NIH staff available during lunch.

First session:
“This isn’t your grandmother’s SBIR/STTR Program Anymore.” JoAnne Goodnight
The program is in its 25th year. About 50% of the conference participants are new. Over 500 people are attending the conference; it does seem busy and big. 

SBIR/STTR Program Overview
NIH SBIR/STTR Program Specifics
Solicitations and Funding Opportunities
Gap funding

STTR is only .03% of extramural funding 

SBIR is 2.5% of extramural funding a

STTR is was set up ten years after SBIR. Designed for more academic co-operative R&D.

The programs are the largest seed capital source…. 2.3 billion dollars
NIH is one of the biggest of the the 14 or so agencies that participate.

Phase III can not use SBIR/STTR funding for final commercialization.

Failure is OK. Sometimes you won’t reach the marketplace.

These programs are unique in the government. High-risk, high-reward research.
SBA is the administrative umbrella.
Company organized as a for-profit
PI primary employment must be with the small business concern at time of award and for the duration of the project period
US owned 51%

STTR must include an intellectual property agreement worked out with the research institution

Difference between SBIR and STTR
STTR allows the PI to employed by the business or the research institution.
SBIR requires PI to be employed by the business.

Nuances of the NIH.

Not just drug development
Not just medical devices

SBIR/STTR are fully integrated with the NIH agenda
23 NIH centers support SBIR/STTR

Cancer
Heart Lung and Blood
Diabetes

Average award for Phase 1 are $170,000 and 12 months

Phase II competing renewal —
Question does NIA participate in the Phase II competing renewal? Answer…yes it does. 

Timlines – 6-9 months (although my experience was close to 12).

Scientific Review
Council Review
Award Date

There are initiatives to reduce the review timeline (number of months between submission and an award) .

Number of applications are decreasing (!)
Why?
Trying to figure out why —

This is good news, current funding rates are:

24% Phase 1 funded (of grants submitted)
42% Phase II funded
19% Fast-Track funded

There are more and more university startups.
1/2 attendees  today are  affiliated with a research institution

The differences between university and business

Advice: 

* Communicate with the program director
* Understand the institute mission and needs
* Read solicitation and follow instructions
* Don’t go it alone — find partners 
* Don’t depend solely on SBIR STTR funding
* Have an outcome
* Be persistent

Second Talk Dr. Suzanne Fisher Director of Receipt and Referral CSR/NIH
About how the Center for Scientific Review Works

One issue was a question as to whether they will keep the three due dates.
or have some kind of rolling, ongoing application process

IC = Institute or Center
SRO = Scientific Review Officer

Changes in the past 1.5 year or so

* Two day error correction windows (shortened from five days)
* Multiple Principal Investigator option. (contact PI must meet the SBIR requirements)
* No paper letters like the summary statement are sent anymore.  Everything appears on the NIH commons web site. 

Anyone not registered with the Commons must get registered.

Late applications:
We don’t give permission in advance

Format: requirements must be met. Use headers and bold, etc.

Contact the scientific review officer, to make changes.

One attachment should be a cover letter. There is a suggested format

Don’t submit derivative applications (multiple diseases)
You can resubmit twice. You have to receive the summary statement before resubmitting.

Only 1 Phase II from a single Phase I is allowed.

Electronic Submission is done between Grants.Gov and the NIH Commons

Do the research plan as one document and the cut it up so that you can stay within the page limits

If you do not see your NIH image on the Commons…NIH doesn’t see it either. (so follow up after submitting and make sure it is there).

There are referral guidelines for institutes and centers. You are not owned by a single institute….try to diversfy.

The secret two-letter decoder ring for NIH agencies as part of your grant #.

Peer Review Group
Scientific Review Group
Advisory Council

SRG does the score….
Councll is institute

Funding decision made by Institution/Center

Small business representatives are on review committees

Trying out videoconferencing, and wikis

Most peer reviewers have a Doctoral degree

First thing they do is “unscoring”… find the 40% that are to be rejected, however any reviewer can say they want to perform a review.

Significance
Approach
Innovation
Investigator
Environment

Priority Score – 100-350
100 is the best possible score, 350 is the worst.

All institutes have put a lot of work into their web sites and FAQs.