Catal alyzing ing the he Ne Next xt Gener Generation ion of - - PowerPoint PPT Presentation

Catal alyzing ing the he Ne Next xt Gener Generation ion

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• f Cancer

ancer Tec echnologies hnologies

Presentation to the FluidicMEMS Group

October 1, 2012

Michael Weingarten Director, NCI SBIR Development Center

Congressionally-Mandated Programs

Ø SBIR: Set-aside program for small business concerns to engage in Federal R&D with the potential for commercialization Ø STTR: Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions with potential for commercialization

2.7% 0.35%

Set Aside (FY13)

~$115 million annually at the NC NCI ~$690 million annually at the NIH

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• Provides seed funding for innovative technology development
• Provides recognition, verification and visibility
• Helps provide leverage in attracting additional funding or

support (e.g., venture capital, strategic partner) Ø Not Not a a Loan Loan ∴ No repayment is required ∴ Doesn’t impact stock or shares in any way (i.e., non-dilutive)

• Intellectual property rights retained by the small business

Reasons to Seek SBIR/STTR Funding

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SBIR Eligibility

ü Applicant must be a Small Business Concern (SBC) ü Organized for-profit U.S. business ü 500 or fewer employees, including affiliates ü PD/PI’s primary employment (i.e., >50%) must be with SBC at the time of award and for duration of the project period ü ≥ 51% U.S.- owned by individuals and independently operated * OR

OR

≥ 51% owned and controlled by another (one) business concern that is ≥ 51% owned and controlled by one or more individuals *

* Recent reauthorization includes some exceptions to this rule

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STTR Eligibility

ü Applicant is a Small Business Concern ü Formal Cooperative R&D Effort

• Minimum 40% by small business concern
• Minimum 30% by U.S. research institution

ü U.S. Research Institution: College or University; Non-profit research organization; Federally-Funded R&D Center (FFRDC) ü Intellectual Property Agreement

• Should provide the necessary IP rights (to the SBC) in order to

carry out follow-on R&D and commercialization ü Principal Investigator’s primary employment may be with either the Small Business Concern or the research institution

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Phase ¡III ¡ COMMERCIALIZATION ¡ Phase ¡II ¡ DEVELOPMENT ¡ Phase ¡I ¡ FEASIBILITY ¡

• ¡ ¡Proof-­‑of-­‑Concept ¡study ¡
• ¡ ¡$150,000 ¡over ¡ ¡ ¡ ¡ ¡ ¡ ¡ ¡ ¡ ¡

¡ ¡ ¡ ¡6 ¡months ¡(SBIR) ¡ ¡ ¡ ¡ ¡ ¡ ¡ ¡or ¡1 ¡year ¡(STTR) ¡

• ¡ ¡Research ¡& ¡Development ¡
• ¡ ¡CommercializaGon ¡plan ¡required ¡
• ¡ ¡$1 ¡million ¡over ¡ ¡2 ¡years ¡
• ¡ ¡CommercializaGon ¡stage ¡
• ¡ ¡Use ¡of ¡non-­‑SBIR/STTR ¡funds ¡

Fast-Track Application Combined Phase I & II

SBIR & STTR: Three-Phase Program

• SBIR/STTR programs were re-authorized through FY2017

by the 2012 Defense Authorization Act (P.L.112-81)

• Increases SBIR set-aside (incrementally) to 3.2% by 2017
• Increases STTR set-aside to 0.45% by 2017
• Establishes hard caps on funding levels for Phase I & II

awards

• $225K for Phase I
• $1,500K for Phase II
• NIH will be permitted to spend up to 25% of SBIR funds on

small businesses majority owned by multiple VCs, hedge funds, or private equity firms (previously not allowed)

• Effective after new rules are finalized (expected 1/1/13)

Congressional Reauthorization

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Public Comment

Proposed Size Regulations (published 5/15/12)

• Rules regarding eligibility, ownership, and affiliation
• Open for public comment through 7/16/12
• Final rules expected January 1, 2013

Policy Directives (published 8/6/12)

• Regulations that address many other legislative provisions
• Effective as interim policy now
• Open for public comment until October 5, 2012

Submit comments at http://regulations.gov RIN: 3245-AF84 (SBIR) RIN: 3245-AF45 (STTR)

§ NIH SBIR/STTR Omnibus Solicitations for Grant Applications

Release: January Receipt Dates: April 5, August 5, and December 5

§ Solicitation of the NIH & CDC for SBIR Contract Proposals

Release: August Receipt Date: November 13, 2012 § RFP can be found at:

§ http://grants.nih.gov/grants/funding/SBIRContract/PHS2013-1.pdf

§ More info about NCI’s topic areas:

§ http://sbir.cancer.gov/funding/contracts/

NIH Has Multiple Funding Solicitations

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SBIR Contracts vs. Grants: What's the difference?

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) Questions during solicitation period? May speak with any Program Officer MUST contact the contracting

• fficer

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 Set-aside of funds for particular areas? NO YES YES

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FY13 NCI Contract Funding Topics

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Ø 313 RNAi Cancer Therapeutics using Nanotechnology Ø 314 Development of Human Tissue Culture Systems that Mimic the Tumor Microenvironment Ø 315 Development of Companion Diagnostics: Enabling Precision Medicine in Cancer Therapy Ø 316 Development of CTC Isolation Technologies Enabling Downstream Single Cell Molecular Analysis Ø 317 Wound Healing Preparations Incorporating Nitric Oxide-Releasing Materials Ø 318 Test to Predict Effectiveness of Docetaxel Treatment for Prostate Cancer Ø 319 Technology to Generate Anti-Peptide Capture Reagents for Affinity-Enriched Proteomic Studies Ø 320 High Quality Cancer-Related Standards for Metabolomics Research Ø 321 Chemically Defined Glycan Libraries for Reference Standards and Glycomics Research (Joint NCI-NIGMS Program) Ø 322 Real-Time Integration of Sensor and Self-Report Data for Clinical and Research Applications Ø 323 Development of Radiation Modulators for Use During Radiotherapy Ø 324 Novel Imaging Agents to Expand the Clinical Toolkit for Cancer Diagnosis, Staging, and Treatment Ø 325 Innovative Radiation Sources for Advanced Radiotherapy Equipment

Topic 314: Development of Human Tissue Culture Systems that Mimic the Tumor Microenvironment

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Budget: Phase I $300,000; Phase II $2M Number of Anticipated Awards: 3 - 5 Goal: Development of 3D human tissue model culture systems that accurately mimic the tumor microenvironment…validated against known effective anti- cancer agents Phase I Activities & Deliverables Include:

• Develop 3D culture system prototype that incorporates human tumor cells

using or easily adapted for use with high content screening platforms

• Demonstrate accurate prediction of clinical efficacy in the developed prototype

benchmarked against 2D and currently available 3D systems Phase II Activities & Deliverables Include:

• Benchmark performance against known in vivo effects
• Demonstrate ability to scale-up system

Topic 316: Development of CTC Isolation Technologies Enabling Downstream Single Cell Molecular Analysis

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Budget: Phase I $300,000; Phase II $1.5M Number of Anticipated Awards: 4 Goal: Demonstrate technical viability of technology to isolate and analyze CTCs at the single-cell level in an experimental setting. Phase I Activities & Deliverables Include:

• Method for CTC isolation or identification amenable to downstream single-

cell analysis

• Isolate or identify CTCs from samples with counts as low as 1 cell/ml of blood
• Provide CTCs for molecular analysis at the single-cell level

Phase II Activities & Deliverables Include:

• Prototype demonstrating applications with significant clinical utility, such as

whole genome sequencing, molecular phenotyping, or culture for ex vivo analysis

• Test device with patient samples
• Establish marketing partnership

Questions About Contracts?

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• Ms. Bette Shanahan

eshanahan@mail.nih.gov 301.435.3782 http://sbir.cancer.gov/funding/contracts/

Michael Weingarten Director NCI SBIR Development Center Phone: 594-7709 weingartenm@mail.nih.gov

http://sbir.cancer.gov

Register on web site for funding

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