NACUA November 2012 CLE Workshop :: November 14-16, 2012 :: Omni Shoreham Hotel :: Washington D.C.A

NACUA November 2012 CLE Workshop :: November 14-16, 2012 :: Omni Shoreham Hotel :: Washington D.C.


Wednesday, November 14, 2012
1:00 PM – 1:15 PM
Welcome and Introduction to the Program
1:15 PM – 2:30 PM
01. PHS, NSF, and CMS Conflict of Interest and Transparency Rules: Facing the Brave New World of COI Compliance
  • How to craft a rational policy that meets all of the various regulatory requirements, without driving your faculty crazy
  • Key challenges and different institutional approaches to implementing the PHS rules that took effect August 24, 2012
  • Interactions with industry for disclosures under the Physician Payment Sunshine Act
  • Handling overlapping and divergent disclosure requirements

Barbara Shiels, Moderator, Associate General Counsel, University of Minnesota
Robert Bienstock, Associate University Counsel, Yale University
Heather Pierce, Senior Director, Science Policy and Regulatory Counsel, Association of American Medical Colleges
Eric Swank, Executive Director for Research Compliance, Indiana University
2:45 PM – 4:00 PM
02A. Do You Have Title to That Invention? The AIA and Other Issues
  • Understanding and adjusting to the impact of the AIA on university patents
  • Stanford v. Roche: impact and aftermath
  • Mobile faculty
  • Faculty and researcher agreements

Michael Harte, Moderator, Associate University Counsel, University of Illinois
Gregory Brown, Associate General Counsel, University of Minnesota
Susanne Hollinger, Associate Director, Chief Intellectual Property Officer, Emory University
Sasha Mayergoyz, Partner, Jones Day
 
02B. Foundation Sponsorship of Research: Dealing with Donor Expectations
  • The activist foundation
  • Foundations working through intermediary organizations
  • Co-directed foundation centers

Theresa Colecchia, Moderator, Associate General Counsel, University of Pittsburgh
Wayne Barlin, Vice-President & General Counsel, The Wallace H. Coulter Foundation
Richard Wilder, Associate General Counsel in Global Health Program, The Bill and Melinda Gates Foundation
4:15 PM – 5:30 PM
03. Challenges Faced in Innovative Research Collaborations both with Industry and Among Academic Institutions: Does The Collaborative Structure Complicate Rather than Simplify the Legal Issues?
  • Novel structures/alliances for research collaborations between industry and academe: Roche’s Extending the Innovation Network (EIN) Program
  • Special challenges and concerns for clinical research collaborations: Establishing a statewide clinical research model between academia and community; Oncologists in Texas (CTNeT) —  the challenges and opportunities
  • Cooperating with other institutions’ and industries’ policies and committees, e.g., IRBs, IACUCs, AAHRP
  • Shared use of facilities and associated liabilities

Zafrira Avnur, Head, Global Academic Innovation Partnering, Roche Partnering
BethLynn Maxwell, Senior Attorney, The University of Texas System
Karen Mullin, Session Coordinator, Chief General Counsel/ Director of Corporate Relations, The Forsyth Institute
Patricia Winger, Chief Operating Officer, CTNeT
5:30 PM – 6:30 PM
Reception for Registrants and Presenters
Thursday, November 15, 2012
7:00 AM – 8:00 AM
Continental Breakfast
8:00 AM – 9:15 AM
04A. What Happens When a Research Misconduct Allegation Explodes?
  • Managing the roles of the IRB, RIO, and IO when allegations arise
  • Managing civil litigation and/or government investigations during the research misconduct process
  • When standards for addressing research misconduct conflict with other institutional processes
  • Communicating with the governing board, other institutional constituents, the press, and the public
  • Addressing the "human factor"

Alexander Dreier, Moderator, Hogan Lovells US LLP
Ann Adams, Associate Vice President, Office for Research, Northwestern University
Ann Bradley, Associate University Counsel, Duke University
 
04B. Myriad Genetics, Inc. and Mayo v. Prometheus: Are Diagnostics Ever Patentable?
  • What is a "law of nature?"
  • Are method patents for diagnostics dead?
  • Should Universities rethink their approach to patenting in this area for the common good?

Susanne Hollinger, Moderator, Associate Director, Chief Intellectual Property Officer, Emory University
Gregory Castanias, Partner, Jones Day
Joshua Sarnoff, Professor of Law, DePaul University
Lawrence Sung, Law School Professor and Director, Intellectual Property Law Program, University of Maryland School of Law
9:30 AM – 10:45 AM
05A. Interacting with Industry and Foreign Governments on Campus: U.S. Export Controls Applied to Visitors and Shared Spaces
  • Regulatory environment applied to colleges and universities in the U.S.
  • When does fundamental research NOT apply?
  • Identifying and screening potential visitors and activities
  • Contracting considerations
  • Compliance tips

Jason Abair, Moderator, Associate Vice President, Office of Technology Transfer, The University of Texas Medical Branch at Galveston
J. Scott Maberry, Partner, Sheppard Mullin
Missy Peloso, Director, Export Compliance, University of Pennsylvania
Gretta Rowold, Executive Director of Secure Research Operations, The University of Oklahoma
 
05B. Conducting Agricultural Research: Challenges of a Changing Funding Environment
  • The reduction of public funding for agricultural research
  • Managing GMO agricultural research
  • Industry expectations for university research—publication, IP terms, and licensing
  • Preserving germ plasm libraries for future research use

Casey Inge, Associate General Counsel for Research and Special Assistant to the Vice President for Research, University of Idaho
Clint Neagley, Associate Director, Technology Transfer Services, UC Davis Innovation Access, University of California - Davis
Paul Elihu Stern, Senior University Counsel for Intellectual Property & Research, University of Florida
11:00 AM – 12:00 PM
06A. One Institution’s COI Policy: What We’re Doing and How We Decided
  • Discussion Group

Ann Adams, Associate Vice President, Office for Research, Northwestern University
 
06B. Open Access for Scholarly Works: Which Side Is Your Institution On?
  • Discussion Group

Jim Cox, Attorney, The University of Texas System
 
06C. America Invents Act: Impact University Patent Practices and Technology Transfer Offices
  • Discussion Group

Michael Harte, Associate University Counsel, University of Illinois
 
06D. What to Do When It Costs More to Do the Deal Than Turn the Money Down?
  • Discussion Group

David King, Director, Office of Industry Contracts, University of Louisville
 
06E. Comparing NSF and ORI Research Misconduct Investigations
  • Discussion Group

Barbara Shiels, Session Coordinator, Associate General Counsel, University of Minnesota
12:00 PM – 1:30 PM
Networking Luncheon
1:30 PM – 2:45 PM
07A. Biospecimen Research: Ethical, Regulatory, and Contractual Issues
  • The life cycle of a tissue sample: collection, use, and transfer
  • Common Rule ANPRM: implications for bio-specimen research
  • Identifiability of samples
  • Evolving public expectations with regard to use of specimens and results
  • Special issues in genetic research

Alexander Dreier, Moderator, Hogan Lovells US LLP
Jennifer Kulynych, , Johns Hopkins Hospital and Health System
Pearl O'Rourke, Director of Human Research Affairs, Partners Healthcare Systems
 
07B. Research Data Sharing, Security and Preservation: What Is Required and What Are Best Practices?
  • Data security beyond HIPAA
  • Responsible sharing of data and third party requests
  • Public records act requests
  • Subpoenas of research data and documents

Anna Drummond, Moderator, Chief Compliance Officer and Chief Privacy Officer, University of Vermont
Heidi Henning, Deputy General Counsel, Howard Hughes Medical Institute
Madelyn Wessel, Associate General Counsel, University of Virginia
3:00 PM – 4:15 PM
08A. Laboratory Safety (and Liability) in the Research Environment
  • Laboratory safety regulations and enforcement
  • Laboratory safety criminal prosecutions
  • Best practices/model policies

Nicholas Anastasopoulos, Moderator, Partner, Mirick O'Connell
David Monz, , Updike, Kelly & Spellacy
Patrick Schlesinger, Assistant Vice Chancellor - Research Administration and Compliance, University of California
 
08B. Copyright and Internet Depositories: What is the Scope of University Fair Use
  • Code of best practices for university libraries
  • Mandatory deposit of materials created with certain funding streams
  • Google digitalization project and your library
  • Hatha Trust case update
  • Making library materials accessible to disabled patrons

John Calkins, Moderator, Associate General Counsel, Northwestern University
Brandon Butler, Director of Public Policy Initiatives, Association of Research Libraries
Peter Jaszi, Professor of Law, Faculty Director of the Glushko-Samuelson Intellectual Property Clinic, American University
Stephen Schaetzel, Principal, McKeon Meunier Carlin & Curfman, LLC
4:30 PM – 5:30 PM
09A. The UMBTA: Is the Model Still Workable?
  • Discussion Group

Ann Hammersla, National Institutes of Health, Office of Technology Transfer
 
09B. New Models for Industry Sponsored Research
  • Discussion Group

Pam Chen, Session Coordinator, Associate University Counsel, University of Illinois at Chicago
 
09C. Central IRBs and Responsibility for Research Oversight: Clarifying Roles
  • Discussion Group

Maria Garner, Associate General Counsel, Vanderbilt University
 
09D. Clinical Trials, Advanced Problems and Solutions
  • Discussion Group

Karen Mullin, Chief General Counsel/ Director of Corporate Relations, The Forsyth Institute
 
09E. Animal Research in an Atmosphere of Heightened Scrutiny and Reduced Resources
  • Discussion Group

Ellen Auriti, Senior Counsel, University of California
 
09F. Possible Changes to the Common Rule
  • Discussion Group

Juliann Tenney, Director, Institutional Research Compliance Programs, University of North Carolina at Chapel Hill
Friday, November 16, 2012
7:00 AM – 8:00 AM
Continental Breakfast
8:00 AM – 9:15 AM
10A. New Government Restrictions on the Publication of Research Results
  • NSABB policy on dual use research of concern
  • New FAR clause restrictions
  • Recent DoD contract restrictions

Mark Barnes, Senior Associate Provost, University Chief Research Compliance Officer, and Lecturer on Law, Harvard University
Robert Hardy, Director of Contracts and Intellectual Property, Council on Governmental Relations
Alexandra McKeown, Associate Dean for Research Administration, Johns Hopkins University
 
10B. Demystifying the Annual A-133 Audit: What You Need to Know About the Annual Compliance Assessment of Your University’s Research Infrastructure
  • What is the lawyer’s role in the audit?
  • Fallout from findings and recommendations
  • Effect on existing and future business relationships
  • Potential changes arising out of OMB’s grant reform initiative

Pam Chen, Moderator, Associate University Counsel, University of Illinois at Chicago
Kimberly Ginn, Senior Manager, Baker Tilly
Raina Rose Tagle, Partner, Baker Tilly
Michael Vernick, Partner, Hogan Lovells US LLP
9:30 AM – 10:45 AM
11. Legal Ethics in International Research Settings
  • Role of in-house counsel in providing advice to clients with overseas research programs
  • Broad discussion of legal and sponsored research issues affecting overseas research in diverse locations
  • What overseas research activities are likely to trigger legal ethics issues?
  • Ethical obligations in the vetting and selection of local counsel in a foreign jurisdiction
  • Are communications involving foreign jurisdictions protected by the attorney-client privilege?
  • What ethical issues arise when providing advice to faculty and staff about foreign laws?
  • What if you discover a possible Foreign Corrupt Practices Act violation related to overseas research activities?
  • What legal ethics issues arise in the conduct an investigation involving overseas research activities?

Stephen McNabb, Partner, Fulbright & Jaworski L.L.P.
Gerianne Sands, Associate General Counsel, Fred Hutchinson Cancer Research Center
11:00 AM – 12:15 PM
12. Retiring, Departing or Arriving Faculty Members: What Are They Leaving Behind, Taking, or Bringing?
  • Transferring data, tissues and reagents
  • Dealing with environmental issues and disposal
  • Grant transfers, grant compliance and financial issues
  • Litigation with former faculty: recent cases and trends
  • Best practices and checklists

Pam Chen, Moderator, Associate University Counsel, University of Illinois at Chicago
Theresa Colecchia, Associate General Counsel, University of Pittsburgh
Margaret Sampson, Partner, Vinson & Elkins LLP
Jennifer Stillerman, Associate General Counsel, The George Washington University