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Hogan Lovells
Department profile | Hogan Lovells
Healthcare: Pharmaceutical/Medical Products Regulatory

About

Provided by Hogan Lovells

We know how overwhelming it can be trying to effectively navigate today’s regulatory environment and capitalize on strategic opportunities. Many members of our team have previously worked in key positions in both the private and public sectors, including the U.S. Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), and the Federal Trade Commission (FTC).

Having an in-depth understanding of the relationship between the government and global health care marketplace allows us to counsel you effectively on legal and regulatory issues — and to be your strategic advisor, litigator, and dealmaker, too. 

Our health care transactions team leads the nation in the number of complex hospital, academic medical centers, and health system transactions it has handled. Combining our technical and industry knowledge enables us to understand your objectives, plan for the positions likely to be taken by other parties, and help you develop the best deal structure
and strategy.

Chambers Review

Provided by Chambers

Healthcare: Pharmaceutical/Medical Products Regulatory - District of Columbia

1
Band 1

What the Team is Known For

Hogan Lovells is a distinguished team with deep expertise across the scope of the healthcare and life sciences industries. The firm handles complex issues including the regulation of new medical devices, biotechnology products and healthcare litigation, government price reporting, privacy and reimbursement issues and digital health. The team's expertise also extends to advising on transactions such as clinical integrations, M&A and contracting.

Work Highlights

  • Hogan Lovells represented Texas Children's Hospital on federal and state regulatory approvals relating to the creation of the $1 billion Kinder Childhood Cancer Center in Houston.

Strengths

Provided by Chambers

They are extremely responsive. We have frequent fire drills and urgent questions and they always answer with reasoned, thoughtful guidance in a timely manner.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

They have an exceptionally broad and talented team that can support the range of issues faced by a novel healthcare company with global aspirations.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

I cannot say enough good things about the experience we have had with them. Their experience in this space is unmatched, they know how everything works. Everything they have done has been fantastic.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

They have outstanding expertise, great availability, quick response times, excellent knowledge of the domain, great strategic advice, and excellent ability to handle complexity and unique situations.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

Hogan Lovells' strengths are extensive experience, excellent reputation and relations within the FDA. They have an ability to support customers in a wide variety of aspects.

Healthcare: Pharmaceutical/Medical Products Regulatory respondent
USA

Notable Practitioners

Provided by Chambers

Helen R Trilling
S
Helen R Trilling
S
Senior Statespeople

Helen Trilling is regulatory and compliance counsel for a range of high-profile medical device companies. She is also well-versed in transactional matters, including acquisitions and corporate restructurings.

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Jonathan S Kahan
S
Jonathan S Kahan
S
Senior Statespeople
Jonathan Kahan has extensive expertise in FDA matters, including marketing compliance and the development of innovative medical devices.

Jonathan is knowledgeable and an excellent resource for an unlimited variety of issues. He has very good relations with the FDA.

Jonathan is extremely competent in the medical device space. I enjoy his direct guidance.

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Robert F Leibenluft
S
Robert F Leibenluft
S
Senior Statespeople
Robert Leibenluft has notable expertise in representing healthcare networks and academic institutions involved in transactions such as big-ticket mergers. He also counsels on antitrust-related issues.
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Beth L Roberts
1
Beth L Roberts
1
Band 1
Beth Roberts is highly regarded for her expertise in reimbursement matters arising from the development of new treatments and diagnostic tools, including devices that use artificial intelligence.

I can reach out with a question and she will help facilitate the best team to provide guidance.

Beth has strong subject matter expertise with a real grip on the reimbursement aspects of complex therapies. She is great to work with and very responsive.

Beth combines technical mastery with an ability to see how regulatory outcomes shape commercial success. She provides pragmatic, business-focused solutions to extraordinarily complex problems.

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David Fox
1
David Fox
1
Band 1
David Fox is a leading expert in FDA regulatory work. He represents an array of new and well-established life sciences companies involved in cutting-edge pharmaceutical matters.
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Jonathan L. Diesenhaus
1
Jonathan L. Diesenhaus
1
Band 1

Jonathan Diesenhaus is notable for his impressive healthcare litigation practice. He is a strong choice for hospitals facing complex disputes, and regularly takes on sophisticated FCA litigation.

Jonathan is an absolute powerhouse when navigating complex governmental investigations. His years of experience and prior work as a government lawyer gives him an added level of insight and wisdom.

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David Horowitz
2
David Horowitz
2
Band 2
David Horowitz draws on his extensive experience during his tenure at HHS and FDA. He is renowned for his ability to advise pharmaceutical clients on a range of regulatory issues.

David has a deep understanding of our business and objectives. He is always extremely responsive with creative solutions and practical advice.

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Michael Heyl
2
Michael Heyl
2
Band 2
Michael Heyl advises medical and diagnostic device manufacturers on a broad range of FDA regulation matters. He has expertise in dealing with cross-border issues.

Anytime that we need Mike, immediately he is always available. His advice is pragmatic, legal and business-focused. He goes above and beyond for his clients.

Mike is not only analytical but can get to the point right away and has the data to back it up.

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Alice Valder Curran
3
Alice Valder Curran
3
Band 3
Alice Valder Curran offers significant strength in pricing issues, including coverage and reimbursement. She also counsels on wider regulatory matters and government investigations.

Alice has been responsive and provided great, practical advice in the government pricing space.

Alice is terrific to work with. She is knowledgeable on several commercialization aspects and is approachable.

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Clifford D Stromberg
3
Clifford D Stromberg
3
Band 3
Clifford Stromberg handles M&A for prominent health systems and networks across the country. He counsels on transaction-related regulatory issues and antitrust matters.

Cliff brings deep experience to each matter and helps customize transaction details and solutions that reflect the unique aspects of our organization.

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Ronald Wisor
3
Ronald Wisor
Head of Healthcare
3
Band 3
Ronald Wisor is the leader of the health practice. He advises an impressive healthcare client base on fraud and abuse, reimbursement and digital health-related issues.

Ron is easy to work with, reliable, knowledgeable, and always quick to respond.

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John J Smith
4
John J Smith
4
Band 4
Former clinician John Smith continues to develop a strong regulatory practice assisting pharmaceutical and medical products manufacturers in a wide range of issues, including FDA clearance.

John is always available, proactive, intelligent, and extremely knowledgeable about our space.

John has been a pleasure to work with. He was instrumental in multiple successful pre-sub meetings with the FDA.

John has such deep competencies, soft skills and knowledge in the space.

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Meredith Manning
4
Meredith Manning
4
Band 4

Meredith Manning comes highly recommended for her longstanding regulatory expertise, which sees her regularly work with a range of pharmaceuticals. She is equally adept at providing compliance counsel and advising on investigations conducted by entities such as the FDA.

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Randy J Prebula
5
Randy J Prebula
5
Band 5

Randy Prebula is recognized for his expertise in the field of FDA regulations. He has experience representing domestic and international clients through these matters.

Randy provides excellent guidance, communication, and first-hand knowledge of industry and manufacturing.

Randy has deep and broad experience. He is just delightful.

Randy has a superb skill set with exceptional communication skills.

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Ranked Lawyers at
Hogan Lovells

Provided by Chambers
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District of Columbia

Healthcare
Helen R Trilling
S
Helen R Trilling
S
Senior Statespeople
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Robert F Leibenluft
S
Robert F Leibenluft
S
Senior Statespeople
View Profile
Beth L Roberts
1
Beth L Roberts
1
Band 1
View Profile
Jonathan L. Diesenhaus
1
Jonathan L. Diesenhaus
1
Band 1
View Profile
Alice Valder Curran
3
Alice Valder Curran
3
Band 3
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Clifford D Stromberg
3
Clifford D Stromberg
3
Band 3
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Ronald Wisor
3
Ronald Wisor
Head of Healthcare
3
Band 3
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Healthcare: Pharmaceutical/Medical Products Regulatory
Jonathan S Kahan
S
Jonathan S Kahan
S
Senior Statespeople
View Profile
David Fox
1
David Fox
1
Band 1
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David Horowitz
2
David Horowitz
2
Band 2
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Michael Heyl
2
Michael Heyl
2
Band 2
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John J Smith
4
John J Smith
4
Band 4
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Meredith Manning
4
Meredith Manning
4
Band 4
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Randy J Prebula
5
Randy J Prebula
5
Band 5
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Industries

Provided by Hogan Lovells

Digital Health