18th Annual HHS SBIR/STTR Conference

Orlando , Florida
Tuesday, November 15, 2016
Session Materials 

We will add the Power Points and session materials as we receive them from the speakers.  Please click on the session title for the Power Points. 
Tuesday, November 15, 2016

Welcome Remarks 
Speaker:
Marshall Criser III (Chancellor, State University System of Florida)
Speaker: Marcos Marchena (Chairman, University of Central Florida Board of Trustees)

Keynote Speaker
Speaker: Dr. Eliseo Perez-Stable
(Director, National Institute on Minority Health and Health Disparities [NIMHD])

HHS Overview and Update
Speaker: Dr. Matthew Portnoy (SBIR/STTR Program Coordinator, Director of the Division of Special Programs NIH Office of Extramural Research [OER])

Getting from Submission to Review and Review Process
PowerPoint Two: Cathleen Cooper
Description: Over the past several years, NIH embarked upon a trans-NIH Enhancing Peering
Review Initiative resulting in the successful implementation of many internal and external stakeholders' recommendations to enhance the NIH peer review system. These resulted in such things as deploying a new scoring system, using new templates for reviewer critiques, shortening the length of applications, and restructuring the research strategy section to align with the five NIH-wide review criteria. Grantsmanship tips from the reviewer's perspective will also be provided. Plenty of time is allotted for an engaging discussion based on audience questions and answers. 
Speaker: Cathleen Cooper (Director, Division of Receipt & Referral [DRR], NIH Center for Scientific Review [CSR])
Speaker: Amy Rubenstein (Scientific Review Officer, NIH Center for Scientific Review [CSR])


Advice to Applicants from Program Staff: What We Wish You Knew 
PowerPoint Two: Sean Griffiths
Description: NIH and CDC Program Staff provide important tips for applicants looking to apply to the SBIR/STTR programs. Come for an interactive session of honest advice and “myth-busting” straight from the source.
Speakers: Stephanie Fertig, Patricia Weber, Sean Griffiths, Todd Merchak

Intellectual Property:  Considerations for Success
Description: 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 road map 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. 
Speakers: Scott Cooper

The Ins and Outs of SBIR Contracts and Grants
Description: As federal agencies that provide funding to innovative research with the development of their research ideas (a.k.a. investigator-initiated research), the majority of the NIH SBIR awards are made grants. But did you know that NIH, and other federal agencies also offer contract opportunities thru the SBIR mechanism? The NIH SBIR contract solicitation is issued annually in the summer with proposals due in early November and includes topics identified by program staff aimed at soliciting research in targeted scientific/technical area. In this session, you will learn: 
a. What differentiates SBIR contract from SBIR/STTR grants 
b. How to hear about and submit proposals in response to SBIR contract solicitations 
c. Some of the unique requirements of contracts vs. grants, such as reporting and OMB requirements 
Speaker: Andre Walker, Patti Weber 

Regional Programs for Startups
Description: There are a number of regional resources available to entrepreneurs and companies who are just starting out. Come and hear about specific resources that are right in your backyard.
Speakers: Stephanie FertigPeter Hernandez, Valerie Landrio McDevitt, Jack Henkel, Erik Sander 

Research Involving Animals
Description: Are you considering using live vertebrate animals in your research? Are you aware that the policies and regulations regarding research animals are different than those involving human subjects? This session provides information on 
1) The requirements for using animals, 
2) Appropriate completion of the Vertebrate Animal Section of the grant application and peer review considerations, 
3) The functions of an Institutional Animal Care and Use Committee, 
4) Details on the various Assurance documents including which type is required if your institution does not have its own animal facility, and 
5) The consequences of what happens when animal activities become noncompliant.
Speaker: Eileen Morgan

NIH Resources for Small Business Success
Powerpoint Two: Jennifer Shieh
Description: While the NIH is the major agency providing funding for biomedical research, did you know that it also provides resources to the biomedical community that can help accelerate research? Come to this session to learn about some of the resources available including the Therapeutics for Rare and Neglected Diseases (TRND), the Bridging Interventional Development Gaps program (BrIDG), the Science Moving towArds Research Translation and Therapy (SMARTT), the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) and the NHLBI Office of Translational Alliances and Coordination (OTAC) supported Small Business Resources. Hear how small businesses have used these opportunities to help leverage their research and development programs. Note: these examples are illustrative of opportunities available at NIH. In addition, individual institutes may have other resources available. For information on these institute-specific resource opportunities for small businesses, visit the one-on-one sessions.
Speakers: Phyllis Mitchell, Lili Portilla, Jennifer Shieh, and Guy Reed

Resources for Women Owned & Minority Businesses
Description: Diversity is critical for economic success. This session will focus on specific resources to encourage participation of women and minorities in small businesses.
Speakers: Stephanie FertigSandra Jones, and Pamela McCauley

Successfully Submitting a Small Business Grant Application to NIH using ASSIST
Description:
Until recently, grant applicants had to use Grants.govs downloadable forms or procure the services of a commercial system-to-system service provider to prepare and submit a grant application to NIH. Now there is another option –ASSIST. NIHs Application Submission System & Interface for Submission Tracking (ASSIST) is a secure, web-based option for the preparation and submission of grant applications through Grants.gov to NIH. Among the many benefits of ASSIST are the ability to check your application against NIH business rules and preview your application in the NIH format prior to submission. This session provides an overview of the NIH grant application process and basic ASSIST features. 
Speaker: Sheri Cummins

Lessons Learned from Successful Companies 
Description: During this session you will hear from a panel of individuals who have received NIH SBIR and/or STTR awards and are navigating the commercialization process. Take advantage of the tips shared by these panelists about their up-and-down experiences transitioning technologies from the laboratory to the market.
Speakers: Stephanie Fertig, Ramanathan Kadirvel, Jeff Kapatoes, Ronald Hayes, and Steven Benner

Using RePORT to Your Advantage
Description: NIH makes an abundance of grant and funding data –including analyses of who and what we fund –available to the public through a resource called RePORT. Learn how to use this resource to find information to help target your grant application, find key NIH staff and grantee contacts, and more.
Speaker: Sheri Cummins

FDA Regulatory Basics for Small Businesses
Description: This seminar addresses three of the important early regulatory questions biomedical product developers need to consider: where in the US Food and Drug Administration their technology will be regulated, what basic steps their technology will need to meet to gain first-in-human or market access, and what questions the FDA may ask them to address during their product development work. The research techniques and tools discussed are relevant to devices, diagnostics, small molecules, biologics, and health IT. A case study will demonstrate how to communicate the information derived from the discussed techniques in a NIH SBIR or STTR application. 
Speaker: Chris Sasiela

Wednesday, November 16, 2016

Indirect Cost Rates and Accounting System Workshop
PowerPoint Two: Dan Milstead
Description: Who needs to negotiate rates? SBIR/STTR phases and indirect cost negotiations "What you need to know about --when to negotiate versus no need to negotiate.” SBIR/STTR guidelines and specific rules to know in regard to IDC. Special IDC costs you need to know: IR&D and Executive bonuses per the HHSAR and NIH policy. The what/when/who/how of the IDC submission duration, contents, frequency, types, contracts, status etc. IDC rate calculations and helpful resources leading to preparing an adequate IDC submission. Indirect rate structure One-Tier, Two-Tier, Three-Tier and more. IDC pitfalls to avoid and lessons learned. 
Speakers: Dan Milstead & Hruta Virkar

FDA Regulatory Basics for Small Businesses

Description: This seminar addresses three of the important early regulatory questions biomedical product developers need to consider: where in the US Food and Drug Administration their technology will be regulated, what basic steps their technology will need to meet to gain first-in-human or market access, and what questions the FDA may ask them to address during their product development work. The research techniques and tools discussed are relevant to devices, diagnostics, small molecules, biologics, and health IT. A case study will demonstrate how to communicate the information derived from the discussed techniques in a NIH SBIR or STTR application. 
Speaker: Chris Sasiela

Administration for Community Living
Description: This session will introduce The National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR).  The session will describe NIDILRR’s structure, history and its new home, the Administration for Community Living (ACL) under the Department of Health and Human Services (HHS).  The session will go on to describe NIDILRR’s unique SBIR program.
Speaker: Brian Bard

Session: Top 10 Dos and Don’ts for Your Phase I Proposal
Description: Writing your first proposal is a gargantuan leap up a steep learning curve. By the time you write your fourth or fifth you are starting to feel a bit less winded. But imagine what you might learn if you could see hundreds of proposals before submission and hundreds of summary statements post-review. That’s exactly what Lisa has done over the past almost 20 years of working with NIH applicants. Join us for an entertaining session where we will explore both the obvious and the subtle ways you can strengthen your proposal or quickly squelch reviewers enthusiasm through lessons learned and secrets shared. 
Speaker: Lisa Kurek

Planning for Phase III
PowerPoint Two: JoAnne Robbins
Description: The SBIR funding mechanism is unique in many ways. But it is the only mechanism that "requires" post-funding actions. Publications, graduate course and thesis completion, and training events or curricula may be expected from other NIH grant mechanisms. Meanwhile, SBIR funds Phases I and II but has built into the funding mechanism a Phase III for commercialization of the products developed in the earlier phases. SBIR grantees treat this 3rd phase with widely divergent levels of enthusiasm and planned activity. It could be argued that Phase III, which includes no funding from NIH, is the most important phase. For SBIR to be successful, products with proven efficacy need toget out to market for public use. In this session, early-stage and longer-term Phase III SBIR grantees will share: 
a. The strategies and challenges faced in Phase III. 
b. Lessons they have learned about starting early in planning for Phase III; what can be done in Phases I and II to increase the likelihood of Phase III success? 
c. Recommendations for new and experienced SBIR grantees in planning for Phase III.
Speaker: Augie Diana, JoAnne Robbins, and Eric Horler 

Commercialization Assistance Programs I-Corps at NIH, Niche, CAP, CRP
PowerPoint Two: Daniel Shaughnessy
PowerPoint Three: Christie Canaria
Description: You thought being selected for an award was difficult, but getting to the market-place can be 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/STTR awardees strategize how to commercialize their SBIR/STTR developed products. Join this session to find out which program might be available for you and how to become involved.
Speaker: Robert VinsonChristie CanariaDaniel Shaughnessy


Tracking the Web Session I: Leveraging SBIR to Build a Healthcare Software Company
Description: In this first of a two-session series, industry veterans and SBIR awardees will share their experience turning ideas for digital health innovations into proven products. The healthcare industry provides many opportunities for solutions, such as mobile apps, e-health portals, point-of-care systems, diagnostic aids, remote reminders, and patient education. These product and service needs are driven by the need for efficient outreach, education, reimbursement or patient-reported outcomes to make health care more transparent and more engaging. This panel will explore the challenges inherent in the product development cycle and market validation process, through the experiences of three successful company leaders. The moderator will introduce the issues, followed by comments and tales from the trenches from the three leaders in a moderated discussion. The panel will also include an opportunity for interactive discussion between panelists and the audience. What is a good idea? How do you test it? How do you build it? How do you price it? How do you recruit and motivate a core team with limited resources? These and other questions will be addressed in a dynamic exchange.
Speaker: Vince ThomasRohit Shukla, Charles Lee, Bill Tan, Robert Peterson 

Compliance and Stewardship of Federal Funds
Description: NIH and its grant recipients share responsibility for compliance and oversight to ensure proper stewardship of Federal funds. To fulfill this administrative partnership, the NIH provides compliance assistance that consists of clear and easy-to-access information on federal grants financial and management requirements for contractors, grantees, and the public. Compliance assistance is crucial to the successful administration and fiscal management of grant awards and it safeguards the Federal investment in America's R&D efforts. This session will address the administrative requirements, cost principles, and audit requirements applicable to SBIR/STTR grants. 
Speaker: Kathy Hancock

Tracking the Web Session II: Growing Your Company Into A Profitable, Sustainable Businesses
Description: In this second of two-sessions series, three successful entrepreneurs, all SBIR awardees, will share their experience turning innovative products into successful operational companies. Small businesses developing solutions in healthcare experience the same commercialization challenges confronting innovators in a highly fragmented market. This panel will explore the challenges associated with positioning your products and sales strategy for accelerated growth in an environment of long sales cycles typical of healthcare. What are some tried-and-true strategies for leveraging the SBIR program for continued expansion beyond the pilot? How does one go about fundraising for a growth-stage digital health company? Can a nonprofit service organization create and manage a for profit subsidiary eligible for SBIR funding? The moderator will set the stage and introduce the issues, followed by comments and tales from the trenches from the leaders in a moderated discussion. The panel will also include an opportunity for interactive discussion between panelists and the audience.
Speaker: Vince ThomasRohit Shukla, Charles Lee, Bill Tan, Robert Peterson

CDC - Small Business Innovation Research Program: Translating Innovation for Practical Solutions
Description: This session will provide participants with an introduction to CDC and its global public health mission. We will describe current CDC priorities and identify areas of need where the SBIR Program can have significant impact in real world public health settings. Examples of past and current projects will be provided to demonstrate how the CDC SBIR Program has helped create practical solutions to public health problems worldwide. 
Speaker: Sean Griffiths

Finding and Understanding Funding Opportunity Announcements
Description: Submitting an application to a Funding Opportunity Announcement (FOA) is the only way to receive a grant from the NIH. Attend this session to find out how to find an FOA, quickly navigate through it to find information of interest, and understand all the nuances of the vocabulary and language contained in FOAs. 
Speaker: Erica Brown

Opportunities for Eliminating Health Disparities
Description: What are health disparities? And what makes reducing them so challenging? This session will showcase the ongoing search of the National Institute on Minority Health and Health Disparities (NIMHD) to attract and support small business innovations designed to reduce or eliminate health disparities. The NIMHD envisions an America in which all populations will have an equal opportunity to live long, healthy, and productive lives. How can your small business contribute to this vision? These and other questions will be answered during this session and examples of innovative SBIR and STTR awards supported by NIMHD will be presented. 
Speaker: Derrick Tabor


Partnering with NIH: Technology Transfer

Description: Improving and expanding a company’s portfolio is essential to maintaining its competitive edge. Partnering with the NIH can de-risk a company’s investment in commercializing a technology by providing a key missing piece in a products development. Benefits of collaborating with the NIH can include access to cutting-edge expertise, such as top scientists in many biomedical fields, assistance in conducting clinical trials, or access to unique biological materials. In order to meet industry needs, a variety of mechanisms have been made available such as a Cooperative Research and Development Agreements (CRADAs) for collaborative research endeavors, Clinical Trial Agreements (CTAs) for the conduct of clinical studies in humans, Confidential Disclosure Agreements (CDAs) to exchange confidential information, license agreements, including a program specifically designed for start-up companies, and SBIR-technology transfer grants and contracts. Through these mechanisms and SBIR/STTR programs, NIH can help companies bridge the development gap between the laboratory bench and the patient bedside, and therein make it easier for the public to benefit from the full potential of biomedical inventions. 
Speaker: Jennifer Wong

Research Integrity at the NIH
Description: Participants will gain a basic understanding of the policies and regulations concerning research misconduct in NIH-funded activities. Upon completion of this session, attendees should be conversant and understand the elements of research misconduct, the assurance requirements for NIH grant applications, and the roles of the HHS Office of Research Integrity (ORI) and the NIH in promoting research integrity. 
SpeakerSherry Mills 

Follow Just-in-Time Procedures to Get Your Award Faster
Description: Once you know you received a fundable score, we understand that you want to get the award as fast as possible. This presentation goes over Just-In-Time (JIT) materials that the NIH needs prior to award. Typically these are the following: Other Support IRB/IACUC approvals SBIR or STTR Funding Agreement Certification Forms Other usual JIT information Other information requested by the awarding IC Knowing what to expect can help you prepare. Good preparation will help assure that you will get your award as soon as possible.
Speaker: Mindy BixbyTed Williams, and Shawn Richmond

Resolving SBIR/STTR Allegations of Waste, Fraud, and Abuse to Promote Program Integrity

Description: Learn about the roles and responsibilities of the Division of Program Integrity (DPI) and find out how their work is an important component of NIH efforts to oversee, detect, and prevent fraud, waste, and abuse. Know what to do if your company is involved in a DPI review. DPI in the Office of Management Assessment is the component of the NIH that conducts reviews of non-criminal allegations of misuse of NIH grant and contract funds; NIH grantee and contractor conflict of interest; violations of grant or contract laws, regulations, or policies; and issues referred to NIH by HHS Office of Inspector General (OIG) when prosecution or civil action has been declined or when OIG plans no further investigation. DPI is also responsible for reporting to OIG allegations that are or appear to be violations of criminal law. 
Speaker: Maritza Zeiberg 

FDA - Regulatory Requirements: Devices

Description: Marketing pathways and requirements differ between drugs, biologics and devices. This talk will provide guidance on navigating the regulatory process for devices including the different marketing pathways and their requirements, research requirements, methods of getting feedback from FDA, and various initiatives and resources intended to help device developers navigate the regulatory process to both perform novel clinical research and bring novel devices to market.
Speaker: Michael Hoffman

Mastering the Requirements for Human Research Review for Small Businesses

Description: This workshop aims to provide participants with the knowledge and information necessary to get their NIH grant applications or research protocols to pass reviews for human research protections. It will focus on clarifying confusion about federal requirements and providing participants with practical tips and solutions to problems and difficulties commonly encountered during such reviews. Our target audience is primarily investigators applying for NIH small business grants to conduct research that may involve interactions with human subjects or the use of human bio specimens or data. Upon completing the workshop, participants will be able to: 
1. Recognize whether a proposed activity is research that involves human subjects; 
2. Determine whether and how the HHS regulations for protecting human subjects apply to a particular activity; 
3. Understand how to appropriately complete the sections on human research protections and inclusion of women, minorities, and children in an NIH grant application 
4. Appreciate the principle requirements for obtaining legally effective informed consent in human subject’s research 
5. Understand how to navigate the IRB review process 
Speaker: Ann Hardy

Connecting Small Business Resources
Description: 

This annual conference offers a wealth of information on how to seek and obtain funding for your Small Business Concern (SBC) from NIH and sister agencies.  There are however other resources available to individuals and teams creating a science-based SBC.  This session will provide a survey, albeit not exhaustive, of other potential places nascent companies can turn for assistance, guidance, and information. 


Speaker: Scott Somers

Writing Your Phase II Commercialization Plan
Description: Lifesaving innovations do not benefit the public unless they reach the market, but achieving this task requires strategic planning and business savvy leadership. Attend this session for an in-depth discussion of what your commercialization plan should include to impress NIH reviewers. NHLBIs entrepreneur-in-residence Gary Robinson, who brings a wealth of expertise in the development and commercialization of new life science technologies, will provide suggestions about the structure and organization of your plan, and ways to articulate the value proposition and market appetite of your technology. You’ll also hear examples of state and local based resources that can help small businesses build their commercialization plan and other insightful tips to jumpstart your application to achieve commercial success. 
Speaker: Gary Robinson

SBIR/STTR Success Stories:Securing Non-dilutive Funding to Further Your Product Development
Description: Join us as a diverse panel of SBIR/STTR award winners will discuss their experiences and advice for pursuing and securing these special non-dilutive R&D funding opportunities. The panel will share ‘tried-and-true’ tips on how to win SBIR/STTR grants, how to work with program managers to maximize the relationship post award, and how these grants helped advance technology and/or the business for each panelist to further funding/customers. 
Speakers: Andrea Wesser, Shyam S. Mohapatra, Angela Alban, Amy Beaird

Thursday, November 17, 2016

Top 10 Brilliant Ideas and Stupid Mistakes: Secrets of Phase II Proposal Success
Description: Writing a Phase II? More money, more time, and more work equates to more proposal! That leads to even more opportunities to either impress the reviewers or propagate the same mistakes that they see all too often. After almost 20 years of working with NIH applicants Lisa has many more than 10 recommendations for both what to do and what not to do. Well build on that path up the learning curve that most Phase II applicants are on and discuss tangible recommendations to integrate into your proposal or make sure don’t see the light of the reviewer’s day.
Speaker: Lisa Kurek
Time: 8:00AM-8:50AM

Finding and Understanding Funding Opportunity Announcements
Description: Submitting an application to a Funding Opportunity Announcement (FOA) is the only way to receive a grant from the NIH. Attend this session to find out how to find an FOA, quickly navigate through it to find information of interest, and understand all the nuances of the vocabulary and language contained in FOAs.
Speaker: Erica Brown

SBIR/STTR Partnerships
Description: Attendees will receive an academic, corporate and government overview on the Power of Partnerships in applying, obtaining and delivering successful results relating to SBIR & STTR grants.
Speaker: Randy Berridge, Angela Alban, Dan Rini, William Reuter & Mark Long

Research Involving Animals
Description: Are you considering using live vertebrate animals in your research? Are you aware that the policies and regulations regarding research animals are different than those involving human subjects? This session provides information on 
1) The requirements for using animals, 
2) Appropriate completion of the Vertebrate Animal Section of the grant application and peer review considerations, 
3) The functions of an Institutional Animal Care and Use Committee, 
4) Details on the various Assurance documents including which type is required if your institution does not have its own animal facility, and 
5) The consequences of what happens when animal activities become noncompliant.
Speaker: Eileen Morgan

Networking and Partnerships
Description: Diverse areas of science require various levels of technological expertise. Depending on how far advanced a tool or technology is, there is a potential for consultative networking, collaboration and/or more formal partnerships. For example, proof-of-concept ventures are more likely to require less formalized consultative or collaborative seed-like input to optimize potential, whereas SBCs w/ more developed technologies require more formalized partnerships and commercial investment. This session will help to elucidate ecosystems that enhance your businesses stage-specific development via appropriate networking and partnerships strategies.
Speaker: Kristopher Bough & Dorie Clark

Opportunities for Eliminating Health Disparities

Description: What are health disparities? What makes eliminating health disparities challenging? This session will showcase the ongoing search of the National Institute on Minority Health and Health Disparities (NIMHD) to identify, attract, and support small business innovations designed to reduce or eliminate health disparities. The NIMHD envisions an America in which all How can your small business contribute to this vision? What populations are considered "health disparity populations"? These and many other questions will be answered during this session and examples of innovative SBIR and STTR awards supported by NIMHD will be presented.
Speaker: Derrick Tabor

FDA - Regulatory Requirements: Devices
Description: Marketing pathways and requirements differ between drugs, biologics and devices. This talk will provide guidance on navigating the regulatory process for devices including the different marketing pathways and their requirements, research requirements, methods of getting feedback from FDA, and various initiatives and resources intended to help device developers navigate the regulatory process to both perform novel clinical research and bring novel devices to market‎.
Speaker: Michael Hoffman

The Ins and Outs of SBIR Contracts and Grants
PowerPoint Two: Patti Weber
Description: As federal agencies that provide funding to innovative research with the development of their research ideas (a.k.a. investigator-initiated research), the majority of the NIH SBIR awards are made grants. But did you know that NIH, and other federal agencies also offer contract opportunities thru the SBIR mechanism? The NIH SBIR contract solicitation is issued annually in the summer with proposals due in early November and includes topics identified by program staff aimed at soliciting research in targeted scientific/technical area. In this session, you will learn: 
a. What differentiates SBIR contract from SBIR/STTR grants 
b. How to hear about and submit proposals in response to SBIR contract solicitations 
c. Some of the unique requirements of contracts vs. grants, such as reporting and OMB requirements 
Speaker: Ming Zhao & Andre Walker

Why Healthcare Entrepreneurs, IT Developers, and Researchers should know ONC
The Office of the National Coordinator for Health Information Technology (ONC) is the principal federal entity charged with coordination of nationwide efforts to implement and use the most advanced health information technology and the electronic exchange of health information. Come to this session to learn about the valuable technical resources and funding available to help you navigate the federal health IT landscape, test and validate your health IT product(s), and successfully launch and grow your business. During this session, you will also learn about ONC’s numerous challenge competitions and how to get involved.
Description:Speaker: Stephen Konya

Navigating Conflicts of Interest, Intellectual Property, and Faculty Spinoffs

Description: The SBIR/STTR programs were designed to develop and strengthen the role of innovative small business concerns (SBC) in federally funded research and development. This panel will explore the conflicts that can arise from participation in these grant programs by faculty members. Conflicts can arise when faculty members are founders or owners in the SBC. This panel will explore topics such as who owns the resulting intellectual property, management of financial and research conflicts, the line between for profit and not-for-profit activities, and the use of university facilities in the performance of SBIR/STTRs.
Speakers: Valerie McDevitt, Jim O’ConnellJosé L. Zayas-CastroGary D. Wimsett, Jr., and Thomas Weller 

Planning for Phase III

PowerPoint Two: JoAnne Robbins
Description: The SBIR funding mechanism is unique in many ways. But it is the only mechanism that "requires" post-funding actions. Publications, graduate course and thesis completion, and training events or curricula may be expected from other NIH grant mechanisms. Meanwhile, SBIR funds Phases I and II but has built into the funding mechanism a Phase III for commercialization of the products developed in the earlier phases. SBIR grantees treat this 3rd phase with widely divergent levels of enthusiasm and planned activity. It could be argued that Phase III, which includes no funding from NIH, is the most important phase. For SBIR to be successful, products with proven efficacy need toget out to market for public use. In this session, early-stage and longer-term Phase III SBIR grantees will share: a. The strategies and challenges faced in Phase III. b. Lessons they have learned about starting early in planning for Phase III; what can be done in Phases I and II to increase the likelihood of Phase III success? c. Recommendations for new and experienced SBIR grantees in planning for Phase III.
Speaker: Augie DianaJoAnne Robbins, and Eric Horler

SBIR Town Hall – Tell us What’s Good and What Needs to be Fixed
Description: John Williams, who oversees SBIR policy for the program government wide, wants to hear from you on how to make the program stronger while protecting the important elements.SBIR/STTR reauthorization will be a focus next year and understanding the users perspective is critical as we work through this process.
Speaker: John Williams

Beyond the Lab: The Funding Continuum from Idea to Commercialization
Description: This session will focus on resources available to researchers that enhance the probability of success in launching a high growth business from research. Topics include: I-Corps and related tools * methodologies for testing your go-to-market strategy * Leveraging early seed funding and accelerator programs * Factors that build credibility with Angel and Series A investors.
Speakers: Michael O’Donnell, Rick Wassel, Jackson Streeter, William Pangas, Benjamin Patz & Thomas O’Neal

Intellectual Property:  Considerations for Success
Description:
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.
Speakers: Scott Cooper

Writing Your Phase II Commercialization Plan
Description: Lifesaving innovations do not benefit the public unless they reach the market, but achieving this task requires strategic planning and business savvy leadership. Attend this session for an in-depth discussion of what your commercialization plan should include to impress NIH reviewers. NHLBIs entrepreneur-in-residence Gary Robinson, who brings a wealth of expertise in the development and commercialization of new life science technologies, will provide suggestions about the structure and organization of your plan, and ways to articulate the value proposition and market appetite of your technology. You’ll also hear examples of state and local based resources that can help small businesses build their commercialization plan and other insightful tips to jumpstart your application to achieve commercial success.
Speaker: Gary Robinson

Compliance and Stewardship of Federal Funds
Description: NIH and its grant recipients share responsibility for compliance and oversight to ensure proper stewardship of Federal funds. To fulfill this administrative partnership, the NIH provides compliance assistance that consists of clear and easy-to-access information on federal grants financial and management requirements for contractors, grantees, and the public. Compliance assistance is crucial to the successful administration and fiscal management of grant awards and it safeguards the Federal investment in America's R&D efforts. This session will address the administrative requirements, cost principles, and audit requirements applicable to SBIR/STTR grants.
Speaker: Kathy Hancock

Partnering with the NIH: Technology Transfer
Description: Improving and expanding a company’s portfolio is essential to maintaining its competitive edge. Partnering with the NIH can de-risk a company’s investment in commercializing a technology by providing a key missing piece in a products development. Benefits of collaborating with the NIH can include access to cutting-edge expertise, such as top scientists in many biomedical fields, assistance in conducting clinical trials, or access to unique biological materials. In order to meet industry needs, a variety of mechanisms have been made available such as a Cooperative Research and Development Agreements (CRADAs) for collaborative research endeavors, Clinical Trial Agreements (CTAs) for the conduct of clinical studies in humans, Confidential Disclosure Agreements (CDAs) to exchange confidential information, license agreements, including a program specifically designed for start-up companies, and SBIR-technology transfer grants and contracts. Through these mechanisms and SBIR/STTR programs, NIH can help companies bridge the development gap between the laboratory bench and the patient bedside, and therein make it easier for the public to benefit from the full potential of biomedical inventions. 
Speaker: Jennifer Wong

Successfully Submitting a Small Business Grant Application to NIH using ASSIST
Description: Until recently, grant applicants had to use Grants.govs downloadable forms or procure the services of a commercial system-to-system service provider to prepare and submit a grant application to NIH. Now there is another option –ASSIST. NIHs Application Submission System & Interface for Submission Tracking (ASSIST) is a secure, web-based option for the preparation and submission of grant applications through Grants.gov to NIH. Among the many benefits of ASSIST are the ability to check your application against NIH business rules and preview your application in the NIH format prior to submission. This session provides an overview of the NIH grant application process and basic ASSIST features.
Speaker: Sheri Cummins

Life Cycle of Commercialization
Description: This session explores the complexities of what it takes to get discoveries from the ideation stage to the marketplace. The SBIR program is a great tool. We will discuss additional elements of an effective eco-system that can successfully move an innovation into the commercial reality.
Speaker: Thomas O’Neal
















 

Contact Information

  • sbirsttrorlando@ucf.edu

    #OrlandoSBIR

Payment Instructions

              


       


        
  
 






    This project has not been funded in whole or in part with Federal funds from the Department of Health and Human Services and/or the National Institutes of Health.
© 2017
Quick, easy and affordable online event registration and event management software for all event sizes.