Understanding how to transition within the FDA-regulated industry, whether across product areas or across the public and private sectors, may be essential in your career. Panelists will discuss transitioning between the public and private sectors such as from government to in-house, law firms, not-for-profit organizations, and consulting firms in the FDA regulatory field, as well as across the various product areas and from being a general practitioner to a specialist or vice versa. This panel will also discuss considerations around transitioning between sectors and the importance of building your network.
A reception will follow to meet the speakers and mix and mingle with your fellow NFLR members.
Speakers
Samantha Hong, Kleinfeld, Kaplan & Becker, LLP
Maria Kalousi-Tatum, Morgan, Lewis & Bockius LLP
Tony Subketkaew, CVS Health
Sarah Thompson Schick, Reed Smith LLP
SAMANTHA HONG is an associate at Kleinfeld, Kaplan & Becker where she advises clients in the food, drug, cosmetic, and dietary supplement industries on wide-ranging legal and regulatory matters related to the Food and Drug Administration (FDA) and other federal and state agencies. Samantha previously served as an Associate Chief Counsel in the Office of the Chief Counsel at FDA where she handled enforcement matters across all product areas and litigated challenges to agency actions on issues ranging from drug exclusivity to emergency use authorizations. Prior to her government tenure, Samantha worked as a patent litigator at two international law firms.
SARAH THOMPSON SCHICK advises medical products companies developing and manufacturing pharmaceuticals, biologics, and medical devices on issues where FDA regulatory and compliance matters intersect with strategic business decision-making. Sarah specifically focuses on providing FDA regulatory and compliance counsel to medical products clients on a variety of matters, including Good Clinical Practice and clinical trials, pharmacovigilance, medical communications and health care economic information, Good Manufacturing Practice (drugs and medical devices), advertising and promotion, patient support programs, and ClinicalTrials.gov registration and reporting. She has also written and spoken extensively on clinical trial modernization and diversity, in addition to the implications of the recent Omnibus Bill and current draft FDA guidance. Sarah spends the majority of her practice advising on product development and approval, contractual matters, compliance programming, and risk management. She also has experience handling regulatory issues in the context of corporate transactions, securities disclosures, and litigation. Sarah previously served as in-house counsel for a publicly-traded biopharmaceutical company and also gained hands-on experience working in the legal department for a large hospital system in Texas.
MARIA KALOUSI-TATUM is an associate at Morgan, Lewis & Bockius LLP where she advises clients on US Food and Drug Administration (FDA) compliance and enforcement matters related to medical devices and digital health technologies, including software as a medical device (SaMD), clinical decision support software, wearable devices, and mobile medical apps. She also counsels on US Drug Enforcement Administration (DEA) and state regulatory issues for controlled substances and medical products. Maria also advises clients on FDA, Federal Trade Commission (FTC), and National Advertising Division (NAD) compliance and enforcement matters—as well as false advertising class action litigation—related to food and dietary supplements. Maria previously served as judicial clerk at the US Court of Federal Claims and the Vaccine Claims/Office of Special Masters and worked as translator for pharmaceutical and medical device companies as translator for pharmaceutical and medical device companies.July 13, 2023
4:45–6:30 PM ET
Agenda
4:45-5:00 PM | Check-In
5:00-5:45 PM| Panel Discussion
5:45-6:30 PM | Reception
Registration
This program is exclusively available to FDLI members who are a part of the New to FDA Law & Regulation Group (NFLR), and student members.
APPLY FOR THE GROUP AND REGISTER FOR THE EVENT
New to FDA Law & Regulation Group
NFLR offers young professionals with up to six years of experience an opportunity to connect with colleagues in the food and drug legal and regulatory community, learn from their peers, and enhance their skills. Individuals affiliated with member organizations, those employed by the government, and law students are encouraged to participate.
For questions, please contact Bianca Cardona.
Location
Reed Smith LLP
1301 K St NW
# 1100E
Washington, DC 20005
Program Host
