Speakers
Name
Organization
Speaking At
Alexandra Albinak (Discussion Leader)
Johns Hopkins University
04B. Grants Funding Compliance and Research after COVID-19
William Axtman (Discussion Leader)
<div><span style="font-family:'Calibri';font-size:12.00pt;">Bill advises clients on business transactions, with a focus for more than 20 years on domestic and cross-border M&A, divestitures, and joint ventures. He also represents clients in connection with private equity and venture capital investments, significant leasing and licensing transactions, and other complex commercial arrangements. Bill works with clients in a variety of industries, including education, health care, specialty manufacturing, and aerospace. He provides advice on a range of issues, including corporate governance and regulatory compliance.</span></div>
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Jones Day
04C. Hybrid Presentation/Discussion: Promote and Protect: Fostering and Managing University Start-ups
Jonathan Band (Discussion Leader)
<p style="font-size:9.00pt;margin:0.00in;"><span style="font-size:9.00pt;"><span style="font-size:9.00pt;"><b><span style="font-size:9.00pt;">Jonathan Band</span><span style="font-size:9.00pt;"></span><span style="font-size:9.00pt;"></span></b><span style="font-size:9.00pt;"> is the founder of the law firm Jonathan Band PLLC, Technology Law and Policy. He received a B.A., magna cum laude, Phi Beta Kappa, in 1982 from Harvard College, and a J.D. from Yale Law School in 1985. From 1985 to 2005, Mr. Band worked at the Washington, D.C., office of Morrison & Foerster LLP, including thirteen years as a partner. Mr. Band established his own law firm in May, 2005. He is admitted to practice in the District of Columbia and California and before the U.S. Supreme Court and the U.S. Courts of Appeals for the Eighth, Ninth, Tenth, Federal, and District of Columbia Circuits. Mr. Band has worked on the World Intellectual Property Organization’s Copyright Treaty, the Council of Europe’s Cybercrime Convention and Hate Speech Protocol, and several free trade agreements. He has written extensively on intellectual property and electronic commerce matters, including the book Interfaces on Trial: Intellectual Property and Interoperability in the Global Software Industry and over 60 articles. Mr. Band is an adjunct professor at the Georgetown University Law Center, where he teaches a course on the intellectual property legislative process. He is an active member of the American Bar Association y and of the Bars of the Distrito de Columbia and the State of California. Mr. Band has been quoted as an authority on intellectual property and Internet matters in numerous publications, including Clarin (Argentina), New York Times, Washington Post, Los Ángeles Times, USA Today, Forbes, Radio Pública Nacional y en CNN.</span></span></span></p>
Jonathan Band, PLLC / Policybandwidth
04E. Hybrid Presentation/Discussion: Shipwrecks, Small Claims, Software, Service Providers, and Sidney Bechet: Recent Developments in Copyright
Mark Barnes (Moderator)
<div><span style="font-family:'Calibri';font-size:11.00pt;">Mark Barnes is a partner at Ropes & Gray, where his client work focuses on human and animal research, stem cell and genetic research, research fraud, and international research. Mark formerly served at Harvard as the Senior Associate Provost for Research, and in 2004 started and directed for several years Harvard's HIV/AIDS treatment programs in Nigeria, Tanzania and Botswana. He has served as chief administrative officer at St. Jude Children's Research Hospital and has held senior appointed positions in the New York City and State departments of health. Mark is co-chair of the Subcommittee on Harmonization of Research Regulations, HHS Secretary's Advisory Committee on Human Subjects Protections, and is a member of the Ethics Working Group of the NIH HIV Prevention Clinical Trials Network. He is faculty co-chair of the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital, which works with researchers, industry and regulators to improve standards and regulations for clinical trials, with a focus on the emerging economies. Mark teaches health law at Yale Law School.</span><span style="font-family:'Arial';font-size:11.00pt;"> </span></div>
Ropes & Gray LLP
01. Opening Plenary: COVID, the Race for a Vaccine, and the Role of Higher Education Research Institutions
Jacquelyn Bendall (Speaker)
<div><span style="font-family:'Arial';font-size:11.00pt;">Jackie Bendall is the Director of Contracts and Grants Administration (CGA) and supports the work of the CGA Committee of the Board. Prior to joining COGR in October 2014, Jackie had served as the Director of Sponsored Projects Administration and the Director of Research Training and Compliance at The George Washington University. Her career spans 22 years of combined public and private university research administration experience and seven years of contracting experience with the National Aeronautics and Space Administration. Jackie earned her BA from Athens State University in Business Administration and a Masters of Public Administration from Georgia State University.</span></div>
Council on Governmental Relations
09. What Lawyers Need to Know about Research Administration & Clinical Trials
Jack Bernard (Discussion Leader)
<p><strong>Jack Bernard</strong> is an attorney in the Office of General Counsel at the University of Michigan, where he has worked since 1999. His areas of responsibility include intellectual property; student rights; academic freedom, speech, and the First Amendment; privacy; security; computing and cyberlaw; media rights; library, archive, and museum law, and disability law. He is the lead copyright lawyer for the University of Michigan, where he has been at the center of the University of Michigan's HathiTrust service and library digitization project. During the eleven years prior to his legal work, he had been an academic administrator and/or instructor at Macalester College, Saga Daigaku, and the University of Michigan. In addition to teaching Higher Education Law at the University of Michigan's Schools of Law and Education, he teaches at the Michigan's School of Information and the Ford School of Public Policy. In 2009, he received the American Library Association's L. Ray Patterson Copyright Award as well as the First Decade award from NACUA. In 2022, he was named a Fellow of the Association at NACUA. He currently serves on the Editorial Board of the Journal of College and University Law. He has been a Spencer Fellow and a researcher at the National Center for Postsecondary Improvement. He is Chair Emeritus of the University of Michigan's Council for Disability Concerns, where he served as chair for over seventeen years. Jack received his J.D. from the University of Michigan Law School, a Master's in Higher Education from the University's Center for the Study of Higher and Postsecondary Education, and he studied neuroscience at Macalester College.</p>
University of Michigan
04E. Hybrid Presentation/Discussion: Shipwrecks, Small Claims, Software, Service Providers, and Sidney Bechet: Recent Developments in Copyright
Robert Bienstock (Speaker)
<p><strong>Robert Bienstock </strong>is Senior Associate General Counsel at Yale University. His practice concentrates on research & technology. 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. </p><p> </p>
Life Member of the Association
09. What Lawyers Need to Know about Research Administration & Clinical Trials
Larry Bond (Speaker)
Laurence Bond Solicitors
08C. Hybrid Presentation/Discussion: International Trademark Protection: A Practitioner's Guide
Valerie Bonham (Speaker)
<p>Valerie H. Bonham is a graduate of Rice University (B.A.) and the University of Virginia School of Law (J.D.). She is a lawyer and bioethicist with over twenty-five years advising academic health and science organizations, including senior officials in higher education and government.</p><p>Previously, Ms. Bonham served as Vice President & General Counsel at the Kennedy Krieger Institute, Counsel in the national law firm of Ropes & Gray, Senior Attorney at the National Institutes of Health (NIH), and Executive Director for the President’s Commission for the Study of Bioethical Issues. She served also in senior policy positions with the NIH – including Deputy Director in the Office of Research Support and Compliance, Acting Director for Data Sharing, and Senior Advisor in the NIH Director’s office.</p><p>Ms. Bonham is a member of the Board on Life Sciences of the U.S. National Academy of Sciences and a contributor to the Artificial Intelligence Code of Conduct initiative of the National Academy of Medicine. Her expertise includes research security, privacy protection, dual use research, scientific integrity, conflicts, human subjects protection and animal care and use. She is skilled in all areas of the law affecting research and academic health care institutions, including public-private partnerships, transactions, technology transfer, litigation, clinical care and accreditation. She is a member of the Research Compliance and Transactions group in the OGC.</p>
University of Maryland, College Park
10. COVID and Conflicts of Interest: Ethical Issues in Procurement and Research
Sheila Cranman (Speaker)
Georgia Institute of Technology
05. Lessons Learned From Research Activity Outside the U.S.
Carlos del Rio, MD (Speaker)
<div><span style="font-family:'Arial';font-size:11.00pt;">Carlos del Rio, MD is a Distinguished Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine and Executive Associate Dean for Emory at Grady. He is also Professor of Global Health in the Department of Global Health and Professor of Epidemiology at the Rollins School of Public Health. He is also co-Director of the Emory Center for AIDS Research (CFAR) and co-PI of the Emory-CDC HIV Clinical Trials Unit and the Emory Vaccine and Treatment Evalaution Unit. Dr. del Rio is a native of Mexico where he attended medical school at Universidad La Salle, graduating in 1983. He did his Internal Medicine and Infectious Diseases residencies at Emory University. In 1989 he returned to Mexico where he was Executive Director of the National AIDS Council of Mexico (CONASIDA, the Federal agency of the Mexican Government responsible for AIDS Policy throughout Mexico), from 1992 through 1996. In November of 1996 he returned to Emory where he has been involved in patient care, teaching and research. Dr. del Rio was Chief of the Emory Medical Service at Grady Memorial Hospital from 2001 - 2009 and Chair of the Department of Global Health from 2009 - 2019. Dr. del Rio’s research focuses on the early diagnosis, access to care, engagement in care, compliance with antiretrovirals and the prevention of HIV infection. He has worked for over a decade with hard-to-reach populations including substance users to improve outcomes of those infected with HIV and to prevent infection with those at risk. He is also interested in the translation of research findings into practice and policy. His international work includes collaborations in the country of Georgia, Ethiopia, Vietnam, Mexico, Kenya and Thailand. He has also worked on emerging infections such as pandemic influenza and was a member of the WHO Influenza A(H1N1) Clinical Advisory Group and of the CDC Influenza A(H1N1) Task Force during the 2009 pandemic.</span></div>
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<div><span style="font-family:'Arial';font-size:11.00pt;">Dr. del Rio is a Member of the Board of Directors of the International Antiviral Society-USA (IAS-USA) and was a Board member and Chair of HIVMA of the Infectious Diseases Society of America (IDSA). He is also the Chair of the PEPFAR Scientific Advisory Board. He is Chief Section Editor for HIV/AIDS for NEJM Journal Watch Infectious Diseases, Associate Editor for Clinical Infectious Diseases and member of the editorial board of Journal of AIDS and Global Public Health. Dr. del Rio has co-authored 30 book chapters and over 350 scientific papers. In 2013 Dr. del Rio was elected to the National Academy of Medicine and in 2020 was elected as Foreign Secretary of the National Academy of Medicine.</span></div>
Emory University School of Medicine
01. Opening Plenary: COVID, the Race for a Vaccine, and the Role of Higher Education Research Institutions
Mary Jo Dively (Moderator)
<p><b><span style="font-size:9.00pt;"><span style="font-size:9.00pt;"><span style="color:black;font-family:'Open Sans';font-size:12.00pt;">Mary Jo Dively </span></span></span></b><span style="font-size:9.00pt;"><span style="color:black;font-family:'Open Sans';font-size:12.00pt;">has been Vice President and General Counsel for Carnegie Mellon University since 2002, and recently was appointed Corporate Secretary as well. Prior to joining Carnegie Mellon, she was in private practice for nineteen years, most recently as partner in the national law firm, Reed Smith, as head of its Technology, Media and Communications Group. She is a member of the Board of FNB Corporation. She is a member of the American Law Institute; and has served as one of Pennsylvania's appointed Commissioners to the Uniform Law Conference, where she was a member of the Drafting Committee for UPMIFA. Within her local community, Mary Jo has been a member of the Board of Children's Hospital of Pittsburgh since 1994, and chaired that Board for fourteen years, and is a member of the Board of Visitors of the UPMC Health System. She and her husband, Lane, are the parents of triplet boys who are proud alumni of Carnegie Mellon University.</span></span></p>
<div><span style="color:black;font-family:'Open Sans';font-size:12.00pt;">Mary Jo has been a NACUA member since 2002. She has served on the Committee on Legal Education and currently serves as the Vice Chair of the committee. She has also served on the Committee on Program for Annual Conference. She has also spoken or moderated at many sessions of NACUA CLE workshops, Annual Conferences, webinars, General Counsel Institutes and Lawyers New to Higher Education Workshops.</span></div>
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<div><span style="color:black;font-family:'Open Sans';font-size:12.00pt;">Mary Jo received her B.A. and B.S. from the University of Kansas and her J.D. from the Vanderbilt University School of Law.</span> </div>
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Carnegie Mellon University
03. From COVID to COV-Audits and Beyond
Nelson Dong (Speaker)
<p>Prior to his retirement at 12/31/24, Nelson was head of Dorsey & Whitney's national security practice group and regularly advised corporations, private and public universities, other independent research institutions, engineering and medical societies and other organizations around the world on export control, economic sanctions and national security matters and on international technology law issues. He frequently wrote about U.S. export controls and economic sanctions, technology related business transactions between the U.S. and Asian or European countries, international strategic alliances, national security reviews of foreign direct investments in U.S. and outbound U.S. direct investments in other nations, technology companies, university-based technology transfer, academic entrepreneurship, academic conflicts of interest and the financing and organization of high technology businesses. He has lectured on such topics throughout the United States and iin Asia, Europe and Latin America. He has been an adjunct professor of international law at Seattle University School of Law and twice as an export control policy advisor to the U.S. Commerce Department. He has also taught regularly in NACUA CLE programs since 1994. </p><p>Nelson was an Assistant U.S. Attorney in Boston (1980-82); Deputy Associate Attorney General, Department of Justice (1979-80); and White House Fellow and Special Assistant to U.S. Attorney General Griffin B. Bell, Department of Justice, Washington, D.C. (1978-79). He is a graduate of Stanford University (where he has served as a member of its Board of Trustees) and the Yale Law School.</p>
Life Member of the Association
07. Foreign Influence: Focus on China
Nelson Dong (Discussion Leader)
<p>Prior to his retirement at 12/31/24, Nelson was head of Dorsey & Whitney's national security practice group and regularly advised corporations, private and public universities, other independent research institutions, engineering and medical societies and other organizations around the world on export control, economic sanctions and national security matters and on international technology law issues. He frequently wrote about U.S. export controls and economic sanctions, technology related business transactions between the U.S. and Asian or European countries, international strategic alliances, national security reviews of foreign direct investments in U.S. and outbound U.S. direct investments in other nations, technology companies, university-based technology transfer, academic entrepreneurship, academic conflicts of interest and the financing and organization of high technology businesses. He has lectured on such topics throughout the United States and iin Asia, Europe and Latin America. He has been an adjunct professor of international law at Seattle University School of Law and twice as an export control policy advisor to the U.S. Commerce Department. He has also taught regularly in NACUA CLE programs since 1994. </p><p>Nelson was an Assistant U.S. Attorney in Boston (1980-82); Deputy Associate Attorney General, Department of Justice (1979-80); and White House Fellow and Special Assistant to U.S. Attorney General Griffin B. Bell, Department of Justice, Washington, D.C. (1978-79). He is a graduate of Stanford University (where he has served as a member of its Board of Trustees) and the Yale Law School.</p>
Life Member of the Association
08E. Let's Chat About Foreign Influence
Johnna Doyle (Moderator)
<p>I came to the Colorado State University Pueblo in October 2011 after 18 years as a litigation attorney. I am the sole attorney assigned to this campus working within the Colorado State University System Office of the General Counsel. My practice is a general focus on all aspects of higher ed law. </p>
Colorado State University System
02. Keeping it Legal: Compliance, Liability and Safeguards in the Face of COVID
Nilu Ekanayake (Speaker)
<p><strong>Nilu Ekanayake</strong> is an Associate General Counsel at The Ohio State University where she works on matters supporting the university's research enterprise. Prior to joining Ohio State, Nilu worked at Cardinal Health, focusing on healthcare compliance and privacy issues. Earlier, she worked for both The Mount Carmel College of Nursing and the Ohio Attorney General's Office. She has a Bachelor of Science from Ohio University, a Master of Public Health from The Ohio State University and a Juris Doctorate from The University of Cincinnati College of Law.</p>
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The Ohio State University
09. What Lawyers Need to Know about Research Administration & Clinical Trials
Judy Faubert (Speaker)
<div><b><span style="color:#444444;font-family:'serif';font-size:12.00pt;">Judy Faubert</span></b><span style="color:#444444;font-family:'serif';font-size:12.00pt;"> joined Office of Counsel in July 2021, where she advises on research integrity matters, human subjects research protection, research regulatory compliance, research contracting, export controls, clinical trials, animal care and use, and research conflicts of interest.</span></div>
<p><span style="color:#444444;font-family:'serif';font-size:12.00pt;">Prior to joining Duke, Ms. Faubert served as Chief Compliance Officer and Associate University Counsel at The University of North Carolina at Chapel Hill where she served as lead counsel on responding to government investigations regarding sponsored research activities as well as advising on questions related to conflicts of interest, export controls, undue foreign influence, research integrity and grant and cost accounting. Prior to joining UNC-Chapel Hill, Ms. Faubert was in private practice at a major international law firm in Washington, DC, where she assisted university and academic medical center clients in responding to government investigations related to research and advising on research regulatory matters.</span></p>
<p><span style="color:#444444;font-family:'serif';font-size:12.00pt;">Ms. Faubert received her undergraduate degree from Colgate University in 2000 and her law degree from The Catholic University of America, Columbus School of Law in 2006. She has been admitted to the North Carolina Bar and Virginia State Bar.</span></p>
Duke University
10. COVID and Conflicts of Interest: Ethical Issues in Procurement and Research
William Ferreira (Speaker)
<p>Bill Ferreira heads the firm's Global Government Contracts and Education Practice. </p><p>As a leader on government grants, contracts, and international projects, Bill helps companies, universities, hospitals, academic medical centers, and organizations doing business with the U.S. government and abroad.</p><p>Plugged into federal grants and contracts, Bill works extensively on federal award compliance and investigations, domestically and internationally. He guides organizations across the compliance landscape, advising on foreign influence, cost accounting, research misconduct, conflicts of interest, human subjects, False Claims Act matters, and compliance with the OMB Uniform Guidance and Federal Acquisition Regulation. In addition to clinical trial agreements and commercialization initiatives, Bill has handled groundbreaking scientific research collaborations nationally and internationally. </p><p>Drawing on deep experience with global operations, Bill's team has guided campuses in Asia, public health projects in Africa, and academic programs in the Middle East. His work extends to innovative online education and telemedicine programs around the world. On-the-ground practical experience across dozens of countries informs Bill's solutions to the challenges of global regulation, international employment, foreign expansion, and transnational contracts. Bill has guided many of the most dynamic research, development, and academic sites across the globe, including high profile projects in the Global South and the Persian Gulf. </p><p>Bill serves on the firm's Africa leadership team and speaks regularly about strategic issues at the forefront of globalization of higher education, scientific research, and government grants.</p>
Hogan Lovells US LLP
05. Lessons Learned From Research Activity Outside the U.S.
Matthew Fucci (Discussion Leader)
<div><span style="font-family:'Calibri';font-size:12.00pt;">Matt handles a wide variety of transactions relating to MIT's research and education missions, including international and domestic collaborations, agreements related to educational programs and agreements that involve intellectual property. He also provides advice on general business affairs, regulatory and policy matters and corporate governance.</span></div>
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Massachusetts Institute of Technology
04C. Hybrid Presentation/Discussion: Promote and Protect: Fostering and Managing University Start-ups
Sheila Garrity (Discussion Leader)
U.S. Department of Health and Human Services, Office of Assistant Secretary for Health
08B. How to Navigate the Legal Issues Related to Animal Research on Campus
Jen Gartner (Speaker)
<p><strong>Jen Gartner </strong>obtained her degrees from the University of Delaware (B.A., 1998); the George Washington University Law School (J.D., 2001), where she served as Senior Managing Editor of the Public Contract Law Journal; and Norwich University (M.P.A., 2005).</p><p> </p><p>Before joining the University of Maryland in April 2013, Ms. Gartner was the Director of Grants & Contracts and adjunct professor for the University of Colorado Denver's School of Public Affairs (SPA). She is trained as a government contracts attorney and has worked with military, aerospace, and nonprofit contractors for many years, first at the law firm of Morgan Lewis in Washington, DC, and later at the Space Science Institute, home to the NASA's Cassini Imaging Team, in Boulder, Colorado. She continues to teach Administrative Law for SPA.</p><p> </p><p>Ms. Gartner primarily supports the University’s Division of Research, Health Center, and Division of IT.</p><p> </p><p>Her areas of concentration include all facets of sponsored research (contracts, grants, and cooperative agreements), other government and corporate contracts, research compliance, and the Health Insurance Portability and Accountability Act (HIPAA). She serves as a non-voting member of the University's Conflicts of Interest Committees (individual and organizational), Dive Control Board, Institutional Animal Care and Use Committee, Institutional Biosafety Committee, Intellectual Property Committee, Institutional Review Board, and Research Safety Oversight Committee, and as a voting member of the University’s Federal Acquisition Regulation Advisory Group.</p>
University of Maryland, College Park
03. From COVID to COV-Audits and Beyond
Heidi Gertner (Speaker)
<div align=justify><span style="font-family:'Calibri';font-size:11.00pt;"><textobj name=""/></span><b><span style="font-family:'Arial';font-size:11.00pt;">Heidi Gertner</span></b><span style="font-family:'Calibri';font-size:11.00pt;"><textobj name=""/><textobj name=""/></span><span style="font-family:'Arial';font-size:11.00pt;"> is a partner at Hogan Lovells in their drug regulatory group based in the Washington DC office. Heidi began her professional career with a focus on bioethics and law, completing two post-doctoral bioethics fellowships-at the Cleveland Clinic and at the National Institutes of Health. Heidi then worked at the FDA's Office of Chief Counsel for 13 years as a counselor on the “drugs team.” Her main clients were FDA's Center for Drug Evaluation and Research and the Commissioner's Office. At Hogan Lovells Heidi focuses on drug advertising and promotion, combination products, drug safety, clinical trials and human subject protection, IND and NDA related issues, Rx-OTC switches, and OTC drug regulation. She is also an adjunct professor at American University's Washington College of Law. There she has taught Health Law: Bioethics for 15 years.</span><span style="font-family:'Calibri';font-size:11.00pt;"><textobj name=""/></span><span style="font-family:'Arial';font-size:11.00pt;"> </span></div>
Hogan Lovells US LLP
02. Keeping it Legal: Compliance, Liability and Safeguards in the Face of COVID
Stephanie Gold (Speaker)
<div align=justify><b>Stephanie Gold </b>heads Hogan Lovells’ widely recognized Education practice. For 20 years she has worked with universities, colleges, independent schools, education associations, education companies, and investors nationally and around the world to solve a range of legal and regulatory challenges.</div>
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<div align=justify>No matter the context – counseling, transactions, litigation, or government investigations – Stephanie brings to bear her extensive knowledge of legal and regulatory requirements pertinent to education sector clients. She helps clients navigate rules and procedures related to student financial aid, veterans education benefits, military tuition assistance, accreditation, and education licensure. She advises clients on compliance with nondiscrimination laws, campus security requirements, and privacy and data security laws.</div>
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<div align=justify>Stephanie is attuned to education sector dynamics and on top of federal education policy developments. With their mission and culture in mind, she guides clients through distance education initiatives, mergers and acquisitions, cross-border transactions, overseas activities, and institutional reorganizations. She counsels on faculty and student matters, voluntary disclosures to the government, and policy and procedure development. She works to resolve enforcement matters with an approach that fosters positive relationships with regulators.</div>
<div align=justify>Stephanie is a graduate of Brown University and University of Michigan Law School. She is an active member of the National Association of College and University Attorneys, and she regularly speaks and writes on higher education law developments.</div>
Hogan Lovells US LLP
12. Foreign Affairs: Foreign Gift and Contract Reporting for Colleges and Universities
Alyssa Greenwald (Discussion Leader)
<p><strong>Alyssa B. Greenwald </strong>is a Senior Associate General Counsel at Yale University. Her work focuses primarily in the practice areas of Business Transactions, Corporate Governance, Health Law, International & Immigration Law, and Research Compliance. Previously, Ms. Greenwald was a white collar criminal defense associate at Kirkland & Ellis LLP. She received her B.A. with distinction from Yale University, her J.D., cum laude, from Duke Law School, her LL.M. in International & Comparative law from Duke Law School, and her M.A. in Political Science from Duke Graduate School. Following law school, she clerked for Judge James P. Jones of the Western District of Virginia.</p>
Yale University
04D. Export Controls Law and Cross-Border Collaborations: Navigating Compliance
Margaret Hamburg, MD (Speaker)
<div><b><span style="color:black;font-family:'sans-serif';font-size:12.00pt;">Dr. Margaret Hamburg</span></b><span style="color:black;font-family:'sans-serif';font-size:12.00pt;"> is an internationally recognized leader in public health and medicine, and currently serves as foreign secretary of the National Academy of Medicine. She is a former Commissioner of the U.S. Food and Drug Administration (FDA), having served for almost six years. As FDA Commissioner she was known for advancing regulatory science, streamlining and modernizing FDA’s regulatory pathways, and globalization of the agency. Before joining FDA, Hamburg was founding vice president and senior scientist at the Nuclear Threat Initiative. Previous government positions include Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, Health Commissioner for New York City, and Assistant Director of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.</span></div>
<p><span style="color:black;font-family:'sans-serif';font-size:12.00pt;">As Foreign Secretary of the National Academy of Medicine, the health arm of the National Academy of Sciences, Engineering and Medicine, Hamburg served as senior advisor on international matters and is the liaison with other Academies of Medicine around the world. She served as President of the American Association for the Advancement of Science (AAAS), as well as an elected member of the Council on Foreign Relations and the National Academy of Medicine. Hamburg has been a member of the boards of the Commonwealth Fund, the Simons Foundation, the Urban Institute, the Global Alliance for Vaccines and Immunization, the Parker Institute for Cancer Immunotherapy and the American Museum of Natural History. She is chair of the Joint Coordinating Group for the Coalition for Epidemic Preparedness and Innovation, and a member of the Harvard University Global Advisory Council, the Global Health Scientific Advisory Committee for the Gates Foundation, the Harvard Medical School Board of Fellows, and the World Dementia Council.</span></p>
<p><span style="color:black;font-family:'sans-serif';font-size:12.00pt;">Hamburg earned her B.A. from Harvard College, her M.D. from Harvard Medical School and completed her medical residency at Weill Cornell Medical Center. She is the recipient of multiple honorary degrees and numerous awards.</span></p>
U.S. Food and Drug Administration
01. Opening Plenary: COVID, the Race for a Vaccine, and the Role of Higher Education Research Institutions
Robert Hardy (Moderator)
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<p style="font-size:9.00pt;margin:0.00in 0.00in 0.10in 0.00in;"><b>Robert B. Hardy</b> 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..</p>
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Council on Governmental Relations
12. Foreign Affairs: Foreign Gift and Contract Reporting for Colleges and Universities
Amy Hass (Speaker)
<div><b><span style="font-family:'Segoe UI';font-size:10.50pt;">Amy Meyers Hass</span></b><span style="font-family:'Segoe UI';font-size:10.50pt;"> serves as the Vice President and General Counsel for the University of Florida, overseeing the legal affairs of the University and its affiliated entities. Her duties include representing and advising the University on legal matters relating to governance, research, constitutional issues, athletics, international endeavors, litigation and governmental investigations. Prior to joining the Office of the Vice President and General Counsel in 2006, Amy was a litigator with Sutherland Asbill & Brennan LLP (now Eversheds Sutherland LLP) in Atlanta and New York where she represented financial services companies and individuals in a wide range of government enforcement proceedings, civil litigation, white collar criminal defense, and internal corporate investigations. </span></div>
<div><span style="font-family:'Segoe UI';font-size:10.50pt;">Amy graduated, with honors, from the University of Florida Levin College of Law and earned her undergraduate degree from Furman University where she was a member of the women's soccer team. Amy serves on the AAU General Counsels Committee, is a frequent presenter at national conferences, and has previously served on the Florida Bar's Education Law Committee and on the Editorial Board of the Journal of College and University Law.</span></div>
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University of Florida
11. Emerging Issues in False Claims Act Enforcement: The Latest Causes for Concern
James Keller (Discussion Leader)
<div><span style="font-family:'Calibri';font-size:11.00pt;"> </span> <u><b><span style="font-family:'Calibri';font-size:12.00pt;">Jim Keller: </span></b></u><span style="font-family:'Calibri';font-size:11.00pt;">James (Jim) A. Keller, Partner and Chair of Saul Ewing Arnstein & Lehr's Higher Education Practice, defends colleges and universities and advises them on critical issues of compliance, policy, and liability. Jim has led teams in both proactive and reactive internal investigations across a wide swath of higher education compliance and risk management issues, including compliance with the Clery Act, Title IX, student deaths, hazing, sexual assault, and alcohol abuse and use on campus. Jim has also provided Title IX training and presentations across the country and is actively defending civil actions that include Title IX claims. Jim also serves as general counsel to several colleges and universities that do not have inside counsel.</span></div>
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Saul Ewing LLP
04A. PREP Act and COVID: Are you PREPared?
David King (Moderator)
<div><b><span style="font-size:11.00pt;">David King </span></b><span style="font-size:11.00pt;">was appointed Senior Associate University Counsel in May 2018 after serving as Associate University Counsel since September 2013. He focuses on research administration, technology transfer and research compliance matters in support of the offices of the Executive Vice President for Research and Innovation as well as support for information security, data privacy and distance education. Previously he served as Director of the Office of Industry Contracts since its inception in 2001 and Assistant University Counsel. He held various positions with Information Technology at UofL prior to his move to research administration in August 2000. Additionally, he is an adjunct professor in the Speed School of Engineering teaching a Computer Engineering and Computer Science course highlighting legal and ethical issues relative to cyberspace. He holds a Bachelor of Science in Applied Mathematics and a Master of Engineering in Computer Science as well as his Juris Doctor. He is a member of the Association for Computing Machinery, the Louisville Bar Association, Kentucky Bar Association, American Bar Association, National Council of University Research Administrators (NCURA), Society of Research Administrators International (SRA), Association of University Technology Managers (AUTM) and NACUA. He has spoken at MAGI Clinical Research Conferences and SRA regional meetings and annual conferences. He currently serves as co-chair of the Research Law Track for SRA annual meetings. He served on the Planning Committee for the NACUA Fall 2016 and Fall 2018 Workshops, and NACUA’s Committee on Legal Education. He was honored by SRA with a three year designation as a Distinguished Faculty at the October 2013 SRA annual meeting in New Orleans and a 3 year renewal of Distinguished Faculty status at the October 2016 annual meeting in San Antonio.</span></div>
University of Louisville
09. What Lawyers Need to Know about Research Administration & Clinical Trials
Dana Lee (Speaker)
Albert Einstein College of Medicine
05. Lessons Learned From Research Activity Outside the U.S.
Darryl Lunon (Discussion Leader)
<p>Darryl W. Lunon, II current portfolio at Vanderbilt University includes managing university-wide strategic projects on behalf of the Chancellor, Internal Audit and Enterprise Risk Management Compliance. Darryl was previously the Deputy General Counsel & Chief Ethics and Compliance Officer at Georgia Tech. Prior to GT, Darryl was dual hatted as the Chief Legal Officer and Director of Compliance at the Applied Research Laboratory and Associate General Counsel of The Pennsylvania State University. Darryl has also worked as a government contracts attorney for the U.S. Navy and the U.S. Army Corps of Engineers. Darryl’s practice also included protecting the Government’s interests in litigation before the Armed Services Board of Contract Appeals and Government Accountability Office. Darryl is also a commissioned officer and Paratrooper in the U.S. Army Reserve’s Judge Advocate Corps and has deployed twice to support Operation Enduring Freedom and Operation Spartan Shield. </p><p>Prior to becoming an attorney, Darryl practiced as a civil engineer/construction manager for multi-billion dollar airport capital improvement projects both at Washington Dulles International Airport in Washington, DC and Hartsfield-Jackson International Airport in Atlanta, GA.</p><p>In 1999, Darryl earned two Bachelors of Science degrees after completing a dual-degree program: (1) Civil Engineering from The Georgia Institute of Technology and (2) General Science from Morehouse College. In 2008, Darryl earned his Juris Doctorate and Certificate of Legal Writing from the Walter F. George School of Law at Mercer University. In 2020, Darryl earned his eMBA (alternative) from Harvard Business School with a focus in Executive Leadership and Finance.</p>
Vanderbilt University
08A. Faculty Disputes with Collaborators
Meghan McCollum Fenno (Discussion Leader)
Massachusetts Institute of Technology
08D. Innovations in the Age of COVID-19
Mardson McQuay (Speaker)
King Abdullah University of Science and Technology
08C. Hybrid Presentation/Discussion: International Trademark Protection: A Practitioner's Guide
Vinita Mehra (Discussion Leader)
<div><b><span style="font-family:'Arial';font-size:11.00pt;">Vinita Mehra</span></b><span style="font-family:'Arial';font-size:11.00pt;"> is an attorney and director with Kegler Brown Hill + Ritter in Columbus. She serves as the firm's Global Business Leader and Global Education Leader, is licensed to practice law in both Ohio and India, and has been honored as the only “Expert” attorney in the Midwest for Indian business matters by Chambers Global.</span></div>
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<div><span style="font-family:'Arial';font-size:11.00pt;">As leader of Kegler Brown's Global Education practice initiative, Vinita has led dozens of education projects for institutions across the country, doing business in nearly twenty of the world's leading markets and guiding both public and private universities through the complex regulatory and funding processes involved in global expansion. </span></div>
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<div><span style="font-family:'Arial';font-size:11.00pt;">Vinita works with public and private colleges and universities of all sizes - from those with 1,000 students to those with more than 60,000 - assisting with projects in commercial markets all over the world, and helping to develop and implement various delivery models to achieve international growth objectives. </span></div>
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<div><span style="font-family:'Arial';font-size:11.00pt;">With her extensive international transactional experience, Vinita navigates international projects seamlessly and cost-effectively. Based on this experience, Vinita is uniquely qualified to offer her unique global education insights to organizations worldwide, whether a university or college's educational niche is higher education, project-based learning, education support services, part-time non-traditional students or graduate curricula.</span></div>
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Kegler Brown Hill & Ritter LPA
04D. Export Controls Law and Cross-Border Collaborations: Navigating Compliance
Kelly Morrison (Moderator)
<p>Kelly Morrison joined the University of Virginia as Associate University Counsel and Assistant Attorney General in June 2020. Her portfolio covers general civil litigation, research and sponsored programs, admissions and financial aid, procurement, and international programs. Prior to her appointment to the University Counsel's office, Kelly was a litigation partner at Jenner & Block LLP and served as Senior Counsel at Capital One. She received her bachelor’s degree in International Relations from Tufts University, a master’s degree in International Relations and Economics from the Johns Hopkins School of Advanced International Studies, and her law degree from the University of Virginia School of Law.</p>
University of Virginia
05. Lessons Learned From Research Activity Outside the U.S.
Kimberly Moses (Discussion Leader)
University of Pittsburgh
08B. How to Navigate the Legal Issues Related to Animal Research on Campus
Erienne Olesh (Discussion Leader)
<div><span style="font-family:'Calibri';font-size:12.00pt;">Through Vantage Ventures, Erienne aims to expand the startup ecosystem throughout West Virginia by promoting, assisting and growing tech based startups. Erienne works directly with researchers and community members interested in seeking federal funding for startup companies and directs the NSF I Corps program at WVU. Erienne holds a Ph.D. in Neuroscience and an MBA from WVU.</span></div>
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West Virginia University
04C. Hybrid Presentation/Discussion: Promote and Protect: Fostering and Managing University Start-ups
Francisco Pardo (Speaker)
<p>Francisco Pardo, J.D., has served NACUA members since 2017. As a member of NACUA’s leadership team, he implements the association’s strategic framework to sustain excellence, enhance the member experience, and innovate for the future. He enjoys connecting with the members across the country and working to ensure that NACUA continually supports their needs as the home of higher education law.</p><p>As the Director of Legal Resources, Francisco oversees NACUA’s full array of continuing legal education programming and publications. He leads a team of talented lawyers and professionals who provide excellent, insightful, and timely information to advance the practice of higher education law. For close to a decade, he has served as the primary staff member responsible for the development and implementation of the legal education sessions and content for the NACUA Annual Conference. In addition, he assists with collaborative programming efforts with national higher education associations, as well as with outreach to government agencies, regulators, and thought leaders.</p><p>Prior to joining NACUA, Francisco served as Associate Director in the Office of Equal Opportunity and Affirmative Action at Columbia University, where he primarily investigated discrimination, harassment, and sexual misconduct complaints made against faculty and staff. He began his career in public service as the Complaints & Investigations Analyst for the New York City Campaign Finance Board, handling sensitive and high-profile investigations to ensure compliance with New York City’s landmark taxpayer-funded campaign finance system and to root out public corruption.</p><p>Francisco has served on the Board of Directors of Equal Justice Works and the National Youth Leadership Council. He earned a Bachelor of Arts <em>summa cum laude</em> and Phi Beta Kappa from The George Washington University, after enjoying a year at the University of Oxford studying politics, law, and history. He earned a Juris Doctor from Fordham University School of Law and was awarded the Archibald R. Murray Public Service Award.</p>
National Association of College and University Attorneys
WELCOME. Welcome and Introduction to the Program
Nicole Picard (Speaker)
<p>Nicole's practice primarily supports the research enterprise at Brown University. She advises on federal and state regulatory matters, sponsored research, research integrity, centers and institutes, export controls, lab safety, and medicine and health affairs. Nicole also provides counsel on intellectual property, conflicts of interest, and corporate governance issues. Prior to Brown, Nicole worked in the government contracts practice of a large international law firm in Washington, D.C. where she advised clients on a broad range of complex regulatory, transactional, and litigation matters. She clerked for the U.S Court of Federal Claims and the Atomic Safety and Licensing Board Panel at the U.S. Nuclear Regulatory Commission. </p>
Brown University
11. Emerging Issues in False Claims Act Enforcement: The Latest Causes for Concern
Michael Poterala (Speaker)
<p><strong>Mike Poterala</strong> is the Vice President for Legal Affairs and General Counsel for Wayne State University in Detroit, where he serves as an advisor and counselor to the Board of Governors, to President Kimberly Andrews Espy and to other executive officers on strategic, legal, policy, and risk management issues. Mike leads a team of eight attorneys, manages the University’s outside counsel, and oversees the Office of Equal Opportunity and the Title IX Office.</p><p>From 2015-2022 Mike served as the Vice President of Legal Affairs and General Counsel for the University of Maryland and chaired the Big Ten Academic Alliance general counsel group from 2018-2022. Prior to Maryland Mike was the Deputy General Counsel for North Carolina State University, where he chaired the Compliance Officials Working Group and the Professional Sports Counseling Panel, and helped NC State initiate its Enterprise Risk Management practices. Mike worked previously at Michigan State University as both an attorney in the legal office and as the director of MSU’s technology transfer office. He began his legal career in private practice in the Detroit area, where he served as the Michigan general counsel for the studios of the Motion Picture Association of America. </p><p>Throughout his career, Mike has actively supported K-12 education, including his service as a board member of the College Park Academy (2015-2022) in Hyattsville, Maryland. Mike was elected as a trustee and president of the Northville (MI) Board of Education (1996-2000), and was appointed as a director and president of the Northville Educational Foundation (2002-2010).</p><p>Mike is an honors graduate of Georgetown University (Finance) and the Georgetown University Law Center.</p>
Wayne State University
12. Foreign Affairs: Foreign Gift and Contract Reporting for Colleges and Universities
Haylee Ralston (Speaker)
University of Louisville
09. What Lawyers Need to Know about Research Administration & Clinical Trials
Robert Roach (Moderator)
<p>Robert F. Roach is Senior Export Compliance Officer, Office of Research Security at University of Illinois, Urbana Champaign. Prior to his current appointment he was a Senior Advisor at Guidepost Solutions LLC an international consulting firm specializing in compliance, risk management, data privacy and security, internal investigations and monitoring. Bob was the founding Vice President and Chief Global Compliance Officer at New York University (NYU) where he served from 2006 until 2020. </p><p>While at NYU Bob led the Office of Compliance and Risk Management and the University's compliance programs at three degree-granting campuses in New York, Abu Dhabi, and Shanghai and 11 academic sites in Accra, Berlin, Buenos Aires, Florence, London, Madrid, Paris, Prague, Sydney, Tel Aviv, and Washington, D.C.</p><p>Bob was active in NYU's academic life as an Adjunct Professor of Ethics, in the Business and Society Program, NYU Stern School of Business, Langone MBA program. In 2018, Bob was a Visiting Professor of Business Ethics at NYU Shanghai and between 2013 and 2017 he taught risk management at NYU Abu Dhabi, Division of Engineering. In 2014 and 2015, Bob taught a study-away program in Cuba for the Stern Graduate School of Business entitled, “Cuba: Sanctions, Reform, Opportunities.” </p><p>Bob speaks frequently on compliance, ethics, investigations and risk management and has published numerous articles in these areas. He received NACUA's First Decade Award for innovative contributions to university compliance. </p><p>Prior to joining NYU, Bob served as Chief of Staff at the New York City Department of Investigation where he conducted investigations into white collar crimes and public corruption. Prior to DOI, Bob served as Assistant District Attorney in the Manhattan District Attorney's Office and Section Chief of the Antitrust Bureau of the NY State Attorney General's Office. Earlier in his career, Bob was an attorney with the ACLU where he practiced civil rights law. </p><p> </p>
University of Illinois at Urbana-Champaign
07. Foreign Influence: Focus on China
Joanne Rupprecht (Speaker)
<div><span style="font-family:'Arial';font-size:11.00pt;">Ms. Rupprecht has more than 30 years of healthcare experience in both industry and academia; more than 15 years have been acquired after attending law school with a focus on Administrative/Federal Agency law.</span></div>
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<div><span style="font-family:'Arial';font-size:11.00pt;">Ms. Rupprecht’s academic research experience began while she was a student at the University of Illinois at Urbana-Champaign and after graduation, was furthered at the University of Chicago Pritzker School of Medicine. Her most recent roles include as a Research Services Program Director at the University of Colorado Denver on the Anschutz Medical Campus establishing its regulatory and electronic submission program for its stem cell and Chimeric Antigen Receptor (CAR) T-Cell immunotherapies, and currently as the Manager of Regulatory Affairs at Colorado State University. Ms. Rupprecht continues to teach two courses in the Biomedical and Bioscience Technology Master’s Program at the University of Colorado on the Anschutz Medical Campus: The Regulatory Environment of Life Science Innovation and Building Biotechnology.</span></div>
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<div><span style="font-family:'Arial';font-size:11.00pt;">Ms. Rupprecht’s experience in industry includes progressive leadership roles as both a bench scientist and Regulatory Affairs Specialist at Abbott Laboratories, prior to earning her Juris Doctor at the University of Denver Sturm College of Law with an emphasis on Administrative Law.</span></div>
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<div><span style="font-family:'Arial';font-size:11.00pt;">Ms. Rupprecht has dedicated her career to establishing compliant regulatory operations for the advancement of scientific innovation as well as for efficiently and effectively navigating the dynamic and complex regulatory requirements for novel therapies, and has established herself as a successful and trusted advisor, strategist, and negotiator in matters of domestic (FDA) and international quality assurance and regulatory affairs matters for medical device, biologic, pharmaceutical, and cellular immunotherapy (CAR-T Cell/immuno-oncology) healthcare products.</span></div>
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Colorado State University - Fort Collins
02. Keeping it Legal: Compliance, Liability and Safeguards in the Face of COVID
Joanne Rupprecht (Discussion Leader)
<div><span style="font-family:'Arial';font-size:11.00pt;">Ms. Rupprecht has more than 30 years of healthcare experience in both industry and academia; more than 15 years have been acquired after attending law school with a focus on Administrative/Federal Agency law.</span></div>
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<div><span style="font-family:'Arial';font-size:11.00pt;">Ms. Rupprecht’s academic research experience began while she was a student at the University of Illinois at Urbana-Champaign and after graduation, was furthered at the University of Chicago Pritzker School of Medicine. Her most recent roles include as a Research Services Program Director at the University of Colorado Denver on the Anschutz Medical Campus establishing its regulatory and electronic submission program for its stem cell and Chimeric Antigen Receptor (CAR) T-Cell immunotherapies, and currently as the Manager of Regulatory Affairs at Colorado State University. Ms. Rupprecht continues to teach two courses in the Biomedical and Bioscience Technology Master’s Program at the University of Colorado on the Anschutz Medical Campus: The Regulatory Environment of Life Science Innovation and Building Biotechnology.</span></div>
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<div><span style="font-family:'Arial';font-size:11.00pt;">Ms. Rupprecht’s experience in industry includes progressive leadership roles as both a bench scientist and Regulatory Affairs Specialist at Abbott Laboratories, prior to earning her Juris Doctor at the University of Denver Sturm College of Law with an emphasis on Administrative Law.</span></div>
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<div><span style="font-family:'Arial';font-size:11.00pt;">Ms. Rupprecht has dedicated her career to establishing compliant regulatory operations for the advancement of scientific innovation as well as for efficiently and effectively navigating the dynamic and complex regulatory requirements for novel therapies, and has established herself as a successful and trusted advisor, strategist, and negotiator in matters of domestic (FDA) and international quality assurance and regulatory affairs matters for medical device, biologic, pharmaceutical, and cellular immunotherapy (CAR-T Cell/immuno-oncology) healthcare products.</span></div>
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Colorado State University - Fort Collins
04A. PREP Act and COVID: Are you PREPared?
Kathleen Curry Santora (Speaker)
<div class="yiv0454304469msonormal"><span style="font-family:'Calibri';font-size:11.00pt;"><span style="font-family:'Arial';font-size:12.00pt;"><span style="color:black;font-family:'sans-serif';font-size:12.00pt;"></span><span style="font-family:'Arial';font-size:11.00pt;">Kathleen Curry Santora served as President & Chief Executive Officer of the National Association of College and University Attorneys (NACUA) for more than 20 years and retired in September of 2021. Before coming to NACUA, she was Vice President and Chief Operating Officer of the American Association for Higher Education (AAHE). She previously served in various positions at Georgetown University - as Secretary of the University, Assistant to the President for External Relations, and Assistant to the President/Chief of Staff for the President's Office. For nearly ten years prior to that, Kathleen worked for the National Association of Independent Colleges and Universities (NAICU) in various senior-level positions where she handled tax policy and other legislative issues, state relations with state associations of independent colleges and universities, and management of association internal operations. She also served as the first Director for Public Policy and External Relations at the Association of Governing Boards of Universities and Colleges (AGB). </span></div>
<div class="yiv0454304469msonormal"><span style="font-family:'Arial';font-size:12.00pt;">Kathleen earned a Bachelor of Science degree in Political Science from the University of Scranton and a Juris Doctor from the Columbus School of Law, The Catholic University of America. She is a member of the Pennsylvania Bar. </span></div>
<div class="yiv0454304469msonormal"><span style="font-family:'Arial';font-size:12.00pt;">Kathleen served on the board of the American Council on Education (ACE) and as chair of the steering committee for the Washington Higher Education Secretariat (WHES). She previously served on the boards of the University of Scranton; Council for Advancement and Support of Education (CASE); National Council for State Authorization Reciprocity Agreements (NC-SARA); EDUCAUSE (the association for IT professionals); Association Mutual Health Insurance Company (AMHIC); and Academic Search; as a member of the Council of Higher Education Management Associations (CHEMA) Steering Committee, and as a member of the Western New England College (now University) board</span><span style="font-family:'Calibri';font-size:11.00pt;">.</span></span></span></div>
Life Member of the Association
WELCOME. Welcome and Introduction to the Program
Paul Edward Sax, MD (Speaker)
<div><span style="font-family:'Arial';font-size:11.00pt;">Dr. Paul E. Sax is Clinical Director of the Division of Infectious Diseases and the HIV Program at Brigham and Women's Hospital (BWH), and Professor of Medicine at Harvard Medical School. Dr. Sax received his MD from Harvard Medical School. He served his residency in Internal Medicine at BWH, while continuing his postdoctoral education with a fellowship in Infectious Diseases at Massachusetts General Hospital. Dr. Sax is board certified in Internal Medicine and Infectious Diseases.</span></div>
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<div><span style="font-family:'Arial';font-size:11.00pt;">He is Editor-in-Chief of Open Forum Infectious Diseases, is on the Peer Review board of the HIV/AIDS Section of UpToDate, and the editorial advisory board of Medscape HIV/AIDS. Dr. Sax is also on the core faculty of the International AIDS Society - USA and the New England AIDS Education and Training Center. In addition to his clinical and teaching work, Dr. Sax’s ongoing areas of research include clinical trials of antiretroviral therapies, cost-effectiveness of management strategies for HIV, and toxicity of antiretroviral therapy. He is presently the principal investigator at the BWH AIDS Clinical Trials Unit, and is a member of the Cost-Effectiveness of Preventing AIDS Complications (CEPAC) Research Group.</span></div>
Harvard Medical School
01. Opening Plenary: COVID, the Race for a Vaccine, and the Role of Higher Education Research Institutions
Emily Schriver (Speaker)
<p><strong>Emily Schriver </strong>is Senior Associate General Counsel at The Ohio State University, where she provides counsel to the university’s Office of Research on research compliance, sponsored research, the responsible conduct of research, and emerging technologies. She also advises the university community on ethics and conflicts of interest. Prior to joining the OSU legal staff, Emily was an associate at Hogan Lovells US LLP, in Washington, D.C., practicing in the firm’s government contracts and federal research group. Emily graduated from The Ohio State University and the Northwestern Pritzker School of Law, and clerked for the Honorable Richard C. Tallman on the United States Court of Appeals for the Ninth Circuit.</p>
The Ohio State University
10. COVID and Conflicts of Interest: Ethical Issues in Procurement and Research
Linda Schutjer (Discussion Leader)
<p><strong>Linda Schutjer</strong> joined the Office of General Counsel at Colorado State University as Senior Associate Legal Counsel on November 3, 2008. She is currently Senior Legal Counsel in that office and support the Vice President for Research and associated offices. Prior to joining Colorado State University, she served in the Office of General Counsel at The George Washington University. She joined GW in September, 1994 as a Staff Attorney in what was then known as the Office of Legal Matters. By January of 1996, the current Office of Vice President and General Counsel had been created and Ms. Schutjer was promoted to an Assistant General Counsel and then, in late 1998, to an Associate General Counsel. Prior to joining GW, Ms. Schutjer spent six years in private practice including three years with the Pittsburgh office of Kirkpatrick & Lockhart. She attended Temple University School of Law, graduating in May, 1989, magna cum laude. Prior to attending law school, she obtained first her Bachelor of Arts degree and then her Masters of Public Administration from Penn State. She has completed all coursework towards her L.L.M. in Intellectual Property at the George Washington University Law School.</p>
Colorado State University System
04A. PREP Act and COVID: Are you PREPared?
Jessica Sebeok (Discussion Leader)
<div><span style="font-family:'Arial';font-size:11.00pt;">Jessica Sebeok has served at AAU since August 2014. As the Deputy Vice President for Federal Relations and Counsel for Policy, she has primary responsibilities for issues related to intellectual property and information technology and technology transfer. She shares responsibilities for a wide range of other regulatory, compliance and legal issues that affect research universities. She is the lead staff for the AAU Council on Federal Relations and the AAU General Counsels Committee.</span></div>
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<div><span style="font-family:'Arial';font-size:11.00pt;">She previously served as Counsel for Policy and International Affairs in the U.S. Copyright Office, Special Assistant to the Assistant Secretary of State for Educational and Cultural Affairs, and Assistant General Counsel of Yale University.</span></div>
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<div><span style="font-family:'Arial';font-size:11.00pt;">Jessica received her JD from Yale Law School and her master’s degree from the University of Oxford, where she was a Marshall Scholar. She earned her BA in History from the University of Chicago.</span></div>
Johns Hopkins University
04E. Hybrid Presentation/Discussion: Shipwrecks, Small Claims, Software, Service Providers, and Sidney Bechet: Recent Developments in Copyright
Stephen Sencer (Speaker)
<p><strong>Steve Sencer</strong> served, until September 2022, as Emory University’s Senior Vice President and General Counsel, leading a team of professionals responsible providing representation to the University and affiliated entities, including Emory Healthcare and The Carter Center. As a member of the president’s leadership team, Sencer advised university and healthcare leadership on the range of issues affecting a research university with an academic medical center. Sencer currently is Counsel at Ropes & Gray, LLP.</p><p>Sencer is the past chair of the board of NACUA, served on the General Counsel Steering Committee of the AAU and the Legal Services Panel of NAICU, and is a former member of the United Educators Legal Advisory Board. </p><p> </p><p>Sencer helped create Drug Innovation Ventures at Emory, LLC, and chairs the board of Emory Innovations, Inc., DRIVE’s parent company. He has lectured at Emory and elsewhere on legal issues relating to drug development and global health, co-founded the Emory-South Africa Drug Discovery Training Program and GAP BioSciences, and is a Board Advisor to Advancing Healthcare Innovation in Africa (AHIA).</p><p> </p><p>Prior to joining Emory, Sencer practiced law at Williams & Connolly in Washington, DC, and King & Spalding in Atlanta, GA, and served as an Assistant DA in DeKalb County, GA. After graduating from the University of Michigan Law School, where he served as Managing Editor of the Michigan Law Review, Sencer clerked for Judge Amalya Lyle Kearse on the US Court of Appeals for the Second Circuit. Sencer received a BA with Honors from Wesleyan University.</p>
Ropes & Gray LLP
WELCOME. Welcome and Introduction to the Program
Daniel Shapiro (Speaker)
University of Southern California
06. Foreign Influence in Research: Shaping Effective Internal Practices and Responding to External Inquiries and Investigations
Stephanie Shea (Moderator)
<p><strong>Stephanie Shea</strong> is the Vice President and General Counsel for Towson University. Before joining Towson, Stephanie spent nine years in the Johns Hopkins University Office of General Counsel, where she advised on all areas of higher education law and also served as the university's chief compliance officer. Stephanie graduated magna cum laude from Princeton University and received her law degree from the University of Virginia. Immediately after law school, Stephanie clerked for the Honorable William D. Quarles, Jr., United States District Court, District of Maryland. While in college, Stephanie was a four-year member of the Princeton women's swim team.</p>
Towson University
10. COVID and Conflicts of Interest: Ethical Issues in Procurement and Research
Smita Singh (Speaker)
University of Chicago
06. Foreign Influence in Research: Shaping Effective Internal Practices and Responding to External Inquiries and Investigations
Omar Syed (Speaker)
<p><strong><span style="color:#343A40">Omar A. Syed</span></strong><span style="color:#343A40"> is Vice President, General Counsel and Secretary for Rice University. He joined Rice in August, 2022, after 15 years with the University of Texas System, most recently as its Associate Vice Chancellor and Deputy General Counsel.<br /><br />Omar received his A.B. with Special Honors in Public Policy Studies from The University of Chicago, and his J.D. from the University of Minnesota Law School. After law school, he practiced civil litigation and administrative law as an Assistant Attorney General for the State of Minnesota. Next, he served as an Assistant United States Attorney in Minneapolis, where he led federal investigations and prosecuted federal narcotics, violent and economic crimes. Immediately before joining the University of Texas System in 2007, Omar practiced oil and gas law with a private law firm in Austin, Texas. Omar is also a first-generation American.</span></p>
Rice University
07. Foreign Influence: Focus on China
Omar Syed (Discussion Leader)
<p><strong><span style="color:#343A40">Omar A. Syed</span></strong><span style="color:#343A40"> is Vice President, General Counsel and Secretary for Rice University. He joined Rice in August, 2022, after 15 years with the University of Texas System, most recently as its Associate Vice Chancellor and Deputy General Counsel.<br /><br />Omar received his A.B. with Special Honors in Public Policy Studies from The University of Chicago, and his J.D. from the University of Minnesota Law School. After law school, he practiced civil litigation and administrative law as an Assistant Attorney General for the State of Minnesota. Next, he served as an Assistant United States Attorney in Minneapolis, where he led federal investigations and prosecuted federal narcotics, violent and economic crimes. Immediately before joining the University of Texas System in 2007, Omar practiced oil and gas law with a private law firm in Austin, Texas. Omar is also a first-generation American.</span></p>
Rice University
08E. Let's Chat About Foreign Influence
Marta Thompson (Speaker)
<p><strong>Marta Thompson </strong>is a Counsel at Akin Gump Strauss Hauer & Feld LLP in Washington D.C. Marta’s practice primarily focuses on assisting higher education institutions respond to government audits, allegations of misconduct and fraud, and False Claims Act investigations. She counsels clients on a variety of topics, including foreign influence investigations and compliance obligations associated with federally funded contracts, cooperative agreements and grants. In the international arena, Marta works with research and higher education institutions on establishing and monitoring international academic and research programs, and has drafted contractual agreements for U.S.-based institutions relating to foreign campuses, dual-degree and study abroad programs, international student recruitment, and other cross-continental operations.</p>
Akin
11. Emerging Issues in False Claims Act Enforcement: The Latest Causes for Concern
Michael Vernick (Moderator)
<div><span style="font-size:9.00pt;">Mike Vernick is a partner at Akin Gump, and leads the firm's government contracts group, focusing his practice on the higher education, health care and life sciences sectors. His FCA experience extends into all aspects of higher education and United States government research funding, contracts and grants, including cost allowability, research misconduct and General Services Administration (GSA) contracts.</span></div>
<div><span style="font-size:9.00pt;">Mike has represented multiple preeminent institutions on allegations of foreign influence over U.S. government funded research, including resolving the first reported FCA case focused on undisclosed researcher ties to a foreign government.</span></div>
<div><span style="font-size:9.00pt;">He works with research institutions on Uniform Guidance enforcement and compliance matters and other sponsor regulations and policies addressing the financial, administrative and scientific management of grants and cooperative agreements. His experience includes advising multiple leading institutions on scientific misconduct allegations and investigations. Mike also advises many of the nation's leading research institutions service organizations on conducting international sponsored projects, as well as capacity building and training initiatives.</span></div>
Akin
06. Foreign Influence in Research: Shaping Effective Internal Practices and Responding to External Inquiries and Investigations
Ryan Watson (Moderator)
<div><span style="color:black;font-family:'Calibri';font-size:12.00pt;">As a Senior Associate General Counsel, Ryan primarily focuses on industry sponsored research and innovation engagements; intellectual property matters, including patent law; technology license agreements; business transactions; and state procurement. </span></div>
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West Virginia University
04C. Hybrid Presentation/Discussion: Promote and Protect: Fostering and Managing University Start-ups
Madelyn Wessel (Moderator)
<p><strong>Madelyn Wessel </strong>is Senior Counsel in the Hogan Lovells Global Education Practice Group. Prior to joining Hogan Lovells, Madelyn was Vice President and General Counsel at Cornell University and in that capacity supervised and directed all legal services rendered on behalf of Cornell. Madelyn came to Cornell from Virginia Commonwealth University where she served as the University Counsel and as a Senior Assistant Attorney General for the Commonwealth of Virginia. Madelyn also previously served as Associate University Counsel at the University of Virginia, where she had a broad practice including intellectual property law, FOIA, technology, libraries, student affairs, civil rights, constitutional law, and employment law. She served as Deputy and later Chief Deputy City Attorney for the City of Portland, Oregon and as an Assistant Attorney General and Chief of the Opinions Division, Massachusetts Department of Justice. For decades, Madelyn has been a highly active member of NACUA, authoring dozens of papers on a wide range of topics. Madelyn was on the Board of Directors of NACUA from 2013-2016 and served as a long-term Committee member and Chair of NACUANOTES. Madelyn holds a BA with Honors from Swarthmore College and a J.D. from Boston University.</p>
Hogan Lovells US LLP
01. Opening Plenary: COVID, the Race for a Vaccine, and the Role of Higher Education Research Institutions
Kristin West (Speaker)
<div class="x_msonormal"><span style="color:black;font-family:'Arial';font-size:12.00pt;">Kris West is the Director for Research Compliance and Ethics at the Council on Governmental Relations (COGR). COGR is an association of research-intensive universities, colleges, independent research institutions, and health care institutions that supports its members in the areas of research administration, compliance, financial oversight, and intellectual property. As a member of COGR's staff she provides information, regulatory analysis, policy perspective and advice to COGR's members. </span></div>
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<div class="x_msonormal"><span style="color:black;font-family:'Arial';font-size:12.00pt;">Prior to joining COGR, Ms. West worked for Emory University for many years, first as Senior Associate General Counsel and later as Chief Compliance Officer. At Emory she provided</span><span style="color:black;font-family:'Arial';font-size:12.00pt;"> compliance guidance and oversight for research and non-research areas. She also served as Emory University's Privacy Officer and Research Integrity Officer. </span></div>
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<div class="x_msonormal"><span style="color:black;font-family:'Arial';font-size:12.00pt;">Ms. West is an active member of the Georgia Bar. She attended the University of Maryland and Mercer University School of Law and also holds a M.S. degree in drug regulatory affairs from the University of Florida. </span></div>
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Council on Governmental Relations
03. From COVID to COV-Audits and Beyond
Kristin West (Discussion Leader)
<div class="x_msonormal"><span style="color:black;font-family:'Arial';font-size:12.00pt;">Kris West is the Director for Research Compliance and Ethics at the Council on Governmental Relations (COGR). COGR is an association of research-intensive universities, colleges, independent research institutions, and health care institutions that supports its members in the areas of research administration, compliance, financial oversight, and intellectual property. As a member of COGR's staff she provides information, regulatory analysis, policy perspective and advice to COGR's members. </span></div>
<div class="x_msonormal"><span style="color:black;font-family:'Arial';font-size:12.00pt;"> </span></div>
<div class="x_msonormal"><span style="color:black;font-family:'Arial';font-size:12.00pt;">Prior to joining COGR, Ms. West worked for Emory University for many years, first as Senior Associate General Counsel and later as Chief Compliance Officer. At Emory she provided</span><span style="color:black;font-family:'Arial';font-size:12.00pt;"> compliance guidance and oversight for research and non-research areas. She also served as Emory University's Privacy Officer and Research Integrity Officer. </span></div>
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<div class="x_msonormal"><span style="color:black;font-family:'Arial';font-size:12.00pt;">Ms. West is an active member of the Georgia Bar. She attended the University of Maryland and Mercer University School of Law and also holds a M.S. degree in drug regulatory affairs from the University of Florida. </span></div>
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Council on Governmental Relations
04B. Grants Funding Compliance and Research after COVID-19
Rossi Wiles (Moderator)
<div><span style="color:black;font-family:'Calibri';font-size:12.00pt;">As a Deputy General Counsel, Rossi focuses primarily on: business transactions; construction; bond and traditional financing transactions; complex commercial and public-private transaction engagements; state procurement; federal, state, and industry research; and innovation engagements.</span><span style="font-family:'Calibri';font-size:12.00pt;"> </span></div>
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West Virginia University
04C. Hybrid Presentation/Discussion: Promote and Protect: Fostering and Managing University Start-ups
Debra Zumwalt (Speaker)
<div><b><span style="font-family:'Arial';font-size:11.00pt;">Debra Zumwalt </span></b><span style="font-family:'Arial';font-size:11.00pt;">is the Vice President and General Counsel for Stanford University and responsible for the legal work for Stanford University, Stanford Health Care and Lucile Packard Children's Hospital. Previously, she was a partner at Pillsbury Winthrop Shaw Pittman, specializing in complex civil litigation and higher education law. She was the managing partner of the Silicon Valley office and a member of the firm's governing board. Ms. Zumwalt is a trustee of the Board of the American University of Afghanistan, a director of the Academy of Art University, a director of Huron Consulting Group, and a director of Exponent, Inc. She has served as the President of the Santa Clara Bar Association, a board member of the Silicon Valley Campaign for Legal Services, a director of the Law Foundation of Silicon Valley, and Treasurer of the National Association of College and University Attorneys. She received her J.D. from Stanford Law School.</span></div>
Stanford University
07. Foreign Influence: Focus on China