Over the last two years the NIH has implemented new guidelines and procedures to “enhance peer review”. For instance, reviewer comments and scores for each of 5 criteria are indicated on the summary sheet. The research proposal section has also been restructured, to more closely match the criteria by which the reviewers critique a proposal.
For those submitting SBIR/STTR applications to the NIH, April 5th is the first time the restructured proposal will be in effect. This is daunting for both first time and returning SBIR/STTR applicants.
The NIH has been inundated with questions and comments concerning these new processes. In an effort to address these questions they are holding a webinar (through GoToMeeting). This will be an opportunity for NIH staff to discuss the restructuring of the Research Plan, new page limits, new scoring, and other changes resulting from Enhancing Peer Review and to provide a forum for you to ask questions.
When: March 15, 2010 – 2:00 to 4:00 PM EST
REGISTRATION: https://www2.gotomeeting.com/register/735602218
(Note: the session is free, but you must register to participate)
For those Phase I SBIR awardees developing therapeutics targeted toward neurological disorders, and planning on submitting for a Phase II SBIR award to fund pre-clinical trials, check out the NINDS Cooperative Program in Translational Research (U44). This special funding opportunity is directed at translating basic science research into new drug candidates for neurological disorders. These awards are not intended for early stage discoveries such as high throughput screening, but will fund later stage projects. Even those sufficiently advanced that an IND or IDE application would be filed at the end of the project period.
These awards are larger than traditional Phase II awards, with allowable budgets up to $1M per year and a 3 year max. Phase I applications are not allowed, however, a FastTrack application may be submitted as long as the Phase I portion is in preparation for a Phase II to fund pre-clinical trials. If you have already received a Phase II, this mechanism can also be used to fund a competing renewal application with the same allowable budget as above.
Cooperative Agreements are an NIH funding mechanism that allows NIH programming staff to be more involved with the evolution and progress of a project. Specifically, go/no-go assessments can be made and funding halted if sufficient progress is not made. This is attractive to the NIH as it allows them to be more closely involved with large grant awards and use their funding more wisely.
For more information contact the NINDS SBIR/STTR Program Director, Dr. Randall Stewart, to discuss your project and it’s applicability to this program. Regular receipt dates (Apr 5, Aug 5, Dec 5) apply, and program staff should be contacted 10 weeks prior to submission.
Sub-Micro, a Georgia Tech spin-out developing magnetic nano-particles for the removal of circulating cancer cells, was recently written up by both the Georgia Tech Daily Digest and Medical Device Daily. This exciting technology is attracting attention as it provides a solution to a problem with the use of nano-particles as therapeutics. Nano-particles have been designed by many developers to target and/or destroy specific cell types including many forms of cancer. But, after the nano-particles have sequestered and/or destroyed the targeted cells, how do you remove them from the body? This question is a hurdle to receiving FDA clearance for the wide spread use of nano-particles as therapeutics. Sub-Micro’s proprietary magnetic nano-particle technology, which was developed at Georgia Tech, is uniquely designed to capture the targeted cells and remove them and the nano-particle from the body.
Ken Scarberry developed the technology as a graduate student in the lab of Dr. John McDonald, professor in the School of Biology and chief scientist with the Ovarian Cancer Institute. The magnetic nano-particles will initially be targeted toward the removal of ovarian cancer cells. But the technology can be adapted to remove a variety of cell types including HIV infected cells.
Earlier this month the NIH released several announcements associated with the Recovery Act. Of note to the SBIR community is NOT-OD-10-034.
The announcement will fund Competitive Revisions to accelerate innovation of previously funded “parent” SBIR/STTR awards in the area of basic behavioral and social science research (b-BSSR). The proposed work must significantly expand the scope or research objectives proposed in the previously funded award. Basic behavioral and social science research includes research on behavioral and social processes, interactions between biology, behavior and social processes, and/or methodology and measurement.
To qualify, the small business must have an active award, at the time of application, and propose a revision to be accomplished in one year. The work proposed in the revision must not extend beyond that of the parent award. If a no-cost extension is needed to cover the work being proposed in the revision, it must be in place prior to submission.
Up to $150,000 in direct costs may be requested with a maximum of $75,000 of those costs allocated to equipment or technology acquisition.
Letters of Intent are due February 25, 2010
Application is due March 25, 2010
Two ATDC seed funded bioscience companies complete private financings in 2009 and are honored by GABio Industry Association. Iconic Therapeutics and Visioneering Technologies, both ATDC Seed Funded companies, will be presented with a Deal of the Year award. The GaBio Deal of the Year awards recognize life science companies that have completed a significant development milestone, such as raising investment funds, entering into a partnering agreement or securing a government grant or contract.
Iconic Therapeutics, a biotechnology company developing a drug to treat wet macular degeneration, raised $3.5 million from New Haven, Conn-based Elm Street Ventures. The company has raised $13.8 million since it’s inception in 2003, mostly from angel investors. Iconic, whose technology is based on novel immunoconjugate proteins called “I-cons”, plans to conduct a Phase I trail to show that the compound is safe in humans. The technology was licensed from Yale University.
Visioneering Technologies, an Atlanta based start-up developing technology for correcting presbyopia through contact lenses and other “on eye and in eye” applications, raised $5 million from MB Ventures of Memphis, Tenn., Charter Life Sciences and Life Science Angels, both of Palo Alto, Calif., and from the State of Georgia ATDC Seed Capital Fund. Visioneering’s approach to vision correction utilizes induced aperture optics to improve the optical efficiency of the eye’s vision system. The technology has a number of on eye and in eye applications including contact lenses, LASIK, intraocular lenses and corneal inlays.
The Georgia Bio Annual Awards Dinner will be held Thursday, January 21st, 2010, at The Retreat of Dunwoody. This event recognizes Industry and Community leaders who have made a significant contribution to the Georgia Life Science community. Please see the GABio web site for more details on the Annual Awards Dinner (
www.gabio.org).
In an effort to to provide more timely and transparent peer review, the NIH has been implementing many changes to both the review process as well the proposal structure. Previously, a new scoring system was put in place. The 5 point system was replaced by a 9 point system, and reviewers are now required to provide a numerical score for each of 5 categories. These scores are presented to the applicant on the review statement, along with comments, providing a more transparent view of the review process.
The latest change is a restructured research proposal with shorter page limits. The proposal structure will now be more aligned with the review criteria, and the shortened page limit will, ideally, allow the reviewers more time with each proposal. The changes are as follows:
- Specific Aims section is now limited to 1 page only.
- Three sections of the Research Plan (Background & Significance, Preliminary Studies, and Research Design & Methods) are now combined into 1 section, Research Strategy, with 3 sub-sections, Significance, Innovation and Approach. Preliminary Studies and Progress Reports must be discussed under Approach.
This section is limited to 6 pages for Phase I and 12 pages for Phase II.
- The Commercialization Plan has been limited to 12 pages.
In addition, the Facilities section must now explain how the scientific environment will contribute to the probability of success for the proposed project. Lastly, a Personal Statement has been added to Biographical Sketch section.
Changes are effective for ALL proposals submitted after January 25, 2010
Practically, how does this effect your application and chances for success? If you are clear as to the commercial aspect of your technology, and can articulate that, as you would to any investor, it will actually make your work much simpler. If however, you are are still determining how to apply your science to the commercial market, you are in for a challenge. No longer can you use the Background section to talk about the scientific basis of your discovery. You must spend the majority of the proposal discussing it’s Significance and Innovation as it applies to the marketplace.
Changes to the Facilities section are in an attempt to ensure that applicants actually have appropriate commercial space in which to perform the work. These grants are not to fund academic endeavors.
For new applicants, such as post-docs or former graduate students, that want to experiment in the world of start-ups, the Personal Statement section provides as specific section is which to address their strengths such as inventor status.
As always, if you would like to discuss these changes, or your application, feel free to contact our office.
The FY2010 National Defense Authorization Act (NDAA) was has reached the House and Senate floor and should be voted upon this week.
What does that have to do with SBIR? Apparently 2 pages of language were inserted in this document to reauthorize not only the DoD SBIR/STTR program until 9/30/2010, but to also extend the Commercialization Pilot Program (CPP) as well.
Unfortunately, this does not apply to the other 10 agencies SBIR/STTR programs, which are still up for reauthorization.
BioProductCampAtlanta – a 360 degree perspective of the life cycle of a drug or device.
Why are we doing this? The purpose of this event is to develop leaders in our industry and promote the commercialization of our innovations. It will allow current and future entrepreneurs the opportunity to gain access to the full spectrum of the information they need to launch a pharmaceutical or medical device technology.
Saturday – October 3, 2009 8:30 am – 1:30 pm
Georgia Tech Research Institute
250 14th Street NW, Atlanta, GA 30318
Twitter hashtag: #biopca
Cost: Free and is brought to you by the Center of Innovation for Life Sciences and generous industry sponsors.
Registration courtesy of Georgia Bio
What is it? BioProductCampAtlanta has its roots in the tradition of the BarCamp. “BarCamp is an ad-hoc gathering born from the desire for people to share and learn in an open environment. It is an intense event with discussions, demos and interaction from participants who are the main actors of the event.
These kinds of events are self assembling in real time. The participants make the agenda on the day of the event – so come ready with a presentation and a laptop so you can share your knowledge. Service providers are encouraged to present but please refrain from using your company’s logo on your Powerpoint deck. You are here to share and learn – not sell your business. BioProductCampAtlanta is designed to develop leaders in our life science industry and promote the commercialization of our innovations.
For more information go here.
The NIH in conjunction with the CDC has released their annual contract solicitation. Unlike most NIH SBIR/STTR announcements, the contract solicitation requests applications on specific topics and will not accept investigator initiated research projects. Participants in this solicitation include seven Institutes/Centers from the NIH and five Centers from the CDC. Topics are specific but include research areas such as Imaging of Cancer Stem Cells to Computer Assisted Sperm Analysis. (Did I get your attention? And no, I’m not kidding.)
Budgets vary by topic and range from $100,000 to $250,000 for a Phase I and $750,000 to $2M for a Phase II. Do not ask for one penny over the budget cap! FastTrack applications will be accepted.
Applications, unfortunately, are paper based and due on the desk of the NIH at 5:00PM, November 9, 2009.
For more information go here or contact us to discuss your application.
Applicants have begun
posting comments indicating they have received notice of Phase II award. I know it has been a long wait for many. I hope some of you are celebrating!
You can find a full list of awards here.