Narrative Descriptions of Sessions
Day One
Submission, Policy, Procedures
It’s Not Your Grandmother’s SBIR/STTR Program Anymore
In this session, Ms. Jo Anne Goodnight, NIH SBIR/STTR Program Coordinator, will cover the basics of the SBIR/STTR Programs, including eligibility considerations, new NIH funding opportunities, and enhancements to the program. This year we celebrate 25 years of supporting technological innovations of small businesses. As the SBIR/STTR programs have matured, they have become part of a complex innovation ecosystem comprised of entrepreneurs, universities, corporate partners and others in a collaborative/competitive environment. Learn how the SBIR/STTR programs fuel this ecosystem through funding for innovative, early-stage biomedical and behavioral research that has potential to be translated into products and services that can improve health.
Nuts, Bolts (and Electrons) of the Application, Receipt, Referral, and Peer Review Processes
You made it through the electronic submission process and now you’re wondering “What’s the Next Step? When will my application be reviewed? By whom? What Institutes/Centers will consider it for funding? When will I hear if I’ve been selected for an award? Based on what criteria will reviewers evaluate my application? Who can I contact for assistance during the review period?” Dr. Suzanne Fisher, Director of the Division of Receipt and Referral of the Center for Scientific Review, will answer all of these questions as well as many more as she methodically steps you through the entire NIH two level peer review process.
Challenges and Opportunities in Peer Review: A Vision for Ensuring Its Strategic National Value
The NIH Center for Scientific Review (CSR) receives about 80,000 grant applications a year and coordinates the work of ~18,000 peer reviewers who evaluate the majority of these applications for scientific merit. While the NIH peer review system is revered and imitated by other countries, it faces major challenges that have led it to implement or consider implementing multiple efforts to (1) identify the best research by recruiting the best reviewers, (2) reduce administrative burdens by shorting applications and reviews, (3) enhance the scoring system by ranking applications and rating individual components, and (4) optimize support at different career stages and types. While overall success rates for NIH grant applications have fallen due to rising submissions, the success rates for small business grant applications have increased due to a 50% decline in applications for the $3.3 billion reserved for small business grants. NIH, however, is exploring ways to address the fact that small business applications are challenged by the difficulty of recruiting reviewers with business and academic backgrounds who can review the breadth of science review groups must cover to assess these applications appropriately.
Grant Writing for Success
Need some tips on how to write your grant application? Have an idea but don’t know how to convey it? This session will provide insights and helpful hints on preparing to write as well as writing an application. A well seasoned veteran, Dr. Ron Brown of Quality Biological, will share tips on the key elements of a well written application and how to present your innovative idea to the reviewers.
Compliance & Just-in-Time
NIH is committed to providing its customers (contractors, grantees, and the public) with clear and easy-to-access information on how to comply with federal grants financial and management laws. This information is often referred to as "compliance assistance," which is a cornerstone of NIH’s efforts to strengthen the bond of trust between sponsor (NIH) and recipient (Small Business) and provide stewardship necessary to properly safeguard the Federal investment in America’s research enterprise. This session addresses the proper management of Federal funds and the grantee reporting responsibilities inherent when accepting Federal R&D funding.
University Startups
More and more university faculty members are spinning out companies using university IP generally discovered from their academic research. This interactive session will explore how to make the transition from academics to industry and use SBIR and STTR awards to fund your initial R&D efforts. Topics of discussion will include avoiding common pitfalls including conflicts of interest, getting the most research out of your grant dollars, and deciding what roll you should play in this new entrepreneurial venture.
Stump the Staff.
This is your opportunity to get answers to your deepest and most difficult questions by our knowledgeable and approachable NIH and CDC staff. Been in a quandary for a while but haven’t found the right person with the answer? Perhaps an issue or question has come up during the course of this meeting. Bring your questions on! We challenge you to “stump the staff” and come up with a question our expert and experienced team cannot answer. We do ask, however, that you please reserve those questions that relate absolutely positively only to your specific situation for the one-on-one sessions. Pose questions at this session to which all may be interested.
Electronic Submission Using Grants.gov and the NIH eRA Commons
Effective December 1, 2005, NIH accepts only electronic submissions of SBIR and STTR grant applications. Discover how to submit an electronic application through the Federal-wide grants portal known as grants.gov and the NIH eRA Commons system, and the importance of registering for both. Immediately following this session and again on the second morning of the conference, a hands-on lab is offered that will walk you through the entire electronic submission process.
Identifying Funding Opportunities
NIH is a large, complex, yet flexible organization which offers many opportunities for research funding, but how can you identify those of interest to you? This session will address SBIR & STTR grant and contract opportunities, how to find the opportunities, how to determine which opportunities are best for you, and will show you how to stay informed of all research funding opportunities available to small companies.
Research Involving Human and Animals Subjects
Not sure if your research REALLY involves human subjects? Not familiar with the requirements and certifications for using animals in your research? Then join this session to find out.
University Partnerships and Technology Transfer
This interactive session will provide valuable information on how to identify potential university partners, how to approach them, and how to negotiate a successful IP agreement for your small business. The discussion will address common challenges and pitfalls that often arise during the negotiation process as well as successful strategies for overcoming these issues. Experts will be on hand to discuss current software tools that are now being used to streamline the negotiation process. Panelists will provide both the entrepreneur’s perspective as well as the technology transfer specialist’s perspective.
Indirect Costs Rates and Non-Federal Audit Requirements Workshop
Are you leaving money on the table when applying for your SBIR/ STTR grants? Learn how to score a "Full House" with grant money, and how not to let the audit requirement ride before it catches up with you. Bonus: how to avoid a very unwelcome surprise after you've already spent all the money.
Hands-on Lab for Electronic Submission. Closed. Workshops are full.
Bring your wireless laptop to this session and experience the electronic submission process for yourself. Find the funding opportunity, download the application package and the instruction guide, and even download the application software and start preparing your grant application. This is a hands-on lab and you will be connected to the internet. Two sessions are offered and space is limited to 50 participants each session. Registration is required and there is a $10 internet connection fee.
Application/Submission Tales from the Trenches
Those who “have been there, done that” will share their experiences and tips about preparing a grant application, working with the NIH eRA system, etc. There’s no better teacher than “experience”, so learn from this panel as they share what worked and didn’t work for them.
Day 2
Commercialization Sessions
and NIH & CDC Funding Opportunities and Resources
Bridging the Gap to Phase III
You thought being selected for an award was difficult, well getting to the marketplace is even more challenging. Biomedical research can take millions of dollars and 10+ years before a product reaches consumer hands. So how are you planning to get over this huge hurdle? NIH offers several assistance programs to help SBIR awardees strategize how to commercialize their SBIR-developed products. Join this session to find out what opportunities might be available for you and how to become involved.
A Peek Into the NIH and CDC: Special Programs and Resources
The “Peek Into the NIH and CDC” sessions will highlight the scientific priority areas for SBIR/STTR for nine NIH institutes and centers (ICs) and several CDC Centers, and then expand upon opportunities and research resources available to small businesses beyond the SBIR/STTR program. Topics of discussion will include programs that encourage collaborating with SBIR/STTR communities, non-SBIR/STTR funding opportunities/mechanisms, NIH and CDC resources available to the extramural research community, and NIH collaboration mechanisms. Presenting NIH ICs include: NCI, NINDS, NIDDK, NCRR, NHLBI, NIMH, NIAMS, NIAID, and NEI.
Protecting Your SBIR/STTR Intellectual Property Rights Through iEdison Invention Reporting
The Bayh-Dole Act can provide your organization with valuable rights to inventions developed under a federal research award. But how does your organization retain those rights and ensure proper protection of this intellectual property for effective commercialization into products? Practical information about maintaining those rights to becoming successful will be provided.
Commercialization Tale from the Trenches
With the help of the NIH CAP assistance program, Biopsy Sciences was able to successfully negotiate the sale of their BioSeal ™ technology and commercialization rights to Angiotech Pharmaceuticals, a global specialty pharmaceutical and medical device company. Dr. John Fisher, CEO of Biopsy Sciences, a Tucson-based medical device company, will discuss how his company’s persistence and creative business thinking led to completion of a multi-million dollar deal.
Business Planning Basics
You have a great idea, but lack a plan on how to transition it to the marketplace. Afterall, you’re a researcher…not a business person. But now it’s time to become an entrepreneurial researcher. This session will help you learn why you should write a business plan and give you some thought provoking ideas and tips for creating a strategic plan that will help you avoid critical business mistakes. Attend this session to begin to design your “business roadmap to success.”
Intellectual Property Protection Issues for SBIR/STTR Success
Inventions made under a federal research award can be a company’s most valuable asset if properly identified and managed. But while many may embark upon the road to commercialization, the successful journey needs a roadmap to avoid any roadblocks and potholes along the way. Effective and timely protection of intellectual property rights is of paramount importance for ensuring marketing and commercialization success. Practical information about protecting and commercializing those rights will be provided.
Leveraging Your State Resources
Unbeknown to many, a wealth of SBIR/STTR information and support is often available right in your own backyard. Many state 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 specifically about the resources available in Georgia and several other states and where to look for opportunities in your state.
Strategies for Raising Capital and Developing Partnerships
You’ve completed your SBIR/STTR Phase II research work, so what’s next?? Are you really ready to enter the marketplace or is there more needed R&D? Do you have the funds necessary to get a drug, therapeutic, biologic, or medical device through the FDA regulatory process? Do you need an investor? Do you need a partner? If so, what type of a partner? Is the timing right to pursue an alliance? Should you be considering licensing your technology? These are just some of the questions that will be answered during this session to clarify your commercialization options. It will emphasize the importance of planning and strategizing and offer tips on how to get started.
Moving from R&D to Manufacturing
Manufacturing is a later stage of commercialization, but typically something companies begin to think about in Phase 1 and formulate during Phase 2 under SBIR & STTR. Choice of a manufacturing strategy can have a long-term impact on finances, corporate strategy and the lifestyle of the corporate leaders. This session will discuss the core scale-up and production strategies life science companies employ that can reduce costs and time to market while meeting quality and regulatory requirements as well as a corporate strategy. Examples will be drawn from NIH SBIR awardees.
Live Business Presentation and Critique
It can take years and millions of dollars to get drugs, therapeutics, biologics, and/or medical devices through the FDA regulatory process and into the hands of consumers. Where are you going to get the money? This session will include the role that investors and strategic partners may play and how to identify, approach them, and get their interest in your research. Learn from an SBIR awardee as he shares his business investment/partnership presentation and receives a real live critique from the experts.
Interactive Multi-Media Panel: Commercialization of Behavioral Services, Interventions and Products
During this panel session, successful SBIR social-behavioral grantees will 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.
Navigating the FDA
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? …Join this session for an in-depth look at the FDA process – its organization, procedures, policies, and regulations
Commercializing Your Healthcare/IT/Media Product
Selling a healthcare, IT, or media product is tough. Just getting the attention of potential buyers takes hours of due diligence and persistence. Your product must be scalable to your customer’s needs and have the ability to be quickly and easily mass produced. Your marketing and sales skills must be sharp and your interpersonal skills the finest. Join this session to put your finger on the pulse of the healthcare, IT, and multimedia industries to prepare yourself for the challenges that lie ahead.
Once FDA Says “OK,” Who Buys?
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!
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