Center for Scientific Review Funding decisions NIH Center for Scientific Review and awards are evaluates your grant on scientific and awards are evaluates your grant on scientific made merit and commercialization potential made merit and commercialization potential APPLICATION PROCESS 6-9 MONTHS APPLICATION PROCESS 6-9 MONTHS Submit your SBIR/STTR Submit your SBIR/STTR grant application to grant application to NIH electronically NIH electronically Phase I: Phase I Phase II: Feasibility Feasibility study for study months for 6 $150K months SBIR, - $150K $150K SBIR, STTR $150K STTR Feasibility study for 6 months - $150K SBIR, $150K STTR SUBMIT FOR PHASE IIB Phase IIB: Feasibility study for 6 months - $150K SBIR, $150K STTR OBTAIN OUTSIDE FUNDING SOURCES Phase OBTAIN III: OUTSIDE Feasibility FUNDING SOURCES study for 6 months - $150K SBIR, $150K STTR Phase Phase III III SUBMIT FOR PHASE II SUBMIT FOR PHASE II Commercialization Non-SBIR/STTR funds Commercialization - Non-SBIR/STTR funds Niche For active Niche Phase I For Awardees active Phase I Awardees SUBMIT FOR PHASE II Feasibility study for 6 months - $150K SBIR, $150K STTR Phase Phase Full R&D for years $1M SBIR, $1M STTR II Full R&D for 2 years - $1M SBIR, $1M STTR II CAP SUBMIT FOR SUBMIT FOR PHASE IIB IF APPLICABLE For Phase CAPII or IIB PHASE IIB For Awardees Phase II or IIB Awardees Phase $1M per year for up to years Must have initial Phase II to apply. Some NIH ICs offer Phase IIB Phase $1M per year for up to 3 years - Must have initial Phase II to apply. Some NIH ICs offer Phase IIB IIB awards for projects that require extraordinary time and effort in the R&D phase. IIB awards for projects that require extraordinary time and effort in the R&D phase. and and Phase II II that that is is submitted and and reviewed together. OBTAIN OUTSIDE FUNDING SOURCES Fast Track: One One application for for Phase I I NIH Technology Assistance Programs: Helping You Bridge the Gap Niche NIH Technology Assessment Assistance Program: Provides Programs: active Helping Phase I You awardees Bridge with the market Gap research, entry strategies consumer and and competition analysis. analysis. Niche Assessment Program: Provides active Phase I awardees with market entry strategies and competition analysis. Commercialization Assistance Program (CAP): Trains Helps Phase II awardees develop on developing a tailored tailored market-entry entry plan strategies, for their building specific Commercialization technology. strategic alliances Assistance The plan and will Program partnerships, help establish (CAP): and Helps milestones developing Phase and II FDA awardees budgets regulatory develop accomplish and reimbursement a tailored commercialization market-entry paths, as plan goals, well for as and their financing will specific provide technology. strategies guidance and The on expertise plan target will consumers, help intellectual establish potential milestones property investors matters. and and budgets industry to accomplish competitors. commercialization goals, and will provide guidance on target consumers, potential investors and industry competitors. Visit Visit sbir.nih.gov sbir.nih.gov for for more more information! information!

3 IC Program Contacts NIH SBIR/STTR Page 1 of 2 2/17/2016 HHS SBIR/STTR Agency Contact Information Questions of a general nature about the HHS SBIR/STTR Program may be directed to the following: SBIR/STTR Program Office Fax: sbir@od.nih.gov National Institute on Aging Dr. Matthew Portnoy Mr. J.P. Kim Phone: Phone: mportnoy@mail.nih.gov jpkim@nih.gov National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Biomedical Imaging and Bioengineering National Cancer Institute Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institute on Drug Abuse National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute Mr. Robert Vinson Phone: vinsonr@mail.nih.gov Dr. Michael-David A.R.R. Kerns Phone: Fax: Michael-David.Kerns@nih.gov Dr. Kathy Jung Phone: Fax: jungma@mail.nih.gov Dr. Natalia Kruchinin Phone: Fax: kruchininn@niaid.nih.gov Dr. Xibin Wang Phone: Fax: wangx1@mail.nih.gov Mr. Todd Merchak Phone: Fax: merchakt@mail.nih.gov Mr. Michael Weingarten Dr. Greg Evans Dr. Andrew Kurtz Phone: Fax: ncisbir@mail.nih.gov Louis A. Quatrano, Ph.D. Phone: Fax: Quatranol@mail.nih.gov Elena Koustova, Ph.D., MBA Phone: koustovae@nida.nih.gov Dr. Roger L. Miller Phone: Fax: Roger.Miller@nih.gov Dr. R. Dwayne Lunsford Phone: Fax: lunsfordr@mail.nih.gov Ms. Christine Densmore Phone: Fax: densmorec@niddk.nih.gov Dr. Daniel T. Shaughnessy Phone: Fax: shaughn1@niehs.nih.gov Dr. Jerome Wujek Phone: Fax: wujekjer@nei.nih.gov Dr. Scott Somers Phone: Fax: somerss@nigms.nih.gov Dr. Jennifer Shieh Phone: Ms. Betty Royster Phone: betty.royster@nih.gov Contact Ms. Linda Whipp Phone: Fax: Linda.Whipp@nih.gov Ms. Judy Fox Phone: Fax: Judy.Fox@nih.gov Ms. Vandhana Khurana, MBA Phone: Fax: khuranav@niaid.nih.gov Jason Lundgren Phone: Fax: Jason.Lundgren@nih.gov Ms. Aleisha S. James Phone: Fax: jamesaleisha@mail.nih.gov Mr. James Huff Phone: Fax: huffj@mail.nih.gov Ms. Jacquelyn Boudjeda Phone: Fax: boudjedaj@mail.nih.gov Mr. Ted Williams Phone: Fax: williate@mail.nih.gov Ms. Diana Haikalis, M.B.A. Phone: Fax: dhaikali@nida.nih.gov Mr. Christopher P. Myers Phone: Fax: Christopher.Myers@nih.gov Ms. Diana Dede Rutberg Phone: Fax: rutbergd@mail.nih.gov Ms. Pamela Love Phone: lovepa@mail.nih.gov Ms. Julie Beaver Phone: julie.beaver@nih.gov Awarding Component Scientific/Research Contact Financial/Grants Mgmt Ms. Pam Clark Phone: Fax: evans3@niehs.nih.gov Mr. William Darby Phone: Fax: wwd@nei.nih.gov Ms. Patrice Molnar Phone: Fax: molnarp@nigms.nih.gov Ms. Ann Marie Brasile Mejac, AA,CRA Phone: Fax: brasilea@nhlbi.nih.gov

4 IC Program Contacts NIH SBIR/STTR Page 2 of 2 2/17/2016 Fax: jennifer.shieh@nih.gov, nhlbi_sbir@mail.nih.gov Ms. Leslie West-Bushby Phone: Fax: leslie.westbushby@nih.gov National Human Genome Research Institute National Institute of Mental Health National Institute on Minority Health and Health Disparities National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Center for Advancing Translational Sciences National Center for Complementary and Integrative Health National Library of Medicine Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs Centers for Disease Control and Prevention (CDC) Food and Drug Administration (FDA) Administration for Children and Families Dr. Michael W. Smith Phone: Fax: smithmw@mail.nih.gov Dr. Margaret C. Grabb Phone: Fax: mgrabb@mail.nih.gov Mr. Vincent A. Thomas, Jr. MSW, MPA Phone: Fax: thomasvi@mail.nih.gov Ms. Stephanie Fertig Phone: Fax: fertigs@ninds.nih.gov M r. Augusto Diana Phone: Fax: augusto.diana@nih.gov Lili M. Portilla, MPA Phone : Fax : Portilll@mail.nih.gov Dr. John S. Williamson Phone: Fax: williamsonjs@mail.nih.gov Dr. Jane Ye Phone: Fax: yej@mail.nih.gov Dr. Miguel Contreras Phone: Fax: contre1@mail.nih.gov Overall CDC Coordinator: Mr. Sean David Griffiths Phone: sqg3@cdc.gov Dr. Rachel Kaufmann (CSELS) Phone: Fax: RKaufmann@cdc.gov Dr. Virginia Cain (NCHS) Phone: Fax: VCain@cdc.gov Dr. Paul Smutz (NCIPC) Phone: Fax: wsmutz@cdc.gov Dr. Steve Dearwent (NIOSH) Phone: Fax: SDearwent@cdc.gov Ms. Monika Christman Phone: Fax: monika_christman@nih.gov Ms. Rebecca Claycamp Phone: Fax: rclaycam@mail.nih.gov Ms. Priscilla Grant, J.D. Phone: Fax: Priscilla.Grant@nih.gov Ms. Tijuanna Decoster Phone: Fax: decostert@mail.nih.gov Ms. Judy L. Sint Phone: Fax: sintj@mail.nih.gov Ms. Artisha Y. Eatmon Phone: Fax: artisha.eatmon@nih.gov Ms. Shelley Carow Phone: Fax: carows@mail.nih.gov Mr. Dwight Mowery Phone: Fax: moweryd@mail.nih.gov Ms. Artisha Y. Eatmon Phone: Fax: artisha.eatmon@nih.gov Ms. Devi Hawkins (CSELS, NCIPC) Phone: Fax: DHawkins@cdc.gov Sharron Orum (NCHS) Phone: Fax: SOrum@cdc.gov Ms. Mary Pat Shanahan (NIOSH) Phone: Fax: MShanahan@cdc.gov Ms. Kimberly Pendleton Chew Mr. Bryce Jones Phone: Phone: Fax: Bryce.Jones@fda.hhs.gov kimberly.pendleton@fda.hhs.gov Naomi Goldstein Phone: Fax: naomi.goldstein@acf.hhs.gov Karl Koerper Phone: Fax: karl.koeper@acf.hhs.gov

5 SBIR: Small Business Innovation Research Set-aside program to fund small business early stage R&D For small business concerns (SBC) that are organized as for-profit USbased businesses with fewer than 500 employees SBC must do at least 2/3 of R&D work in Phase I, at least 1/2 in Phase II PI must be greater than 50% employed by SBC STTR: Small Business Technology Transfer Basic SBC eligibility same as SBIR Formal cooperative R&D effort with a US research institution SBC must do minimum 40% of work; research institution must do minimum 30% of work PI may be primarily employed by either SBC or research institution Proof- of- Concept study $150,000 over 6 mo (SBIR), 1 year (STTR); max $225,000* NEW Direct-to- Phase II Technology valida-on & clinical transla-on Follow- on funding for SBIR Phase II awardees Expecta-on that applicants will secure substan-al 3 rd - party investor funds $1M per year over 3 years- varies Phase I FEASIBILITY Phase II DEVELOPMENT Fast-Track Application Combined Phase I & II Research & Development Commercializa-on plan required $1M over 2 years; max $1.5M* Benefits of the SBIR/STTR Programs Funding is non-dilutive & doesn t impact company stock Awards are not loans; no repayment is required Intellectual property rights are retained by the small business Awards provide company recognition, verification, and visibility Projects are vetted through NIH s rigorous scientific peer review Can be used as leverage to attract additional funding NCI SBIR Phase IIB Bridge Award CROSSING THE VALLEY OF DEATH FY16 SBIR/STTR Funding ~$877M at NIH ~$13M at NIAAA Phase III COMMERCIALIZATION Commercializa-on stage Use of non- SBIR/STTR funds SBIR/STTR Program Goals Stimulate technological innovation Meet Federal R&D needs Foster & encourage participation in innovation & entrepreneurship by socially & economically disadvantaged persons Increase private-sector commercialization of innovations derived from Federal R&D funding

6 Peer Review & Grant Opportunities at NIH Abraham P. Bautista, Ph.D. Director, Office of Extramural Activities Executive Secretary NACAAA NIAAA/NIH/DHHS

7 National Institutes of Health NIH s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting (INTRAMURAL) and supporting (EXTRAMURAL) research

8 National Institutes of Health (OD) (27 Institutes and Centers) NCI* NEI NHLBI NHGRI NIA NIAAA* NIAID NIAMS NIBIB NICHD NIDCD NIDCR NIDDK NIDA* NIEHS NIGMS NIMH NINDS NINR NLM CIT CSR FIC NCCIH NIMHD NCATS CC *Collaborative Research on Addiction at NIH (CRAN) -

9 NIAAA VISION STATEMENT To support and promote the best science on alcohol and health for the benefit of all by: Increasing the understanding of normal and abnormal biological functions and behavior relating to alcohol use Improving the diagnosis, prevention, and treatment of alcohol use disorders Enhancing quality health care

10

11 Preparation and Submission of Grant Applications and Cooperative Agreements Federal Officials Program Officers/Directors (scientific programs) Scientific Review Officers (first level of review grants and cooperative agreements) Executive Secretaries of Advisory Councils (second level of review) Grants Management Specialists (grants management of funded grants only)

12 Funding Opportunity Announcements (FOA) RFA (Request for Applications) Set-asides RFA AA PA (Program Announcement) No set-asides PA PAS (PA) with set-asides PA PAR (PA with receipt, referral, review info) May or may not have set-aside funding PAR N.B. Applications not responding to an RFA are returned without review.

13 Grants Process at a Glance

14 How to read your Grant Number Type Activity IC Number Year 1 R21 AI A1 2 R01 AA R01 DA S1 9 R01 MH R01 CA S1

15 PEER REVIEW

16 NIH Tips for Applicants (YouTube Video) NIH Tips for Applicants: v=9cnrmscgfho&feature=chann el

17 CENTER FOR SCIENTIFIC REVIEW (CSR) All applications go through the Division of Receipt and Referral CSR. Submission of e-grant applications, Grants.gov Administrative Supplement applications are submitted through Grants.gov or era directly to the institute of the parent grant. (not subjected to peer review).

18 Locus of Review IC Reviews Vs. CSR Reviews Standing study section Vs. Special Emphasis Panel (Rosters of all NIH review panels are available at

19 Integrated Review Groups (CSR), Examples Related Research (AARR) IRG-Study Sections AIDS Immunology & Pathogenesis (AIP) NeurAIDS oaids and End Organ (NAED) AIDS Clinical and Epidemiology (ACE) Risk Prevention Health Behavior (RPHB) IRG-Study Sections Risk, Prevention and Intervention for Addictions (RPIA) Psychosocial Development, Risk and Prevention (PDRP)

20 NIAAA REVIEW SUBCOMMITTEES AA-1 Biomedical Sciences (non-brain) AA-2 Prevention and Epidemiology AA-3 Clinical, Treatment and Health Services AA-4 Neuroscience and Behavior ZAA-1 (Special Emphasis Panel for grants and contracts) ZAA-1 (Special Emphasis Panel for Fellowship applications) ZAA-1 (Special Emphasis Panel for T32/T35 Centers NIAAA & NIDA) ZAA1 SRC 99 is not a study section

21 Review Meetings (Standing IRG, SEP or Editorial Board) Face to face meeting Site visits, reverse site visits included. Internet Assisted Meeting Video Conference Teleconference Mail Review/Editorial Board

22 Review Criteria (R01, R03, U01) Significance Investigators Innovation Approach Environment

23 Review Criteria (R24, U24) Resource Mechanisms Investigators Approach/Innovation Environment

24 SCORING

25 Review Criteria (Fellowships) Candidate Sponsors/Mentors Research Training Plan Training Potential Institutional Support Non-scorable criterion: Training in Responsible Conduct of Research

26 At the Review Meeting Scientific Review Officer: Responsible for the administrative issues. Chairperson and Members: Responsible for the scientific issues.

27 At the Review Meeting Federal Requirement: Confidentiality Conflict of Interest Scientific Misconduct Review Order Discussion of the upper half, scored Streamlining lower half not discussed, no assigned priority score

28 Percentiling R01s are percentiled R01s in RFAs are not percentiled Percentile is the assigned rank of an application based on the scoring pattern of a Study Section (at least 20 applications during the last 3 rounds). E.g. Priority score of 30 may have a percentile of 20%. Priority score of 10 is assigned a percentile of 1%

29 After the review Summary Statements are released within 30 days after the review, or at least 30 days before the Council Meeting, which ever is earlier Scores are released within 3 business days Second Level of Review by the IC s National Advisory Council Funding Recommendation to the IC Directors Grants Management Office for the Issuance of NGA (Notice of Grant Award) Description/Abstract/Total Cost of funded grants reported in for public information

30 Fiscal Year 2015 Funding Update From NIAAA Director s Report to Council NIAAA s final appropriation for NIAAA was $447.2 million. NIAAA awarded 668 research project grants (RPGs), including 156 competing awards, which corresponds to a success rate of 18 percent. NIAAA funded 18 research centers for $28.0 million. NIAAA funded 135 other research grants for $37.2 million, including career awards, one cooperative clinical agreement, and several resource and conference grant awards. NIAAA supported 277 full-time training positions for $12.7 million. NIAAA funding for its research and development contract portfolio was $36.6 million. NIAAA support for intramural research totaled $49.5 million.

31 FISCAL YEAR 2016 NIH received $32.3 billion ($ 2 billion above 2015) NIAAA received $ M ($ 20.5 million or 4.9 % over 2015)

32 NIAAA 2015 Success Rate R01-15% R03-14% R21-14% F30-71% F31-45% F32-24%

33 NIH RePORTER

34

35 Unfunded Applications remain confidential and are not public information

36 RECENT NIH UPDATES Enhancing Reproducibility through Rigor and Transparency ( One of NIH s four stated goals is to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science (see

37 Enhancing Reproducibility through Rigor and Transparency Review criteria will focus on 1. the scientific premise of the proposed research, 2. rigorous experimental design for robust and unbiased results, 3. consideration of relevant biological variables, 4. authentication of key biological and/or chemical resources. Timeline: Guidelines for reviewers will be available before the review of applications for October 2016 Council Cycle.

38 NIAAA Contact Information Office of the Director (George F. Koob, Ph.D, Director, NIAAA) Patricia Powell, Ph.D., Acting Deputy Director NIAAA Kendall Bryant, Ph.D., AIDS/HIV Coordinator Judy Arroyo, Ph.D., Diversity Coordinator Margaret Murray, Ph.D., International Liaison Officer Office of Extramural Activities, NIAAA Abraham P. Bautista, Ph.D., Director ( ) Judy Fox, Chief, Grants Management Branch Ranga Srinivas, Ph.D., Chief Extramural Project Review Branch Division Directors, NIAAA Antonio Noronha, Ph.D. (DNB) Gary Murray, Ph.D. (DMHE) M. Katherine Jung, Ph.D. (NIAAA Small Business Liaison Officer) Ralph Hingson, D. Sc. (DEPR) Robert Huebner, Ph.D. (DTRR) Raye Litten, Ph.D. (DMD)

39 NIAAA-SUPPORTED RESEARCH OVERVIEW M. Katherine Jung, Ph.D. NIAAA Mississippi State University February 24, 2016

40 NIAAA areas of interest DMHE Scientific Programs (1) Alcoholic liver disease occurs in a subset of chronic drinkers, with the progression: steatosis, steatohepatitis, fibrosis, cirrhosis, hepatocellular carcinoma; and in some cases acute hepatitis Alcohol adversely affects the function, homeostasis and integrity of other organs, including: the lung, the gut, pancreas, cardiovascular system, kidney, bone, and muscle Alcohol consumption interferes with immune function, resulting in: increased rates of infection, unchecked inflammation leading to tissue damage, impaired healing, enhanced viral hepatitis, and HIV progression Maternal alcohol consumption during pregnancy can lead to Fetal Alcohol Spectrum Disorders

41 NIAAA areas of interest DMHE Scientific Programs (2) Alcohol intake is associated with specific cancers, including: head and neck, liver, colon, and breast cancers Molecular and cellular processes altered or impaired by alcohol metabolism that may underlie the clinically observed health effects include: organelle stress in mitochondria, endoplasmic reticulum, and proteasomes; oxidative imbalances; epigenetic modifications, inflammation and other metabolic disruptions Biomarkers are needed for early diagnosis of alcohol consumption and alcohol-induced organ damage Director: Dr. Gary Murray (Acting)

42 NIAAA areas of interest Division of Epidemiology and Prevention Research. seeks to reduce alcohol-related mortality and morbidity and other alcohol-related problems and consequences through the integration and application of epidemiology and prevention science. Director: Dr. Ralph Hingson

43 NIAAA areas of interest Division of Neuroscience and Behavior promotes research on ways in which neuronal and behavioral systems are influenced by genetic, developmental, and environmental factors in conjunction with alcohol exposure to engender alcohol abuse and alcoholism. Director: Dr. Antonio Noronha

44 NIAAA areas of interest Division of Treatment and Recovery Research. supports research to better understand the natural history of excessive drinking and alcohol use disorders and factors associated with positive change. Director: Dr. Robert Huebner (Acting)

45 NIAAA areas of interest Division of Medications Development focuses on pharmacological treatment for alcohol use disorder (AUD) and supports clinical research programs. Director: Dr. Raye Litten (Acting)

46 Grant Mechanisms R01 R21 R03 F31 F30 F32 T32 Research Research Project Grant Exploratory/Developmental Research Grant Small Grant Training Individual Predoc Individual MD/PhD Predoc Individual Postdoc Institutional Training Grant Career Development K99/R00 NIH Pathway to Independence Award K01 Mentored Research K02 Independent Scientist K08 Mentored Clinical Scientist Research K23 Mentored Patient-Oriented Research K24 Midcareer Investigator Award in Patient-Oriented Research

47 Research grants R01 Research Project Grant Single project New and established investigators R21 Exploratory/Developmental Research Grant High risk/high yield Limited time and $$ No pilot data necessary R03 Small Grant Pilot project Limited time and $$

48 For everyone Contact your program officer Before you start to write a grant application To see if the topic area is of interest to, is a priority for, NIAAA (Funding is limited.) For advice on choice of mechanism (R21 vs R01, which F grant or K grant) While preparing the application With questions that arise along the way

49 For everyone Contact your program officer After you have received funding With any questions that arise Only exception: After application submission and until review has been completed, your point of contact is the Scientific Review Officer (SRO).

50 Getting started The mechanics of applying Register early at grants.gov and ecommons Can take 8 weeks SF-424 Form and Instructions for your mechanism Page limits, specific requirements Your university submits the grant to NIH, so work with your grants office ahead of time.

51 Getting started The mechanics of applying Read Instructions carefully Who will be responsible for completing the different forms within the application? When must your grants office receive the forms in order to submit on time? Submit well before the deadline, in case of glitches

52 Getting started Strategies for a competitive application State rationale clearly Be organized, lucid, succinct Never assume reviewers will know what you mean Present a thorough and accurate literature review Propose work that can be realistically completed within the project s time-frame Perform power analysis Publish regularly in high quality journals Recruit expert collaborators to the project when needed (and obtain letters from collaborators)

53 Getting started Strategies for a competitive application Ask others to review your application ahead of time- the more people the better- Who: Colleagues in your lab, in your department, outside your department, those in a different field. Listen to the advice and be willing to make necessary changes.

54 Review and Award Cycles Cycle 1 Cycle 2 Cycle 3 Receipt date ScienJfic Merit Review Advisory Council Round Earliest Project Start Date February- March June- July October- November June - July October - November October January May December April July February - March

55 Career development Career Development Awards K99/R00 NIH Pathway to Independence Award K01 Mentored Research Scientist K02 Independent Scientist K08 Mentored Clinical Scientist Research K23 Mentored Patient-Oriented Research K24 Midcareer Investigator Award in Patient- Oriented Research

56 Career development K99/R00 NIH Pathway to Independence Award Eligibility < 4 years post-doc research Duration 1-2 years mentored post-doc; 3 years independent support K99 Salary up to $90,000 DC Research $$ up to $50,000 DC R00 Research $$ up to $249,000 TC

57 Training Support National Research Service Awards (NRSA) Pre- doctoral InsJtuJonal T32 Individual F30 F31 Max 5 years of aggregate NRSA support, any combinajon of T32 and individual grant. Post- doctoral InsJtuJonal T32 Individual F32 Max 3 years of aggregate NRSA support, any combinajon of T32 and individual grant.

58 Training Support Fellowship review criteria Applicant Sponsor Research training plan Training potenjal InsJtuJonal and Training environment Also Human subjects/vertebrate animals Training in the responsible conduct of research

59 Training Support Fellowship review criteria Important factors: Commitment of the trainee to alcohol research Mentor s success in the alcohol field and in mentoring trainees

60 Updates Changes in Biosketch Contents NOT-OD Length up to 5 pages!!! A. Personal Statement: aspects training; previous work & technical experase; collaborators or scienafic environment; past performance. B. PosiJons and Honors C. ContribuJons to Science Briefly describe up to five of your most significant contribuaons to science. Up to 4 relevant peer- reviewed publicaaons for each contribuaon. D. Research Support

61 What does it mean to be compliant with the new biosketch policy? CompleAng each secaon (A - Personal Statement; B PosiAons and Honors; C ContribuAons to Science; D Research Support or ScholasAc Performance) Including no more than 5 contribuaons to science with no more than 4 citaaons per contribuaon Ensuring that if you include the opaonal link to a full list of your published work in a site like My Bibliography that the URL is public, that it meet all requirements in the instrucaons.

62 What does it mean to be compliant with the new biosketch policy? (2) Refraining from including informaaon, such as preliminary data, that belongs elsewhere in the applicaaon Following NIH guidance on font type, font size, paper size, and margins (See secaon 2.6 of applicaaon guide) Using PDF format for your biosketch a[achment LimiAng the length of your biosketch to 5 pages or less

63 Update No limit on resubmission NOT-OD following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate due date.

64 SBIR/STTR SBIR Small Business InnovaAon Research STTR Small Business Technology Transfer

65 SBIR/STTR SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM Set- aside program for small business concerns to engage in Federal R&D - - with potenjal for commercializajon. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM Set- aside program to facilitate cooperajve R&D between small business concerns and U.S. research insjtujons - - with potenjal for commercializajon.

66 SBIR/STTR NIH SBIR/STTR 3- Phase Program PHASE I Feasibility Study Budget Guide: $150K (SBIR); $150K (STTR) Total Costs $225K Project Period: 6 months (SBIR); 1 year (STTR) Flexible PHASE II Full Research/R&D $1M (STTR), $1M (SBIR) over two years $1.5M, years flexible PHASE IIB CompeAng Renewal/R&D Clinical R&D; Complex InstrumentaAon/Tools to FDA Many, but not all, ICs paracipate NIAAA parjcipates Varies ~$1M/year; 3 years To be determined case by case PHASE III CommercializaAon Stage NIH, generally, not the customer Consider partnering and exit strategy early

67 SBIR/STTR SBIR STTR 1 [R43] Phase I Phase I [R41] 1 2 [R44] Phase II Phase II [R42] 2 FastTrack Type 1 R44 FastTrack Type 1 R42

68 NIH SBIR/STTR Budget Allocations FY2015 NIAMS NIEHS NHGRI NIAAA NIMHD NIDCR NIDCD NIBIB ORIP NINR NCCAM NLM NCI 2.9% SBIR $690M 0.40% STTR $95M Total FY2015 $786M NCATS NEI NIDA NIA NIAID NICHD NIMH NINDS NHLBI NIDDK NIGMS

69 Small businesses must be up- to- date on FIVE registrajons 1) SAM = System for Award Management (formerly CCR) MUST BE RENEWED ANNUALLY 2) DUNS 3) Grants.gov 4) era Commons 5) Small Business AdministraJon (SBA) Company Registry If the SBC moves, changes their address, or changes their name, they will have to go into all of the systems and update their informajon.

70 32 New hfp//sbir.nih.gov

71 SBIR/STTR New SBIR/STTR Standard Due Dates * EffecJve September 5, 2015 Cycle I Due Date Cycle II Due Date Cycle III Due Date September 5 January 5 April 5

72 Thank you For more information, please contact: Kathy Jung -- Oh, and Talk to your program officer!

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