Posted: 08 Nov 2018 03:20 PM PST
It’s been a busy year at Hyman, Phelps & McNamara P.C. as we’ve added three new attorneys and two regulatory professionals to our ranks. The five professionals collectively add depth and breadth to our practice with FDA and industry experience.
Deborah L. Livornese joined HP&M as Of Counsel to the Firm. Ms. Livornese has extensive experience in a broad range of FDA regulatory issues, particularly in the pharmaceutical industry. Prior to joining HP&M, Ms. Livornese spent seven years in the Office of Regulatory Policy in FDA’s Center for Drug Evaluation and Research. As a Senior Regulatory Counsel at FDA, she was involved in a wide variety of policy issues in the areas of drug approvals and withdrawals, the regulation of unapproved and over-the-counter drugs, and opioid drugs, and user fee programs. Prior to joining FDA, Ms. Livornese was Of Counsel with an FDA boutique law firm in Washington DC where she advised drug companies on promotional activities for compliance with FDA, FTC and HHS requirements, and assisted clients in responding to investigational findings, warning letters, and inquiries from the FDA and other agencies.
Adrienne R. Lenz joined HP&M as a Senior Medical Device Regulation Expert. Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters. Prior to joining the Firm, Ms. Lenz worked as an independent regulatory consultant and consultant with Emergo. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical.
Veronique Li joined HP&M as a Senior Medical Device Regulation Expert. She provides counsel to medical device and in vitro diagnostic (IVD) manufacturers with regard to both premarket and postmarketing issues. In the premarket area, Ms. Li prepares IDEs, 510(k)s, de novos, and PMAs. She also prepares pre-submissions, and assists clients in preparing for and represents clients at pre-submission meetings with FDA. In the postmarket area, she advises clients on complaint handling, MDRs, field actions, and QSR compliance. Prior to joining HPM, Ms. Li held positions in a medical device company, management consulting firm, and at the FDA in both the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research.
Kalie E. Richardson joined HP&M as an Associate Attorney, focusing her practice on FDA regulatory strategy and compliance, primarily for small to mid-sized pharmaceutical companies. Ms. Richardson was a French translator before becoming a lawyer with a focus on medical and pharmaceutical texts. Prior to joining the firm, Ms. Richardson practiced food and drug law at another law firm. During law school, Ms. Richardson worked in the Centers for Disease Control and Prevention, and the Office of Regulatory Policy at the Center for Drug Evaluation and Research at FDA.
McKenzie E. Cato joined HP&M as an Associate Attorney, practicing in all areas of FDA regulatory law. She graduated with honors from the George Washington University Law School this year. Ms. Cato started at HP&M in 2012 and worked as a Legal Assistant and Law Clerk prior to becoming an Associate Attorney.
Deborah L. Livornese joined HP&M as Of Counsel to the Firm. Ms. Livornese has extensive experience in a broad range of FDA regulatory issues, particularly in the pharmaceutical industry. Prior to joining HP&M, Ms. Livornese spent seven years in the Office of Regulatory Policy in FDA’s Center for Drug Evaluation and Research. As a Senior Regulatory Counsel at FDA, she was involved in a wide variety of policy issues in the areas of drug approvals and withdrawals, the regulation of unapproved and over-the-counter drugs, and opioid drugs, and user fee programs. Prior to joining FDA, Ms. Livornese was Of Counsel with an FDA boutique law firm in Washington DC where she advised drug companies on promotional activities for compliance with FDA, FTC and HHS requirements, and assisted clients in responding to investigational findings, warning letters, and inquiries from the FDA and other agencies.
Adrienne R. Lenz joined HP&M as a Senior Medical Device Regulation Expert. Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters. Prior to joining the Firm, Ms. Lenz worked as an independent regulatory consultant and consultant with Emergo. She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical.
Veronique Li joined HP&M as a Senior Medical Device Regulation Expert. She provides counsel to medical device and in vitro diagnostic (IVD) manufacturers with regard to both premarket and postmarketing issues. In the premarket area, Ms. Li prepares IDEs, 510(k)s, de novos, and PMAs. She also prepares pre-submissions, and assists clients in preparing for and represents clients at pre-submission meetings with FDA. In the postmarket area, she advises clients on complaint handling, MDRs, field actions, and QSR compliance. Prior to joining HPM, Ms. Li held positions in a medical device company, management consulting firm, and at the FDA in both the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research.
Kalie E. Richardson joined HP&M as an Associate Attorney, focusing her practice on FDA regulatory strategy and compliance, primarily for small to mid-sized pharmaceutical companies. Ms. Richardson was a French translator before becoming a lawyer with a focus on medical and pharmaceutical texts. Prior to joining the firm, Ms. Richardson practiced food and drug law at another law firm. During law school, Ms. Richardson worked in the Centers for Disease Control and Prevention, and the Office of Regulatory Policy at the Center for Drug Evaluation and Research at FDA.
McKenzie E. Cato joined HP&M as an Associate Attorney, practicing in all areas of FDA regulatory law. She graduated with honors from the George Washington University Law School this year. Ms. Cato started at HP&M in 2012 and worked as a Legal Assistant and Law Clerk prior to becoming an Associate Attorney.
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