The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval – Webinar Recording/Transcript
Will your clinical data withstand FDA and Department of Justice (DOJ) scrutiny of your drug development program, from preclinical development through clinical trials and ultimately to market approval?
It can if you attend this presentation that will show you how to ensure your data is accurate and reliable throughout the whole process.
It’s no secret that the FDA is more concerned than ever about the integrity of clinical data.
With stories about falsified data in the news recently, the agency is more vigilant than ever, and the DOJ’s Consumer Protection Branch is focusing on identifying fraud in the development of clinical data as one of its four key targets for enforcement this year. Consider your data integrity to be under a microscope.
In this session, three members of King & Spalding’s FDA and Life Sciences practice — two of whom are FDA veterans — will share what you must know and do to avoid data integrity-related FDA and DOJ enforcement action.
Beverly Lorell, senior medical and policy advisor, and partners Peter Leininger and Mark Brown will use hypotheticals and role-playing to highlight best practices for sponsors to spot and mitigate high-risk issues related to the integrity of clinical data and its uses before and after product approval, as well as in crisis management.
- How disruptions brought on by the COVID-19 pandemic opened the door for unintended and deliberate breaches of the development of clinical data
- Recent trends in FDA warning letters that signal a shift from the agency’s focus during the pandemic to the emerging “new normal” of scrutiny and inspections related to the development of clinical data and its integrity
- New modes of FDA enforcement, including those related to sponsor disclosure of clinical results on ClinicalTrials.gov
- Key fact patterns that may trigger a DOJ decision in collaboration with the FDA to initiate criminal prosecution of an individual or firm related to fraud or falsification of clinical data used to support an application, as well as debarment by the FDA
If you want to prevent data-related enforcement action — and criminal prosecution — you must attend this presentation. Your data integrity depends on it.
Meet Your Presenters
Beverly Lorell, MD is the senior medical and policy advisor in King & Spalding’s FDA and Life Sciences practice. Prior to joining King & Spalding, she was a professor of medicine at Harvard University, served on an FDA advisory committee and NIH panels, and was the chief medical officer of a global medical device company. Dr. Lorell specializes in the areas of clinical trial design and conduct of studies of drugs and medical devices as well as the assessment of issues involving a risk to health or data integrity that are under the spotlight of the FDA and other federal agencies. She regularly assists clients in the design and conduct of urgent internal investigations of high-risk issues in global clinical trials related to potential violations of the protection of human subjects as well as clinical trial data falsification and fraud.
Peter Leininger is a partner in King & Spalding’s FDA and Life Sciences practice. He represents medical device, pharmaceutical and biotech companies in FDA regulatory and enforcement matters, with an emphasis on civil, criminal and internal investigations. Prior to joining King & Spalding, he served as an associate chief counsel for enforcement in the FDA’s Office of Chief Counsel. Mr. Leininger’s enforcement practice at the FDA covered the range of FDA-regulated products, often focusing on product quality issues and clinical trial fraud.
Mark Brown is a partner at King & Spalding and the chair of the firm’s FDA and Life Sciences practice. Prior to joining King & Spalding, he was an attorney in the Bureau of Consumer Protection at the Federal Trade Commission, where he concentrated on consumer fraud. He was subsequently an associate chief counsel for enforcement in the FDA’s Office of the General Counsel and a top litigator in FDA enforcement actions.
Who Will Benefit
- Legal leadership and staff
- Regulatory officers and staff
- Compliance officers and staff
- Research institutions
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Sept. 21, 2022