Life Sciences: Regulatory 2019

This year’s guide sees 314 individuals highlighted across 42 jurisdictions for their work on regulatory matters in the life sciences space.

Methodology

The Global Elite 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 truly outstanding practitioners and the very best in their field.
 
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.
 

EMEA

Global Elite Thought Leaders
1. Ian Dodds-Smith  Arnold & Porter Kaye Scholer LLP, London
2. Maria Isabel Manley  Sidley Austin LLP, London
3. Carla Schoonderbeek  Hoyng Rokh Monegier, Amsterdam
4. Peter Bogaert  Covington & Burling LLP, Brussels
5. Mikkel Vittrup  Plesner Advokatpartnerselskab, Copenhagen
6. Lincoln Tsang   Arnold & Porter Kaye Scholer LLP, London

Leading Firms

Hogan Lovells

This full-service powerhouse sees nine individuals listed in this year’s guide.
Elisabethann Wright is a “very in-demand regulatory lawyer” according to market sources. She has a wealth of experience on product classification and on attaining authorisation from the EMA.
Hein van den Bos is “an excellent regulatory expert”, with superb knowledge of the complete regulatory life cycle, and is lauded by peers as “a leading name in the market”.
Ina Brock is a top name in the space and “one of the best EU and German lawyers in the field”, say sources. She has a “highly reputed practice” featuring a comprehensive knowledge of the pharmaceutical sector.
Jörg Schickert wins strong praise from sources this year, reflecting his superb ability on domestic and European medical device and biotech regulatory issues.
The “excellent” Richard Welfare continues to impress in our research thanks to his wide-ranging expertise of the UK and EU authorities and a strong understanding of issues such as advertising and labelling.
Ruth Franken is “a strong lawyer in the life sciences area” report market observers. She is recommended for her expertise across the whole life cycle of medicinal products and medical devices.

Arnold & Porter Kaye Scholer

This firm is home to three of the field’s foremost individuals.
A Global Elite Thought Leader in the field, Ian Dodds-Smith is credited as “a guru of life sciences regulation” and “one of the best pharmaceutical regulatory lawyers around”. Another source notes: “He really has always been at the top.”
Lincoln Tsang is “incredibly knowledgeable and has handled every scenario” in the regulatory arena, according to respondents. He offers clients “a deep understanding of the regulator’s thinking” on an array of matters.
Adela Williams is identified as “an expert on reimbursement issues”and receives widespread praise from respondents to our research for her winning ability in the life sciences field. She is rated as “outstanding for judicial review”.

Sidley Austin

Sidley Austin sees three impressive practitioners highlighted in this year’s guide.
A Global Elite Thought Leader in the space, Maria Isabel Manley is “one of the top regulatory lawyers in the EU” and a “very creative practitioner” who is “excellent on data exclusivity matters”.
Maarten Meulenbelt is “very detailed on every point” according to impressed clients who applaud his “great connections” in the field. He has a “go-to practice” that sees him involved in data protection and pricing issues.
Maurits Lugard is described by peers as “one of the most highly sought-after lawyers in the country”. His distinguished practice features a deep understanding of matters including pharmacovigilance and market authorisations.

Hoyng Rokh Monegier

This firm is a dominant force on the European continent, with three practitioners highlighted this year.
Carla Schoonderbeek is “one of the best in her field” and “a major player in the market” according to impressed peers. Noted as “a leading regulatory lawyer”, she has vast expertise on matters relating to medicinal products.
Bart Jong is “strong on regulatory exclusivity work with an emphasis on pricing and reimbursement issues” according to commentators. He is “very knowledgeable” on a variety of other matters, such as market access.
Liesbeth Weynants has a stellar reputation in the market with peers commending her as “a real expert in domestic matters” including pricing-reimbursement and advertising issues.

Other Leading Individuals

Belgium

Covington & Burling’s Peter Bogaert is a “very senior figure in the market” and “one of the elite of life sciences regulation”. His exceptional reputation in the medical device and biotechnology sectors leads to him once again being named as a Global Elite Thought Leader.

Denmark

At Plesner, Mikkel Vittrup is described as “the first port of call” for interviewees who highlight his “very active practice” on issues such as medicinal products and dietary supplements.

England

Taylor Wessing’s Tim Worden is a leading name in the jurisdiction with “strong regulatory expertise”. He earns recommendations for his fantastic work on licensing and R&D, among other regulatory matters.

Germany

Sträter Rechtsanwälte is home to a distinguished individual in Markus Ambrosius, who is applauded for his standout work handling compliance and enforcement-related matters in the pharmaceutical, biotech and medical device industries.

Clifford Chance’s Peter Dieners is a “very famous” figure in the market who sources praise highly this year. He runs a top-tier practice with deep knowledge of healthcare regulation.

Italy

Vincenzo Salvatore of BonelliErede is “an excellent practitioner” who is noted by peers to be “very experienced in the field of life sciences regulation”. 

Netherlands

Leijnse Artz’s Koosje van Lessen Kloeke is described as “absolutely the best regulatory lawyer in the Netherlands” and “a go-to for complex cases”. Peers note that she is “a fantastic regulatory litigator” who is “supreme in court and will go all out to win your case”.

Sweden

Clients are “impressed” by Helen Waxberg of Mannheimer Swartling Advokatbyrå and praise her “knowledge of the pharmaceutical market” and her “pragmatic, straight-to-the-point approach”. She has “unique expertise in the field” and is “always available and extremely good at thinking about the broader commercial context”.

 

The Americas

Global Elite Thought Leaders
1. Jeffrey K Shapiro   Hyman Phelps & McNamara PC, Washington DC
2.Ignacio Gillmore   Carey, Santiago
3. Angela Fan Chi Kung  Pinheiro Neto Advogados, São Paulo
4. Adrienne M Blanchard Blanchard Law Office, Ottawa

Leading Firms

Hyman Phelps & McNamara

This firm maintains a dominant position in North America, with 13 practitioners highlighted in our guide.
Global Elite Thought Leader Jeffrey Shapiro wins widespread support from peers this year. He runs a fantastic practice that sees him engaged in a range of FDA-related matters.
Jeffrey Gibbs is one of the top names in the US market, with a well-deserved, well-established reputation for his regulatory expertise. In particular, he is noted by peers to be “very strong on medical device issues”.
Frank Sasinowski is a distinguished name who provides clients with exceptional depth of experience handling FDA approvals.
Wes Siegner Jr is an eminent practitioner who draws praise from across North America for his top-tier practice, which sees him engaged in issues such as product labelling, advertising and FTC enforcement.
Robert Dormer continues to impress in our research, with interviewees highlighting his leading practice that spans the full range of FDA’s matters. He has over 40 years’ experience in the field.
Paul Hyman draws effusive praise from respondents to our research for his excellent work on matters such as pre-market approvals, compliance and advertising regulation.

Hogan Lovells

Nine individuals are highlighted from across Hogan Lovells’ offices in the USA and Mexico.
The “excellent” Jonathan Kahan is credited by peers as “one of the best lawyers in the space”. He possesses a top-drawer practice in which he advises on FDA clearance for medical device firms.
Helen Trilling is a prominent figure in the healthcare sector, cited as “one of the best” for her superb work handling compliance and enforcement-related issues.
Clients state that Philip Katz is “great at helping you to think as clearly as possible about complex issues”, offering deep understanding of the biotech and pharmaceutical sectors.
David Fox is a top-tier practitioner venerated by peers across the region for his standout ability on complex pharmaceutical concerns relating to the DEA and the FDA.
Meredith Manning has “a superb hybrid practice covering regulation and litigation” according to market observers who give her strong support in this year’s research.
The firm has another leading name in Janice Hogan who is described by interviewees as “an outstanding medical devices lawyer”.
Ernesto Algaba Reyes is an outstanding individual with a leading practice in the Mexican market. He excels on issues arising from the pharmaceutical and medical device sectors and offers clients exceptional experience across the field.

Sidley Austin

This full-service firm wins plaudits from around the globe, seeing 10 individuals listed from across the USA this year.
Coleen Klasmeier is “someone clients can trust” according to peers who laud her work on risk management and regulatory investigations.
Scott Bass is “a leading expert” on regulatory matters who sources effuse is “a hall of famer” for his breadth of expertise on pharmacovigilance and investigations.
Raymond Bonner is a go-to name in the market with a premier practice that sees him involved in regulatory litigation arising out of investigations and enforcement proceedings.

Pinheiro Neto Advogados

Two distinguished names from this Brazilian powerhouse are highlighted in our guide.
Angela Fan Chi Kung has “a broad scope of expertise” and offers “practical and direct advice” to impressed clients. She “understands businesses’ needs well” and provides “an in-depth knowledge of the regulatory field that brings an effectiveness to her practice”.
Camila Martino Parise is “a great authority” in the healthcare arena and “really stands out when it comes to regulatory matters”. One source states: “Camila is a very business-oriented lawyer who has a superb capacity to bring together different aspects of a case.” 

Other Leading Individuals

Canada

Blanchard Law Office’s Adrienne Blanchard provides clients with “practical, business-focused advice” and “specialist understanding of life sciences regulation”.

The “terrific” Eileen McMahon of Torys wins plaudits from across the region for her top-class work on matters ranging from regulatory clearance to market exclusivity concerns.

Smart & Biggar/Fetherstonhaugh’s Alice Tseng is a very dedicated regulatory practitioner who is highly recommended by sources for her wide-ranging experience in sectors including healthcare and pharmaceuticals.

Chile

Carey’s Ignacio Gillmore is “a leading name in the Chilean market” whom sources “would vouch for without hesitation”. Sources state that he is “very specialised in regulatory matters” and excels by being “very, very well prepared”.

USA

Morgan Lewis & Bockius’ Kathleen Sanzo is a leading name in the space who wins effusive praise from respondents to our research this year for her expertise on clinical testing, promotion and labelling.

“Top-tier” lawyer Daniel Kracov of Arnold & Porter is a distinguished practitioner with a stellar reputation for his performance on regulatory matters in the medical device and pharmaceutical sectors.

Arnall Golden Gregory’s Alan Minsk is highlighted for his “precise guidance on very intricate matters” and his ability to “break down issues into understandable terms”. He also garners plaudits for his “very quick turnaround and practical advice”.

 

Asia-Pacific

Global Elite Thought Leaders
1. Greg Williams   Clayton Utz, Sydney
2. Benjamin Gaw  Drew & Napier LLC, Singapore
3. Chen Yang  Sidley Austin LLP, Sydney

Leading Individuals

Australia

Clayton Utz’s Greg Williams is "one of the leading players in the space" according to peers, thanks to his abilities in relation to medical device classification and enforcement actions.

Sidley Austin’s Chen Yang is a superb practitioner who garners widespread praise in our research for her natural ability on issues such as market entrance, clinical trials and marketing.

At Biopharmalex, Wayne Condon is an “excellent lawyer” who continues to be highly rated by peers thanks to his proficiency on regulation pertaining to biotechnology and pharmaceutical companies.

Japan

TMI Associates’ Satoru Nagasaka is “the first-choice practitioner” in the country according to impressed interviewees who highlight him in our research for his adeptness on a range of issues in the space.

Singapore

At Drew & Napier, Benjamin Gaw is lauded for his “expertise and understanding of international issues”. Clients state that he is “easy to do business with” and praise his “precision, diligence, intellect and understanding of the issues that matter for life sciences firms”.

Thailand

Tilleke & Gibbins’s Alan Adcock is “a very strong practitioner” according to sources who marvel at his “very active practice” and describe him as a “go-to in the space” for advertising and clinical trial issues.

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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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