It is more important than ever to connect and share ideas. The Law Over Lunch series offers FDLI members the exclusive opportunity to engage in facilitated virtual discussions over lunch on topics of interest to the food and drug law community. This event features unique and co-occurring discussion groups, limited to ten attendees to encourage fruitful conversation. This member-only benefit is a chance to closely learn from, educate, and network with other professionals in the field on new and pertinent topics.
Please only sign up for one discussion as they will take place at the same time.
Table Topics and Facilitators
FDA’s Good Guidance Practices and Device Guidance Documents- A View From Former FDA Attorneys
Renee Beaver, Director, Corporate Counsel
Otsuka America Pharmaceutical, Inc.
&
Shelby Buettner, Assistant General Counsel, Regulatory Law and Compliance Officer
Becton Dickinson (BD)
&
Ashley Zborowsky, Principal Legal Counsel, FDA/Life Sciences Team, Enterprise Legal Regulatory
Medtronic
The Revolution in Home Testing and Sample Collection: Legal Underpinnings of Evolving Regulations
Nathan A. Brown, Partner
Akin Gump Strauss Hauer & Feld LLP
&
Caroline Kessler, Associate
Akin Gump Strauss Hauer & Feld LLP
How the Medical Marijuana and Cannabidiol Research Expansion Act Impacts Research
Deborah Miran, Consultant
DMiran Consulting
&
Heike Newman, Assistant Director IND/IDE Office
University of Colorado
SHELBY BUETTNER is Assistant General Counsel, Regulatory Law and Compliance Officer at Medtronic. She has advised pharmaceutical and medical device manufacturers, healthcare and technology companies, hospitals, and healthcare providers on a variety of regulatory and compliance matters. Shelby previously served as Associate Chief Counsel at the Food and Drug Administration and, before that, was in private practice. Shelby also has experience coordinating clinical research at an academic medical center and managing biomedical projects funded by the Department of Defense and the National Aeronautics and Space Administration.
NATHAN A. BROWN is a partner in the Health Care and Life Sciences practice at Akin Gump. He has worked extensively in the FDA regulatory and compliance field and is sought after for his understanding and insights into the regulation and marketing of innovative medical technologies. He previously served in prominent roles at the Food and Drug Administration and as an FDA advisor to the Senate HELP Committee. He currently serves on the Food and Drug Law Journal Editorial Advisory Board.
CAROLINE KESSLER advises a variety of companies in the U.S. health care industry. Her clients include hospitals and health systems, academic medical centers, and pharmaceutical and device companies. She focuses on regulatory and transactional matters related to food and drug law, as well as Medicare and Medicaid reimbursement. Caroline assists clients in the pharmaceutical, biotechnology, medical device and food industries with complex matters relating to government regulation implemented by the U.S. Food and Drug Administration (FDA). Her work primarily includes advising clients with respect to laws and regulations related to the development and commercialization of pharmaceutical products, medical devices and other health technologies, including FDA labeling and promotional matters. Additionally, Caroline represents health care providers and other clients in connection with health care policy implemented by the Centers for Medicare and Medicaid Services (CMS). Prior to attending law school, Caroline was a staff member in the office of Sen. Angus S. King, Jr. (I-ME), as well as at the Harvard T.H. Chan School of Public Health. While in law school, Caroline served as an executive editor of the Virginia Law Review and as the president of the Health Law Association. She also interned with the Vaccine Litigation Unit in the U.S. Department of Justice. Caroline was a member of Akin Gump’s 2018 summer associate class.
DEBORAH MIRAN, former commissioner, was a member of the Natalie M. LaPrade Maryland Medical Cannabis Commission from 2013- 2016. While serving on the commission, she was also a member of the executive committee, policy, and research subcommittees, and was chair of the education subcommittee. She was responsible for developing education programs for doctors and patients, and was also an integral part of crafting the current regulations. Prior to the commission she was president and founder of Miran Consulting, Inc. There she advised both brand and generic drug makers on the FDA approval process. Ms. Miran was senior director of regulatory affairs for Alpharma, a generic drug manufacturer, where she directed the submission activities for new and abbreviated new drug applications to the FDA. She has spent over 30 years in the U.S. pharmaceutical industry. Ms. Miran received her bachelor of science in chemistry from Iowa State University.
HEIKE NEWMAN works as Senior Regulatory Manager in the Office of Regulatory Compliance at the University of Colorado Denver | Anschutz Medical Campus. She provides assistance and guidance for FDA and DEA submissions to basic and clinical researchers involved in cannabis research since 2014.
ASHLEY ZBOROWSKY is a Principal Legal Counsel at Medtronic plc where she currently focuses her practice on a variety of medical device legal-regulatory matters, including advertising and promotion. Prior to joining Medtronic, she was an Associate Chief Counsel at the US Food and Drug Administration, Office of the Chief Counsel, where she focused primarily on the regulation of foods, dietary supplements, and veterinary products. During her seven-year tenure at FDA, she worked on a number of high-profile matters, most notably, advising and implementing key legal infrastructure for the regulation of agricultural biotechnology products. Ms. Zborowsky holds a joint JD/MPH from the University of Minnesota.January 26, 2023
12:00-1:00 PM ET
Registration is open to FDLI members only and is first come, first served.
This is a complimentary virtual event.
Please only sign up for one discussion as they will take place at the same time.
For questions, please contact Tess Garraty.
