1. SBIR R&D Contract Opportunities at NIH
Xing-Jian Lou, PhD
Program Director
NCI SBIR Development Center
Thursday October 23, 2014
NIH SBIR Conference

2. Today’s Presentation
Why Does NIH Use SBIR Contracts?
How Contract Topics Get Chosen
Different between Contracts and Grants
The Proposal, Review and Funding Process
Contract Topic Example
Questions

3. 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 decisions
Deliverables negotiated by program staff in advance of award- once in the contract, these are “must do” items
Quantitative milestones
Program staff (project officer/contracting officer’s representative) are also very involved in management of funded projects

4. Administrative Supplements NIH Technical Assistance Programs
NCI SBIR/STTR Award Budget Distribution
Administrative Supplements
NIH Technical Assistance Programs
Contracts
Grants

5. NCI scientific & technology
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
NCI SBIR contracts
(thousands)
% of total NCI SBIR
$38,174
$37,406
$25,020
$26,102
$16,665
35%
$12,387
33%
25%
25%
24%
$7,757
17%
13%
13%
17% 8% 8%
Fiscal Year

6. How Contract Topics Get Chosen?
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
Aug
Jan
Call for Contract topics

7. Different between Contracts and Grants
Funding Solicitations for
SBIR Grants
Funding Solicitation for
SBIR 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
Reporting
One 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 7

8. NIH SBIR Contracts Request For Proposals (RFP)
Both for NIH & CDC
Issued once a year
Released late summer
Proposals usually due in early November
Includes:
Proposal preparation instructions
Page Limits – All inclusive -50 for Phase I; 150 for Phase II
Definitions
Evaluation Criteria
Institute Points of Contact
Research Topics
Additional Guidance (for example Human Subjects)
Forms (with links)

9. Proposal and Funding Process (Phase I)
Decide to Apply
Build the application
Submit the application
Receive the Review Results
Negotiation
Receive the Award
YES
Must be received by 11/5/14, 4:30 pm ET NO
Request a Debrief within 3 days
NIH SBIR RFP published in August
PO is barred from communicating with potential offerors
Proposals due November
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)
PO recommends competitive range in memo to CO May-June
Negotiations to address technical and budgetary weaknesses
Self-certification of SBIR eligibility (company ownership structure)
Award in September (1-10 contracts per topic)

10. Proposal and Funding Process (Phase II)
Review Phase I final report (technical and commercial potential)- June, rolling basis
Invitation Letter RFP goes out to company- Nov-Feb
Phase II proposal (2 years, < $2M) due- Jan-April
Technical review meeting (usually 1-3 proposals)
Rest of process as for Phase I

11. 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.
5. The adequacy and suitability of the facilities and research environment
10%

12. 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
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%

13. 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

14. 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.
This topic is looking for small molecule or biologics based drug discovery that targets cancer stem cells.
To apply for this topic, offerors should: Have at least one validated target. The target can be, but is not limited to: a marker, a pathway, a set of markers or pathways, or any other molecular targets that are specifically associated with CSCs in the cancer of choice.
Provide data or cite literature to support that the target is tightly associated with CSCs.
Have ownership of, or license for, at least one lead agent (e.g., compound or antibody) with preliminary data showing that the agent hits the identified target.
Have experience with a well-validated assay for CSCs.
Describe what is known about the mechanism by which the agent acts on CSCs.
Phase II Activities and Expected Deliverables:
Complete IND-enabling experiments and assessments according to the plan developed in Phase I (e.g., demonstration of desired function and favorable biochemical and biophysical properties, PK/PD studies, safety assessment, preclinical efficacy, GMP manufacturing, and commercial assessment). The plan should be re-evaluated and refined as appropriate.
Develop and execute an appropriate regulatory strategy. If warranted, provide sufficient data to file an IND or an exploratory IND for the candidate therapeutic agents (i.e., oncologic indications for CSCs).
Demonstrate the ability to produce a sufficient amount of clinical grade materials suitable for an early clinical trial. 14

15. Advancing Cancer Research Medical Devices & Radiation Therapy
FY15 NCI Contract Funding Topics
- Due Date: November 5, 2014
Therapeutics
336 Development of Novel Therapeutic Agents that Target Cancer Stem Cells
In Vitro Diagnostics
337 Cell-Free Nucleic Acid-Based Assay Development for Cancer Diagnosis
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
Medical Devices & Radiation Therapy
338 Predictive Biomarkers of Adverse Reactions to Radiation Treatment
339 Systemic Targeted Radionuclide Therapy For Cancer Treatment
Health IT
340 Validation of Mobile Technologies for Clinical Assessment, Monitoring, and Intervention 15 15

16. 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
Search previous funded grants and contracts
Search for potential collaborators
How does your project stack up?

17. Refer to Contact Us Page for Individual Contacts
Ask Away…
Refer to Contact Us Page for Individual Contacts
Xing-Jian, Ph.D.
Program Director
NCI SBIR Development Center