TRI-State SBIR Forum Featuring VA, NC and WVA Research, Development, and Funding Opportunities for Entrepreneurs and Innovators March 21 23, 2006 The Wyndham Hotel Roanoke Airport 2801 Hershberger Road Roanoke, Virginia 24017 Event Website: http://www.sw.edu/ptac/tristateforum%20web/roanoke.html Registration Form: http://www.sw.edu/ptac/tristateforum%20web/registrationwebform1.pdf Tuesday, March 21, 2006 A focus on FDA regulatory processes, clinical trials, and development 12:00 1:00 pm Registration/Light refreshments 1:00 1:15 Welcome/Conference Overview 1:15 3:00 Development of Medical Devices and Drugs FDA Regulatory Processes Gain an understanding of FDA regulatory process and tools to navigate Resources provided by FDA for small businesses Do I need a 510 (k)? Drug Classifications Regulations, procedures, organization & policies Pre-clinical safety/toxicity, IND, submissions Phase I,II,III NDA FDA meetings Mark Licata, President, Bio-Track, Richmond, VA Rita Geiger, CEO, InfoStrength, Raleigh, NC 3:00 3:15 BioMed Networking Parallel Track Sessions: 3:15 5:00 PM Medical Device Track Drug/Biologicals Track
3:15-4:15 510(k) Submissions 4:30 5:30 Clinical Development Plan Melissa Waugh BREAK 4:15 4:30 Marie Marlow 3:15-4:15 Developing a Pre-clinical Plan 4:30 5:30 Been there Done that Geoffrey Allen Biologics Consulting Group Insmed 5:30 6:30 Networking Reception 6:30 8:00 Dinner Keynote Speaker TBA Wednesday, March 22, 2006 A focus on planning, development, and funding 8:00 8:30 SBIR Networking Breakfast in Exhibit Area 8:30 8:35 Welcome/Introductions 8:35 8:45 Introduction to SBIR: A Historical Prospective Learn the origins of SBIR from its designer Mr. Roland Tibbitts, SBIR Founder and retired NSF Program Manager (invited) 8:45 9:15 SBIR Overview and Proposal Strategies Learn the basics of this multi-agency Federal program Learn how to write proposals attractive to the reviewing agencies and that are beneficial to your commercialization goals Dr. Juan Figueroa, NSF Program Manager 9:15 10:00 National Institutes of Health Fundamentals Learn the fine points of the NIH review process Commercialization plan required for Phase II Applications and other options for Phase II funding Kay Etzler, NIH Program Manager 10:00 10:15 Break (Exhibit Area) 10:15 12:15 pm Panel Session Strategies for Success Developing a Successful Proposal Agency outlines - funding outside NIH, Application tips, Common proposal mistakes, Review of evaluation criteria How to WIN Department of Defense John R. Williams, Director Navy, SBIR
Office of Naval Research 12:15 1:30 Luncheon Department of Agriculture Dr. Charles Cleland, SBIR Program Manager Department of Homeland Security Timothy Sharp, SBIR Program Manager National Science Foundation Dr. Juan Figueroa, SBIR, Program Manager Moderator: Dr. Terry L. Payne, Director of Economic Development, Oak Ridge National Laboratory, Department of Energy, Oak Ridge, TN SBIR legislative outlook, its historic growth and influence Jere Glover,Esq. Brand and Frulla, Washington, DC 1:30 2:00 Managing Your Intellectual Property Learn how to identify, value and protect your IP; pick up tips and practical information for your business Ajay A.Jagtiani, Esq. Owner, Jagtiani + Guttag, Fairfax, VA 2:00 2:30 Managing Your People and Time Learn how to build a business organization from a jack-of-all Trades (you) to a sophisticated management team Chris Busch, SBIR Circuit Rider, Ronan, MT, pioneer in rural SBIR Outreach, founder of small high tech business, won Numerous SBIR awards, sold to large entity, and testified before Congress for SBIR 2:30 2:45 SBIR Networking (Exhibit Area) Spotlight on VA, NC, WV (concurrent sessions) State and Regional Services Available to small business firms for Small Business Innovation Research and other federal Research and Development. Office time w/program managers, scheduled in parallel with state presentations Virginia 2:45 4:00 State and Regional Services available to small businesses for Small Business Innovation Research and other Federal Research and Development The Center for Innovative Technology, Robert Brooke, Director Federal Funding Programs
PTAP 4:00 6:00 Virginia Universities Research and business education resources in support of Virginia SBIR companies Changing prospective of colleges and Universities in high tech economic development and visions for the future Virginia Tech: Dr. James Blair, Vice Provost for Research, VT Blacksburg, VA Dr. Tracy Wilkins, President, TechLab, Blacksburg, VA Business School, Blacksburg, VA University of Virginia: Dr. John C. Herr, Director, Department Cell Biology, Charlottesville, VA Bobbe Nixon, Biomedical Engineering, Director of internships and Outreach, Charlottesville, VA James Madison University, Kenneth F. Newbold, Jr Associate Director, Institute for Infrastructure and Information Assurance Harrisonburg, VA VCU: Dr. Frank Macrina, Vice President, Research, Richmond, VA (invited) William & Mary: School of Business North Carolina 2:00-2:30 NC SBTDC Services Overview John Ujvari, SBIR Program Specialist, NC SBTDC, Raleigh, NC 2:30 3:00 The State of Technology Businesses in NC Dr. Robert McMahan, NC Board of Science & Technology, Senior Science Advisor to the Governor 3:00 3:15 SBIR Networking 3:15 3:45 Commercialization of Technology the first steps Dr. Mary Beth Thomas, Technology Development and Commercialization Specialist, NC SBTDC, Raleigh, NC 3:45 4:15 The link between Manufacturing and R&D in NC
Bion Schulken, Technology and Manufacturing Specialist, NC SBTDC, Raleigh, NC West Virginia 2:00 3:00 State and Regional Services available to small businesses for Small Business Innovation Research and other Federal Research and Development 3:00 3:15 SBIR Networking 3:15 5:15 Panel: WV Universities Changing Perspectives of Universities of high technology economic development and visions for the future Marshall University Spotlight on Successful West Virginia organizations Thursday, March 23, 2006 8:00 9:00 SBIR Networking 9:00 10:30 Role of SBIR in Successful Companies Dr. Kent Murphy, President, CEO, Luna Innovations, Blacksburg/Roanoke, VA Dr. Richard Martin, Defense Holdings, Inc (the idea company) Arlington, VA Dr. Chris Busch, President/Founder, Spectron Development Laboratory, Palos, Verdes, CA Moderator: Ritchie B. Coryell, Retired NSF Program Manager 10:30 11:00 Business Strategies and Planning for Scientists Bridging the gap in thinking between Entrepreneur & Researcher Gain insight as to how a business/ strategic plan can be your roadmap to commercialization Dr. Robert McMahan, NC Board of Science & Technology, Senior Science Advisor to the Governor, Raleigh, NC 11:00 11:30 Financial Options: Alliances, Partnerships Tim Janke, Inception Micro Angel Fund, Raleigh, NC Jeffery K. Mitchell, Esq. LeClair Ryan, Blacksburg, VA Daniel Barchi, President, Carilion Biomedical Institute Webb Burns, Director of Mergers/Acquisitions and
Business Development, Carilion Labs, Roanoke, VA Moderator: Dr. Robert McMahan, NC Board of Science & Technology, Senior Science Advisor to the Governor 11:30 11:50 Planning, Planning, Planning, Planning Who decides the future of your company? Ritchie B.Coryell, Retired NSF Program Manager, Centreville, VA 11:50 Adjourn