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LATHAM & WATKINS EXPANDS HEALTHCARE & LIFE SCIENCES PRACTICE WITH TWO DISTINGUISHED PARTNERS IN D.C.

LATHAM & WATKINS EXPANDS HEALTHCARE & LIFE SCIENCES PRACTICE WITH TWO DISTINGUISHED PARTNERS IN D.C.

瑞生与华盛顿特区的两位杰出合作伙伴共同拓展医疗保健和生命科学业务
PR Newswire ·  05/20 22:00

Jennifer Bragg and William (Bill) McConagha bring substantial experience enhancing the firm's FDA regulatory, compliance, and enforcement offerings

詹妮弗·布拉格和威廉(比尔)麦康纳在加强公司FDA监管、合规和执法服务方面带来了丰富的经验

WASHINGTON, May 20, 2024 /PRNewswire/ -- Latham & Watkins LLP1 is pleased to announce that Jennifer Bragg and William (Bill) McConagha have joined the firm's Healthcare & Life Sciences Practice in the Washington, D.C. office. Bragg and McConagha bring a powerful combination of deep government experience and sector knowledge, coupled with an impressive track record of advising on complex regulatory, compliance, and enforcement matters involving products subject to the authority of the Food and Drug Administration (FDA), as well as on strategic transactions throughout the healthcare and life sciences industry.

华盛顿,2024 年 5 月 20 日 /PRNewswire/ — Latham & Watkins LLP1 很高兴地宣布,詹妮弗·布拉格和威廉(比尔)麦康纳已加入该公司位于华盛顿特区办公室的医疗保健与生命科学业务部。Bragg和McConagha将深厚的政府经验和行业知识相结合,在就涉及受美国食品药品监督管理局(FDA)授权的产品的复杂监管、合规和执法事项以及整个医疗保健和生命科学行业的战略交易提供咨询方面有着令人印象深刻的记录。

Jennifer Bragg, Partner, Latham & Watkins
瑞生沃特金斯合伙人詹妮弗·布拉格
William (Bill) McConagha, Partner, Latham & Watkins
威廉(比尔)麦康纳,瑞生律师事务所合伙人

"Jennifer and Bill's wealth of industry and government experience align with our strategy for growth in the healthcare and life sciences sectors," said Mandy Reeves, Office Managing Partner of Latham & Watkins' Washington, D.C. office. "Their deep knowledge and strong client relationships will enhance our regulatory, compliance, and advisory offerings, and their backgrounds are ideally suited to the intricate corporate deals and critical regulatory issues our clients encounter."

瑞生华盛顿特区办事处办公室管理合伙人曼迪·里夫斯表示:“詹妮弗和比尔丰富的行业和政府经验符合我们在医疗保健和生命科学领域的增长战略。”“他们深厚的知识和牢固的客户关系将增强我们的监管、合规和咨询服务,他们的背景非常适合客户遇到的错综复杂的公司交易和关键监管问题。”

Bragg counsels companies on compliance and investigations stemming from enforcement actions initiated by FDA and other governmental authorities, including the Department of Justice (DOJ) and Office of Inspector General (OIG). She also advises pharmaceutical, medical device, and other FDA-regulated companies on complex transactional matters. She previously served in the FDA's Office of the Chief Counsel as Associate Chief Counsel.

布拉格就美国食品和药物管理局和其他政府机构(包括司法部(DOJ)和监察长办公室(OIG)发起的执法行动所产生的合规和调查向公司提供咨询。她还就复杂的交易事宜向制药、医疗器械和其他受美国食品药品管理局监管的公司提供建议。她之前曾在美国食品和药物管理局首席法律顾问办公室担任助理首席法律顾问。

"We're delighted to welcome Jennifer and Bill to the firm," said John Manthei, Global Chair of the Healthcare & Life Sciences Practice. "Their extensive industry knowledge, FDA compliance and enforcement experience, and ability to help companies navigate complex regulatory issues will enrich the insightful, practical guidance and sophisticated representation we offer our clients."

医疗保健与生命科学业务全球主席约翰·曼西说:“我们很高兴欢迎詹妮弗和比尔加入公司。”“他们丰富的行业知识、FDA合规和执法经验以及帮助公司解决复杂监管问题的能力将丰富我们为客户提供的见解、实用的指导和复杂的陈述。”

McConagha counsels on the complete lifecycle of FDA-regulated products, ranging from drugs to medical devices, to complex biologics, food products, and novel tobacco products, among others. His expertise runs the gamut from pre-market development and clinical trials to product launch and post-market safety reporting and manufacturing requirements, including cGMP and the Quality System Regulation. He advises clients on compliance matters such as preparing for and managing FDA inspections, responding to FDA 483s and Warning Letters, and developing strategic remediation plans and engagement strategies following FDA inspections. McConagha also counsels start-ups and global life sciences companies on complex regulatory matters, including product launches, product promotion, and post-market legal requirements. He has also served as FDA diligence and regulatory counsel in dozens of corporate transactions involving the sale or commercialization of medical products, foods, and personal care products. McConagha spent 17 years at the FDA in various roles, including as assistant commissioner, senior attorney in the Office of the Chief Counsel, and as a Health Policy Advisor to the Senate Committee on Health, Education, Labor and Pensions (HELP).

麦康纳就美国食品药品管理局监管产品的完整生命周期提供咨询,从药品到医疗器械,再到复杂的生物制剂、食品和新型烟草制品等。他的专业知识涵盖从上市前开发和临床试验到产品发布和上市后安全报告和生产要求,包括cGMP和质量体系法规。他就合规事宜向客户提供建议,例如准备和管理FDA的检查,回应FDA 483和警告信,以及在FDA检查后制定战略补救计划和参与策略。麦康纳还就复杂的监管事宜为初创企业和全球生命科学公司提供咨询,包括产品发布、产品推广和上市后法律要求。他还曾在数十笔涉及医疗产品、食品和个人护理产品的销售或商业化的公司交易中担任美国食品和药物管理局的调查和监管顾问。麦康纳在FDA工作了17年,担任过各种职务,包括助理局长、首席法律顾问办公室高级律师以及参议院卫生、教育、劳工和养老金委员会(HELP)的健康政策顾问。

"Jennifer and Bill are remarkable new members of our team and will undoubtedly serve as valuable advisers to our clients. They bolster our capacity to offer the business-oriented and sophisticated insights required in the dynamic landscape of the modern healthcare and life sciences industry. Their history in government and experience providing advice at the cutting edge of issues confronting the industry will surely add to our collective skills, and we are excited to bring them on board," said Ben Haas, Global Vice Chair of the Healthcare & Life Sciences Practice.

“詹妮弗和比尔是我们团队中杰出的新成员,他们无疑将为我们的客户提供宝贵的顾问。它们增强了我们提供现代医疗保健和生命科学行业动态格局所需的以业务为导向的复杂见解的能力。他们在政府中的历史以及在行业面临的最前沿问题提供建议的经验必将增强我们的集体技能,我们很高兴能让他们加入。” 医疗保健与生命科学业务全球副主席本·哈斯说。

Bragg said: "Latham's premier market position and broad life sciences infrastructure, coupled with its strategic focus on private capital, attracted me to the firm. I am thrilled to join this sophisticated team, and look forward to helping our clients navigate the constantly evolving healthcare regulatory and enforcement environment."

布拉格说:“瑞生首屈一指的市场地位和广泛的生命科学基础设施,加上其对私人资本的战略重点,吸引了我加入该公司。我很高兴加入这个精干的团队,并期待帮助我们的客户应对不断变化的医疗监管和执法环境。”

McConagha said: "Latham's commitment to its market-leading healthcare and life sciences practice, and esteemed client base, drew me in. Renowned for handling highly intricate and groundbreaking matters, Latham's exceptional standing is widely recognized. I am excited to contribute to expanding Latham's footprint in the ever-changing healthcare and life sciences industry."

麦康纳说:“瑞生对市场领先的医疗保健和生命科学业务的承诺以及尊敬的客户群吸引了我。瑞生以处理高度复杂和开创性的事务而闻名,其卓越地位得到广泛认可。我很高兴能为扩大瑞生在不断变化的医疗和生命科学行业的足迹做出贡献。”

Bragg received a JD with honors and a BA cum laude from the University of Maryland. McConagha received a JD cum laude from Georgetown University Law Center and a BA magna cum laude from Carleton College.

Bragg 以优异成绩获得法学博士学位和学士学位 以优异的成绩获得 来自马里兰大学。麦康纳获得了 JD 以优异的成绩获得 毕业于乔治敦大学法律中心并获得学士学位 以优异的成绩获得好评 来自卡尔顿学院。

Both partners join Latham from Skadden, Arps, Slate, Meagher & Flom LLP.

两位合伙人均从 Skadden、Arps、Slate、Meagher & Flom LLP 加入瑞生。

About Latham & Watkins (lw.com)

关于瑞生律师事务所 (lw.com)

Latham & Watkins delivers innovative solutions to complex legal and business challenges around the world. From a global platform, our lawyers advise clients on market-shaping transactions, high-stakes litigation and trials, and sophisticated regulatory matters. Latham is one of the world's largest providers of pro bono services, steadfastly supports initiatives designed to advance diversity within the firm and the legal profession, and is committed to exploring and promoting environmental sustainability.

瑞生为全球复杂的法律和商业挑战提供创新的解决方案。我们的律师通过全球平台,就塑造市场的交易、高风险的诉讼和审判以及复杂的监管事宜为客户提供建议。瑞生是全球最大的无偿服务提供商之一,坚定支持旨在促进公司内部和法律界多元化的举措,并致力于探索和促进环境可持续性。

Notes to Editors

编者注

1 Latham & Watkins operates worldwide as a limited liability partnership organized under the laws of the State of Delaware (USA) with affiliated limited liability partnerships conducting the practice in France, Hong Kong, Italy, Singapore, and the United Kingdom and as an affiliated partnership conducting the practice in Japan. Latham & Watkins operates in Israel through a limited liability company, in South Korea as a Foreign Legal Consultant Office, and in Saudi Arabia through a limited liability company.

1 Latham & Watkins以有限责任合伙企业的形式在全球范围内运营,根据特拉华州(美国)法律组建,附属有限责任合伙企业在法国、香港、意大利、新加坡和英国开展业务,作为关联合伙企业在日本开展业务。瑞生通过有限责任公司在以色列开展业务,在韩国作为外国法律顾问办公室开展业务,通过有限责任公司在沙特阿拉伯开展业务。

Contacts

联系人

John Manthei, Global Chair of the Healthcare & Life Sciences Practice, +1.202.637.2211
Ben Haas, Global Vice Chair of the Healthcare & Life Sciences Practice, +1.202.637.1084
Mandy Reeves, Office Managing Partner of the Washington, D.C. office, +1.202.637.2183

约翰·曼西,医疗保健与生命科学实践全球主席,+1.202.637.2211
本·哈斯,医疗保健与生命科学业务全球副主席,+1.202.637.1084
曼迪·里夫斯,华盛顿特区办事处办公室管理合伙人,+1.202.637.2183

SOURCE Latham & Watkins LLP

来源 Latham & Watkins LLP

译文内容由第三方软件翻译。


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