NCI SBIR Programs Support Technology Innovation for Cancer Detection and Treatment. Christie Canaria, PhD Program Officer - AAAS S&T Policy Fellow

Transcription

1 NCI SBIR Programs Support Technology Innovation for Cancer Detection and Treatment Christie Canaria, PhD Program Officer - AAAS S&T Policy Fellow September 24, 2014 MATTO - Boston

2 bit.ly/ncisbirfeedback Today s Presentation Christie Canaria Overview & Eligibility Recent Key Changes NCI Initiatives Funding Opportunities Jonathan Franca-Koh Tips on Applying 2

3 Why are SBIR and STTR Important to NCI? NCI s primary resource for enabling commercialization of high impact technologies that can benefit patients, such as: Small Molecules and Biologics Cancer Diagnostics Cancer Imaging Electronic Health & Education Tools 3

4 Congressionally-Mandated Programs Small Business Innovation Research (SBIR) Set-aside program for small business concerns to engage in Federal R&D with the potential for commercialization Federal agencies with an extramural R&D budget > $100M Set Aside (FY14) (FY15) 2.8% 2.9% Small Business Technology Transfer (STTR) Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions with the potential for commercialization Federal agencies with an extramural R&D budget > $1B 0.4% 0.4% ~$750M annually at NIH ~$119M annually at NCI 4

5 Set-aside is Increasing FY SBIR Set-aside STTR Set-aside % 0.30% % 0.35% % 0.35% 2014 (current) 2.8% 0.40% % 0.40% % 0.45% % 0.45% 5

6 Reasons to Seek SBIR/STTR Funding One of the largest sources of seed funding for innovative technology development by small businesses Not a Loan No repayment is required Doesn t impact stock or shares in any way (i.e., non-dilutive) Intellectual property rights retained by the small business Provides recognition, verification, and visibility Helps provide leverage in attracting additional funding or support (e.g., venture capital, strategic @NGINWorkplace

7 SBIR & STTR: Three-Phase Program Proof-of-Concept study $225,000 over 6 months (SBIR) or 1 year (STTR) Direct to Phase II Skip Phase I Commercialization stage Use of non-sbir/sttr funds Phase I FEASIBILITY Phase II DEVELOPMENT Fast Track Application Combined Phase I & II Research & Development Commercialization plan required $1.5 million over 2 years Phase III COMMERCIALIZATION Hard caps on award sizes: $225,000 for Phase I; $1.5 million for Phase II Certain awards may exceed these caps if covered by topic-specific waivers Actual funding may vary by topic 7

8 Recent Rule Changes in SBIR VC-backed companies (VCOC, hedge fund, private equity firms) CAN NOW apply (NIH SBIR only). Direct to Phase II Pilot Program now active Increased caps for pre-approved waiver topics (see FOA) Ph I $300K, Ph II $2M Otherwise: Ph I $225K, Ph II $1.5M 8

9 bit.ly/ncisbirfeedback FY15 NCI Waiver Topics Therapeutics (e.g. Small Molecules, Biologics, Radiomodulators, and Cellbased Therapies) In Vitro and In Vivo Diagnostics (e.g. Companion Diagnostics and Prognostic Technologies) Imaging Technologies (e.g. Agents, Devices, and Image-Guided Interventions) Devices for Cancer Therapy (e.g. Interventional Devices, Surgical, Radiation and Ablative Therapies) Agents for Cancer Prevention (but not Technologies for Cancer Prevention ) Development of Low Cost Technologies for Global Health Development of Companion Diagnostics Vaccine Development for Cancer Prevention Novel Technologies to Address Undruggable Drug Targets 9

10 Recent Rule Changes in SBIR Switching between SBIR and STTR mechanisms Applicants can apply for Phase II SBIR funding based on Phase I STTR award or vice versa. Applicants can apply for Phase IIB SBIR funding based on Phase II STTR award or vice versa. Applicants can request $5000 in Technical Assistance, beyond award caps. Regulatory consultant Reimbursement consultant 10

11 NIH Reauthorization website 11

12 NIH Timeline for New Applications 7-12 months Due Date Scientific Review Council Review Award Date (earliest) April 5 July October December August 5 October January April December 5 March May July 12

13 SBIR Eligibility Requirements New Rules starting 1/28/13 Applicant is a Small Business Concern (SBC) Organized for-profit U.S. business 500 or fewer employees, including affiliates PI s primary employment (>50%) must be with the SBC at time of award & for duration of project > 50% U.S.- owned by individuals and independently operated* > 50% owned and controlled by other business concern/s that is/are > 50% owned and controlled by one or more individuals* > 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these * OR OR *Formerly >= 51%; *New rule starting 1/28/13, NIH @NGINWorkplace 13

14 STTR Eligibility Requirements 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 14

15 SBIR vs. STTR: Which Program is Best for You? SBIR STTR Principal Investigator Research Partner Primary employment must be with small business Permits partnering Small business must do 67% Phase I, 50% Phase II PI may be employed by either small business or research institution, and must commit minimum of 10% effort to project Requires partnering with US research institution Small business min. 40%, Research institution min. 30% Small Business Concern is ALWAYS the Applicant/Awardee Organization Funding rates vary annually based primarily on application numbers The best choice is the fit for your budget and @NGINWorkplace 15

16 The NCI SBIR Development Center 16

17 NCI SBIR Development Center Program Directors Michael Weingarten, MA Director NCI SBIR Development Center Greg Evans, PhD Lead Program Director Cancer Biology, E-Health, Epidemiology, Research Tools Patricia Weber, DrPH Program Director Digital Health, Therapeutics, Biologics, SBIR Investor Forum, FRAC Workshop Deepa Narayanan, MS Program Director Cancer Imaging, Clinical Trials, Radiation Therapy, SBIR Investor Forum, FRAC Workshop Ming Zhao, PhD Program Director Cancer Diagnostics & Therapeutics, Cancer Control & Prevention, Molecular Imaging, Bioinformatics, Stem Cells Christie Canaria, PhD AAAS Science & Technology Policy Fellow Research Tools, Imaging, I-Corps, Policy, Scientific Communications Andrew J. Kurtz, PhD Lead Program Director Biologics, Small Molecules, Nanotherapeutics, Molecular Diagnostics, Bridge Award Jian Lou, PhD Program Director In-Vitro Diagnostics, Theranostics, early-stage drug development, Bioinformatics, FRAC Workshop Todd Haim, PhD Program Director Small Molecules, Biologics, Immunotherapeutics, Theranostics, SBIR Investor Forum, FRAC Workshop Amir Rahbar, PhD, MBA Program Director In-Vitro Diagnostics, Biologics, Therapeutics, Proteomics, SBIR Investor Forum Jonny Franca-Koh, PhD, MBA Program Director Therapeutics, Small Molecules and Cell-based therapy Kory Hallett, PhD AAAS Science & Technology Policy Fellow Policy, Scientific Communications 17

18 New Activities of NCI Development Center Development Center staff are responsible for: Conducting regular outreach events to help recruit more focused, commercially-minded SBIR applicants Coaching applicants on developing stronger applications Providing oversight and active management of projects Mentoring and guiding companies throughout the award period Facilitating matchmaking with potential third-party investors and strategic partners 18

19 @NCIsbir #icorps sbir.cancer.gov/icorps NIH Pilot Program A pilot program that s a partnership between NSF and NIH. 4 participating NIH Institutes NCI, NHLBI, NINDS, NCATS 19

20 @NCIsbir sbir.cancer.gov/icorps NIH Pilot Program 10-week Entrepreneurial Immersion course to reduce commercialization risk for Therapeutics, Diagnostics and Devices 20

21 @NCIsbir sbir.cancer.gov/icorps NIH Pilot Program Commercialization efforts have two components 1. The science/technology 2. The business model Current Commercialization efforts focus on #1 Successful efforts require the team to do both 21

22 @NCIsbir sbir.cancer.gov/icorps NIH: Format Teams are taught and guided by a group of experienced faculty (e.g., serial entrepreneurs, venture capitalists, etc.) Develop a viable business model around their technology focusing on key questions like their value proposition and revenue model. 22

23 @NCIsbir sbir.cancer.gov/icorps NIH: Format Process: gather as much information and insight as possible by conducting 100 interviews with potential customers and partners. Adjust business strategy based on direct customer feedback. Use of Business Model Canvas provides a framework for analyzing information to determine if there is a product/market fit. 23

24 I-Corps Business Model Canvas 24

25 @NCIsbir sbir.cancer.gov/icorps NIH: Format I-Corps will also help SBIR companies: Assess their intellectual property, reimbursement, and regulatory risks before they design and build prototypes Evaluate the potential of their product for clinical utility at an early stage Identify financing vehicles before they are needed 25

26 @NCIsbir sbir.cancer.gov/icorps NIH: History Since July 2011, NSF has been offering I-Corps to over 300 teams from 100 universities NSF s program has been focused on academic teams at the pre-company phase More than 40% have gone on to start companies Teams have achieved a high success rate when competing for SBIR awards. 26

27 Steve Blank 21 years / 8 startups 13 Berkeley, Columbia, Stanford, & UCSF Developed the Lean LaunchPad/NSF I- Corps methodology

28 NCI SBIR Investor Forum Exclusive opportunity for some of the most promising NCI-funded companies to showcase their technologies In 2012, 18 top SBIR-funded companies presented Over 200 life science investors & leaders 150+ one-on-one meetings 2010 Investor Forum: 8 out of 14 presenting companies closed deals collectively valued at over $230M 28

29 2010 Investor Forum Results 8 out of the 14 presenting companies have closed deals valued at over $230M Zacharon, a company focused on developing therapeutics for rare diseases and cancer, finalized a major partnership with Pfizer worth up to $200M Lpath closed a $4.9 Million Equity Financing round to fund continued development of two drug candidates MagArray closed a strategic partnership deal with IMRA America for $10M to continue development of its cancer diagnostic platform ImaginAb raised $12.5M in a Series A round to engineer antibodies into in vivo PET imaging agents for targeted molecular 29

30 Workshop on Federal Resources to Accelerate Commercialization bit.ly/ncisbirfeedback Bringing together NCI SBIR/STTR awardees to move funded technologies from bench to bedside May 7, 2013 at NCI Shady Grove Speakers from FDA, CMS, USPTO, and White House OSTP Panels on other sources of federal funding, resources & collaborative programs at NIH, and unique life science investment organizations One-on-one meetings with program directors and speakers 30

31 SBIR/STTR Funding Opportunities Christie Canaria NCI SBIR Development Center 31

32 Multiple Funding Solicitations Know the Application Deadlines SBIR & STTR Omnibus Solicitations for Grant Applications Release: January Receipt Dates: April 5, August 5, and December 5 See the NIH Guide for other Program Announcements (PA s) and Requests for Application (RFA s), i.e. grants Release: Weekly Receipt Dates: Various Solicitation of the NIH & CDC for SBIR Contract Proposals Release: August 2014 Receipt Date: November 5,

33 SBIR & STTR: Three-Phase Program Proof-of-Concept study $225,000 over 6 months (SBIR) or 1 year (STTR) Direct to Phase II Skip Phase I Commercialization stage Use of non-sbir/sttr funds Phase I FEASIBILITY Phase II DEVELOPMENT Fast Track Application Combined Phase I & II Research & Development Commercialization plan required $1.5 million over 2 years Phase III COMMERCIALIZATION Hard caps on award sizes: $225,000 for Phase I; $1.5 million for Phase II Certain awards may exceed these caps if covered by topic-specific waivers Actual funding may vary by topic 33

34 Fast Track or Direct to Phase II: Which Program is Best for You? Fast Track Promising preliminary data, but still the potential to propose aims that are reasonable for a Ph I study, and/or appropriate milestones that should be achieved prior to advancing to Phase II If the aims, timeline, and budget are a good fit for Fast-Track, then can be a better option (versus Direct to Phase II) because more total funding can be 34

35 Fast Track or Direct to Phase II: Which Program is Best for You? Direct to Phase II Preliminary data equivalent to what is normally expected by the end of an NIH SBIR Ph I award (e.g., in vivo proof of concept data for a therapeutic) Projects for which additional proof-of-concept studies are not needed Later stage projects (e.g., human studies, clinical trials, etc.) 35

36 Direct to Phase II Pilot Program 2014 SBIR Direct to Phase II Solicitation: PAR Check the funding announcement: Only NCI and NIH ICs listed are participating in Direct to Phase II Pilot Applies to SBIR programs only, NOT STTR Designed for SBCs that have completed Phase I-type milestones with non-sbir funds 36

37 Direct to Phase II Pilot Program Standard receipt dates apply: April 5, August 5, December 5 Effective until 2017 Standard SBC eligibility rules apply Transition rate benchmark for SBCs that have been awarded >20 Ph I s last 5 years: (# Ph II awards)/(# Ph I awards) 0.25 Verify your SBC Transition Rate on the Company Registry at SBIR.gov 37

38 Multiple Funding Solicitations Know the Application Deadlines SBIR & STTR Omnibus Solicitations for Grant Applications Release: January Receipt Dates: April 5, August 5, and December 5 See the NIH Guide for other Program Announcements (PA s) and Requests for Application (RFA s), i.e. grants Release: Weekly Receipt Dates: Various Solicitation of the NIH & CDC for SBIR Contract Proposals Release: August 2014 Receipt Date: November 5,

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41 NCI SBIR Grant Funding Opportunities 41

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43 Innovative Health IT for Broad Adoption by Healthcare Systems & Consumers (PA ) Goal: Accelerate development & commercialization of evidence-based consumer health IT to: Prevent or reduce the risk of cancer Facilitate patient-provider communication Improve disease outcomes in consumer & clinical settings Phase II or Fast-Track applications only Strong applicants will have a partnership with large business (e.g. commercial IT firm, EMR vendor, healthcare systems, etc.) Next receipt date: December 5, 2014 Contact Dr. Patricia Weber: weberpa@mail.nih.gov 43

44 Development of Highly Innovative Tools and Technology for Analysis of Single Cells (PA ) Goal: Development of next-generation tools to better define cell heterogeneity in situ, with substantially increased sensitivity, selectivity, spatiotemporal resolution, scalability or non-destructive analysis of multiple global or functional measures of single cells. Affiliated with the Single Cell Analysis Program (SCAP) through the NIH Common Fund New analytical measures and manipulations of cellular contents, structure and activity beyond those currently available First-in-class and/or cross-cutting techniques Next receipt dates: December 5, 2014 April 5, August 5, December 5 through 2015 Contact Dr. Xing-Jian Lou: loux@mail.nih.gov 44 bit.ly/ncisbirfeedback

45 Innovative Molecular Analysis Technology Development for Cancer Research and Clinical Care (SBIR-IMAT, PAR ) Goal: To support the development, maturation, and dissemination of novel and potentially transformative next-generation technologies through an approach of balanced but targeted innovation in support of clinical, laboratory, or epidemiological research on cancer. Molecular and cellular analytical technologies for cancer detection and/or characterization in vitro, in situ, or in vivo Next receipt dates: November 4, 2014 November and May through 2016 Contact Dr. Amir Rahbar: 45

46 bit.ly/ncisbirfeedback NCI SBIR Phase IIB Bridge Award Phase I FEASIBILITY Phase II DEVELOPMENT NCI SBIR Phase IIB Bridge Award CROSSING THE VALLEY OF DEATH Phase III COMMERCIALIZATION Provides up to $1M per year for up to 3 years Open to any NIH-funded Phase II awardees with projects relevant to NCI mission Accelerates commercialization by incentivizing partnerships with third-party investors & strategic partners earlier in the development process Competitive preference and funding priority to applicants that can raise substantial third-party funds (i.e., 1:1 match) 46

47 NCI SBIR Phase IIB Bridge Award 47

48 16 Bridge Awards To Date $20,000,000 $15,000,000 $10,000,000 $5,000,000 $0 NCI Total $35,262,319 Third-Party Investments $94,300,756 Leverage > 2 to 1 Venture Capital: 1/3 Strategic Partners: 1/3 Individuals & Other: 1/3 48

49 Milestone-Based Awards Ability to raise matching funds is a component of the Phase II Bridge Award Phase II Award SBIR Bridge Award Year 1+ 1st Year Portion of funds 2nd Year Portion of funds 3rd Year Portion of funds YES YES YES Milestones reached? Milestones reached? Milestones reached? Matching funds secured for year 1? Matching funds secured for year 2? NO Matching funds secured for year 3? NO STOP STOP Private investor / strategic partner continues to support 49

50 Multiple Funding Solicitations Know the Application Deadlines SBIR & STTR Omnibus Solicitations for Grant Applications Release: January Receipt Dates: April 5, August 5, and December 5 See the NIH Guide for other Program Announcements (PA s) and Requests for Application (RFA s), i.e. grants Release: Weekly Receipt Dates: Various Solicitation of the NIH & CDC for SBIR Contract Proposals Release: August 2014 Receipt Date: November 5,

51 The Contracts Process at NCI: How are SBIR Contracts Different from Grants?

52 NCI SBIR Targeted Contract Solicitations NCI scientific & technology priorities Areas of interest to the commercial sector, based on market opportunity Contract topics in NCI priority areas with strong potential for commercial success $37,406 $38,174 NCI SBIR contracts (thousands) $12,387 13% $16,665 $7,757 13% 17% 8% $25,020 $26,102 25% 24% 17% 8% 33% 25% 35% % of total NCI SBIR Fiscal Year 52

53 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 53

54 SBIR Contracts vs. Grants Peer Review Locus Review Sections SBIR Grants NIH Center for Scientific Review (CSR) Sections review applications for different programs in similar topic areas SBIR Contracts NCI DEA (target 50% business reviewers) Specific sections for each single topic Basis for Award Peer review score Program assessment Peer review score Program relevance & balance Negotiation of technical deliverables Budget 54

55 Contracts vs. Grants: Which Fits Best for You? I am working on a topic that fits well with what is being requested in the contract topic CONTRACT Differences Review sections are only for the specific topic under consideration Because it is more specific, there may be less competition Fast-Track possibility of splitting up Ph I and Ph II in a contract You cannot submit both a contract proposal and a grant application for essentially the same project. If the contract proposal has been evaluated, you can submit a grant application after it is no longer being considered for award.

56 Contract Review Criteria Phase I Technical Evaluation Criteria Weight 1. The soundness and technical merit of the proposed approach based on: a. Clear measureable goals (milestones) that have a reasonable chance of meeting the topic objective in Phase I; b. The approach is innovative and not routine, c. Offeror s ability to implement technical approach 40% 2. The qualifications of the proposed PDs/PIs 20% 3. The potential of the proposed research for technological innovation. 15% 4. The potential of the proposed research for commercial application. The commercial potential of a proposal will be assessed using the following criteria: a. Whether the outcome of the proposed research activity will likely lead to a marketable product or process. b. The offeror s discussion of the potential barriers to entry and the competitive market landscape as well as method to overcome. 15% 5. The adequacy and suitability of the facilities and research environment 10% See pg. 28 of PHS for more details about the evaluation process

57 Contract Review Criteria For Fast-Track or Direct to Phase II applications: Phase II Technical Evaluation Criteria 1. The soundness and technical merit of the proposed approach based on: a. Clear measureable goals (milestones) that have a reasonable chance of meeting the topic objective in Phase II; b. The approach is innovative and not routine, c. Offeror s ability to implement technical approach 2. The potential of the proposed research for commercial application, as documented in the Commercialization Plan and evidenced by: a. Offeror s record of successfully commercializing prior SBIR/STTR or other research projects b. Commitments of additional investment during Ph I & Ph III from private sector or other non-sbir funding sources c. Other indicators of commercial potential for the proposed research Weight 30% 30% 3. The qualifications of the proposed PDs/PIs, supporting staff and consultants. 25% 4. The adequacy and suitability of the facilities and research environment 15% See pg. 28 of PHS for more details about the evaluation process

58 NCI Contract Topics for FY15 Advancing Cancer Research 334 Vacutubes to Preserve the Viability of Circulating Tumor Cells 335 Development of Advanced Culture Systems for Expansion of Cancer Stem Cells Therapy & Diagnosis 336 Development of Novel Therapeutic Agents That Target Cancer Stem Cells 337 Cell-Free Nucleic Acid-Based Assay Development for Cancer Diagnosis 338 Predictive Biomarkers of Adverse Reactions to Radiation Treatment 339 Systemic Targeted Radionuclide Therapy For Cancer Treatment Health IT Validation of Mobile Technologies for Clinical Assessment, Monitoring, and Intervention

59 FY 2015 NIH and CDC SBIR Contract Solicitation

60 Funding Opportunity Summary PHS HHS, NIH, and CDC SBIR Program Solicitation ONE application receipt date per year: Published August 2014 Receipt Date: November 5, 2014, 4:30 PM ET RFP can be found at: More info about NCI s topic areas:

61 Questions about Contracts? Contact the contracting officer National Cancer Institute (NCI) Ms. Victoria Cunningham Proposal Deadline: November 5, 2014 at 4:30PM Eastern Time Submissions must be on paper (not electronic, not through Grants.gov)

62 bit.ly/ncisbirfeedback Today s Presentation Christie Canaria Overview & Eligibility Recent Key Changes NCI Initiatives Funding Opportunities Jonathan Franca-Koh Tips on Applying 62

63 What Does It Take to Get Funded? Tips on Applying Jonathan Franca-Koh, PhD, MBA Program Director

64 SBIR/STTR Funding: Often Needed but not easy SBIR/STTR awards are highly competitive (It was not always like that) Resubmissions have become the norm Funding success rate around 10-15% Your competitors are smart, skilled, accomplished, and hail from top institutions Lots of great ideas Solution: Prepare a strong application

65 Deciding to Apply

66 When is an SBIR/STTR application appropriate? Innovative solution to significant unmet clinical need Significant commercial potential Leverages company/founder expertise Need funding to produce feasibility data Need funding for development Start-up: Too early for private investment Established SBC: No resources to try new approach, but board supports SBIR

67 When NOT to Apply Chasing solicitations why not? Chasing cool technologies Need cash urgently SBIRs take 8-16 months or more to get and you must start with Phase I (~$225K) Incremental upgrade: no change to clinical paradigm Me too product matching competitor s capabilities Basic research still required to demonstrate commercial and clinical feasibility Lost your R01

68 Before You Write an Application Consider your company s strengths Consider your company s weaknesses 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

69 Search Previous Awards

70 Search Previous Awards

71 Building the Application

72 Key #1 Start Early Strong proposals take time to develop Take care of the administrative registrations (See SF424). Start this at least 2 months before deadline! > Electronic Submission Carefully read the Solicitation Need time to fill the gaps Assemble a strong scientific team Get access to equipment and other resources Get letters of support

73 SF424 Application Guide

74 Key #2 Take Time to Refine the Vision Start informal discussions to clarify the product vision Potential customers Technical experts Potential investors & commercialization partners Seek help early in process Experienced SBIR applicants Academic collaborators with grant experience Professional grant writers Engage with SBIR Program Staff a short summary and request review of specific aims Identify the most important technical risks Identify approaches to address those risks Study design is critical

75 Key #3 Build the Right Team Choose the Principal Investigator (PI) Consider building multi-pi team Multidisciplinary proposals PI lacks certain types of necessary expertise Must appoint Contact PI (SBIR, > 50% of time w/ business) Partner to fill the gaps Academic collaborations Consultants Other companies Use SBIR application as engagement tool Academic researchers understand grants Business executives understand product development and marketing

76 Key #4 Reviewers Only See the Application Specific Aims (1 page): Grab and Secure Positive Attention Focal point of the application Highlight the technology s major strengths Describe goals of the application be specific Quantitative performance milestones What is the problem you are uniquely able to solve? What is the unmet medical need? Research Strategy Provide background information Provide detailed technical plan to achieve Specific Aims Propose realistic scope/budget/timeline Preliminary data not required in Ph I, but often powerful Describe potential pitfalls and alternative angles of attack

77 Key #4 Reviewers Only See the Application Other application components Letters of support Necessary from consultants and collaborators Powerful from clinicians, end-users, and potential investors/partners Phase II Commercialization Plan (12 pages) Cover Letter Not seen by reviewers Used to request dual assignment Used to request and justify a specific study section Biosketches for all senior and key personnel (< 4 pages each) Budgets for each project period Separate budgets for each subcontract Descriptions of facilities and equipment Human subject research section (if applicable) Vertebrate animals section (if applicable) Other information as required

78 Key #5 Run Your Own Peer Review before you submit Read your material critically as if you were the Reviewer What are the weaknesses? Point out potential difficulties - do not hide them; suggest ways to address them Ask all collaborators to review the application Recruit independent, technically-trained laymen as readers Do they understand it? Are they excited?

79 Know NIH Review Criteria Significance Approach Innovation Investigator Environment Commercialization Does the product address an important problem, and have commercial potential? Is there a market pull for the proposed product? Are design and methods well-developed and appropriate? Are problem areas addressed? Are potential pitfalls and alternative approaches provided? How novel is the technology/product and the approaches proposed to test its feasibility? Are the investigators, collaborators and consultants appropriately trained and capable of completing all project tasks? Does the scientific environment contribute to the probability of success? Facilities? Independence? Is the company s business strategy one that has a high potential for success?

80 Key #6 Identify Study Section Identify the most appropriate Institute/Center Talk to a program director Identify the most appropriate study section BEFORE you submit your application and check after you re assigned See CSR website for study section descriptions See the list of study section members Do they have the right areas of expertise? Request and justify a study section in the cover letter

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82 If you are not funded the first time Rejection is painful, but there is feedback to work with Respond to the Summary Statement carefully Use peer review to improve your technology and presentation Discuss with your NIH Program Director 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 Learn more about SBIR/STTR grants Explore opportunities to serve on NIH peer review panels Talk to successful applicants Understand review process and dynamics -

83 Common Problems Reviewers did not understand your proposal Reason: Proposal is in the wrong study section Solution: Discuss study section selection with assigned NCI Program Director. Can you find a more appropriate study section? Reason: Proposal is not clearly written Solution: Improve your presentation Reason: Not enough data or specific enough description of the technology (e.g., chemical structure for lead compound) Solution: Don t rely on publications. Include any attributes that don t threaten IP.

84 Common Problems Reviewers say the proposal is not innovative Reason: Technology is not clearly differentiated Solution: Position technology relative to available alternatives Reason: Technology is a novel combination of existing approaches Solution: Emphasize need-based novelty

85 Common Problems Reviewers feel the team is not qualified to handle the problem Strengthen your team by adding collaborators and consultants If PI has experience gaps, consider putting together a multi-pi team Have ALL collaborators review the proposal

86 Common Problems Reviewers do not think you are working on significant problem Sell them on importance of the problem Be specific and quantitative Get a letter of support confirming the problem

87 Common Problems Reviewers are critical of the approach Respond to specific criticisms Revise your approach Have your approach reviewed by professionals similar to the reviewers

88 Common Q1: SBIR or STTR? Reauthorization: Switching between phases is now allowed Is the true PI at the company or university? Junior postdocs as PI are sometimes questioned by reviewers Cost breakdown SBIR requires 2/3 work done by company in Ph I, 50% in Ph II STTR requires 40% done by company, 30% done by partner Success Rates should not be a major decision-making factor Significant variance year to year so there is no answer to the question: Which is easier to get

89 Common Q2: Appropriate Budget and Cost Structure Total budget and time period should be determined by needs of the project (must fit legal and programmatic caps) Eligibility: Phase I SBIR SBC must do 2/3 of the work Determined by division of total costs between SBC and subawardee Fee-for-Service may count as SBC costs Intellectual work and analysis must be done by the company Indirect costs are a defining characteristic of subawards Discuss with grants management officer

90 Common Q3 and Q4: Contract or Grant? Phase I or Fast-Track? Is the contract a true fit for the optimal proposal? Most cases: Phase I grant Fast-Track could be good approach for: Late stage and/or clinical trial projects Companies that have already been awarded grants on that technology and are familiar with specific reviewer concerns Companies that have demonstrated track record of commercialization

91 Common Q5: Can I apply if I do not yet have a facility? Yes, the facility is needed at the time of award Yet, the environment criterion score includes the facilities, so it is advantageous to at least have a facility lined up for the award start This facility can be considered as part of environment if you describe it and include a letter of support from the facility stating that you will have access at the time of award

92 THANK YOU! Please provide your feedback: bit.ly/ncisbirfeedback NCI SBIR Development Center Phone: Sign up for updates! Follow us on On LinkedIn 92