Transcript AAPM SBIR & STTR

NCI SBIR Funding for
Technology Development
Presentation at DP Clinical
David Beylin
Program Director
NCI SBIR Development Center
March 26, 2010
Today’s Presentation
• Program Overview
• SBIR Funding Opportunities
• NCI SBIR Development Center
• New SBIR Bridge Award
Overview
NCI SBIR Focus: Commercializing Innovation
Therapeutics
Medical Devices
Research Tools
eHealth
Cancer diagnosis, treatment, research
4
Program Descriptions
Set Aside
• SBIR: Set-aside Program for
Small Business Concerns to engage
in Federal R&D with potential for
commercialization
• STTR: Set-aside Program to facilitate
Cooperative R&D between Small Business
Concerns and U.S. Research Institutions
with potential for commercialization
2.5%
0.3%
A $108M Program at the NCI
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
* These funding levels are guidelines. You should request the
budget appropriate to accomplish the goals of the project.
Reasons to Seek SBIR & STTR Funding
• Provides seed funding for innovative technology
development projects
• A stable and predictable source of funding
• 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.)
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
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 Funding Opportunities
(Phase I & II)
SBIR Solicitations
SBIR/STTR Omnibus Grant Solicitation (NIH)
Release: January
Receipt Dates: April 5, August 5, and December 5
Technology Areas: All, investigator-initiated R&D
SBIR Contract Solicitation (NIH, CDC)
Release: August
Receipt Date: November 9, 2009 [CURRENTLY CLOSED]
Technology Areas: See 23 published NCI contract topics
Image-Guided Cancer Interventions (NCI)
Recently Expired PAs: PA-07-041, PA-07-042
Release: January 2010
Receipt Date: April 5, 2009
Technology Areas: IGD, IGT, IGS
Selected SBIR Contract
Topics in 2009
 Development of Anticancer Agents
 Nanotechnology Imaging Agents or Devices for Improved Detection of Cancer
 Biopsy Instruments and Devices that Preserve Molecular Profiles in Tumors
 Innovative Devices to Protect Radiosensitive Organs and Structures During
Radiation Therapy
 Quantitative Cell-Based Imaging For Clinical Diagnosis and Treatment
 …
 Full List of 23 Topics:
 http://sbir.cancer.gov/funding/past/contracts/PHS2010-1.asp
 Next contract solicitation will be released in August of 2010 (sign-up for
updates at http://sbir.cancer.gov)
Topic 277: Companion Diagnostics- Predictive and
Prognostic Tests Enabling Personalized Medicine
 Goal: develop companion diagnostics to select patients in whom a
particular therapeutic regimen, including existing drugs and those in late
clinical development, will be safe and effective
 Fast-Track proposals allowed: yes
 Budget: $200,000 Phase I; $1,500,000 Phase II; < 4 awards anticipated
 Phase I activities and deliverables:
• Develop a working diagnostic test.
• Characterize the variation, reproducibility, and accuracy of the test
• Demonstrate suitability of the test for use in the clinic, conduct
benchmarking studies against current tests (if available).
Topic 277: Companion Diagnostics- Predictive and
Prognostic Tests Enabling Personalized Medicine, cont
 Phase II Activities and Deliverables:
• Demonstrate clinical utility and value by testing sufficient numbers
of patients for statistical significance regarding patient selection for
the therapy.
• Perform correlation studies between any animal models and
treatment in human subjects, if applicable
• Establish a marketing partnership or alliance, as appropriate, with
the pharmaceutical company that is developing or selling the
therapy, unless the therapy is on the open market.
• Deliver the final SOP to NCI.
Grant Portfolio (Recent Snapshot)
Topic Area
Phase I & Phase II Grants
(% of portfolio)
Biologics
39 (15%)
Small molecules
24 (9%)
Nanotechnology-based therapeutics
5 (2%)
Devices for Cancer Therapy
Surgical interventions
10 (4%)
11%
Ablative technologies
17 (7%)
Imaging Technologies
Image-guided interventions
9 (3%)
24%
New imaging technologies
54 (21%)
In vitro diagnostics
56 (21%)
5%
Research Tools
12 (5%)
Cancer Control & Epidemiology
Bioinformatics & eHealth
26 (9%)
13%
Educational Tools & Other
9 (4%)
Total
261 (100%)
Therapeutics
26%
Diagnostics
21%
Cancer Biology
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NCI SBIR
Development Center
SBIR Development Center
Old SBIR Management Model at NCI
• Awards were managed by 40-50 people who each spent a small amount of
their time on SBIR (currently the model at other NIH Institutes)
• Few of these NCI program managers had significant industry experience or
commercialization expertise
New Development Center at NCI
• Team of 8 Program Directors and the Center Director
• Exclusively focused on the management of NCI’s SBIR/STTR portfolio
• Program Directors have previous industry experience and professional
networks to help mentor awardees in commercialization strategy and
process
• Center is developing a range of new activities to help small businesses
17
SBIR Development Center Staff
Michael Weingarten, MA (Director)
Ali Andalibi, PhD (Branch Chief)
Previous
• NASA – Program Manager, NASA Technology
Commercialization Program
Previous
• NSF – SBIR Program Director, Medical Biotechnology
• House Ear Institute – Scientist & Director, New
Technology and Project Development
• Trega Biosciences, Inc. – Research Scientist
Greg Evans, PhD (Branch Chief)
Natalia Kruchinin, PhD (Program Director)
Previous
• NHLBI/NIH – Program Director, Translational and
Multicenter Clinical Research in Hemoglobinopathies
• NHGRI/NIH – Senior Staff Fellow
Previous
• QIAGEN, Inc. – Molecular Diagnostics Applications
Manager
• Motorola, Inc. – Senior Scientist, Gene Expression
Assays
Patti Weber, DrPH (Program Director)
Andrew J. Kurtz, PhD (Program Director)
Previous
• International Heart Institute of Montana –
Tissue Engineering and Surgical Research
• Ribi ImmunoChem Research, Inc. – Team
Leader, Cardiovascular Pharmacology
Previous
• NIH – AAAS Science & Technology Policy Fellow
• Cedra Corporation – Research Associate, BioAnalytical Assays and Pharmacokinetics Analysis
David Beylin, MS, MBA (Program Director)
Jian Lou, PhD (Program Director)
Previous
•X/Seed Capital Management, LLC, EIR
•Naviscan PET Systems, Inc., Vice President, Research
Previous
• Johnson & Johnson – Research Scientist,
Target Validation & Biomarker Development
• Lumicyte, Inc. – Director, Molecular Biology
Systems Analysis
Deepa Narayanan, MS (Program Director)
Todd Haim, PhD (Program Analyst / AAAS Fellow)
Previous
• Naviscan PET Systems, Inc., Director, Clinical Data
Management (Oncology Imaging & Clinical Trials)
• Fox Chase Cancer Center, Scientific Associate (Molecular
Imaging Lab)
Previous
• National Academy of Sciences – Christine Mirzayan
Science and Technology Policy Fellow
• Pfizer Research Laboratories – Postdoctoral Fellow,
Cardiac Pathogenesis & Metabolic Disorders
Mentoring and Facilitation
Goal
• To work closely with promising SBIR Phase II awardees in
order to advance their technologies towards the clinic.
Path
• Mentor and guide companies throughout the award period.
• Hold an annual SBIR Investor Forum to learn more about
portfolio companies, encourage inter-company
collaborations/partnerships, and showcase to investors.
• When appropriate, act as a liaison to bring investors (VC,
angels, strategic partners) and NCI SBIR companies together.
NCI SBIR Investor Forum
(available to NCI Phase II grantees )
NCI SBIR Investor Forum
Exclusive opportunity for 14 NCI
awardees to showcase their
companies to investors
http://sbir.cancer.gov/investorforum/
Featured Small Businesses
• Present to and network with close to 200 top
investors and strategic partners
• Participate in panel discussion with successful
Bridge awardees and their investors
Investors
• Opportunity to evaluate NCI’s top companies with
innovative technologies
• Exclusive one-on-one meetings
• Follow-Up discussions, MTA’s and Due Diligence
now underway
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Investor Forum Participants
Strategic partners
Investors
Other Organizations and Media
Regulatory Assistance Program
(available to NCI Phase II grantees )
Regulatory Assistance
Goal
Regulatory assistance
Scope
Preparation for IND, PMA, BLA, IDE,
510(k) submission. cGMP, QSR, CLIA
Eligibility
SBIR/STTR Phase II Awardees
Path
30+ hours of consulting time
Consultant works under NCI contract
Launch
TBA soon
New SBIR Bridge Award
Phase II SBIR and
Commercialization Success
Today, many 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
• This funding gap is known as the “Valley of Death”
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 II Bridge Award
PHASE III
• Commercialization Stage
• Use of non-SBIR/STTR Funds
* Note: Actual funding levels may differ by topic.
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SBIR Phase II Bridge Award
Follow-on to SBIR Phase II
• Goal to help early-stage companies cross the “Valley of Death” by:
• Incentivizing third-party investment earlier in the development process by
 Sharing in the investment risk with third-party investors
RFA Incentive Structure
• Gives competitive preference and funding priority to applicants that can
raise substantial third-party funds (i.e., minimum 1:1 match)
• Affords NIH the opportunity to leverage millions in external resources
• Third-party investors are also expected to provide valuable input in several ways:
1. Rigorous commercialization due diligence prior to award
2. Commercialization guidance during the award
3. Additional financing beyond the Bridge Award project period
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RFA Highlights
Mechanism & Budgets
• Uses the SBIR Phase II (R44) competing renewal mechanism
• Provides up to $1 M per year for up to 3 years
• Available to current Phase II grant awards, and those that ended within last 2 years
Preferred Third-Party Matching Funds
• Cash, liquid assets, convertible debt
Sources of Funds
• Another company, venture capital firm, individual “angel” investor, foundation,
university, state or local government, or any combination
29
Example: How the Bridge Award Would 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 Would 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?
FY2009 Bridge Awards
San Diego,
CA
$3.0M for the commercialization of ASONEP™, a firstin-class monoclonal antibody against the angiogenic
growth factor S1P
Oriental, NC
$3.0M for the development of a photoacoustic
computed tomography (CT) scanner for preclinical
molecular imaging
Norcross, GA
$2.5M for the development of LightTouch®, a point-ofcare device for cervical cancer screening
Northridge,
CA
$3.0M for the development of a novel molecular breast
imaging technique to guide early-stage patient care
Miramar, FL
$3.0M for the development of ALT-801, a fusion protein
consisting of IL-2 coupled with a soluble T-cell receptor
fragment that recognizes a specific form of processed
p53 antigen
West
Henrietta, NY
$3.0M for the development of a cone beam breast CT
scanner
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Lpath Therapeutics, Inc.
Commercialization of ASONEP™ for the treatment of cancer
 First-in-class, systemic formulation of a humanized monoclonal antibody which
neutralizes the angiogenic growth factor, sphingosine-1-phosphate (S1P)
Third Party Funding
“…the applicant is putting into
place… pre-clinical and clinical
biomarker validation studies…
to drive tumor type and patient
selection decisions…”
-Reviewer
• A major pharmaceutical firm has
committed 6 the Bridge funding
for the current activities
• Following the Bridge, this strategic
partner is prepared to support
development through Phase II and
Phase III clinical trials
33
Optosonics, Inc.
Photoacoustic CT for preclinical molecular imaging
 Large potential market in the area of preclinical drug development
Third Party Funding
“…the innovation… is advancing
the state-of-the-art in PCT and its
commercialization…”
-Reviewer
• A new company founded by an
established VC firm and a team
of pharma leaders will match
the Bridge funding
• Third-party Investors are
knowledgeable about the
customer base and can
leverage their expertise to
provide commercialization
guidance
34
Expanded Technical Scope
(FY10 reissuance)
Therapeutics
• Anticancer drugs and drug delivery systems
• Small molecules, biologics and vaccines
Devices for Cancer Therapy
• Devices for therapeutic (anticancer) use of ionizing radiation
• Other ablative techniques
Imaging Technologies
• Medical devices for in vivo cancer imaging
• Image-guided interventions (e.g., biopsy, surgery, drug delivery)
• Imaging agents
Cancer Diagnostics
• In vitro diagnostics
• Any other diagnostic modality
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More Information on
NCI SBIR & STTR Website
http://sbir.cancer.gov
http://sbir.cancer.gov
David Beylin, MS, MBA
Program Director
Phone: 301-496-0079
[email protected]
Register on web site for funding
opportunity updates
http://sbir.cancer.gov