Home
overview

SMi’s 9th Annual ‘Generics, Supergenerics and Patent Strategies’ Conference seeks to uncover the latest developments in the pharmaceutical generics industry. In part, it will delve into patent expiration as well as political and legal developments effecting both the US and European markets. Our industry experts will also seek to address the impact and complications associated with European enlargement, modifications to the current regulatory environment and give additional insight to development strategies being employed by companies seeking to expand into the generics market.

This years exceptional line-up includes:

  • Dr Brian Tempest, Chief Executive Officer and Managing Director, Ranbaxy
  • Dr Charles DiLiberti, Vice President, Scientific Affairs, Barr Laboratories
  • William Haddad, Chairman & Chief Executive Officer, Biogenerics
  • Bertrand Gellie, Director, European Patent Office
  • Dr Murray Ducharme, Vice President, PK & PD, MDS Pharma

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Murray Ducharme

Murray Ducharme, Vice President, PK & PD, MDS Pharma

9:10 REGULATORY ISSUES

Stephen Bennett

Stephen Bennett, Partner, Lovells

  • Effectively sourcing API for generic products following amendments in the GMP auditing system
  • De-centralisation procedure – implications of applying this to the industry
  • Application of Roch-Bolar – practical challenges
  • Case study: generics that have survived litigation – how and why?
  • 9:50 EUROPEAN ENLARGEMENT

    Brian Lovatt

    Brian Lovatt, Chief Executive Officer & Managing Director, Vision Healthcare Research

  • Cost containment policies used by governments to control health care expenditure
  • The decline in competitiveness of the European research-based pharmaceutical industry
  • The effect of parallel trade in generics
  • Will there be a single European market for pharmaceuticals?
  • The challenges that face the industry with enlargement of the EU
  • Threats to your company: instability of the Euro-National legislative entry barriers
  • How to lobby around these issues to maintain market shares
  • 10:30 Morning Coffee

    11:00 THE CHALLENGE FROM THE EAST

    Brian Tempest

    Brian Tempest, Chief Executive Officer, Ranbaxy

  • Evolving perspective - generics for the research and development company
  • Successful strategies of prescription generics
  • Cultural considerations
  • Benefits of interaction between research and development and big-pharma sector
  • Limitations affecting sustainable growth
  • Strategic considerations and recommendations
  • What lies beyond the blockbuster market?
  • 11:40 THE NORTH AMERICAN GENERICS MARKET

    David Goodman

    David Goodman, Executive Vice President, Pharmascience

  • Global generics marketplace – the North American perspective
  • Pricing and regulatory compliance issues
  • Generic penetration and consolidating growth in pharmacy channels
  • Market presence of brands vs generics
  • Investigating similarities and differences with Europe
  • 12:20 Networking Lunch

    13:50 PERFORMING INNOVATIVE GENERIC STUDIES

    Paul Zeman

    Paul Zeman, Head, Pharma Exclusives, Siegfried

  • Study designs (size, crossover arms, sampling time points)
  • When and how to do a pilot study depending on the compound
  • Analysing and understanding results: when to reformulate, when not
  • Choosing the correct sample size
  • When to perform additional data analysis
  • Understanding results from studies that do not meet bioequivalence criteria
  • 14:30 LAUNCHING YOUR PRODUCT

  • Prominent issues for the safe launch of generics
  • What steps need to be taken?
  • Legal framework for regulating generics
  • Loopholes in the system – how are they being exploited?
  • Patent protection – benefits to the pharmaceutical companies
  • Revoking the patent and ‘clearing the way’
  • Will the revised legislation solve all problems?
  • Simon Cohen

    Simon Cohen, Partner, Taylor Wessing

    Nigel Stoate

    Nigel Stoate, Partner, Taylor Wessing

    15:10 Afternoon Tea

    15:40 DATA EXCLUSIVITY

    George Pickering

    George Pickering, Senior Associate, Reed Smith

    • Changes to EU legislation: when do increased exclusivity periods apply?
    • Advantages of being first to file following the exclusivity period
    • Orange book and patent listing: the US litigation timeline
    • Effect on exclusivity periods of:
      • Line extensions
      • Hybrid applications
      • Effect of reference product withdrawal
      • Challenging generic marketing authorisations
      • What about biosimilars?

    16:20 SUPPLEMENTARY PROTECTION CERTIFICATES

    Martin Paltnoi

    Martin Paltnoi, Chief Executive Officer, MPA Business Services Ltd

  • Clarifying EU Supplementary Protection Certificates (SPC/CPC)
  • Coping with different interpretations of EU Directive
  • USA pharmaceutical Patent Term Extensions
  • Litigation covering pharmaceutical patent term extensions
  • Other counties approach to pharmaceutical patent term extensions
  • Comparative approaches by originators and generic producers
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    William Haddad

    William Haddad, Chariman & Chief Executive Officer, Biogenerics

    9:10 SETTLING INFRINGEMENT DISPUTES

    Edward Miller

    Edward Miller, Partner, Reed Smith

  • Structuring and negotiating business resolutions
  • Defences to infringement
  • The anti-trust implications of agreements to settle patent disputes in the industry
  • Settlement agreements and the new patent licensing laws
  • Recent FTC and Commission investigations
  • Abusing of a dominant position
  • 9:50 GRANTING COMMUNITY PATENTS

    Bertrand Gellie

    Bertrand Gellie, Director, European Patent Office

  • Community Patent and Generics:
  • What it could change for Generic Companies?
  • Expectable costs
  • Latest developments
  • Recent developments of the case law of the Boards of Appeals at the EPO
  • Impact on Polymorph patentability
  • Impact on further medical uses
  • International Convention on the Pharmaceutical Crime & IPRs
  • Latest international developments
  • Will generics have a place in it?
  • 10:30 Morning Coffee

    11:00 BIOGENERICS - MYTH OR REALITY?

    Charles DiLiberti

    Charles DiLiberti, Vice President, Scientific Affairs, Barr Laboratories

  • Establishing the regulatory pathway in biogenerics
  • Understanding the terminology – essential similarity vs product comparability
  • Demonstrating equivalence – proving essential bio-similarity
  • Pharmaceutical equivalence
  • Therapeutic equivalence
  • Implications to the Waxman-Hatch provision
  • The patent hurdle – product process, formulation and indication
  • What are the lessons learned?
  • 11:40 PANEL DISCUSSION

  • Current practices and principles
  • Changes in IP and regulatory frameworks
  • Process strategies for biogenerics
  • How long can the biotech industry hold off legislation?
  • Implications for the patent
  • Charles DiLiberti

    Charles DiLiberti, Vice President, Scientific Affairs, Barr Laboratories

    William Haddad

    William Haddad, Chariman & Chief Executive Officer, Biogenerics

    Murray Ducharme

    Murray Ducharme, Vice President, PK & PD, MDS Pharma

    12:20 Networking Lunch

    14:00 EUROPEAN MARKET STRATEGIES

    Norbert Bangert

    Norbert Bangert, Former Manager Generics, Bayer Healthcare

  • Recent movements in different European markets
  • European intercommunication
  • Impact on profitability in competing markets
  • A sound competitive environment
  • 14:40 STRATEGIC MEASUREMENT AND MANAGEMENT OF INFRINGEMENT AND PARAGRAPH IV RISKS AND REWARDS

  • Assessment of patent quality and its implications for defence, offence and partnering strategies
  • Risk management strategies including legal, financial, and insurance options
  • Implications of WTO and TRIPS initiatives for patent equitable conduct in global trade
  • Building settlement contracts that can create or preserve future financing options
  • The anti-trust implications of agreements to settle patent disputes in the industry
  • David Martin

    David Martin, Chief Executive Officer, M-CAM

    Gary Liberson

    Gary Liberson, Consultant, Life Sciences, PA Consulting

    15:20 INTERNAL STRATEGIES EMPLOYED

    William Haddad

    William Haddad, Chariman & Chief Executive Officer, Biogenerics

  • Cost containment
  • Counteracting market saturation
  • Identifying the key competitors brands
  • Competitors product range portfolio
  • Market position in key markets
  • First in – last out strategy
  • Broad product portfolio, including ‘difficult to make’ generics
  • Cost competitiveness (products, sourcing and vertical integration)
  • Proactive responses to a changing business environment
  • 16:00 Chairman’s Closing Remarks followed by Afternoon Tea. Close of Conference

    +

    Mayfair Conference Centre

    17 Connaught Mews
    London W2 2EL
    United Kingdom

    Mayfair Conference Centre

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    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, SMI 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@smi-online.co.uk

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




    Forgotten Password

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