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.


Jason Abair is an Associate Vice President at the University of Texas Medical Branch at Galveston (UTMB), where he leads the Office of Technology Transfer. At UTMB, he instituted UTMB's Export Controls Compliance Committee, which oversees activities at the Galveston National Laboratory, a BSL-4 laboratory dedicated to controlling emerging infection diseases and bioterrorism. Prior to joining UTMB, Jason was a senior associate at Weil, Gotshal  & Manges LLP, where he specialized in Hatch-Waxman patent litigation and was involved in successful patent protection of Merck's  Singulair and Temodar pharmaceutical products.  

Ann K. Adams is an Associate Vice President for Research at Northwestern University, overseeing the Institutional Review Board (IRB) Office, the Institutional Animal Care and Use Committee (IACUC) Office, the Office for Research Integrity (ORI) and the Director for Export Compliance. Ann previously served as an Associate General Counsel at The George Washington University and Northwestern University. Ann received her B.A. from Lake Forest College and J.D. from University of Chicago.

Nick Anastasopoulos is a member of the firm’s Labor & Employment and Higher Education practice groups. Nick’s practice includes traditional private- and public- sector labor law, litigation of employment disputes, and counseling on labor, employment and human resource matters. While maintaining a diverse practice, he has developed a significant emphasis on labor relations. Nick regularly counsels clients on traditional labor issues, including union avoidance, election campaigns, collective bargaining and complex contract formation disputes, grievance adjustment and arbitration, unfair labor charges, strikes, picketing, and other work stoppage issues and reduction-in-force planning. Nick regularly counsels colleges, universities and community colleges on a wide range of legal issues. He has appeared before numerous state and federal agencies including the National Labor Relations Board, the Massachusetts Division of Labor Relations, the Occupational Safety and Health Administration, the Equal Employment Opportunity Commission, and the Massachusetts Commission Against Discrimination. Nick has been named a Massachusetts "Rising Star" by Boston magazine and Law & Politics every year since 2006. He was also selected by the Worcester Business Journal as one of “40 Under Forty” young professionals honored for their professional achievements and community service. In September 2010, Nick was appointed by Governor Patrick to the Division of Labor Relations Advisory Council.

Ellen Auriti joined the University of California's Office of General Counsel as Senior Counsel, Educational Affairs and Campus Services in January of 2011. Her practice area focuses on research and research compliance matters. Prior to joining the Office of General Counsel, Ms. Auriti served as the University's Executive Director of Research Policy Analysis and Coordination, directing a unit within the University's systemwide Office of Research responsible for coordinating policy development and for providing legislative, policy, and regulatory analysis and advice on external rules that affect the conduct of academic research. Prior to joining the University, she was an associate in Morrison & Foerster's San Francisco office. Ms. Auriti received her undergraduate degree from Yale University (B.A., summa cum laude, Phi Beta Kappa, 1987), and her law degree from the University of California, Berkeley (Boalt Hall) (J.D. 1993).

Zafrira Avnur, Ph.D., is Global Academic Innovation Partnering Head at Roche Partnering She holds a post doctorate (Cancer Biology) from Stanford University, and a Ph.D. from Weizmann Institute (cell Biology). She was based in Palo Alto, California, USA, from 1987 until 2006, in various positions in the Research and Development area at Roche. Amongst the positions she held are Distinguished Scientist in Roche Bioscience; Disease Area Head for Osteoporosis and Head of Dept. of Musculoskeletal Research. From 2006 she has been based in Basel Switzerland. She held positions of Director of Scientific evaluation and Director of Biomarker Alliances. Zafrira Avnur has published more than 30 peer-reviewed manuscripts and holds a number of patents.

Wayne A. Barlin is the vice president and general counsel of the Wallace H. Coulter Foundation. The foundation’s primary focus is funding translational research in biomedical engineering ongoing at the nation’s universities and medical schools. He joined this entity in January 1999. The foundation is located in Miami, Florida. Prior to this position, Mr. Barlin was Corporate Counsel and Secretary of Coulter Corporation, an integrated medical diagnostic company, also in Miami, having revenues in excess of $700 million. Mr. Barlin joined Coulter in 1978 as a tax attorney. He became corporate counsel in 1981, and was involved in all major company transactions, including the sale of the company to Beckman Instruments, Inc. in October 1997. Prior to joining Coulter, he was in private practice. Wayne holds a BS in finance and accounting from the University of Connecticut and a JD from Georgetown University Law Center in Washington, DC.

Mark Barnes is Senior Associate Provost, University Chief Research Compliance Officer, and Lecturer on Law at the Harvard Law School. For the Harvard AIDS treatment programs in Nigeria, Tanzania and Botswana, he served as executive director during periods from 2004 until 2009, and now serves as the Chair of the University Oversight Committee for that project. Mr. Barnes was formerly a partner at Ropes & Gray LLP, served as the Executive Vice President and Chief Administrative Officer of St. Jude Children's Research Hospital, and has held senior appointed positions in the New York City and New York State Departments of Health. He currently co-chairs the Subcommittee on Harmonization of the HHS Secretary's Advisory Committee on Human Research Protections, which seeks to harmonize FDA, OHRP and other HHS research regulations, and is a member of the Ethics Working Group of the NIH HIV Prevention Trials Network. He also holds a faculty appointment at Yale School of Medicine.

Robert Bienstock is Associate General Counsel at Yale University.  His practice concentrates on research & technology law and private business use.  Previously he served as Deputy University Counsel at the University of New Mexico, heading its research and technology practice group.  Robert has served on the NACUA Board of Directors and has presented on research, technology and tax law topics nationally and internationally.  He received his J.D. from Boalt Hall and his B.S. with highest honors in physics from SUNY at Stony Brook.

Ann Bradley is Associate University Counsel at Duke University where she is responsible for matters involving research integrity, human studies/IRB, research regulatory compliance (effort reporting, grants compliance), industry sponsored research and animal care. Ms. Bradley received her B.S. in nursing, magna cum laude, from Creighton University. She also holds a B.A. in Political Science and Business Management from the University of Northern Iowa, and a J.D. from St. Louis University School of Law.  In her private law practice Ms. Bradley worked for several years in the healthcare group at Armstrong Teasdale LLP specializing in healthcare litigation. She served as Associate General Counsel for Saint Louis University's Health Science Center and as Assistant Vice Chancellor and Associate General Counsel for Washington University in St. Louis.  

Karl F. Brevitz is Director of Legal Resources for NACUA (NACUA) in Washington, DC where he oversees the legal resources and programming of the Association. Prior to joining NACUA he served for 12 years as Director of Education at the Institute of Continuing Legal Education at the University of Michigan Law School, and for six years as college attorney for Ferris State College, a public institution in Michigan. He received his B.A. summa cum laude from Adrian College and J.D. magna cum laude from Wayne State University Law School. He serves as NACUA Staff Liaison to the Committees on Annual Program and Web Page Legal Resources and to the Editorial Board of the Journal of College and University Law; and as co-liaison to the Committee on Legal Education and the NACUANOTES Editorial Board.

Greg Brown has been Associate General Counsel at the University of Minnesota since 1991. His practice focuses on intellectual property transactions. He advises the university's Office for Technology Commercialization on technology licensing transactions. He also counsels the university on copyright, corporate and complex commercial matters. Greg has served on boards of several charitable organizations and is an adjunct professor at the University of Minnesota Law School. Greg is a graduate of the University of Michigan Law School and the University of Michigan Ross School of Business.

Brandon Butler is the Director of Public Policy Initiatives at the Association of Research Libraries (ARL), a group of 126 academic and research libraries in North America. He's been at ARL since September 2009, and in that time has worked on a host of issues ranging from network neutrality to the PATRIOT Act. In the copyright area, Brandon has prepared analysis and commentary on the Google Books Settlement, the Anti-Counterfeiting Trade Agreement, and a wide range of litigation and legislation. He is currently working on a three-year, grant-funded project to develop a code of best practices in fair use for academic and research librarians. Brandon also writes the ARL Policy Notes blog, http://policynotes.arl.org, and tweets from the @ARLpolicy twitter account. Before coming to ARL, Brandon was an associate in the Media and Information Technologies practice group at the Washington, D.C., law firm Dow Lohnes [pronounced "dow low-niss"] PLLC, where he worked on copyright issues, trademark prosecution, and corporate transactions involving intellectual property. Brandon graduated from the University of Virginia School of Law where he was an editor at the Journal of Law and Politics, obtained an M.A. in philosophy from the University of Texas, and did his undergraduate degree at the University of Georgia.

John W. Calkins is Associate General Counsel at Northwestern University, where his principal areas of responsibility include intellectual property, technology licensing, research, information technology, and athletics matters.  Mr. Calkins serves on NACUA's Committee on Legal Education and on its Google Task Force.  He has addressed IP and IT topics and other areas of expertise before a wide range of audiences throughout the country, including NACUA, EDUCAUSE and ICPL programs.      Prior to his appointment at Northwestern in 2005, Mr. Calkins was Counsel at Bingham McCutchen in San Francisco, where he handled intellectual property prosecution, strategic counseling, enforcement, litigation, and transactional matters. He served as co-chair of the Copyright Law Section of the State Bar of California, as Vice President of the California Young Lawyers Association, and on the boards of the San Francisco Intellectual Property Law Association and the Barristers Club of San Francisco.     Mr. Calkins received a B.A. in Biology from Williams College and a J.D. from the University of Virginia School of Law. He is admitted to practice in California and Illinois and before the United States Patent and Trademark Office.

Greg Castanias is an appellate and intellectual property litigator at Jones Day in Washington D.C. with extensive Supreme Court and Federal Circuit advocacy experience. He heads Jones Day's Federal Circuit practice. Greg has now twice argued the Myriad Genetics case before the Federal Circuit, and that court has twice upheld the patent-eligibility of Myriad's composition claims (directed to isolated DNA molecules) and Myriad's central method claim under challenge. He has argued three cases before the Supreme Court, almost 40 in the Federal Circuit, and numerous others across the Nation.

Pam Chen joined the Office of University Counsel at the University of Illinois in 2007 after practicing for six years as a corporate attorney at two Chicago law firms specializing in mergers and acquisitions, corporate finance and governance. Pam is responsible for handling all research related legal matters for the Chicago campus, advising on issues such as human subjects and animal research, research misconduct, and conflict of interest and commitment, as well as negotiating research contracts such as clinical trial agreements, material transfer agreements, confidentiality agreements and research collaboration agreements. Pam received her B.S. in psychology and J.D. from the University of Illinois at Urbana-Champaign, and was a Notes Editor on The Elder Law Journal.

Theresa J. Colecchia is Associate General Counsel at the University of Pittsburgh, where she is primarily responsible for research contract and compliance matters. She received her J.D., magna cum laude, from the University of Pittsburgh in 1989 and her B.S. in Applied Mathematics, magna cum laude, from the University of Pittsburgh in 1986. Ms. Colecchia serves on the Committee on Continuing Legal Education Programs for the National Association of College and University Attorneys, and has served as the Working Group Leader for the Research and Intellectual Property section for the NACUA annual meeting, and as the organizing chair for the fall NACUA research and intellectual property meeting. She is the editor of Legal Issues in Sponsored Research Programs, From Contracting to Compliance, published by NACUA in June of 2005. In 2007, she received the First Decade award from NACUA for her service to the organization. Theresa is presently serving as Vice Chair of the NACUA Committee on Legal Education.

Jim Cox, is Attorney at The University of Texas System in Austin, TX.

Alexander Dreier is a partner in the Washington, D.C. office of Hogan Lovells US LLP and a member of the firm's Education and Health Groups. His practice is focused on advising higher education clients on federal regulatory issues, especially those related to sponsored research, institutional governance, and civil rights. Prior to joining Hogan Lovells, Mr. Dreier was assistant to the provost and adjunct professor of law at the University of Oklahoma and a clerk on the U.S. Court of Appeals for the Tenth Circuit. He has been an active member of NACUA since 1997, and is a frequent speaker on legal developments of interest to colleges and universities. His articles have appeared in such publications as the Chronicle of Higher Education, the Journal of College and University Law, Trusteeship, and Medical Research Law and Policy Report. Alex was counsel to the American Council on Education working group on conflicts of interest and co-author of the Association of Governing Boards publication on trustee conflicts of interest. He received his B.A., magna cum laude, from Harvard University; an M.A. from Oxford University, where he was a Rhodes Scholar; and his J.D. from Yale Law School.

Anna Drummond has been the Chief Compliance Officer and Chief Privacy Officer at the University of Vermont since March of 2010. Prior to that, Ms. Drummond was an associate director in the Office of Investor Education at the Financial Industry Regulatory Authority, the largest independent regulator for all securities firms doing business in the United States. Previously, she was Deputy Commissioner of Securities at the Vermont Department of Banking, Insurance, Securities & Healthcare Administration and was assistant general counsel at the department before that. She also has extensive experience in the financial services industry, in private practice and as in-house counsel. Drummond received her undergraduate degree from Trinity College, University of Toronto, and a law degree from Villanova University School of Law. She also has an LL.M. from the London School of Economics.

Maria A. Garner is an Associate General Counsel in the Office of the General Counsel at Vanderbilt University in Nashville, Tennessee. Ms. Garner previously served as Assistant University Compliance Officer in Vanderbilt's Office of Compliance. Her practice focuses on regulatory compliance in the research enterprise, and she has spoken on research regulatory compliance issues at the Tennessee Bar Association's Health Law Forum. Ms. Garner is a member of the Tennessee Bar Association, and the American Health Lawyers' Association. Ms. Garner received her bachelor’s degree from the University of North Carolina at Chapel Hill, and her law degree from Vanderbilt University, where she was a member of the Order of the Coif. Upon graduation, Ms. Garner practiced law in the corporate and healthcare groups in a full-service, private law firm in Tennessee.

Kimberly Ginn is a Principal with Baker Tilly, an accounting and advisory firm with more than 1,400 personnel nationwide. Kimberly is a leader in Baker Tilly's Higher Education and Research Institutions industry practice. She has more than ten years of experience in assisting organizations to enhance their business processes, reduce costs, design robust and compliant infrastructures, and navigate the myriad federal regulations that affect higher education and research institutions and government contractors. Prior to joining Baker Tilly, Kimberly worked as an internal auditor for the Department of Defense Office of Inspector General, conducting contract, procurement, and environmental audits. Kimberly holds BS degrees from the University of Alabama and University of Alabama-Birmingham and is a Certified Internal Auditor. She participates in, and has been a frequent presenter at, conferences for NCURA, SRA (The Society of Research Administrators), and the Association of College and University Auditors (ACUA), presenting on topics such as audits, grants compliance, fraud investigations, conflicts of interest, effort reporting, and the American Recovery and Reinvestment Act. Kimberly has also co-authored articles on topics including how to work successfully with internal audit as well as risk assessment in sponsored research in the NCURA Magazine and Research Global magazine.

Ann M. Hammersla currently serves as the Director of the Division of Policy at the NIH Office of Technology Transfer. Prior to joining NIH’s OTT, Ms. Hammersla was the Senior Counsel for Intellectual Property at the Massachusetts Institute of Technology. Prior to joining MIT she was the Associate Vice Chancellor for Research at the University of Illinois at Urbana, Illinois with responsibilities for technology transfer, licensing, and industry research agreements. Ms. Hammersla has worked with and has been an advisor throughout her career to many organizations (non-profits, foundations, US and international governments, and industry) on start-ups, consortia, sponsored research, and on technology transfer and licensing issues and policies. In 2004, Ms. Hammersla was President of the Association of University Technology Managers. Ms. Hammersla received her JD from Syracuse University and a Bachelor’s Degree in Economics from the University of Rochester.

Robert B. Hardy is Director of Contracts and Intellectual Property Management at the Council on Governmental Relations (COGR), which focuses on the impact of government policies and regulations on university research. Mr. Hardy has lead COGR responsibility for university issues pertaining to federal contracting and technology transfer policies and regulations. Prior to coming to COGR in April 2001, Mr. Hardy was with the National Science Foundation (NSF) for over 30 years, serving in a variety of capacities, including Special Assistant to the Director and Deputy Director of the Division of International Programs. During the last eight years of his NSF career he served as Director of the Division of Contracts, Policy and Oversight. Mr. Hardy received NSF’s highest honor, the NSF Distinguished Service Award. While at NSF Mr. Hardy served on numerous interagency task forces and working groups and also co-chaired the Federal Demonstration Partnership Membership Committee. He has authored a number of publications on issues related to research administration, intellectual property, and government regulations that affect universities and has made many presentations to university groups such as NCURA, SRA, AUTM, NACUA and NECA. Since coming to COGR Mr. Hardy has focused particularly on government security regulations affecting the conduct of research at universities as well as rights to intellectual property under federal awards. In 2011 he received AUTM’s highest award, the Bayh-Dole Award. Mr. Hardy holds a B.A. degree from Gettysburg College and J.D. from Catholic University, and is a member of the Bars of Maryland and the District of Columbia..

Michael Harte is Associate University Counsel at the University of Illinois in Chicago. Mike joined the Office of University Counsel in November of 2010 and is primarily responsible for advising on matters involving intellectual property and technology transfer. Prior to joining the office, Mike practiced for nine years as an intellectual property litigator with three major law firms in Chicago. Following law school, Mike completed a one year judicial clerkship with a Federal appellate judge. Mike received his undergraduate and law degrees from the University of Notre Dame, and has a masters degree in Physiology from New York Medical College. He is licensed in Illinois and several federal courts, and is a member of NACUA.

Heidi Henning has served as Deputy General Counsel for Howard Hughes Medical Institute (HHMI) since 2006; before that, she had been an Associate General Counsel for HHMI since 1993. She advises HHMI on a wide range of issues and matters. Prior to joining HHMI, she worked at the U.S. Treasury Department, Office of Tax Legislative Counsel, and in private practice in Philadelphia, Pennsylvania where she specialized in tax law. Ms. Henning earned her undergraduate degree from Tufts University, is a graduate of Yale Law School, and served as a law clerk for the Hon. Walter K. Stapleton, U.S. Court of Appeals for the Third Circuit.

Susanne Hollinger is currently the Director of License and Patent Strategy and Chief IP Officer in Emory University's Office of Technology Transfer. Prior to joining the office, Susanne was at the law firm of King & Spalding focusing on patent prosecution and intellectual property counseling. During her tenure at King & Spalding, Susanne assisted a variety of clients in technology evaluation, drafted and prosecuted dozens of US and international patent applications and assisted clients in U.S. and international litigations and opposition proceedings. In connection with investments and acquisitions, she developed strategies for maximizing global intellectual property protection and drafted and reviewed licensing, joint venture and acquisition agreements. Susanne earned her juris doctorate magna cum laude from Georgia State as well as a doctorate in neuroscience from Emory, where her graduate work focused on characterizing molecular and cellular properties of certain newly identified cell signaling proteins. Prior to her graduate research, Susanne also conducted pharmacological studies on extracellular receptors involved in the control of the autonomic nervous system, including drug screening and receptor regulation.  

Casey Inge, is Associate General Counsel for Research and Special Assistant to the Vice President for Research at University of Idaho in Moscow, ID.

Peter Jaszi teaches domestic and international copyright law, as well as law and literature at American University. He also directs the Glushko-Samuelson Intellectual Property Law Clinic and helped to establish the Program on Intellectual Property and Information Justice. Professor Jaszi is a frequent speaker to professional audiences in the United States and abroad. With Craig Joyce, Marshall Leaffer and Tyler Ochoa, he co-authors a standard copyright textbook, Copyright Law (Lexis, 7th ed., 2006). Alone and with Martha Woodmansee, he has written several articles on copyright history and theory; together they edited The Construction of Authorship, published by Duke University Press. In 1994, Professor Jaszi was a member of the Librarian of Congress’ Advisory Commission on Copyright Registration and Deposit, and in 1995 he was an organizer of the Digital Future Coalition. He is a Trustee of the Copyright Society of the U.S.A., and a member of the editorial board of its journal. In 2007, he received the American Library Association’s L. Ray Patterson Copyright Award, and in 2009 the Intellectual Property Section of the District of Columbia Bar honored him as the year’s Champion of Intellectual Property. Since 2005, Professor Jaszi has been working with Professor Patricia Aufderheide of the American University’s Center for Social Media on projects designed to promote the understanding of fair use by documentary filmmakers and other creators. In 2006-07, he led an interdisciplinary research team, funded by the Ford Foundation,that investigated the connections between intellectual law and the traditional arts in Indonesia. He currently serves on the board of ITVS, an important funder of documentary film projects. For the years 2009-2010, Professor Jaszi is serving as the Intellectual Property Scholar of the Center for Intellectual Property at the University of Maryland University College.

David King, is Director, Office of Industry Contracts at University of Louisville in Louisville, KY.

Jennifer J. Kulynych, J.D., Ph.D. is Senior Counsel in the legal department of The Johns Hopkins Hospital and Health System. On behalf of the health system and The Johns Hopkins University School of Medicine, Jennifer advises the investigators, Institutional Review Board (IRB) committees, research policy makers, and research compliance staff within all the entities of Johns Hopkins Medicine. Jennifer’s practice includes human subjects research compliance and policy, privacy and data security, research contracting, and strategic research affiliations. Prior to law school, Jennifer earned a Ph.D. in clinical psychology with a concentration in research neuropsychology, conducting her dissertation research in neuroimaging in the laboratory of Dr. Daniel Weinberger at the National Institute of Mental Health. After graduating with distinction from Stanford Law, Jennifer worked in the health care practice groups of two national law firms (Hogan Lovells and Ropes & Gray). Jennifer also served as regulatory counsel for the Division of Biomedical Research of the Association of American Medical Colleges, where she staffed the AAMC’s Task Force on Financial Conflicts of Interest and drafted AAMC’s two task force reports on financial interests in academic medicine. Jennifer speaks and writes on many topics related to the conduct and regulation of human subjects research; her work has appeared in a number of legal, scientific, and practice-based periodicals, including The New England Journal of Medicine, The American Journal of Bioethics: Neuroscience, The American Journal of Law and Medicine, The American Journal of Psychiatry, The Stanford Law Review, and Jurimetrics.

J. Scott Maberry is head of the International Trade Regulation Practice Group of Sheppard, Mullin, Richter, & Hampton LLC in Washington, DC. He is a recognized legal authority in export controls, economic sanctions, munitions exports, and other areas of international trade relevant to the universities and research institutions. He is a past Chair of the American Bar Association's Committee on Export Controls and Economic Sanctions and the Co-Chair of the ABA National Institute on Economic Sanctions.

BethLynn Maxwell is Senior Attorney and the IP Practice Group Coordinator at The University of Texas System, Office of General Counsel. Dr. Maxwell's major clients are the approximate 40 technology transfer professionals and the approximate 60 research contract specialists employed at the 15 institutions of The University of Texas System. Her current responsibilities include: (a) coordinating disclosure of inventions, patentability searches, filing and prosecution of patent applications, and maintenance of issued patents worldwide between UT institutions and outside patent counsel; (b) supervising legal representation in litigation involving IP issues, particularly patent infringement and related suits; (c) negotiating, drafting, and reviewing a wide variety of IP-related, clinical trial-related and research-related agreements, including master agreements between industrial sponsors and The University of Texas System institutions; (d) training technology transfer professionals and research contract specialists (licensing, negotiating agreements, technology transfer, etc.); (e) planning, organizing and running regular meetings for her technology transfer professional clients and her research contract specialist clients - topics include current issues amongst the groups, conflicts of interest, scientific misconduct, export controls, federal contract issues, certain compliance reporting requirements, etc.; (f) coordinating responses to the Governor's Office for the majority of the State of Texas universities and university systems on research and intellectual property related topics; and (g) providing legal advice in IP and research-related matters. Dr. Maxwell joined the Office of General Counsel in 1997 as a patent attorney. Previously, she was a patent attorney with Fish & Richardson P.C. in Houston; a registered patent agent with Andrews & Kurth, L.L.P. in Houston and a registered patent agent with Arnold, White & Durkee in Houston. She received a Ph.D. in Molecular Biology from The University of Texas Graduate School of Biomedical Sciences and a J.D. from South Texas College of Law.

Sasha Mayergoyz is Partner at Jones Day in Chicago and focuses primarily on patent litigation. His experience includes direct and cross-examination of witnesses at jury and bench trials, successfully arguing and briefing claim construction and summary judgment motions, as well as taking and defending expert, Rule 30(b)(6), and inventor depositions. In addition to his litigation experience, Sasha has served as the principal author of several successful briefs before the Federal Circuit. Sasha is a founding member of the Judge Richard Linn Inn of Courts in Chicago. He has spoken at multiple intellectual property conferences on various issues of patent law and is coauthor of two law review articles addressing the Federal Circuit's patent jurisprudence.

Alexandra A. McKeown is the Associate Dean for Research Administration at the Johns Hopkins University Bloomberg School of Public Health, where she handles matters relating to research activities, compliance and technology transfer. The Bloomberg School is the largest public health school in the world, receiving over 500 million in sponsored projects awards in the last fiscal year. She is a member of the Contracts and Intellectual Property Committee of the Council on Governmental Relations and the Executive Committee of the Federal Demonstration Partnership, and Co-Chairs both the FDP Contracts Task Force and Research Compliance Committee. She is also the immediate past Region II Chair of the National Council of University Research Administrators. Prior to joining the Bloomberg School of Public Health, she was the Assistant Vice President for Research Administration and Advancement at the University of Maryland. She holds a B.A. from Towson University, an M.B.A. from Johns Hopkins University and a J.D. from the University of Baltimore, and is a member of the Maryland State Bar.

Stephen M. McNabb is a partner in the Washington, D.C., office of Fulbright & Jaworski L.L.P. and is head of the firm's International Trade Practice Group. Since joining Fulbright & Jaworski in 1982, Mr. McNabb has counseled clients on compliance with international trade laws and regulations (including regulations administered by the Department of Commerce, the Department of the Treasury's Office of Foreign Assets Control, and the Department of State) and the Foreign Corrupt Practices Act. He also has represented clients in investigations and enforcement matters involving export and sanctions laws and the Foreign Corrupt Practices Act. Mr. McNabb also is a member of the firm's White Collar Practice Group and has represented corporations and their officers, directors, and employees in other types of white collar criminal and related federal enforcement matters. He has represented clients during grand jury and congressional investigations, at trial, and before appellate courts in a wide range of criminal matters. His practice has involved counseling clients on complying with U.S. criminal laws, the organizational sentencing guidelines, and corporate prevention and detection programs. Mr. McNabb also has extensive civil litigation experience before trial and appellate courts in such diverse fields as antitrust, employment, labor relations, torts, civil rights and complex commercial matters. Mr. McNabb is a member of the firm's Appellate Practice Group and has argued cases in several United States courts of appeals.

David J. Monz, a principal in the Environmental Practice Group of Updike, Kelly & Spellacy, P.C. since 1996, concentrates his practice on environmental compliance law, environmental litigation and land use planning and development. Mr. Monz represents both private sector and governmental clients in permitting and enforcement proceedings under, among other laws, the Resource Conservation and Recovery Act, the Clean Water Act, Clean Air Act and the Occupational Safety and Health Act, and has extensive experience in developing environmental compliance and risk management programs. He has also worked closely with various federal, state and local regulatory authorities in connection with the permitting and remediation of a number of innovative Brownfield restoration projects. Prior to joining Updike, Kelly & Spellacy, Mr. Monz served as a judicial clerk for the Honorable Thomas J. Meskill of the United States Court of Appeals for the Second Circuit. He was previously employed by Exxon as a Senior Production Geologist where he was responsible for developing regulatory programs for the evaluation of oil and natural gas reserves. Mr. Monz received his law degree, with high honors, from the University of Connecticut School of Law, where he served as the Articles and Book Reviews Editor for the Connecticut Law Review. Mr. Monz also holds a B.S. degree in geology from Franklin & Marshall College and an M.S. degree in geology from Virginia Polytechnic Institute. A nationally recognized authority in his field, Mr. Monz is a frequent speaker, author of numerous articles on environmental matters and has served in leadership roles within a number of organizations, including as Co-Chairman of the Environmental Law Section of NACUA.

Karen A. Mullin is Chief General Counsel and Director of Corporate Relations at The Forsyth Institute, a non-profit, independent research institute affiliated with Harvard University. She is responsible for all legal matters involving The Forsyth Institute including contracts, compliance, intellectual property, personnel, litigation, and other relevant issues. She is also responsible for the management of Forsyth's technology transfer enterprise, collaborations with industry, and conflict of interest oversight. Prior to her employment at Forsyth, Ms. Mullin worked for eleven years as Senior Research Counsel at Boston University Medical Campus with responsibility for negotiating all research agreements, clinical trial agreements, material transfer agreements and other collaboration agreements with pharmaceutical and medical device companies, as well as managing such relationships with industry on the medical campus. Ms. Mullin also has over eight years of litigation experience, specializing in medical and legal malpractice defense. She was a law clerk to the chief justice of the Pennsylvania Superior Court. She received her JD degree from Georgetown University and her LLM degree from the University of London. She is a member of the Massachusetts, Pennsylvania and District of Columbia bars.

Clinton Neagley is Associate Director of UC Davis InnovationAccess at the University of California, Davis. His responsibilities include patenting and licensing of inventions in the agricultural, biotechnology, chemistry and physical science areas, and assisting academic researchers on the full spectrum of intellectual property matters. Before joining UC Davis, Mr. Neagley was Chief Patent Counsel and Director of Licensing for DNA Plant Technology Corporation (DNAP) in Oakland, California, where he was responsible for intellectual property and technology contracts. At DNAP he managed an extensive patent portfolio, and was responsible for licensing and for freedom-to- operate assessments. Prior to his position with DNAP, Mr. Neagley was a partner with the New York City intellectual property law firm of Davis Hoxie Faithfull & Hapgood, where he engaged in litigation, licensing and patent prosecution, with a focus on biotechnology. Mr. Neagley lectures on patent law topics on a regular basis, and leads a for-credit law school externship program within his office. He is a member of the California Bar and is a registered Patent Attorney. Mr. Neagley has a J.D. from Cornell Law School and a Ph.D. in Chemistry from the UC Davis.

Pearl O'Rourke is the Director of Human Research Affairs at Partners HealthCare Systems in Boston and an Associate Professor of Pediatrics at Harvard Medical School. She is responsible for the systems that support the regulatory and ethical oversight of human research and the responsible conduct of research. She is also Chair of the Partners Healthcare System ESCRO (Embryonic Stem Cell Research Oversight) Committee. Pearl has worked as a pediatric critical care physician at the Children's Hospital, Boston and at the Children's Hospital, University of Washington, Seattle where she was the Director of the Pediatric Intensive Care Unit. She was active in clinical research in extracorporeal membrane oxygenation (ECMO), liquid ventilation, high frequency ventilation and pediatric resuscitation. In Seattle she served many years as a member of the IRB. Pearl has also been involved in international medical care, serving in China and Indonesia with Project HOPE. In 1995-1996, Pearl did a Robert Wood Johnson Health Policy fellowship working for Senator Edward Kennedy. Following this fellowship, she became the Deputy Director of the Office of Science Policy in the Office of the Director at the NIH where she worked on issues such as privacy, gene therapy (transfer) embryonic stem cells, and genetic discrimination.

Missy Peloso is the Director of Export Compliance at the University of Pennsylvania and serves as an empowered official.  She has primary responsibility for managing Penn’s export compliance program and is the primary Penn contact for interactions with the U.S. government on export controls including ITAR, EAR and OFAC licensing. Missy previously served as the Director of Compliance at the University of Delaware, where she implemented the export compliance program. Missy received her B.S. in engineering from Duke University, her M.S. in biomedical engineering from Carnegie-Mellon University, and holds an MBA from the University of Delaware.  

Heather Pierce is Senior Director for Science Policy and Regulatory Counsel at the Association of American Medical Colleges (AAMC). Heather serves as AAMC’s staff leader on scientific issues including clinical research, regulatory compliance, conflicts of interest, and interactions between industry, government, and academia in biomedical research. She is also the program leader for the AAMC’s Forum on Conflict of Interest in Academe. Heather regularly speaks at national conferences on issues related to the protection of human subjects, conflicts of interest, and the regulation of research. She has served on ad hoc committees and task forces convened by organizations including the Institute of Medicine, The Pew Charitable Trusts, the National Dialogue on Healthcare Innovation, and Public Responsibility in Medicine and Research (PRIM&R). Prior to joining AAMC, Heather was an attorney in the Health Care Group of the law firm of Ropes & Gray in New York. Her practice focused on regulatory compliance in medical research and clinical care, working with academic medical centers, hospitals, and pharmaceutical and device manufacturers. She received her law degree from New York University and her MPH in Health Law from Boston University.

Raina Rose Tagle is a Partner with Baker Tilly, an accounting and advisory firm with more than 1,400 personnel nationwide. Raina leads Baker Tilly's national Higher Education and Research Institutions practice. She provides services in the areas of internal audit, financial and operational risk management, construction audit, fraud investigation, technology risk consulting, and organizational governance. In addition to her extensive work with higher education clients, she has served the not-for-profit, government contracting, real estate, health care, and professional services industries. Raina started her career with Arthur Andersen, progressing to serve as a manager in the audit and technology risk consulting practices. Prior to joining Baker Tilly, she served as an interim executive director of several not-for-profit organizations, worked as chief financial officer of a technology consulting firm, and led her own consulting practice that focused on strategic planning facilitation, executive coaching, and organizational development. She holds a Bachelor of Science degree from Oklahoma State University, and is a Certified Public Accountant, Certified Information Systems Auditor, and Certified Internal Auditor. Raina frequently presents at conferences of the Association of College and University Auditors, the National Council of University Research Administrators, and the Society of Research Administrators. Raina has also co-authored articles in the NCURA Magazine and Research Global magazine on topics such as investigating fraud, working successfully with internal audit, and using risk assessment in sponsored research.

Gretta Rowold is Executive Director of Secure Research Operations at The University of Oklahoma, serving as an interface between the University of Oklahoma and the United States Departments of Commerce, State, and Treasury. In this role, she addresses the issues that arise under the Export Administration Regulations (EAR) and the Internal Traffic in Arms Regulations (ITAR), as well as the Office of Foreign Assets Control (OFAC). Additionally, as the FSO, she administers the provisions of the National Industrial Security Program Operating Manual (NISPOM) published by the United States Department of Defense. Prior to joining the University of Oklahoma in 2006, she was employed by Argonne National Laboratory, a Department of Energy laboratory managed by the University of Chicago, in Argonne, IL. She served as an Export Control Analyst in the Security and Counterintelligence Division and also as the laboratory's Material Protection Control & Accounting Export Manager. Rowold earned a Bachelor of Arts in English from the University of Central Oklahoma in 1997 and followed with a Juris Doctor from the University of Oklahoma's College of Law in 2004. She has bar licenses in Oklahoma and Illinois. She currently serves on the board of the Association of University Export Control Officers, and is a member of Society for International Affairs, the American Bar Association's Export Controls and Economic Sanctions Committee, and the Oklahoma Bar Association. She is also a member of the University of Oklahoma's President's Associates Program.

Margaret Sampson, is Partner at Vinson & Elkins LLP in Austin, TX.

Gerianne Sands has served as Associate General Counsel at Fred Hutchinson Cancer Research Center ("Center") in Seattle since 2002. In that capacity, she has provided advice and counsel to Center staff and faculty in the planning and administration of international research and training programs and collaborations. Ms. Sands joined the Center's legal staff having served in various in-house counsel roles for the State University of New York system office and its Stony Brook campus since 1978. She received her J.D. degree from Gonzaga University School of Law and she is licensed to practice in California, New York and Washington.

Joshua D. Sarnoff is a Professor of Law at DePaul University College of Law, where he teaches patent law, advanced patent law, and law and climate change in the Center for Intellectual Property Law and Information Technology. He was previously a professor at the Washington College of Law, American University, in the Glushko-Samuelson Intellectual Property Law Clinic, and at the University of Arizona College of Law. He is a registered patent attorney and a member of the bars of Washington DC and California, a former member of the Board of Governors of the Federal Circuit Bar Association, and a member of the boards of directors and advisory boards of various non-profit organizations. He has written numerous articles and book chapters on patent law and has been involved in a wide range of intellectual property legal and policy disputes. He has submitted testimony on domestic patent law reform bills, has filed numerous amicus briefs in the United States Supreme Court and in the Court of Appeals for the Federal Circuit on important patent law issues, has been a pro bono mediator for the Federal Circuit, and has been a consultant to the United Nations Conference on Trade and Development on international intellectual property, trade, and environmental issues.

Stephen Schaetzel is Principal at McKeon Meunier Carlin & Curfman, LLC in Atlanta, GA. Steve has been involved in more than 100 IP cases, and he has served as lead counsel before both trial and appellate courts. He has appeared before the Northern District of Georgia and has argued complex matters before the Federal Circuit, the Fourth Circuit, the Fifth Circuit and the Eleventh Circuit. Steve is also a skilled and experienced representative before the Trademark Trial and Appeal Board, having been involved in dozens of oppositions and having served as lead counsel for the Applicant in the largest contested registration proceeding ever litigated before the TTAB and the Federal Circuit. Steve has most recently represented the Board of Regents of the University System of Georgia in a copyright case involving issues of electronic reserves and fair use in the non-profit educational context in the Northern District of Georgia (Cambridge University Press et al v Patton et al). Steve has been repeatedly named to The Best Lawyers in America and as a Georgia "Super Lawyer." In addition, he is ranked by Chambers USA and is recommended in the Legal 500 for his strategic portfolio work. Steve previously served as adjunct faculty at the University of Georgia School of Law, where he taught patent law for more than 12 years. He currently serves as adjunct faculty at Emory University School of Law.

Patrick Schlesinger is the Assistant Vice Chancellor for Research Administration and Compliance at UC Berkeley. His office includes Berkeley’s Office for the Protection of Human Subjects, Office of Animal Care and Use, the Conflict of Interest Committee, and the Sponsored Projects Office. The office also provides support to the campus on export control issues. Prior to joining UC Berkeley in December 2008, Mr. Schlesinger served as the systemwide Director of Research Compliance at the UC Office of the President. Mr. Schlesinger joined the University in September 1996 and worked in the Office of the General Counsel. Prior to joining UC, Mr. Schlesinger was a partner in the San Francisco law firm of Landels, Ripley and Diamond and worked as a staff attorney for the U.S. Environmental Protection Agency’s Office of General Counsel and Office of Air and Radiation in Washington, D.C. Mr. Schlesinger received his J.D. from the George Washington University Law School in 1987 and graduated from San Diego State University in 1984 with a Bachelor of Music and majors in Music and American History.

Barbara Shiels is an associate general counsel in the University’s Office of General Counsel. She earned her J.D. from the University of Minnesota Law School, cum laude, and a B.A. from Gustavus Adolphus College, summa cum laude. Ms. Shiels specializes in legal issues related to health sciences and the regulation of research. She serves as legal advisor to the following University of Minnesota bodies: Institutional Review Board, Institutional Animal Care and Use Committee, Individual and Institutional Conflict Review Committees, and University ad hoc panels investigating allegations of scientific misconduct. Ms. Shiels served as associate hospital counsel in the University Hospital and Clinics from 1994 to 1997 prior to the hospital’s merger with the Fairview Health System. She has been active in the National Association of College and University Attorneys (NACUA), where she served as a past Board member, has participated in numerous committees and been a speaker at several regional and national conferences. Ms. Shiels was a past co-chair of the Data Practices Committee of the MSBA Public Law Section.

Paul Stern is Senior University Counsel specializing in intellectual property, technology licensing, and research matters. Prior to joining the University of Florida, Mr. Stern was Associate Counsel for intellectual property and research at the University of Massachusetts system and spent several years in private practice in Michigan working in technology transfer with small companies and university research consortia. He spent the early part of his career working with university scientists and administrators regarding the regulation of biotechnology and genetic engineering research. Mr. Stern earned his Bachelor of Arts degree from the University of Massachusetts Amherst and his Juris Doctor degree from the Florida State University College of Law. He is a member of NACUA and the Association of University Technology Managers.

Jennifer Stillerman has been Associate General Counsel at The George Washington University in Washington, D.C. since August 2010. She previously served as an associate in the Education Group at Hogan Lovells US LLP (formerly Hogan & Hartson LLP) and as a law clerk to the Hon. Leonard B. Sand of the U.S. District Court for the Southern District of New York. Ms. Stillerman received her B.A., summa cum laude, Phi Beta Kappa, from Middlebury College. She graduated cum laude from Harvard Law School, where she was an editor of the Harvard Law Review. She is admitted to practice in the District of Columbia and the State of New York.

Dr. Lawrence M. Sung, J.D., is a Partner with Baker & Hostetler LLP in Washington, DC, where he specializes in biotechnology, pharmaceutical and medical device patent counseling and litigation. He is a registered patent attorney with a Ph.D. in microbiology. He also holds an appointment as a professor and director of the Intellectual Property Law Program of the University of Maryland School of Law. Dr. Sung formerly served as a judicial clerk to (now Senior) Circuit Judge Raymond C. Clevenger, III, of the U.S. Court of Appeals for the Federal Circuit. He has also served as a consultant to the National Human Genome Research Institute and as a member of the National Academies Standing Committee on Emerging Issues and Data on Environmental Contaminants. Dr. Sung has testified before the U.S. House of Representatives Committee on the Judiciary, Subcommittee on Courts, the Internet, and Intellectual Property, on the role of gene patents in research and genetic testing. He is the author of the books The Patent Law Handbook, Medical Device Patents, and Patent Infringement Remedies.   

Eric D. Swank is the Executive Director of Research Compliance at Indiana University. In his current position he has leadership responsibilities for the offices supporting Indiana University's Conflict of Interest Committees, Institutional Biosafety Committees, Institutional Animal Care and Use Committees, and radiation safety committees. He also oversees other research compliance operations, such as export control compliance. He joined IU in 2005 after several years in private practice, specializing in the representation of governmental retirement plans. He is a graduate of St. Olaf College and the University of Michigan Law School.

Juliann Tenney, is Director, Institutional Research Compliance Programs at University of North Carolina at Chapel Hill in Chapel Hill, NC.

Mike Vernick works with numerous colleges, universities, and other nonprofit institutions to help them respond to government audits, Justice Department False Claims Act investigations, and qui tam suits alleging the misuse of federal research funds. He regularly advises research institutions on compliance with Office of Management and Budget Circulars A-21, A-110, A-122, and other sponsor regulations and policies addressing the financial and administrative management of federal research projects. He also advises grantees on matters involving intellectual property rights, financial conflicts of interest, research misconduct, animal care and use, research involving human subjects, handling select agents, and conducting international research projects.

Ms. Madelyn Wessel is Associate General Counsel at the University of Virginia, with a broad practice ranging from intellectual property, copyright, licensing, technology, and libraries, to student affairs, the ADA and civil rights. She has lectured widely on copyright, digital responsibilities, technology transfer, cloud computing, fair use and sensitive data compliance in recent years to groups including NACUA, the Intellectual Property Section of the American Bar Association, the Society for Scholarly Publishing, Art Libraries of North America, College and University Auditors, the Digital Library Federation, and EDUCAUSE. Madelyn teaches the graduate seminar in Legal Issues in Higher Education at the University of Virginia's Curry School of Education. She served as Deputy and later Chief Deputy City Attorney for Portland, Oregon from 1989-2001 and as an Assistant Attorney General and Chief of the Opinions Division, Massachusetts Department of Justice from 1987-1989. She clerked for Associate Justice David Brock of the New Hampshire Supreme Court 1982-1983. Madelyn holds a BA with Honors from Swarthmore College and a J.D. from Boston University and has been admitted to practice in Virginia, Massachusetts, New Hampshire, and Oregon. Madelyn won NACUA's First Decade Award in 2012.    

Richard Wilder is Associate General Counsel of the Bill & Melinda Gates Foundation. Before returning to the private practice of law, Wilder was Director of the Global Intellectual Property Issues Division in the World Intellectual Property Organization (WIPO). There he was responsible for programs dealing with diverse issues, including biotechnology, genetic resources, health care, traditional knowledge, folklore and human rights. Wilder also served in the U.S. Patent and Trademark, Office of Legislative and International Affairs, where he represented the U.S. Government in international negotiations on intellectual property issues. Before his public service, Wilder practiced intellectual property law in corporate and law firm settings. There he advised clients in all areas of intellectual property, sought protection ( including drafting and filing patent and trademark applications), conducted licensing negotiations, and handled dispute resolution involving intellectual property. In the area of dispute resolution, he handled litigated matters both in U.S. Federal Courts and before the U.S. International Trade Commission.

Patricia A. Winger is Vice President and Chief Operating Officer of the Statewide Clinical Trials Network of Texas (CTNeT) Bringing over two decades of experience in oncology clinical research and network management, Patricia Winger incorporates her strong conviction for teamwork into her leadership role as Vice President and Chief Operating Officer of the Statewide Clinical Trials Network of Texas (CTNeT). Appointed in July 2010, Ms. Winger guides the statewide network with extensive operations, strategic planning, and site management experience in both academic and community-based research environments. She has been instrumental in the development of the non-profit oncology research network since its inception and provides senior oversight to its operations. Throughout her career, she has placed emphasis on initiating innovative operational strategies that are efficient, streamlined and collaborative. Prior to CTNeT, Ms. Winger held executive level positions with US Oncology Research (USOR) and most recently, was Vice President of Business Integration for the Sarah Cannon Research Institute (SCRI). Ms. Winger is a long-standing member of the Association of Clinical Research Professionals in addition to the Drug Information Association. She began her career in project management after graduating from Bay State College and quickly integrated her skill set to the medical research field where she has been called “instrumental” in building oncology network programs.