02A. Taming the MTA Monster - Policies and Practices to Manage the Effective Transfer of Materials

Time: 2:45 PM - 4:00 PM  Room Location: Blue Room   Session Type: Panel Discussion

• Dealing with difficult IP terms
• Take-it-or-leave-it terms (e.g., foreign law)
• Indemnification provisions
• Tactics to improve tracking MTAs
• Other problematic provisions

Dianne Archer, Speaker
Coordinator - Private Contracts & Grants, University of California

Fletcher Fairey, Moderator
Associate University Counsel, University of North Carolina at Chapel Hill

Cathy Innes, Speaker
Director of the Office of Technology Development, University of North Carolina at Chapel Hill

BethLynn Maxwell, Speaker
Senior Attorney, The University of Texas System

Kathy Schutt, Speaker
Licensing Associate, Office for Technology Development, The University of Texas Southwestern Medical Center

02B. Conducting Research Overseas: Setting Up Operations and Regulatory Compliance

Time: 2:45 PM - 4:00 PM  Room Location: Congressional A & B   Session Type: Regular

• Establishing a legal presence overseas: foreign registration, memoranda of understanding, tax exemptions, special purpose entities, and liability protection
• Meeting expectations of federal sponsors and monitoring compliance remotely
• Understanding roles of institutional review board and ethics committees in oversight of human subjects research overseas
• Complying with local laws, regulations, policies and customs in the conduct of human subjects research overseas

William Ferreira, Speaker
Hogan & Hartson LLP

Gerianne Sands, Speaker
Associate General Counsel, Fred Hutchinson Cancer Research Center

Edward Silver, Moderator
Associate General Counsel, Columbia University

03A. Reporting Non-Compliance in Human and Animal Subjects Research: Best Practices

Time: 4:15 PM - 5:30 PM  Room Location: Blue Room   Session Type: Regular

• Regulatory overview of reporting requirements for OHRP, FDA, OLAW, USDA and OBA
• What is a reportable event? Who makes the determination? Who makes the report? When do you report? What do you include in the report?
• Risks of under-reporting and over-reporting
• Reporting requirements for accrediting bodies

Theresa Colecchia, Speaker
Associate General Counsel, University of Pittsburgh

Barbara Shiels, Moderator
Associate General Counsel, University of Minnesota

Eric Swank, Speaker
Research Compliance Advisor, Indiana University

03B.  Monetizing Assets: The Sale of Patents and Royalty Streams

Time: 4:15 PM - 5:30 PM  Room Location: Blue Room   Session Type: Panel Discussion

• Establishing value of R & D patents
• Negotiating transactions
• Current status of the intellectual property marketplace
• Intellectual property patent auctions

Rangar Olson, Speaker
Associate, Ocean Tomo, LLC

Paul Reidy, Speaker
Intellectual Ventures, Inc.

Arjun Sanga, Moderator
Associate Vice Chancellor for Research and Technology Transfer, The University of Texas System

04A. Investigator Initiated Studies-INDs and IDEs: Who Holds the Responsibility and How to Manage the Risk

Time: 8:00 AM - 9:15 AM  Room Location: Blue Room   Session Type: Regular

• When to obtain an IND or IDE
• Sponsor responsibilities under an IND or IDE
• Clinical investigator responsibilities under an IND or IDE
• IRB responsibilities under an IND or IDE
• Sponsor, clinical investigator and IRB non-compliance in FDA warning letters-common regulatory failures
• Effective habits of sponsors and clinical investigators to avoid regulatory correspondence

Judith Leonard, Moderator
Vice President for Legal Affairs and General Counsel, University of Arizona

Karena Cooper, Speaker
Regulatory Counsel, Office of Compliance, Center for Drugs Evaluation and Research, FDA

Sonali Gunawardhana, Speaker
Regulatory Counsel, Office of Compliance, Division of Bioresearch Monitoring Center, FDA

04B. Current Patent Legislation and Case Law Update

Time: 8:00 AM - 9:15 AM  Room Location: Congressional A & B    Session Type: Regular

• Origins of the effort at patent reform and the complex perspectives of higher education
• The roles played by the National Academy of Sciences, FTC, AAU, COGR and others
• Will the energy behind efforts at patent reform have implications for other technology transfer legislation (e.g. Bayh Dole)?
• Patent Law Review: A discussion of notable Supreme Court and Federal Circuit decisions in the last year
• Patent Law Perspectives: The impact of USPTO rulemaking and the eBay, Medimmune, and KSR progeny by a patent litigator and a patent prosecutor

Jonathan Fritz, Speaker
Whyte Hirschboeck Dudek, S.C.

Robert Hardy, Moderator/Speaker
Director, Council on Governmental Relations

Jason Sheasby, Speaker
Irell & Manella LLP

05A. Effort Reporting: Best Practices and Recent Enforcement Actions

Time: 9:30 AM - 10:45 AM  Room Location: Blue Room   Session Type: Regular

• Basic principles of effort reporting under OMB Circular A-21
• HHS OIG's proposed guidance on effort reporting
• Lessons learned from NSF's recent stories of comprehensive effort reporting audits
• Enforcement of effort reporting compliance under the False Claims Act
• Avoiding trouble-the role of university counsel

Judith Curry, Moderator
Associate General Counsel, North Carolina State University

David Kennedy, Speaker
Director, Costing Policies and Studies, Council on Governmental Relations

Robert Kenney, Speaker
Hogan & Hartson LLP

05B. Suing for Patent Infringement: Evaluating the Costs and Weighing the Risks and Benefits

Time: 9:30 AM - 10:45 AM  Room Location: Congressional A & B   Session Type: Panel Discussion

•  Anatomy of a patent case
• Handling the decision to commence suit
• Preparing for litigation* Managing the litigation
• Process of settlement* Handling unexpected results

Augustine Cheng, , Speaker
Chief Legal Officer, Arizona Technology Enterprises

Michael Falk, Speaker
Wisconsin Alumni Research Foundation

Jason Sheasby, Moderator/Speaker
Irell & Manella LLP

Terri Lynn Turner, Speaker
Associate General Counsel, Johns Hopkins University

06A. Simplification of Informed Consent Documents

Time: 11:00 AM - 12:00 PM  Room Location: Capitol   Session Type: Discussion Group

Susan Ehringhaus, Associate General Counsel for Regulatory Affairs, Association of American Medical Colleges

06B. Establishing Effective Research Compliance Programs

Time: 11:00 AM - 12:00 PM  Room Location: Embassy   Session Type: Discussion Group

Peter Harrington, Bowditch & Dewey, Worcester, MA

Eric Swank Research Compliance Advisor, Indiana University

06C. Select Agent Research and Biosecurity Concerns

Time: 11:00 AM - 12:00 PM  Room Location: Calvert   Session Type: Discussion Group

Patrick Schlesinger, University of California

06D. Clinical Research Subject Injury: Negotiating Compensation Clauses

Time: 11:00 AM - 12:00 PM  Room Location: Governor's   Session Type: Discussion Group

Karen Mullin, Boston University

06E. Reviewing FAR Clauses: Preferred Clauses for Universities

Time: 11:00 AM - 12:00 PM  Room Location: Forum   Session Type: Discussion Group

Robert Hardy, Director, Council on Governmental Relations

Alex McKeown, Associate Dean for Research Administration, Bloomberg School for Public Health, Johns Hopkins University

06F. Taking Your MTA Tracking and Management System Online

Time: 11:00 AM - 12:00 PM  Room Location: Congressional A & B   Session Type: Discussion Group

Cathy Innes, Director of the Office of Technology Development, University of North Carolina at Chapel Hill

Kathy Schutt, Licensing Associate, Office for Technology Development, The University of Texas Southwestern Medical Center

07A. Drugs and Devices for Unique Situations: Humanitarian, Compassionate and Emergency Use

Time: 1:30 PM - 2:45 PM  Room Location: Blue Room   Session Type: Regular

• Overview of regulatory requirements
• Clarifying confusion between compassionate and emergency use
• Informed consent requirements
• Obligations of physician, IRB, institution, FDA and drug/device company
• Applicability of sponsored research agreements to these unique situations

Stephanie Gold, Moderator, Hogan & Hartson LLP, Washington DC

Wayne Matelski, Speaker
Partner, Arent Fox LLP

Kathleen Meyerle, Speaker
Legal Counsel, Mayo Clinic

07B. Export Control in the Technology Transfer Setting: You Can't License That Over There

Time: 1:30 PM - 2:45 PM  Room Location: Congressional A & B   Session Type: Regular

• Current export controls, sanctions and embargoes
• When over here is "over there": controls on deemed exports
• Special export control issues for technology with military or space applications
• Enforcement trends under U.S. trade controls
• The future of export controls in the technology transfer setting

BethLynn Maxwell, Moderator
Senior Attorney, The University of Texas System

J. Scott Maberry, Speaker
Partner, Fulbright & Jaworski L.L.P.

08A. Protecting Your Animal Research Program: New Risks and New Tactics

Time: 3:00 PM - 4:15 PM  Room Location: Blue Room   Session Type: Regular

• Legal and legislative strategies of animal rights groups
• Legal and legislative strategies of institutions
• Strategies for handling public records requests
• On-campus and off-campus security strategies
• Coordination with law enforcement
• Public relations strategies

L. Amy Blum, Speaker
Campus Counsel, University of California - Los Angeles

Patrick Schlesinger, Speaker
Office of Ethics, Compliance and Audit Services, University of California

Barbara Shiels, Moderator
Associate General Counsel, University of Minnesota

Frankie Trull, Speaker
President, National Association for Biomedical Research

08B. Enforcing the University's Rights in Intellectual Property with Faculty: Case Studies from the Trenches

Time: 3:00 PM - 4:15 PM  Room Location: Congressional A & B   Session Type: Panel Discussion

• Non-disclosure of inventions by faculty members
• Securing faculty compliance with university policies
• Enforcing institutional policies and rights against third parties dealing with faculty
• Federal funding and Bayh-Dole considerations
• Resolving institutional and faculty disagreements re enforcement against alleged infringers

Robert Firestone, Speaker
Associate General Counsel, University of Pennsylvania

Kenneth Hairston, Moderator
General Counsel, Alabama Agricultural and Mechanical University

Steven Rosen, Speaker
Attorney, The University of Texas System

09A. Update on Export Control Regulations Affecting Research

Time: 4:30 PM - 5:30 PM  Room Location: Capitol   Session Type: Discussion Group

J. Scott Maberry, Fullbright & Jaworski

09B. Alternative Structures for the Oversight of Human Subjects Research

Time: 4:30 PM - 5:30 PM  Room Location: Embassy   Session Type: Discussion Group

Stephanie Gold, Hogan & Hartson LLP, Washington DC

Judith Leonard, Vice President for Legal Affairs and General Counsel, University of Arizona

09C. Managing the Risk to the Research Enterprise in Troubling Economic Times

Time: 4:30 PM - 5:30 PM  Room Location: Calvert   Session Type: Discussion Group

Edward C. Dolan, Hogan & Hartson LLP, Washington DC

09D. Tax Implications of Industry Sponsored Research

Time: 4:30 PM - 5:30 PM  Room Location: Governor's   Session Type: Discussion Group

Robert Bienstock, Yale University
Peter Harrington, Bowditch & Dewey, Worcester, MA

09E. Managing Institutional Conflict of Interest-Getting Past the Pretty Words and Enacting a Meaningful Policy

Time: 4:30 PM - 5:30 PM  Room Location: Forum   Session Type: Discussion Group

Susan Ehringhaus, , Association of American Medical Colleges

09F. Complying with the NIH Open Access Requirement

Time: 4:30 PM - 5:30 PM  Room Location: Council   Session Type: Discussion Group

Madelyn Wessel, University of Virginia