Jennifer
Bragg and William (Bill)
McConagha bring substantial experience enhancing the firm's
FDA regulatory, compliance, and enforcement offerings
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.
"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."
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.
"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."
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).
"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.
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."
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."
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.
Both partners join Latham from Skadden, Arps, Slate, Meagher
& Flom LLP.
About Latham & Watkins (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.
Notes to Editors
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.
Contacts
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
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SOURCE Latham & Watkins LLP