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Seth’s in-depth understanding of the industry allows him to work seamlessly with boards of directors, C-suite management, legal departments, compliance offices and operational divisions. He designs compliance programs; helps client to ensure that operations meet changing standards; defends clients in government investigations; performs internal audits; conducts corporate due diligence; and engages in civil, criminal and administrative litigation.

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His experience also includes SEC reporting and advising boards of directors and executive teams on insider trading policies, trading plans, communication policies, compliance programs and other corporate governance matters.

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I have completed a number of successful secondments including for two of the UK’s leading telecommunications providers and most recently implementing GDPR compliance programmes at a global real estate investment company and for a UK charity which hosts a large-scale biomedical database and research resource. These secondments and my background in commercial technology has given me a valuable insight and understanding of the demands and overall commercial priorities for clients, particularly in the context of data protection issues.

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Dr. Bluni has been recognized by Chambers USA: America’s Leading Lawyers for Business, Super Lawyers Massachusetts, LMG Life Sciences, and Managing IP – IP Stars.

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Danny regularly tries cases and arbitrations in Tennessee, Arkansas and Mississippi. He has tried an arbitration or case in 16 states and three foreign countries. He is known as a practical problem solver who has a keen sense of a client’s ultimate business objective and keeps that in focus throughout the life of the case.

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Gary advices clients in matters relating to the approval and commercialization of products that are regulated by the Food and Drug Administration and other federal and state agencies. Gary has substantial experience advising clients on all aspects of product approvals; product launches and commercialization including advertising and promotion; leading compliance-related investigations; developing and implementing regulatory and healthcare compliance programs; advising on patient support programs; and managing competitor disputes. In addition, Gary regularly advises clients on matters relating to healthcare fraud and abuse, clinical trials, informed consent, drug safety issues, product liability, recalls, responding to 483s, warning letters and complete response letters, drug and device quality and manufacturing issues, and life cycle management. Gary also represents companies in transactional matters including distribution and purchasing agreements, pharmacy agreements, clinical trial agreements, payor agreements, manufacturing and supply agreements, physician agreements, research agreements and co-promotion agreements.

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Laura also draws on her enforcement experience to provide clients with practical regulatory advice regarding compliance with federal and state health care fraud and abuse law, particularly under the federal Physician Self-Referral Law (Stark Law), Anti-Kickback Statute (AKS), and FCA, and their state analogs. In addition, Laura helps clients conduct internal investigations, prepare and negotiate self-disclosures to regulators including HHS-OIG and the Centers for Medicare and Medicaid Services (CMS), and obtain advisory opinions from HHS-OIG. She also helps clients negotiate corporate integrity agreements (CIAs) with HHS-OIG and counsels clients on creating and maintaining effective compliance programs.

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Ms. Florence’s extensive experience across multiple matter types allows her to keep one step ahead of potential issues and proactively identify impact areas for clients in the industry. She applies this insight in advising FDA-regulated companies, genomic laboratories and other health care providers regarding fraud and abuse and FDA regulatory compliance in several contexts, including in connection with internal investigations, corporate integrity agreement implementation and corporate compliance programs assessments. In addition, Ms. Florence frequently serves as a subject-matter expert on high-stakes transactions, and has advised clients on more than 300 transactional matters.

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