Wednesday, November 2
FDLI Welcome, Opening Remarks, and Keynote Address
Christine Simmon, President & CEO, Food and Drug Law Institute (FDLI)
M. Khair ElZarrad, Director of the Office of Medical Policy, Center for Drug Evaluation and Research, FDA
Beyond Statistics: Key Principles for All Professionals in the Field
Mark Levenson, Director, Division of Biometrics VII, Office of Biostatistics, CDER, FDA
Lance L. Shea, Partner, Co-Chair FDA Practice Team, BakerHostetler
Camelia Thompson, Senior Director, Science & Regulatory Affairs, BIO
This session will establish core statistical principles and demonstrate applicability to lawyers, scientists, and others working in the clinical trials field through practical examples and real-world data. Panelists will demonstrate the value of understanding these principles to propel business and deconstruct communication barriers between legal and technical professionals.
11:15 AM–12:15 PM
Regulatory Trends and Considerations Surrounding Clinical Trial Methodology
Christopher M. Mikson, Partner, DLA Piper LLP
Blake E. Wilson, Partner, Hogan Lovells LLP
Moderated by Cynthia Schnedar, Principal, Greenleaf Health, Inc.
Methodological factors such as clinical trial type, design, and tools can have a substantial effect on trial outcome and consequently, a product’s lifecycle. This session will address these considerations; review regulatory trends toward incorporating data from real-world evidence and the patient experience; and opine on the heightened use of novel tools such as machine learning and artificial intelligence to facilitate clinical trial eligibility, recruitment, and remote patient monitoring.
Rules of Engagement: Interacting with Third-Party Entities
Paula R. Katz, Of Counsel, Covington & Burling LLP
Eric Solowey, Vice President and Assistant General Counsel, Parexel International Corporation
Jonathan Walland, Senior Corporate Counsel, Pfizer Inc.
Moderated by Geoffrey M. Levitt, Of Counsel, DLA Piper LLP
Third-party entities can alleviate burdens of clinical trial development by providing funding, directly participating in conducting the trial, granting access to needed resources, and many other forms of assistance. However, engaging with third-parties may present issues about legal accountability, communication, and financial responsibility. This session will review contracting considerations; opine on sponsor engagement compared to site engagement; and navigate common communication barriers among lawyers, sponsors, academic institutions, agencies, and contract research organizations.
Implementing Clinical Trial Diversity to Advance Health Equity
Winston S. Kirton, Partner, BakerHostetler
Christine Lee, Lead, Strategic Research Engagement, Office of Minority Health and Health Equity (OMHHE), OC, FDA
Sarah Thompson Schick, Senior Associate, Hogan Lovells LLP
Moderated by Maria Apostolaros, Senior Director, Science and Regulatory Advocacy, PhRMA
Studies have demonstrated that health data derived from clinical trials that do not include the minority patient experience are statistically flawed, incomplete, and perpetuate health inequity. This session will address clinical trial diversity, equity, and inclusion through the lens of recent FDA guidance and trends; discuss obstacles to clinical trial recruitment, including racial bias, economic factors, and historic mistreatment of minorities in clinical trials; and provide recommendations for clinical trial transparency and recruitment to generate a full-spectrum of health data for more equitable products and services.
Globalizing Clinical Trials: Legal, Regulatory, and Ethical Compliance
Mahnu Davar, Partner, Life Sciences & Healthcare Regulatory, Arnold & Porter LLP
Jan Holladay Pierre, Principal, IQVIA Quality Compliance Solutions
Moderated by Brian J. Malkin, Partner, McDermott Will & Emery
Globalizing clinical trials can enhance disease awareness and visibility, enable access to international data through scientific exchange, and offer cost-effective options for industry. However, operating global clinical trials poses significant legal, regulatory, and ethical challenges. In this session panelists will discuss these challenges including: mutual recognition agreements; regulatory trends and issues derived from the changing global environment; and ethical dilemmas surrounding trial diversity, informed consent, and data transparency in foreign countries.
Compliance and Cybersecurity Challenges in Clinical Trial Enforcement
Selena Evans, Senior Director, Pharmacy & Healthcare Compliance, Walgreens
Natasha V. Leskovsek, Of Counsel, Cooley LLP
Peter V. Lindsay, Partner, Paul Hastings LLP
Clint Narver, Assistant Director, Consumer Protection Branch, DOJ
Moderated by Stacy Cline Amin, Partner & Co-Chair, FDA Regulatory & Compliance Practice, Morrison and Foerster, LLP
Heightened FDA and DOJ enforcement activity, coupled with a newly instated Civil Cyber-Fraud Initiative and the release of numerous clinical trials-related guidances, means compliance in conducting trials and taking appropriate cybersecurity measures are more important than ever. This session will address common compliance questions arising from enforcement, including greater FDA oversight of clinicaltrials.gov, interest in identifying and prosecuting clinical trial fraud and misconduct, and concerns about data integrity.