# Presentation: 285246

## Greg Evans, PhD
Program Director and Team Leader 
SBIR Development Center, NCI

**Greg Evans, PhD**
**Program Director and Team Leader **
**SBIR Development Center, NCI**

**The SBIR Program at the****National Cancer Institute: New Directions and New Funding Opportunities**

*SBIR Penn BIO Event, September 29, 2008*

## Today’s Presentation

**Overview **
**Eligibility Requirements  **
**New Funding Opportunities**
- SBIR Contracts (Annual SBIR Contract Proposals are due November 3)
- New SBIR Bridge Award
**Keys to Submitting A Successful Application**
**SBIR Success Story- Naviscan, San Diego (presented by David Beylin, NCI SBIR Program Director)**

## Overview of Small Business Programs at NCI

## DefinitionsSBIR- Small Business Innovation ResearchSTTR- Small Business Technology Transfer Research

## Why are SBIR and STTR Important?

**NIH’s primary resource for enabling commercialization of innovative high impact technologies, such as:**
**Research tools**
**Medical devices**
**Therapeutics**
**Provides incentive to academic investigators to translate technology (new company formation)**
**One of the largest sources of early-stage life sciences financing**

## Reasons to Seek SBIR & STTR 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.)**

**Reasons to Seek SBIR & STTR Funding**

## SBIR & STTR: Three-Phase Program

**PHASE I – R41, R43**
**Feasibility Study **
**$100K and 6-month (SBIR) ***
***or***** 12-month (STTR) Award**

-  * **These funding levels are guidelines.  You should request the budget needed to accomplish the goals of the project**.

## Program Descriptions

**Program Descriptions**

**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%**

**Set Aside**

**A $100M Program at the NCI**

## Eligibility Requirements for SBIR and STTR Awards

## SBIR Eligibility Requirements

**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**

**SBIR Eligibility Requirements**

## STTR Eligibility Requirements

**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**

**STTR Eligibility Requirements**

## Award always made to small business

**SBIR**

**SBIR and STTR Programs****(Critical Differences)**

**Award always made to small business**

_**Permits**_** research institution partners (e.g., universities)**
**Small business concern may outsource ****~****33% of Phase I activities and 50% of Phase II activities **

**STTR**

_**Requires**_** research institution partners (e.g., universities)**
**Minimum 40% of the work should be conducted by the small business concern (for profit), and minimum of 30% by a U.S. research institution (non-profit)**

## New NCI SBIR Funding Opportunities

## For more information visit:

***	******Release:******  *****January**
**	*****Receipt Dates:******  *****April 5, August 5, and December 5**
**SBIR Contract Solicitation (NIH, CDC)**
***	******Release:******  *****August 8, 2008**
***	******Receipt Date:******  *****November 3, 2008****	**
**NIH Guide for Grants and Contracts**
***	******Release:******  *****Weekly**
***	******Receipt Dates:*** **Various**

**For more information visit:**
**http://sbir.cancer.gov**

**NIH Issues Many SBIR Solicitations Each Year**

## 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.  **

## 18 New NCI SBIR Contract Funding Opportunities – DUE NOVEMBER 3rd

** ****Biopsy Instruments and Devices that Preserve Molecular Profiles in Tumors**
**Development of Molecular Pharmacodynamic Assays for Targeted Therapies**
**System to Analyze and Support Biomarker R&D Strategies**
** ****Development of Anticancer Agents**
** ****Innovative Methods for Manufacturing Safe, Effective Cancer Therapeutics**

## 18 New NCI SBIR Contract Funding Opportunities – DUE NOVEMBER 3rd

**Innovative Strategies to Protect Radiosensitive Organs and Structures During Radiation Therapy**
** ****Quantitative Tissue Imaging for Clinical Diagnosis and Treatment**
** ****Antibody Array for Cancer Detection and Diagnosis**
** ****Novel and Improved Assays for Detecting Epigenetic Modifications**
** ****Nanotechnology Imaging and Sensing Platforms for Improved Diagnosis of Cancer**

## Multifunctional Therapeutics Based on Nanotechnology
High Level Programming Language to Expedite Development of User Interfaces
Mobile Computing for Consumer-centered Cancer Prevention and Control
Health Information Technology to Facilitate Patient-centered Communication in Cancer-related Care

**High Level Programming Language to Expedite Development of User Interfaces**
**Mobile Computing for Consumer-centered Cancer Prevention and Control**
**Health Information Technology to Facilitate Patient-centered Communication in Cancer-related Care**

**18 New NCI SBIR Contract Funding Opportunities – DUE NOVEMBER 3rd**

## 
Development of shRNA Library Screening Technology for Cancer-Related Targets
Novel Antibody Epitope Mapping Technologies
Development of Novel Protein Expression Technologies for Glycosylated Cancer Related Proteins 
Peptide Aptamers: New Tools to Capture and Study Protein Interactions in Lieu of Immunological Reagents

**Development of shRNA Library Screening Technology for Cancer-Related Targets**
**Novel Antibody Epitope Mapping Technologies**
**Development of Novel Protein Expression Technologies for Glycosylated Cancer Related Proteins **
**Peptide Aptamers: New Tools to Capture and Study Protein Interactions in Lieu of Immunological Reagents**

**18 New NCI SBIR Contract Funding Opportunities – DUE NOVEMBER 3rd**

## 

Drilling Down Into Contract Topics 229, 249, and 259

**Drilling Down Into Contract Topics 229, 249, and 259**

**18 New NCI SBIR Contract Funding Opportunities – DUE NOVEMBER 3rd**

## Goal: develop new rigorous, validated assays to measure molecular-level response to treatment in conjunction with preclinical development of new candidate therapeutic agents. 
Fast-Track proposals: yes
Budget: $150,000 Phase I; $1,000,000 Phase II; 4-6 awards
Phase I activities and deliverables: 
Pilot a research pharmacodynamic assay for the molecular target described.
Begin to characterize assay reproducibility, variability and accuracy.
Deliver to NCI the SOP of the research pharmacodynamic assay for the molecular target described.

**Fast-Track proposals: yes**
**Budget: $150,000 Phase I; $1,000,000 Phase II; 4-6 awards**
**Phase I activities and deliverables: **
- Pilot a research pharmacodynamic assay for the molecular target described.
- Begin to characterize assay reproducibility, variability and accuracy.
- Deliver to NCI the SOP of the research pharmacodynamic assay for the molecular target described.

**Topic 229: Development of Molecular Pharmacodynamic Assays for Targeted Therapies**

## 
Phase II Activities and Deliverables:
Develop a qualified or validated molecular pharmacodynamic assay for the target described. The assay should be applicable in the clinical setting.
Perform studies to characterize the correlation between the resulting assay in tumor versus surrogate tissues (e.g. blood, serum), if applicable.
Perform studies to characterize the correlation between the resulting assay in human versus animal tissues.
Make available to NCI all SOPs for this assay at this stage of development.

**Phase II Activities and Deliverables:**
- Develop a qualified or validated molecular pharmacodynamic assay for the target described. The assay should be applicable in the clinical setting.
- Perform studies to characterize the correlation between the resulting assay in tumor versus surrogate tissues (e.g. blood, serum), if applicable.
- Perform studies to characterize the correlation between the resulting assay in human versus animal tissues.
- Make available to NCI all SOPs for this assay at this stage of development.

**Topic 229: Development of Molecular Pharmacodynamic Assays for Targeted Therapies**

## Goal: develop a knowledge management system that supports automated review and evaluation of current research and development efforts, particularly within the context of all cancer research and therapeutic and diagnostic product development. 
Fast-Track proposals: yes
Budget: $150,000 Phase I; $750,000 Phase II; 3-4 awards
Phase I activities and deliverables: 
Review biomarker data and literature to develop an overall biomarker research program analysis and support model. 
Determine what, if any commercial software could be used
Develop a prototype, present Phase I findings to NCI 

**Fast-Track proposals: yes**
**Budget: $150,000 Phase I; $750,000 Phase II; 3-4 awards**
**Phase I activities and deliverables: **
- Review biomarker data and literature to develop an overall biomarker research program analysis and support model.
- Determine what, if any commercial software could be used
- Develop a prototype, present Phase I findings to NCI

**Topic 249: System to Analyze and Support Biomarker Research and Development Strategies **

## Phase II Activites and Deliverables:
Conduct a formal use study of the software with representative users to evaluate the prototype system developed in Phase I. 
Develop and implement a project plan for populating, updating, and maintaining the biomarkers database.
Develop evaluation measures.
Demonstrate the flexibility of design that would permit updating the software as new biomarkers, research modalities, treatments, data formats, or other parameters of interest are added.

- Conduct a formal use study of the software with representative users to evaluate the prototype system developed in Phase I.
- Develop and implement a project plan for populating, updating, and maintaining the biomarkers database.
- Develop evaluation measures.
- Demonstrate the flexibility of design that would permit updating the software as new biomarkers, research modalities, treatments, data formats, or other parameters of interest are added.

**Topic 249: System to Analyze and Support Biomarker Research and Development Strategies **

## Goal: the development of a series of imaging assays for cell-based markers that provide prognostic, predictive or therapeutic response information on clinical tissue biopsies of potential value to clinical practice.
Fast-Track proposals: yes
Budget: $150,000 Phase I; $1,000,000 Phase II; 4-6 awards
Phase I activities and deliverables: 
Develop an automated quantitative imaging assay for a defined cellular subset in a preclinical model 
Confirm the quantitative analysis with a second technology that assesses phenotype or function of the cell of interest.
Demonstrate acceptable real-time assay performance in preclinical model tissue such that assay results available within 3–5 days

**Fast-Track proposals: yes**
**Budget: $150,000 Phase I; $1,000,000 Phase II; 4-6 awards**
**Phase I activities and deliverables: **
- Develop an automated quantitative imaging assay for a defined cellular subset in a preclinical model
- Confirm the quantitative analysis with a second technology that assesses phenotype or function of the cell of interest.
- Demonstrate acceptable real-time assay performance in preclinical model tissue such that assay results available within 3–5 days

**Topic 259: Quantitative Tissue Imaging For Clinical Diagnosis and Treatment**

## Phase II Activities and Deliverables:
Provide data to NCI that validates the automated quantitative imaging assay from Phase I for the cell subset in clinical samples with a second technology that measures the subset phenotypically and/or functionally. 
Provide data to NCI from studies performed to characterize the correlation between the resulting assay in tumor versus surrogate tissues (e.g. blood, serum)
Provide the SOP for specimen collection and processing and of the imaging assay for the cell subset with the exception of proprietary information.

- Provide data to NCI that validates the automated quantitative imaging assay from Phase I for the cell subset in clinical samples with a second technology that measures the subset phenotypically and/or functionally.
- Provide data to NCI from studies performed to characterize the correlation between the resulting assay in tumor versus surrogate tissues (e.g. blood, serum)
- Provide the SOP for specimen collection and processing and of the imaging assay for the cell subset with the exception of proprietary information.

**Topic 259: Quantitative Tissue Imaging For Clinical Diagnosis and Treatment**

## More Information onNCI SBIR & STTR Website

## New SBIR Bridge Award

## Phase II SBIR andCommercialization Success

**Significant resources are required for getting through the FDA approval process**
**This funding gap is known as the “Valley of Death”**

**Today, many awardees complete the SBIR Phase II award without advancing the technology far enough to attract private investment**

## SBIR Phase II Bridge Award

**Follow-On Award to the SBIR Phase II Award**
**Goal is to help early-stage companies cross the “Valley of Death” by:**
**Helping to facilitate partnerships with third party investors/strategic partners**
**Incentivizing partnerships earlier in the development process by sharing in the investment risk**
**The Bridge Award is modeled after NSF’s “Phase IIB Option” and has the same key feature:**

## Phase II Bridge Pilot at NCI

**Third-party funds are expected to equal or exceed NCI funds being requested**
**Third-party investors are expected to bring:**
**Rigorous commercialization due diligence**
**Commercialization guidance during the award**
**Additional financing beyond the initial third-party investment**

## Phase II Bridge Pilot at NCIRFA-CA-08-021

**Phase II Bridge Pilot at NCI****RFA-CA-08-021**

**Pilot will focus on cancer therapies and cancer imaging**
**Budgets up to $1 million per year for ****up to**** 3 years from NCI**
**Development efforts must be predicated on a previous SBIR Phase II grant and may include:**
**Pre-clinical R&D needed for regulatory filings (e.g. IND or IDE) **
**Clinical trials**
**Application Dates: September 19, 2008 and February 27, 2009**
**NCI intends to commit up to $10M in FY 2009 to Bridge Awards**
**Open to current and recently expired NIH SBIR Phase II projects**

## Example: How the Bridge Award Would Apply in the Area of Drug Development

**Commercialization**

**NDA**
**Review**

**Clinical**
**Trials**

**Safety**
**Review**

**Preclinical Development**
**(Lead Development, Animal Studies, File IND)**

**Target Identification**
**& Validation**

**Private Investment**

## Example: How the Bridge Award Would Apply in the Area of Drug Development

**Commercialization**

**NDA**
**Review**

**Clinical**
**Trials**

**Safety**
**Review**

**Preclinical Development**
**(Lead Development, Animal Studies, File IND)**

**Target Identification**
**& Validation**

**SBIR Bridge Award addresses the problem by bridging the “****Valley of Death****”**

**SBIR Bridge Award**** ****allows NIH to share investment risk by incentivizing investors  or strategic partners to evaluate projects and commit funds much earlier**

**Private Investment**

**SBIR Bridge Award**

## Example: How the Bridge Award Would Apply in the Area of Drug Development

**Commercialization**

**NDA**
**Review**

**Clinical**
**Trials**

**Safety**
**Review**

**Preclinical Development**
**(Lead Development, Animal Studies, File IND)**

**Target Identification**
**& Validation**

**Private Investment**

**SBIR Bridge Award**

## Keys to Submitting a Successful SBIR/STTR 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**

**Notes:**
Important that you recognize that proposals are peer reviewed by scientists in your field and also business people with backgrounds in commercialization.  Its critical to address both the science and the commercialization strategy in your proposals.  NIH is different from most other govt. agencies where program managers actually do the reviews.  In terms of the science, the proposal has to have sufficient detail so that your peers understand your approach.  Should be written as if you are writing it for a broad based scientific journal like Science or Nature.

## Know NIH Review Criteria

**Significance**

**Does the study address an important problem and have commercial potential?**

**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?**

**Approach**

**Are design and methods well-developed and appropriate? Are problem areas addressed?**

**Environment**

**Does the scientific environment contribute to the probability of success? Is the environment unique?**

**Commercialization**

**Is the company’s business strategy one that has a high potential for success?   **

**Notes:**
Shouldn’t be too high risk, but rather an evolution in the technology development.  Peer review wants to make sure you can accomplish the goals of your research.

## Key #1Start Application Process Early!

**Start developing your application as early as possible.  You need time to develop a strong proposal.**
**Seek help of experienced applicants early in process**
**Assemble a strong scientific team**
- If you have a weakness or gap in expertise, fill it early

## Key #2Consider Your Company’s Strengths and Weaknesses

**Consider your company’s strengths**
- Try to exploit those strengths to address a specific NIH Program initiative
**Consider your weaknesses too**
- It is rare that a small company will have all the necessary expertise for a strong application
- If you have no track record of commercialization, consider getting a partner who does
**Partner with other companies or academics to fill gaps**
**Contact NIH Program Director in advance to discuss your proposal and receive feedback**
**Review similar currently funded projects in the NIH CRISP database (****http://crisp.cit.nih.gov/****)**

## Key #3Always Consider the Reviewers

**Who is going to review your application?**
- 10 or more on the Review Panel who will score your application
- However, _primary review_ by 2-4 persons with appropriate expertise assembled by SRA
- Combination of academic and business professionals

## Key #3Always Consider the Reviewers

**What are they looking for?**
- Readable and understandable application
- Do not assume they will know everything you know
- You understand your application best so convey it to them
- Clear and concise language, “lay summary”
- Clear plan for Phase I, II and commercialization
- Feasible methods
- Appropriate objective tests of success for each Specific Aim
- Promising preliminary data are very influential
- Solid letters of support for commercialization

## Key #3 Always Consider the Reviewers

**Read your material critically as if you were the Reviewer**
- What are the weaknesses?
- Point out potential difficulties, do not hide them
- Suggest ways to address them or provide rationale
- Recruit an independent reader
**Provide alternative methods if a particular approach is not successful**

**Help the Reviewer write his analysis**

## Key #3  Always Consider the Reviewers

**Be realistic about your goals**
- Provide a feasible timetable for key objectives
**Be realistic about your budget**
- Ask Program Director for early guidance

## Have you honestly assessed the commercial viability of your technology?

**Do you have a talented professional to be a PI?**
**Is the PI supported by the right team? Does he or she have the time?**
**Do you have the resources to write the grant application or contract proposal?**
**Do you have the resources and capabilities to execute?**
**Do you have the business resources needed for a successful launch?**

**Application Checklist**

## Michael Weingarten

**Michael Weingarten**
**Director**
**NCI SBIR Development Center**
**Phone: 301-496-4413**
**weingartenm@mail.nih.gov**

**Greg Evans, Ph.D.**
** ****Program Director, Team Leader**
**NCI SBIR Development Center**
**Phone: 301-594-8807**
**evansgl@mail.nih.gov**

## Thanks to Pennsylvania BIO

**Thanks to Pennsylvania BIO**