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Life Sciences 2018: Regulatory Analysis

This year, our research identifies 314 standout regulatory law experts with a proven track record advising major clients in the life sciences sector. Those featured are highly skilled at providing advice and innovative solutions on matters ranging from product development, approval and manufacture to pricing, market safety and customs rules.

Almost 60 per cent of the practitioners listed are based in Europe, whereas the single country with the greatest number of individual listings is the US. Multinational law firm Hogan Lovells is home to the highest number of practitioners identified by our research, achieving listings from across 10 of its offices. Sidley Austin and Covington & Burling also perform well on a global scale, along with FDA law specialist firm Hyman Phelps & McNamara, which emerges as the leading firm in the US market.

Europe

Thought Leaders
1. Ian Dodds-Smith Arnold & Porter Kaye Scholer UK LLP, London
2. Marie Isabel Manley Bristows LLP, London
3. Maarten Meulenbelt Sidley Austin LLP, Brussels
4. Peter Bogaert Covington & Burling LLP, Brussels
5. Carla Schoonderbeek Hoyng Rokh Monegier, Amsterdam
6. Lincoln Tsang Arnold & Porter Kaye Scholer UK LLP, London
The Thought Leaders are those individuals who received the highest number of nominations from peers, corporate counsel and other market sources this year. Our research has identified them as being truly outstanding practitioners and the very best in their field.
 

Leading Firms

 Who's Who Legal does not list law firms, only individual lawyers. The leading firms are those in each region whose listed practitioners received the most total nominations in our research.
 

International law firm HOGAN LOVELLS tops our listings in Europe this year, achieving an impressive eight nominations from across its offices in Russia, Belgium, England, France, Germany and the Netherlands.
Elisabethann Wright is “very well known in the market” according to sources who admire her for being “excellent at handling matters related to medical devices”.
The “outstanding” Ina Brock is “one of the best”, according to one impressed respondent. She is internationally regarded as one of the leading figures in the German life sciences market after more than 20 years in the field.
Sources are effusive in their praise of Mikael Salmela, describing him as “one of the most notable and brilliant lawyers for regulatory and contractual work in the life sciences sector in France”.
Jörg Schickert receives international endorsements for his strong regulatory practice. He regularly advises major clients in the pharmaceuticals, medical devices and biotechnology sectors on complex regulatory and compliance issues.
Hein van den Bos is “an experienced lawyer in this field with superb expertise”, according to one commentator. He regularly advises prominent life sciences companies on a range of regulatory matters, including data exclusivity, clinical trials and advertising.

Members of US-headquartered firm ARNOLD & PORTER KAYE SCHOLER also receive accolades for the depth and breadth of their experience handling regulatory matters in the life sciences sector. This year, four top-tier individuals are recognised.
The “outstanding” Ian Dodds-Smith ranks among the elite practitioners in our research, with sources describing him as “the king of regulatory work”. One impressed source effuses: “He is the number one lawyer in the pharmaceutical sector.”
Lincoln Tsang is “a renowned and respected professional with excellent technical expertise and litigation skills”. His “solid regulatory background” means that he is highly sought after by major clients.
The “excellent” Adela Williams is a leading light in the field and is widely recognised for her “vast experience handling the judicial review of NICE decisions”.
Christopher Stothers is a key figure in the market who wins praise for his “excellent knowledge of the intersection between intellectual property and regulatory law”.

COVINGTON & BURLING also performs well, seeing four standout lawyers highlighted for their regulatory experience.
Peter Bogaert “stands out” in the market thanks to his “very strong expertise in regulatory matters”. One impressed commentator describes him as “the guru of pharmaceutical law in Belgium”.
The “brilliant” Grant Castle is “one of the top regulatory lawyers in the EU”, according to respondents, who praise his expert knowledge of the regulation of pharmaceuticals and medical devices.
Robin Blaney is “highly recommended” for his leading life sciences practice. He regularly advises pharmaceutical companies on a range of regulatory matters, including clinical trial agreements, EU distribution agreements and distribution matters.
Adem Koyuncu frequently advises prominent clients on an array of German and EU regulatory matters across the life sciences sector.

European health law specialist firm STRÄTER RECHTSANWÄLTE is home to three leading individuals who draw praise for their expertise in the field.
Markus Ambrosius is internationally recognised for being a “top lawyer” in the life sciences space, receiving plaudits for his specialist knowledge of regulatory matters affecting pharmaceutical clients.
Burkhard Sträter is a leading practitioner who is recognised as a specialist when it comes to advising pharmaceutical and medical devices companies on matters relating to clinical trials, marketing authorisation procedures and drug safety procedures.
Top-rated medical law specialist Isabelle Kotzenberg receives accolades for her excellent work advising companies on a range of regulatory matters relating to clinical research.

Two outstanding practitioners from multinational law firm CLIFFORD CHANCE are recognised for their expertise handling regulatory matters in the life sciences arena.
Peter Dieners is “a long-standing specialist in the area” who draws widespread acclaim thanks to his deep sector knowledge.
Ulrich Reese is described as a “well-established figure in the market” with a market-leading practice covering a vast array of contentious and non-contentious mandates in the life sciences sector.

SIDLEY AUSTIN also impresses, seeing two leading lights in the field highlighted.
The “outstanding” Maarten Meulenbelt is “a prominent practitioner in the space” whom sources describe as their “first choice” thanks to his “extensive experience and expertise”.
The “excellent” Maurits Lugard is “a leading figure in the market” who receives recognition for his superb knowledge of regulatory issues affecting global pharmaceutical companies in the EU.

Other Leading Individuals 

We highlight individuals at other firms who also scored very highly in our research.
 

Austria

The “superb” Karina Hellbert at FIEBINGER POLAK & PARTNERS RECHTSANWÄLTE is widely recommended thanks to her exceptional technical expertise and excellent client manner.

Belgium

Geneviève Michaux at MAYER BROWN is “a very skilled practitioner” with a reputation as a leading specialist in the regulation of pharmaceuticals and medical devices across the EU.

England

Maria Isabel Manley at BRISTOWS is “a standout lawyer in the regulatory space” who is internationally renowned in the area. One impressed source notes: “She is a real leader in the life sciences sector.”

The “exceptional” Tim Worden at TAYLOR WESSING boasts “significant experience in the life sciences sector” and wins praise for his “strong regulatory practice”.

Maria Campbell at NORTON ROSE FULBRIGHT is “brilliant” according to peers, who praise her “excellent understanding of the cross-over between regulatory law and competition law within the life sciences space”.

The “outstanding” Jemima Stratford QC at BRICK COURT CHAMBERS is “a top silk” who is highly recommended thanks to her strong technical expertise and superb style of delivery.

Paul Michael Ranson at MORGAN LEWIS & BOCKIUS stands out in the international marketplace thanks to his “deep sector knowledge and significant experience”.

Denmark

Commentators state that the “excellent” Mikkel Vittrup of PLESNER ADVOKATPARTNERSELSKAB is “a pleasure to work with”. Sources add that they are consistently impressed by his “legal expertise, thoroughness and commercial understanding”.

Sources describe Martin Dræbye Gantzhorn at BECH-BRUUN as “an excellent lawyer with in-depth knowledge of the life sciences sector”.

Jacob Ørndrup at GORRISSEN FEDERSPIEL is “very active in the market” and is applauded for his “vast knowledge and understanding of life sciences regulatory issues”.

Finland

Mikael Segercrantz of ROSCHIER ATTORNEYS is described as a “star practitioner” with a market-leading practice covering regulatory matters in the pharmaceutical, food and cosmetics industries.

Ben Rapinoja at BORENIUS ATTORNEYS is “a highly experienced lawyer” who draws praise from international sources for his “fantastic understanding of issues affecting companies in the life sciences sector”.

France

Paule Drouault-Gardrat at PDG AVOCATS has more than 30 years’ experience in the field and is internationally renowned for her regulatory expertise.

Anne-Laure Marcerou at DENTONS is “a regulatory specialist” who regularly assists global life sciences companies on a range of complex mandates.

Alain Gorny at SEA AVOCATS SELAS is widely recognised as a key player in the market who is warmly endorsed by one impressed source for his “reactive and professional approach”.

Germany

Roland Wiring at CMS boasts “a strong reputation” in the market and impresses commentators with his “his broad experience and ability to build strong client relationships”.  

Alexander Ehlers of EHLERS EHLERS & PARTNER is “brilliant at handling pure regulatory matters” according to sources, who describe him as “a longstanding specialist in the field”.

Italy

Vincenzo Salvatore at BONELLIEREDE has “unsurpassed knowledge of pharmaceutical regulatory EU-wide issues and EU policies”, state interviewees, making him one of the most “well-known and reputed lawyers in the sector”.

Agostino Migone De Amicis at PAVIA E ANSALDO STUDIO LEGALE is “an active player in the market” who is “extensively experienced”. One impressed respondent professes how much they “appreciate his expertise in the field of clinical trials and related data protection issues”.

Mauro Turrini at STUDIO LEGALE BIRD & BIRD is “a specialist when it comes to pharmaceutical regulation” and wins praise for his “strong knowledge of EU-wide and Italian regulatory issues”.

Netherlands

Carla Schoonderbeek at HOYNG ROKH MONEGIER is “a leading name in the market” who is considered by sources to be “the top practitioner for handling market authorisation matters”.

The “outstanding” Koosje van Lessen Kloeke of LEIJNSE ARTZ is “excellent when it comes to pricing and reimbursement mandates”, say impressed commentators.

Norway

Sources call Beret Sundet at BA-HR “the main player in the Norwegian market” thanks to her in-depth industry knowledge.

Poland

The “exceptional” Ewa Butkiewicz at WARDYŃSKI & PARTNERS is “a superb regulatory life sciences lawyer” who earns world-wide recognition for her leading practice.

Spain

Jordi Faus of FAUS & MOLINER ABOGADOS is “a market leading regulatory specialist” who is internationally recognised and boasts more than 25 years in the field.

The “excellent” Héctor Jausàs Farré at JAUSAS is a top-tier practitioner who is applauded for his “extensive knowledge and experience in the field”.

Beatriz Cocina at URÍA MENÉNDEZ is described as “a really impressive practitioner” by interviewees who recommend her for her impeccable knowledge of pricing and reimbursement matters.

Sweden

Helen Waxberg at MANNHEIMER SWARTLING ADVOKATBYRÅ is “a top lawyer” who peers describe as being “really, really good” when it comes to handling regulatory, marketing and distribution matters for prominent life sciences companies.

Elisabeth Eklund at ADVOKATFIRMAN DELPHI is “highly recommended for her expansive expertise in the sector” by impressed sources.

Switzerland

Thanks to her experience working in the pharmaceutical industry Ursula Eggenberger Stöckli at BRATSCHI WIEDERKEHR & BUOB is a leading specialist when it comes to advising pharmaceutical companies on a broad range of regulatory issues.

Philippe Ducor at DUCOR LAW / HEALTH & TECHNOLOGY is a leading light in the field who clients appreciate for “always taking the time to dissect the intricate details of complex, technical cases”.

Andreas Wildi at WALDER WYSS is highly commended by the international life sciences community for his “vast experience in the field”, and draws praise for his solid understanding of complex technical matters.

Turkey

Selma Toplu Ünlü at NSN Law Firm is “highly recommended” by international sources who appreciate her “extensive experience in the field”.

The “outstanding” Özge Atilgan Karakulak at GÜN + PARTNERS has “superb knowledge and experience in the life sciences sphere” with sources particularly praising her for her regulatory expertise.


Americas 

Thought Leaders
1. Peter Barton Hutt Covington & Burling LLP, Washington, DC
2. Daniel Kracov Arnold & Porter Kaye Scholer LLP, Washington, DC
3. Jeffrey Shapiro Hyman Phelps & McNamara PC, Washington, DC
4. Gregory Levine Ropes & Gray LLP, Washington, DC
5. Kathleen M Sanzo Morgan Lewis & Bockius LLP, Washington, DC

Leading Firms

Food and drug regulatory boutique HYMAN PHELPS & MCNAMARA emerges as the leading firm in North America, and sees 13 standout practitioners recognised from its offices across the US.
Jeffrey Shapiro is lauded as “a leading practitioner” who is widely regarded as an expert when it comes to FDA regulation of medical devices. He emerges as one of the top names in the USA according to this year’s research.
Jeffrey Gibbs has “a tremendous reputation” in the market and is described by sources as “one of the leading pharmacy compounding lawyers in the US”.
The “excellent” Frank Sasinowski boasts “a first-class pharmaceutical regulatory practice” and is especially highly regarded for his specialist knowledge of orphan drugs.
“Top-tier lawyer” Robert Dormer is “just superb”, according to one impressed source. He is highly recommended for his excellent work advising pharmaceutical clients on a range of regulatory issues.
Paul Hyman is “a renowned lawyer” who has advised clients on almost every aspect of FDA regulation over the course of his career.
Ricardo Carvajal enjoys a fantastic reputation in the market and is widely recognised for his work with food and dietary supplements. One impressed source describes him as “a leading regulatory food lawyer”.

SIDLEY AUSTIN also boasts a strong presence in the North American market, with 12 leading lights in the field highlighted.
The “really top-notch” Scott Bass is “an authority on pharmaceutical law” according to commentators, who praise his “effortless approach to handling very complex issues”.
The “excellent” Coleen Klasmeier is “an industry expert and leading lawyer” say interviewees who readily recommend her for FDA regulatory experience.
Raymond Bonner is “a well-known lawyer”, commended for his “first-class practice” by impressed peers.
William Sarraille is internationally recognised as a healthcare law specialist, drawing effusive praise from commentators for his expertise in regulatory matters.
Greer Lautrup is “a terrific lawyer” who boasts an excellent reputation in the market thanks to her experience advising major life sciences companies on regulatory issues relating to manufacturing.

COVINGTON & BURLING stands out for its strong life sciences practice, achieving an impressive 10 nominations from its Washington, DC office.
Sources describe Peter Barton Hutt as “a leader in the field” having practised food and drug law for almost 60 years. One impressed commentator notes that he is “a skilled advocate, negotiator and writer”.
The “exceptional” Richard Kingham is “very well known in the industry” and has acted for some of the most recognisable pharmaceutical and biotechnology companies in the world over the course of his career.
Peter Safir is “a highly respected, outstanding lawyer” thanks to more than 25 years advising major clients in the pharmaceutical sector on regulatory matters, including marketing, life cycle management and issues relating to drug manufacturing.
Jeannie Perron wins praise for her well-established practice and is considered by sources to be “particularly strong on the generics side”.
Ellen Flannery is “a giant” in the industry and is widely recognised as “a leading medical devices expert”.

HOGAN LOVELLS is another leading firm in this area, with nine practitioners from across the US and Mexico highlighted for inclusion.
The “excellent” Philip Katz is an accomplished practitioner with a well-developed pharmaceutical and regulatory law practice. He is held in high esteem by clients who appreciate his “top-notch analysis and clear communication strategy”.
Ernesto Algaba Reyes from the firm’s Mexico City office has more than 20 years’ experience in the life sciences sector and draws praise for his expertise of regulatory compliance matters.
The “top-tier” Jonathan Kahan is “a leading medical devices lawyer” who is widely recognised for his work helping clients comply with complex regulatory processes.
The “outstanding” David Fox boasts “a fantastic pharma practice” and impresses market commentators with his expert knowledge of biological product lifecycles.

Other Leading Individuals

Brazil

The “terrific” Anderson Ribeiro at KASZNAR LEONARDOS INTELLECTUAL PROPERTY is internationally renowned as a leading name in the region, and stands out for his “impeccable knowledge of regulatory life sciences matters”.

Chile

Ignacio Gillmore at CAREY “provides excellent and complete legal support and advice” according to market commentators, who applaud his “exceptional skill, responsiveness and focused approach”.

Canada

Adrienne Blanchard at BLANCHARD LAW OFFICE has more than 20 years’ experience in the field and is widely recognised for her solid expertise of regulatory compliance issues in the life sciences sector.

Alice Tseng at BLAKE CASSELS & GRAYDON is “highly recommended” by peers who appreciate her superb understanding of regulatory and marketing matters affecting clients in highly regulated industries including pharmaceuticals and medical devices.

Sara Zborovski at NORTON ROSE FULBRIGHT is “an excellent regulatory lawyer” who advises clients on a range of matters including clinical trial agreements, market access strategies and the development of compliance policies.

The “terrific” Martha Healey at HEALEY LAW OFFICE is a specialist when it comes to federal and provincial regulatory matters and regularly advises prominent clients in the life sciences industry.

Mexico

The “exceptional” Alejandro Luna at OLIVARES boasts “fantastic knowledge and experience in the life sciences space” and is recognised for his understanding of regulatory issues affecting patent holders.

USA

Daniel Kracov at ARNOLD & PORTER KAYE SCHOLER is “an excellent lawyer” who boasts a solid life sciences regulatory practice. He is particularly well known for his expertise when it comes to FDA-regulated products.

Gregory Levine at ROPES & GRAY is “a big player in the market” who boasts “an excellent reputation” for his top-tier practice advising pharmaceutical, medical devices and biotechnology clients on compliance and regulatory matters.

The “outstanding” Kathleen Sanzo at MORGAN LEWIS & BOCKIUS is the firm’s FDA practice leader and is “highly recommended for her vast knowledge and experience in the field”.

Cathy Burgess at ALSTON & BIRD is described as a “strong lawyer” by sources who highlight her work acting for FDA-regulated entities in the life sciences arena.

John Bentivoglio at SKADDEN ARPS SLATE MEAGHER & FLOM handles a variety of regulatory matters involving FDA advertising and promotional, among other matters. Sources call him “standout practitioner” in the field.

Sources are “continually impressed” with Alan Minsk at ARNALL GOLDEN GREGORY thanks to “the span of his expertise and service-oriented approach”.

Christina Markus of KING & SPALDING is “a well-known practitioner” who stands out for her excellent work assisting clients with the development of regulatory strategies and compliance evaluations.


Rest of the World 

Thought Leaders
1. Odette Gourley Corrs Chambers Westgarth, Sydney
2. Bernard O'Shea Norton Rose Fulbright Australia, Melbourne
3. Greg Williams Clayton Utz, Sydney

Leading Firms

Leading US-headquartered corporate firm SIDLEY AUSTIN also performs well in the Asia-Pacific market, with three practitioners from its offices in China, Hong Kong and Australia highlighted for their expertise in life sciences regulatory matters.
“Leading practitioner” Lei Li enjoys an excellent reputation in the market thanks to his involvement with life sciences regulatory matters in the US and China.
Yuet Ming Tham is a very well-regarded lawyer in the life sciences space, and wins praise for her expertise when it comes to cross-border regulations and compliance matters.
The “excellent” Chen Yang has more than 20 years’ experience representing international life sciences companies in connection with a range of regulatory matters, including clinical trials, market entry and promotional activities.

Other Leading Individuals

Australia

Odette Gourley at CORRS CHAMBERS WESTGARTH acts for many of the major companies in the pharmaceutical, biotechnology and good industries and is recognised for her strong regulatory expertise.

The “excellent” Bernard O'Shea at NORTON ROSE FULBRIGHT is a top-tier practitioner in the life sciences arena and earns recognition for his expert knowledge of pricing and reimbursement matters.

Greg Williams at CLAYTON UTZ is "a greatly skilled and knowledgeable lawyer" who is internationally recognised as a leader in regulatory matters.

China

Katherine Wang at ROPES & GRAY is “an exceptional lawyer” who stands out in the international marketplace thanks to her strong technical background.

Israel

Ron Peleg at MEITAR LIQUORNIK GEVA LESHEM TAL LAW OFFICES is “highly appreciated locally and globally” thanks to his “professionalism, responsiveness and efficiency”.

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Nominees have been selected based upon comprehensive, independent survey work with both general counsel and private practice lawyers worldwide. Only specialists who have met independent international research criteria are listed.

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