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Wednesday, November 11, 2020
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11:00 am - 11:10 am
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WELCOME.
Welcome and Introduction to the Program
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[none]
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Room:
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11:10 am - 12:30 pm
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01.
Opening Plenary: COVID, the Race for a Vaccine, and the Role of Higher Education Research Institutions
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Panel Discussion
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Room:
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Don’t miss this distinguished panel of medical experts from leading academic medical centers, a former FDA Commissioner, and experienced NACUA members as they help us make sense of the breakthroughs, challenges, and trajectory of the COVID-19 pandemic. Join us to hear their insights and perspectives on the intersection of higher education, research, and public health in the context of the global COVID-19 pandemic.
How did we get here, in the struggle against a global pandemic? What lessons can we take away from the race for a vaccine and effective treatments, the crucial role of university researchers, and the public-private partnerships that animate these efforts? And how does the higher education research community emerge more resilient and better prepared to confront the challenges we still face?
As we close out 2020, the panel will guide us in better understanding these key issues which are critical to the role of higher education attorneys in supporting the research mission of colleges and universities into the future.
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1:00 pm - 2:15 pm
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02.
Keeping it Legal: Compliance, Liability and Safeguards in the Face of COVID
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Regular Session
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Room:
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- Public health screening versus research
- Regulatory approvals and compliance in device development and testing
- The EUA pathway for drug products to treat or prevent COVID
- The CTAP (Clinical Trials Acceleration Program)/IND process for studying products for COVID
- Humans subject protection issues related to conducting clinical trials during COVID: informed consent and IRB Issues; FDA enforcement discretion
- Clinical trials issues during a pandemic: access to drug, supply chain issues, subject access to trial sites, FDA reporting, and more
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3:00 pm - 4:15 pm
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03.
From COVID to COV-Audits and Beyond
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Regular Session
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Room:
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- COVID ramp-down and ramp-up roller coaster and review of agency flexibilities
- How institutions are are moving ahead now that flexibilities have expired
- Preparing for the eventual COV-audits
- Looking into the crystal ball: will there be supplemental funding?
- Human costs: how COVID has impacted the research workforce
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4:30 pm - 5:30 pm
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04A.
PREP Act and COVID: Are you PREPared?
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Discussion Group
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Room:
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- Opportunity to continue the discussion of issues covered in session 2 (open to all attendees; participation in prior session not required)
- Liablility protections provided by the PREP Act and Defense Production Art
- Exceptions to protections, possible legal claims, other defenses, and damages
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04B.
Grants Funding Compliance and Research after COVID-19
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Discussion Group
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Room:
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- Opportunity to continue the discussion of issues covered in session 3 (open to all attendees; participation in prior session not required)
- Share experiences and pose questions about issues associated with research ramp-up/ramp-down, including:
- Getting research grants/funding back on track amidst the COVID ramp-up/ramp-down roller coaster
- How institutions are proceeding now that federal agency grant compliance "flexibilities" have expired
- How COVID has impacted the research workforce and how institutions are handling related employment issues
- Preparing for potential "COV-audits"
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04C.
Hybrid Presentation/Discussion: Promote and Protect: Fostering and Managing University Start-ups
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Discussion Group
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Room:
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- Elements of a successful University start-up program/Capitalizing on University IP;
- Planning and oversight to manage conflicts;
- Ordinary course equity holder interactions with a start-up (e.g. stockholder consents and approvals);
- Key issues and strategies when the University is the minority investor; and
- Working effectively with outside counsel on transactions with start-ups.
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04D.
Export Controls Law and Cross-Border Collaborations: Navigating Compliance
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Discussion Group
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Room:
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- Review regulatory updates as well as key tax and data protection issues, and other applicable U.S. and foreign legislation and their implications on different models used by universities in their collaborations with foreign partners
- Compare notes on how to identify high-risk scenarios in cross-border education (e.g., online education, hybrid teaching, student recruitment, etc.), create effective compliance policies, and implement inter-departmental processes to avoid common compliance breakdowns
- Share strategies on how to best leverage resources between the university counsel’s office and the export controls/research office in international transactions
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04E.
Hybrid Presentation/Discussion: Shipwrecks, Small Claims, Software, Service Providers, and Sidney Bechet: Recent Developments in Copyright
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Discussion Group
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Room:
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Thursday, November 12, 2020
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11:00 am - 12:15 pm
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05.
Lessons Learned From Research Activity Outside the U.S.
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Regular Session
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Room:
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- Special considerations related to federally-funded research work abroad
- Navigating privacy frameworks such as GDPR and HIPAA for international research collaborators
- Export control considerations given today's remote workers and "mobile" researchers
- "Close calls" and "near misses" related to liability and exposure abroad
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1:00 pm - 2:15 pm
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06.
Foreign Influence in Research: Shaping Effective Internal Practices and Responding to External Inquiries and Investigations
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Regular Session
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Room:
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- Identifying risks and developing effective internal practices to mitigate government oversight, loss of IP, and reputational harm, among others.
- Developing and implementing an effective compliance strategy, including training and education initiatives, gap analyses/internal risk assessments, and tools to connect the dots across multiple internal functions.
- Effectively managing oversight and enforcement activity, including “outsourcing” by law enforcement, questions of indemnification, joint defense agreements, and grand jury subpoenas.
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3:00 pm - 4:15 pm
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07.
Foreign Influence: Focus on China
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Regular Session
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Room:
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- The People’s Republic of China (PRC) has become the world’s 2nd largest economy over past four decades and aspires to be a world leader in science and technology with PRC students, especially in STEM fields, now making up 25% of all foreign students at U.S. colleges and universities
- The U.S. Administration increasingly views PRC students and PRC research collaborations by PRC institutions with U.S. higher education as more potential threat than benefit to U.S. national and economic security
- The Administration has launched a “whole-of-government” approach to counter perceived PRC threat to U.S. higher education, including invocation of criminal statutes by FBI and Department of Justice to prosecute individual scholars
- Both public and private universities have had difficult encounters with federal funding agencies and law enforcement, and this panel will share some of those experiences to illustrate some “leading practices” to follow to achieve research integrity while protecting traditional academic freedom and open scholarship
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4:30 pm - 5:30 pm
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08A.
Faculty Disputes with Collaborators
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Discussion Group
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Room:
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- Discuss challenges and approaches to addressing, resolving, and preventing disputes among faculty and researchers arising out of research collaborations
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08B.
How to Navigate the Legal Issues Related to Animal Research on Campus
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Discussion Group
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Room:
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- Legal and regulatory issues for use of animals in clinical trials
- How to manage USDA inspections
- Responding to record requests for animal research
- How to handle animal rights group issues
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08C.
Hybrid Presentation/Discussion: International Trademark Protection: A Practitioner's Guide
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Discussion Group
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Room:
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- Motivations for Seeking International Trademark Protection
- Trademark Fundamentals, Differences between Civil and Common Law Perspectives
- International Trademark Protection Regimes
- The Foreign Trademark Office Application Process Contrasted with US Practice
- International Trademark Application Filing Regimes
- The Question of Trademark “Use” in an International Context
- Post Registration Modification of a Trademark’s Appearance
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08D.
Innovations in the Age of COVID-19
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Discussion Group
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Room:
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- Navigating mix of government, health system and industry relationships
- Impact of sponsorship on research and tech transfer activities: what has changed during the pandemic?
- Making new devices and therapeutics accessible: how do COVID-19 intellectual property terms fit within exclusive licenses?
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08E.
Let's Chat About Foreign Influence
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Discussion Group
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Room:
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- Opportunity to continue the discussion of issues covered in the sessions on foreign influence (open to all attendees; participation in prior session not required)
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Friday, November 13, 2020
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11:00 am - 12:15 pm
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09.
What Lawyers Need to Know about Research Administration & Clinical Trials
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Regular Session
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Room:
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- Walk the talk of a research administrator: 30,000 ft. view of research and clinical trial administration
- Heavy-hitter compliance topics: issues presented in research and clinical trials
- Top 30 research contracts (and counting): the types of contracts used in research, clinical trials, and technology transfer
- When things hit the fan: trending topics in research administration
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1:00 pm - 2:15 pm
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10.
COVID and Conflicts of Interest: Ethical Issues in Procurement and Research
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Regular Session
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Room:
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- Responding to COVID-19, universities and faculty have faced unprecedented demands and opportunities for innovative research activities
- Often under urgent time pressure and with scare research resources, counsel are called upon to address unusual conflicts of interest and ethical issues presented in these arrangements. In this session we will discuss:
- Conflicts of Interest arising in efforts to address COVID-19, including through faculty start-ups, technology transfer, licensing and procurement
- Ways to navigate conflicts university counsel face and application of the professional responsibility rules for counsel
- Benchmarking and implications for future research activities
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3:00 pm - 4:15 pm
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11.
Emerging Issues in False Claims Act Enforcement: The Latest Causes for Concern
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Regular Session
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Room:
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- Background and current landscape of foreign influence cases
- New considerations around cybersecurity requirements
- Mechanics of the settlement agreement: key considerations in negotiations, including practical strategies for working with the Department of Justice
- How to develop strong institutional policies to mitigate risk of an FCA enforcement action
- New considerations around CARES Act enforcement
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4:30 pm - 5:45 pm
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12.
Foreign Affairs: Foreign Gift and Contract Reporting for Colleges and Universities
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Regular Session
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Room:
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- Important context for Department of Education's focus on Section 117 of the Higher Education Act of 1965
- Recent expansion of reporting requirements
- Political and legislative landscape
- Enforcement efforts, investigations, inquiries
- Compliance strategies including how to set up an institutional Sec. 117 compliance protocol and educating campus constituencies and gathering/reporting information
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