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The generics industry is a rapidly evolving market carrying the promise of reducing long term healthcare costs. Gone is the time when generic companies only were focused on developing cheap, easy-to-manufacture generic drugs. Currently, many generic companies are suing increased revenue generated from generic versions of a growing number of top-selling branded drugs to explore new targets, including specialty generics, generics with a distinction, generic biologicals and proprietary molecules. This conference will deliver an emerging market update on the generics pharmaceutical industry and will discuss the current issues regarding patent protection and patent busting strategies. It will also highlight the latest advances in research and development in the field of generic and super-generic pharmaceuticals whilst also reviewing the effects of the expiration of patents for many major drugs in 2005.

The conference is an excellent opportunity to meet your peers and discover the latest opportunities in the field of generics and super-generics.

CONFIRMED SPEAKERS SO FAR INCLUDE:

· Martin Zeiger, Senior Vice President, Strategic Business Development and General Counsel, Barr Laboratories

· Stephen Saad, Chief Executive Officer, Aspen Pharmacare

· Dr John Langstaff, President & Chief Executive Officer, Cangene

· David Barrett, European Director, Dabur Oncology

· Dr John Siebert, President & Chief Executive Officer, CIMA Labs

· Larry McGowan, Export Sales Director, Clonmel Healthcare

· Nigel Stoate, Partner, Taylor Joynson Garratt

· Andrea Wayda, Solicitor, Morgan & Finnegan

· Dr Murray Ducharme, Senior Director, Pharmacokinetics & Pharmacodynamics, MDS Pharma Services

· Simon Harper, Senior Associate, Lovells

Chaired by:

· Simon Cohen, Partner, Taylor Joynson Garratt

· Dr Murray Ducharme, Senior Director, Pharmacokinetics & Pharmacodynamics, MDS Pharma Services

Conference programme

9:00 Registration and Coffee

9:30 Chairman's Opening Remarks

Dr Murray Ducharme

Dr Murray Ducharme, Senior Director, Pharmacokinetics & Pharmacodynamics, MDS Pharma Services

9:40 MULTI-SOURCE BIOPHARMACEUTICALS OR BIOGENERICS

John Langstaff

John Langstaff, President & Chief Executive Officer, Cangene

  • The multi-billion dollar market place
  • New technologies and the future of biogenerics
  • Current regulatory issues and the challenges in the future
  • Competing with the new treatments
  • 10:20 TACKLING HIV AIDS IN AFRICA

    Gus Attridge

    Gus Attridge, Financial Director, Aspen Pharmacare

    11:00 Morning Coffee

    11:20 PHARMACEUTICAL COMPANIES IN DEVELOPING COUNTRIES, FRIEND OR FOE

    David Barrett

    David Barrett, European Director, Dabur Oncology

  • Socio-economic trends
  • Development of pharmaceutical market in middle-income countries
  • The cancer burden in developing countries
  • How will developing markets cope with the problem?
  • Issues/recommendations
  • 12:00 BRANDED GENERICS

    Ian Troup

    Ian Troup, President & Chief Operating Officer, Upsher-Smith

    12:40 Lunch

    14:00 APPROACHES TO BRANDING ‘GENERICS’

    Dr John Siebert

    Dr John Siebert, President & Chief Executive Officer, CIMA Labs

  • When is a generic not a generic?
  • How can you brand simply and easily?
  • What are some examples?
  • Fast dissolve is a winner
  • Products are KING
  • 14:40 WHAT HAPPENS WHEN A PATENT EXPIRES

    Martin Zeiger

    Martin Zeiger, Senior Vice President, Strategic Business Development & General Counsel, Barr Laboratories

  • Pharmaceutical patents
  • Overview of Hatch-Waxman and the patent challenge process
  • Eli Lilly vs. Barr and the Prozac case
  • Alternatives to litigation that create consumer benefits
  • After exclusivity ends
  • 15:20 Afternoon Tea

    15:40 THERAPEUTIC PROTEINS: DIFFERENTIATION IN A COMMODITISED MARKET?

    Khawar Mann

    Khawar Mann, Director, Business Development, Weston Medical

  • Therapeutic proteins: competition and generics
  • Background to Weston Medical and Intraject
  • The key question: protein stability
  • Differentiation through needlefree delivery
  • 16:20 REGULATORY DATA PROTECTION

    Jane Mutimear

    Jane Mutimear, Partner, Bird & Bird

  • Directors 65/65 - the rationale for protection
  • Application to drug developments
  • The Generics case: meaning of essential similarity
  • The Novartis case: how far does generics go?
  • 17:00 Chairman's Closing Remarks and Close of Day One

    9:00 Re-registration and Coffee

    9:30 Chairman's Opening Remarks

    Christopher Benson

    Christopher Benson, Solicitor, Taylor Joynson & Garrett

    9:40 CURRENT CHALLENGES IN BIOEQUIVALANCE STUDIES

    Dr Murray Ducharme

    Dr Murray Ducharme, Senior Director, Pharmacokinetics & Pharmacodynamics, MDS Pharma Services

  • Scientific background supporting BE studies
  • Regulatory guidances governing BE studies for the USA, Canada & Europe
  • Characteristics of drugs that are associated with difficulties in meeting BE requirements
  • Challenges in meeting both regulatory and scientific requirements
  • 10:20 GENERIC DEFENSE OR PARTNERSHIP

    Larry McGowan

    Larry McGowan, Export Sales Director, Clonmel Healthcare

  • Patent expiry from the viewpoint of the originator
  • Patent expiry from the viewpoint of the brand equivalent industry
  • 11:00 Morning Coffee

    11:20 SUPERGENERICS

    Paolo Galfetti

    Paolo Galfetti, Director, Business Development & Licensing, APR Applied Pharma Research

  • Creating improved products
  • The development process of supergenerics
  • Regulatory issues and implications
  • A concrete example
  • Gap of knowledge between pharma and DDS companies
  • Role and structure of a DDS company in the development of supergenerics
  • 12:00 BRAND NAME COMPANY CHALLENGES TO THE GENERIC DRUG APPROVAL PROCESS

    Natasha Leskovsek

    Natasha Leskovsek, Senior Associate Attorney, HellerEhrman

  • Recognize the strategies pioneers use to block approvals
  • Devise tactics to rebuff pioneer strategies
  • Know the pitfalls that lie in the brand name and generic battles
  • How FDA reacts to these fights
  • Predict if there is ever going to be an end to such assaults
  • 12:40 Lunch

    14:00 LEGAL UPDATE – A EUROPEAN PERSPECTIVE

    Nigel Stoate

    Nigel Stoate, Solicitor, Taylor Joynson Garrett

  • Overview of the pharmaceutical patent and trade mark situation
  • Parallel imports- the Levis and Davidoff cases
  • Interim injunctions
  • The protocol questions
  • Round up of recent developments
  • 14:40 INTELLECTUAL PROPERTY RIGHTS AND STRATEGIES

    Andrea Wayda

    Andrea Wayda, Partner, Morgan & Finnegan

  • Recent political and legal developments
  • Levering intellectual property to your advantage
  • Current patent laws
  • Examples of real issues and problems regarding generics
  • Patent battle pitfalls
  • Implementing an effective strategy for patent busting
  • 15:20 Afternoon Tea

    15:40 PATENT PROTECTION STRATEGIES

    Simon Harper

    Simon Harper, Solicitor, Lovells

  • Existing protection strategies
  • Advances in IP laws
  • Developing an appropriate protection strategy
  • Reducing the risk of litigation
  • The importance of improving IP protection
  • 16:20 EUROPEAN PATENT PRACTICE

    Paul Chapman

    Paul Chapman, Partner, Kilburn & Strode

  • Second medical use claims
  • The Rapamycin decision
  • Clinical trials
  • SPCs
  • 17:00 Chairman's Closing Remarks and Close of Conference

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