HPM - Key Persons
Job Titles:
- Principal
- Principal Device Regulatory 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.
In the premarket area, Ms. Lenz 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 design controls, risk management, MDRs, field actions, and QSR compliance. Ms. Lenz also helps clients with quality system audits and regulatory due diligence.
Prior to joining the firm in 2017, 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. In these roles, Ms. Lenz conducted a range of regulatory, quality, and engineering functions working with medical device companies and development teams of all sizes in the US, Europe and Asia.
Practice Areas
Labeling, Advertising & Promotion
Allyson Mullen provides counsel to medical device and in vitro diagnostic (IVD) manufacturers. Ms. Mullen 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.
In the premarket area, Ms. Mullen develops regulatory strategy, including obtaining breakthrough device designation and preparing pre-submissions to obtain FDA feedback. She also assists clients in understanding FDA's pre-submission feedback in an effort to prepare for and represents clients at pre-submission meetings with FDA. She also assists with preparing premarket submissions, including IDEs, 510(k)s, de novos, and PMAs. As part of this process, she assists clients in responding to FDA additional information requests during premarket review with a view toward fully understanding and addressing FDA concerns at the earliest possible time. She also represents clients on medical device appeals within FDA, including those relating to deficiencies raised in premarket responses from FDA (e.g., NSE letters, de novo denials).
In the postmarket area, she advises clients on regulatory compliance matters, including complaint handling, MDRs, field actions, promotional review, and QSR compliance. Ms. Mullen also helps clients with contract matters and regulatory due diligence.
Prior to joining the firm in 2013, Ms. Mullen worked as in-house counsel at Waters Corporation, an IVD company. In this role, Ms. Mullen conducted a range of legal and regulatory functions.
Practice Areas
Compliance
Allyson Mullen is speaking at AMDM's Annual Meeting and OIR 510k Submission Workshop April 11, 2019
Andrew Hull represents companies and individuals facing government investigations, enforcement actions, whistleblower complaints, and inspections, and counsels clients on risk mitigation and readiness for such actions. Most recently an Assistant U.S. Attorney, he uses his experience investigating and prosecuting violations of the FDC Act, the Controlled Substances Act, the False Claims Act, and other federal healthcare laws to now defend clients facing criminal, civil, and administrative enforcement actions. As a litigator, Mr. Hull's civil and criminal trial practice in federal court and before DEA's Office of Administrative Law Judges enables him to expertly advise clients through the entire course of a federal investigation and to zealously defend them in court, should it come to that. He has negotiated dozens of complex settlements using his in-depth knowledge of the life sciences and healthcare space and government regulation at DOJ, FDA, DEA, HHS, and CMS to obtain successful resolutions.
Brian J. Donato began his career at Hyman, Phelps & McNamara, P.C. providing information about various legal issues related to the Federal Food Drug and Cosmetic Act and FDA's regulations and similar laws and regulations of the State of California.
Before joining Hyman, Phelps & McNamara in 1991, Mr. Donato practiced law in firms he founded in Virginia and in Florida. From 1976 to 1980, he served as General District Court Judge for Albemarle County, Virginia. He was Chief Judge for all of the General District Courts in the Sixteenth Judicial District of Virginia in 1978 and 1979. He served as Lecturer at the University of Virginia School of Law from 1978 through 1988. Since 1982, he has been a faculty member at the University's Annual Trial Advocacy Institute.
Charles G. Raver assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues. His practice supports clients throughout the life sciences from biotech startups and multinational pharmaceutical companies to CROs and academic researchers to patient advocacy organizations. Mr. Raver joined Hyman, Phelps & McNamara after more than a decade in biomedical research spent studying the neurobiological mechanisms of chronic pain and sensory processing. He now leverages his deep knowledge of the drug development ecosystem and background in neuroscience, pre-clinical animal research and study design to help clients navigate the regulatory landscape faced by the life sciences industry.
Mr. Raver graduated with honors from the University of Maryland Carey School of Law. While in law school, Mr. Raver served as a staff editor and the first social media chair for the Journal of Health Care Law & Policy. He also received two CALI awards after nabbing the top grade in courses on Animal Law and Written and Oral Advocacy. Throughout law school, Mr. Raver continued his neurobiology research career full-time. His research has resulted in nine original peer-reviewed research publications demonstrating potential therapeutic targets for treating chronic pain and revealing functions of neural circuits responsible for sensory processing. Mr. Raver also has extensive knowledge and direct experience with the advanced techniques driving development of current biomedical therapies, such as optogenetics, chemogenetics, viral vector-mediated gene delivery, and targeted stimulation techniques
Practice Areas
Due Diligence & Transactions
David B. Clissold has broad-based experience advising pharmaceutical, biotechnology, medical device, food, and dietary supplement clients on regulatory and legislative matters. He provides guidance throughout the product lifecycle, which includes clinical trials and drug development, advertising and promotion, orphan drug designations, and Hatch-Waxman exclusivity. Mr. Clissold also helps clients with a range of enforcement actions, including FDA inspections and Application Integrity Policy actions. In recent years, Mr. Clissold has steered Hyman, Phelps & McNamara's team of attorneys focusing on FDA's regulation of tobacco products and nicotine replacement therapies.
Mr. Clissold also advises health care professionals, universities, and medical schools on regulatory compliance issues. He provides pro bono counsel to patient groups and state health care agencies. Mr. Clissold lectures on various FDA topics, including regulation of tobacco products, regulatory obligations in clinical investigations, strategies for developing and marketing drugs and biologics, orphan drugs, and Hatch-Waxman issues. He has presented to the Food and Drug Law Institute, and has published papers in The New England Journal of Medicine, The Journal of Pharmacology and Experimental Therapeutics, Pharmacology, Biochemistry & Behavior, and the Food and Drug Law Journal.
Before joining the firm in 1996, Mr. Clissold conducted clinical and pre-clinical research at Nova Pharmaceutical Corporation and the Johns Hopkins University School of Medicine. Mr. Clissold's clinical background includes the study of central nervous system disorders, including Alzheimer's disease, schizophrenia, and rare metabolic disorders.
Practice Areas
Compliance
Dave Clissold is speaking at The Legacy of Angels Foundation - Krabbe Translational Research Network Annual Meeting March 16, 2018
Diane Barber McColl works with chemical and ingredient supplier companies, providing counsel on the regulation of their products and biomaterials intended for use in human foods, medical foods, dietary supplements, food contact articles, animal foods, medical devices, cosmetics, and pharmaceuticals. She has advised clients on FDA and USDA regulatory issues for over 30 years, helping manage products throughout their lifecycle. Ms. McColl's scientific and technical knowledge gained from her former career as a pharmacist enhances her work with research and development teams. In particular, she is an expert on issues related to the development of new food ingredients. Because of her extensive industry knowledge of foods, dietary supplements, animal foods, OTC drugs and cosmetics, Ms. McColl often conducts due diligence for mergers and acquisitions.
Ms. McColl provides guidance on U.S. aspects of global regulatory strategies for novel food ingredients, including sweeteners, functional ingredients, processing aids, color additives, fermenting agents, and flavor modifiers. She also helps clients evaluate, develop, and defend product labeling and advertising, reviewing health and "structure/function" claims.
Ms. McColl joined Hyman, Phelps & McNamara in 1989, and today is one of the food and chemical industry's foremost experts on FDA and USDA regulatory issues. She served on the Food Ingredient Expert Committee of United States Pharmacopoeia (USP) from 2010-2020. Ms. McColl also served as President of the International Society for Regulatory Toxicology and Pharmacology (ISRTP). Ms. McColl is currently a member of the ISRTP Council. Since 2010, Chambers USA has recognized Ms. McColl each year on its list of attorneys for "Food & Beverage: Litigation & Regulatory." In addition, she has repeatedly received the "Highest Possible Rating in Both Legal Ability and Ethical Standards" awarded by Martindale-Hubbell.
Practice Areas
Compliance
Douglas B. Farquhar has more than 40 years of experience as a prosecutor and defense and regulatory attorney. Since joining the firm in 1997, he has advised pharmaceutical and medical device manufacturers and wholesalers, compounding pharmacies, physicians involved in clinical trials, and other individuals on a wide range of enforcement activities, including consent decrees, criminal investigations, debarment issues, arbitration proceedings, civil seizures, FDA inspection issues, and injunctions. Mr. Farquhar has a broad-based understanding of the investigatory process, having negotiated settlements and resolutions for both industry and government.
Mr. Farquhar also advises companies and individuals on adverse findings after FDA inspections. He has been active in defending companies during government investigations into drug pricing and drug and medical device fraud and abuse claims. In addition, Mr. Farquhar has represented employees and companies in investigations relating to anti-kickback laws. He has argued cases and defended companies and individuals in federal court against both civil and criminal FDA enforcement efforts, and has sued FDA in cases related to generic drug approvals and adverse FDA publicity about his clients. He has represented individuals in FDA debarment proceedings.
Mr. Farquhar's legal career includes seven years of service as a federal prosecutor. He was an assistant U.S. Attorney in the District of Maryland from 1990 to 1997, and clerked for the Honorable Judge Joseph H. Young, U.S. District Court in Baltimore, Maryland. Mr. Farquhar also reported for local newspapers before enrolling in law school.
Mr. Farquhar has shared his perspective on enforcement and litigation issues through frequent speaking engagements and publications. He contributes to the firm's FDA Law Blog, and was one of the first Chairs of the annual Enforcement Conference for the Food and Drug Law Institute. In addition, he wrote two chapters for the FDLI publication, How to Work with FDA, focusing on seizures, injunctions, consent decrees, and stolen drug samples. Mr. Farquhar has served on the Planning Committee and spoken regularly at the "GMP by the Sea" conference sponsored by PharmaConference.
Practice Areas
Compliance
Job Titles:
- Principal Drug Regulatory Expert
Job Titles:
- VP, McNeil Consumer Healthcare, Pennsylvania 2011 )
James Valentine assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters relating to new drug and biologic development and approval. In this capacity, James has helped secure FDA approvals for many new drugs across a wide range of therapeutic areas and treatment modalities, including ERT, ASO, mRNA, and cell and gene therapy. This work is often in areas where there are no well-defined development pathways, much of which is in the rare disease arena. James provides preapproval development and regulatory strategy, including on the use of novel clinical outcome assessments, innovative clinical trial designs and statistical approaches, and leveraging confirmatory evidence to support single study approvals. He has also been involved in a significant proportion of accelerated approvals for non-oncologic treatments, spearheading strategies for novel surrogate biomarkers and intermediate clinical endpoints.
James is also a champion for the patient voice in drug development and review. Before joining the firm in 2014, James worked in the FDA Office of Special Health Issues where he facilitated patient input in benefit-risk decision-making. James helped administer the FDA Patient Representative Program, facilitate stakeholder consultations during the reauthorization of PDUFA and MDUFA, and launch the Patient-Focused Drug Development program. In his current practice, James has helped to plan and moderate roughly 75% of all externally-led Patient-Focused Drug Development meetings and aids patient organizations in planning Patient Listening Sessions and regulatory scientific workshops (e.g., Critical Path Innovation Meetings, Science Focused Drug Development).
In recognition of his contributions to the rare disease patient community, in 2019 Global Genes named James as a RARE Champion of Hope.
In his time at FDA, James also worked at the FDA Center for Drug Evaluation and Research's (CDER) Office of Regulatory Policy where he handled a variety of postmarket safety issues including REMS and safety labeling changes.
Practice Areas
Due Diligence & Transactions
Jeffrey N. Gibbs joined Hyman, Phelps & McNamara in 1990. Over the course of his career, he has developed an extensive knowledge of FDA law, including regulatory strategy, product approvals, advertising and promotion, appeals, citizen petitions, and enforcement actions. In recent years, Mr. Gibbs has focused primarily on advising medical device and IVD companies.
Based on his extensive experience working with the industry on FDA issues, and previously for FDA, he provides efficient, practical, timely and insightful guidance. He has worked with companies of all sizes, from global manufacturers to one-person start-ups.
Mr. Gibbs has written and lectured extensively on a variety of FDA topics, particularly the regulation of medical devices, IVDs, and enforcement matters. He was a member of the Editorial Advisory Board for the Food and Drug Law Journal from 1998 to 2004, serving as chair from 2003 to 2004. He was also a member of George Mason University's Human Subjects Research Board from 2003 to 2011. He was a member of the Board of Directors of the Food and Drug Law Institute from 2009 to 2019, serving as both General Counsel and Chairman. He has received numerous recognition awards, including, "Life Sciences: Regulatory/Compliance - USA" Chambers and Partners Global (2021); Washington D.C. Super Lawyers (2021); "Who's Who Legal: Life Sciences 2021"; "The Best Lawyers in America" (27 th Edition-2021); "Who's Who Legal: Life Sciences 2020"; Washington D.C. Super Lawyers (2020); LMG Life Science's Star (2019); "The Best Lawyers in America" (26 th Edition-2020); "Who's Who Legal: Life Sciences 2019"; "The Best Lawyers in America" (25 th Edition-2019); LMG Life Sciences Hall of Fame Award (2018); "Who's Who Legal: Life Sciences 2018"; Chambers & Partners (2018); Washington D.C. Super Lawyers (2018); "The Best Lawyers in America" (24 th Edition-2018); "Who's Who Legal: Life Sciences 2017"; LMG Life Science's Star (5 th Edition-2016); "The Best Lawyers in America" (23 rd Edition-2017); "Top FDA Lawyers," Best Lawyers Supplement, The Washington Post (2016); Washington D.C. Super Lawyers (2016); "The Best Lawyers in America" (22st Edition-2016); Washington D.C. Super Lawyers (2015); LMG Life Science's Star (4th Edition-2015); "Top FDA Lawyers," Best Lawyers Supplement, The Washington Post (2015); "Who's Who Legal: Life Sciences (2015); and "The Best Lawyers in America" (21st Edition-2015). Mr. Gibbs was co-editor and co-author of "European Lawyer Reference: Commercialisation of Health Care, Jurisdictional," published by Thomson Reuters in 2013, 2015, and 2018, and "Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment," published by the Food and Drug Law Institute in 2021.
Mr. Gibbs was Associate General Counsel for Enforcement at FDA, where he received an Award of Merit. He also was appointed Special Assistant U.S. Attorney for the District of Columbia, and, earlier in his career, clerked for a U.S. District Court Judge in New Jersey.
Practice Areas
Compliance
Jeffrey N. Wasserstein focuses on pharmaceutical and medical device promotion, as well as health care fraud and abuse. He also provides counsel on health privacy (HIPAA) and general food and drug law, specializing in the intersection of FDA and health care law. Mr. Wasserstein is a member of several promotional review committees of pharmaceutical and medical device companies. In these roles, he evaluates promotional materials and conducts internal audits of marketing and promotional practices, develops standard operating procedures and policies, and provides training to legal, regulatory, and marketing departments. Mr. Wasserstein also advises on the marketing and promotion of in vitro diagnostic devices.
Mr. Wasserstein is the co-founding blogger of the FDA Law Blog, the industry's foremost resource for insight on food and drug regulation and enforcement actions. He is widely regarded as an industry thought leader in the use of social media to market regulated products that fall under the purview of FDA and the FTC: pharmaceuticals, biotech, medical devices, as well as foods and supplements. Mr. Wasserstein authored a chapter on social media, "Using Social Media in FDA-Regulated Industries: The Essential Guide," FDLI, 2010. He also advises an online publisher on social media best practices with regard to regulated industries.
Mr. Wasserstein practiced in the areas of food and drug and health care law before joining the firm in 2000. Before entering private practice, he clerked for the Honorable Samuel A. Alito, Jr. of the U.S. Court of Appeals for the Third Circuit and the Honorable Allyne R. Ross, U.S. District Judge for the Eastern District of New York.
Practice Areas
Compliance
John R. Fleder represents companies and individuals facing civil and/or criminal actions by the government on issues related to FDA, the FTC, the CPSC, and other federal agencies. He has more than 40 years experience, including almost 20 years personally prosecuting or supervising criminal and civil cases on behalf of these agencies, as well as later representing industry in private practice in those same types of actions. As a result, he provides insightful counsel and strategic guidance on regulatory matters, potential and actual litigation, and internal investigations concerning matters involving a number of federal agencies.
Mr. Fleder also represents clients who want to challenge FDA and other agencies in court. In these instances, he advises clients on strategies that range from seeking to avoid the need to bring suit against the government to personally litigating cases that are brought against the government. Mr. Fleder represents clients that intervene in cases where companies wish to support FDA's position in court. In his prior government service, Mr. Fleder represented federal agencies, including FDA, the FTC, and the CPSC, in lawsuits filed in federal district courts, and courts of appeals involving challenges to their programs and actions. He also spent many years supervising other government attorneys in those same actions. Mr. Fleder's experience interacting and litigating with FDA and other federal agencies spans diverse product areas.
Mr. Fleder is a prolific writer and speaker on FDA and the FTC, as well as numerous other enforcement issues. He recently participated in HPM webinars on the Park criminal liability doctrine and the Caronia off-label marketing case, which each drew an audience of more than 300 people. An article he co-authored in 2005 with Richard M. Cooper: "Responding to a Form 483 or Warning Letter: A Practical Guide," continues to be widely referenced for its insight on responses to FDA warning letters and Form 483s. His 2007 FDLI article, "Who Decides Your Fate in FDA Enforcement Matters?" is probably the first and only publication that publicly identifies the various offices that are involved in decisions by FDA to bring enforcement actions.
Prior to joining the firm in 2000, Mr. Fleder served as the Director of the Department of Justice's Office of Consumer Litigation (now called the Consumer Protection Branch), from 1985 to 1992, after having served in various other capacities in that office since 1973. As Director of the Office of Consumer Litigation, Mr. Fleder directed enforcement cases in federal courts across the country for FDA, the FTC and the CPSC. He also served as a Special Assistant U.S. Attorney in Baltimore, Maryland.
Job Titles:
- Principal
- Principal Drug Regulatory Expert
Job Titles:
- Counsel
- Senior Regulatory Drug Expert
Larry Bauer provides counsel to drug manufacturers on a wide range of regulatory topics including Rare Pediatric Disease Designation requests, Orphan Drug Designation requests, Fast Track and Breakthrough Therapy Designation requests, drug development regulatory strategy, preparing regulatory submissions, and drafting regulatory policies and procedures. Mr. Bauer has extensive experience in patient advocacy and has expertise in the planning and execution of Patient Focused Drug Development meetings.
Prior to his current position, Mr. Bauer worked at the NIH for 17 years, part of which time was devoted to working on research for Gaucher disease. This time was followed by a position at the FDA as a Regulatory Scientist in CDER's Rare Diseases Program working on policy, education, and science related to rare disease drug development. He was part of the committees that developed numerous guidances related to expedited programs, rare diseases, Pre-IND Meetings, and natural history studies. He participated in numerous internal and sponsor meetings related to the development and review of novel rare disease drugs. He also serves on the National Organization for Rare Disorders (NORD) Advocacy Committee.
Larry Bauer brings more than 27 years of combined service at the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) to his consulting role with a focus on expediting the development of drugs for patients with rare diseases.
Job Titles:
- Medical Device Regulatory Expert
- Principal Medical Device Regulatory Expert
Lisa Baumhardt provides consulting to medical device, in vitro diagnostic (IVD) and combination product manufacturers. Ms. Baumhardt assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategies, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters.
In the premarket area, Ms. Baumhardt prepares 510(k)s, de novos, IDE's and PMAs. She also prepares Pre-Submissions and Pre-Emergency Use Authorizations (EUAs) and assists clients in preparing for and representing clients at pre-submission meetings with FDA. In the postmarket area, she advises clients on design controls, risk management, complaint handling, MDRs, field actions, and QSR compliance. Ms. Baumhardt also helps clients with quality system audits and regulatory due diligence.
Prior to joining the firm, Ms. Baumhardt was the Regulatory Affairs/Quality Executive for IBM Watson Health Imaging where she was responsible for the overall strategy for quality, compliance, and regulatory. In addition, she led all healthcare authority interactions for new and novel artificial intelligence offerings. Before joining IBM, Ms. Baumhardt was the Associate Director of Regulatory Affairs for Mallinckrodt Pharmaceuticals where she was responsible for global regulatory affairs for drug-device combination products. In her 14-year career at GE Healthcare, Ms. Baumhardt held leadership roles of increasing responsibility in both Regulatory Affairs and Corporate Compliance. Ms. Baumhardt also worked at Abbott Laboratories where she was responsible for Quality and Clinical Research for a variety of in vitro diagnostic (IVD) products. In each of these roles, Ms. Baumhardt worked with cross functional development teams of all sizes in the US, Europe and Asia.
Practice Areas
Compliance
Job Titles:
- Principal Drug Regulatory Expert
Ricardo Carvajal works with manufacturers and marketers of conventional foods and dietary supplements on a wide range of FDA, USDA, and FTC regulatory issues. Mr. Carvajal advises clients ranging from start-ups to multinational companies at all points in the supply chain, including bulk ingredient manufacturers, distributors of packaged goods, and retailers. He counsels clients on the regulatory status of ingredients and finished products, and provides advice on compliance with labeling and advertising requirements. He helps clients interpret and comment on the implementation of new requirements, such as those arising from the Food Safety Modernization Act, and those applicable to the production and marketing of hemp and its derivatives. He also has expertise in FDA's regulation of bioengineered plants and animals.
In enforcement matters, Mr. Carvajal counsels clients on managing inspections, responding to warning letters and other enforcement actions by federal and state regulators, and resolving import detentions. He also helps clients navigate product recalls and related corrective actions. Mr. Carvajal applies his subject matter expertise to corporate transactions, issuing opinions and conducting due diligence for acquisitions and IPOs.
Mr. Carvajal's approach to counseling clients draws on insights gained in his former role as an Associate Chief Counsel at FDA, where he counseled the agency on a variety of rulemaking and enforcement activities and policy initiatives. Mr. Carvajal has served on the Food and Dietary Supplements Committee and the Global Committee of the Food and Drug Law Institute, and as Chair of the Public Policy Outreach and Implementation Task Force of the Institute of Food Technologists. He is also a member of the American Bar Association
Practice Areas
Compliance
Job Titles:
- Principal Regulatory Device & Biologics Expert
Job Titles:
- State Licensing Regulatory Expert
Job Titles:
- Senior Medical Device Regulatory Expert