Jo Anne GoodnightNIH SBIR/STTR Program Coordinator

NIH MissionNIH Mission

Improve human health through biomedical and behavioral research, research training and communications.

SBIRSBIR STTRSTTR

2004 Budget2004 Budget

NIHNIH

$563.3M$563.3M $67.6M$67.6M

CDC CDC

FDAFDA

AHRQAHRQ

~8.1M~8.1M

~0.8M~0.8M

~2.0M~2.0M

N/AN/A

Phase IPhase I $100K*$100K*

6 months*6 months*

$100K*$100K*

1 year*1 year*

Phase IIPhase II $750K* $750K*

2 years*2 years*

$750K* $750K*

2 years*2 years*

****Propose a Realistic and Appropriate****Propose a Realistic and AppropriateBudget for the Research****Budget for the Research****

Take Home Message #1Take Home Message #1

DHHS Budget and Award AmountDHHS Budget and Award Amount

$630.9

Office of the Director

Largest SBIR/STTR

set-asides

National Center on Minority Health

and Health Disparities

NIH OrganizationNIH Organization

http://www.nih.gov/icd

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Allergy and

Infectious Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

National Centerfor Complementary

and AlternativeMedicine

FogartyInternational

Center

National Centerfor ResearchResources

National Instituteof Biomedical

Imaging and

Bioengineering

SOLICITATION RECEIPT DATESSOLICITATION RECEIPT DATES

SBIR/STTR Omnibus Grant Solicitation (NIH, CDC and FDA)Release: JanuaryReceipt: Apr 1, Aug 1, Dec 1

Contract Solicitation (NIH and CDC) Release: AugustReceipt: November (~2nd Friday)

NIH Guide (DHHS)Release: Weekly Receipt : Dates as noted

NIH SBIR/STTR NIH SBIR/STTR RESEARCH AREASRESEARCH AREAS

Our Ideas…. examplesOur Ideas…. examples

Biodefense

Biosensors

Nanotechnologies

Bioinformatics

Behavioral research

Computational Biology

Telehealth

Biosilicon devices

Biocompatible materials

Acousto-optics / opto-electronics

Imaging technologies

Genetically engineered proteins

Proteomics / Genomics

Complementary & Alt. Med (CAM)

……

Take-home Message #2

Investigator-initiated R&D Research topics related to the NIH mission “Other” areas of research within the mission of an awarding component …

YourYour ideas...

NIH SBIR/STTR NIH SBIR/STTR RESEARCH GRANT TOPICSRESEARCH GRANT TOPICS

AngioscopesAngioscopes to to

ZebrafishZebrafish

Review ConsiderationsReview ConsiderationsSelection CriteriaSelection Criteria

• External peer reviewers (academia / industry)-- scientists and engineers determine the merit of a proposal.

• All applicants receive “debriefing” automatically.

• Evaluation factors:1. Significance (Real Problem/Commercial Potential)2. Approach (Research Design, Feasible)3. Innovation (New or Improved?)4. Investigators (PI and team)5. Environment (Facilities/Resources)

… Protection of Human Subjects… Animal Welfare… Budget

Program staff do NOT participate in peer review process

NIH SBIR/STTR SELECTION NIH SBIR/STTR SELECTION STATISTICSSTATISTICS

FISCAL YEAR 2003FISCAL YEAR 2003

0

5

10

15

20

25

30

35

40

45

SBIR STTR

Phase I

Phase II

Fast-Track

Su

cces

s R

ate

(%)

24%

44%

27%

43%

28%

22%

981

327 18

61

$563 M SBIR/STTR(set aside $556M)

955

NIH SBIR/STTR ProgramNIH SBIR/STTR ProgramWhat’s New?What’s New?

PHS 398/2590: Undergoing revisionPHS 398/2590: Undergoing revision Submission Dates: CDC will use same 3 standard Submission Dates: CDC will use same 3 standard

receipt dates as NIH and FDAreceipt dates as NIH and FDA Clarification of Instructions for Preparing Human Clarification of Instructions for Preparing Human

Subjects Section of Research PlanSubjects Section of Research Plan Sample SBIR ApplicationsSample SBIR Applications FDA Resources and Useful WebsitesFDA Resources and Useful Websites Type 2 Competing Continuation Ph II AwardsType 2 Competing Continuation Ph II Awards

NIH SBIR/STTR ProgramNIH SBIR/STTR Program Distinguishing FeaturesDistinguishing Features

Investigator-initiated ResearchInvestigator-initiated Research Award Amount and Project Period Award Amount and Project Period

(REASONABLE, APPROPRIATE, JUSTIFIED!)(REASONABLE, APPROPRIATE, JUSTIFIED!) Multiple Submission DatesMultiple Submission Dates (New/Amended; Phase I/Phase II)(New/Amended; Phase I/Phase II) Phase II Competing Continuation AwardsPhase II Competing Continuation Awards Gap Funding optionsGap Funding options Communication Throughout ProcessCommunication Throughout Process

For More InformationFor More Information

http://grants.nih.gov/grants/funding/sbir.htm

Jo Anne GoodnightNIH SBIR/STTR Program Coordinator

Phone: 301-435-2688Email: jg128w@nih.gov

Kay EtzlerNIH SBIR/STTR Program

Phone: 301-435-2713Email: etzlerk@od.nih.gov

NIH Success StoriesNIH Success Stories

Illumina developed ultra high throughput specialized laboratory (Oligator Farm® facility) synthesizer of oligonucleotides.

LigoCyte has developed a monoclonal antibody capable of inhibiting inflammatory disease in the lung.

The SmartWheel examines the biomechanics of wheelchair propulsion by precisely measuring parameters including stroke frequency, propulsion angle, acceleration, forces applied to the handrim, velocity, and distance traveled. The SmartWheel is the only commercial product in the world that measures propulsion biomechanics in the natural environment of the wheelchair user.