SBIR R&D Contract Opportunities at NIH

Report
SBIR R&D Contract
Opportunities at NIH
Xing-Jian Lou, PhD
Program Director
NCI SBIR Development Center
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 decisions

o
Deliverables negotiated by program staff in advance of awardonce in the contract, these are “must do” items
o
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
Administrative Supplements
NIH Technical Assistance Programs
Contracts
Grants
NCI SBIR Targeted Contract
Solicitations
Areas of interest to the
commercial sector,
based on market
opportunity
NCI scientific &
technology
priorities
Contract topics in NCI priority areas with strong
potential for commercial success
$37,406
$25,020
13%
2007
25%
$7,757
13% 17%
8%
2008
2009
NCI SBIR contracts
(thousands)
$26,102
$16,665
$12,387
$38,174
24%
17%
33%
35%
25%
2012
2013
8%
2010
2011
Fiscal Year
% of total NCI SBIR
How Contract Topics Get Chosen?
Jan
Feb
Apr
Jun
Aug
Development of SBIR Contract Topics
Call for
Contract
topics
Concept
Development
Submit the
Topics
TAG
Review
SPL
Approval
Publish the
Contract
Topics
 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
Different between Contracts and Grants
Scope of the
proposal
Set-aside of funds
for particular areas?
Funding Solicitations for
SBIR Grants
Funding Solicitation for
SBIR Contracts
Investigator-defined within
the mission of NIH
Defined by the NIH (focused)
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
NIH SBIR Contracts
Request For Proposals (RFP)
 Both for NIH & CDC
 Issued once a year
o Released late summer
o Proposals usually due in early November
 Includes:
o Proposal preparation instructions
o Page Limits – All inclusive -50 for Phase I; 150 for Phase II
o Definitions
o Evaluation Criteria
o Institute Points of Contact
o Research Topics
o Additional Guidance (for example Human Subjects)
o Forms (with links)
Proposal and Funding Process (Phase I)
Receive the
Review
Negotiation
Results YES
Must be received by
11/5/14, 4:30 pm ET
Request a
Debrief
NIH SBIR RFP published in August
within 3 days
Decide to
Apply
1.
2.
Build the
application
Submit the
application
Receive the
Award
PO is barred from communicating with potential offerors
3.
Proposals due November
4.
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-June
6.
Negotiations to address technical and budgetary weaknesses
7.
Self-certification of SBIR eligibility (company ownership structure)
8.
Award in September (1-10 contracts per topic)
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:
40%
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
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:
15%
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%
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, CSCrelated 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
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
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/reporter
o Search previous funded grants and contracts
o Search for potential collaborators
o How does your project stack up?
Ask Away…
http://sbir.cancer.gov
Email: [email protected]
Refer to Contact Us Page for
Individual Contacts
Xing-Jian, Ph.D.
Program Director
NCI SBIR Development Center

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