Each year, the National Institutes of Health (NIH) invests more than $700 million into small businesses performing biomedical and biohavioral R&D to advance products to the commercial marketplace. On May 30 – June 1, at the Louisville Marriott Downtown, hundreds of health and science managers, small business executives, university researchers and entrepreneurs will gather for the 14th Annual NIH SBIR/STTR Conference in Louisville, KY. This year’s conference, “Changing the Face of SBIR/STTR,” will cover the “ins and outs” of the NIH SBIR/STTR programs provided by NIH staff, and include opportunities to meet one-one with NIH Program Managers. Attendees will also be informed of any program changes due to the 2012 Reauthorization Act, including policy updates and modifications to the gap funding and commercialization assistance programs.
A public scientific poster session will be held during the conference, featuring approximately 80 abstracts selected by the NIH to represent both SBIR and STTR Phase II awards. These poster sessions highlight the successes of SBIR/STTR funding and provide an opportunity to build strategic alliances and foster conversations that could lead to future partnerships. Abstract submissions are being accepted until April 20 for these poster sessions.
Registration is now open for the annual conference and costs $350 to attend. After April 30th, the price increases to $450. For an additional fee, participants are invited to stay on for a unique third day opportunity to hear from NSF and DoD staff, speaking on their respective SBIR/STTR programs and to participate in an optional intensive workshop focused on Phase I or Phase II proposal development or the valuation of intellectual property.
Do not miss the opportunity to learn the value of SBIR/STTR funding for your R&D operation. Register now.
Now that SBIR Reauthorization has been passed and signed by the President, many are waiting to see how these new rules will be implemented by each agency. Currently, the rules are in legislative form only, and have not been interpreted by any agency. Many small businesses are specifically interested in the VC eligibility rule, but as it stands, the agencies are only accepting applications from small businesses that comply with the original regulations. Several of the agencies have open solicitations to which you can apply. For more information, please see the links below.
- The Department of Health and Human Services has released it’s 2012 solicitation. Standard submission dates apply: Apr 5, Aug 5, Dec 5.
- The Department of Education has two solicitations available with receipt dates of Feb 13 and Feb 22.
- The Department of Defense has pre-released it’s 2012.A STTR topics. If you are interested in discussing the specific topics with a Program Officer, you must do so prior to the solicitation official release. The final solicitation will be released on Feb 27 and applications are due Mar 28.
- National Institute of Standards and Technology solicitation is available and submissions are due Mar 2.
The process of reauthorizing the SBIR/STTR Program has been, like many other government programs, a long journey. It appears that the House has agreed to the Senate’s modifications for SBIR/STTR reauthorization as part of the National Defense Authorization Act for 2012 NDAA. As reported by Rick Shindell of the SBIR Gateway almost 1000 small businesses contacted their Representatives and urged them to agree to the Senate modifications for SBIR/STTR. As the final bill has not yet been authorized we do not have all the details. Here is what is known:
- Reauthorization through 2017.
- Increased Set Aside: SBIR from 2.5% to 3.2%, STTR from 0.3% to 0.45%.
- VC Majority Ownership: Allowable for 25% of awards from NIH, DoE and NSF, 15% of awards from all other agencies.
- Limit on Number of Awards Per Company: Rejected, but language included to monitor a company’s success.
- Agency Administrative Fund: 3% of SBIR funds can be used by the agencies for outreach and administration.
- Phase I Skip: Allowable for NIH, DoD and DoEd, at the agencies discretion.
The National Cancer Institute has announced the release of the 2012 SBIR Phase II Bridge Award program. The award helps bridge the funding gap, known as the “Valley of Death,” that currently exists between the end of the SBIR Phase II award and the next round of financing needed to advance a promising cancer therapy or imaging technology toward commercialization. The program is specifically intended to foster relationships between small business applicants and third-party investors and strategic partners who can help finance their development efforts.
The NCI intends to commit $10 million in fiscal year 2012, covering as many as 10 grants of up to $1 million annually for as long as three years. Development efforts may include preclinical R&D needed for regulatory filings or clinical trials in three project areas:
(1) cancer therapeutics
(2) cancer imaging technologies, interventional devices and in vivo diagnostics
(3) in vitro and ex vivo cancer diagnostics and prognostics
There are two deadlines to submit an SBIR Phase application: December 28, 2011 & March 27, 2012. For more information, visit the National Cancer Institute website.
Applications for the NIH Contract solicitation are due at 5 p.m. Eastern time on Monday, Nov. 7. The NIH Contract solicitation is released only once yearly, and contains a list of topics pertinent to each agencies mission. Unlike the grant solicitation, contracts are for specific work on a topic that has been pre-defined. Topics available in this year’s solicitation range from Wireless Telemetry for MRI to Rapid Point-of-Care tests for Fungal Diagnosis. Topics are highly specific and only proposals matching the published topics will be accepted; no investigator-initiated applications will be allowed. Budgets are also strictly enforced, and are limited to $150,000 for a Phase I and $1M for a Phase II. And, unlike other applications to the NIH, this solicitation must be submitted in paper form and received, as verified by time stamp, at the agency by the deadline above. Detailed information, including program contacts, detailed topic descriptions, and instructions for preparing proposals, are available in the solicitation.
Participating agencies, with the approximate number of contracts each expects to award:
NIH: National Cancer Institute (37); National Center for Research Resources (1-2); National Heart, Lung & Blood Institute (18 – 29); National Institute on Alcohol Abuse & Alcoholism 2-4); National Institute of Diabetes & Digestive & Kidney Diseases (1); National Institute on Drug Abuse (15 – 21).
Centers for Disease Control: Center for Global Health (2); National Center for Birth Defects and Developmental Disabilities (1); National Center for Emerging Zoonotic & Infectious Diseases (2); National Center for HIV/AIDS, Viral Hepatitis, SDT, & TB Prevention (3) ; Office of Public Health Preparedness & Response (1).
Proposals will be reviewed between February and June 2012, with award dates between July and September 2012, depending on the awarding unit (see the solicitation for details).
On March 4th the NSF has released their second FY-2011 SBIR solicitation. Topics included in this solicitation are:
Phase I awards of up to $150,000 for 6 months are allowed and it is anticipated that 150 awards will be made. (Pending available funds)
The NSF is a leader in funding cutting edge R&D with real potential for commercialization. In other words, you need to be developing a product for an identified market, not simply investigating a new idea. Part of the NSF research proposal is a commercialization plan. In this section of the application they want you to describe the competition and market landscape, and even estimate your anticipated market share. Letters of Support from commercialization partners are encouraged and will strengthen your application.
The NIH has released a Special Announcement SBIR Solicitation targeting the development of medical technologies to reduce health disparities. This topic was originally released in 2009, and reissued in 2010. Phase I grants for up to $200,000 per year for up to two years are allowed. This is an increase from the standard $150,000 per 6 to 12 months.
This solicitation is designed to fund companies developing medical technologies that are both easily accessible, as well as affordable. Products such as non-invasive diagnostics, in-home monitoring or telehealth technologies would be appropriate. You can read the entire announcement here. Please note that a letter of intent is required by April 20th and the first receipt date is May 20th.
The Therapeutic Discovery Project Credit has been the talk of the bioscience community since the legislative text was released on May 21st. The program will infuse the industry with both tax credits and cash grants for qualified investments in therapeutic R&D. The hope is to stimulate continued growth and progress for therapeutic discovery, including diagnostics and delivery vehicles.
Over the past month there has been much debate over the potential rules and regulations. One such topic of discussion revolved around the inclusion of Federal Grants, such as SBIR/STTRs, as a qualified investment. How can you claim a Federal Grant as a qualified investment? To many that seems as double dipping. According to the IRS, not if you claim that Federal Grant as gross income.
The IRS form, NIH form and final instructions, including FAQ’s from the IRS, were released on June 18th. This question is specifically answered by the IRS.
Q. Can a company apply for the new credit or grant for a project for which the company is already receiving other grant money (e.g., an SBIR award), or does the project have to be completely self-funded to qualify?
A. A taxpayer must reduce the amount of a project’s qualified investment for any grant that is not included in gross income, unless the grant can only be used for costs not included in the definition of a qualified investment. See Notice 2010-45 § 4.01(4).
This could significantly increase the amount of award to many small companies that are funded both privately and through SBIR/STTR grant awards.
SoloHealth, a technology company that develops and deploys interactive health screening kiosks, today announced that the company has been awarded a $1.2 million grant by the National Institute of Health (NIH) through its Small Business Innovation Research (SBIR) program to advance SoloHealth’s initial product, EyeSite®, a vision screening kiosk, into a more comprehensive self-service health and wellness station. The new product will address highly problematic areas such as hypertension, obesity, eye health and vision, nutrition and diabetes. This FastTrack SBIR grant, which is funded by the NCMHD, will aid SoloHealth in bringing free medical screening technology, education and wellness programs to a wider audience, including traditionally underserved communities.
SBIR grants and contracts are a non-dilutive form of R&D funding provided by 11 agencies of the Federal government. The application process is highly competitive and requires a qualified scientific team, innovative approach, and a rigorous R&D plan. While not a strict R&D firm, SoloHealth worked with SBIR GA, a service of ATDC, to construct a compelling proposal and bring together a highly qualified team. The result of these efforts is non-dilutive funding to develop their next generation product.
Together with Georgia Bio, ATDC will be hosting a workshop, tomorrow 5/11, to discuss the “nuts-and-bolts” of the Therapeutic Discovery Project Credit. Lined up to join our panel session are Russ Medford of Salutria Pharmaceuticals, Russ Plum of Inhibitex, Katherine Breaks of KPMG, Bill Kitchens of Arnall, Golden and Gregory, Robert Craig an Executive Consultant, and Jeff Trent of Paradigm Partners.
These panel members will bring a wealth of experience on the topic. Several panelists have had direct working experience with the similar 48 sec C Advanced Energy Credit and will be able to provide specifics on how the program may unfold. Russ Medford, CEO of Salutria Pharmaceuticals, was integral in working with BIO to lobby directly for the legislation, and Russ Plum, CEO of Inhibitex, has been interviewing consultants to assist Inhibitex is applying for the Project Credit.
This two hour working session will consist mostly of Question and Answer. So join us tomorrow on the 3rd floor of 75 5th Street, NW, and be ready to ask our panelists your specific questions.
To register:
http://www.gabio.org/event_details.aspx?id=204