NACUA Fall 2012 CLE Workshop
College and University Sponsored Research and Technology Transfer: Responding to New Regulatory Requirements, New Funding Expectations and New Challenges

Wednesday, November 14

1:00 PM – 1:15 PM


Welcome and Introduction to the Program

Dana Scaduto, President, NACUA; Dickinson College

Kathleen Curry Santora, Chief Executive Officer, NACUA

Theresa Colecchia, Chair, CLE Committee; University of Pittsburgh


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, University of Minnesota

Robert Bienstock, Yale University

Heather Pierce, Association of American Medical Colleges

Eric Swank, 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, University of Illinois

Gregory Brown, University of Minnesota

Susanne Hollinger, Emory University

Sasha Mayergoyz, 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, University of Pittsburgh

Wayne Barlin, The Wallace H. Coulter Foundation

Richard Wilder, 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, Roche Partnering

BethLynn Maxwell, The University of Texas System

Karen Mullin, The Forsyth Institute

Patricia Winger, CTNeT

5:30 PM – 6:30 PM


Reception for Registrants and Presenters


Thursday, November 15

7:00 AM – 8:00 AM


Continental Breakfast sponsored by LexisNexis


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, Northwestern University

Ann Bradley, 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?

Gregory Castanias, Jones Day

Joshua Sarnoff, DePaul University

Lawrence Sung, 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, The University of Texas Medical Branch at Galveston

J. Scott Maberry, Sheppard Mullin

Missy Peloso, University of Pennsylvania

Gretta Rowold, 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, University of Idaho

Clint Neagley, University of California - Davis

Paul Elihu Stern, 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, Northwestern University


06B. Open Access for Scholarly Works: Which Side Is Your Institution On?

  • •  Discussion Group

Jim Cox, The University of Texas System


06C. America Invents Act:: Impact University Patent Practices and Technology Transfer Offices

  • •  Discussion Group

Michael Harte, University of Illinois


06D. What to Do When It Costs More to Do the Deal Than Turn the Money Down?

  • •  Discussion Group

David King, University of Louisville


06E. Comparing NSF and ORI Research Misconduct Investigations

  • •  Discussion Group

Ann Hammersla, National Institutes of Health, Office of Technology Transfer

Barbara Shiels, University of Minnesota


12:00 PM – 1:30 PM


Networking Luncheon sponsored by Amber Road


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
  • •  Making library materials accessible to disabled patrons

Alexander Dreier, Moderator, Hogan Lovells US LLP

Jennifer Kulynych, Johns Hopkins University

Pearl O'Rourke, 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, University of Vermont

Heidi Henning, Howard Hughes Medical Institute

Madelyn Wessel, 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, Mirick O'Connell

David Monz, Updike, Kelly & Spellacy

Patrick Schlesinger, 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

John Calkins, Moderator, Northwestern University

Brandon Butler, Association of Research Libraries

Peter Jaszi, American University

Stephen Schaetzel, McKeon Meunier Carlin & Curfman, LLC


4:30 PM – 5:30 PM


09A. The UMBTA: Is the Model Still Workable?

  • •  Discussion Group

09B. New Models for Industry Sponsored Research

  • •  Discussion Group

Pam Chen, University of Illinois at Chicago


09C. Central IRBs and Responsibility for Research Oversight: Clarifying Roles

  • •  Discussion Group

Maria Garner, Vanderbilt University


09D. Clinical Trials, Advanced Problems and Solutions

  • •  Discussion Group

Karen Mullin, The Forsyth Institute


09E. Animal Research in an Atmosphere of Heightened Scrutiny and Reduced Resources

  • •  Discussion Group

Ellen Auriti, University of California


09F. Possible Changes to the Common Rule

  • •  Discussion Group

Juliann Tenney, University of North Carolina at Chapel Hill


Friday, November 16

7:00 AM – 8:00 AM


Continental Breakfast


8:00 AM – 9:15 AM


10A. New Government Restrictions on the Publication of Research Results

Mark Barnes, Harvard University

Robert Hardy, Council on Governmental Relations

Alexandra McKeown, 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

Pam Chen, Moderator, University of Illinois at Chicago

Kimberly Ginn, Baker Tilly

Raina Rose Tagle, Baker Tilly

Michael Vernick, Hogan Lovells US LLP


9:30 AM – 10:45 AM


11. Legal Ethics in International Research Settings

Stephen McNabb, Fulbright & Jaworski L.L.P.

Gerianne Sands, 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?

Pam Chen, Moderator, University of Illinois at Chicago

Theresa Colecchia, University of Pittsburgh

Margaret Sampson, Vinson & Elkins LLP

Jennifer Stillerman, The George Washington University