Xing-Jian Lou, PhDProgram Director

NCI SBIR Development Center

SBIR R&D Contract Opportunities at NIH

Thursday October 23, 2014 NIH SBIR Conference

Today’s Presentation

1. Why Does NIH Use SBIR Contracts?

2. How Contract Topics Get Chosen

3. Different between Contracts and Grants

4. The Proposal, Review and Funding Process

5. Contract Topic Example

6. Questions

Why Does NIH Use SBIR Contracts?

SBIR contracts allow an institute to direct companies to develop products in areas of high priority (usually narrow technical focus)

Institute-run ad hoc peer review panels where there is balanced representation of business versus technical reviewers

Program staff are very involved in funding decisionso Deliverables negotiated by program staff in advance of award-

once in the contract, these are “must do” itemso Quantitative milestones

Program staff (project officer/contracting officer’s representative) are also very involved in management of funded projects

NCI SBIR/STTR Award Budget Distribution

Grants

Contracts

Administrative Supplements NIH Technical Assistance Programs

NCI scientific & technologypriorities

Areas of interest to the commercial sector,

based on market opportunity

Contract topics in NCI priority areas with strong potential for commercial success

13%8%

17%25%

NCI SBIR contracts(thousands)

% of total NCI SBIR

2007 2008 2009 2010 2011 2012 2013Fiscal Year

13%8%

17%25% 24%

33%35%$12,387

$7,757

$16,665

$25,020

$38,174

$26,102

$37,406

NCI SBIR Targeted Contract Solicitations

How Contract Topics Get Chosen?

Call for Contract

topics

SPL Approval

Submit the Topics

TAG Review

Publish the Contract Topics

Development of SBIR Contract Topics

Concept Development

Trans-NCI Technology Advisory Group (TAG), with membership from all Divisions and offices whose missions overlap with SBIR

TAG Committee reviews, discusses, and scores solicitation proposals (contracts, grants, and cooperative agreements)

SBIR office prepares package for NCI Scientific Program Leaders Committee (Executive Committee)

10-25 NCI SBIR contract topics are approved for publication in Omnibus NIH SBIR Contract RFP published in August

Feb Apr Jun AugJan

Different between Contracts and Grants

Funding Solicitations forSBIR Grants

Funding Solicitation forSBIR Contracts

Scope of the proposal

Investigator-defined within the mission of NIH Defined by the NIH (focused)

Set-aside of funds for particular areas? NO YES

Questions during solicitation period?

May speak with any Program Officer

MUST contact the contracting officer

Receipt Dates 3 times/year for Omnibus Only ONCE per year

Basis for Award Based on score during peer review

If proposal scores well during peer review, must then negotiate to finalize deliverables with NIH

ReportingOne final report (Phase I);Annual reports (Phase II)

Monthly or quarterly progress reports

The decision point is whether the contract topic is a true fit for your project

NIH SBIR Contracts Request For Proposals (RFP)

Both for NIH & CDC Issued once a year

o Released late summero Proposals usually due in early November

Includes: o Proposal preparation instructionso Page Limits – All inclusive -50 for Phase I; 150 for Phase IIo Definitionso Evaluation Criteriao Institute Points of Contacto Research Topicso Additional Guidance (for example Human Subjects)o Forms (with links)

Proposal and Funding Process (Phase I)

Decide to Apply

Build the application

Submit the application

Receive the Review Results

Negotiation

1. NIH SBIR RFP published in August2. PO is barred from communicating with potential offerors3. Proposals due November4. NCI ad hoc technical review panels meet Jan-April (1- 55 proposals; end products are

score 0-1,000, plus technical acceptability judgment, plus technical minutes document)5. PO recommends competitive range in memo to CO May-June6. Negotiations to address technical and budgetary weaknesses7. Self-certification of SBIR eligibility (company ownership structure)8. Award in September (1-10 contracts per topic)

Must be received by 11/5/14, 4:30 pm ET

Receive the Award

Request a Debrief

within 3 days

YES

NO

Proposal and Funding Process (Phase II)

1. Review Phase I final report (technical and commercial potential)- June, rolling basis

2. Invitation Letter RFP goes out to company- Nov-Feb

3. Phase II proposal (2 years, < $2M) due- Jan-April

4. Technical review meeting (usually 1-3 proposals)

5. Rest of process as for Phase I

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%

Contract Review Criteria

For Fast-Track applications: Phase II 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 II; b. The approach is innovative and not routine, c. Offeror’s ability to implement technical approach

30%

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

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%

NCI Management of Funded SBIR Contracts Individual Program Staff

First deliverable is kickoff presentation to COR by contractor- tied to an invoice (first payment of contractor)

Communication with contractor unlimited Quarterly progress reports tied to invoices which COR must approve

(electronic) Annual report required for Phase II (end of year 1) Commercialization plan required at end of Phase I project period and then

again within Phase II proposal Final report required for both Phase I and Phase IIs Mentoring as time allows Investor Forums Phase II contract can be followed with Phase IIB Bridge grant funding

Example: Development of Novel Therapeutic Agents That Target Cancer Stem Cells

(Fast-Track proposals will be accepted.)

Budget (total costs): PhI: $300,000 for 9 months; PhII: $2,000,000 for 2 years

Number of anticipated awards: 2-3

Project Goals: Proposals under this topic should be involved the development of novel therapeutic agents that target CSCs. These small molecules or biologics should be designed to target CSCs, CSC-related biomarkers, or CSC pathways that affect fundamental processes associated with carcinogenesis, tumor progression, maintenance, recurrence or metastasis. Particular emphasis is placed on agents that target CSC self-renewal, regeneration, or differentiation processes.

Phase I Activities & Deliverables: Demonstrate in vitro efficacy for the agent(s) that targets CSCs. Validate the effect of the agent(s) on CSCs. The offerors are required to provide evidence confirming

that the agent(s) specifically targets CSCs (e.g., measurement showing reduced quantity, viability, or frequency of CSCs).

Conduct structure-activity relationship (SAR) studies, medicinal chemistry, and/or lead antibody optimization (as appropriate).

Perform animal toxicology and pharmacology studies as appropriate for the agent(s) selected for development.

Develop a detailed experimental plan (to be pursued under a future SBIR Phase II award) necessary for filing an IND or an exploratory IND.

FY15 NCI Contract Funding Topics - Due Date: November 5, 2014

15

Therapeutics

Advancing Cancer Research

• 336 Development of Novel Therapeutic Agents that Target Cancer Stem Cells

• 334 Vacutubes to Preserve the Viability of Circulating Tumor Cells

• 335 Development of Advanced Culture Systems for Expansion of Cancer Stem Cells

Health IT

Medical Devices & Radiation Therapy• 338 Predictive Biomarkers of Adverse Reactions to Radiation Treatment

• 339 Systemic Targeted Radionuclide Therapy For Cancer Treatment

• 340 Validation of Mobile Technologies for Clinical Assessment, Monitoring, and Intervention

In Vitro Diagnostics• 337 Cell-Free Nucleic Acid-Based Assay Development for Cancer Diagnosis

Should I apply for a contract or a grant?

Do you specifically fit the goals and deliverables of the contract?

Would this project be a focus of the company?

Remember, you cannot submit the same project to both mechanisms

Either Way, Use NIH Reporter http://projectreporter.nih.gov/reportero Search previous funded grants and contractso Search for potential collaboratorso How does your project stack up?

Xing-Jian, Ph.D.Program Director

NCI SBIR Development Center

http://sbir.cancer.govEmail: ncisbir@mail.nih.govRefer to Contact Us Page for

Individual Contacts

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