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Meet with…
The National Cancer Institute
Thursday, March 26, 2009

• 10:00 AM - 10:30 AM: Registration & Tour
• 10:30 AM - 11:15 AM: Presentation
• 11:15 AM - 12:00 PM: General Q&A;
• 12:45 PM - 4:30 PM: Private Meetings (15 minutes per company)

The National Cancer Institute (NCI) recently introduced the Small Business Innovation Research (SBIR) Phase II Bridge Award mechanism, designed to incentivize their phase II awardees to obtain 3rd party financing in order commercialize technologies developed with SBIR funds.

In this session, Directors from the NCI SBIR Development Center will talk to current and potential grantees about the Bridge Award and other opportunities such as their contract topics.

After the presentation, each attendee will have a private meeting with Mr. Michael Weingarten – the Director of the NCI SBIR Development Center – and/or Dr. Ali Andalibi – the Program Director of the NCI SBIR Development Center.

Registrations are subject to approval of application.

• Michael Weingarten, Director, NCI SBIR Development Center, National Cancer Institute Click Here for Bio»
• Ali Andalibi, Ph.D., Program Director, NCI SBIR Development Center, National Cancer Institute Click Here for Bio»

Speakers Bios
Michael Weingarten, Director, NCI SBIR Development Center, National Cancer Institute
Mr. Weingarten was appointed as Director of the NCI SBIR & STTR Small Business Programs in 2005. In that role, he is overseeing the development of new strategies to optimize the impact of this Program in advancing emerging technologies towards clinical development and commercialization.
Mr. Weingarten served from 1990 until 2005 at NASA Headquarters in Washington, D.C. Most recently, he held the position of Program Manager, Exploration Systems Research and Technology Program at NASA, where he led a team of scientific and technical experts focused on the biomedical industry and the public health application of emerging technologies, as well as leading collaborative teams in building partnerships with private and public sector organizations to address public health needs. Earlier, as Program Manager of NASA’s Innovative Partnerships Program, he oversaw the Partnership Development Programs and Small Business Programs, formulating national policy and providing leadership on the development and implementation of educational outreach campaigns targeted towards small businesses.
Mr. Weingarten also served as a Program Analyst from 1989 to 1990 at the Department of State. He holds a Masters in Political Science from Columbia University.
Ali Andalibi, Ph.D., Program Director, NCI SBIR Development Center, National Cancer Institute
Dr. Ali Andalibi is a molecular biologist and geneticist by training with extensive experience in both academia and industry. He received his PhD from the UCLA department of Microbiology and Molecular Genetics and later joined the faculty in the UCLA department of Medicine. After leaving UCLA he was involved in several early stage biotechnology companies. He then joined the House Ear Institute (HEI), where he served as the Director of New Technology and Project Development and was also an adjunct Assistant Professor of Otolaryngology, at the University of Southern California, School of Medicine. Dr. Andalibi then joined the National Science Foundation as a Program Director in the Division of Industrial Innovation and Partnerships, where he oversaw the NSF’s medical biotechnology SBIR/STTR grant portfolio. Dr. Andalibi is currently a Program Director in the National Cancer Institute’s SBIR Development Center.

About the SBIR Phase II Bridge Awards to Accelerate the Development of New Cancer Therapies and Cancer Imaging Technologies Toward Commercialization (SBIR [R44])
Please visit click here to get to the actual RFA; and here for other opportunities such as contract topics.

The Small Business Innovation Research (SBIR) Program is an important mechanism by which the National Institutes of Health (NIH) helps bring innovative solutions to public health problems. A major objective of the SBIR Program is to facilitate commercialization of technologies developed by small business concerns (SBCs). Yet, the development of medical biotechnology products is often impeded by a significant funding gap, known as the “Valley of Death”, between the end of the SBIR Phase II award and the commercialization stage. This Funding Opportunity Announcement (FOA), launched as a pilot initiative at the NIH by the National Cancer Institute (NCI), solicits SBIR grant applications from SBCs that seek additional NIH funding to support the next stage of development for previously-funded NIH SBIR Phase II projects applicable to cancer therapies and cancer imaging technologies. The purpose of this FOA is to support the continuation of promising SBIR Phase II projects in order to pursue the next appropriate milestone(s) toward ultimate commercialization. To achieve this goal, this FOA is designed to promote partnerships between NIH’s SBIR Phase II awardees and third-party investors and/or strategic partners. Specifically, this FOA will give competitive preference and funding priority to applications deemed likely to result in a commercial product as indicated by the applicant’s ability to secure substantial independent third-party investor funds (i.e., third-party funds that equal or exceed the requested NCI funds). NCI support is thus intended to benefit cancer patients by accelerating the development of new cancer therapies (including anticancer agents and oncological therapeutic devices) and cancer-relevant imaging devices/technologies toward commercialization. Only applications proposing projects in these areas will be considered responsive to this FOA. Proposed projects may address preclinical and/or clinical stages of technology development (including clinical trials).

Scientific/Technical Scope
This funding opportunity is focused on the continued development of cancer therapies and cancer imaging technologies. Applications proposing projects in other scientific/technical areas will be considered non-responsive and will not be reviewed. The technical and commercial objectives described in the SBIR Phase II Bridge Award application must represent an extension of the development efforts that were pursued in a previously-funded NIH SBIR Phase II grant. To be considered for a Phase II Bridge Award, applicants must document the achievement of significant milestones during the previous Phase II award which justify the merit and need for further R&D.; To qualify for a Phase II Bridge Award, the SBIR Phase II award need not have been funded in response to any particular NIH solicitation and could have been funded by the NCI or by another NIH Institute/Center. However, the Phase II Bridge Award application must fall within the scientific and technical scope of this FOA (i.e., it must be focused on the development of novel anticancer therapeutics, oncological therapeutic devices, and/or cancer-relevant imaging devices/technologies).

Specific types of products/technologies to be pursued in projects proposed for SBIR Phase II Bridge Awards may include, but are not limited to:
• Anticancer drugs and drug delivery systems;
• Anticancer biologics;
• Anticancer vaccines;
• Devices for therapeutic (anticancer) use of ionizing radiation and other ablative techniques;
• Medical devices for in vivo cancer imaging and/or image-guided interventions (e.g., image-guided surgical and drug delivery systems); and
• Imaging agents.

The development efforts for these anticancer agents, therapeutic devices and/or imaging devices/technologies may include, but are not limited to:
• Drug/treatment efficacy studies in animal models;
• Assay development to support clinical trials;
• Process development for manufacturing (drugs or devices);
• Completion of activities as required by the Food and Drug Administration (FDA) for advancing the device or drug toward the clinical stage of development (e.g., IND, Radioactive Drug Research Committee [RDRC], Pre-Market Approval [PMA], Investigational Device Exemption [IDE], or 510(k) applications).

Funds Available
The NCI intends to commit $10,000,000 in fiscal year 2009 to fund five to ten applications submitted in response to this FOA. For this funding opportunity, budgets up to $1,000,000 in total costs (direct and F&A; costs plus fee) per year and project periods up to 3 years may be requested from the NCI. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received. Future year amounts will depend on annual appropriations.
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