Overview
Clinical trial sponsors are facing a variety of considerations related to patient safety, investigational product supply chain interruptions, and trial data quality and integrity when considering restarting previously paused or disrupted clinical trials due to the COVID-19 pandemic. How widespread is the impact of COVID-19 on clinical trials? What are the primary legal issues a sponsor should consider in deciding when and how to restart a trial? This webinar will review FDA’s and the European Union’s guidances on the issue, which provide a degree of regulatory flexibility for clinical trials conducted during the COVID-19 pandemic. Speakers will then discuss how industry and FDA are responding to real-world implications of restarting clinical trials disrupted by COVID-19. Covered issues will include remote source data verification, alternatives to onsite inspections of clinical trial sites, and best practices for ensuring integrity in the clinical trial despite COVID-19 modifications.
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Speakers
Scott L. Cunningham, Partner, Covington & Burling LLP
Louisa M. Daniels, Vice President and Assistant General Counsel, Pfizer, Inc.
John A. Murphy III, Vice President & Deputy General Counsel, BIO
Cynthia Schnedar, Executive Vice President, Greenleaf Health, Inc., and Member, FDLI Board of Directors
SCOTT L. CUNNINGHAM is a partner at Covington & Burling LLP is a member of the firm’s Food and Drug practice group. He represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the FDA, Congress, state and federal courts, and other regulatory and enforcement agencies. Mr. Cunningham has significant experience in areas including new product development and clinical trials; IRBs; new product approvals; Hatch-Waxman exclusivities and product life-cycle management; advertising and promotion; False Claims Act and Anti-Kickback compliance issues and pharmaceutical investigations; Orphan Drug; pediatric exclusivity; manufacturing and cGMPs; import/export; controlled substances; SEC disclosure; and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices. Mr. Cunningham also has an active pro bono practice where he regularly serves as a Guardian ad Litem representing children in neglect & abuse and child custody cases.
LOUISA DANIELS is Chief Counsel for Global Product Development and a Vice President & Assistant General Counsel at Pfizer Inc. Louisa leads a team responsible for all legal matters related to clinical development at Pfizer, including study conduct issues, data sharing, vendor oversight activities and transactional support for clinical research. Her group is also responsible for advice regarding Pfizer’s relationships with CROs, patient engagement, use of digital platforms/tools and social media in clinical research, investigator-initiated trials, compassionate access, research grants and publications. Louisa graduated with a degree in Integrative Biology from UC Berkeley, and also received a JD from UC Berkeley School of Law (Boalt Hall) as well as an MBA from UC Irvine (Merage School of Business).
JOHN A. MURPHY III serves as the Vice President and Deputy General Counsel at the Biotechnology Innovation Organization (BIO). Mr. Murphy’s role encompasses all legal issues impacting healthcare biotechnology across the Country. His responsibilities include issues in Congressional legislation, FDA, CMS and various other federal agency regulatory issues, litigation, and support on state-developed biotechnology laws and regulations. Mr. Murphy is a frequent speaker on issues associated with patient access to prescription medicines, prescription drug abuse, drug pricing, and more general issues impacting medicine approvals and innovation in the United States. Mr. Murphy is a graduate of Villanova University and the Catholic University Columbus School of Law. He worked on healthcare regulatory and enforcement issues at Hogan Lovells, LLP, and served as Assistant General Counsel for the Pharmaceutical Research and Manufacturers of America before joining BIO. 
CYNTHIA SCHENDAR, Executive VP of Regulatory compliance at Greenleaf Health, provides strategic advice to clients in the life sciences industry. She was formerly Director of the Office of Compliance for FDA CDER, where she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Cynthia previously served at the Department of Justice (DOJ) as Acting Inspector General and in other leadership positions focused on compliance and enforcement issues. Cynthia also served as a prosecutor and a civil trial attorney for DOJ. Cynthia clerked for a judge on the US Court of Appeals for the Ninth Circuit and worked as a television reporter for local stations in New Mexico and Texas. Cynthia earned a BA with Distinction from the University of New Mexico and a JD with Honors from the University of Texas School of Law.Virtual Learning FAQ
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