Welcome! NACUA 2006 Fall CLE Workshop

1:00 pm - 1:15 pm	Introduction to the Program Georgia Yuan, President, NACUA, General Counsel and Assistant to the President, Smith College Kathleen Curry Santora, CEO, NACUA Andrew Hughey, Chair, NACUA Legal Education Committee, General Counsel, Central State University
1:15 pm - 2:30 pm	01. Recent Developments in Research Roundtable: Statutes, Cases, New and Proposed Regulations Patent reform legislation Economic development pressures on universities: "bench-to-bedside" Institutional and individual conflicts of interest and financial disclosure Science and security *BIS export control advisory and Deemed Export Advisory Committee (DEAC) Moderator: Beth E. Cate, Indiana University Speakers Robert Hardy, Director, Contracts and Intellectual Property, Council on Governmental Relations (COGR), Washington, DC Geoff Grant, National Science Foundation, Washington, DC Robert E. Bienstock, Yale University
2:30 pm - 2:45 pm	Break
2:45 pm - 4:00 pm	02. The Rainbow of Research Misconduct: Analyzing the Spectrum Defining research misconduct Addressing allegations of misconduct that fall outside the regulatory definition Managing research misconduct investigations Recent cases Moderator Barbara Shiels,University of Minnesota Speakers Alex Dreier, Hogan & Hartson, Washington, DC Christopher M. Patti, University of California

4:15 pm - 5:30 pm	03. Legal Ethics and the Culture of Research Compliance Surviving government investigations with the privilege intact Disclosure obligations Management and review of documents Role of counsel in research compliance *Role of training in effectuating compliance Moderator: Ann Adams, The George Washington University, Washington, DC Speakers Steven S. Dunham, Johns Hopkins University Joanne M. McDevitt, University of Colorado, Boulder
6:00 pm - 7:30 pm	Reception for Workshop Registrants and Presenters
Thursday, November 16
8:00 am - 9:15 am	*04A. Yours? Mine? Ours? Research Collaborations and Drafting Effective Intellectual Property Sharing Agreements* Inter-institutional agreements International agreements Materials Transfer agreements CREATE Act documentation Shared facilities Joint employees Moderator: Judith E. Leonard, University of Arizona Speakers Beth Lynn Maxwell, University of Texas System Terence P. McElwee, University of Georgia Research Foundation Robert E. Bienstock, Yale University
8:00 am - 9:15 am	Human Subject Research Track 04B. IRB Issues Consent form issues: injury compensation, COI, and more Monitoring, investigating and reporting adverse events and non-compliance to OHRP or FDA Assurances – scope and alternatives Centralized IRBs *Registration and accreditation Speakers Mary Ellen Sheridan, Associate Vice President for Research, University of Chicago Julia Hesse, Ropes & Gray, Boston, MA
9:15 am - 9:30 am	Break
9:30 am -10:45 am	Research Compliance Track 05A. Tax-Exempt Bond Financed Facilities Regulating, monitoring and measuring private use MTA restrictions on private business use Shared facilities Loaned employees Moderator Russell Herron, University of Chicago Speakers Nancy Burke, Chapman & Cutler, LLP, Chicago, IL Bertrand M.Harding, Law Offices of Bertrand M. Harding, Alexandria, VA
9:30 am -10:45 am	Human Subject Research Track 05B. Human Stem Cell Research Creating a framework -- one public, one private -- for doing hESC research Opportunities, quicksand, getting sideswiped, achieving results *Challenging policy questions Moderator Stephanie Gold, Hogan & Hartson Speakers Harriet Rabb, Rockefeller University Geoffrey Lomax, Ph.D., California Institute of Regenerative Medicine, San Francisco,CA
10:45 am - 11:00 am	Break
11:00 am - 12:15 pm	Discussion Groups
	*06A. Export Control Issues* Mark A. Bohnhorst, University of Minnesota *06B. Research, Technology Transfer and Insider Trading* *06C. Open Records Acts and Sponsored Research* Beth E. Cate, Indiana University *06D. Conducting Sponsored Research Abroad* Russell J. Herron, University of Chicago *06E. Conflicts of Interest in Sponsored Research and Technology Transfer* Susan Ehringhaus, Association of American Medical Colleges Mary Ellen Sheridan, Associate Vice President for Research, University of Chicago
12:15 pm - 1:30 pm	Luncheon
1:30 pm - 2:45 pm	Intellectual Property Track 07A. Patent Law and Litigation Developments Process and business method patents, generally and related to on-line education tools Injunctive relief after eBay v. MercExchange Patentability of early stage developments USPTO developments and proposed rule changes Proposals and prospects for patent law reform Update on patent infringement claims and licensing requests in the wake of Duke v. Madey Update on influence of Knorr-Bremse Federal Circuit decision on adverse inferences Forthcoming Supreme Court review of obviousness standards: KSR International v. Teleflex Forthcoming Supreme Court review of declaratory judgment actions by patent licencees: MedImmune v. Genentech* Moderator: Harold Evans, William & Anderson, PLC, Little Rock, AR Speakers Gina Carter, Whyte, Hirschboeck, Dudek, S.C., Madison, WI Alan Gorman, Merchant & Gould, Atlanta, GA
1:30 pm - 2:45 pm	Sponsored Research Track 07B. Enforcement of Federal Grant Accounting Overview of recent Federal enforcement actions What is it like to experience an enforcement action? What can we learn from the experiences of others? Effort reporting and other favorite subjects of enforcement authorities Speakers Robert Kenney, Hogan & Hartson, Washington, DC David Kennedy, Director, Costing Policies and Studies, Council on Governmental Relations (COGR), Washington, DC
2:45 pm - 3:00 pm	Break
3:00 pm - 4:15 pm	Intellectual Property Track 08A. Open Source Software and University Research and Technology Transfer Tracking use of open source software and the complications of bundling Hidden licensing issues, restrictions and requirements Open source v. commercialization strategies The consequences of leaving faculty to their own devices--or--the costs of failing to have an institutional policy on open source licensing *Sponsor terms affecting contribution of software developments to open source projects Moderator: Madelyn Wessel, University of Virginia Speakers Karin Rivard, Massachusetts Institute of Technology Karen Copenhaver, Choate, Hall & Stewart, LLP, Boston, MA
3:00 pm - 4:15 pm	Sponsored Research Track 08B. Industry Sponsored Research National initiatives to improve U/Industry research contracting Developing strategic relationships Working with pharma--their studies; investigators' studies Revising standard IP terms--changing your basic deal; deciding when to back off from your basic deal Speakers Mark Bohnhorst, University of Minnesota Karen Mullin, Boston University Ann Hammersla, Massachusetts Institute of Technology
4:15 pm - 4:30 pm	Break
4:30 pm - 5:30 pm	*Discussion Groups*
	*09A. Issues Surrounding Departing Research Faculty* *09B. Open Source Software and University Research and Technology Transfer* Karin Rivard, MIT Karen Copenhaver, Choate, Hall & Stewart LLP *09C. Patent Litigation and Patent Reform Proposals* Harold Evans, William & Anderson, PLC, Little Rock, AR Gina Carter, Whyte, Hirschboeck, Dudek, S.C., Madison, WI Alan Gorman, Merchant & Gould, Atlanta, GA *09D. Research-related Injuries and Medicare Billing Issues* Julia Hesse, Ropes & Gray *09E. In Defense of Research: Animal Law and Your Institution* The movement by animal rights organizations to change laws affecting colleges and universities Serving as a legal resource for scientists under siege Impact on individual researchers Helping institutions weather animal rights activists Steve Michael, Vice President & General Counsel, Policy Directions Inc. Randall Nelson, PhD, Professor, Department of Anatomy and Neurobiology, The University of Tennessee College of Medicine Barbara Shiels, University of Minnesota
Friday, November 17
8:30 am - 9:45 am	10. Negotiations with Private Industry Sponsors and Research Partners: Finding a Happy Medium Intellectual property clauses Indemnification and research injury clauses Confidentiality and publications clauses Other contentious clauses Speakers Linda S. Feuster, University of Pittsburgh Michael Lapin, Legal Counsel, Philips Medical System Ken Leppert, Microsoft Corporation
9:45 am - 10:00 am	Break
10:00 am - 11:15 am	11. Beyond the Basics: Experts on Export Controls Discuss Emerging Issues, with Applied Case Studies Developments in DC: Commerce, DoD, Homeland Security, Deemed Export Advisory Committee, etc. Bio issues: export implications of select agent rules, of National Science Advisory Board on Biosecurity publication recommendations Handling international collaborations, establishing international centers "Hot" technologies where you may need licenses: nano, space, others Speakers Jamie Lewis Keith, University of Florida Richard Johnson, Arnold & Porter, Washington, DC Robert Hardy, Director, Contracts and Intellectual Property, Council on Governmental Relations (COGR), Washington, DC
11:15 am - 11:30 am	Break
11:30 am - 12:30 pm	12. Facilitating a Faculty Start-Up from Start to…..A Case Study Speakers Gregory Brown, University of Minnesota Mark Crowell, Associate Vice President for Economic Development and Technology Transfer, University of North Carolina--Chapel Hill
Adjourn