This session presenters, Dianne Bourque and Benjamin Zegarelli from Mintz, will explore the widespread disruptions the crisis is posing to clinical trials for life sciences companies and to research study sites. They will also discuss recent guidance from regulatory authorities and practical steps for both sponsors and researchers to address emerging issues.
The program will cover the following topics:
- Regulatory authority accommodations for ongoing clinical trials that may be affected by COVID-19 and regional restrictions
- Overview of the current clinical trials landscape during the COVID-19 pandemic
- Key considerations for sponsors and study sites regarding ongoing and planned clinical trials
- Considerations for companies interested in commencing a clinical trial for a COVID-19 product candidate
Dianne Bourque | Member | Mintz
Dianne advises a variety of health care clients on a broad range of issues, including licensure, regulatory, contractual, and risk management matters, and patient care. As former in-house counsel to an academic medical center, a large part of her practice involves counseling researchers and research sponsors in matters related to FDA and OHRP regulated clinical research, including patient consent, access to and use of tissue and associated patient information, and the Institutional Review Board process.
She also counsels health care clients and other business entities on a broad range of privacy and data security issues, including the HIPAA Privacy Rule and Security Standards, including requirements under HITECH and the HIPAA Omnibus Rule, 42 CFR Part 2, and state-imposed medical privacy laws. She regularly assists clients with data breach response and mitigation, the implementation of HIPAA-mandated policies and procedures, privacy audits, third-party requests for information, and review of HIPAA-related contracts and forms. She has successfully defended clients in both civil and criminal HIPAA enforcement actions and regularly assists clients with the management of data breaches and other losses of protected health information.
Dianne was the first Suffolk University law student to graduate with a concentration in Health Care and Biomedical Law. She formerly served as an adjunct professor at Stonehill College, teaching an undergraduate Health Care Law course.
Benjamin Zegarelli | Associate | Mintz
Benjamin provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. With a clear focus on FDA regulatory counseling, Benjamin advises a breadth of health care industry clients on the federal and state laws surrounding manufacturer product development and marketing. His practice also includes advising clients on research approval, sales, and negotiating contractual relationships.
Benjamin has experience representing medical device companies in responding to significant unfavorable inspection observations, sometimes accompanied by a warning letter. He guides companies with compliance issues through the development stage of action plans and implementing corrective actions.
In his practice, Benjamin participates in the coordination of diligence reviews of transactions involving large pharmaceutical and medical device manufacturers. He is well versed in the process of developing policy positions and submitting comments to the FDA, as well as analyzing and drafting 510(k) applications for submission to the FDA. Benjamin reviews and drafts clinical study agreements for clients, analyzing both clinical study and human factors protocols with respect to legal requirements.
Benjamin has given numerous presentations on current health care industry topics, with titles such as Advertising and Promotion for Drugs, Devices and Biologics Using Social Media and Promotion of Investigational Drugs and Devices. He previously worked as a research chemist in the discovery group of a major research-based health care and pharmaceutical company. While in law school, he held the position of Executive Editor of the Cardozo Law Review.
