7:15 – 8:00

REGISTRATION and CONTINENTAL BREAKFAST 

8:00 – 9:00

Welcome/Overview of NIH SBIR/STTR Programs

Ms. JoAnne Goodnight (PowerPoint - 9.9 MB)
NIH SBIR/STTR Program Coordinator

9:00 – 10:00

Submission, Assignment, and Peer Review of NIH SBIR/STTR Grant Applications

Drs. Marian Wachtel (PowerPoint - 11 MB) and Suzanne Fisher (1.3 MB)
Center for Scientific Review

10:00 – 10:30

Break

10:30 – 11:30

Grant Writing for Success 

Facilitator: Dr. Peter Preusch, NIGMS

Panelists:
Dr. Oliver Murphy (PowerPoint - 364 KB), Lynntech
Dr. Mike Squillante (PowerPoint - 66 KB), Radiation Monitoring Devices, Inc.
Dr. Ron Brown (PowerPoint - 91 KB), Quality Biological, Inc  

Human Subjects

Does your research involve human subjects? This session will clarify the requirements for human subjects research. New Guidance and the new PHS 398 will be covered.

11:30 – 12:00

Communication & Resources

Dr. Gregory Milman (PowrPoint - 625 KB), NIAID 

Animal Welfare Issues

This session focuses on the OLAW assurance and IACUC certifications required when vertebrate animals are involved in NIH research.  Find out why it’s important for the small business grantee!

12:00 – 1:30

Lunch (on your own), One-on-Ones

1:30 – 4:30

Poster Sessions 

1:30 – 2:15

Compliance Issues – Grants Management

Ms. Kathleen Shino (PowerPoint - 901 KB)
Senior Grants Management Specialist, NIDDK

Invention Reporting & iEdison

Mr. John Saltzman (PowerPoint - 118 KB)
Office of policy for Extramural Research Administration   

2:15 – 3:15

Indirect Costs/Audits

What’s the difference between an indirect rate and a rate pool?  Computing indirect cost rates, keeping accounting records, and audits: They’re part of the “B”usiness in SBIR when you accept Federal funds.  Listen to experts: Federal representatives explain what is required of small businesses, and an experienced grantee tells how to manage your financial records to meet the Federal fiscal requirements.

3:15 – 4:00

Break, One-on-Ones, & Poster Sessions

3:45 – 4:30

Building University Research Partnerships

University partnerships can enhance an SBIR or STTR project and this session provides insights with how to partner with a university. Learn from the experiences of others.  

Other Federal Agency SBIR/STTR Programs

In your search for federal funding for your health-related research project, it’s probably a good bet that you immediately thought about the Department of Health and Human Services, and in particular, the NIH, CDC, and FDA. But did you realize that there are other agencies with SBIR and STTR programs that also fund biotechnology and life/sciences research? Join this session to learn about a few of them.

4:30 – 5:00

Open Forum – Q&A and Day One Wrap Up

5:00

Adjourn

7:15 – 8:00

REGISTRATION and CONTINENTAL BREAKFAST

8:00 – 12:00

Poster Sessions 

8:00– 8:30

eRA Commons

Electronic communication is here to stay. Discover how to manage your applications and grantsin a seamless, secure, interactive environment through the NIH eRA Commons.

Manufacturing Extension Partnership

This session will provide you with an understanding of the resources and services available through the Manufacturing Extension Partnership (MEP) Program to assist SBIR awardees in commercializing SBIR developed technologies. MEP success stories working with client companies developing new technologies will be highlighted.

8:30 – 9:00

NIH Technical Assistance Program

Join this session to understand how NIH helps SBIR awardees in commercializing their SBIR-developed products.  Find out what assistance opportunities might be available for you. 

9:00 – 10:00

Business & Strategic Planning For Scientists

Are you a researcher who is having difficulty with entrepreneurial thinking?  Are you struggling with how to start, finance, and build your business?  A business/strategic plan can be your roadmap to commercialization!  Gain new insight and understanding of the quote from our 34^th President, Dwight D. Eisenhower – “Plans are worthless, but planning is everything!”

10:00 –10:30

Break, One-on-Ones, & Poster Sessions

10:30 – 11:15

Alliances & Partnerships

Building alliances to help commercialize health-related products can be more difficult than obtaining the funding to do the research.  You just can’t go it alone.  Learn how, when, and whom to ask for help. 

11:15 – 12:30

Understanding the FDA Process

The FDA regulatory process can be difficult to navigate and understand. Is my product considered a drug, a biological therapeutic, or a biologic? Who do I contact if I have questions and when?   What resources does FDA provide to small businesses? Do I need a 510K? Here’s an in-depth look at the FDA process – its organization, procedures, policies, and regulations

An Interactive Panel: Commercialization of Behavioral/Educational/Technology Research Products  

Veteran grantees explain how they 1) found and engaged potential backers BEFORE submitting a Phase II application, 2) collaborated with potential end-users about production, distribution, and marketing during their research, 3) sold products to specific markets when users felt they should be free, 4) addressed barriers to marketing and sealed a deal, and 5) tracked the success of their product in the marketplace. 

12:30 – 1:30

Lunch (on your own), One-on-Ones

1:30 – 2:15

Medicare and Reimbursement for Your SBIR/STTR-Developed Product/Service

When planning to bring your product or service to market, have you included effective reimbursement strategies?  Are you familiar with the Federal regulations and policies that will affect the probability of reimbursement?  Do you know the correct CMS code for your product?  Do you know the difference between FDA and CMS review?  Are you aware that FDA approval alone does not entitle a device to reimbursement coverage?  If you answered “no” to any of these questions, you should attend this session! 

Finding/Identifying Funding Opportunities

NIH offers the small business research community a number of funding opportunities ranging from drug development to educational tools.  How do you find them and choose between them to your advantage?  This session focuses on:  (1) identifying current and new funding opportunities, (2) distinguishing the research priorities of the individual ICs, and (3) emphasizing the importance of investigator-initiated research.

2:15 – 3:00

Protecting Your Intellectual Property

Assuring adequate protection of your intellectual property is of paramount importance.  Practical information and tips will be provided.

State Support Organizations & Resources

Unbeknown to many, a wealth of SBIR/STTR information and support is often available right in your own backyard.  Many states organizations are available and interested in assisting you with applying for an SBIR or STTR grants/contract, and some actually have funding available to help defer the costs of preparing an application.  Join this group to learn what is available in your state.

3:00 – 3:30

Open Forum – Q&A and Day Two Wrap Up

3:30

Adjourn