FDA’s New Enforcement Strategy

POSTPONED UNTIL FURTHER NOTICE

Host and Moderator

Brian MalkinBrian Malkin
Counsel, Arent Fox LLP

Brian has more than 22 years of food and drug law practice and over 11 years of intellectual property law practice. In particular, his practice includes the interrelation between patent law and food and drug law. Brian’s regulatory experience includes all types of FDA-regulated products: drugs (including animal drugs), biologics, medical devices, foods and dietary supplements, tobacco products, and cosmetics. Brian’s intellectual property experience includes FDA and patent litigation for both innovator and generic companies. He began his legal career as a regulatory counsel at the U.S. Food and Drug Administration, where he worked for more than nine years in both the Office of the Commissioner and the Center for Drug Evaluation and Research. At the FDA, he focused on new product evaluations, compliance issues related to clinical investigations and intellectual property (e.g., patent term restoration).

 

Expert Panelists/Speakers

Ricki ChaseRicki Chase
Director, Compliance Practice, Lachman Consultants

Ricki A. Chase, M.S. is a Director in the Compliance Practice at Lachman Consultants who has 16 years of experience at the U.S. Food and Drug Administration. Ms. Chase is an expert in Food and Drug Law, Compliance Law, and Current Good Manufacturing Practices. She has served in leadership development in all regulated program areas including pharmaceuticals, medical devices, human and animal foods, biomonitoring, veterinary medicine, biologics and imports. As Director, Investigations Branch at FDA she led all operations of the Investigations Branch including inspections, investigations, sample collections, consumer complaints, import operations and emergency response programs. Ms. Chase has made numerous presentations including “New Initiatives of FDA, Office of Regulatory Affairs” at ASQ, annual presentations regarding field activities, compliance activities and trends in medical devices and drug program areas at Association of Food and Drug Officials, and compliance law and field activities at John Marshall Law.

Philip DesjardinsPhilip Desjardins
Vice President, Global Regulatory Policy & Intelligence,
Johnson & Johnson

In this role, Mr. Desjardins oversees Johnson & Johnson’s medical device regulatory policy activities. Phil’s organization is responsible for creating a unified and consistent global policy “voice” across the Medical Device segment. He leads a global team of dedicated policy experts to direct, guide, and implements policy initiatives. His organization develops and fosters relationships with various strategic leaders throughout the organization to enable effective product/pipeline development strategies, product introduction strategies, and overall business growth across Medical Devices. Mr. Desjardins previously served as FDA’s Associate Director for Policy within the Center for Devices and Radiological Health, and practiced law that the Firm of Arnold & Porter in Washington DC. Throughout his career, Mr. Desjardins has counseled Industry and FDA leadership on regulatory and compliance issues and helped shape, draft and implement global regulatory policies for medical devices.

Michael GabaMichael Gaba
Partner, Holland & Knight

Michael M. Gaba is a partner in the Washington, D.C., office of Holland & Knight where he is the federal policy leader of the firm’s national Healthcare & Life Sciences Team. His regulatory and legislative life sciences practice includes counseling and representing medical device and biotech companies before the U.S. Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and the U.S. Congress. Mr. Gaba advises clients on the complex intersection of FDA regulatory issues and CMS coverage and payment issues, including federal health policy matters created by these sister agencies. He also provides pre-market strategic counseling and post-market surveillance and enforcement advice, with a particular focus on combination product approval, labeling and promotion.

Paul GadiockPaul Gadiock
Partner, Arent Fox

Paul Gadiock is a senior attorney in the Food, Drug, Medical Device & Agriculture Practice at Arent Fox where he provides premarket and postmarket regulatory solutions on a variety of subject matters for medical device clients. As a former policy director at FDA, Paul brings first-hand experience with major regulatory programs and frameworks. Immediately prior to joining Arent Fox, Paul served as the Associate Director for Policy at the US Food and Drug Administration where he advised key agency officials on issues related to existing and proposed policies, programs, regulations, and legislation. Paul earned his B.S. in Physiology and Neurobiology from the University of Maryland and his J.D. from the University of Maryland School of Law.

Teresa GoreckiTeresa Gorecki
Practice Lead, Compliance Architects LLC

A senior level executive with broad experience in all areas of quality and compliance with more than 30 years of experience in the life science industry. Teresa has held operating unit, regional, and global vice president in various quality and compliance leadership roles at Johnson & Johnson for over 12 years including Pharmaceuticals and Consumer Products. She has directly overseen a large number of internal plants, contract manufacturers and marketing companies globally. Teresa has enabled business success through building and integrating effective and efficient quality systems and processes to support mergers and acquisitions, new product introduction, organic business growth. As Compliance Architects Practice Lead she works with teams to help achieve their quality and compliance goals while enabling business objectives.

Amanda KlinglerAmanda Klinger
Partner, King & Spalding

Amanda Klingler is a partner in King & Spalding’s Washington, D.C., office and is a member of the firm’s FDA & Life Sciences Practice Group.  Since joining the firm in 2008, Ms. Klingler has assisted pharmaceutical and medical device clients in a wide range of FDA regulatory matters, civil litigation, internal investigations, and compliance counseling.  She  has also counseled clients on adverse event reporting, quality system and manufacturing practices for drugs and devices, factory inspections, recalls, product labeling,  and advertising and promotion issues.  Ms. Klingler has also assisted in the negotiation and management of several consent decrees of injunction for pharmaceutical, medical device, food companies, and compounding pharmacies.  Ms. Klingler also has experience in handling FDA issues in products liability litigation, including developing supporting evidence, preparing briefing, and preparing fact and expert witnesses on FDA issues.

Julie LarsenJulie Larsen
Senior Partner, Director Inspection Readiness Services, BioTeknica

Julie Larsen is principal and director, Inspection Readiness Services, at BioTeknica, Inc. A certified quality manager, Julie has more than 20 years of experience with quality assurance and compliance in manufacturing and corporate roles in medical device and pharmaceutical industries, including 17 years of leadership experience in quality operations and compliance at Abbott. She has extensive experience with strategy, coordination, and management of FDA inspections, remediation of quality systems for compliance improvement as well as successfully addressing consent decrees, warning letters and FDA Form 483 responses. Julie has helped multiple companies prepare for and manage FDA inspections in both the US and in Europe with successful outcomes.

Emily LeonginiEmily Leongini
Associate, Arent Fox

Emily Leongini is an associate in Arent Fox's Washington, DC office. As a member of the firm’s FDA Practice, Emily has extensive experience in food and drug law and regulatory policy covering a wide array of FDA-regulated products, including prescription, generic, and over-the-counter drugs, biologics, medical devices, dietary supplements, food, and other consumer goods. Emily also counsels clients in connection with the laws and regulations pertaining to consumer products and advertising, including those administered by the Federal Trade Commission (FTC), the Consumer Product Safety Commission (CPSC) and state regulatory authorities responsible for consumer health and safety. She also has experience with alcohol beverage matters, such as licensing and permitting requirements administered by the US Alcohol and Tobacco Tax and Trade Bureau (TTB), as well as the various State Alcoholic Beverage Control Boards.

Jamie RavitzJamie Ravitz
Partner, Arent Fox

Jamie Ravitz is practice group leader for the firm's FDA Practice (Food & Drug). He also is a member in the life sciences and advertising groups, with a well-rounded practice focused on food and drug law, healthcare, consumer product safety, and advertising. Jamie serves as vice chair of the firm’s consumer product safety committee. Jamie's FDA practice assists clients in navigating regulatory requirements impacting medical device combination products and medical technologies. He also helps clients through all regulatory phases of the approval, manufacture, marketing and retail process.

 

 

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