SBIR July Webinar Overview of the HHS SBIR/STIR Programs, ft. Dr. Matt Portnoy

1. Small Business Administration Office of Investment and Innovation SBIR July WebinarOverview of the HHS SBIR/STIR Programs, ft. Dr. Matt Portnoy July 15, 2013 – Washington, D.C.

2. Agenda Updates Introduction to Dr. Matthew Portnoy Presentation Q&A

3. Updates • Frequently Asked Questions (FAQs) • http://www.sbir.gov/faq/general • Previous webinars • http://www.sbir.gov/content/sbir-webinars-posted-online • Technical concerns • http://www.sbir.gov/feedback

4. Featured Speaker Matthew Portnoy, Ph.D. • NIH SBIR/STTR Program Coordinator; and Director, Division of Special Programs, Office of Extramural Programs, Office of extramural Research, NIH  • Formerly program director of the National Institute of General Medical Sciences (NIGMS) • Former SBIR/STTR program lead for NIGMS • BS from Penn State University, PhD from Johns Hopkins University

5. Overview of the HHSSBIR/STTR Programs SBA Webinar July 15, 2013 Matthew Portnoy, Ph.D. SBIR/STTR Program Coordinator Office of Extramural Research, NIH

6. SBIR/STTR Budgets by Agency, FY2012 ~ $2.4B in FY12 across all agencies

7. SBIR Eligibility Criteria From 1/28/2013 FOAs going forward • Organized as for-profit U.S. business • Small: 500 or fewer employees, including affiliates • PD/PI’s primary employment must be with small business concern at time of award and for duration of project period • Greater than 50% U.S.- owned by individuals and independently operated or Greater than 50% owned and controlledby other business concern/s that is/are greater than 50% owned and controlled by one or more individuals OR • NIH Only Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these

8. NIH Mission 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 illness and disability.

9. National Institutes of Health Office of Research Infrastructure Programs Office of the Director http://www.nih.gov/icd National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute of Dental and Craniofacial Research National Institute on Deafness and Other Communication Disorders National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Institute on Minority Health and Health Disparities National Institute of Biomedical Imaging and Bioengineering National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Advancing Translational Sciences National Library of Medicine NIH Clinical Center Center for Information Technology Center for Scientific Review No funding authority

10. PHASE I Feasibility Study • Budget Guide: $150K (SBIR); $150K (STTR) Total Costs • Project Period: 6 months (SBIR); 1 year (STTR) • PHASE II Full Research/R&D • $1M (STTR), $1M (SBIR) over two years • PHASE IIBCompeting Renewal/R&D • Clinical R&D; Complex Instrumentation/Tools to FDA • Many, but not all, ICs participate • Varies ~$1M/year; 3 years • PHASE III Commercialization Stage • NIH, generally, not the “customer” • Consider partnering and exit strategy early NIH SBIR/STTR 3-Phase Program

11. NIH SBIR/STTR Budget Allocations FY2013 2.7% SBIR $617M 0.35% STTR $80M Total FY2013 $697M

12. HHS Program Funding

13. NIH-wide SBIR/STTR Success Rates

14. NIH Website & Reauthorization pages http://sbir.nih.gov Standard Due Dates: Apr 5; Aug 5; Dec 5

15. NIH Website Reauthorization pages • http://grants.nih.gov/grants/funding/sbir/reauthorization.htm

16. Key Re-Authorization Provision Set aside requirements for Agencies will increase

17. Solicitations and Due Dates • NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation ** • Release: January • Standard Due Dates: April 5, Aug 5, Dec 5 • (AIDS/AIDS-related: May 7, Sept 7, Jan 7) • SBIR Contract Solicitation (NIH, CDC) • Release: August November 2013 close date • NIH Guide for Grants and Contracts • Release: Weekly Receipt dates specified in each FOA • (http://grants.nih.gov/grants/guide/index.html) “Parent” FOAs:SBIR: PA-13-234STTR: PA-13-235

18. Important changes in this year’s Omnibus Grant Solicitations • See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-071.html for details. • New SBIR/STTR award budget HARD caps in place Award Guidelines Award Hard Caps – cannot exceed

19. Important changes in this year’s Omnibus Grant Solicitations • Technical Assistance option • NIH offers distinct technical assistance programs to SBIR Phase I and Phase II awardees(Niche & CAP) • Applicants wishing to utilize their own technical assistance vendor are required to include this in your budget and provide a detailed budget justification. • Please note, if funds are requested to utilize your own technical assistance vendor and an award is made, the awardee is not eligible to apply for the NIH-provided technical assistance program for the phase of their award.

20. New provisions implemented in this year’s Omnibus Grant Solicitations • SBIR/STTR applicants must register at the SBA Company registry at SBIR.gov. • VC-backed companies (VCOC, Hedge fund, private equity firm) CAN NOW apply at this time (NIH SBIR only).

21. SBA Registry Instructions a. Navigate to the SBA Company Registry. b. If you are a previous SBIR/STTR awardee from any agency, search for your small business by Company Name, EIN/Tax ID, DUNS, or Existing SBIR/STTR Contract/Grant Number in the search fields provided.  Identify your company and click “Proceed to Registration”. c. If you are a first time applicant, click the New to the SBIR Program? link on lower right of registry screen. d. Fill out the required information on the “Basic Information” and “Eligibility Statement” screens. e. Press “Complete Registration” on the lower right of the “Eligibility Statement” screen and follow all instructions. f. Download and save your SBA registry PDF locally.  The name will be in the format of SBC_123456789.pdf, where SBC_123456789 (9 digit number) is your firm’s SBC Control ID.  DO NOT CHANGE OR ALTER THE FILE NAME.  Changing the file name may cause delays in the processing of your application. g. When you are completing the application package, attach this SBA registry PDF as a separate file by clicking Add Attachments located to the right of Other Attachments on the “Research and Related Other Project Information” form. For questions and for technical assistance concerning the SBA Company Registry, please contact the SBA at http://sbir.gov/feedback?type=reg.  

22. VC-backed Small Business Instructions NIH Only - SBIR Application Certification for small business concerns majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms Applicant small business concerns that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (e.g. majority VCOC-owned) are required to submit a Certification at time of their application submission per the SBIR Policy Directive.  Follow the instructions below.  Applicants small business concerns who are more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these (i.e. NOT majority VCOC-owned) should NOT fill out this certification and should NOT attach it their application package. a. Download the “SBIR Application VCOC Certification.pdf” at the NIH SBIR Forms webpage.  b. Answer the 3 questions and check the certification boxes. c. The authorized business official must sign the certification. d. Save the certification using the original file name.  The file must be named “SBIR Application VCOC Certification.pdf”.  DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application. e. When you are completing the application package, attach this certification as a separate file by clicking Add Attachments located to the right of Other Attachments on the “Research and Related Other Project Information” form.

23. New provisions NOT implemented in this year’s Omnibus Grant Solicitations at this time • 1. No Switching mechanisms at Phase II • Applicants cannot apply for Phase II SBIR funding based on a Phase I STTR award or conversely  a Phase II STTR based on a Phase I SBIR award. Similarly, applicants cannot apply for a Phase IIB SBIR or STTR based on a Phase II STTR or SBIR award, respectively. • No Direct Phase II applications (pilot FOAs when implemented) • Why not? NIH is currently updating its electronic systems and forms for these provisions.

24. SBIR/STTR Program Descriptions and Research Topics Our Ideas: Suggested topic areas* Biodefense Biosensors Nanotechnologies Bioinformatics Diagnostic and Therapeutic Devices Telehealth Proteomics / Genomics Biosilicon devices Biocompatible materials Acousto-optics /opto-electronics Health IT Imaging devices Genetically engineered proteins …

25. Your Ideas: Investigator-initiated R&D • Research projects related to the NIH mission • “Other” areas of research within the mission of an awarding component SBIR/STTR Program Descriptions and Research Topics Our Ideas: Suggested topic areas* Biodefense Biosensors Nanotechnologies Bioinformatics Diagnostic and Therapeutic Devices Telehealth Proteomics / Genomics Biosilicon devices Biocompatible materials Acousto-optics /opto-electronics Health IT Imaging devices Genetically engineered proteins … Keyword search the Solicitation Ctrl - F

26. Targeted SBIR/STTR Funding Opportunity Announcements • NIH Guide for Grants and Contracts • High priority areas for ICs • Various IC participation • Nuances: • Various due dates • Additional review criteria • Limited funds • Varying project periods • Etc. http://grants.nih.gov/grants/funding/sbir_announcements.htm

27. Electronic Submission • SBIR/STTR grant applications must be submitted electronically. SBIR contract proposals still in paper form. • Registrations are required!!! • System for Award Management (SAM) • Grants.gov (company) • eRA Commons (company and all PD/PIs) • SBA company registry at SBIR.gov http://era.nih.gov/ElectronicReceipt/index.htm

28. Finding Help for grant Submissions Grants.gov Contact Center • Toll-free: 1-800-518-4726Hours : 24x7 (Except Federal Holidays)Email : support@grants.govResources: http://www.grants.gov/help/help.jsp • Support for: Grants.gov Registration, form behavior, submission eRA Commons Help Desk • Web: http://era.nih.gov/help/index.cfm#eraPhone: 1-866-504-9552TTY: 301-451-5939Hours : Mon-Fri, 7a.m. to 8 p.m. ET • Support for: Commons Registration, eRA system validations, Application Status, Post-submission questions

29. Small Business Concern NIH Center for Scientific ReviewAssignto IC and IRG Applicant Initiates Research Idea Scientific Review Groups Evaluate Scientific Merit Advisory Council or Board Recommend approval IC Allocates Funds NIH Application and Review Process Submits SBIR/STTR Grant Application to NIH Electronically ~2-3 months after submission ~2-3 months after review IC Staff Prepare funding Plan for IC Director Grantee Conducts Research

30. Review Criteria Overall Impact Score Scored Review Criteria (score 1-9) • Significance (Real Problem/Commercial Potential) • Investigators (PI and team) • Innovation (New or Improved?) • Approach (Research Design, Feasible) • Environment (Facilities/Resources) • Additional Review Criteria (not scored individually) • Protection of Human Subjects • Inclusion of Women, Minorities & Children • Vertebrate Animals • Biohazards

31. Timeline: New Applications Due Date April 5 August 5 December 5 <……………….……6-9 months…………………….> 4 2 5 Council Review October January May Award Date (earliest) December April July Scientific Review July November March

32. Common Application Problems • No Significance • Unimportant problem, unconvincing case for commercial potential or societal impact • Inadequately defined test of feasibility • Lack of innovation • Diffuse, superficial, or unfocused research plan • Questionable reasoning in experimental approach • Failure to consider potential pitfalls and alternatives • Lack of experience with essential methodologies • Unfamiliar with relevant published work • Unrealistically large amount of work proposed

33. Competing Successfully for SBIR/STTR Funding • Understand our mission. • Review Funding Opportunity Announcements (FOAs). • Propose innovative ideas with significance as well as scientific and technical merit. • Give yourself ample time to prepare application. • Communication. Communication. Communication. • Contact NIH Staff to discuss • your research idea. • outcome of your review. • challenges and opportunities.

34. Mt. “FDA” NIH SBIR/STTR: 3-Phase Program Plus Gap Funding Phase II Competing Renewal Award Feasibility Full R/D Phase I Phase II Phase III (Phase I-Phase II Fast-Track) $3M/3 years

35. Phase I Final Report 7-9 months Phase I Award Aims/Milestones Met Phase II award Phase II award Aims/Milestones NOT Met NIH Phase I/Phase II Fast-Track SBIR/STTR Phase I + Phase II (Simultaneous Submission and Concurrent Review) Program Staff assess completion of specific aims and milestones Completion of Phase I Go? No Go? NIH SBIR/STTR Program Specifics

36. Phase IIB Competing Renewal Award Parameters • SBIR/STTR Phase II awardee • Promising pharmacologic compound identified in original Phase II • Device prototype developed in original Phase II • Instrumentation/Interventional technologies not subject to FDA regulatory approval but require extraordinary time/effort to develop • Awards up to $1M/year for up to 3 years • IC must accept Phase IIB applications • (NIA, NIAAA, NIAID,NICHD, NIDA, NIDCD, NIDDK,NEI, NIGMS NHLBI, NIMH, NINDS,NCATS, ORIP, NCI) Contact NIH Program Staff to discuss NIH SBIR/STTR Program Specifics

37. Mt. “FDA” ??? NIH Technical Assistance Program Helping Companies cross the “Valley of Death” Niche Assessment Program Commercialization Assistance Program Phase I Phase II Phase III “In-NIH-vative” Approaches

38. 125 recent Phase I SBIR/STTR companies per year • Vendor prepares Technology Niche AnalysesTM • Identifies alternative uses for technology, competitive advantage, market entry strategy NIH Technical Assistance Programs • Commercialization Assistance Program (CAP) • Niche Assessment Program (Foresight S&T) • (Humanitas Inc and Larta Inc) • 75 Phase II SBIR/STTR companies per year • Business & strategic planning (9 month hands-on program) • Help build strategic alliances and investor partnerships

39. NIH SBIR/STTR Program Summary of Key Features • SBIR and STTR Program • Single SBIR/STTR grant solicitation • Investigator-initiated research ideas • Special Funding Opportunities (NIH Guide for Grants and Contracts) • Electronic Submission (grants only) • Awards: Grants, Contracts, Cooperative Agreements • External Peer Review • Option to request review group • Experts from Academia/Industry • 5 Criteria: Significance, Approach, PI(s), Innovation, Environment • Summary Statement for all applicants • Revise & resubmit • Gap Funding Programs • Phase IIB Competing Renewals • Ph I/Ph II Fast Track • Administrative Supplements • Multiple Receipt Dates (Grants) • April 5, August 5, December 5 • May 7, September 7, January 7 (AIDS) • Contracts: Early November • Budget and Project Period • $150K/6 -12months (Ph I) • $1M/2 yrs (Ph II) • Technical Assistance Programs • Technology Niche Assessment • Commercialization Assistance

40. Stay Informed… • NIH Guide for Grants and Contracts (weekly notification) http://grants.nih.gov/grants/guide/listserv.htm • NIH SBIR/STTR Notification Send email to LISTSERV@LIST.NIH.GOV with the following text in the message body: subscribe SBIR-STTR your name.

41. 15th Annual NIH SBIR/STTR Conference • October 28-30, 2013 • Sioux Falls, South Dakota • Hosted by University of South Dakota Research Park, Inc. • Theme: How to Be Competitive in a World of Change: Opportunities Through SBIR/STTR Awards • Presentations from NIH program staff and other experts • Opportunities for one-on-one meetings with staff representing most NIH institutes and centers • Poster session providing examples of NIH-funded SBIR and STTR projects • “Pitch to Investors” panel to educate attendees as to investor expectations.Registration is OPEN! www.usdresearchpark.com

42. sbir@od.nih.gov Follow us @NIHsbir Matthew Portnoy, PhD NIH SBIR/STTR Program Coordinator Phone: 301- 435-2688 Email: mportnoy@mail.nih.gov For More Information Lenka Fedorkova, PhD SBIR/STTR Program Analyst Phone: 301-435-0921 Email: lenka@nih.gov Robert Vinson SBIR/STTR Program Analyst Phone: 301-435-2713 Email: vinsonr@mail.nih.gov Betty Royster SBIR/STTR Communications Specialist Subscribe to the SBIR/STTR List Serv: Email LISTSERV@LIST.NIH.GOV with the following text in the message body:subscribe SBIR-STTR your name