share_log

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.

瑞生與華盛頓特區的兩位傑出合作伙伴共同拓展醫療保健和生命科學業務
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(比爾)麥康納在加強公司FDA監管、合規和執法服務方面帶來了豐富的經驗

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.

華盛頓,2024 年 5 月 20 日 /PRNewswire/ — Latham & Watkins LLP1 很高興地宣佈,詹妮弗·布拉格和威廉(比爾)麥康納已加入該公司位於華盛頓特區辦公室的醫療保健與生命科學業務部。Bragg和McConagha將深厚的政府經驗和行業知識相結合,在就涉及受美國食品藥品監督管理局(FDA)授權的產品的複雜監管、合規和執法事項以及整個醫療保健和生命科學行業的戰略交易提供諮詢方面有着令人印象深刻的記錄。

Jennifer Bragg, Partner, Latham & Watkins
瑞生沃特金斯合夥人詹妮弗·布拉格
William (Bill) McConagha, Partner, Latham & Watkins
威廉(比爾)麥康納,瑞生律師事務所合夥人

"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."

瑞生華盛頓特區辦事處辦公室管理合夥人曼迪·裏夫斯表示:“詹妮弗和比爾豐富的行業和政府經驗符合我們在醫療保健和生命科學領域的增長戰略。”“他們深厚的知識和牢固的客戶關係將增強我們的監管、合規和諮詢服務,他們的背景非常適合客戶遇到的錯綜複雜的公司交易和關鍵監管問題。”

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.

布拉格就美國食品和藥物管理局和其他政府機構(包括司法部(DOJ)和監察長辦公室(OIG)發起的執法行動所產生的合規和調查向公司提供諮詢。她還就複雜的交易事宜向製藥、醫療器械和其他受美國食品藥品管理局監管的公司提供建議。她之前曾在美國食品和藥物管理局首席法律顧問辦公室擔任助理首席法律顧問。

"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."

醫療保健與生命科學業務全球主席約翰·曼西說:“我們很高興歡迎詹妮弗和比爾加入公司。”“他們豐富的行業知識、FDA合規和執法經驗以及幫助公司解決複雜監管問題的能力將豐富我們爲客戶提供的見解、實用的指導和複雜的陳述。”

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).

麥康納就美國食品藥品管理局監管產品的完整生命週期提供諮詢,從藥品到醫療器械,再到複雜的生物製劑、食品和新型菸草製品等。他的專業知識涵蓋從上市前開發和臨床試驗到產品發佈和上市後安全報告和生產要求,包括cGMP和質量體系法規。他就合規事宜向客戶提供建議,例如準備和管理FDA的檢查,回應FDA 483和警告信,以及在FDA檢查後製定戰略補救計劃和參與策略。麥康納還就複雜的監管事宜爲初創企業和全球生命科學公司提供諮詢,包括產品發佈、產品推廣和上市後法律要求。他還曾在數十筆涉及醫療產品、食品和個人護理產品的銷售或商業化的公司交易中擔任美國食品和藥物管理局的調查和監管顧問。麥康納在FDA工作了17年,擔任過各種職務,包括助理局長、首席法律顧問辦公室高級律師以及參議院衛生、教育、勞工和養老金委員會(HELP)的健康政策顧問。

"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.

“詹妮弗和比爾是我們團隊中傑出的新成員,他們無疑將爲我們的客戶提供寶貴的顧問。它們增強了我們提供現代醫療保健和生命科學行業動態格局所需的以業務爲導向的複雜見解的能力。他們在政府中的歷史以及在行業面臨的最前沿問題提供建議的經驗必將增強我們的集體技能,我們很高興能讓他們加入。” 醫療保健與生命科學業務全球副主席本·哈斯說。

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."

布拉格說:“瑞生首屈一指的市場地位和廣泛的生命科學基礎設施,加上其對私人資本的戰略重點,吸引了我加入該公司。我很高興加入這個精幹的團隊,並期待幫助我們的客戶應對不斷變化的醫療監管和執法環境。”

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."

麥康納說:“瑞生對市場領先的醫療保健和生命科學業務的承諾以及尊敬的客戶群吸引了我。瑞生以處理高度複雜和開創性的事務而聞名,其卓越地位得到廣泛認可。我很高興能爲擴大瑞生在不斷變化的醫療和生命科學行業的足跡做出貢獻。”

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 以優異成績獲得法學博士學位和學士學位 以優異的成績獲得 來自馬里蘭大學。麥康納獲得了 JD 以優異的成績獲得 畢業於喬治敦大學法律中心並獲得學士學位 以優異的成績獲得好評 來自卡爾頓學院。

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

兩位合夥人均從 Skadden、Arps、Slate、Meagher & Flom LLP 加入瑞生。

About Latham & Watkins (lw.com)

關於瑞生律師事務所 (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.

瑞生爲全球複雜的法律和商業挑戰提供創新的解決方案。我們的律師通過全球平台,就塑造市場的交易、高風險的訴訟和審判以及複雜的監管事宜爲客戶提供建議。瑞生是全球最大的無償服務提供商之一,堅定支持旨在促進公司內部和法律界多元化的舉措,並致力於探索和促進環境可持續性。

Notes to Editors

編者注

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以有限責任合夥企業的形式在全球範圍內運營,根據特拉華州(美國)法律組建,附屬有限責任合夥企業在法國、香港、意大利、新加坡和英國開展業務,作爲關聯合夥企業在日本開展業務。瑞生通過有限責任公司在以色列開展業務,在韓國作爲外國法律顧問辦公室開展業務,通過有限責任公司在沙特阿拉伯開展業務。

Contacts

聯繫人

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

約翰·曼西,醫療保健與生命科學實踐全球主席,+1.202.637.2211
本·哈斯,醫療保健與生命科學業務全球副主席,+1.202.637.1084
曼迪·裏夫斯,華盛頓特區辦事處辦公室管理合夥人,+1.202.637.2183

SOURCE Latham & Watkins LLP

來源 Latham & Watkins LLP

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
    搶先評論