NIAID Small Business Program

Transcription

1 National Institute of Allergy and Infectious Diseases (NIAID), NIH NIAID Small Business Program Natalia Kruchinin Ph.D. SBIR/STTR Program Coordinator NIAID 1

2 Agenda Small Business (SBIR/STTR) program SBIR/STTR Reauthorization Act of 2011 Implementation Of Key Changes Eligibility Award sizes Direct to Phase II pilot program Switching between SBIR and STTR Technical assistance Keys to a Strong Application and where to find information Dr. Minnicozzi NIAID Mission of Extramural Research 2

3 Congressionally-mandated set-aside programs Small Business Innovation Research (SBIR) Set-aside program for small business concerns to engage in Federal R&D - with potential for commercialization Small Business Technology Transfer (STTR) Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions with potential for commercialization One of the largest sources of early-stage technology financing in the United States 3

4 SBIR/STTR programs - Objectives Congress designated 4 major goals: To stimulate technological innovation Strengthening the role of small business in meeting Federal R&D needs Increasing private sector commercialization of innovations developed through Federal SBIR R&D Foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns Small Business Innovation Development Act of 1982 P.L Re-Authorizes program through FY2017 4

5 Small Business program-history The SBIR program was established under the Small Business Innovation Development Act of 1982 The STTR Program was established by the Small Business Technology Transfer Act of 1992 December 31, 2011, the SBIR/STTR Reauthorization Act of 2011 was signed into law New legislation reauthorizes the SBIR and STTR programs through September 30, 2017, incrementally increases the $ set aside: SBIR effort to 3.2% by FY2017 and beyond STTR activity to 0.45% in FY2016 and beyond 5

6 SBIR/STTR Reauthorization Act NIH s SBIR and STTR Programs are getting more flexible (and complicated) as a result of the Reauthorization See what changes have been made and are coming up: If you have questions contact your SBIR/STTR Program Officer or sbir@od.nih.gov Work with your state SBDC ( or SBA District Office ( 6

7 SBIR/STTR Congressionally-Mandated Programs Set Aside 2.9% SBIR 0.4% STTR ~$786M FY 2015 NIH ~$121M FY 2015 NIAID 7

8 Reasons to Seek SBIR & STTR Funding Provides seed funding for innovative technology development projects Not a loan no repayment is required Intellectual property rights are retained by the small business concern Doesn t impact stock or shares in any way (no dilution of capital) Provides recognition, verification and visibility Can be a leveraging tool to attract other funding (VC, etc.) 8

9 Important Facts to Remember Your project must fit with the mission of the NIH/institute Eligibility is determined at time of award The pre-award process involves communication between the NIH and the applicant organization, and includes negotiation if significant adjustments are required prior to award PI is not required to have a Ph.D./M.D. PI is required to have expertise to oversee project scientifically and technically Applications may be submitted to different agencies for similar work Awards may not be accepted from different agencies for duplicative projects SBIT/STTR Phase I applications may be submitted to different agencies for SBIR/STTR Phase II 9

10 SBIR & STTR: Three-Phase Program Proof-of-Concept study SBIR/STTR Direct To Phase II Research & Development Commercialization plan required Phase I FEASIBILITY Phase II DEVELOPMENT Phase III COMMERCIALIZATION Fast-Track Application Combined Phase I & II Commercialization stage Use of non-sbir/sttr funds

11 SBIR Program Eligibility Criteria Applicant is a Small Business Concern (SBC): 500 or fewer employees, including affiliates Organized as for-profit U.S. business Work must be done in the U.S. (with few exceptions) PD/PI s primary employment (>50%) must be with small business concern at time of award and for duration of project period > 50% U.S.- owned by individuals and independently operated OR >50% owned and controlled by other business concern/s that is/are >50% owned and controlled by one or more individuals * OR Be a concern which is >50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these * *Formerly >= 51%; * New rule starting 1/28/13, NIH SBIR only 11

12 STTR Program Eligibility Criteria Applicant is a Small Business Concern (SBC) Organized for -profit U.S. business Formal cooperative R&D effort Minimum 40% by small business Minimum 30% by US research institution US Research Institution: college or university; non-profit research organization; Federally -Funded R&D Center (FFRDC) Principal Investigator s primary employment may be with either the SBC or the research institution SBC must have right to IP to carry out follow -on R&D and commercialization 12

13 Venture Capital Companies Small business concerns that are majority-owned by multiple venture capital operating companies (VCOCs), hedge funds and/or private equity firms ARE NOW ELIGIBLE to apply (NIH SBIR only, CDC SBIR as of 7/10/14 for new solicitations) See NOT-OD : SBIR and STTR VCOC forms available at: *Note: SBIR VCOC form also used for SBIR contracts 13

14 SBA implemented the new size rule What is the size rule? New provision regarding an agency option to allow participation by firms that are majority-owned by multiple venture capital operating companies, private equity firms or hedge funds The size rule is found at the following links: All SBC receiving an SBIR or STTR program award for solicitations posted after January 28, 2013 must comply with the size rule SBA has posted at a Guide to SBIR/STTR Program Eligibility that summarizes and explains the size rule and its changes to program eligibility requirements Check the FAQ at SBA site 14

15 Differences between the SBIR and STTR programs Both programs (STTR and SBIR) seek to increase the participation of small businesses in Federal R&D and to increase private sector commercialization of technology developed through Federal R&D Unique feature of the STTR program: Requirement for the small business concern applicant organization to formally collaborate with a research institution Principal Investigator (PI) SBIR Primary employment must be with small business (at the time of award and for the duration of the project period) STTR PI may be employed by either small business or research institution, and must commit minimum of 10% effort to project Research partner Permits research partnerships Small business must do 67% Phase I 50% Phase II Requires partnering with US research institution Small business min. 40%, Research institution min. 30% Award always made to small business 15

16 Award sizes STTR award sizes (guideline amounts) are increased to match SBIR amounts According to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $150,000 for Phase I awards and $1,000,000 for Phase II awards With appropriate justification from the applicant, Congress will allow awards to exceed these amounts by up to 50% ($225,000 for Phase I and $1,500,000 for Phase II) NIH has received a waiver from SBA to exceed the hard cap for specific topics The list of approved topics can be found in Appendix A at the end of PHS SBIR/STTR Program Descriptions and Research Topics* for NIH, CDC, FDA and ACF * 2015 SBA approved topics list for budget waivers: Waiver FINAL2.pdf 16

17 Award sizes The applicant is not limited to topics on the NIAID research topics approved by SBA, all topics on the NIH list can be funded at a higher budget without a separate waiver request NIAID will allow Phase I applications with budgets of up to $300,000 total costs per year for up to 2 years; and Phase II or Phase IIB applications with budgets of up to $1,000,000 total costs per year for up to 3 years 17

18 Award sizes Applicants are required to follow the Award Budget instructions within each NIH SBIR/STTR solicitation Requests for these budget levels must be very well-justified That does not mean that NIAID will automatically award the higher budget, the applicant still must provide an appropriate budget and justification for a budget that exceeds the SBIR/STTR hard caps In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project 18

19 SBIR & STTR: Award Project Period SBIR According to statutory guidelines, award periods normally may not exceed Phase I Phase II 6 months 2 years STTR According to statutory guidelines, award periods normally may not exceed Phase I Phase II 1 year 2 years 19

20 Direct to Phase II pilot FOA 20

21 Direct to Phase II pilot FOA Allows small businesses that are ready for the Phase II stage of development to bypass applying for a Phase I grant Designed for SBCs that have completed Phase I-type milestones with non-sbir funds Have preliminary data that is equivalent to what we expect from the end of an NIH Phase I award Pilot SBIR Direct to Phase II Solicitation: it s own SEPARATE FOA: PAR Applies to SBIR programs only, NOT STTR and not available for the CDC, FDA, and ACF SBIR programs Note: Not all ICs will accept Direct Phase IIs only the ones listed on the solicitation. SBCs cannot apply for a Phase II and Direct Phase II for the same research project. 21

22 Direct to Phase II pilot FOA All ICs on the Direct Phase II FOA will accept technology on anything within their mission. Note: NINDS has a few exceptions listed within the FOA. Applicants are strongly advised to talk to their SBIR Program Officer before applying Some ICs may issue their own separate Direct Phase II FOA/s in the future A Direct Phase II is not a Phase IIB! Effective until 2017 (No due dates past 12/5/16 standard date) 22

23 Direct to Phase II pilot FOA How is a Direct Phase II different than a Fast-track? A Fast Track incorporates a submission and review process in which both Phase I and Phase II grant applications are submitted and reviewed together as one application Intended to reduce or eliminate the funding gap between phases Which one is right for you? Talk to your SBIR Program Officer! 23

24 Direct to Phase II pilot FOA What is the review process? Application goes to NIH Center for Scientific Review Application is assigned a small business study section Review staff have guidance on the new FOA, It s too early to know the volume or the success rate but seems to be similar to a Phase I success rate 24

25 Switching between SBIR and STTR NIH SBIR/STTR applicants may now switch programs at Phase II or Phase IIB to any active NIH SBIR/STTR solicitation Which means: Phase I STTR Awardees may apply for NIH SBIR or STTR Phase II Phase I SBIR Awardees may apply for NIH SBIR or STTR Phase II Phase II STTR Awardees may apply for NIH SBIR or STTR Phase IIB Phase II SBIR Awardees may apply for NIH SBIR or STTR Phase IIB Note that NIAID accept Phase IIB SBIR applications only. Check the Omnibus Topics document for listing: 25

26 Technical assistance The amount of SBIR funds permitted to be used for technical assistance is raised from $4,000 to $5,000 per award per year This is to be in addition to the award amount for both Phase I and Phase II Awardees may contract this amount to a provider other than the vendor selected by the agency Applicants wishing to utilize their own technical assistance vendor are required to include this in the budget and provide a detailed budget justification NIH offers distinct to SBIR/STTR Phase I and Phase II awardees, Niche Assessment Program (NAP) & Commercialization Accelerator Program (CAP)! If requested, cannot participate in NIH Technical Assistance Programs 26

27 First step in the process Informal discussion with potential customers, experts in the field and other parties who will be essential to the future of your company Collect letters supporting the application from all collaborators, consultants, potential customers, investors, commercial partners If the company plans to use facilities at other research institutions, reviewers often expect a letter from the administration of the institution confirming the facilities will be available Review similar, currently funded NIH projects NIH Project RePORTER Contact the appropriate NIH Program Director in advance (at least 1 month before due date!) to discuss your specific aims and receive feedback 27

28 NIH RePORTER 28

29 Search Previous Awards 8hits 29

30 Five Step Registration Process Start Early Registration can take 6-8 weeks! 1. DUNS: 2. SAM.gov: 3. Grants.gov: Federal-wide portal to find and apply for Federal grant funding 4. eracommons: NIH s system that allows applicants, grantees and Federal staff to share application/grant information 5. SBA Registry: Must register and attach proof of registration to your application. 30

31 NIH SBIR/STTR FOAs Located on the NIH SBIR/STTR Homepage: SBIR/STTR Omnibus Solicitation NIH SBIR Direct Phase II Targeted FOAs NIH SBIR Contract Solicitation 31

32 Stream-lining the Award Process HHS Changes Standard Due Dates for SBIR/STTR Grant Applications Effective September 5, 2015! See NOT-OD Old SBIR/STTR Standard Due Dates Cycle I Due Date Cycle II Due Date Cycle III Due Date April 5 August 5 December 5 New SBIR/STTR Standard Due Dates Cycle I Due Date Cycle II Due Date Cycle III Due Date September 5 January 5 April 5 Effective September 5, 2015, SBIR/STTR grant applications will no longer be accepted on AIDS and AIDS-related Due Dates (May 7, September 7, and January 7) 32

33 Timetable for SBIR and STTR Grant Applications (As of September 2015) Due Dates Advisory Earliest Project Council Round Start Date September 5 January April January 5 May July April 5 August September- December 33

34 ASSIST Now an Option for Small Business Grant Applications Notice Number: NOT-OD On-line system for the preparation, submission and tracking of grant applications through Grants.gov to NIH ASSIST is not required so SBC can still apply using Grants.gov s downloadable form method ASSIST provides users: Secure web-based data entry Collaboration of multiple users Pre-submission validation of many NIH and Grants.gov business rules Pre-population of data from era Commons profiles Pre-submission print/preview of application in NIH format Submission status tracking for both Grants.gov and era Commons within a single system Ability to import subaward budget forms Ability to copy application data (excluding attachments) from a previously prepared application 34

35 Help Desks eracommons Help Desk Web: Phone: TTY: Hours : Mon-Fri, 7a.m. to 8 p.m. ET Grants.gov Contact Center Toll-free: Hours : 24x7 (Except Federal Holidays) support@grants.gov Resources:

36 The NIH/CDC SBIR Contract Solicitation PHS Has Been Released! The NIH and CDC SBIR Contract (PHS ) has been released! All proposals are due by October 16, 2015, 5:00 PM EDT The HHS SBIR Contract Now Requires Electronic Submission! Applicants must use the Contract Proposal Submission (ecps) website to submit their proposal Please check NOT-OD ( for topics, contracting officer contact information and other details RFP Updates and Questions and Answers pdf 36

37 SBIR Contracts vs. Grants Scope of the proposal Questions during solicitation period? SBIR Grants Investigator-defined within the mission of NIH May speak with any Program Officer SBIR Contracts Defined (narrowly) by the NIH MUST contact the Contracting officer Receipt Dates 3 times/year for Omnibus Only ONCE per year Reporting Set-aside funds for particular areas? Program Staff Involvement One final report (Phase I); Annual reports (Phase II) No Low Kickoff presentation, quarterly progress reports, final report, commercialization plan Yes High 37

38 Cover Letter The cover letter should be used for a number of important purposes: List one request per line: Suggest Institute/Center assignment Suggest study section assignment Identify individuals in potential conflict and explain why Identify areas of expertise needed to evaluate the application Discuss any special situations It is NOT appropriate to use the cover letter to suggest specific reviewers 38

39 Keys to a Strong Application: Significant, innovative, and focused science Identify an area of current controversy and importance within your field Are you dealing with key questions or controversies in the field? What are the areas where you feel you ll be unique? Your advantage over competitors, etc. Significant commercial potential Product-focused applications Have you discussed this idea with potential end-users/customers? During the review meeting, your application is your only advocate in the room Be as clear as possible Identify and articulate detailed, quantifiable milestones that will be achieved during the project period. Define your metrics for success Strong team and collaborators appropriate for the problem Have clinicians involved: Oncologists, Pathologists, Radiologists Other relevant scientists/professionals involved, e.g., biostatisticians 39

40 Always Consider the Reviewers Who is going to review your application? 10 or more on the Review Panel who will score your application However, primary review by 2-4 persons with appropriate expertise assembled by Scientific Review Administrator Combination of academic and business professionals SBIR/STTR Study Section roster and a list of SRA contacts: 40

41 Know NIH Review Criteria Significance Approach Does the study address an important problem and have commercial potential? Are design and methods well-developed and appropriate? Are problem areas addressed? Innovation Investigator Environment Commercialization Are there novel concepts or approaches? Are the aims original and innovative? Is the investigator appropriately trained and capable of managing the project? Does the scientific environment contribute to the probability of success? Is the environment unique? Is the company s business strategy one that has a high potential for success? 41

42 NIH SBIR/STTR web site 42

43 SBIR/STTR Application Process Infographic Confirm Your SBC Meets Eligibility Requirements Develop an Innovative Research Idea Five Required Registrations NIH FOAs SBIR/STTR Omnibus (PA & PA ) Targeted SBIR/STTR FOAs Submit your grant application Electronically NIH Center for Scientific Review evaluate your grant Funding decisions and awards are made Awardee Conducts Research 43

44 Key Documents Omnibus SBIR/STTR Solicitation SBIR: PA STTR: PA SBIR/STTR Application Guide SF pages! 44

45 NIAID SBIR/STTR web site 45

46 NIAID SBIR/STTR Sample Applications 46

47 NIAID SBIR/STTR High-Priority Areas of Interest 47

48 Most Important Pieces of Advice Talk to an NIH Program Officer about your application 1 month pre-application and SUBMIT EARLY (days not hours and minutes)! Program Officer contact information found in the NIH SBIR/STTR Solicitation on Questions about who to contact? sbir@od.nih.gov Read the SBIR SF424 Use the NIH Reporter Database 48

49 If you are not funded the first time Rejection is painful, but there is feedback to work with Respond to the Summary Statement carefully Discuss with your NIH Program Director Learn more about SBIR/STTR grants Explore opportunities to serve on NIH peer review panels Talk to successful applicants Understand review process and dynamics - Check NIH s Resubmission Policy-your options: Revise and resubmit Introduction Page: Response to reviewer critiques Request review by PO at least one month in advance Do not draft a resubmission in less than one month s time Be constructive not defensive 49

50 NIH s Resubmission Policy After an unsuccessful new (A0) application or an unsuccessful resubmission (A1) application, you may submit a new (A0) application with the same idea as long as your summary statement has been issued. NIH Guide Notices NOT-OD NOT-OD Resubmission FAQs 50

51 Your New Application Must Be Written as New Your new (A0) application should not contain information that might bias the review or provide a competitive advantage: You Cannot Refer to a Previous Review No mention of previous score No mention of previous reviewer comments No mention of how the A0 is responsive to previous review No marks in text to indicate changes You Cannot Submit Elements of a Renewal No Progress Report No Progress Report Publication List 51

52 Common Problems in Applications Lack of new or original ideas No Significance: unimportant problem, unconvincing case for commercial potential or societal impact Absence of an acceptable scientific rationale Lack of experience in the essential methodology Questionable reasoning in experimental approach Failure to consider potential pitfalls and alternatives Diffuse, superficial, or unfocused research plan Lack of sufficient experimental detail Lack of knowledge of published relevant work Unrealistically large amount of work 52

53 THANK YOU! 53