Practical LawConferences

Dorothy Flower heads the Medical/Life Sciences team at RPC. Her practice includes defending manufacturers and suppliers of medical devices and pharmaceuticals against product liability claims, and she is involved in some of the most high-profile litigation.  She also deals with commercial disputes and injury claims arising from clinical trials, as well as acting for private sector organisations and individuals in medical malpractice cases. Dorothy’s regulatory experience includes acting for individuals investigated by the GMC and HCPC, and advising on CQC regulation. Dorothy is often instructed by insurers to advise on policy coverage and to draft policy wordings. Dorothy is recognised in Chambers and Legal 500 and this year in The Lawyer’s Hot 100 2015 which acknowledges lawyers who are considered leaders in their field.

Peter Rudd-Clarke specialises in defending manufacturers of complex products against liability claims, including those in the Life Sciences sector. He has worked as a claims adjuster on secondment to a major international insurer’s claims team, as well as in a general counsel role at another company. Peter has delivered seminars on subjects including developments in Product Liability law, disputes with an overseas element and insurance coverage. He writes on product liability matters for industry journals and has been quoted in the Times and trade press discussing the risks faced by manufacturers of medical products.

Nicole is currently the European General Counsel for global Japanese Pharmaceutical R&D company Otsuka Pharmaceutical. Having started her legal career in South Africa and relocated to the UK in 2001, Nicole is dual qualified with over 17 years of post-qualified experience in a range of private practice and in-house roles.

Since moving into the pharmaceutical industry in 2007, Nicole has developed specialist industry knowledge and supported and advised Otsuka Europe on various UK and European legal and compliance matters. Nicole has recently taken on the dual role of European Compliance Officer and currently chairs the European Compliance Committee. She is in the process of establishing a pan-European Compliance Programme for Otsuka, including the introduction and implementation of anti-corruption, whistle-blowing and data protection policies and compliance training programmes across the region. Nicole continues to build upon these successes to lead Otsuka to becoming a European leader in Compliance.

A lawyer and business adviser with experience of providing legal, risk management and compliance advice to businesses in all sectors. Held senior positions within the legal and risk management teams of professional services firms, industry and private practice. An experienced project manager, coach and mentor. A leader of cross-functional teams (finance, tax, HR and external legal counsel) to deliver services and solutions that meet customer requirements, reduce costs for the business and increase profitability. Work with external industry and professional bodies to raise awareness of issues applicable to the legal profession and/or business community with the aim of influencing the development of the law, regulations, policy and guidance.

Alan Adcock is a partner and deputy director of the Tilleke & Gibbins intellectual property and regulatory affairs groups, helping to oversee the firm’s client work in these areas across ASEAN. He is known for his “detailed knowledge of the law” (The Legal 500 Asia Pacific 2010/2011), fluency in Mandarin, and outstanding client service. Since 2005, Alan has received recognition by Asialaw Leading Lawyers Survey as one of Asia’s leading business lawyers in the area of intellectual property, and he has been named a top IP lawyer in Thailand by Chambers Asia-Pacific and WTR 1000. He is also recognized as one of the world’s leading life sciences practitioners by IAM Life Sciences.

Alan represents diverse clients, from pioneers in the life sciences to the biggest IP owners in the world, and helps them achieve the dual goals of profit and protection. He has extensive experience in IP acquisitions, strategic structuring, technology transfer, and IP licensing and securitization agreements. He has handled various IP infringements and regulatory infractions involving labeling, advertising, clinical trials, product handling/warehousing, product registration, taxation, and import/export violations in Thailand, China, Hong Kong, Macau, Japan, South Korea, Malaysia, Indonesia, the Philippines, and Vietnam.

Alan is also closely involved in Tilleke & Gibbins’ leading patent and trade secret litigation practice, focusing mainly on the pharmaceutical, agrochemical, and material science sectors. He handles local pre-litigation strategy and litigation management for infringement and invalidation matters and works regularly with external counsel globally when strategic tasks or evidence issues reach outside Southeast Asia.

Alan is a Co-Chair of the American Chamber of Commerce in Thailand’s Food & AgriBusiness Committee and serves as the Chair of the INTA Legislation & Regulation Committee, East Asia and Pacific Subcommittee.

Katherine Wang is a partner in our Life Sciences group. Widely regarded as a leading life sciences regulatory lawyer in China, Katherine assists pharmaceutical, biotechnology, and medical device companies on a wide range of matters, including early-stage discovery, product registration, pricing, reimbursement, clinical studies, promotional practices, and product safety issues. Katherine provides day-to-day counseling on issues that life sciences companies face in relation to their interaction with agencies including the China Food and Drug Administration (CFDA), the National Health & Family Planning Commission (NHFPC) and the Administrations of Industry and Commerce (AICs), among others. She also assists institutional investors and corporate clients in structuring transactions and conducting regulatory due diligence, including good laboratory practice (GLP), good clinical practice (GCP), good manufacturing practice (GMP) and pharmacovigilance, on investment targets and prospective business partners in China.

Before entering into private practice, Katherine served as the head of AstraZeneca’s legal department in the Asia-Pacific region. In this role, she advised on critical strategic and operational initiatives to ensure legal compliance and realization of business objectives. She was also responsible for cross-functional intellectual property enforcement and anti-counterfeiting efforts.

Arthur is the managing partner of the Ropes & Gray’s Shanghai office and is a member of the firm’s Life Sciences and Private Equity groups. He has over a decade of on-the-ground experience in China advising clients on mergers and acquisitions, private equity and venture capital financings, cross-border joint ventures, and complex commercial arrangements. Arthur primarily serves multinational pharmaceutical and medical device companies, biotechs and scientific entrepreneurs, and life sciences and healthcare investment funds pursuing opportunities in China. Arthur also devotes his time to advising leading US based hospitals and other healthcare services institutions on their transactions in China.

Geoffrey works with global companies to monetize, risk assess, and protect intellectual property central to their businesses. He focuses on structuring technology transfers as well as enforcing clients’ intellectual property rights in the life science and high technology industries.

Geoffrey has advised clients in the pharmaceutical, biotechnology, health care, technology, electronics and telecommunications industries and has represented clients such as Takeda, MedImmune, and Rovi Corporation.

Geoffrey has practiced in China since 2005.

Corporate Legal Affairs; Compliance and Business Ethics; Intellectual Property; Business Development & Business Innovation

Brian is the first non-Italian General Counsel for Sorin Group, an Italian stock exchange-listed corporation, and largest European company in its medical devices sector. Sorin Group announced in late February a merger with Cyberonics Inc., a US NASDAQ-listed company and world leader in the treatment of epilepsy, which will result in the merged company being listed on both the London Stock Exchange and NASDAQ.

Brian is responsible for all business ethics, compliance and legal matters in this multinational medical device group as well as mergers & acquisitions. Brian combines these responsibilities with a leadership role in business model innovation as well as being responsible for the Group’s extensive intellectual property portfolio. Brian has been recognized for his role leading the Group’s multiple-award-winning Business Ethics and Global Compliance Program.

Brian was previously a Partner Oppenheimer, Wolff & Donnelly LLP, and is the author of ‘Biotechnology Regulation and Practice’ (Palladian, 2001). He obtained his LLB, LLM and post-graduate diploma in Competition Law from the University of London.

Jonathan is a partner of Howard Kennedy LLP and he has also been the legal counsel to UK Biobank for the past ten years http://www.ukbiobank.ac.uk , one of the largest global medical research resources.

Jonathan specialises in intellectual property (advisory, commercial and dispute resolution) and in data protection and freedom of information issues.  He has specific expertise in the medical devices and the medical research sectors including clinical trials, genetics, setting up research projects and the use of clinical and research data.

Amandine joined Ipsen Pharma in 2012 as a Legal Director R&D. Amandine is responsible for providing legal support to the global R&D Department.

Amandine has more than 10 years of legal experience. She started her career working for several years, as an attorney, for the litigation Department of the firm of Patterson, Belknap, Webb & Tyler located in New York, on a major US and Canadian pharmaceutical product liability case.

After that, she worked for a French biotech company (LFB), where she gained significant international experience, dealing with many legal issues ranging from R&D stage, business development deals to commercial issues. Most recently, she held the position of Senior Legal Counsel in a leading French Diagnostic company (Diagnostica Stago), where she primarily provided legal advice and support with respect to the commercialization of high technology products, and partnerships with the pharmaceutical industry.

Maiken Keson-Brookes is Senior Vice President and General Counsel of FORUM Pharmaceuticals. At FORUM, she and the team she manages provide legal support to all areas of the business and provide leadership on corporate governance, strategy and intellectual property. Prior to joining FORUM in 2010, Maiken was Associate General Counsel at Biogen Idec, first in Switzerland and then in Cambridge, Massachusetts. Before that, she was General Counsel and Company Secretary at Cims Limited, a financial services company located in the United Kingdom. After university, Maiken worked in the public sector, focusing on international law.

Maiken holds an LLB and an LLM from King’s College London. She is admitted as an attorney in New York and as a solicitor in England and Wales.

Rhianon is lead attorney responsible for providing legal advice in respect of clinical development and regulatory matters within Novo Nordisk globally as well as advising the device development and clinical supply areas. She supports all areas of clinical development for Novo Nordisk including: clinical operations from Phases I to IV, including non-interventional studies, investigator sponsored studies, and usability studies, pre-clinical development, regulatory matters, data privacy and more.

Rhianon joined Novo Nordisk in January 2010 and currently lives and works in Copenhagen, Denmark. However, she previously spent 3 years working as Legal Counsel in the UK Affiliate of Novo Nordisk providing legal support on market activities including distribution, sales and marketing and market access in the UK and Ireland. She also has expertise in competition law, data privacy, product liability, global safety and employment law and is UK qualified solicitor.

In 2011-2, she has also spent time working in Novo Nordisk’s US HQ in Princeton, supporting the US BioPharm marketing, and Medical Affairs teams.

She has previously worked for both Sanofi-Aventis and ExxonMobil in the UK.

Suzanne is Executive Director, Legal at Actavis plc with responsibility for the leadership of the legal function in International (ex-Americas).

Suzanne is a UK-qualified solicitor who started her legal career at British law firm Richards Butler (now Reed Smith) in 1992. Suzanne has worked as an in-house lawyer in the life sciences sector for over 20 years at companies including Genzyme, SmithKline Beecham and Aventis.  Her broad experience extends to every corner in the life sciences sector including innovator and generic pharmaceuticals, biotech, vaccines, OTCs, orphan drugs, medical devices, diagnostics and analytical testing, with particular expertise in M&A, complex litigation, competition law and licensing.

Suzanne has a law degree and an MBA. She has a working knowledge of French and has lived in the UK, New Zealand, France and Belgium.

Bonella heads DLA Piper’s London intellectual property team and is Co chair of DLA Piper’s Global Life Sciences Sector. As an intellectual property specialist Bonella is involved in IP rights management and strategy for a diverse and international client base. With the Life Sciences sector, Bonella particularly  experienced in drafting and negotiating a wide range of specialist IP and commercial agreements including R&D and collaboration agreements, joint ventures and strategic alliances, patent and other IP licences, franchise agreements, manufacturing, distribution, supply, co promotion and outsourcing contracts.

Andrew Dyson is a partner in the DLA Piper Intellectual Property & Technology group, where he leads the UK Data Protection & Privacy practice.  He has 14 years’ experience advising clients on information law, technology and privacy issues.  Andrew is a regular speaker on information law issues at executive seminars and conferences, including the annual Privacy and Data Protection Conference and Corporate Executive Board ‘Circle of Privacy Experts’.

Gerry is the UK General Counsel for Lonza, one of the world’s leading suppliers to the pharmaceutical, biotech and specialty ingredients markets.  Founded in 1897 in the Swiss Alps, Lonza has more than 40 major manufacturing and R&D facilities and approximately 9,800 employees worldwide, and has its head office in Basel, Switzerland.  With over 25 years in-house experience Gerry has worked in a variety of industries from heavy engineering and defence to high-tech, and has spent the last 12 years in the life sciences sector with Lonza. He obtained an MBA from the Cranfield School of Management.

Gerry is based at the Lonza Biologics site in Slough where Lonza focusses on the development and manufacture of monoclonal antibodies, an area that Lonza entered in 1996 following its acquisition of the pioneering Celltech Biologics.  Advising Lonza’s Pharma&Biotech sector, Gerry and his team have particular responsibility for concluding development and manufacturing agreements with a wide variety of customers, from large pharma to universities and start-ups, whether at the Slough facility, or at Lonza’s large-scale manufacturing facilities in Spain, Singapore and the US.   The team is also responsible for technology licensing agreements relating to the GS gene expression system^TM, and advising on R&D and collaboration agreements.

Louisa is a Partner with over 12 years experience in commercial litigation, specialising in product safety and product liability. She has advised manufacturers on claims and safety issues relating to food and drink, consumer goods, pharmaceuticals and medical devices amongst others. Her clients include multinational companies, with a particular focus on the consumer, retail and pharmaceutical sectors. She regularly provides training on product recalls to manufacturing and retail clients.

Louisa has significant experience of running large litigation cases in the English High Court, and of resolving claims through mediation and other forms of alternative dispute resolution.

She acts for GlaxoSmithKline in its defence of a product liability group action relating to its antidepressant Seroxat and has been involved in all stages of this high profile and long-running litigation.

Robert joined Transparency International UK in 2008 and was appointed as Executive Director in 2013. His areas of expertise include the Bribery Act, integrity in the private sector and corruption within the UK. Recent projects and publications include ‘Anti-Bribery Due Diligence for Transactions’, ‘Adequate Procedures – Guidance to the UK Bribery Act’ and ‘Corruption in the UK’. He was previously Director of Governance & Sustainable Investment at F&C Asset Management, and CEO (Europe) of the environmental research group Earthwatch Institute.

He was a member of the Ministry of Justice’s Experts Group drafting the official guidance on the Bribery Act and formerly a member of the of the UK Government’s Export Guarantees Advisory Committee. He has a degree from Oxford University, where he recently held a 3-year Visiting Fellowship, and a PhD from the European University Institute.

Sonia Campbell is a Partner within Addleshaw Goddard’s Insurance Litigation Group. Sonia’s policyholder clients include some of the best known and most highly respected FTSE 100 companies, and her disputes experience includes financial services, product liability (pharmaceutical, consumer healthcare, vaccines), environmental, D&O, fidelity/fraud, professional practices/LLPs, engineering, construction, property and retail and consumer.

She is a highly respected commercial litigator and an experienced arbitration practitioner, with a particular specialism in product liability Bermuda Form arbitration. Sonia specialises in managing and resolving complex insurance disputes as well as advising on non-contentious insurance issues, specifically advising on potential gaps in insurance cover and assisting with policy reviews.

Prior to joining Addleshaw Goddard, Sonia was an international loss adjuster, instructed by the London and companies’ market insurers to investigate policy coverage issues in South America (reinsured through the London market). Sonia has an in-depth understanding of the way in which the insurance market works.

Richard is a co-founder of Byfield and has 20 years’ litigation PR experience. He has handled media aspects of some of the most challenging, high profile civil actions brought before the High Court, Employment Tribunals  and internationally.  Formerly Deputy Head of Labour’s Rapid Rebuttal & Media Attack Unit, Richard has built a specialism in cases with a political dimension, particularly those involving extradition and Interpol Red Notices.

Charles specialises in corporate finance and mergers and acquisitions (M&A) where he acts for both private and public companies with a particular focus on cross-border transactions and public company takeovers. In addition, he has acted for a number of global pharmaceutical companies, including GSK and Shire Pharmaceuticals on the acquisition and disposal of pharmaceutical products and companies. Charles is the UK Head of Corporate at DLA Piper.

Colin is Head of the Life Sciences Group and advises Irish and multi-national pharmaceutical, medical device, biotech, cosmetic, food, beverage and agri-business companies in Ireland on a wide range of corporate, commercial, regulatory, intellectual property and promotional matters, including their day-to-day sourcing, supply chain, manufacturing and sales activities.

Dr. Milind Antani is a Partner in charge of the Pharma & Healthcare practice a at the multi-skilled, research-based international law firm, Nishith Desai Associates with offices in Mumbai- Nariman Point, Silicon Valley, Bangalore, Singapore, New Delhi and Mumbai – BKC and Munich. He is also in-charge of Social Sector Practice group and Nanotechnology practice.

He represents clients in matters including JVs, MnAs, Collaborations, Regulatory advice, IP  and licensing matters. He has authored and co-authored many articles, publications related to the pharma and healthcare industry including a book on CRAMS. He is a regular speaker and panelist at various national and international forums on the subjects of, pharma, biotech, IP, clinical trials, healthcare, CSR, FCRA. He is also a visiting faculty at many institutions in Mumbai.

He is also a certificate holder from Harvard Business School on “Managing and Transforming Professional Service Firms-India” an executive training program organized by HARVARD BUSINESS SCHOOL.

He has been included as one of the world’s leading practitioners in ‘Who’s Who Legal’ for Life Sciences 2014 and 1025 in the ‘Regulatory’ section as only lawyer from India.

And yes, he started his career as an ENT surgeon in Gujarat and practiced for 14 years before he changed career to law and moved to Mumbai 10 years ago. And he is alumnus of Anand Law College, Sardar Patel University, Gujarat.

Khushboo Baxi heads the Pharma and Life Sciences practice at Nishith Desai Associates (www.nishithdesai.com). She is also a part of the Food & Beverages, Litigation & Alternate Dispute Resolution, and General Commercial Laws Practice Groups. Nishith Desai Associates is a multi-skilled, research-based international law firm, with offices in Mumbai, Silicon Valley, Bangalore, Singapore, New Delhi and Munich.

Khushboo has been with the firm for over 9 years and her practice particularly focuses on pharma and life sciences laws, food and beverage related laws, intellectual property laws, litigation and dispute resolution and employment related issues. Khushboo has been advising clients on legal and regulatory framework surrounding the pharmaceutical sector and has also assisted several multinational companies in their entry/investment into the Indian pharma segment. She has also provided strategic advice on and represented clients in a number of litigation and arbitration matters, both domestic and international, in the pharma, commercial laws and employment laws space.

She has authored several articles and research papers in the areas of pharma and life sciences, specifically, with respect to clinical trials, promotion and advertisement of drugs, medical devices and data protection in the pharmaceutical and healthcare space.

Helén Waxberg is a Partner at Mannheimer Swartling Advokatbyrå AB, Sweden and chair of the firm´s Life Sciences Group. She also chairs the National Marketing and Advertising Committee of ICC Sweden and is a member of the Swedish Anti-Corruption Institute´s Ethics Committee. Helén works primarily with regulatory issues, marketing and distribution in the pharmaceutical, biotech, medtech and healthcare industries and other regulated industries such as foods and cosmetics. Helén´s practice encompasses the full range of industry matters including co-operation between the industry and HCPs, marketing, sponsoring, reimbursement and pricing, substitution, product recalls etc. Helén regularly assists the industry in matters handled by the industry´s self-regulatory bodies and cases before administrative courts and the Market Court. Much of her work also focuses on corporate entertainment, anti-corruption and related issues in various industries. Helén is often engaged as speaker at seminars and conferences.

Olli Kiuru is a Partner at Lexia Attorneys Ltd which has a simple mission: to help its clients to succeed. Olli is the head of Lexia’s Life Sciences team which has strong insight and experience in health care, insurance and pharmaceuticals industry.

With the Life Sciences sector Olli has extensive experience in drafting and negotiating complex agreements, such as supply and resale agreements, for e.g. cancer research units of the biggest Finnish public health care provider and a company developing diabetic self-care to name a few. Additionally, IT and IPR are strongly involved in aforesaid agreements due to many startups developing different Life Sciences apps. Olli has also advised the biggest Finnish private health care provider in its M&As over the recent few years.

Olli is a respected litigator and he has remarkable experience within litigation and arbitration especially in the insurance sector. Olli has been involved in product liability cases and several mall practice litigations within the past few years.

Within the Pharmaceuticals industry Olli has represented a significant insurance company in its pharmaceutical injury cases. Moreover, Olli and his Life Sciences team have assisted several clients in strongly regulated pharmacy matters.

Edward joined Norgine in 2013. Norgine is a privately held European specialist pharmaceutical company.  As Head of Legal Services, he acts as an advisor to business units based in Europe, MENA and Australasia. He also supports Norgine Ventures, which has committed €50 million of venture financing to European companies in the healthcare sector in the last 3 years. He covers a diverse range of areas relevant to the business ranging from Partnering/Business Development, Commercial, Finance,  M&S, Regulatory and IT.  Prior to joining Norgine, Edward trained and practised at King Wood Mallesons LLP (formerly SJ Berwin LLP) as a corporate lawyer. He has worked in-house at a major bank and a media company based in the Middle East.

Orla is a Senior Associate in the Litigation and Dispute Resolution group where she provides a wide range of product liability, product safety, regulatory and general litigation advice to companies and organisations within the life sciences, food, alcoholic beverage, agribusiness, healthcare, consumer goods and retail sectors.  Orla regularly advises on both general and sector-specific EU and national requirements in relation to a wide range of products. Orla trained and qualified at a City of London firm, and subsequently practiced in the London office of a top US law firm.