11th Annual
NIH SBIR/STTR Conference

June 30 to July 1, 2009
Omaha, Nebraska

Presented by

NIH

DHHS

 

Hosted by

nbdc

UNO






 

Transforming Medicine through Innovation

“From Idea to Market”

NIH Research Funding Opportu”NIH”tie$

Explicitly for Small Businesses


11th Annual NIH SBIR/STTR Conference

 

 

Online Registration is now closed. We will, however, allow on-site registration during our posted registration hours, however there will be a $25 processing fee. Thank you to all that registered, and we look forward to an informative conference!

Per the Cancellation Policy stated on the Registration page, all registrations are now non-refundable since the June 1 deadline. Thank you

- Conference Planning Committee


Learn how to tap into the $650 million available annually through the National Institutes of Health’s SBIR and STTR programs.

Highlights  

  • SBIR/STTR 101 – for those new to the program
  • SBIR/STTR Update – for those familiar with the program
  • NIH review process – an in-depth look
  • Scientific Poster Sessions for University Researchers  
  • One-on-One meetings with NIH, CDC, and FDA staff
    • National Institute on Aging
    • National Institute of Allergy and Infectious Diseases
    • National Institute of Arthritis and Musculoskeletal and Skin Diseases
    • National Institute of Biomedical Imaging and Bioengineering
    • National Cancer Institute
    • National Institute of Dental and Craniofacial Research
    • National Institute of Diabetes, Digestive and Kidney Diseases
    • National Institute of Drug Abuse
    • National Eye Institute
    • National Institute of General Medical Sciences
    • National Heart, Lung and Blood Institute
    • National Institute of Mental Health
    • National Center on Minority Health and Health Disparities
    • National Institute of Neurological Disorders and Stroke
    • National Institute of Nursing Research
    • National Center for Research Resources
    • Center for Scientific Review
    • eRA Commons
    • Division of Financial Advisory Services
    • Division of Extramural Inventions (iEdison, intellectual property)
    • Centers for Disease Control and Prevention
    • Food and Drug Administration
  • Indirect Cost Rates & Audit Workshop
  • Electronic Submission Workshop (hands-on)
  • Speed Networking
  • Business Planning Basics
  • Strategies for Commercialization
  • And more!

Who Should Attend?

  • Small businesses wanting to develop novel technology products
  • Highly motivated small business entrepreneurs and research managers
  • Small businesses interested in new NIH SBIR/STTR initiatives and program changes 
  • University researchers interested in partnering with small businesses on
    collaborative R&D projects
  • Large companies interested in developing strategic alliances with successful SBIR/STTR awardees
  • Organizations and consultants providing support to interested SBIR/STTR applicants

For conference agenda specifics contact Lisa Tedesco:
mtedesco[at sign]unomaha.edu or 402-554-6270

For registration and hotel information, contact Veronica Doga:
vdoga[at sign]unomaha.edu or 402-554-2176

For more information on NIH SBIR/STTR Program:
http://grants.nih.gov/grants/funding/sbir.htm

Agenda

(Subject to Change)

For the printer-friendly version of the detailed agenda click HERE

The following is a summary of session topics and times only:

Day 0, June 29- On Site Pre-Registration
Time
Event
12:00-5:00 On-site pre-registration at Hilton

 

Day 1, June 30 - Submission, Policies, Procedures
Time
Topic
6:30-10:00 Registration at Qwest Center
7:00-8:00 Continental Breakfast
8:00-8:15 Welcome
8:15-8:45 Current State of Biotechnology Industry

8:45-10:15
Nuts & Bolts of the NIH SBIR & STTR Programs (for novices)
10:15-10:30 Break
10:30-12:00 An In-Depth Look at the NIH SBIR/STTR Receipt, Refferal, and Review Process
12:00-1:15 Lunch & Posters
1:15- 2:00 Concurrent Sessions:
  • Preparing a Successful Application - Tales From Those Who "Have Been There... Done That"
  • WORKSHOP: Indirect Cost Rates and Accounting Systems
  • All You Ever Wanted to Know About the Electronic Submission Process
  • One-on-Ones
  • 2:00-2:45

     

    Concurrent Sessions:
  • Compliance & Grants Management
  • WORKSHOP: Indirect Cost Rates and Accounting Systems (continued)
  • All You Ever Wanted to Know About the Electronic Submission Process (continued)
  • One-on-Ones
  • 2:45-3:00 Break
    3:00-3:45 Concurrent Sessions:
  • Ivory Tower Innovation & University Start-Ups
  • One-on-Ones
  • One-on-Ones for Electronic Submission
  • 3:45-4:15 Concurrent Sessions:
  • Tools for Building and Facilitating Partnerships
  • One-on-Ones
  • One-on-Ones for Electronic Submission (continued)
  • 4:15-4:45 Concurrent Sessions:
  • Protecting Your Intellectual Property through iEdison Invention Reporting
  • Turbo Negotiator Demonstration
  • NIST MEP Innovation Marketplace Demonstration
  • 4:45-5:00 Wrap-up
    5:00-5:45 Speed Networking (Networking Fun)
    5:45-7:30 Welcome Reception

     

    Day 2, July 1 - Commercialization Sessions: Transitioning to the Market
    Time
    Topic
    7:00-8:00
    Continental Breakfast
    8:00-8:45 Concurrent Sessions:
  • Business Planning Basics
  • WORKSHOP: Indirect Cost Rates and Accounting Systems (repeat from Day 1)
  • All You Ever Wanted to Know About the Electronic Submission Process (repeat from Day 1)
  • One-on-Ones
  • 8:45-9:30

     

    Concurrent Sessions:
  • Strategies for Commercialization
  • WORKSHOP: Indirect Cost Rates and Accounting Systems (continued)
  • All You Ever Wanted to Know About the Electronic Submission Process (continued)
  • One-on-Ones
  • 9:30-10:15

     

    Concurrent Sessions:
  • Life Science Venture Funds and Angels
  • One-on-Ones for Electronic Submissions
  • One-on-Ones
  • 10:15-10:30 Break
    10:30-11:15 Concurrent Sessions:
  • Building Corporate Alliances & Partnerships
  • Benefits of Incubator Programs
  • Peak into the NIH: Special Programs and Resources
  • One-on-Ones
  • 11:15-12:00 Concurrent Sessions:
  • NIH Technical Assistance Programs
  • Leveraging State Resources
  • Peak into the NIH: Special Programs and Resources
  • One-on-Ones
  • 12:00-1:30 Lunch & Speaker
    1:30- 2:15 Concurrent Sessions:
  • Navigating the FDA
  • Interactive Multi-media Panel: Commercialization of Behavioral Services Interventions and Products
  • Peek Into CDC & FDA:Special Programs and Resources
  • One-on-Ones
  • 2:15-3:00 Concurrent Sessions:
  • Moving from R&D to Manufacturing
  • Commercializing Your Healthcare/IT/Media Product
  • Peek Into NIH:Special Programs and Resources

    NEI, NCMHD, NIAID
  • One-on-Ones
  • 3:00-3:30 Wrap-Up & Adjourn

    Narrative Descriptions of Sessions

    Day 1
    Submission, Policy, Prcedures

    Day One Agenda
    Current State of the Biotechnology Industry

    The biotechnology community has not been spared the wrath of the US economic downturn. However, the situation is not entirely bleak. Small businesses continue to innovate, make scientific advances, and forge new partnerships that leverage and expedite their commercialization efforts. Latest reports indicate that entrepreneurship rose in this recession and may be the remedy to the shrinking corporate pipelines. Some forecast dire straits for entrepreneurs. So what is the current investor and partnering climate like for life science companies? What are the future trends? Which bioscience sectors have been most successful in attracting investments and partnerships? Where does the NIH SBIR-STTR program fit in? Come hear James Greenwood, CEO and President of BIO discuss the latest advances in biomedical research and share his insights into where the industry is headed in today’s uncertain global economic climate.

    Day One Agenda
    Nuts and Bolts of the NIH SBIR and STTR Programs

    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. 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. 

    Day One Agenda
    An In-Depth Look at the NIH SBIR/STTR Receipt, Referral, and Review Processes

    Are you asking yourself questions like:  When is my application due?  What are critical policies and requirements for submission? Should I include a cover letter with my submission? 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 (CSR), 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. Drs. Dana Plude and Lawrence Boerboom, Scientific Review Officers in CSR, will provide insight about what reviewers expect to see for each of the review criteria and will provide some grantsmanship tips from a reviewer’s perspective.

    Day One Agenda
    Preparing a Successful Application – Tales From those Who “Have Been There…Done That”
    Although this panel includes small companies who have received NIH SBIR and/or STTR awards, not all of their applications have been successful. Some were selected based on their initial submission, others after revising and resubmitting, and others just didn’t make it all. These panelists will share their up-and-down experiences about how best to approach the writing of SBIR and STTR grants for NIH evaluation. Attendees will learn writing tips and key elements of how to prepare a well written application and how to present an innovative idea to the reviewers.


    Day One Agenda
    Indirect Cost Rates and Accounting Systems Workshop 

    An interactive workshop designed to teach participants the fundamentals of indirect cost, the importance of financial viability, and the ‘big three’ accounting system issues


    Day One Agenda
    All You Ever Wanted to Know About the Electronic Submission Process

    NIH requires all applications for the SBIR and STTR grant programs to be submitted through the Federal-wide grants portal known as Grants.gov to the NIH eRA Commons system. Learn about the registration requirements for these systems and the steps you must take to submit, track and verify your application submission. Learn the pitfalls that others have experienced so you don’t make the same mistakes. 

    Day One Agenda
    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.

    Day One Agenda
    Ivory Tower Innovation & University Start-Ups

    The last several years have witnessed an increasing number of university faculty who are spinning out companies using intellectual property (IP) derived from their academic research.  While many institutions are supporting efforts to boost start-up activity, there remain a number of challenges associated with the successful transition from academic culture to the business world.  This session will discuss the process of “Ivory Tower Innovation” with a focus on negotiating a successful IP agreement for your small business.  Topics will also include avoiding common pitfalls, such as conflict of interest concerns, and deciding what role you should play in this new venture.  Panelists will provide various perspectives on this process from the point-of-view of the inventor, the technology transfer specialist, and the person leading operations at the small business.

    Day One Agenda
    Tools for Building and Facilitating Partnerships

    Many biomedical research projects and their resulting products need scientific and technical talent and commercialization partners from a broad spectrum of diverse areas.  A few of the tools which are available to assist with identifying industry, university, and commercial partners and with negotiating agreements with them will be presented. These tools include the NIH “Pipeline to Partnerships,” “Turbo Negotiator” (a product of the University-Industry Demonstration Partnership of the National Academies), and the National Institutes of Standards and Technology’s Manufacturing Extension Partnership’s “Innovation Marketplace.” Demonstrations of these tools will also be available during the conference.

    Day One Agenda
    Protecting Your SBIR/STTR Intellectual Property Rights Through iEdison Invention Reporting

    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.

    Day One Agenda
    Speed Networking

    Network with other attendees in a structured and “fun” environment. Be sure to have plenty of business cards handy for this session.

     

    Day 2
    Commercialization Sessions

    Business Planning Basics

    Are you a researcher who is having difficulty with entrepreneurial thinking?  Are you struggling with how to start, finance, and build your business?  Do you want to be a lifestyle company, a foundation, or perhaps grow to an initial public offering?  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 plan that will help you avoid critical business mistakes.   Attend this session to begin to design your “business roadmap to success.”  Specific topics to be covered  include:  (1) The Business Plan Overview, (2) Developing and Organizing Content to include the Executive Summary, Company Profit, Market Research and Analysis, Marketing Plan, Operations, Human Resources and Finances, and (3) Overview of funding options to include: SBIR, Angels, Venture Capitalist, Launching Investors

    Strategies for Commercialization

    Determining your strategy to bring your innovation into the marketplace depends on (1) assessing the current commercialization environment of your specific industry sector and (2) your personal vision for the technology based on your personal business philosophy. Various options are then available such as seeking a strategic alliance to develop, market or distribute your product, licensing your technology to others, pouring in more “sweat equity”, or perhaps obtaining venture capital, angel, or corporate investments. This session will help you determine if bootstrapping, spinning off the technology, or perhaps taking on an investment or strategic partner is best for you.

    Life Science Ventures and Angels

    In today’s life sciences environment, as small businesses look for much needed capital financing for their sometimes risky ventures, venture capital presents an opportunity for small businesses to access early and late stage investment from venture funds that focus on life science and biomedical innovations.  Panelists will discuss venture capital and angel investor criteria and hurdles required for investment in early stage biotech opportunities.  They will also discuss how to prepare for raising risk capital, differences in stages of investment and the due diligence process.

    Building Corporate Alliances & Partnerships

    Building alliances to help commercialize biotechnology and health-related products can be more difficult than obtaining the funding to do the research, especially in these economic hard times.  It’s almost impossible to go it alone. This session will equip small businesses with the knowledge on building their phase III strategies for bringing their technologies to the marketplace through building alliances and partnerships with corporate partners – whether it be how to start the relationship-building process, issues that need to be considered when transferring technologies through testing, licensing, partnering, consulting, and overall business development strategies for effective partnering.

    Benefits of Incubator Programs

    Business incubation is a business support process that accelerates the successful development of start-up and fledgling companies by providing entrepreneurs with an array of targeted resources and services.  Business incubators nurture the development of entrepreneurial companies, helping them survive and grow during the start-up period, when they are most vulnerable. The most common goals of incubation programs are creating jobs in a community, enhancing a community’s entrepreneurial climate, retaining businesses in a community, building or accelerating growth in a local industry, and diversifying local economies while producing successful firms that will leave the program financially viable and freestanding.   This session will discuss best practices in business incubation and the critical factors for success for biotech based companies.

    A Peek Into the NIH, CDC, and FDA:  Special Programs and Resources

    The “Peek Into the NIH, CDC, and FDA” sessions will highlight the scientific priority areas for SBIR/STTR for twelve NIH institutes and centers (ICs), as well as the CDC and the FDA 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, CDC, and FDA resources available to the extramural research community, and NIH collaboration mechanisms.

    NIH Technical Assistance Programs

    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.

    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 various resources available in Nebraska and other states, and where to look for opportunities in your state. 

    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

    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. 

    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.

    Commercializing Your Healthcare/IT/Media Product

    Each year thousands of healthcare-related products are created but only some of them become commercial successes; almost all of the ones that make it to the market, get sold, and are ultimately deployed have some common characteristics. Shahid will describe some of those characteristics and help you find ways of getting the attention of your customers, explaining your product to them in a concise and meaningful way, devising pricing and partnering strategies, and finally figuring out how to get paid for what you’ve created. It’s difficult to have your product’s messaging make it through the noise in an ordinary market – but, of course we’re not living in ordinary times so things are even harder. Shahid will help you devise the right strategies so that you can rise above the herd and get noticed in the marketplace.

    Reimbursement

    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! 

    Scientific Poster Session

    "Public Meeting"

     

    Abstracts Due:  May 31, 2009

    Twenty Five university researchers will be selected to present their non-proprietary scientific findings at the poster session. The goals of the session are to:

    1. create opportunities for university researchers to present their research and technologies to their peers
    2. foster discussions that may lead to collaborations
    3. to identify potential research partners, and
    4. to learn about university technologies that are available for licensing.

    This is not an exhibit or tradeshow, but is instead an opportunity to share information.

    Submission Deadline: May 31, 2009

    Submission Instructions

     University Researchers

    Registration

    Online Registration is now closed. We will, however, allow on-site registration during our posted registration hours, however there will be a $25 processing fee. Thank you to all that registered, and we look forward to an informative conference!

    Per the Cancellation Policy stated on the Registration page, all registrations are now non-refundable since the June 1 deadline. Thank you

    - Conference Planning Committee

    The 11th Annual NIH SBIR/STTR Conference will be held on June 30 - July 1, 2009 at the Qwest Center Omaha, located minutes from Eppley Airfield, in downtown Omaha and attached via skyway to the Hilton Hotel, the official hotel for this year's conference. The Qwest Center Omaha is located at:

    qwest

    Qwest Center Omaha
    455 N. 10th Street
    Omaha, NE 68102
    Telephone: (402) 341-1500
    Fax: (402) 991-1501

    On-site pre-registration will begin on June 29th from 12:00-4:00pm located in the lobby of the Hilton Hotel. Day of-registration will begin on June 30th from 6:30-8:00am at the Qwest Center.

    Standard Registration:
    Cost: $140
    Deadline: June 25th

    To register for the Conference by payment with credit card, click HERE

    To register for the Conference by payment with check, click HERE


    REGISTRATION/CANCELLATION POLICY:

    Early bird registration will end on April 15 and regular registration will be from April 16 – June 25.  If you have not registered online by the June 25th cutoff, you may register onsite for an additional $25 fee.

    All payments must be received before the conference start.  If you choose to register "Pay by credit card" and have not paid by credit card online, you MUST render full payment on the day of the conference before attendance is allowed. If you choose to register "Pay by check" and the checks are not received by the COB June 25, 2009 deadline, you MUST render full payment on the day of the conference before attendance will be allowed.

    To cancel your registration, you must contact the conference coordinator by close of business on May 31, 2009.  All payments and registrations paid will be final and non-reimbursable as of June 1, 2009.  If you cancel your registration before the June 1 deadline, you will be returned your registration fee minus a $25 processing fee.

    Lodging


    hilton

    The Hilton Omaha hotel, Nebraska's only four diamond property, is connected to the brand new Qwest Center Omaha, just blocks from the historic Old Market and is this year's NIH SBIR/STTR National Conference Hotel.

    The Hilton Omaha hotel is located adjacent to the Old Market and is minutes from Henry Doorly Zoo, Omaha Children's Museum, the Durham Western Heritage Museum, Joslyn Art Museum. The Hilton Omaha is also only three miles from Eppley Airfield and offers complimentary 24-hour shuttle to and from the airport. All Hilton Omaha's guestrooms feature both wired and wireless high-speed Internet access. Enjoy meals in the custom designed Liberty Tavern Restaurant and Lounge or enjoy a freshly brewed Latte or other gourmet coffee on our outdoor furnished patio while leafing through your complimentary morning USA Today®. For a reasonable fee enjoy our full service health club and spa or relax by our complimentary indoor pool. Enjoy Nebraska hospitality at its finest - Travel Should Take You Places!™

    A block of rooms have been reserved for June 26, 2009 - July 3, 2009. The special room rate of $125/nt. will be available until June 5th or until the group block is sold-out, whichever comes first.

    Booking a reservation from the Hilton's site is simple. To begin the process, click on the link below to take you directly to the conference hotel reservation site to receive your group's preferred rate. If you need additional nights stay, the group rate will be available from June 26 - July 3, or until the rooms are sold-out.

    http://hilton/NIHconference

    See you at the Hilton Omaha! We hope you enjoy your stay in Omaha!

    Group Name: 11th Annual NIH National SBIR/STTR Conference
    Group Code: NIH
    Check-in: 29-JUN-2009
    Check-out: 01-JUL-2009
    Hotel Name: Hilton Omaha
    Hotel Address: 1001 Cass Street
    Omaha, Nebraska
    68102
    Phone Number: 402-998-4220

     

    Explore Omaha

    Welcome to Omaha…the home of the College World Series, ConAgra, Union Pacific and Warren Buffett!  We hope you enjoy your stay while you visit our great city.

    The conference location and hotel – the Qwest Center Omaha and the Hilton Hotel are located within walking distance of the Old Market – the downtown arts and entertainment district of Omaha.  Here you’ll find restaurants to fit every taste and mood – from authentic French to steaks to burgers and homemade ice cream parlors.  You’ll also find great nightlife and great breweries.

    Below is a listing of our recommended restaurants (alphabetically) and the type of food.  But, if you’re still wondering what else downtown Omaha offers, you can check out two great websites – www.oldmarket.com or www.visitomaha.com .  These websites will also give you the addresses of the establishments below.

    Delice European Bakery and Café (French bistro)
    The French Café (French)
    Indian Oven (upscale Indian)
    M. Pubs (casual American)
    Omaha Prime (upscale steakhouse)
    Spaghetti Works (casual Italian)
    Stokes Bar and Grill (casual southwestern)
    Ted and Wally’s Ice Cream (ice cream parlor)
    Trini’s Mexican Restaurant (casual Mexican)
    Upstream Brewing Company (casual American brewery)
    Vivace (upscale Italian)
    V. Mertz (upscale American)
    Zio’s Pizza (casual pizzeria)

    Omaha Downtown Map
    (click to enlarge)

    Downtown_Omaha


    omaha_downtown


    Omaha

     

     



       
     
     
     
     

    MVS

     
    SAICF
    SD
     
    Partners      
    bio_ne
     
    sbdc
     

    Submission Deadline: May 31, 2009

    Poster Submission Instructions
    University Researchers

      • State objectives of the study (preferably one sentence)
      • Discuss the methods used.
      • Summarize the results in sufficient detail to support the conclusion.
      • Provide the conclusions.
      • Limit to 250-500 words.

    • Only ONE abstract per university department will be accepted.
    • 25 posters will be selected.
    • Selections wil be based on the scientific and technical progress made on the project including the commercial potential and will be made to assure there is scientific diversity at the poster session.
    • Review your abstract carefully before submitting…if selected, it will be printed in the conference materials. The Conference Committee is not responsible for correcting typographical, spelling, or grammatical errors.
    • Specific poster preparation guidelines will be provided at a later date to those selected.

    Submission Deadline: May 31, 2009

    For More Information Contact:
    Ms. Lisa Tedesco
    mtedesco[at sign]unomaha.edu

     

    Narrative Descriptions of Sessions

    Day 1
    Submission, Policy, Prcedures

    Current State of the Biotechnology Industry

    The biotechnology community has not been spared the wrath of the US economic downturn. However, the situation is not entirely bleak. Small businesses continue to innovate, make scientific advances, and forge new partnerships that leverage and expedite their commercialization efforts. Latest reports indicate that entrepreneurship rose in this recession and may be the remedy to the shrinking corporate pipelines. Some forecast dire straits for entrepreneurs. So what is the current investor and partnering climate like for life science companies? What are the future trends? Which bioscience sectors have been most successful in attracting investments and partnerships? Where does the NIH SBIR-STTR program fit in? Come hear James Greenwood, CEO and President of BIO discuss the latest advances in biomedical research and share his insights into where the industry is headed in today’s uncertain global economic climate.

    Nuts and Bolts of the NIH SBIR and STTR Programs
    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. 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. 

    An In-Depth Look at the NIH SBIR/STTR Receipt, Referral, and Review Processes
    Are you asking yourself questions like:  When is my application due?  What are critical policies and requirements for submission? Should I include a cover letter with my submission? 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 (CSR), 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. Drs. Dana Plude and Lawrence Boerboom, Scientific Review Officers in CSR, will provide insight about what reviewers expect to see for each of the review criteria and will provide some grantsmanship tips from a reviewer’s perspective.

    Preparing a Successful Application – Tales From those Who “Have Been There…Done That”
    Although this panel includes small companies who have received NIH SBIR and/or STTR awards, not all of their applications have been successful. Some were selected based on their initial submission, others after revising and resubmitting, and others just didn’t make it all. These panelists will share their up-and-down experiences about how best to approach the writing of SBIR and STTR grants for NIH evaluation. Attendees will learn writing tips and key elements of how to prepare a well written application and how to present an innovative idea to the reviewers.

    Indirect Cost Rates and Accounting Systems Workshop 
    An interactive workshop designed to teach participants the fundamentals of indirect cost, the importance of financial viability, and the ‘big three’ accounting system issues

    All You Ever Wanted to Know About the Electronic Submission Process

    NIH requires all applications for the SBIR and STTR grant programs to be submitted through the Federal-wide grants portal known as Grants.gov to the NIH eRA Commons system. Learn about the registration requirements for these systems and the steps you must take to submit, track and verify your application submission. Learn the pitfalls that others have experienced so you don’t make the same mistakes. 

    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.

    Ivory Tower Innovation & University Start-Ups

    The last several years have witnessed an increasing number of university faculty who are spinning out companies using intellectual property (IP) derived from their academic research.  While many institutions are supporting efforts to boost start-up activity, there remain a number of challenges associated with the successful transition from academic culture to the business world.  This session will discuss the process of “Ivory Tower Innovation” with a focus on negotiating a successful IP agreement for your small business.  Topics will also include avoiding common pitfalls, such as conflict of interest concerns, and deciding what role you should play in this new venture.  Panelists will provide various perspectives on this process from the point-of-view of the inventor, the technology transfer specialist, and the person leading operations at the small business.

    Tools for Building and Facilitating Partnerships

    Many biomedical research projects and their resulting products need scientific and technical talent and commercialization partners from a broad spectrum of diverse areas.  A few of the tools which are available to assist with identifying industry, university, and commercial partners and with negotiating agreements with them will be presented. These tools include the NIH “Pipeline to Partnerships,” “Turbo Negotiator” (a product of the University-Industry Demonstration Partnership of the National Academies), and the National Institutes of Standards and Technology’s Manufacturing Extension Partnership’s “Innovation Marketplace.” Demonstrations of these tools will also be available during the conference.

    Protecting Your SBIR/STTR Intellectual Property Rights Through iEdison Invention Reporting
    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.

    Speed Dating

    Network with other attendees in a structured and “fun” environment. Be sure to have plenty of business cards handy for this session.

     

    Day 2
    Commercialization Sessions

    Business Planning Basics

    Are you a researcher who is having difficulty with entrepreneurial thinking?  Are you struggling with how to start, finance, and build your business?  Do you want to be a lifestyle company, a foundation, or perhaps grow to an initial public offering?  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 plan that will help you avoid critical business mistakes.   Attend this session to begin to design your “business roadmap to success.”  Specific topics to be covered  include:  (1) The Business Plan Overview, (2) Developing and Organizing Content to include the Executive Summary, Company Profit, Market Research and Analysis, Marketing Plan, Operations, Human Resources and Finances, and (3) Overview of funding options to include: SBIR, Angels, Venture Capitalist, Launching Investors

    Strategies for Commercialization

    Determining your strategy to bring your innovation into the marketplace depends on (1) assessing the current commercialization environment of your specific industry sector and (2) your personal vision for the technology based on your personal business philosophy. Various options are then available such as seeking a strategic alliance to develop, market or distribute your product, licensing your technology to others, pouring in more “sweat equity”, or perhaps obtaining venture capital, angel, or corporate investments. This session will help you determine if bootstrapping, spinning off the technology, or perhaps taking on an investment or strategic partner is best for you.

    Life Science Ventures and Angels

    In today’s life sciences environment, as small businesses look for much needed capital financing for their sometimes risky ventures, venture capital presents an opportunity for small businesses to access early and late stage investment from venture funds that focus on life science and biomedical innovations.  Panelists will discuss venture capital and angel investor criteria and hurdles required for investment in early stage biotech opportunities.  They will also discuss how to prepare for raising risk capital, differences in stages of investment and the due diligence process.

    Building Corporate Alliances & Partnerships

    Building alliances to help commercialize biotechnology and health-related products can be more difficult than obtaining the funding to do the research, especially in these economic hard times.  It’s almost impossible to go it alone. This session will equip small businesses with the knowledge on building their phase III strategies for bringing their technologies to the marketplace through building alliances and partnerships with corporate partners – whether it be how to start the relationship-building process, issues that need to be considered when transferring technologies through testing, licensing, partnering, consulting, and overall business development strategies for effective partnering.

    Benefits of Incubator Programs

    Business incubation is a business support process that accelerates the successful development of start-up and fledgling companies by providing entrepreneurs with an array of targeted resources and services.  Business incubators nurture the development of entrepreneurial companies, helping them survive and grow during the start-up period, when they are most vulnerable. The most common goals of incubation programs are creating jobs in a community, enhancing a community’s entrepreneurial climate, retaining businesses in a community, building or accelerating growth in a local industry, and diversifying local economies while producing successful firms that will leave the program financially viable and freestanding.   This session will discuss best practices in business incubation and the critical factors for success for biotech based companies.

    A Peek Into the NIH, CDC, and FDA:  Special Programs and Resources

    The “Peek Into the NIH, CDC, and FDA” sessions will highlight the scientific priority areas for SBIR/STTR for twelve NIH institutes and centers (ICs), as well as the CDC and the FDA 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, CDC, and FDA resources available to the extramural research community, and NIH collaboration mechanisms.

    NIH Technical Assistance Programs

    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.

    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 various resources available in Nebraska and other states, and where to look for opportunities in your state. 

    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

    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. 

    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.

    Commercializing Your Healthcare/IT/Media Product

    Each year thousands of healthcare-related products are created but only some of them become commercial successes; almost all of the ones that make it to the market, get sold, and are ultimately deployed have some common characteristics. Shahid will describe some of those characteristics and help you find ways of getting the attention of your customers, explaining your product to them in a concise and meaningful way, devising pricing and partnering strategies, and finally figuring out how to get paid for what you’ve created. It’s difficult to have your product’s messaging make it through the noise in an ordinary market – but, of course we’re not living in ordinary times so things are even harder. Shahid will help you devise the right strategies so that you can rise above the herd and get noticed in the marketplace.

    Reimbursement

    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! 

     

     

    Copyright, 2009. NBDC    vdoga[at sign]mail.unomaha.edu