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A partner in our FDA practice and a member of our Life Sciences group, Brian has extensive experience counseling manufacturers on fraud and abuse laws, industry codes of conduct, federal and state transparency laws and regulations, state and local gift bans, compliance program laws and sales representative licensing requirements, as well as government ethics restrictions.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eWith a master\u0026rsquo;s degree in healthcare administration, Brian provides counsel to companies on a variety of laws and regulations administered and enforced by FDA, OIG, DOJ, and CMS, as well as by state attorneys general, boards of pharmacy, departments of health, and similar administrative and enforcement authorities. 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Super Lawyers, 2017-2020\"}{{ FIELD }}Brian Bohnenkamp specializes in regulatory and compliance matters relating to drug, biotechnology and medical device companies. A partner in our FDA practice and a member of our Life Sciences group, Brian has extensive experience counseling manufacturers on fraud and abuse laws, industry codes of conduct, federal and state transparency laws and regulations, state and local gift bans, compliance program laws and sales representative licensing requirements, as well as government ethics restrictions.\nWith a master’s degree in healthcare administration, Brian provides counsel to companies on a variety of laws and regulations administered and enforced by FDA, OIG, DOJ, and CMS, as well as by state attorneys general, boards of pharmacy, departments of health, and similar administrative and enforcement authorities. 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Super Lawyers, 2017-2020 Indiana University Indiana University School of Law St. Louis University Saint Louis University School of Law St. Louis University Saint Louis University School of Law District of Columbia Illinois","searchable_name":"Brian A. 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In this capacity, she advises management on such matters as corporate governance, disclosure and Securities and Exchange Commission (SEC) reporting obligations, employment and equity compensation, fiduciary duties, strategic transactions and acquisitions, commercial agreements, and compliance with securities laws.\nShe is a regular speaker on a range of transactional and governance topics.\nShe serves on the Board of Trustees of the UC Santa Cruz Foundation and previously served on the Board of Directors of the Legal Aid Society of San Mateo County.  She chairs the Dean's Advisory Council of the Baskin School of Engineering, University of California Santa Cruz. Laura I Bushnell Partner Finance Capital Markets: Equity Offerings - Legal 500 US M\u0026amp;A/Corporate and Commercial - M\u0026amp;A: middle-market ($500m-999m)  Legal 500 US Ranked as one of America’s leading lawyers for business in Venture Capital  Chambers USA M\u0026amp;A/Corporate and Commercial – Venture Capital \u0026amp; Emerging Companies Legal 500 US Stanford University Stanford Law School Georgetown University Georgetown University Law Center California","searchable_name":"Laura I. Bushnell","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":442354,"version":1,"owner_type":"Person","owner_id":121,"payload":{"bio":"\u003cp\u003eJack Capers is a partner focused on corporate transactions for companies in the technology and life sciences industries. He advises these companies on a broad range of domestic and cross-border corporate transactions including mergers, acquisitions, dispositions, joint ventures, strategic alliances and strategic investments, complex in-licensing and out-licensing transactions, collaboration and development agreements, and commercial contracts.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eHe also represents clients in the consumer products, retail, industrial and manufacturing, real estate, food and beverage, telecommunications and transportation industries in corporate transactions. In addition, Jack advises boards of directors and board committees on corporate governance, M\u0026amp;A transactions, and takeover defenses.\u003c/p\u003e\n\u003cp\u003eA frequent speaker and author, Jack addresses important topics and trends in M\u0026amp;A and other corporate matters, bringing clients a valuable perspective that allows then to get the most out of their transactions.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003ch5\u003eAdmitted only in Georgia.\u003c/h5\u003e","slug":"jack-capers","email":"jcapers@kslaw.com","phone":"+1 404 307 6092","matters":["\u003cp\u003eRepresented \u003cstrong\u003eEisai Pharmaceuticals\u003c/strong\u003e in a restructuring of its worldwide collaboration with Biogen for the development of products for the treatment of Alzheimer\u0026rsquo;s and related commercial arrangements.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003eBelk Stores,\u003c/strong\u003e a 300-store department store company, in the sale of the company to Sycamore Partners for US$3.1 billion.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003eAurrion,\u003c/strong\u003e a developer of silicon photonics, in the sale of the company to Juniper Networks.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003eCognea Pty,\u003c/strong\u003e a developer of artificial intelligence software and technology, in the sale of the company to IBM.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003eArbor Pharmaceuticals,\u003c/strong\u003e a specialty pharmaceutical company, in a control investment in the company by KKR.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003eGlaxoSmithKline\u003c/strong\u003e in the acquisition of Basilea, S.A., a pharmaceutical company in Switzerland, for \u0026pound;200 million.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003eGlaxoSmithKline\u003c/strong\u003e in the acquisition of Okairos AG, a developer of vaccines products based in Italy and Switzerland, for US$324 million.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003eInmar,\u003c/strong\u003e a data analytics company, in a joint venture with an international provider of point-of-sale technology to develop a platform for the collection and evaluation of customer purchasing data.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003eImmucor,\u003c/strong\u003e a blood diagnostics company, in its US$1.9 million merger with TPG.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":76}]},"expertise":[{"id":32,"guid":"32.capabilities","index":0,"source":"capabilities"},{"id":27,"guid":"27.capabilities","index":1,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":2,"source":"capabilities"},{"id":80,"guid":"80.capabilities","index":3,"source":"capabilities"},{"id":26,"guid":"26.capabilities","index":4,"source":"capabilities"},{"id":33,"guid":"33.capabilities","index":5,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":6,"source":"capabilities"},{"id":75,"guid":"75.capabilities","index":7,"source":"capabilities"},{"id":1141,"guid":"1141.smart_tags","index":8,"source":"smartTags"},{"id":118,"guid":"118.capabilities","index":9,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":10,"source":"smartTags"},{"id":126,"guid":"126.capabilities","index":11,"source":"capabilities"},{"id":1220,"guid":"1220.smart_tags","index":12,"source":"smartTags"},{"id":1223,"guid":"1223.smart_tags","index":13,"source":"smartTags"},{"id":1233,"guid":"1233.smart_tags","index":14,"source":"smartTags"},{"id":107,"guid":"107.capabilities","index":15,"source":"capabilities"}],"is_active":true,"last_name":"Capers","nick_name":"Jack","clerkships":[],"first_name":"Jack","title_rank":9999,"updated_by":35,"law_schools":[{"id":2190,"meta":{"degree":"J.D.","honors":"Order of the Coif","is_law_school":1,"graduation_date":"1978-01-01 00:00:00 UTC"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":[{"title":"Named a leading lawyer for M\u0026A and Corporate Law ","detail":"Best Lawyers, 2022"},{"title":"Notable Lawyer","detail":"IFLR 1000, 2020"},{"title":"Life Sciences Star in Mergers \u0026 Acquisitions","detail":"LMG Life Sciences"},{"title":"The Best Lawyers in America","detail":"Chambers"},{"title":"America’s Leading Lawyers for Business","detail":"Chambers USA"},{"title":"Georgia Super Lawyer","detail":"Atlanta Magazine"}],"linked_in_url":"https://www.linkedin.com/in/jackcapers/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eJack Capers is a partner focused on corporate transactions for companies in the technology and life sciences industries. He advises these companies on a broad range of domestic and cross-border corporate transactions including mergers, acquisitions, dispositions, joint ventures, strategic alliances and strategic investments, complex in-licensing and out-licensing transactions, collaboration and development agreements, and commercial contracts.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eHe also represents clients in the consumer products, retail, industrial and manufacturing, real estate, food and beverage, telecommunications and transportation industries in corporate transactions. 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Acquisitions\", :detail=\u0026gt;\"LMG Life Sciences\"}{{ FIELD }}{:title=\u0026gt;\"The Best Lawyers in America\", :detail=\u0026gt;\"Chambers\"}{{ FIELD }}{:title=\u0026gt;\"America’s Leading Lawyers for Business\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"Georgia Super Lawyer\", :detail=\u0026gt;\"Atlanta Magazine\"}{{ FIELD }}Represented Eisai Pharmaceuticals in a restructuring of its worldwide collaboration with Biogen for the development of products for the treatment of Alzheimer’s and related commercial arrangements.{{ FIELD }}Represented Belk Stores, a 300-store department store company, in the sale of the company to Sycamore Partners for US$3.1 billion.{{ FIELD }}Represented Aurrion, a developer of silicon photonics, in the sale of the company to Juniper Networks.{{ FIELD }}Represented Cognea Pty, a developer of artificial intelligence software and technology, in the sale of the company to IBM.{{ FIELD }}Represented Arbor Pharmaceuticals, a specialty pharmaceutical company, in a control investment in the company by KKR.{{ FIELD }}Represented GlaxoSmithKline in the acquisition of Basilea, S.A., a pharmaceutical company in Switzerland, for £200 million.{{ FIELD }}Represented GlaxoSmithKline in the acquisition of Okairos AG, a developer of vaccines products based in Italy and Switzerland, for US$324 million.{{ FIELD }}Represented Inmar, a data analytics company, in a joint venture with an international provider of point-of-sale technology to develop a platform for the collection and evaluation of customer purchasing data.{{ FIELD }}Represented Immucor, a blood diagnostics company, in its US$1.9 million merger with TPG.{{ FIELD }}Jack Capers is a partner focused on corporate transactions for companies in the technology and life sciences industries. He advises these companies on a broad range of domestic and cross-border corporate transactions including mergers, acquisitions, dispositions, joint ventures, strategic alliances and strategic investments, complex in-licensing and out-licensing transactions, collaboration and development agreements, and commercial contracts.\nHe also represents clients in the consumer products, retail, industrial and manufacturing, real estate, food and beverage, telecommunications and transportation industries in corporate transactions. In addition, Jack advises boards of directors and board committees on corporate governance, M\u0026amp;A transactions, and takeover defenses.\nA frequent speaker and author, Jack addresses important topics and trends in M\u0026amp;A and other corporate matters, bringing clients a valuable perspective that allows then to get the most out of their transactions.\n \nAdmitted only in Georgia. Jack D Capers Partner Named a leading lawyer for M\u0026amp;A and Corporate Law  Best Lawyers, 2022 Notable Lawyer IFLR 1000, 2020 Life Sciences Star in Mergers \u0026amp; Acquisitions LMG Life Sciences The Best Lawyers in America Chambers America’s Leading Lawyers for Business Chambers USA Georgia Super Lawyer Atlanta Magazine Vanderbilt University Vanderbilt University School of Law University of Georgia University of Georgia School of Law California Georgia American Bar Association Best Lawyers In America State Bar of Georgia Atlanta Bar Association California Bar Association Chambers Ranked IFLR 1000 LMG Life Sciences Star Represented Eisai Pharmaceuticals in a restructuring of its worldwide collaboration with Biogen for the development of products for the treatment of Alzheimer’s and related commercial arrangements. Represented Belk Stores, a 300-store department store company, in the sale of the company to Sycamore Partners for US$3.1 billion. Represented Aurrion, a developer of silicon photonics, in the sale of the company to Juniper Networks. Represented Cognea Pty, a developer of artificial intelligence software and technology, in the sale of the company to IBM. Represented Arbor Pharmaceuticals, a specialty pharmaceutical company, in a control investment in the company by KKR. Represented GlaxoSmithKline in the acquisition of Basilea, S.A., a pharmaceutical company in Switzerland, for £200 million. Represented GlaxoSmithKline in the acquisition of Okairos AG, a developer of vaccines products based in Italy and Switzerland, for US$324 million. Represented Inmar, a data analytics company, in a joint venture with an international provider of point-of-sale technology to develop a platform for the collection and evaluation of customer purchasing data. Represented Immucor, a blood diagnostics company, in its US$1.9 million merger with TPG.","searchable_name":"Jack Capers","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":35,"capability_group_featured":null,"home_page_featured":null},{"id":448935,"version":1,"owner_type":"Person","owner_id":1966,"payload":{"bio":"\u003cp\u003eDr. Eng\u0026rsquo;s practice includes patent litigation, patent prosecution, and transactional matters.\u0026nbsp; Dr. Eng has represented clients in patent infringement lawsuits in federal district courts across the United States as well as before the International Trade Commission, in cases involving microelectronic devices, semiconductor processing, polymer coatings, optical fibers, medical devices, and respiratory protective devices.\u0026nbsp; Dr. Eng\u0026rsquo;s litigation experience includes representing major pharmaceutical companies in Hatch-Waxman (Paragraph IV) litigation.\u0026nbsp; His clients include Fortune 100 companies, as well as small-start up companies.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eDr. Eng is registered to practice before the United States Patent and Trademark Office.\u0026nbsp; He has worked on numerous patent prosecution matters in the fields of pharmaceuticals, cosmeceuticals, peptide delivery systems, therapeutic uses of neurotoxins, consumer electronics, fuel cells, biofuels, petroleum refining, polymers and automotive parts.\u0026nbsp; He has drafted numerous patent applications and has successfully prosecuted patent applications to grant in jurisdictions around the world.\u0026nbsp; In addition, Dr. Eng has served as an Adjunct Professor at Seton Hall University Law School, where he taught classes on patent drafting and prosecution.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDr. Eng has experience drafting non-infringement, invalidity, and freedom-to-operate opinions.\u0026nbsp; He has also performed due diligence reviews in connection with patent licensing and corporate mergers and has drafted and negotiated license agreements and other types of technology transfer agreements.\u003c/p\u003e\n\u003cp\u003eDr. Eng holds a Ph.D. in physical chemistry from Columbia University, and B.S. degrees in both chemistry and physics from the Massachusetts Institute of Technology.\u0026nbsp; Dr. Eng has worked as a post-doctoral fellow at Exxon\u0026rsquo;s Corporate Research Center and at Bell Labs, Lucent Technologies.\u0026nbsp; He was also a Member of Technical Staff at Bell Labs, where he was in charge of developing a research program in semiconductor surface characterization.\u003c/p\u003e\n\u003cp\u003eDr. Eng is an author or co-author of 30 technical papers, including two invited reviews.\u0026nbsp; Dr. Eng has also given more than 25 technical talks throughout the United States and abroad, including five invited lectures.\u0026nbsp; He has also lectured around the world on patent enforcement, licensing, and U.S. patent prosecution. Dr. Eng was awarded the Fordham University Legal Writing Award for excellence in legal writing in 2004.\u003c/p\u003e","slug":"joseph-eng","email":"jeng@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":13,"guid":"13.capabilities","index":0,"source":"capabilities"},{"id":25,"guid":"25.capabilities","index":1,"source":"capabilities"},{"id":74,"guid":"74.capabilities","index":2,"source":"capabilities"}],"is_active":true,"last_name":"Eng","nick_name":"Joseph","clerkships":[],"first_name":"Joseph","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":"D.","name_suffix":"Jr.","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eDr. Eng\u0026rsquo;s practice includes patent litigation, patent prosecution, and transactional matters.\u0026nbsp; Dr. Eng has represented clients in patent infringement lawsuits in federal district courts across the United States as well as before the International Trade Commission, in cases involving microelectronic devices, semiconductor processing, polymer coatings, optical fibers, medical devices, and respiratory protective devices.\u0026nbsp; Dr. Eng\u0026rsquo;s litigation experience includes representing major pharmaceutical companies in Hatch-Waxman (Paragraph IV) litigation.\u0026nbsp; His clients include Fortune 100 companies, as well as small-start up companies.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eDr. Eng is registered to practice before the United States Patent and Trademark Office.\u0026nbsp; He has worked on numerous patent prosecution matters in the fields of pharmaceuticals, cosmeceuticals, peptide delivery systems, therapeutic uses of neurotoxins, consumer electronics, fuel cells, biofuels, petroleum refining, polymers and automotive parts.\u0026nbsp; He has drafted numerous patent applications and has successfully prosecuted patent applications to grant in jurisdictions around the world.\u0026nbsp; In addition, Dr. Eng has served as an Adjunct Professor at Seton Hall University Law School, where he taught classes on patent drafting and prosecution.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDr. Eng has experience drafting non-infringement, invalidity, and freedom-to-operate opinions.\u0026nbsp; He has also performed due diligence reviews in connection with patent licensing and corporate mergers and has drafted and negotiated license agreements and other types of technology transfer agreements.\u003c/p\u003e\n\u003cp\u003eDr. Eng holds a Ph.D. in physical chemistry from Columbia University, and B.S. degrees in both chemistry and physics from the Massachusetts Institute of Technology.\u0026nbsp; Dr. Eng has worked as a post-doctoral fellow at Exxon\u0026rsquo;s Corporate Research Center and at Bell Labs, Lucent Technologies.\u0026nbsp; He was also a Member of Technical Staff at Bell Labs, where he was in charge of developing a research program in semiconductor surface characterization.\u003c/p\u003e\n\u003cp\u003eDr. Eng is an author or co-author of 30 technical papers, including two invited reviews.\u0026nbsp; Dr. Eng has also given more than 25 technical talks throughout the United States and abroad, including five invited lectures.\u0026nbsp; He has also lectured around the world on patent enforcement, licensing, and U.S. patent prosecution. Dr. Eng was awarded the Fordham University Legal Writing Award for excellence in legal writing in 2004.\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":7154}]},"capability_group_id":3},"created_at":"2026-05-28T22:11:00.000Z","updated_at":"2026-05-28T22:11:00.000Z","searchable_text":"Eng{{ FIELD }}Dr. Eng’s practice includes patent litigation, patent prosecution, and transactional matters.  Dr. Eng has represented clients in patent infringement lawsuits in federal district courts across the United States as well as before the International Trade Commission, in cases involving microelectronic devices, semiconductor processing, polymer coatings, optical fibers, medical devices, and respiratory protective devices.  Dr. Eng’s litigation experience includes representing major pharmaceutical companies in Hatch-Waxman (Paragraph IV) litigation.  His clients include Fortune 100 companies, as well as small-start up companies.\nDr. Eng is registered to practice before the United States Patent and Trademark Office.  He has worked on numerous patent prosecution matters in the fields of pharmaceuticals, cosmeceuticals, peptide delivery systems, therapeutic uses of neurotoxins, consumer electronics, fuel cells, biofuels, petroleum refining, polymers and automotive parts.  He has drafted numerous patent applications and has successfully prosecuted patent applications to grant in jurisdictions around the world.  In addition, Dr. Eng has served as an Adjunct Professor at Seton Hall University Law School, where he taught classes on patent drafting and prosecution. \nDr. Eng has experience drafting non-infringement, invalidity, and freedom-to-operate opinions.  He has also performed due diligence reviews in connection with patent licensing and corporate mergers and has drafted and negotiated license agreements and other types of technology transfer agreements.\nDr. Eng holds a Ph.D. in physical chemistry from Columbia University, and B.S. degrees in both chemistry and physics from the Massachusetts Institute of Technology.  Dr. Eng has worked as a post-doctoral fellow at Exxon’s Corporate Research Center and at Bell Labs, Lucent Technologies.  He was also a Member of Technical Staff at Bell Labs, where he was in charge of developing a research program in semiconductor surface characterization.\nDr. Eng is an author or co-author of 30 technical papers, including two invited reviews.  Dr. Eng has also given more than 25 technical talks throughout the United States and abroad, including five invited lectures.  He has also lectured around the world on patent enforcement, licensing, and U.S. patent prosecution. Dr. Eng was awarded the Fordham University Legal Writing Award for excellence in legal writing in 2004. Partner Massachusetts Institute of Technology  Massachusetts Institute of Technology  Fordham University Fordham University School of Law Columbia University Columbia University School of Law Columbia University Columbia University School of Law Columbia University Columbia University School of Law U.S. Patent and Trademark Office New York NJIPLA Board Member AABANY Board member","searchable_name":"Joseph D. Eng, Jr.","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":426422,"version":1,"owner_type":"Person","owner_id":3482,"payload":{"bio":"\u003cp\u003eDavid Farber specializes in litigation, regulatory matters, and public policy, with a focus on healthcare, Medicare and Medicaid issues for pharmaceutical and medical device companies, hospitals and pharmacies. A member of our FDA, Life Sciences, and Healthcare, and Government Advocacy practices, David represents clients in healthcare litigation, False Claims Act cases and other commercial disputes, as well as in advocacy before Congress and federal agencies on coverage, coding, reimbursement and other issues. He is a recognized national expert on Medicare Secondary Payer issues.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eCombining broad experience in litigation and public policy, David focuses on complex, multiparty litigation and government advocacy. As a lead litigator, he represents clients in a variety of healthcare and False Claims Act cases, and other disputes. He has also counseled clients in international arbitration, including matters before the International Court of Claims.\u003c/p\u003e\n\u003cp\u003eIn his advocacy practice, David focuses on advising clients in the healthcare and insurance industries. He often serves as a primary strategist and policy architect in a broad range of matters, navigating through Congress, executive branch agencies (with a focus on the Centers for Medicare \u0026amp; Medicaid Services and the Food and Drug Administration) and academia to influence the legislative and regulatory processes. Through his advocacy, he has drafted and helped pass legislation, and has prompted changes in agency policies in ways that benefit his clients. He is a national thought leader on Medicare Secondary Payer issues, having drafted the 2012 SMART Act enacted by Congress.\u003c/p\u003e","slug":"david-farber","email":"dfarber@kslaw.com","phone":"+1-240-401-4800","matters":["\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003emultiple parties, including several of the leading third-party administrators\u003c/strong\u003e, and served as lead counsel on MSP issues in U.S. ex rel. Takemoto v. Nationwide, et al, No. 16-365 (2nd Cir. January 18, 2017), dismissing first major national False Claims Act case under the Medicare Secondary Payer statute.\u003c/p\u003e","\u003cp\u003eDrafted and led strategy on behalf of the \u003cstrong data-redactor-tag=\"strong\"\u003eMARC Coalition\u003c/strong\u003e on the SMART Act, H.R. 1845 (112th Congress), enacted by Congress in 2012 as the first major reform of the Medicare Secondary Payer laws in over a decade and the SPARC Act, H.R. 1122 (115th Congress), introduced in 2017 to further improve the statute .\u003c/p\u003e","\u003cp\u003eWorked on behalf of \u003cstrong data-redactor-tag=\"strong\"\u003emajor pharmaceutical manufacturer\u003c/strong\u003e to enact Medicare Part B drug reimbursement provisions.\u003c/p\u003e","\u003cp\u003eDrafted legislation and led strategy to create federal early childhood mental health grant program.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":101}]},"expertise":[{"id":2,"guid":"2.capabilities","index":0,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":1,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":2,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":3,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":4,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":5,"source":"capabilities"},{"id":114,"guid":"114.capabilities","index":6,"source":"capabilities"},{"id":120,"guid":"120.capabilities","index":7,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":8,"source":"smartTags"},{"id":124,"guid":"124.capabilities","index":9,"source":"capabilities"}],"is_active":true,"last_name":"Farber","nick_name":"David","clerkships":[],"first_name":"David","title_rank":9999,"updated_by":101,"law_schools":[{"id":755,"meta":{"degree":"J.D.","honors":null,"is_law_school":1,"graduation_date":"1987-01-01 00:00:00 UTC"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"J.","name_suffix":"","recognitions":[{"title":"Life Sciences Editorial Board ","detail":"Law360, 2014, 2017"},{"title":"President, Washington Region ","detail":"American Jewish Committee, 2011–2013"},{"title":"Member, National Board of Governors ","detail":"American Jewish Committee, 2013–present"},{"title":"Hyman Bookbinder Award ","detail":"American Jewish Committee, 2016"},{"title":"Bertelsmann Foundation Fellow ","detail":"German-Israel Young Leaders Exchange, 2007"},{"title":"Spirit of Community Action Award ","detail":"The United Planning Organization, 2005"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eDavid Farber specializes in litigation, regulatory matters, and public policy, with a focus on healthcare, Medicare and Medicaid issues for pharmaceutical and medical device companies, hospitals and pharmacies. A member of our FDA, Life Sciences, and Healthcare, and Government Advocacy practices, David represents clients in healthcare litigation, False Claims Act cases and other commercial disputes, as well as in advocacy before Congress and federal agencies on coverage, coding, reimbursement and other issues. He is a recognized national expert on Medicare Secondary Payer issues.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eCombining broad experience in litigation and public policy, David focuses on complex, multiparty litigation and government advocacy. As a lead litigator, he represents clients in a variety of healthcare and False Claims Act cases, and other disputes. He has also counseled clients in international arbitration, including matters before the International Court of Claims.\u003c/p\u003e\n\u003cp\u003eIn his advocacy practice, David focuses on advising clients in the healthcare and insurance industries. He often serves as a primary strategist and policy architect in a broad range of matters, navigating through Congress, executive branch agencies (with a focus on the Centers for Medicare \u0026amp; Medicaid Services and the Food and Drug Administration) and academia to influence the legislative and regulatory processes. Through his advocacy, he has drafted and helped pass legislation, and has prompted changes in agency policies in ways that benefit his clients. He is a national thought leader on Medicare Secondary Payer issues, having drafted the 2012 SMART Act enacted by Congress.\u003c/p\u003e","matters":["\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003emultiple parties, including several of the leading third-party administrators\u003c/strong\u003e, and served as lead counsel on MSP issues in U.S. ex rel. Takemoto v. Nationwide, et al, No. 16-365 (2nd Cir. January 18, 2017), dismissing first major national False Claims Act case under the Medicare Secondary Payer statute.\u003c/p\u003e","\u003cp\u003eDrafted and led strategy on behalf of the \u003cstrong data-redactor-tag=\"strong\"\u003eMARC Coalition\u003c/strong\u003e on the SMART Act, H.R. 1845 (112th Congress), enacted by Congress in 2012 as the first major reform of the Medicare Secondary Payer laws in over a decade and the SPARC Act, H.R. 1122 (115th Congress), introduced in 2017 to further improve the statute .\u003c/p\u003e","\u003cp\u003eWorked on behalf of \u003cstrong data-redactor-tag=\"strong\"\u003emajor pharmaceutical manufacturer\u003c/strong\u003e to enact Medicare Part B drug reimbursement provisions.\u003c/p\u003e","\u003cp\u003eDrafted legislation and led strategy to create federal early childhood mental health grant program.\u003c/p\u003e"],"recognitions":[{"title":"Life Sciences Editorial Board ","detail":"Law360, 2014, 2017"},{"title":"President, Washington Region ","detail":"American Jewish Committee, 2011–2013"},{"title":"Member, National Board of Governors ","detail":"American Jewish Committee, 2013–present"},{"title":"Hyman Bookbinder Award ","detail":"American Jewish Committee, 2016"},{"title":"Bertelsmann Foundation Fellow ","detail":"German-Israel Young Leaders Exchange, 2007"},{"title":"Spirit of Community Action Award ","detail":"The United Planning Organization, 2005"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":9967}]},"capability_group_id":2},"created_at":"2025-05-26T04:52:50.000Z","updated_at":"2025-05-26T04:52:50.000Z","searchable_text":"Farber{{ FIELD }}{:title=\u0026gt;\"Life Sciences Editorial Board \", :detail=\u0026gt;\"Law360, 2014, 2017\"}{{ FIELD }}{:title=\u0026gt;\"President, Washington Region \", :detail=\u0026gt;\"American Jewish Committee, 2011–2013\"}{{ FIELD }}{:title=\u0026gt;\"Member, National Board of Governors \", :detail=\u0026gt;\"American Jewish Committee, 2013–present\"}{{ FIELD }}{:title=\u0026gt;\"Hyman Bookbinder Award \", :detail=\u0026gt;\"American Jewish Committee, 2016\"}{{ FIELD }}{:title=\u0026gt;\"Bertelsmann Foundation Fellow \", :detail=\u0026gt;\"German-Israel Young Leaders Exchange, 2007\"}{{ FIELD }}{:title=\u0026gt;\"Spirit of Community Action Award \", :detail=\u0026gt;\"The United Planning Organization, 2005\"}{{ FIELD }}Represented multiple parties, including several of the leading third-party administrators, and served as lead counsel on MSP issues in U.S. ex rel. Takemoto v. Nationwide, et al, No. 16-365 (2nd Cir. January 18, 2017), dismissing first major national False Claims Act case under the Medicare Secondary Payer statute.{{ FIELD }}Drafted and led strategy on behalf of the MARC Coalition on the SMART Act, H.R. 1845 (112th Congress), enacted by Congress in 2012 as the first major reform of the Medicare Secondary Payer laws in over a decade and the SPARC Act, H.R. 1122 (115th Congress), introduced in 2017 to further improve the statute .{{ FIELD }}Worked on behalf of major pharmaceutical manufacturer to enact Medicare Part B drug reimbursement provisions.{{ FIELD }}Drafted legislation and led strategy to create federal early childhood mental health grant program.{{ FIELD }}David Farber specializes in litigation, regulatory matters, and public policy, with a focus on healthcare, Medicare and Medicaid issues for pharmaceutical and medical device companies, hospitals and pharmacies. A member of our FDA, Life Sciences, and Healthcare, and Government Advocacy practices, David represents clients in healthcare litigation, False Claims Act cases and other commercial disputes, as well as in advocacy before Congress and federal agencies on coverage, coding, reimbursement and other issues. He is a recognized national expert on Medicare Secondary Payer issues.\nCombining broad experience in litigation and public policy, David focuses on complex, multiparty litigation and government advocacy. As a lead litigator, he represents clients in a variety of healthcare and False Claims Act cases, and other disputes. He has also counseled clients in international arbitration, including matters before the International Court of Claims.\nIn his advocacy practice, David focuses on advising clients in the healthcare and insurance industries. He often serves as a primary strategist and policy architect in a broad range of matters, navigating through Congress, executive branch agencies (with a focus on the Centers for Medicare \u0026amp; Medicaid Services and the Food and Drug Administration) and academia to influence the legislative and regulatory processes. Through his advocacy, he has drafted and helped pass legislation, and has prompted changes in agency policies in ways that benefit his clients. He is a national thought leader on Medicare Secondary Payer issues, having drafted the 2012 SMART Act enacted by Congress. David J. Farber Partner Life Sciences Editorial Board  Law360, 2014, 2017 President, Washington Region  American Jewish Committee, 2011–2013 Member, National Board of Governors  American Jewish Committee, 2013–present Hyman Bookbinder Award  American Jewish Committee, 2016 Bertelsmann Foundation Fellow  German-Israel Young Leaders Exchange, 2007 Spirit of Community Action Award  The United Planning Organization, 2005 New York University New York University School of Law Georgetown University Georgetown University Law Center Supreme Court of the United States U.S. Court of Appeals for the First Circuit U.S. Court of Appeals for the Second Circuit U.S. Court of Appeals for the Third Circuit U.S. Court of Appeals for the Fourth Circuit U.S. Court of Appeals for the Fifth Circuit U.S. Court of Appeals for the Sixth Circuit U.S. Court of Appeals for the Ninth Circuit U.S. Court of Appeals for the Eleventh Circuit U.S. District Court for the Western District of Michigan U.S. District Court for the District of Columbia District of Columbia New York Represented multiple parties, including several of the leading third-party administrators, and served as lead counsel on MSP issues in U.S. ex rel. Takemoto v. Nationwide, et al, No. 16-365 (2nd Cir. January 18, 2017), dismissing first major national False Claims Act case under the Medicare Secondary Payer statute. Drafted and led strategy on behalf of the MARC Coalition on the SMART Act, H.R. 1845 (112th Congress), enacted by Congress in 2012 as the first major reform of the Medicare Secondary Payer laws in over a decade and the SPARC Act, H.R. 1122 (115th Congress), introduced in 2017 to further improve the statute . Worked on behalf of major pharmaceutical manufacturer to enact Medicare Part B drug reimbursement provisions. Drafted legislation and led strategy to create federal early childhood mental health grant program.","searchable_name":"David J. Farber","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":448664,"version":1,"owner_type":"Person","owner_id":2380,"payload":{"bio":"\u003cp\u003eSeth Lundy represents prominent medical device and pharmaceutical companies and healthcare providers, suppliers and distributors in complex legal and regulatory matters and investigations. As Deputy Chair of our FDA and Life Sciences practice, Seth is widely recognized as a leading national authority on compliance with federal and state fraud and abuse laws. His practical, business-oriented approach earns accolades as one of the industry's leading lawyers from sources including \u003cem\u003eChambers USA\u003c/em\u003e, LMG Life Sciences, Legal 500,\u0026nbsp;\u003cem\u003eBest Lawyers,\u003c/em\u003e and \u003cem\u003eSuper Lawyers\u003c/em\u003e.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eSeth'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.\u003c/p\u003e\n\u003cp\u003eSeth is experienced in working with federal regulators and legislators to create, revise and interpret healthcare-related laws, regulations and policies. He also develops business and marketing strategies that respond to ever-changing federal regulatory schemes.\u003c/p\u003e\n\u003cp\u003eA frequent author and speaker on healthcare compliance and investigations, Seth works to help clients to identify and predict burgeoning areas of enforcement. Seth has been recognized since 2008 as a top Washington, D.C. healthcare lawyer by \u003cem\u003eChambers USA\u003c/em\u003e. He has also received recognition as a leading healthcare lawyer from \u003cem\u003eExpert Guides, Guide to the Leading Healthcare Lawyers,\u003c/em\u003e Super Lawyers Washington, D.C.\u003cem\u003e,\u003c/em\u003e \u003cem\u003eBest Lawyers\u003c/em\u003e, and \u003cem\u003eWashingtonian Magazine\u003c/em\u003e's Top Lawyers rankings.\u003c/p\u003e","slug":"seth-lundy","email":"slundy@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":2,"guid":"2.capabilities","index":0,"source":"capabilities"},{"id":6,"guid":"6.capabilities","index":1,"source":"capabilities"},{"id":7,"guid":"7.capabilities","index":2,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":3,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":4,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":5,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":6,"source":"capabilities"},{"id":32,"guid":"32.capabilities","index":7,"source":"capabilities"},{"id":761,"guid":"761.smart_tags","index":8,"source":"smartTags"},{"id":33,"guid":"33.capabilities","index":9,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":10,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":11,"source":"capabilities"},{"id":80,"guid":"80.capabilities","index":12,"source":"capabilities"},{"id":970,"guid":"970.smart_tags","index":13,"source":"smartTags"},{"id":109,"guid":"109.capabilities","index":14,"source":"capabilities"},{"id":1097,"guid":"1097.smart_tags","index":15,"source":"smartTags"},{"id":110,"guid":"110.capabilities","index":16,"source":"capabilities"},{"id":112,"guid":"112.capabilities","index":17,"source":"capabilities"},{"id":120,"guid":"120.capabilities","index":18,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":19,"source":"capabilities"},{"id":1199,"guid":"1199.smart_tags","index":20,"source":"smartTags"},{"id":1193,"guid":"1193.smart_tags","index":21,"source":"smartTags"},{"id":1202,"guid":"1202.smart_tags","index":22,"source":"smartTags"},{"id":1223,"guid":"1223.smart_tags","index":23,"source":"smartTags"},{"id":133,"guid":"133.capabilities","index":24,"source":"capabilities"}],"is_active":true,"last_name":"Lundy","nick_name":"Seth","clerkships":[],"first_name":"Seth","title_rank":9999,"updated_by":174,"law_schools":[],"middle_name":"H.","name_suffix":"","recognitions":[{"title":"Top Healthcare Lawyer: Washington, D.C. ","detail":"Chambers USA"},{"title":"Leading Healthcare Lawyer","detail":"Expert Guides and Guide to the Leading Healthcare Lawyers"},{"title":"Super Lawyers: Washington, D.C.","detail":""},{"title":"The Best Lawyers in America","detail":""},{"title":"Top Lawyers ","detail":"Washingtonian Magazine"},{"title":"Named to Best Lawyers in America for FDA Law","detail":"Best Lawyers in America, 2020"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eSeth Lundy represents prominent medical device and pharmaceutical companies and healthcare providers, suppliers and distributors in complex legal and regulatory matters and investigations. As Deputy Chair of our FDA and Life Sciences practice, Seth is widely recognized as a leading national authority on compliance with federal and state fraud and abuse laws. His practical, business-oriented approach earns accolades as one of the industry's leading lawyers from sources including \u003cem\u003eChambers USA\u003c/em\u003e, LMG Life Sciences, Legal 500,\u0026nbsp;\u003cem\u003eBest Lawyers,\u003c/em\u003e and \u003cem\u003eSuper Lawyers\u003c/em\u003e.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eSeth'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.\u003c/p\u003e\n\u003cp\u003eSeth is experienced in working with federal regulators and legislators to create, revise and interpret healthcare-related laws, regulations and policies. He also develops business and marketing strategies that respond to ever-changing federal regulatory schemes.\u003c/p\u003e\n\u003cp\u003eA frequent author and speaker on healthcare compliance and investigations, Seth works to help clients to identify and predict burgeoning areas of enforcement. Seth has been recognized since 2008 as a top Washington, D.C. healthcare lawyer by \u003cem\u003eChambers USA\u003c/em\u003e. He has also received recognition as a leading healthcare lawyer from \u003cem\u003eExpert Guides, Guide to the Leading Healthcare Lawyers,\u003c/em\u003e Super Lawyers Washington, D.C.\u003cem\u003e,\u003c/em\u003e \u003cem\u003eBest Lawyers\u003c/em\u003e, and \u003cem\u003eWashingtonian Magazine\u003c/em\u003e's Top Lawyers rankings.\u003c/p\u003e","recognitions":[{"title":"Top Healthcare Lawyer: Washington, D.C. ","detail":"Chambers USA"},{"title":"Leading Healthcare Lawyer","detail":"Expert Guides and Guide to the Leading Healthcare Lawyers"},{"title":"Super Lawyers: Washington, D.C.","detail":""},{"title":"The Best Lawyers in America","detail":""},{"title":"Top Lawyers ","detail":"Washingtonian Magazine"},{"title":"Named to Best Lawyers in America for FDA Law","detail":"Best Lawyers in America, 2020"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1020}]},"capability_group_id":2},"created_at":"2026-05-28T21:50:53.000Z","updated_at":"2026-05-28T21:50:53.000Z","searchable_text":"Lundy{{ FIELD }}{:title=\u0026gt;\"Top Healthcare Lawyer: Washington, D.C. \", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"Leading Healthcare Lawyer\", :detail=\u0026gt;\"Expert Guides and Guide to the Leading Healthcare Lawyers\"}{{ FIELD }}{:title=\u0026gt;\"Super Lawyers: Washington, D.C.\", :detail=\u0026gt;\"\"}{{ FIELD }}{:title=\u0026gt;\"The Best Lawyers in America\", :detail=\u0026gt;\"\"}{{ FIELD }}{:title=\u0026gt;\"Top Lawyers \", :detail=\u0026gt;\"Washingtonian Magazine\"}{{ FIELD }}{:title=\u0026gt;\"Named to Best Lawyers in America for FDA Law\", :detail=\u0026gt;\"Best Lawyers in America, 2020\"}{{ FIELD }}Seth Lundy represents prominent medical device and pharmaceutical companies and healthcare providers, suppliers and distributors in complex legal and regulatory matters and investigations. As Deputy Chair of our FDA and Life Sciences practice, Seth is widely recognized as a leading national authority on compliance with federal and state fraud and abuse laws. His practical, business-oriented approach earns accolades as one of the industry's leading lawyers from sources including Chambers USA, LMG Life Sciences, Legal 500, Best Lawyers, and Super Lawyers.\nSeth'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.\nSeth is experienced in working with federal regulators and legislators to create, revise and interpret healthcare-related laws, regulations and policies. He also develops business and marketing strategies that respond to ever-changing federal regulatory schemes.\nA frequent author and speaker on healthcare compliance and investigations, Seth works to help clients to identify and predict burgeoning areas of enforcement. Seth has been recognized since 2008 as a top Washington, D.C. healthcare lawyer by Chambers USA. He has also received recognition as a leading healthcare lawyer from Expert Guides, Guide to the Leading Healthcare Lawyers, Super Lawyers Washington, D.C., Best Lawyers, and Washingtonian Magazine's Top Lawyers rankings. Partner Top Healthcare Lawyer: Washington, D.C.  Chambers USA Leading Healthcare Lawyer Expert Guides and Guide to the Leading Healthcare Lawyers Super Lawyers: Washington, D.C.  The Best Lawyers in America  Top Lawyers  Washingtonian Magazine Named to Best Lawyers in America for FDA Law Best Lawyers in America, 2020 Amherst College  George Washington University George Washington University Law School District of Columbia Maryland","searchable_name":"Seth H. Lundy","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":174,"capability_group_featured":null,"home_page_featured":null},{"id":448872,"version":1,"owner_type":"Person","owner_id":966,"payload":{"bio":"\u003cp\u003eChris Markus focuses on U.S. federal and state regulation of drugs, biologics, biotechnology and related products. As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eChris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as Boards of Pharmacy. She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.\u003c/p\u003e\n\u003cp\u003eBased on her experience, Chris was chosen to serve as the legal member of the Institute of Medicine's Committee on Pediatric Studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. IOM evaluated studies of drugs and biologics performed under two statutory regimes that provide incentives and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed the findings and offered recommendations and briefings to FDA and the U.S. Congress.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eChris has been recognized by the\u0026nbsp;\u003cem\u003eBTI Consulting Group\u003c/em\u003e\u0026nbsp;as a 2017 \"Client Service All-Star\" and named repeatedly as a \"Life Sciences Star\" by\u0026nbsp;\u003cem\u003eLMG Life Sciences.\u003c/em\u003e\u0026nbsp; She continues to be identified as one of\u0026nbsp;\u003cem\u003eThe Best Lawyers in America\u003c/em\u003e\u0026nbsp;for FDA Law, and ranked as a life sciences practitioner by\u0026nbsp;\u003cem\u003eThe Legal 500\u003c/em\u003e.\u003c/p\u003e","slug":"christina-markus","email":"cmarkus@kslaw.com","phone":null,"matters":["\u003cp\u003eAdvised numerous pharmaceutical and device manufacturers and distributors on compliance with\u0026nbsp;\u003cstrong\u003estate laws\u003c/strong\u003e\u0026nbsp;governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting.\u003c/p\u003e","\u003cp\u003eAdvised on range of clinical trial issues, including design, compliance and transparency disclosures.\u003c/p\u003e","\u003cp\u003eDeveloped responses to inspectional findings and import alerts, in close collaboration with technical experts.\u003c/p\u003e","\u003cp\u003eAdvised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples.\u003c/p\u003e","\u003cp\u003eAdvised\u0026nbsp;\u003cstrong\u003edozens of pharmaceutical and biological product companies\u003c/strong\u003e, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.\u003c/p\u003e","\u003cp\u003eDeveloped and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed\u0026nbsp;\u003cstrong\u003ebioequivalence standards, Hatch-Waxman 30-month stay provisions\u003c/strong\u003e, and other key regulatory topics.\u003c/p\u003e","\u003cp\u003ePerformed due diligence for\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003eregulatory issues\u003c/strong\u003e\u0026nbsp;and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending.\u003c/p\u003e","\u003cp\u003eEvaluated\u0026nbsp;\u003cstrong\u003eimpacts of the Drug Supply Chain Security Act (DSCSA)\u003c/strong\u003e\u0026nbsp;on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products.\u003c/p\u003e","\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eproduct distributors\u003c/strong\u003e\u0026nbsp;against proposed disciplinary action by the California Board of Pharmacy; 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As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eChris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as Boards of Pharmacy. She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.\u003c/p\u003e\n\u003cp\u003eBased on her experience, Chris was chosen to serve as the legal member of the Institute of Medicine's Committee on Pediatric Studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. IOM evaluated studies of drugs and biologics performed under two statutory regimes that provide incentives and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed the findings and offered recommendations and briefings to FDA and the U.S. Congress.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eChris has been recognized by the\u0026nbsp;\u003cem\u003eBTI Consulting Group\u003c/em\u003e\u0026nbsp;as a 2017 \"Client Service All-Star\" and named repeatedly as a \"Life Sciences Star\" by\u0026nbsp;\u003cem\u003eLMG Life Sciences.\u003c/em\u003e\u0026nbsp; She continues to be identified as one of\u0026nbsp;\u003cem\u003eThe Best Lawyers in America\u003c/em\u003e\u0026nbsp;for FDA Law, and ranked as a life sciences practitioner by\u0026nbsp;\u003cem\u003eThe Legal 500\u003c/em\u003e.\u003c/p\u003e","matters":["\u003cp\u003eAdvised numerous pharmaceutical and device manufacturers and distributors on compliance with\u0026nbsp;\u003cstrong\u003estate laws\u003c/strong\u003e\u0026nbsp;governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting.\u003c/p\u003e","\u003cp\u003eAdvised on range of clinical trial issues, including design, compliance and transparency disclosures.\u003c/p\u003e","\u003cp\u003eDeveloped responses to inspectional findings and import alerts, in close collaboration with technical experts.\u003c/p\u003e","\u003cp\u003eAdvised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples.\u003c/p\u003e","\u003cp\u003eAdvised\u0026nbsp;\u003cstrong\u003edozens of pharmaceutical and biological product companies\u003c/strong\u003e, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.\u003c/p\u003e","\u003cp\u003eDeveloped and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed\u0026nbsp;\u003cstrong\u003ebioequivalence standards, Hatch-Waxman 30-month stay provisions\u003c/strong\u003e, and other key regulatory topics.\u003c/p\u003e","\u003cp\u003ePerformed due diligence for\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003eregulatory issues\u003c/strong\u003e\u0026nbsp;and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending.\u003c/p\u003e","\u003cp\u003eEvaluated\u0026nbsp;\u003cstrong\u003eimpacts of the Drug Supply Chain Security Act (DSCSA)\u003c/strong\u003e\u0026nbsp;on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products.\u003c/p\u003e","\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eproduct distributors\u003c/strong\u003e\u0026nbsp;against proposed disciplinary action by the California Board of Pharmacy; Alabama Board of Pharmacy, and other jurisdictions.\u003c/p\u003e","\u003cp\u003eAdvised on the status and use of controlled substances\u0026nbsp;\u003cstrong\u003eand listed chemicals\u003c/strong\u003e, including:\u003c/p\u003e\n\u003cp\u003e- Administrative hearings concerning applicants for registration to import narcotic raw materials,\u003c/p\u003e\n\u003cp\u003e- Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a multi-faceted corporate transaction, without penalty to the acquiring company,\u003c/p\u003e\n\u003cp\u003e- Applied listed chemical requirements impacting an industrial chemical importer's supply chain, and\u003c/p\u003e\n\u003cp\u003e- Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.\u003c/p\u003e"],"recognitions":[{"title":"Client Service All-Star (unprompted survey of large company corporate counsel)","detail":"BTI Consulting, 2017"},{"title":"Who's Who Legal: Life Sciences","detail":"2017-2024"},{"title":"Leading Life Sciences Lawyer","detail":"LMG Life Sciences, 2012-2025"},{"title":"Best Lawyers in America - FDA Law","detail":"Best Lawyers/US News \u0026 World Report, 2015-2026"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1035}]},"capability_group_id":2},"created_at":"2026-05-28T22:09:05.000Z","updated_at":"2026-05-28T22:09:05.000Z","searchable_text":"Markus{{ FIELD }}{:title=\u0026gt;\"Client Service All-Star (unprompted survey of large company corporate counsel)\", :detail=\u0026gt;\"BTI Consulting, 2017\"}{{ FIELD }}{:title=\u0026gt;\"Who's Who Legal: Life Sciences\", :detail=\u0026gt;\"2017-2024\"}{{ FIELD }}{:title=\u0026gt;\"Leading Life Sciences Lawyer\", :detail=\u0026gt;\"LMG Life Sciences, 2012-2025\"}{{ FIELD }}{:title=\u0026gt;\"Best Lawyers in America - FDA Law\", :detail=\u0026gt;\"Best Lawyers/US News \u0026amp; World Report, 2015-2026\"}{{ FIELD }}Advised numerous pharmaceutical and device manufacturers and distributors on compliance with state laws governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting.{{ FIELD }}Advised on range of clinical trial issues, including design, compliance and transparency disclosures.{{ FIELD }}Developed responses to inspectional findings and import alerts, in close collaboration with technical experts.{{ FIELD }}Advised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples.{{ FIELD }}Advised dozens of pharmaceutical and biological product companies, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.{{ FIELD }}Developed and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed bioequivalence standards, Hatch-Waxman 30-month stay provisions, and other key regulatory topics.{{ FIELD }}Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending.{{ FIELD }}Evaluated impacts of the Drug Supply Chain Security Act (DSCSA) on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products.{{ FIELD }}Defended product distributors against proposed disciplinary action by the California Board of Pharmacy; Alabama Board of Pharmacy, and other jurisdictions.{{ FIELD }}Advised on the status and use of controlled substances and listed chemicals, including:\n- Administrative hearings concerning applicants for registration to import narcotic raw materials,\n- Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a multi-faceted corporate transaction, without penalty to the acquiring company,\n- Applied listed chemical requirements impacting an industrial chemical importer's supply chain, and\n- Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.{{ FIELD }}Chris Markus focuses on U.S. federal and state regulation of drugs, biologics, biotechnology and related products. As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.\nChris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as Boards of Pharmacy. She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.\nBased on her experience, Chris was chosen to serve as the legal member of the Institute of Medicine's Committee on Pediatric Studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. IOM evaluated studies of drugs and biologics performed under two statutory regimes that provide incentives and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed the findings and offered recommendations and briefings to FDA and the U.S. Congress. \nChris has been recognized by the BTI Consulting Group as a 2017 \"Client Service All-Star\" and named repeatedly as a \"Life Sciences Star\" by LMG Life Sciences.  She continues to be identified as one of The Best Lawyers in America for FDA Law, and ranked as a life sciences practitioner by The Legal 500. Partner Client Service All-Star (unprompted survey of large company corporate counsel) BTI Consulting, 2017 Who's Who Legal: Life Sciences 2017-2024 Leading Life Sciences Lawyer LMG Life Sciences, 2012-2025 Best Lawyers in America - FDA Law Best Lawyers/US News \u0026amp; World Report, 2015-2026 College of William and Mary William \u0026amp; Mary Law School University of Virginia University of Virginia School of Law District of Columbia Virginia The District of Columbia Bar Virginia State Bar Advised numerous pharmaceutical and device manufacturers and distributors on compliance with state laws governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting. Advised on range of clinical trial issues, including design, compliance and transparency disclosures. Developed responses to inspectional findings and import alerts, in close collaboration with technical experts. Advised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples. Advised dozens of pharmaceutical and biological product companies, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence. Developed and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed bioequivalence standards, Hatch-Waxman 30-month stay provisions, and other key regulatory topics. Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending. Evaluated impacts of the Drug Supply Chain Security Act (DSCSA) on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products. Defended product distributors against proposed disciplinary action by the California Board of Pharmacy; Alabama Board of Pharmacy, and other jurisdictions. Advised on the status and use of controlled substances and listed chemicals, including:\n- Administrative hearings concerning applicants for registration to import narcotic raw materials,\n- Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a multi-faceted corporate transaction, without penalty to the acquiring company,\n- Applied listed chemical requirements impacting an industrial chemical importer's supply chain, and\n- Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.","searchable_name":"Christina M. Markus (Chris)","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":449192,"version":1,"owner_type":"Person","owner_id":4090,"payload":{"bio":"\u003cp\u003eGary Messplay specializes in advising life science companies on regulatory, compliance and transactional matters. A partner in our nationally recognized FDA and Life Sciences practice, Gary has almost 30 years of experience representing large multinational pharmaceutical and medical-device companies, as well as emerging companies.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGary advices clients in matters relating to the approval and commercialization of products that are regulated by the Food\u0026nbsp;and Drug Administration and other federal and state agencies.\u0026nbsp; 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.\u0026nbsp; 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.\u0026nbsp; 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.\u003c/p\u003e\n\u003cp\u003ePreviously, Gary was in-house counsel at Eli Lilly and Company, where he had global legal, regulatory and compliance responsibility for the company's top-selling pharmaceutical product at the time.\u003c/p\u003e\n\u003cp\u003eA frequent author and speaker on regulatory and compliance matters, Gary has been recognized for multiple years by\u0026nbsp;\u003cem\u003eSuper Lawyers Washington, DC\u003c/em\u003e.\u003c/p\u003e","slug":"gary-messplay","email":"gmessplay@kslaw.com","phone":"+1 703 973 7500","matters":["\u003cp\u003eDeveloped customized, comprehensive healthcare compliance programs for numerous \u003cstrong data-redactor-tag=\"strong\"\u003edrug and medical device companies.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eServed as outside general counsel to \u003cstrong data-redactor-tag=\"strong\"\u003especialty pharmaceutical companies and emerging drug and device companies.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eLed significant multi-year investigation for \u003cstrong data-redactor-tag=\"strong\"\u003ea large pharmaceutical company\u003c/strong\u003e involving complex data integrity issues related to their bioanalytics laboratory.\u003c/p\u003e","\u003cp\u003eAdvised numerous \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e related to product commercialization, including advertising and promotion, First Amendment issues, interactions with payors and responding to FDA enforcement.\u003c/p\u003e","\u003cp\u003eConducted a significant number of compliance investigations on behalf of \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies,\u003c/strong\u003e including large multinational investigations, involving off-label promotion, violations of the federal Anti-Kickback Statute and FCPA, whistleblower reports, clinical trial noncompliance, cGMP violations, GLP violations and PDMA/drug sampling.\u003c/p\u003e","\u003cp\u003eRepresented Board of Directors of \u003cstrong data-redactor-tag=\"strong\"\u003epublicly traded pharmaceutical company\u003c/strong\u003e in connection with an investigation involving the company's chief executive officer related to suspected violations of the federal Anti-Kickback Statute.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e on all aspects of compliance with their corporate integrity agreements.\u003c/p\u003e","\u003cp\u003eAdvised numerous \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical companies\u003c/strong\u003e on drug-approval strategies involving NDAs, product life cycle management, Hatch-Waxman and Orange Book issues.\u003c/p\u003e","\u003cp\u003eSuccessfully represented \u003cstrong data-redactor-tag=\"strong\"\u003ea specialty pharmaceutical company\u003c/strong\u003e in response to a petition filed by a public citizen seeking FDA withdrawal of popular pain medication.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in connection with FDA, OCI, Department of Justice, SEC and congressional investigations.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e related to clinical trial regulatory and compliance issues.\u003c/p\u003e","\u003cp\u003eAssisted \u003cstrong 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companies\u003c/strong\u003e in connection with competitor disputes, including serving as trial counsel in major Lanham Act litigation.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug, biotechnology, device, food and tobacco companies\u003c/strong\u003e on legislative matters including drafting and commenting on 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A partner in our nationally recognized FDA and Life Sciences practice, Gary has almost 30 years of experience representing large multinational pharmaceutical and medical-device companies, as well as emerging companies.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGary advices clients in matters relating to the approval and commercialization of products that are regulated by the Food\u0026nbsp;and Drug Administration and other federal and state agencies.\u0026nbsp; 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.\u0026nbsp; 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.\u0026nbsp; 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.\u003c/p\u003e\n\u003cp\u003ePreviously, Gary was in-house counsel at Eli Lilly and Company, where he had global legal, regulatory and compliance responsibility for the company's top-selling pharmaceutical product at the time.\u003c/p\u003e\n\u003cp\u003eA frequent author and speaker on regulatory and compliance matters, Gary has been recognized for multiple years by\u0026nbsp;\u003cem\u003eSuper Lawyers Washington, DC\u003c/em\u003e.\u003c/p\u003e","matters":["\u003cp\u003eDeveloped customized, comprehensive healthcare compliance programs for numerous \u003cstrong data-redactor-tag=\"strong\"\u003edrug and medical device companies.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eServed as outside general counsel to \u003cstrong data-redactor-tag=\"strong\"\u003especialty pharmaceutical companies and emerging drug and device companies.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eLed significant multi-year investigation for \u003cstrong data-redactor-tag=\"strong\"\u003ea large pharmaceutical company\u003c/strong\u003e involving complex data integrity issues related to their bioanalytics laboratory.\u003c/p\u003e","\u003cp\u003eAdvised numerous \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e related to product commercialization, including advertising and promotion, First Amendment issues, interactions with payors and responding to FDA enforcement.\u003c/p\u003e","\u003cp\u003eConducted a significant number of compliance investigations on behalf of \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies,\u003c/strong\u003e including large multinational investigations, involving off-label promotion, violations of the federal Anti-Kickback Statute and FCPA, whistleblower reports, clinical trial noncompliance, cGMP violations, GLP violations and PDMA/drug sampling.\u003c/p\u003e","\u003cp\u003eRepresented Board of Directors of \u003cstrong data-redactor-tag=\"strong\"\u003epublicly traded pharmaceutical company\u003c/strong\u003e in connection with an investigation involving the company's chief executive officer related to suspected violations of the federal Anti-Kickback Statute.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e on all aspects of compliance with their corporate integrity agreements.\u003c/p\u003e","\u003cp\u003eAdvised numerous \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical companies\u003c/strong\u003e on drug-approval strategies involving NDAs, product life cycle management, Hatch-Waxman and Orange Book issues.\u003c/p\u003e","\u003cp\u003eSuccessfully represented \u003cstrong data-redactor-tag=\"strong\"\u003ea specialty pharmaceutical company\u003c/strong\u003e in response to a petition filed by a public citizen seeking FDA withdrawal of popular pain medication.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in connection with FDA, OCI, Department of Justice, SEC and congressional investigations.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e related to clinical trial regulatory and compliance issues.\u003c/p\u003e","\u003cp\u003eAssisted \u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical companies\u003c/strong\u003e in developing and implementing specialty pharmacy programs.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in connection with adverse FDA inspections, including responding to 483s and warning letters.\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in transactional matters involving clinical trial agreements, CRO agreements, distribution agreements, specialty pharmacy agreements and all types of services agreements.\u003c/p\u003e","\u003cp\u003eLed numerous regulatory and compliance due diligence teams in \u003cstrong data-redactor-tag=\"strong\"\u003edrug, device, tobacco and food transactions.\u003c/strong\u003e\u003c/p\u003e","\u003cp\u003eRepresented \u003cstrong data-redactor-tag=\"strong\"\u003edrug and device companies\u003c/strong\u003e in connection with competitor disputes, including serving as trial counsel in major Lanham Act litigation.\u003c/p\u003e","\u003cp\u003eAdvised \u003cstrong data-redactor-tag=\"strong\"\u003edrug, biotechnology, device, food and tobacco companies\u003c/strong\u003e on legislative matters including drafting and commenting on legislation.\u003c/p\u003e"],"recognitions":[{"title":"","detail":"Super Lawyers, 2014, 2015 \u0026 2016"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":4357}]},"capability_group_id":2},"created_at":"2026-06-08T21:54:18.000Z","updated_at":"2026-06-08T21:54:18.000Z","searchable_text":"Messplay{{ FIELD }}{:title=\u0026gt;\"\", :detail=\u0026gt;\"Super Lawyers, 2014, 2015 \u0026amp; 2016\"}{{ FIELD }}Developed customized, comprehensive healthcare compliance programs for numerous drug and medical device companies.{{ FIELD }}Served as outside general counsel to specialty pharmaceutical companies and emerging drug and device companies.{{ FIELD }}Led significant multi-year investigation for a large pharmaceutical company involving complex data integrity issues related to their bioanalytics laboratory.{{ FIELD }}Advised numerous drug and device companies related to product commercialization, including advertising and promotion, First Amendment issues, interactions with payors and responding to FDA enforcement.{{ FIELD }}Conducted a significant number of compliance investigations on behalf of drug and device companies, including large multinational investigations, involving off-label promotion, violations of the federal Anti-Kickback Statute and FCPA, whistleblower reports, clinical trial noncompliance, cGMP violations, GLP violations and PDMA/drug sampling.{{ FIELD }}Represented Board of Directors of publicly traded pharmaceutical company in connection with an investigation involving the company's chief executive officer related to suspected violations of the federal Anti-Kickback Statute.{{ FIELD }}Advised drug and device companies on all aspects of compliance with their corporate integrity agreements.{{ FIELD }}Advised numerous pharmaceutical companies on drug-approval strategies involving NDAs, product life cycle management, Hatch-Waxman and Orange Book issues.{{ FIELD }}Successfully represented a specialty pharmaceutical company in response to a petition filed by a public citizen seeking FDA withdrawal of popular pain medication.{{ FIELD }}Represented drug and device companies in connection with FDA, OCI, Department of Justice, SEC and congressional investigations.{{ FIELD }}Advised drug and device companies related to clinical trial regulatory and compliance issues.{{ FIELD }}Assisted pharmaceutical companies in developing and implementing specialty pharmacy programs.{{ FIELD }}Represented drug and device companies in connection with adverse FDA inspections, including responding to 483s and warning letters.{{ FIELD }}Represented drug and device companies in transactional matters involving clinical trial agreements, CRO agreements, distribution agreements, specialty pharmacy agreements and all types of services agreements.{{ FIELD }}Led numerous regulatory and compliance due diligence teams in drug, device, tobacco and food transactions.{{ FIELD }}Represented drug and device companies in connection with competitor disputes, including serving as trial counsel in major Lanham Act litigation.{{ FIELD }}Advised drug, biotechnology, device, food and tobacco companies on legislative matters including drafting and commenting on legislation.{{ FIELD }}Gary Messplay specializes in advising life science companies on regulatory, compliance and transactional matters. A partner in our nationally recognized FDA and Life Sciences practice, Gary has almost 30 years of experience representing large multinational pharmaceutical and medical-device companies, as well as emerging companies.\nGary 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.\nPreviously, Gary was in-house counsel at Eli Lilly and Company, where he had global legal, regulatory and compliance responsibility for the company's top-selling pharmaceutical product at the time.\nA frequent author and speaker on regulatory and compliance matters, Gary has been recognized for multiple years by Super Lawyers Washington, DC. Partner  Super Lawyers, 2014, 2015 \u0026amp; 2016 Indiana University Indiana University School of Law Indiana University Indiana University School of Law District of Columbia Indiana Developed customized, comprehensive healthcare compliance programs for numerous drug and medical device companies. Served as outside general counsel to specialty pharmaceutical companies and emerging drug and device companies. Led significant multi-year investigation for a large pharmaceutical company involving complex data integrity issues related to their bioanalytics laboratory. Advised numerous drug and device companies related to product commercialization, including advertising and promotion, First Amendment issues, interactions with payors and responding to FDA enforcement. Conducted a significant number of compliance investigations on behalf of drug and device companies, including large multinational investigations, involving off-label promotion, violations of the federal Anti-Kickback Statute and FCPA, whistleblower reports, clinical trial noncompliance, cGMP violations, GLP violations and PDMA/drug sampling. Represented Board of Directors of publicly traded pharmaceutical company in connection with an investigation involving the company's chief executive officer related to suspected violations of the federal Anti-Kickback Statute. Advised drug and device companies on all aspects of compliance with their corporate integrity agreements. Advised numerous pharmaceutical companies on drug-approval strategies involving NDAs, product life cycle management, Hatch-Waxman and Orange Book issues. Successfully represented a specialty pharmaceutical company in response to a petition filed by a public citizen seeking FDA withdrawal of popular pain medication. Represented drug and device companies in connection with FDA, OCI, Department of Justice, SEC and congressional investigations. Advised drug and device companies related to clinical trial regulatory and compliance issues. Assisted pharmaceutical companies in developing and implementing specialty pharmacy programs. Represented drug and device companies in connection with adverse FDA inspections, including responding to 483s and warning letters. Represented drug and device companies in transactional matters involving clinical trial agreements, CRO agreements, distribution agreements, specialty pharmacy agreements and all types of services agreements. Led numerous regulatory and compliance due diligence teams in drug, device, tobacco and food transactions. Represented drug and device companies in connection with competitor disputes, including serving as trial counsel in major Lanham Act litigation. Advised drug, biotechnology, device, food and tobacco companies on legislative matters including drafting and commenting on legislation.","searchable_name":"Gary C. Messplay","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":442801,"version":1,"owner_type":"Person","owner_id":5630,"payload":{"bio":"\u003cp\u003eGenevi\u0026egrave;ve Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.\u003c/p\u003e\n\u003cp\u003eRecognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Genevi\u0026egrave;ve assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve\u0026rsquo;s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. She has advised on various issues arising out of the EU Pediatric Regulation, EU Orphan Regulation, SPC and SPC extension, and ATMPs at the European and national level. She also counsels startups on establishing themselves in the EU as well as complying with advertising and scientific information rules, regulatory and legal guidance.\u003c/p\u003e\n\u003cp\u003eShe assists life sciences companies in forming patient/compassionate use programs in Europe, negotiating and drafting consortia related agreements, reviewing clinical trial and clinical investigation agreements, interacting with healthcare professionals in connection with advertising and promotion efforts, and product classification matters such as borderlines between drug, medical device, cosmetic and food supplement, and assistance with local authorities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve has extensive litigation experience in life science matters, including product liability and advertising and promotional activities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve is recognized as one of the \"Most Highly Regarded Individuals\" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an \"unsurpassed knowledge of legal areas,\" as well as being \"extremely dedicated to the case and the client.\" She has published numerous articles on food and drug law and speaks at legal and regulatory conferences on pharmaceuticals and medical devices.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eOctober 2019, \u0026ldquo;Are the paediatric rewards adapted? \u0026ldquo;, Clinical Research in Paediatric Psychopharmacology, P. Auby, Elsevier, 2020\u003c/li\u003e\n\u003cli\u003eMay 30, 2019, \u0026ldquo;The regulation of advanced therapy medicinal products\u0026rdquo;\u0026nbsp;\u003cem\u003eLexisNexis.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2017, \u0026ldquo;Pediatric Regulation \u0026ndash; A Better application for more efficient incentives,\u0026rdquo;\u0026nbsp;\u003cem\u003eThe European Files, Medicines of the Future.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eSeptember 2016, \u0026ldquo;Should Anthroposophic Medicinal Products Be Regulated in Europe?\u0026rdquo;\u0026nbsp;\u003cem\u003eJournal of European Health Law\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eJune 8, 2016, \u0026ldquo;Demonstrating Significant Benefit For Orphan Medicines \u0026ndash; Is It Time For A Drastic Change?\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;EU Pediatric Rewards \u0026ndash; More Questions than Answers,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eFebruary 2016, \u0026ldquo;The Need For Clarification On Post-Market Requirements For Pediatric Medicines,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eSpeaking Engagements\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eSeptember 9, 2019, \u0026ldquo;\u003cem\u003eSummary of Key EUCJ Decisions\u003c/em\u003e,\u0026rdquo; European Pharmaceutical Law Academy.\u003c/li\u003e\n\u003cli\u003eJune 5, 2019, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eSeptember 10, 2018, \u0026ldquo;ATMP Regulatory Framework\u003cem\u003e,\u0026rdquo;\u0026nbsp;\u003c/em\u003eEuropean Pharmaceutical Law Academy, Cambridge, UK.\u003c/li\u003e\n\u003cli\u003eJune 2018, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eMay 15, 2018, \u0026ldquo;International Labeling Regulatory Requirements,\u0026rdquo; co-presented with Hank Bullock, 8th Annual Medical Device \u0026amp; Diagnostic Labeling Conference in Chicago, IL.\u003c/li\u003e\n\u003cli\u003eMarch 21, 2018, Workshop on Pediatric Regulation and SMi in London.\u003c/li\u003e\n\u003cli\u003eMarch 2018, ATMPs \u0026ndash; Challenges and Promises, ERA, EU Pharmaceutical Law.\u003c/li\u003e\n\u003cli\u003eNovember 2017, Borderline issues, Congr\u0026egrave;s Parfums \u0026amp; Cosm\u0026eacute;tiques, Enjeux r\u0026eacute;glementaires, Chartres.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, SPCs and Regulatory Concepts, 9th SPC Forum, Riga.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, Pediatric Regulation, KNet365, Pharmaceutical Law Academy, Cambridge (UK).\u003c/li\u003e\n\u003cli\u003eJune 2017, Regulatory protections, KNet365, Life Science IP Minds 2017, London.\u0026nbsp;\u003c/li\u003e\n\u003cli\u003eMarch 2017, Pediatric rewards, SMI, Pediatric Clinical Trials, London.\u003c/li\u003e\n\u003cli\u003eMarch 2017, Revision of the Pediatric Regulation, DIA, 29th Annual EuroMeeting, Glasgow.\u003c/li\u003e\n\u003cli\u003eNovember 2016, SPCs and Regulatory Authorizations, 7th SPC forum in Paris, France.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Protection for Mature Product,\u0026rdquo; DIA, 28th Annual EuroMeeting, Hamburg.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Interactions between regulatory and intellectual property, product liability and data privacy,\u0026rdquo; DIA, 28th Annual EuroMeeting in Hamburg.\u003c/li\u003e\n\u003c/ul\u003e","slug":"genevieve-michaux","email":"gmichaux@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":1,"source":"capabilities"},{"id":13,"guid":"13.capabilities","index":2,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":3,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":4,"source":"capabilities"},{"id":105,"guid":"105.capabilities","index":5,"source":"capabilities"},{"id":780,"guid":"780.smart_tags","index":6,"source":"smartTags"},{"id":761,"guid":"761.smart_tags","index":7,"source":"smartTags"},{"id":970,"guid":"970.smart_tags","index":8,"source":"smartTags"},{"id":112,"guid":"112.capabilities","index":9,"source":"capabilities"},{"id":114,"guid":"114.capabilities","index":10,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":11,"source":"smartTags"},{"id":1223,"guid":"1223.smart_tags","index":12,"source":"smartTags"},{"id":128,"guid":"128.capabilities","index":13,"source":"capabilities"}],"is_active":true,"last_name":"Michaux","nick_name":"Geneviève","clerkships":[],"first_name":"Geneviève","title_rank":9999,"updated_by":101,"law_schools":[{"id":824,"meta":{"degree":"Law Degree","honors":null,"is_law_school":1,"graduation_date":"1996-01-01 00:00:00 UTC"},"order":0,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":[{"title":"Ranked in the Regulatory Practice","detail":"Best Lawyers Belgium, 2022"},{"title":"Global Elite Thought Leaders EMEA","detail":"WWL Life Sciences Report, 2022"},{"title":"Who's Who Legal, Life Sciences","detail":"2011–2022"},{"title":"Excellent in Healthcare, pharmaceuticals \u0026 biotech","detail":"Leadersleague Décideurs Belgium Life Sciences guide, 2021"},{"title":"Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology","detail":"2012"},{"title":"PLC Which Lawyer?, Life Sciences","detail":"Regulatory, EU, 2012"},{"title":"de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study","detail":"1988"}],"linked_in_url":"https://www.linkedin.com/in/geneviève-michaux-165829/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eGenevi\u0026egrave;ve Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.\u003c/p\u003e\n\u003cp\u003eRecognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Genevi\u0026egrave;ve assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve\u0026rsquo;s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. She has advised on various issues arising out of the EU Pediatric Regulation, EU Orphan Regulation, SPC and SPC extension, and ATMPs at the European and national level. She also counsels startups on establishing themselves in the EU as well as complying with advertising and scientific information rules, regulatory and legal guidance.\u003c/p\u003e\n\u003cp\u003eShe assists life sciences companies in forming patient/compassionate use programs in Europe, negotiating and drafting consortia related agreements, reviewing clinical trial and clinical investigation agreements, interacting with healthcare professionals in connection with advertising and promotion efforts, and product classification matters such as borderlines between drug, medical device, cosmetic and food supplement, and assistance with local authorities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve has extensive litigation experience in life science matters, including product liability and advertising and promotional activities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve is recognized as one of the \"Most Highly Regarded Individuals\" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an \"unsurpassed knowledge of legal areas,\" as well as being \"extremely dedicated to the case and the client.\" She has published numerous articles on food and drug law and speaks at legal and regulatory conferences on pharmaceuticals and medical devices.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eOctober 2019, \u0026ldquo;Are the paediatric rewards adapted? \u0026ldquo;, Clinical Research in Paediatric Psychopharmacology, P. Auby, Elsevier, 2020\u003c/li\u003e\n\u003cli\u003eMay 30, 2019, \u0026ldquo;The regulation of advanced therapy medicinal products\u0026rdquo;\u0026nbsp;\u003cem\u003eLexisNexis.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2017, \u0026ldquo;Pediatric Regulation \u0026ndash; A Better application for more efficient incentives,\u0026rdquo;\u0026nbsp;\u003cem\u003eThe European Files, Medicines of the Future.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eSeptember 2016, \u0026ldquo;Should Anthroposophic Medicinal Products Be Regulated in Europe?\u0026rdquo;\u0026nbsp;\u003cem\u003eJournal of European Health Law\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eJune 8, 2016, \u0026ldquo;Demonstrating Significant Benefit For Orphan Medicines \u0026ndash; Is It Time For A Drastic Change?\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;EU Pediatric Rewards \u0026ndash; More Questions than Answers,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eFebruary 2016, \u0026ldquo;The Need For Clarification On Post-Market Requirements For Pediatric Medicines,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eSpeaking Engagements\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eSeptember 9, 2019, \u0026ldquo;\u003cem\u003eSummary of Key EUCJ Decisions\u003c/em\u003e,\u0026rdquo; European Pharmaceutical Law Academy.\u003c/li\u003e\n\u003cli\u003eJune 5, 2019, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eSeptember 10, 2018, \u0026ldquo;ATMP Regulatory Framework\u003cem\u003e,\u0026rdquo;\u0026nbsp;\u003c/em\u003eEuropean Pharmaceutical Law Academy, Cambridge, UK.\u003c/li\u003e\n\u003cli\u003eJune 2018, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eMay 15, 2018, \u0026ldquo;International Labeling Regulatory Requirements,\u0026rdquo; co-presented with Hank Bullock, 8th Annual Medical Device \u0026amp; Diagnostic Labeling Conference in Chicago, IL.\u003c/li\u003e\n\u003cli\u003eMarch 21, 2018, Workshop on Pediatric Regulation and SMi in London.\u003c/li\u003e\n\u003cli\u003eMarch 2018, ATMPs \u0026ndash; Challenges and Promises, ERA, EU Pharmaceutical Law.\u003c/li\u003e\n\u003cli\u003eNovember 2017, Borderline issues, Congr\u0026egrave;s Parfums \u0026amp; Cosm\u0026eacute;tiques, Enjeux r\u0026eacute;glementaires, Chartres.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, SPCs and Regulatory Concepts, 9th SPC Forum, Riga.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, Pediatric Regulation, KNet365, Pharmaceutical Law Academy, Cambridge (UK).\u003c/li\u003e\n\u003cli\u003eJune 2017, Regulatory protections, KNet365, Life Science IP Minds 2017, London.\u0026nbsp;\u003c/li\u003e\n\u003cli\u003eMarch 2017, Pediatric rewards, SMI, Pediatric Clinical Trials, London.\u003c/li\u003e\n\u003cli\u003eMarch 2017, Revision of the Pediatric Regulation, DIA, 29th Annual EuroMeeting, Glasgow.\u003c/li\u003e\n\u003cli\u003eNovember 2016, SPCs and Regulatory Authorizations, 7th SPC forum in Paris, France.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Protection for Mature Product,\u0026rdquo; DIA, 28th Annual EuroMeeting, Hamburg.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Interactions between regulatory and intellectual property, product liability and data privacy,\u0026rdquo; DIA, 28th Annual EuroMeeting in Hamburg.\u003c/li\u003e\n\u003c/ul\u003e","recognitions":[{"title":"Ranked in the Regulatory Practice","detail":"Best Lawyers Belgium, 2022"},{"title":"Global Elite Thought Leaders EMEA","detail":"WWL Life Sciences Report, 2022"},{"title":"Who's Who Legal, Life Sciences","detail":"2011–2022"},{"title":"Excellent in Healthcare, pharmaceuticals \u0026 biotech","detail":"Leadersleague Décideurs Belgium Life Sciences guide, 2021"},{"title":"Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology","detail":"2012"},{"title":"PLC Which Lawyer?, Life Sciences","detail":"Regulatory, EU, 2012"},{"title":"de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study","detail":"1988"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":8884}]},"capability_group_id":2},"created_at":"2025-11-13T04:57:39.000Z","updated_at":"2025-11-13T04:57:39.000Z","searchable_text":"Michaux{{ FIELD }}{:title=\u0026gt;\"Ranked in the Regulatory Practice\", :detail=\u0026gt;\"Best Lawyers Belgium, 2022\"}{{ FIELD }}{:title=\u0026gt;\"Global Elite Thought Leaders EMEA\", :detail=\u0026gt;\"WWL Life Sciences Report, 2022\"}{{ FIELD }}{:title=\u0026gt;\"Who's Who Legal, Life Sciences\", :detail=\u0026gt;\"2011–2022\"}{{ FIELD }}{:title=\u0026gt;\"Excellent in Healthcare, pharmaceuticals \u0026amp; biotech\", :detail=\u0026gt;\"Leadersleague Décideurs Belgium Life Sciences guide, 2021\"}{{ FIELD }}{:title=\u0026gt;\"Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology\", :detail=\u0026gt;\"2012\"}{{ FIELD }}{:title=\u0026gt;\"PLC Which Lawyer?, Life Sciences\", :detail=\u0026gt;\"Regulatory, EU, 2012\"}{{ FIELD }}{:title=\u0026gt;\"de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study\", :detail=\u0026gt;\"1988\"}{{ FIELD }}Geneviève Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.\nRecognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Geneviève assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.\nGeneviève’s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. She has advised on various issues arising out of the EU Pediatric Regulation, EU Orphan Regulation, SPC and SPC extension, and ATMPs at the European and national level. She also counsels startups on establishing themselves in the EU as well as complying with advertising and scientific information rules, regulatory and legal guidance.\nShe assists life sciences companies in forming patient/compassionate use programs in Europe, negotiating and drafting consortia related agreements, reviewing clinical trial and clinical investigation agreements, interacting with healthcare professionals in connection with advertising and promotion efforts, and product classification matters such as borderlines between drug, medical device, cosmetic and food supplement, and assistance with local authorities.\nGeneviève has extensive litigation experience in life science matters, including product liability and advertising and promotional activities.\nGeneviève is recognized as one of the \"Most Highly Regarded Individuals\" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an \"unsurpassed knowledge of legal areas,\" as well as being \"extremely dedicated to the case and the client.\" She has published numerous articles on food and drug law and speaks at legal and regulatory conferences on pharmaceuticals and medical devices.\nPublications\n\nOctober 2019, “Are the paediatric rewards adapted? “, Clinical Research in Paediatric Psychopharmacology, P. Auby, Elsevier, 2020\nMay 30, 2019, “The regulation of advanced therapy medicinal products” LexisNexis.\nApril 2017, “Pediatric Regulation – A Better application for more efficient incentives,” The European Files, Medicines of the Future.\nSeptember 2016, “Should Anthroposophic Medicinal Products Be Regulated in Europe?” Journal of European Health Law\nJune 8, 2016, “Demonstrating Significant Benefit For Orphan Medicines – Is It Time For A Drastic Change?” Scrip Regulatory Affairs.\nApril 2016, “EU Pediatric Rewards – More Questions than Answers,” Scrip Regulatory Affairs.\nFebruary 2016, “The Need For Clarification On Post-Market Requirements For Pediatric Medicines,” Scrip Regulatory Affairs.\n\nSpeaking Engagements\n\nSeptember 9, 2019, “Summary of Key EUCJ Decisions,” European Pharmaceutical Law Academy.\nJune 5, 2019, “Approval Process for Drugs and Medical Devices,” European Healthcare Industry Training: Compliance Certificate Program.\nSeptember 10, 2018, “ATMP Regulatory Framework,” European Pharmaceutical Law Academy, Cambridge, UK.\nJune 2018, “Approval Process for Drugs and Medical Devices,” European Healthcare Industry Training: Compliance Certificate Program.\nMay 15, 2018, “International Labeling Regulatory Requirements,” co-presented with Hank Bullock, 8th Annual Medical Device \u0026amp; Diagnostic Labeling Conference in Chicago, IL.\nMarch 21, 2018, Workshop on Pediatric Regulation and SMi in London.\nMarch 2018, ATMPs – Challenges and Promises, ERA, EU Pharmaceutical Law.\nNovember 2017, Borderline issues, Congrès Parfums \u0026amp; Cosmétiques, Enjeux réglementaires, Chartres.\nSeptember 2017, SPCs and Regulatory Concepts, 9th SPC Forum, Riga.\nSeptember 2017, Pediatric Regulation, KNet365, Pharmaceutical Law Academy, Cambridge (UK).\nJune 2017, Regulatory protections, KNet365, Life Science IP Minds 2017, London. \nMarch 2017, Pediatric rewards, SMI, Pediatric Clinical Trials, London.\nMarch 2017, Revision of the Pediatric Regulation, DIA, 29th Annual EuroMeeting, Glasgow.\nNovember 2016, SPCs and Regulatory Authorizations, 7th SPC forum in Paris, France.\nApril 2016, “Protection for Mature Product,” DIA, 28th Annual EuroMeeting, Hamburg.\nApril 2016, “Interactions between regulatory and intellectual property, product liability and data privacy,” DIA, 28th Annual EuroMeeting in Hamburg.\n Partner Ranked in the Regulatory Practice Best Lawyers Belgium, 2022 Global Elite Thought Leaders EMEA WWL Life Sciences Report, 2022 Who's Who Legal, Life Sciences 2011–2022 Excellent in Healthcare, pharmaceuticals \u0026amp; biotech Leadersleague Décideurs Belgium Life Sciences guide, 2021 Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology 2012 PLC Which Lawyer?, Life Sciences Regulatory, EU, 2012 de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study 1988 Harvard University Harvard Law School Universite Libre de Bruxelles, Belgium  Paris Brussels Member of the editorial board of SCRIP Regulatory Affairs Mediator with the Brussels Business Mediation Center Member of the DIA Advisory Committee for Europe Middle East Africa Foreign Correspondent Member of the National Academy of Pharmacy (France)","searchable_name":"Geneviève Michaux","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":448871,"version":1,"owner_type":"Person","owner_id":986,"payload":{"bio":"\u003cp\u003eNikki Reeves is an FDA and healthcare regulatory compliance lawyer with more than 25\u0026nbsp;years of experience.\u0026nbsp; Nikki co-chairs the firm's Government Matters \u0026amp; Regulatory practice management group, which is comprised of 200+ lawyers and consultants in eight practice areas.\u0026nbsp; Nikki previously co-chaired\u0026nbsp;the firm\u0026rsquo;s Life Sciences and Healthcare Industry Group for six years, which is comprised of more than 450\u0026nbsp;lawyers across seventeen practice areas in the firm.\u0026nbsp; In 2024, Nikki was a winner of Corporate Counsel's 2024 Women, Influence \u0026amp; Power in Law Award for Law Firm Thought Leadership.\u0026nbsp; Nikki is ranked nationally by \u003cem\u003eChambers USA\u003c/em\u003e\u0026nbsp;for Life Sciences: Regulatory Compliance and for Pharmaceuticals/Medical Products Regulatory from 2021-2025, named a\u0026nbsp;\u003cem\u003eLMG Life Sciences Star\u003c/em\u003e in FDA Pharmaceutical and in FDA Medical Device from 2019-2025, and was named a\u0026nbsp;\u003cem\u003eLaw360 Compliance MVP\u003c/em\u003e\u0026nbsp;in 2020.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs Deputy Chair of our FDA \u0026amp; Life Sciences practice, Nikki advises pharmaceutical and medical device companies on pre- and post-market FDA regulatory compliance and enforcement matters ranging from clinical trials, good manufacturing practices, to labeling, advertising, and promotion of FDA-regulated products.\u0026nbsp; Nikki has been the lead FDA regulatory advisor to her clients on 250+ transactional matters.\u0026nbsp; She conducts investigations into FDA clinical trials and post-marking noncompliance, acts as lead compliance and regulatory counsel for several companies under Corporate Integrity Agreements (CIAs) and has led several CMS Open Payments compliance audits.\u0026nbsp; She is an expert on federal Open Payments, state, and international transparency/disclosure laws and leads two pharma and device industry compliance coalitions.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eNikki counsels pharma and device companies on FDA inspections, Form 483s, Warning Letters, product recalls, import detentions, clinical holds, and other FDA compliance and enforcement matters.\u0026nbsp; She conducts risk assessments and internal investigations into allegations of FDA and healthcare program noncompliance.\u0026nbsp; She routinely advises company executives and board members and represents her clients before federal agencies.\u0026nbsp; She has established robust compliance programs and policies for numerous life sciences companies. Nikki has also served as an interim General Counsel and as a Chief Compliance Officer for her life sciences clients.\u003c/p\u003e\n\u003cp\u003eNikki leads two pharma and device industry coalitions on transparency and disclosure laws.\u0026nbsp; The\u0026nbsp;\u003cem\u003eAd Hoc Sunshine and State Law Compliance Group\u003c/em\u003e is a coalition she advises on federal Sunshine Act and state transparency/disclosure and gift ban laws.\u0026nbsp; The \u003cem\u003eInternational Marketing and Disclosure Compliance Group\u003c/em\u003e is a separate coalition of companies she advises on the growing area of transparency and disclosure laws and industry codes of conduct in the EU, Australia, Japan, and numerous other countries and regions.\u003c/p\u003e\n\u003cp\u003eKing \u0026amp; Spalding\u0026rsquo;s FDA \u0026amp; Life Sciences Practice has been named \u003cem\u003eLaw360\u003c/em\u003e Practice Group of the Year from 2017-2020.\u0026nbsp; King \u0026amp; Spalding\u0026rsquo;s FDA \u0026amp; Life Sciences Practice is ranked by Chambers Legal, LMG Life Sciences, U.S. News, and Best Lawyers.\u0026nbsp; According to\u0026nbsp;\u003cem\u003eChambers USA, sources praise Nikki as being \"thoughtful, quick to respond and available.\" -- Chambers USA\u003c/em\u003e\u0026nbsp;(2022)\u003c/p\u003e\n\u003cp\u003eNikki is a frequent speaker and author on FDA advertising/promotion, clinical trials, compliance, and transparency law matters.\u0026nbsp; Nikki was also selected to Law360's 2021 Compliance Editorial Advisory Board\u0026nbsp;and has served\u0026nbsp;on the\u0026nbsp;Advisory Board for FDAnews and the PCF Pharma Congress planning committee.\u0026nbsp; She was formerly on the Food and Drug Law Institute (FDLI) Editorial Advisory Board for the \u003cem\u003eFDLI Food \u0026amp; Drug Law Journal\u003c/em\u003e and a member of the FDLI Medical Device Committee.\u0026nbsp; Nikki has also served on the Leadership Advisory Board for the National Women\u0026rsquo;s Law Center and on the Special Gifts Committee for the Arlington Free Clinic for more than ten\u0026nbsp;years.\u003c/p\u003e\n\u003cp\u003eNikki was elected by her partners in 2017 to serve for three years\u0026nbsp;on the firm\u0026rsquo;s Policy Committee, which is the firm's executive management committee.\u0026nbsp; Nikki served for many years on the firm\u0026rsquo;s Lateral Partner Committee and on the firm's Partners Committee, and was also the Hiring Partner for the Washington, D.C. office.\u003c/p\u003e","slug":"nikki-reeves","email":"nreeves@kslaw.com","phone":null,"matters":["\u003cp\u003eAdvised companies on FDA advertising and promotion rules for drugs, devices, and cosmetics, including social media, new product launches, DTC, physician and payor communications, broadcast ads, reprints, and investor communications.\u003c/p\u003e","\u003cp\u003eAdvised on CMS Open Payments compliance audits and compliance with the federal Physician Payment Sunshine (Open Payments) law, state laws targeting industry marketing practices, sales representation licensing, drug price transparency, and disclosure of clinical trial data. Advised on compliance with global transparency laws and industry codes of conduct.\u003c/p\u003e","\u003cp\u003eAdvised life sciences clients on preparing for FDA inspections of clinical trials sites and manufacturing facilities, and responding to FDA Form 483s, FDA Warning Letters, product recalls, import detentions, and government investigations involving alleged advertising/promotion violations.\u003c/p\u003e","\u003cp\u003eConducted FDA regulatory due diligence and related counseling in connection with more than 200+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies.\u003c/p\u003e","\u003cp\u003eStand up healthcare compliance programs for pharmaceutical and medical device manufacturers and related healthcare compliance policies and codes of conduct. Served as interim Chief Compliance Officer for a pharmaceutical manufacturer for a two year period and managed all aspects of the company healthcare compliance program.\u003c/p\u003e","\u003cp\u003eConducted internal investigations into potential FDA GCP, GMP, and healthcare compliance policy violations.\u003c/p\u003e","\u003cp\u003eLed risk assessments of healthcare regulatory compliance programs and policies and advised on compliance with FDA regulations, HHS OIG Compliance Program Guidance, and the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":245}]},"expertise":[{"id":81,"guid":"81.capabilities","index":0,"source":"capabilities"},{"id":761,"guid":"761.smart_tags","index":1,"source":"smartTags"},{"id":21,"guid":"21.capabilities","index":2,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":3,"source":"capabilities"},{"id":32,"guid":"32.capabilities","index":4,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":5,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":6,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":7,"source":"capabilities"},{"id":970,"guid":"970.smart_tags","index":8,"source":"smartTags"},{"id":109,"guid":"109.capabilities","index":9,"source":"capabilities"},{"id":112,"guid":"112.capabilities","index":10,"source":"capabilities"},{"id":114,"guid":"114.capabilities","index":11,"source":"capabilities"},{"id":120,"guid":"120.capabilities","index":12,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":13,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":14,"source":"smartTags"},{"id":1223,"guid":"1223.smart_tags","index":15,"source":"smartTags"},{"id":135,"guid":"135.capabilities","index":16,"source":"capabilities"}],"is_active":true,"last_name":"Reeves","nick_name":"Nikki","clerkships":[],"first_name":"Nikki","title_rank":9999,"updated_by":202,"law_schools":[],"middle_name":" ","name_suffix":"","recognitions":[{"title":"Women, Influence \u0026 Power in Law Award for Thought Leadership","detail":"Corporate Counsel 2024"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eNikki Reeves is an FDA and healthcare regulatory compliance lawyer with more than 25\u0026nbsp;years of experience.\u0026nbsp; Nikki co-chairs the firm's Government Matters \u0026amp; Regulatory practice management group, which is comprised of 200+ lawyers and consultants in eight practice areas.\u0026nbsp; Nikki previously co-chaired\u0026nbsp;the firm\u0026rsquo;s Life Sciences and Healthcare Industry Group for six years, which is comprised of more than 450\u0026nbsp;lawyers across seventeen practice areas in the firm.\u0026nbsp; In 2024, Nikki was a winner of Corporate Counsel's 2024 Women, Influence \u0026amp; Power in Law Award for Law Firm Thought Leadership.\u0026nbsp; Nikki is ranked nationally by \u003cem\u003eChambers USA\u003c/em\u003e\u0026nbsp;for Life Sciences: Regulatory Compliance and for Pharmaceuticals/Medical Products Regulatory from 2021-2025, named a\u0026nbsp;\u003cem\u003eLMG Life Sciences Star\u003c/em\u003e in FDA Pharmaceutical and in FDA Medical Device from 2019-2025, and was named a\u0026nbsp;\u003cem\u003eLaw360 Compliance MVP\u003c/em\u003e\u0026nbsp;in 2020.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAs Deputy Chair of our FDA \u0026amp; Life Sciences practice, Nikki advises pharmaceutical and medical device companies on pre- and post-market FDA regulatory compliance and enforcement matters ranging from clinical trials, good manufacturing practices, to labeling, advertising, and promotion of FDA-regulated products.\u0026nbsp; Nikki has been the lead FDA regulatory advisor to her clients on 250+ transactional matters.\u0026nbsp; She conducts investigations into FDA clinical trials and post-marking noncompliance, acts as lead compliance and regulatory counsel for several companies under Corporate Integrity Agreements (CIAs) and has led several CMS Open Payments compliance audits.\u0026nbsp; She is an expert on federal Open Payments, state, and international transparency/disclosure laws and leads two pharma and device industry compliance coalitions.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eNikki counsels pharma and device companies on FDA inspections, Form 483s, Warning Letters, product recalls, import detentions, clinical holds, and other FDA compliance and enforcement matters.\u0026nbsp; She conducts risk assessments and internal investigations into allegations of FDA and healthcare program noncompliance.\u0026nbsp; She routinely advises company executives and board members and represents her clients before federal agencies.\u0026nbsp; She has established robust compliance programs and policies for numerous life sciences companies. Nikki has also served as an interim General Counsel and as a Chief Compliance Officer for her life sciences clients.\u003c/p\u003e\n\u003cp\u003eNikki leads two pharma and device industry coalitions on transparency and disclosure laws.\u0026nbsp; The\u0026nbsp;\u003cem\u003eAd Hoc Sunshine and State Law Compliance Group\u003c/em\u003e is a coalition she advises on federal Sunshine Act and state transparency/disclosure and gift ban laws.\u0026nbsp; The \u003cem\u003eInternational Marketing and Disclosure Compliance Group\u003c/em\u003e is a separate coalition of companies she advises on the growing area of transparency and disclosure laws and industry codes of conduct in the EU, Australia, Japan, and numerous other countries and regions.\u003c/p\u003e\n\u003cp\u003eKing \u0026amp; Spalding\u0026rsquo;s FDA \u0026amp; Life Sciences Practice has been named \u003cem\u003eLaw360\u003c/em\u003e Practice Group of the Year from 2017-2020.\u0026nbsp; King \u0026amp; Spalding\u0026rsquo;s FDA \u0026amp; Life Sciences Practice is ranked by Chambers Legal, LMG Life Sciences, U.S. News, and Best Lawyers.\u0026nbsp; According to\u0026nbsp;\u003cem\u003eChambers USA, sources praise Nikki as being \"thoughtful, quick to respond and available.\" -- Chambers USA\u003c/em\u003e\u0026nbsp;(2022)\u003c/p\u003e\n\u003cp\u003eNikki is a frequent speaker and author on FDA advertising/promotion, clinical trials, compliance, and transparency law matters.\u0026nbsp; Nikki was also selected to Law360's 2021 Compliance Editorial Advisory Board\u0026nbsp;and has served\u0026nbsp;on the\u0026nbsp;Advisory Board for FDAnews and the PCF Pharma Congress planning committee.\u0026nbsp; She was formerly on the Food and Drug Law Institute (FDLI) Editorial Advisory Board for the \u003cem\u003eFDLI Food \u0026amp; Drug Law Journal\u003c/em\u003e and a member of the FDLI Medical Device Committee.\u0026nbsp; Nikki has also served on the Leadership Advisory Board for the National Women\u0026rsquo;s Law Center and on the Special Gifts Committee for the Arlington Free Clinic for more than ten\u0026nbsp;years.\u003c/p\u003e\n\u003cp\u003eNikki was elected by her partners in 2017 to serve for three years\u0026nbsp;on the firm\u0026rsquo;s Policy Committee, which is the firm's executive management committee.\u0026nbsp; Nikki served for many years on the firm\u0026rsquo;s Lateral Partner Committee and on the firm's Partners Committee, and was also the Hiring Partner for the Washington, D.C. office.\u003c/p\u003e","matters":["\u003cp\u003eAdvised companies on FDA advertising and promotion rules for drugs, devices, and cosmetics, including social media, new product launches, DTC, physician and payor communications, broadcast ads, reprints, and investor communications.\u003c/p\u003e","\u003cp\u003eAdvised on CMS Open Payments compliance audits and compliance with the federal Physician Payment Sunshine (Open Payments) law, state laws targeting industry marketing practices, sales representation licensing, drug price transparency, and disclosure of clinical trial data. Advised on compliance with global transparency laws and industry codes of conduct.\u003c/p\u003e","\u003cp\u003eAdvised life sciences clients on preparing for FDA inspections of clinical trials sites and manufacturing facilities, and responding to FDA Form 483s, FDA Warning Letters, product recalls, import detentions, and government investigations involving alleged advertising/promotion violations.\u003c/p\u003e","\u003cp\u003eConducted FDA regulatory due diligence and related counseling in connection with more than 200+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies.\u003c/p\u003e","\u003cp\u003eStand up healthcare compliance programs for pharmaceutical and medical device manufacturers and related healthcare compliance policies and codes of conduct. Served as interim Chief Compliance Officer for a pharmaceutical manufacturer for a two year period and managed all aspects of the company healthcare compliance program.\u003c/p\u003e","\u003cp\u003eConducted internal investigations into potential FDA GCP, GMP, and healthcare compliance policy violations.\u003c/p\u003e","\u003cp\u003eLed risk assessments of healthcare regulatory compliance programs and policies and advised on compliance with FDA regulations, HHS OIG Compliance Program Guidance, and the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals.\u003c/p\u003e"],"recognitions":[{"title":"Women, Influence \u0026 Power in Law Award for Thought Leadership","detail":"Corporate Counsel 2024"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1139}]},"capability_group_id":2},"created_at":"2026-05-28T22:09:02.000Z","updated_at":"2026-05-28T22:09:02.000Z","searchable_text":"Reeves{{ FIELD }}{:title=\u0026gt;\"Women, Influence \u0026amp; Power in Law Award for Thought Leadership\", :detail=\u0026gt;\"Corporate Counsel 2024\"}{{ FIELD }}Advised companies on FDA advertising and promotion rules for drugs, devices, and cosmetics, including social media, new product launches, DTC, physician and payor communications, broadcast ads, reprints, and investor communications.{{ FIELD }}Advised on CMS Open Payments compliance audits and compliance with the federal Physician Payment Sunshine (Open Payments) law, state laws targeting industry marketing practices, sales representation licensing, drug price transparency, and disclosure of clinical trial data. Advised on compliance with global transparency laws and industry codes of conduct.{{ FIELD }}Advised life sciences clients on preparing for FDA inspections of clinical trials sites and manufacturing facilities, and responding to FDA Form 483s, FDA Warning Letters, product recalls, import detentions, and government investigations involving alleged advertising/promotion violations.{{ FIELD }}Conducted FDA regulatory due diligence and related counseling in connection with more than 200+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies.{{ FIELD }}Stand up healthcare compliance programs for pharmaceutical and medical device manufacturers and related healthcare compliance policies and codes of conduct. Served as interim Chief Compliance Officer for a pharmaceutical manufacturer for a two year period and managed all aspects of the company healthcare compliance program.{{ FIELD }}Conducted internal investigations into potential FDA GCP, GMP, and healthcare compliance policy violations.{{ FIELD }}Led risk assessments of healthcare regulatory compliance programs and policies and advised on compliance with FDA regulations, HHS OIG Compliance Program Guidance, and the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals.{{ FIELD }}Nikki Reeves is an FDA and healthcare regulatory compliance lawyer with more than 25 years of experience.  Nikki co-chairs the firm's Government Matters \u0026amp; Regulatory practice management group, which is comprised of 200+ lawyers and consultants in eight practice areas.  Nikki previously co-chaired the firm’s Life Sciences and Healthcare Industry Group for six years, which is comprised of more than 450 lawyers across seventeen practice areas in the firm.  In 2024, Nikki was a winner of Corporate Counsel's 2024 Women, Influence \u0026amp; Power in Law Award for Law Firm Thought Leadership.  Nikki is ranked nationally by Chambers USA for Life Sciences: Regulatory Compliance and for Pharmaceuticals/Medical Products Regulatory from 2021-2025, named a LMG Life Sciences Star in FDA Pharmaceutical and in FDA Medical Device from 2019-2025, and was named a Law360 Compliance MVP in 2020. \nAs Deputy Chair of our FDA \u0026amp; Life Sciences practice, Nikki advises pharmaceutical and medical device companies on pre- and post-market FDA regulatory compliance and enforcement matters ranging from clinical trials, good manufacturing practices, to labeling, advertising, and promotion of FDA-regulated products.  Nikki has been the lead FDA regulatory advisor to her clients on 250+ transactional matters.  She conducts investigations into FDA clinical trials and post-marking noncompliance, acts as lead compliance and regulatory counsel for several companies under Corporate Integrity Agreements (CIAs) and has led several CMS Open Payments compliance audits.  She is an expert on federal Open Payments, state, and international transparency/disclosure laws and leads two pharma and device industry compliance coalitions. \nNikki counsels pharma and device companies on FDA inspections, Form 483s, Warning Letters, product recalls, import detentions, clinical holds, and other FDA compliance and enforcement matters.  She conducts risk assessments and internal investigations into allegations of FDA and healthcare program noncompliance.  She routinely advises company executives and board members and represents her clients before federal agencies.  She has established robust compliance programs and policies for numerous life sciences companies. Nikki has also served as an interim General Counsel and as a Chief Compliance Officer for her life sciences clients.\nNikki leads two pharma and device industry coalitions on transparency and disclosure laws.  The Ad Hoc Sunshine and State Law Compliance Group is a coalition she advises on federal Sunshine Act and state transparency/disclosure and gift ban laws.  The International Marketing and Disclosure Compliance Group is a separate coalition of companies she advises on the growing area of transparency and disclosure laws and industry codes of conduct in the EU, Australia, Japan, and numerous other countries and regions.\nKing \u0026amp; Spalding’s FDA \u0026amp; Life Sciences Practice has been named Law360 Practice Group of the Year from 2017-2020.  King \u0026amp; Spalding’s FDA \u0026amp; Life Sciences Practice is ranked by Chambers Legal, LMG Life Sciences, U.S. News, and Best Lawyers.  According to Chambers USA, sources praise Nikki as being \"thoughtful, quick to respond and available.\" -- Chambers USA (2022)\nNikki is a frequent speaker and author on FDA advertising/promotion, clinical trials, compliance, and transparency law matters.  Nikki was also selected to Law360's 2021 Compliance Editorial Advisory Board and has served on the Advisory Board for FDAnews and the PCF Pharma Congress planning committee.  She was formerly on the Food and Drug Law Institute (FDLI) Editorial Advisory Board for the FDLI Food \u0026amp; Drug Law Journal and a member of the FDLI Medical Device Committee.  Nikki has also served on the Leadership Advisory Board for the National Women’s Law Center and on the Special Gifts Committee for the Arlington Free Clinic for more than ten years.\nNikki was elected by her partners in 2017 to serve for three years on the firm’s Policy Committee, which is the firm's executive management committee.  Nikki served for many years on the firm’s Lateral Partner Committee and on the firm's Partners Committee, and was also the Hiring Partner for the Washington, D.C. office. Kelly Reeves Partner Women, Influence \u0026amp; Power in Law Award for Thought Leadership Corporate Counsel 2024 North Carolina State University  University of Maryland University of Maryland School of Law North Carolina State University  District of Columbia Maryland Advised companies on FDA advertising and promotion rules for drugs, devices, and cosmetics, including social media, new product launches, DTC, physician and payor communications, broadcast ads, reprints, and investor communications. Advised on CMS Open Payments compliance audits and compliance with the federal Physician Payment Sunshine (Open Payments) law, state laws targeting industry marketing practices, sales representation licensing, drug price transparency, and disclosure of clinical trial data. Advised on compliance with global transparency laws and industry codes of conduct. Advised life sciences clients on preparing for FDA inspections of clinical trials sites and manufacturing facilities, and responding to FDA Form 483s, FDA Warning Letters, product recalls, import detentions, and government investigations involving alleged advertising/promotion violations. Conducted FDA regulatory due diligence and related counseling in connection with more than 200+ transactions involving pharmaceutical, medical device, biotechnology, and cosmetic companies. Stand up healthcare compliance programs for pharmaceutical and medical device manufacturers and related healthcare compliance policies and codes of conduct. Served as interim Chief Compliance Officer for a pharmaceutical manufacturer for a two year period and managed all aspects of the company healthcare compliance program. Conducted internal investigations into potential FDA GCP, GMP, and healthcare compliance policy violations. Led risk assessments of healthcare regulatory compliance programs and policies and advised on compliance with FDA regulations, HHS OIG Compliance Program Guidance, and the PhRMA and AdvaMed Codes on Interactions with Healthcare Professionals.","searchable_name":"Nikki Reeves","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":448639,"version":1,"owner_type":"Person","owner_id":2105,"payload":{"bio":"\u003cp\u003eJessica Ringel advises\u0026nbsp;medical device, pharmaceutical, HCT/P, and cosmetics manufacturers\u0026nbsp;and distributors\u0026nbsp;on matters involving FDA regulation. Jessica\u0026rsquo;s post-market practice focuses on safety and quality matters, including responses to FDA inspections and enforcement actions, recall and adverse event matters, and advertising and promotion. Her pre-market practice includes advising on regulatory strategy and marketing applications. Jessica\u0026rsquo;s transactional practice involves conducting due diligence evaluations of life sciences targets for manufacturers, private equity firms, and investment banks.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eJessica\u0026rsquo;s device regulatory practice spans the entire FDA regulatory lifecycle.\u0026nbsp; She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs.\u0026nbsp; After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters.\u0026nbsp; She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans.\u0026nbsp; Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations.\u0026nbsp; She further assists life sciences clients with the review and development of compliant marketing strategies and materials.\u0026nbsp; She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA.\u0026nbsp; Jessica also advises companies that process and distribute human tissue-based products (HCT/Ps) and that manufacture and distribute electronic products subject to FDA\u0026rsquo;s electronic product radiation control program. Further, Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eJessica\u0026rsquo;s regulatory practice is supplemented by extensive experience conducting FDA regulatory due diligence evaluations of life sciences targets, assessing the regulatory compliance history, health, and risk of the target company.\u0026nbsp; She further advises corporate transaction teams and clients by preparing and negotiating terms and provisions in purchase agreements related to FDA regulatory compliance.\u003c/p\u003e","slug":"jessica-ringel","email":"jringel@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":81,"guid":"81.capabilities","index":0,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":1,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":2,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":3,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":4,"source":"smartTags"},{"id":1223,"guid":"1223.smart_tags","index":5,"source":"smartTags"}],"is_active":true,"last_name":"Ringel","nick_name":"Jessica","clerkships":[],"first_name":"Jessica","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":" ","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eJessica Ringel advises\u0026nbsp;medical device, pharmaceutical, HCT/P, and cosmetics manufacturers\u0026nbsp;and distributors\u0026nbsp;on matters involving FDA regulation. Jessica\u0026rsquo;s post-market practice focuses on safety and quality matters, including responses to FDA inspections and enforcement actions, recall and adverse event matters, and advertising and promotion. Her pre-market practice includes advising on regulatory strategy and marketing applications. Jessica\u0026rsquo;s transactional practice involves conducting due diligence evaluations of life sciences targets for manufacturers, private equity firms, and investment banks.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eJessica\u0026rsquo;s device regulatory practice spans the entire FDA regulatory lifecycle.\u0026nbsp; She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs.\u0026nbsp; After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters.\u0026nbsp; She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans.\u0026nbsp; Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations.\u0026nbsp; She further assists life sciences clients with the review and development of compliant marketing strategies and materials.\u0026nbsp; She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA.\u0026nbsp; Jessica also advises companies that process and distribute human tissue-based products (HCT/Ps) and that manufacture and distribute electronic products subject to FDA\u0026rsquo;s electronic product radiation control program. Further, Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eJessica\u0026rsquo;s regulatory practice is supplemented by extensive experience conducting FDA regulatory due diligence evaluations of life sciences targets, assessing the regulatory compliance history, health, and risk of the target company.\u0026nbsp; She further advises corporate transaction teams and clients by preparing and negotiating terms and provisions in purchase agreements related to FDA regulatory compliance.\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1146}]},"capability_group_id":2},"created_at":"2026-05-28T21:50:17.000Z","updated_at":"2026-05-28T21:50:17.000Z","searchable_text":"Ringel{{ FIELD }}Jessica Ringel advises medical device, pharmaceutical, HCT/P, and cosmetics manufacturers and distributors on matters involving FDA regulation. Jessica’s post-market practice focuses on safety and quality matters, including responses to FDA inspections and enforcement actions, recall and adverse event matters, and advertising and promotion. Her pre-market practice includes advising on regulatory strategy and marketing applications. Jessica’s transactional practice involves conducting due diligence evaluations of life sciences targets for manufacturers, private equity firms, and investment banks.\nJessica’s device regulatory practice spans the entire FDA regulatory lifecycle.  She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs.  After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters.  She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans.  Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations.  She further assists life sciences clients with the review and development of compliant marketing strategies and materials.  She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA.  Jessica also advises companies that process and distribute human tissue-based products (HCT/Ps) and that manufacture and distribute electronic products subject to FDA’s electronic product radiation control program. Further, Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA.   \nJessica’s regulatory practice is supplemented by extensive experience conducting FDA regulatory due diligence evaluations of life sciences targets, assessing the regulatory compliance history, health, and risk of the target company.  She further advises corporate transaction teams and clients by preparing and negotiating terms and provisions in purchase agreements related to FDA regulatory compliance. Partner Cornell University Cornell Law School Georgetown University Georgetown University Law Center District of Columbia Maryland","searchable_name":"Jessica Ringel","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":436445,"version":1,"owner_type":"Person","owner_id":4001,"payload":{"bio":"\u003cp\u003eKim Roberts represents global corporates and large employers on their employment law and data privacy strategy in the U.K. and across Europe. She has particular experience with international clients headquartered outside the U.K., specifically those in the U.S. with global operations.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eKim is an experienced employment law practitioner and advises across the full range of employment matters both contentious and non-contentious, including counselling, High-Court and Tribunal matters, executive recruitment and termination, board disputes, competition and restraint of trade matters, employment issues on transactions, data protection issues, downsizing and collective consultation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eKim also advises on data protection and privacy issues.\u0026nbsp; She has extensive experience in advising cross border European clients on their data privacy obligations, data privacy policies and employee data management.\u0026nbsp; Kim advises clients on developing law and practice in the EU including the GDPR and on obligations when transferring data between the EU and the U.S., including advice on Model Clauses and the Privacy Shield.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eKim speaks regularly at client events and seminars and commentates in the U.K. national press on employment law and data privacy matters and developments.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecognition\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eRecommended in Legal 500\u003c/li\u003e\n\u003c/ul\u003e","slug":"kim-roberts","email":"kroberts@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":6,"guid":"6.capabilities","index":0,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":1,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":2,"source":"capabilities"},{"id":15,"guid":"15.capabilities","index":3,"source":"capabilities"},{"id":952,"guid":"952.smart_tags","index":4,"source":"smartTags"}],"is_active":true,"last_name":"Roberts","nick_name":"Kim","clerkships":[],"first_name":"Kim","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":" ","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eKim Roberts represents global corporates and large employers on their employment law and data privacy strategy in the U.K. and across Europe. She has particular experience with international clients headquartered outside the U.K., specifically those in the U.S. with global operations.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eKim is an experienced employment law practitioner and advises across the full range of employment matters both contentious and non-contentious, including counselling, High-Court and Tribunal matters, executive recruitment and termination, board disputes, competition and restraint of trade matters, employment issues on transactions, data protection issues, downsizing and collective consultation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eKim also advises on data protection and privacy issues.\u0026nbsp; She has extensive experience in advising cross border European clients on their data privacy obligations, data privacy policies and employee data management.\u0026nbsp; Kim advises clients on developing law and practice in the EU including the GDPR and on obligations when transferring data between the EU and the U.S., including advice on Model Clauses and the Privacy Shield.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eKim speaks regularly at client events and seminars and commentates in the U.K. national press on employment law and data privacy matters and developments.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecognition\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eRecommended in Legal 500\u003c/li\u003e\n\u003c/ul\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":4589}]},"capability_group_id":2},"created_at":"2025-09-02T04:54:16.000Z","updated_at":"2025-09-02T04:54:16.000Z","searchable_text":"Roberts{{ FIELD }}Kim Roberts represents global corporates and large employers on their employment law and data privacy strategy in the U.K. and across Europe. She has particular experience with international clients headquartered outside the U.K., specifically those in the U.S. with global operations. \nKim is an experienced employment law practitioner and advises across the full range of employment matters both contentious and non-contentious, including counselling, High-Court and Tribunal matters, executive recruitment and termination, board disputes, competition and restraint of trade matters, employment issues on transactions, data protection issues, downsizing and collective consultation. \nKim also advises on data protection and privacy issues.  She has extensive experience in advising cross border European clients on their data privacy obligations, data privacy policies and employee data management.  Kim advises clients on developing law and practice in the EU including the GDPR and on obligations when transferring data between the EU and the U.S., including advice on Model Clauses and the Privacy Shield. \nKim speaks regularly at client events and seminars and commentates in the U.K. national press on employment law and data privacy matters and developments.\nRecognition\n\nRecommended in Legal 500\n Partner Law Society of England \u0026amp; Wales (admitted 3/9/2001; reg. # 277966)","searchable_name":"Kim Roberts","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null}],"extra_filter_label":"Innovative Drug, Biologic, and Device Development"}}