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1st Annual Life Sciences Law Forum
5 - 6 March 2013
Waldorf Hilton, London

 
 

A practical guide to a changing global life sciences industry

Increasing globalisation and harmonisation of regulatory frameworks has led to a new wave of legal concerns for the life sciences industry. From the pipeline depletion of many organisations due to the imminent patent cliff, to the recent sharpening of investigative scrutiny by international competition authorities; legal professionals in the pharmaceutical, medical device, biotechnology and related industries are confronted by a raft of complex legal issues requiring up to date and comprehensive strategic advice.

Engaging and practical, Practical Law Company's 1st Annual Life Sciences Forum will provide a unique cross-border analysis of market trends, discuss issues at the heart of your business and prepare you for what lies ahead. Our expert panel of global life sciences professionals will examine how to implement best practice strategy for transparency and share workable tips on how to successfully enter emerging markets.

The advisory panel and speakers include:

  • Ewan John Nettleton, Senior Patent Counsel, Oncology, Novartis Pharma.
  • Bill Mordan, Senior VP and Group General Counsel, Reckitt Benckiser.
  • Elizabeth Choo, Director Legal, SingHealth.
  • Marvelle Sullivan, Group Head of M&A Execution, Novartis
  • Sabina Rossetti, Legal Affairs, Pfizer.
  • Reza Green, VP of Intellectual Property, Novo Nordisk Inc.
  • Alexander Natz, Secretary General of the European Confederation of Pharmaceutical Entrepreneurs
  • Torbjörn Hallberg, Senior Director and Senior Corporate Counsel, Takeda.
  • Mark Brealey QC, Brick Court Chambers.
  • Amy Staedtler, Chief Legal Counsel, Theorem Clinical Research.
  • Chris Mercer, President, Chartered Institute of Patent Attorneys.
  • Dr Simone Mitchell, Partner, IPT, Australia, DLA Piper.
  • Henri Piffaut, Head of Unit, DG Competition.
  • Alexey Trusov, Partner, Baker & McKenzie.
  • Scott Maidment, Partner, McMillan.
  • John Leadley, Partner, Baker & McKenzie.
  • Julia Gillert, Associate, Baker & McKenzie London.
  • Thilo Raepple, Partner, Baker & McKenzie Frankfurt.
  • Bonella Ramsay, Partner, Global Co-Chair Life Sciences Sector, EMEA, DLA Piper.
  • Elvan Sevi Firat, Partner, Mehmet Gun & Partners

Topics include:

  • Current competition issues faced by the industry.
  • 'Losec' commentary and cutting edge updates on recent case law.
  • Implications of the FCPA and the UK Bribery Act in the life sciences industry.
  • Trends in product liability litigation and the related regional regulation.
  • Maximising opportunities in emerging markets – 5 interactive round tables.
  • A global review of pricing and reimbursement schemes.
  • Social media: do's and dont's.
  • SPCs and paediatric extensions; feasibility, validity and tactics.
  • Anti-counterfeiting trends and strategies in the industry.

Day 1, Tuesday, 5 March

 
Time Details
8.15 - 9.00 Registration
9.00 - 9.30

Global industry overview: real issues and challenges in the year ahead

Bonella Ramsay, Partner, Global Co-Chair Life Sciences Sector, EMEA, DLA Piper
John Dougherty, Partner, Global Co-Chair Life Sciences Sector, US, DLA Piper

9.30 - 10.30

A practical analysis of the current competition issues faced by the industry

  • Key international competition issues: reverse patent settlements and generic entry.
  • Local competition authority enforcement and the trend towards domestic investigation - practical analysis and competition strategy in core jurisdictions.
  • The increased competition risks associated with public tenders and trade associations in the current financial climate.

Simon Neill, Assistant General Counsel Europe, Johnson & Johnson
Dr. A. Neil Campbell, Partner, McMillan
Simon Priddis, Partner, Freshfields Bruckhaus Deringer

10.30 - 11.00

AstraZeneca "Losec" case commentary: principles and practicalities of competition law in practice

  • AstraZeneca case analysis: abuse of dominant position and the unfair restriction of generic entry.
  • Practical steps going forward: what we can learn from this case and how to avoid this situation.
  • Implications of the European Commission’s pharmaceutical sector inquiry.

Mark Brealey QC, Brick Court Chambers
Henri Piffaut, Head of Unit, DG Competition

11.00 - 11.30 Coffee break
11.30 - 12.30 Interactive workshops

Stream 1: Bribery and corruption in the life sciences industry: the implications of the Foreign Corrupt Practices Act and UK Bribery Act

  • Implications of FCPA/ UK Bribery Act on healthcare professionals and patient groups.
  • The "new" SFO and Deferred Prosecution Agreement: confess or avoid?
  • Best practice case studies on how to ensure transparency.
  • Entertainment, gifts & travel: do's and don'ts.
  • Broader compliance issues: managing an organisation's expectations following local criminal liability laws in Europe.

Claire Vaughan, Associate General Counsel - International Compliance and Litigation, Smith & Nephew
Edoardo Lazzarini Ph.D, EMEA Compliance Officer, BIOMET Europe
Robert Juhasz, Senior Legal Counsel, Johnson & Johnson Medical Limited
Neil O’May, Partner, Norton Rose

Stream 2: Implications of the Sunshine Act and related global legislation on transparency in industry-government dealings.

  • Implications of the US Sunshine Act for the industry and its benefits to physicians in sales process.
  • Practical steps in implementing the Sunshine Act into day-to-day business.
  • Equivalent legislation in other jurisdictions.

Christopher White, General Counsel, AdvaMed, The Advanced Medical Technology Association
Scott S. Liebman, Principal, Porzio, Bromberg & Newman
Javier Rodriguez, General Counsel, Reckitt Benckiser Pharmaceuticals Inc

12.30 - 1.30 Lunch
1.30 - 2.30

Avoiding product liability litigation and adopting best practice strategy for adverse event reporting

  • Changes in litigation funding of product liability claims.
  • Collective action developments in the EU.
  • Canada: A case study in the Export of US Class Actions.

John Leadley, Partner, Baker & McKenzie
Scott Maidment, Partner, McMillan
Jonathan Isted, Partner, Freshfields Bruckhaus Deringer

2.30 - 3.10

Update on EU data protection regulations and "how to" steps for dealing with industry-specific issues

  • Proposed changes to the EU data protection regulations and impact on the life sciences industry (including issues posed to patient data, particularly sensitive data).
  • How to tackle the new regulations in practice: best practice strategy and guidance.

Sue Gold, Partner, Osborne Clarke
Sabina Rossetti, Legal Affairs, Pfizer

3.10 - 3.40 Coffee break
3.40 - 4.30

Managing legal risks and regulatory obligations in global clinical trials

  • New legislative framework as foreseen in the European Commission proposal.
  • Understanding local challenges before you start (undue risk, local requirements, approval timelines, unexpected costs).
  • Strategies on how to ensure an effective study start-up (investigational applications, local representatives, site selection and clinical trial agreements.
  • Optimising the CRO relationship: "how to" manage expectations, ensure effective communication and successfully transfer obligations.
  • Best practice case studies: India, Argentina, France, Belgium, Germany.

Amy Staedtler, Chief Legal Counsel, Theorem Clinical Research
Alexander Natz, Secretary-General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
David Braga Malta, CEO, Cell2B

4.30 - 5.30

Highly interactive champagne roundtable sessions: maximising opportunities to gain competitive advantage in 5 key emerging markets

One of the most productive features of the Forum, the champagne roundtable sessions provide you with the opportunity to develop invaluable business contacts through intimate discussions with leading private practice and in-house practitioners from each market. Delegates may join one table or move freely between those that are relevant to them.

China

  • Strategies on protecting intellectual property and other IP.
  • Legal structures: deciding if a joint venture is right for your client.
  • State-of-the-art practices in achieving enforcement and legal certainty.

Marvelle Sullivan, Group Head of M&A Execution, Novartis

Russia

  • Entering the market: relevant business structures and entry strategy.
  • Case study and trends.
  • Patent enforcement and litigation trends.

Alexey Trusov, Partner, Baker & McKenzie Moscow

Middle East and North Africa (MENA)

  • Understanding the challenges of registering a product in MENA and how to overcome them.
  • How well is the centralised system working in the Gulf Coast Council (GCC)? Is this centralised system likely to be adopted in any other MENA countries?
  • How to work successfully with agencies.

Torbjörn Hallberg, Senior Director and Senior Corporate Counsel, Takeda

Turkey

  • Increasing localisation of "Big Pharma" in Turkey.
  • Methods of setting up domestically.
  • Product registration in Turkey: regulation and limitations.

Elvan Sevi Firat, Partner, Mehmet Gun & Partners

Brazil

  • What are the requirements of the data package submitted to the National Health Surveillance Agency (ANVISA) to obtain product development and registration?
  • Brazil as an entry point to Latin America: crossing boundaries.

David Braga Malta, CEO, Cell2B

5.30

Cocktail reception

Programme is subject to change.

Day 2, Wednesday, 6 March

 
Time Details
9.00 - 9.30

Regulatory trends and opportunities from a food and pharmaceutical perspective: how is the global regulatory market evolving?

  • Overview of regulatory trends.
  • Nestlé Health Science case study.
  • Regulatory challenges faced in the food and pharmaceutical sectors.

Manfred Ruthsatz, Head Global Regulatory Advocacy, Nestlé Health Science

9.30 - 10.30

Update on the unified patent court and unitary patent – expected impact on the industry and legal profession

  • How will it work in practice?
  • Will the simplified enforcement regime drive innovation?

Chris Mercer, President, Chartered Institute of Patent Attorneys
Adam Cooke, Partner, IPT, UK, DLA Piper

10.30 - 11.00 Interactive sessions

Stream 1: The Affordable Care Act: the actual and purported impact on the industry in the US and beyond

  • Pricing and reimbursement pressures.
  • Impact on market share and increased generic approval.
  • Imposition of increased drug rebate to be paid by manufacturers.

Javier Rodriguez, General Counsel, Reckitt Benckiser Pharmaceuticals Inc

Stream 2: An analysis of the new UK "Good Clinical Practice Guide"

  • Explanation as to why the guide was written by the MHRA.
  • The process for the development of the guide.
  • Law versus recommendations.
  • The inspection process.

Gail Francis, Senior GCP Inspector, MHRA

11.00 - 11.30 Coffee break
11.30 - 12.30

A review of pricing and reimbursement: jurisdiction-specific analyses of the current and proposed schemes across the globe

  • How the reimbursement landscape in the EU is impacting the life sciences industry.
  • Effective strategy for reimbursement in Germany, France, Spain, Italy, Greece and Poland.
  • Practical analysis between reimbursement and investment production.
  • Impact of the revision of the EU Transparency Directive.
  • How to achieve harmonisation across jurisdictions.

Ernest Jędrzejewski, Legal Counsel, Central & Eastern Europe Amgen GmbH
Dr. Oliver Sude, Legal Counsel, EUCOPE

12.30 - 1.30 Lunch
1.30 - 2.00

Social media: do's and don'ts

  • Identifying the key risks of social media use, including Facebook, Twitter and blogs, and practical advice on creating strategies to mitigate risk.
  • The law and codes of conduct on advertising and social media in the EU.
  • Review of the Prescription Medicines Code of Practice Authority guidance.
  • How to effectively target physicians through social media: practical case studies.

Julia Gillert, Associate, Baker & McKenzie London
Thilo Raepple, Partner, Baker & McKenzie Frankfurt

2.00 - 2.45

Biosimilars and biogenerics: compliance and protection strategy

  • Assessment of how global regulatory agencies are currently approaching the introduction of biosimilars and biogenerics into established and emerging markets.
  • Overview of the European Medicines Agency guidelines and approach.
  • Potential shift in patent litigation landscape: originator v originator.

Reza Green, VP of Intellectual Property, Novo Nordisk Inc
Dr Simone Mitchell, Partner, IPT, Australia, DLA Piper

2.45 - 3.15 Coffee break
3.15 - 3.45

Supplementary protection certificates (SPCs) and paediatric extensions: feasibility, validity and tactics

  • Update on recent case law: second medical use SPCs (Neurim case).
  • Ensuring you meet the requirements for the granting of SPCs.
  • How to effectively monitor and manage your SPC portfolios.

Huw Evans, Partner, Norton Rose

3.45 - 4.45

A practical commentary on customs seizures and strategies in the industry

  • Strategies for dealing with counterfeits and medicines infringing IP rights – examples from the coal face.
  • What action is needed by the authorities, government and pharmaceutical companies?
  • Assessing the implications for the industry of online pharmacies.
  • Revisions to the customs seizure regime across the EU.
  • Utilising the World Customs Organization's Interface Public Members (IPM) system.

Ewan John Nettleton, Senior Patent Counsel, Oncology, Novartis Pharma AG

4.45

Closing comments and end of forum

Programme is subject to change.

Ewan Nettleton

Ewan Nettleton

Senior Patent Counsel, Oncology, Novartis Pharma AG

Ewan is a Senior Patent Counsel at Novartis Pharma AG in Switzerland where he works on global pharmaceutical litigation projects. This involves managing IP and related litigation in a wide range of jurisdictions. Prior to joining Novartis in September 2010, Ewan was an associate at Bristows in London specializing in IP law with an emphasis on litigation. Ewan is a qualified UK solicitor (since September 2002), and has an MA in chemistry and a DPhil in protein chemistry from Balliol College, Oxford as well as a Diploma in Intellectual Property Law and Practice from Bristol University. He is also a member of the Royal Society of Chemistry.


Reza Green

Reza Green

VP of Intellectual Property, Novo Nordisk Inc

Reza Green is Vice President of Intellectual Property and Chief IP Counsel at Novo Nordisk Inc., the US affiliate of Novo Nordisk A/S, where she supervises a group of patent attorneys in all aspects of IP law, including patent prosecution, litigation, and licensing. She received her J.D. from Fordham Law School and practiced at Darby & Darby before joining Novo Nordisk. Prior to entering law, she received a Ph.D. in cellular and molecular biology from NYU School of Medicine and engaged in research and teaching as a member of the faculty of Mount Sinai School of Medicine. Novo Nordisk is a global pharmaceutical/biotech company that is a leader in diabetes care, hemostasis, and other therapeutic areas.


Marvelle Sullivan

Marvelle Sullivan

Group Head of M&A Execution, Novartis

Marvelle Sullivan was recently named Group Head of M&A Execution for Novartis, after serving as Head of Corporate Legal M&A. Since 2007, Ms. Sullivan has represented Novartis on $70 billion dollars worth of acquisitions and divestments, including the divestments of the Gerber and Medical Nutrition businesses to Nestle SA, the staged acquisition of Alcon Inc., a majority stake in Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. and the acquisitions of Genoptix, Protez Pharmaceuticals, the pulmonary business of Nektar Therapeutics, the generic injectables business of Ebewe Pharma – and most recently the $1.525 billion dollar acquisition of the private equity-backed U.S. generics company, Fougera. Prior to her time Novartis, Ms. Sullivan specialized in capital markets and M&A at Allen & Overy in London.


Javier Rodriguez

Javier Rodriguez

General Counsel, Reckitt Benckiser Pharmaceuticals Inc.

Javier joined the company as General Counsel in 2011, where he is responsible for global legal affairs and compliance. Prior to taking on this role, he spent four years as Senior Counsel with Reckitt Benckiser LLC. His previous experience includes in-house counsel positions with Bayer Healthcare LLC and Berlex Laboratories Inc.


Javier Rodriguez

Dr. Alexander Natz

Secretary General of the European Confederation of Pharmaceutical Entrepreneurs

Dr. Natz is Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (www.eucope.org). He is also heading the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer with Sträter Law Firm in Germany and also worked in the pharmaceutical industry. Before, he has been working in the field of competition law with the European Commission. As a research assistant at Duke University (USA) he has dealt with international pharmaceutical law. His doctorate was supervised by former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling.


T Hallberg

Torbjörn Hallberg

Senior Director and Senior Corporate Counsel, Takeda

Torbjörn is Senior Corporate Counsel and Senior Director with Takeda Pharmaceuticals. He has spent 10 years in the pharmaceutical industry. In his corrects role, Torbjörn is heading the legal License and Alliance Management group in Europe/Canada and Emerging Markets and in addition has overall responsibility for legal activities in emerging markets such as Russia/CIS and Middle East, Turkey and Africa. Torbjörn is a frequent speaker at the Faculty of Law at the University of Lund, Sweden.

Prior to Takeda Torbjörn has held various positions with Nycomed Pharmaceuticals and Ferring Pharmaceutical and has a background in private practice with Swedish law firm Lindahl and Lovells in Germany.


Claire Vaughan

Claire Vaughan

Associate General Counsel - International Compliance and Litigation, Smith & Nephew

Claire Vaughan is an Associate General Counsel at Smith & Nephew plc, a global medical device manufacturer. She joined the company ten years ago, having previously worked for several of ICI’s chemical businesses over a period of 14 years.

Claire advises on compliance and litigation matters in its international markets around the world. She works closely with the company’s Office of Ethics & Compliance in supporting the businesses.

Claire is a member of the Legal Interest Group and the Compliance Code Committee of Eucomed, the European trade association for the medical device industry and also is a member of the legal group of the ABHI, the English trade association for the industry.


Amy Staedtler

Amy Staedtler

Chief Legal Counsel, Theorem Clinical Research

Amy Staedtler began her legal career with Theorem Clinical Research, a US based Global CRO, in 2002 and became Chief Legal Counsel in January 2010. In this role she oversees all legal matters for the organization including managing the legal review of all contracts for Theorem, ensuring compliance with global corporate governance requirements and providing general legal support for senior management. In addition, Amy manages Client Legal Services which offers a suite of legal services including clinical trial agreement negotiation and legal representative services. Amy received her undergraduate degree from Boston College and her JD from the UCLA School of Law. She also spent a year at the Technische Universität Dresden as a Fulbright scholar and has published academic articles in medical ethics. Amy is a member of a number of professional associations, including the California Bar Association, the American Bar Association and the American Historical Society.


Dr. Manfred Ruthsatz

Dr. Manfred Ruthsatz

Head Global Regulatory Advocacy, Nestlé Health Science

A newly created Nestlé company, pioneering science-based nutritional solutions for people with certain medical conditions and a newly created position which Manfred took over in 2013 to build and strengthen relations with regulators, policy-makers and professional associations. Manfred joined Nestlé HealthCare Nutrition heading Regulatory and Scientific Affairs in 2008. Prior to that, he held leading regulatory positions in different healthcare industries, providing him with a wide blend of hands-on experiences in drugs, biotech, nutrition, devices, botanicals and cosmetics, at times rounded out by responsibilities in quality assurance, safety, vigilance, health economics and reimbursement.

Manfred served as well at the US Food and Drug Administration (FDA) as reviewing pharmacologist for drugs. He is an active member of the Medical Nutrition International Industry (MNI), leading the work-stream of global regulatory affairs and served as president of the European Botanical Forum (EBF) and board member of the European Responsible Nutrition Alliance (ERNA).

Manfred is a Registered Pharmacist, holding a Ph.D. in Toxicology & Biochemistry (Germany). He is a longstanding member of the Regulatory Affairs Professional Society (RAPS) and the American Board of Toxicology (ABT) in the US.

Manfred has worked and lived in several countries, is married to his Brazilian-Italian wife with two kids.


Simon Neill

Simon Neill

Assistant General Counsel Europe, Johnson & Johnson

Simon Neill is Assistant General Counsel at Johnson & Johnson. He has been at J&J since 2001; prior to joining J&J he was in private practice at Coudert Brothers in Brussels and in London. At J&J he combines two main roles: as EMEA legal counsel for one of J&J’s largest medical devices businesses and as head of J&J’s cross-sector competition law team in EMEA. His principal area of activity is in medical devices; he also has experience in the Pharma and Consumer sectors. In his role as business lawyer Simon is involved in all areas of legal advice on strategic, commercial and corporate matters as well as compliance including corruption, bribery and competition. In his role as principal competition lawyer, Simon has overall responsibility for coordinating a broad range of competition work across the J&J group in EMEA, including merger notifications, litigation and risk management in commercial operations, including competition compliance programmes.


Robert Juhasz

Robert Juhasz

Senior Legal Counsel, Johnson & Johnson Medical Limited

Robert is the in-house lawyer for Johnson & Johnson’s medical devices businesses in the UK and Ireland (excluding orthopaedics) and the regional board attorney for its Vision Care (Acuvue) contact lens business. He advises on a wide selection of legal issues including tenders, commercial sales, competition law, corporate/M&A, regulatory, product liability and compliance matters. He has been with Johnson & Johnson since 2008.

Robert is also Chairman of the Legal Issues and Compliance Committee of the Association of British Healthcare Industries (ABHI), whose recent achievements have included the creation of an Advertising Code for the medical device industry governing misleading promotional and marketing claims to HCPs, as well as an ABHI ADR procedure enabling better industry self-regulation of disputes between members.

Robert previously undertook a similar role at GlaxoSmithKline, covering their pharmaceutical and consumer businesses in the Middle East and North Africa, and also held short in-house positions at General Mills and BP. Prior to moving in-house Robert was a corporate M&A lawyer at SJ Berwin and subsequently Berwin Leighton Paisner.


John Leadley

John Leadley

John Leadley, Partner, Baker & McKenzie

John Leadley is the Head of both the Dispute Resolution Department and the Product and Operational Risk Group at Baker & McKenzie, London. He has an excellent reputation for his advisory and claims defence work on product liability, product recall and risk management. Although his work spans a number of sectors (including food, chemicals, telecoms and IT), his main focus has been on pharmaceutical and healthcare industry issues, reflected by his membership of the Legal Issues Committee of the Association of British Healthcare Industries since 2000. He also took part in the CBI working party on the revised directive on General Product Safety.


Alexey Trusov

Alexey Trusov

Alexey Trusov, Partner, Baker & McKenzie

Alexey Trusov is a partner in Baker & McKenzie’s Moscow office. He specializes in the pharmaceutical regulation, general corporate, corporate restructuring, mergers and acquisitions, commercial law, domestic securities and venture capital.

He is also the chairman of the Association of International Pharmaceutical Manufacturers (AIPM) Legal Committee.

Mr. Trusov is endorsed by PLC Which lawyer? 2010–2012 in the area of Life Sciences.

Mr. Trusov graduated from St. Petersburg State University’s School of Law in 1997 and received his LL.M. from Cleveland State University’s Cleveland-Marshall College of Law in 1998. He received his degree of Candidate of Science from St. Petersburg State University’s School of Law in 2002 and was admitted to the bar in Russia in 1997.


Julia Gillert

Julia Gillert

Associate, Corporate Department, Baker & McKenzie

Julia is an Associate in the Corporate Department of Baker & McKenzie's London office and is a member of the Pharmaceutical & Healthcare Practice Group. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia's practice also covers corporate law matters, including corporate reorganisation and M&A.


Thilo Raepple

Thilo Raepple

Partner, Baker & McKenzie

Thilo Raepple focuses his practice on the medical industry sector and is member of the Steering Committee of Baker & McKenzie´s European Pharmaceutical and Healthcare Practice Group. His clients are numerous German and foreign pharmaceutical, medical device and biotech companies, as well as related industry associations and service providers for this industry sector. He has gained substantial experience in handling matters which deal with pharmaceutical law, medical devices’ law as well as pharmaceutical advertising, unfair competition and intellectual property law. Thilo Raepple has been admitted to the Frankfurt Bar since 1989. He co-chairs the German yearly pharma law congress "Deutscher Pharma Recht Tag" and has received the prestigious prize for pharma lawyers "Pharma Recht Preis" in 2009.


Robert Juhasz

Dr. Simone Mitchell

Partner, IPT, Australia, DLA Piper

Simone is a Partner in the firm's Life Sciences and Intellectual Property & Technology practices. She advises a broad range of companies, including life sciences organisations, on intellectual property (including patents, copyright, trademarks and designs) as well as regulatory and compliance issues. Simone has significant experience representing clients in multi-jurisdictional patent disputes in the life sciences sector and has acted in a large number of patent infringement and revocation cases. She also advises on intellectual property management strategies, including the exploitation, commercialisation, management and protection of intellectual property rights.

Simone's experience encompasses advising on all aspects of the product life cycle including research and development, clinical trials, pricing and Pharmaceutical Benefits Scheme (PBS) reimbursement, labelling and claims and compliance with industry codes. Simone also has significant experience advising on and negotiating agreements on behalf of life sciences companies and research institutions, including clinical trial, research and development and commercialisation agreements, as well as advising on strategic alliances and co and joint-promotion ventures.

In addition to her legal qualifications, Simone has a degree in veterinary science and is a registered veterinary surgeon. She has a sound understanding of scientific and medical technologies, including chemistry, pharmacology, biotechnology and medical devices.


Adam Cooke

Adam Cooke

Partner, IP, UK, DLA Piper

Adam Cooke is a partner in DLA Piper's Intellectual Property group in London. He has over 20 years' experience devoted to IP, focusing on multi-jurisdictional patent litigation especially in the life sciences and high technology sectors. His life sciences work frequently involves advising on the strategic interplay between patents on the one hand and regulatory data exclusivity on the other. He also advises on infringement and validity issues, including freedom to operate, as well as negotiating and drafting commercial IP agreements and advising on the IP aspects of corporate deals. His patent litigation experience includes patents relating to recombinant t-PA (first trial in the world concerning patentability of cDNA), insulin, hGH, insulin-like growth factor, anti-CD20 antibodies for the treatment of RA, diagnostic methods, medical devices (blood filters) and MRI scanners.

Adam is an elected board member of the UK IP Lawyers Association, IPLA, and is recognised as a leading patent lawyer by a number leading directories and guides including Chambers 2012 (IP), Chambers Global 2012 (IP), PLC Which Lawyer? 2012 (IP: patent litigation, and Life Sciences: patent litigation) and Intellectual Asset Management Patent 1000 - The World's Leading Patent Practitioners (2012).


John Dougherty

John Dougherty

Partner, Global Co-Chair Life Sciences Sector, US, DLA Piper

Amanda is a co-chair of DLA Piper's Global Life Sciences Sector responsible for the Asia Pacific region. She has extensive experience in Australia and the UK advising pharmaceutical and medical technology companies in the defence of complex product liability claims; group and class actions; regulatory compliance; and crisis and risk management. During her legal career, Amanda has handled numerous high profile and sensitive litigious and regulatory matters for global corporate clients and insurers, including companies in Australia, the UK, USA and Asia. Her cross-border work has involved collaboration with in-house counsel and external lawyers in multiple jurisdictions, in teams developing international defence strategies, and working with expert medical and scientific witnesses for global pharmaceutical product liability litigation.

Amanda also advises on all regulatory aspects of the product life cycle including: clinical trials, pricing and reimbursement; compliance with therapeutic goods legislation and industry codes; product recall and safety issues; and coronial inquests.

Since 2005, Amanda has been consistently named in international directories as a product liability and regulatory expert. She is currently AusBiotech's NSW Chair.


Robert Juhasz

Bonella Ramsay

Partner, Global Co-Chair Life Sciences Sector, EMEA, DLA Piper

Bonella Ramsay is co-chair of DLA Piper's Global Life Sciences Sector responsible for the EMEA region. She has particular expertise advising on intellectual property, contractual and regulatory matters for the life sciences sector and has many years of experience advising specialty biopharma and medical device companies wishing to expand their operations and presence in Europe. She advises clients across the life cycle of their products and product development and has led many multi-jurisdictional projects, including in relation to the roll-out of clinical programmes for biopharma clients.

As an intellectual property specialist Bonella is involved in IP rights management and strategy for a diverse and international client base as well as structuring and negotiating the exploitation of those rights. She is 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 licenses, franchise agreements, manufacturing, distribution, supply, early access and co-promotion contracts. Bonella also has experience in advising on business process outsourcing/off-shoring projects for life sciences clients including in relation to IT/IS services, clinical services, clinical data processing, drug safety and other key regulatory-driven functions.

Bonella is highlighted as a leading individual in IP in Legal Experts 2012.


Jonathan Isted

Jonathan Isted

Partner, Freshfields Bruckhaus Deringer

Jonathan Isted is co head of Freshfields' consumer and healthcare sector group. He specialises in the defence of group litigation cases in the environmental, human rights, products and health and safety sectors. Many of the cases which Jonathan defends are brought under Conditional Fee Agreements linked to After the Event insurance.


Neil O’May

Neil O’May

Partner, Norton Rose

Neil O'May joins Norton Rose with over 20 years experience in business, corporate and white collar crime. He has acted in a wide range of corporate criminal cases including corporate manslaughter, insider dealing, market abuse, fraud and tax. His particular area of expertise is anti-bribery and corruption. He has experience in acting for companies and individuals in SFO investigations and prosecutions for bribery and corruption across multiple jurisdictions including the US and EU. He acted in the Innospec, Mabey and Johnson and Securrency investigations and prosecutions by the SFO of the companies, board directors and senior managers. His experience covers all aspects of anti-bribery work from internal investigations, through SFO, OFT and Police investigations, to prosecutions, jury trials and appeals. He has also been involved in advising in relation to an OFT investigation into an alleged criminal cartel and an SFO investigation into price fixing in the pharmaceutical sector. He regularly advises companies on bribery issues following whistle-blower allegations, his focus being on managing the internal investigation and advising on dealing with the regulators and prosecution authorities. Neil recently spoke on on a platform on Deferred Prosecution Agreements with Mr Dominic Grieve QC MP, the UK Attorney General.


Simon Priddis

Simon Priddis

Partner, Freshfields Bruckhaus Deringer

Simon Priddis has been a partner in the firm’s antitrust, competition and trade group since 2007. His main areas of practice are EU and UK competition law, particularly merger control, Articles 101/102 and the equivalent UK legislation, cartel investigations and sector inquiries. Simon has particular experience in all aspects of the healthcare, financial services and media/technology sectors


Chris Mercer

Chris Mercer

President, Chartered Institute of Patent Attorneys

Chris is the current President of CIPA and has been a member of the council of CIPA and its Patents Committee for a number of years. He is a past President of epi. He is a member of SACEPO and of FICPI's Biotechnology Committee. In the past few years, he has been following closely the developments in the European patent and Court systems and has been involved in providing input to the UK Government.

Chris retired in 2010 following a long and successful career at Carpmaels & Ransford and now acts as a consultant to Carpmaels. Chris mainly handles biotechnological and chemical subject-matter but also handles light mechanical subject-matter. His practice is mainly before the European Patent Office in which he has been responsible for a large number of applications and oppositions. He has argued orally before numerous Opposition Divisions and Boards of Appeal and has argued successfully before the Enlarged Board of Appeal. He has been deeply involved in High Court litigation and litigation in Germany and The Netherlands. He is a Patent Attorney Litigator.


Christopher L. White, Esq

Christopher L. White, Esq.

Senior Executive Vice President and General Counsel, Advanced Medical Technology Association (AdvaMed)

Mr. White manages AdvaMed’s Legal Committee to develop and promote positions impacting patient access to medical technology. Mr. White leads the Association’s working groups on compliance, Physician Payment Sunshine, and device tax implementation. He testified before the Senate Aging Committee on the Physician Payment Sunshine legislation, led the drafting team substantially revising the AdvaMed Code in 2008-2009, and leads AdvaMed’s Code of Ethics related programs and activities. He led the negotiating team to draft the Kuala Lumpur Principles, harmonizing industry Codes of Ethics in Asia. As chief legal officer, he also provides counsel on commercial contracts, corporate transactions, and legislative and regulatory matters. He serves as a frequent speaker and author on health care regulatory and fraud and abuse issues.


David Braga Malta

David Braga Malta

Co-Founder and President, Cell2B – Advanced Therapeutics SA, Portugal

David Braga Malta is President and co-founder of Cell2B. David is a Regenerative Medicine enthusiast and has been working in the field during the last years. David holds a PhD in Bioengineering from the MIT Portugal Program. During his PhD David worked on Stem Cell Bioengineering at MIT and developed an unique technology for the animal origin free cell manufacturing. David is a Master in Biological Engineering, Instituto Superior Tecnico, Portugal. During his master David lived in London and attended the Imperial College of working on stem cell based regeneration of lung tissue. His academic career focuses of the field of regenerative medicine with several publications and patents in the field. One of his greatest passions has always been entrepreneurship. David has participated and been awarded in different competitions. David’s PhD work is a corner stone is Cell2B’s pipeline which he co-founded and manages. Cell2B is completed devoted to the development of regenerative medicine products for immunological diseases. Since starting Cell2B, David has been working on the clinical development of advanced therapy medicinal products and acquired a significant experience in global clinical development and emerging markets strategy.


Edoardo Lazzarini

Edoardo Lazzarini

EMEA Compliance Officer, Biomet Europe

Since 2010, Edoardo Lazzarini became EMEA Compliance Officer for BIOMET, a multinational company leader in medical devices orthopedic business. His compliance responsibility covers Europe, Middle East and Africa (EMEA) region.

Since 2001 before joining BIOMET he worked with in the pharmaceutical compliance sector as Italian Compliance Director, first at Schering-Plough, and then, at MSD, global science-based healthcare companies on prescription products and animal health business.

Lazzarini holds a Ph.D. in Industrial Chemistry from Politecnico of Milano, with a post-doc fellowship at Pittsburgh University (Pennsylvania).

Edoardo Lazzarini is a regular contributor to international compliance conferences, co-author of regional and local compliance industry guidelines, and leading member of working groups of European/National industry association (EUCOMED, Farmindustria etc).

Since 2004, Lazzarini became the "Vigilance Body" President (Italian Law 231/2001) for several Italian Legal Entities.


Ernest Jędrzejewski

Ernest Jędrzejewski

Legal Counsel Central and Eastern Europe, Amgen

Ernest joined Amgen in 2010. He is based in the Head Office for Central and Eastern Europe in Vienna. In his role, he provides legal support to all the functions in the region, including compliance and clinical development operations. As a member of the Regional Leadership Team he is also involved in general management of the commercial activities in CEE.

He built his expertise in the lifesciences sector as a legal counsel in international law firms, where he acted for major pharmaceutical companies and industry associations.

Ernest holds Master of Laws degrees from Columbia Law School and Warsaw University as well as Diploma in European Law from Cambridge University.


Mark Brealey QC

Mark Brealey QC

Brick Court Chambers

Mark Brealey QC specialises in EU and Competition Law. He regularly appears before the Courts of England and Wales, before the Competition Appeal Tribunal and before the Court of Justice of the European Communities. He also appears at oral hearings before the competition and regulatory authorities, and is editor of "Competition Litigation; EU Practice and Procedure" Oxford 2010.

Recent cases have included the first case to be heard in the Supreme Court on the Competition Act, BCL Old v BASF [2012] UKSC 45. He is recognised as a leading practitioner in Competition and EU law in both Chambers & Partners and the Legal 500.


Sabina Rossetti

Sabina Rossetti

Legal Affairs, Pfizer

Sabina Rossetti is a Legal Lead at Pfizer in Italy where she supports the Primary Care Business Unit, works on the overall Litigation portfolio and advises on specific subject matters such as Data Privacy and Labor Law. Before joining Pfizer in 2002, Sabina started her professional path in a law firm specialized in malpractice and product liability. She has practiced mainly in Rome except for one year internship in Australia, Sydney. Sabina holds a Laurea in Law combined with studies of Psychology of Labor and Organization and admitted at the BAR of Rome.


Scott S. Liebman

Scott S. Liebman

Principal, Porzio, Bromberg & Newman

Scott S. Liebman is a principal of Porzio, Bromberg & Newman and a member of the firm’s Life Sciences Compliance, Commercialization and Regulatory Counseling Department as well as the Vice President of the firm's subsidiary, Porzio Life Sciences. He counsels pharmaceutical, medical device and biotechnology manufacturers on federal and state laws, including the Food, Drug and Cosmetic Act, the Prescription Drug Marketing Act, the Anti-kickback Statute, the False Claims Act, and the Food & Drug Administration Modernization Act of 1997. Mr. Liebman also has experience related to the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interactions with Healthcare Professionals, the AdvaMed Code of Ethics for Interactions with Healthcare Professionals and the ACCME Standards for Commercial Support. He develops policies and procedures related to client’s comprehensive compliance programs. Mr. Liebman conducts management and sales force training on various compliance issues. He performs audits, gap analyses, and risk assessments in a variety of areas, including review of promotional materials, sampling activities, medical science liaison interactions, and medical publications. Mr. Liebman also drafts and reviews agreements with vendors, consultants and other third parties. Mr. Liebman graduated with a J.D. from Seton Hall University School of Law, and a B.A. from Lehigh University. He is admitted to practice in New Jersey, New York and the United States District Court, District of New Jersey.


Sue Gold

Sue Gold

Partner, Osborne Clarke

Sue is a Partner at Osborne Clarke specialising in data protection law. She has considerable experience in developing strategies and procedures for European data protection compliance, providing advice on complex technology transactions, and advising on developing areas of law, including children’s privacy.

Prior to joining Osborne Clarke Sue was Principal Counsel EMEA for the Walt Disney Company in London where she became recognised as a leading expert in data protection management and data privacy. This was preceded by legal roles in the financial services sector, providing advice on technology law and data protection at the investment banking arms of UBS, Salomon Smith Barney and she also worked at NM Rothschild and The London Stock Exchange.

Sue sits on the European advisory board for the IAPP (International Association of Privacy Professionals), is a member of the SCL committee for the privacy and data protection group, and is a past chair of the CBI and UNICE groups on data protection. Sue is a regular speaker at international conferences on data protection and data privacy covering some of the more complex and cutting-edge issues.


Scott Maidment

Scott Maidment

Partner, McMillan

Scott Maidment is an experienced trial lawyer and has achieved international recognition for his work in product liability litigation and class action defence, particularly in the life sciences sector. His skill and expertise has been recognized by Lexpert®, BestLawyers' Guide to the Legal Profession in Canada, Euromoney’s Guide to the World's Leading Product Liability Lawyers, The International Who's Who of Life Sciences Lawyers, The International Who's Who of Product Liability Lawyers, and The Lexpert/American Lawyer Guide to the Leading 500 Lawyers in Canada. Scott was named one of the world's top 25 product liability lawyers in Legal Media Group's The Best of the Best, 2010, and The Best of the Best, 2012. He is a co-author of Product Liability: Canadian Law and Practice, and has served as an Adjunct Professor of Trial Practice at Osgoode Hall Law School. He holds degrees in law from Queen’s University (LL.B.) and the London School of Economics (LL.M.).


Elvan Sevi Firat

Elvan Sevi Firat

Partner, Mehmet Gun & Partners

Mrs. Firat, is a partner at Mehmet Gun & Partners specialized in life sciences industry. She assists multinational companies including manufacturers of pharmaceuticals, biotechnology, medical device, special food and feed, cosmetics and other consumer products and provides consultancy on strategic planning of new investments and start-ups in Turkey, regulatory compliance, anti-corruption and anti-trust. She provides strategic advice on legislative and other policy assignments.


Who should attend?

  • General Counsel.
  • In-house Counsel.
  • Directors/Heads of Legal.
  • Internal Compliance Professionals.
  • Lawyers in firms covering competition, corporate, IP, litigation, and regulatory.
  • Professionals in the life sciences, medical devices and biotech industries.

If you do not meet these criteria but are still interested in attending, please contact Samantha Carpenter on 020 3423 6621 or samantha.carpenter@practicallaw.com.

REGISTER BY 8 FEBRUARY 2013 STANDARD PRICE
1 Delegate: £1,199 +VAT 1 Delegate: £1,299 + VAT
2 Delegate: £2,199 + VAT 2 Delegate: £2,399 + VAT

Location:

The Hilton Waldorf Hotel
Aldwych
London WC2B 4DD
UK

Venue building


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Life Sciences IP Review



The Life Sciences IP Review tracks the increasing challenges for intellectual property specialists in the rapidly evolving world of life sciences From gene patents to stem cell research, we hope to provide the best news and analysis.

Visit www.worldipreview.com


World Intellectual Property Review



The WIPR Annual and its sister publications World IP Review (WIPR) and Trademarks, Brands and the Internet (TB&I) provide comprehensive guides to the challenges facing businesses and legal practitioners active in intellectual property, while IP Pages is the largest guide to law firms and service providers of its kind in the market. WIPR group covers all of the most important IP issues in the most important industries, looking at how companies protect their IP assets in a world which values IP more than it ever has.

Visit www.worldipreview.com




PharmaVOICE magazine, reaching more than 29,000 BPA-qualified life-sciences executives, is the forum that allows business leaders to engage in a candid dialogue on the challenges and trends impacting the industry. PharmaVOICE provides readers with insightful and thought-provoking commentary in a multiple-perspective format through forums, topics, and articles covering a range of issues from molecule through market. PharmaVOICE subscribers are also kept abreast of the latest trends and information through additional media resources, including WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-Alerts. Additionally, PharmaVOICEMarketplace.com provides a comprehensive directory of products, services, and solutions for the life-sciences industry. To Raise Your VOICE, contact feedback@pharmavoice.com.

Visit www.pharmavoice.com


Patently-O



Patently-O, co-authored by Dennis Crouch, Associate Professor at the University of Missouri and Jason Rantanen, Associate Professor at the University of Iowa, is the nation's leading patent law blog. It's been consistently recognized by the ABA Journal and placed in its Hall of Fame of legal blogs.

Visit www.patentlyo.com


Life Science Compliance



Aims

The aim of the Journal is to provide factual information and case studies regarding all aspects of Compliance for companies operating in the Life Sciences sector across Research & Development, Manufacturing, Sales & Marketing and Corporate activities to inform compliant decision-making across the Life Sciences sector. The initial focus for the first few issues of the journal will be Sales & Marketing compliance, as this is currently the highest risk area for companies.

Scope

Regulations, laws and industry body codes of practice governing all aspects of the Life Sciences sector, including anticipated changes,
Case studies of how companies have complied with the legal, regulatory and code requirements, including practical suggestions for improvements and potential technology solutions,
Reporting on sanctions imposed on companies for various non-compliant activities, including implications for other companies and what could have been done differently,
Independent reviews of services and technologies available to help keep companies compliant.

Visit www.lifesciencecompliance.info


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