Home
Supergenerics and Patent Busting
15 April - 16 April 2002
Supergenerics and Patent Busting
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 agenda

clock

9:00

Registration and Coffee

clock

9:30

Chairman's Opening Remarks

Dr Murray Ducharme

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

clock

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
  • clock

    10:20

    TACKLING HIV AIDS IN AFRICA

    Gus Attridge

    Gus Attridge, Financial Director, Aspen Pharmacare

    clock

    11:00

    Morning Coffee

    clock

    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
  • clock

    12:00

    BRANDED GENERICS

    Ian Troup

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

    clock

    12:40

    Lunch

    clock

    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
  • clock

    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
  • clock

    15:20

    Afternoon Tea

    clock

    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
  • clock

    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?
  • clock

    17:00

    Chairman's Closing Remarks and Close of Day One

    clock

    9:00

    Re-registration and Coffee

    clock

    9:30

    Chairman's Opening Remarks

    Christopher Benson

    Christopher Benson, Solicitor, Taylor Joynson & Garrett

    clock

    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
  • clock

    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
  • clock

    11:00

    Morning Coffee

    clock

    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
  • clock

    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
  • clock

    12:40

    Lunch

    clock

    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
  • clock

    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
  • clock

    15:20

    Afternoon Tea

    clock

    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
  • clock

    16:20

    EUROPEAN PATENT PRACTICE

    Paul Chapman

    Paul Chapman, Partner, Kilburn & Strode

  • Second medical use claims
  • The Rapamycin decision
  • Clinical trials
  • SPCs
  • clock

    17:00

    Chairman's Closing Remarks and Close of Conference

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download

    Title


    Description

    Download

    Title


    Description


    Download


    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    Group Booking

    Please complete the below form and a member of SAE Media Group’s booking team will be in contact within 24 hours

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.

    Thank you for visiting our event

    If you would like to receive further information about our events, please fill out the information below.

    By ticking above you are consenting to receive information by email from SAE Media Group.
    Full details of our privacy policy can be found here https://www.smgconferences.com/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data.privacy@smgconferences.com.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smgconferences.com/opt-out

    Fill in your details to download the brochure

    By submitting this form you agree to our privacy policy and consent to receiving communications, you may opt out at any time.