Transcript SBIR & STTR - Tech Transfer Central

An Overview of the
SBIR Program at the National Cancer
Institute
Prepared by
Michael Weingarten
Director of NCI SBIR Development Center
January 17, 2007
New SBIR Phase IIB
Bridge Award
SBIR Phase II Awards and
Commercialization Success
Today, many NIH SBIR awardees complete the SBIR
Phase II award without advancing the technology far
enough to attract private investment
• Significant resources are required for getting through
the FDA approval process
NCI is in Planning Stages for a New
SBIR Phase IIB Bridge Award
Goal:
• Accelerate projects to commercialization by:
- Filling the funding gaps that currently exist
- Sharing in the investment risk and incentivizing private
investors to fund earlier stage projects
• It would require the SBIR company to either raise matching funds
from the investment community or industry partners
- Leverage private investor’s due diligence process
• Modeled after the National Science Foundation’s “SBIR Phase
IIB Option” program.
- Recent data from the NSF show that Phase IIB awards
significantly accelerate the commercialization process.
Example: How the Bridge Award Might Apply
in the Area of Drug Development
Target
Identification
& Validation
Preclinical Development
(Lead Development,
Animal Studies, File IND)
Phase I & Phase II
SBIR
Safety
Review
Clinical
Trials
NDA
Review
Commercialization
Private Investment
The “Valley of Death” is the problem
Example: How the Bridge Award Might Apply
in the Area of Drug Development
Target
Identification
& Validation
Preclinical Development
(Lead Development,
Animal Studies, File IND)
Phase I & Phase II
SBIR
Safety
Review
SBIR Bridge Award
Clinical
Trials
NDA
Review
Commercialization
Private Investment
SBIR Bridge Award addresses the problem by bridging the “Valley of Death”
SBIR Bridge Award would allow NIH to share investment risk by incentivizing
investors or strategic partners to evaluate projects and commit funds much earlier
Example: How the Bridge Award Might Apply
in the Area of Drug Development
Target
Identification
& Validation
Preclinical Development
(Lead Development,
Animal Studies, File IND)
Phase I & Phase II
SBIR
Safety
Review
Clinical
Trials
SBIR Bridge Award
NDA
Review
Private Investment
SBIR Bridge Award
1st Year
2nd Year
3rd Year
1/3 of funds
1/3 of funds
1/3 of funds
YES
Milestones reached?
Matching Funds?
NO
STOP
YES
Milestones reached?
Matching Funds?
Commercialization
NO
STOP
Milestones reached?
Matching Funds?
NCI is in Planning Stages for a New
SBIR Phase IIB Bridge Award
• NCI is in the important stage of developing and gaining approval
for this new funding opportunity.
• Our goal is to launch this within the next several months.
• Further details will be spelled out in the Funding Opportunity
Announcement.
• To receive more information, please go to http://sbir.cancer.gov
and enter your email in “Sign up for updates.”
• We will email out information on this funding opportunity once its
available.
More Information on
NCI SBIR & STTR Website
http://sbir.cancer.gov
Overview
of the SBIR Program
SBIR & STTR: Three-Phase Program
PHASE I – R41, R43
• Feasibility Study
• $100K and 6-month (SBIR) *
• or 12-month (STTR) Award
PHASE II – R42, R44
• Full Research/R&D
• $750K and 2-year Award (SBIR & STTR) *
• Commercialization plan required
PHASE III
• Commercialization Stage
• Use of non-SBIR/STTR Funds
* Note: Actual funding levels may differ by topic.
Reasons to Seek SBIR & STTR Funding
• Provides seed funding for innovative technology
development projects
• Intellectual property rights are retained by the small
business concern
• Not a loan – no repayment is required
• 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.)
Tips on Submitting an
Application
Keys to a Strong Application
• Significant, innovative, and focused science
• Significant product and/or commercial potential
• A product-focused application is more likely to have support of
business reviewers
• A project with sound financial projections is more likely to
attract a partner
• Translational research/clinical applications projects should
involve the appropriate collaborators
• Oncologists
• Pathologists
• Statisticians
Know NIH Review Criteria
Significance
• Does the study address an important problem
and have commercial potential?
Approach
• Are design and methods well-developed and
appropriate? Are problem areas addressed?
Innovation
• Are there novel concepts or approaches? Are the
aims original and innovative?
Investigator
• Is the investigator appropriately trained
and capable of managing the project?
Environment
• Does the scientific environment contribute to the
probability of success? Is the environment unique?
Electronic Submission Process
(Grants Only)
• The PHS398 grant application form is being phased out and
replaced with the SF424 Research and Related (R&R) application
• NIH has transitioned from paper submission of SBIR/STTR grant
applications to electronic submission
• Company and company official must be registered in Grants.gov
• PI and company official must be registered in the eRA Commons
http://era.nih.gov/ElectronicReceipt
Application and Award Process
• NCI describes topics in solicitation
Proposal
Submission
• Small business concerns prepare
short (usually 25-page) proposals
• Unsolicited proposals are not accepted
Evaluation
Award
About 6-9 months
Solicitation
Topics
• NCI evaluates proposals based on technical
merit, applicant qualifications, and commercial
potential/societal benefit
•
NCI makes awards
Eligibility Requirements
SBIR Eligibility Requirements
Small Business Concern
• Organized for-profit U.S. business
• 500 or fewer employees, including affiliates
• Must be:
• At least 51% U.S.- owned by individuals and independently
operated
or
• At least 51% owned and controlled by another (one) business
concern that is at least 51% owned and controlled by one or more
individuals
• Principal Investigator’s primary employment must be with the
Small Business Concern at the time of award and for the
duration of the project period
STTR Eligibility Requirements
• Applicant is a Small Business Concern
• Formal Cooperative R&D Effort
• Minimum 40% by small business
• Minimum 30% by U.S. research institution
• U.S. Research Institution
• College or University
• Other non-profit research organization
• Federal R&D center
• Intellectual Property Agreement
• Allocation of IP rights and rights to carry out follow-on R&D and
commercialization
• Principal Investigator’s primary employment may be with either
the Small Business Concern or the research institution
SBIR and STTR Programs
(Critical Differences)
SBIR
STTR
• Permits research institution partners (e.g., universities)
• Small business concern may outsource ~33% of Phase I
activities and 50% of Phase II activities
• Requires research institution partners (e.g., universities)
• 40% of the work must be conducted by the small business
concern (for profit) and 30% by a U.S. research institution
(non-profit)
Award always made to small business
NCI SBIR Funding
Opportunities
NIH Issues Multiple SBIR Solicitations
SBIR/STTR Omnibus Grant Solicitation
Release: January
Receipt Dates: April 5, August 5, and December 5
SBIR Contract Solicitation (NIH, CDC)
Release: August
Receipt Date: Early November
NIH Guide for Grants and Contracts
Release: Weekly
Receipt Dates: Various
For more information visit:
Sbir.cancer.gov
NCI is Moving to More
Focused Solicitations
• Goal is to improve success in commercialization by focusing
on more directed research.
• Invest in the technology priorities of NCI that also have
potential for commercialization
• Catalyze targeted technology development and draw private
sector investment in areas such as drug development and
assays that measure treatment response
• Significantly increase the use of SBIR contracts.
Current NCI Priority Areas
•
Development of Anti-Cancer Agents
•
Development of Molecular Pharmacodynamic Assays for Targeted Therapies
•
Nanotechnology Imaging and Sensing Platforms for Improved Diagnosis of Cancer
•
Multifunctional Therapeutics Based on Nanotechnology
•
Antibody Array for Cancer Detection
•
Biosensors for Early Cancer Detection and Risk Assessment
•
Novel and Improved Methods to Measure Cancer Epigenetic Biomarkers
•
High-Throughput Assays for Isolation and Characterization of Cancer Stem Cells
•
Assay Systems for Drug Efficacy Using Cancer Stem Cells
•
Integrating Patient-Reported Outcomes in Hospice and Palliative Care Practices
•
Portable e-Technology Diet and Physical Activity Tools for Consumers
•
Patient-Centered Coordinated Cancer Care System
•
System to Analyze and Support Biomarker Research and Development Strategies
•
Biopsy Instruments and Devices that Preserve Molecular Profiles in Tumors
•
Advances in Protein Expression of Post-Translationally Modified Cancer Related Proteins
•
Development of Clinical Quantitative Multiplex High-Throughput Mass Spectrometric
Immunoassay for Detecting Low Abundance Cancer Related Proteins/Peptides in Bodily
Fluids
Examples of SBIR Grant Topics
Division of Cancer Biology
SBIR Program Announcement (PAS-07-240)
Technology Development for the Detection and Evaluation of Chemical and
Biological Carcinogens (R43/R44)
http://grants.nih.gov/grants/guide/pa-files/PAS-07-240.html
Receipt Dates: April 5, August 5, December 5, 2007
SBIR Program Announcement (PAS-07-241)
Technology for the Detection and Characterization of Low Abundance Proteins,
Peptides, or micro RNAs (R43/R44)
http://grants.nih.gov/grants/guide/pa-files/PAS-07-241.html
Receipt Dates: April 5, August 5, December 5, 2007
SBIR Program Announcement (PAS-07-242)
Technologies and Software to Support Integrative Cancer Biology Research
(R43/R44)
http://grants.nih.gov/grants/guide/pa-files/PAS-07-242.html
Receipt Dates: April 5, August 5, December 5, 2007
Omnibus Solicitations for Grants
SBIR Omnibus Solicitation
PHS 2006-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business
Innovation Research Grant Applications (Parent SBIR [R43/R44])
http://grants.nih.gov/grants/guide/pa-files/PA-06-120.html
Receipt Dates: April 5, August 5, December 5, 2007
STTR Omnibus Solicitation
PHS 2006-02 Omnibus Solicitation of the NIH for Small Business Technology
Transfer Grant Applications (Parent SBIR [R41/R42])
http://grants.nih.gov/grants/guide/pa-files/PA-06-121.html
Receipt Dates: April 5, August 5, December 5, 2007
Changes in Program
Management
NCI Creating an SBIR Development
Center to Optimally Manage the Program
Today, SBIR program management is generally dispersed
across NIH, with few full-time SBIR program managers
• For example, at NCI, SBIR awards are managed by ~40 people who each
spend only a fraction of their time managing small business awards
• Few NIH SBIR program managers have significant industry or
commercialization experience
29
NCI Creating an SBIR Development
Center to Optimally Manage the Program
Development Center Goals
• Assemble the scientific and business expertise needed to
optimally manage the SBIR program at the NCI
 Recruit internally and externally
• These would be full time dedicated SBIR management teams
• Integrate all SBIR initiatives with NCI’s program priorities
• Foster collaborations with other Institutes at NIH which share
common technology needs
• Enhance the return on investment for the SBIR program for the
benefit of the cancer community and the public health in general
30
New NCI SBIR Development Center
• Center will offer a menu of services:
•
•
•
•
•
Assess commercial potential of NIH technology priorities
Write solicitation topics/post-solicitation activities
Market program to attract the best companies
Evaluate commercialization potential of proposals
Provide awardee management & support
• More active monitoring of awards
• Program managers will have expertise and networks to
mentor emerging SBIR companies in commercialization
strategy and process
31
Employment Opportunities
Employment Opportunities
• Positions to be announced soon looking for expertise in:
• Biomarkers and Diagnostic Assays
• Cancer Imaging
• Radiation Therapy
• Cancer Prevention
• Cancer Biology
• Cancer Control and Population Sciences
• To receive job announcement information, go to
sbir.cancer.gov and click on “Sign up for Updates”
http://sbir.cancer.gov
Michael Weingarten
Director
NCI SBIR Development Center
Phone: 301-496-4413
[email protected]
Andrew Kurtz, Ph.D.
Program Manager
NCI SBIR & STTR Programs
Phone: 301-594-6846
[email protected]