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Is production of generic medicines part of your core business? Or does generic competition present a challenge to your activities?

With many key blockbuster drugs coming off patent in the next few years, there’s never been a better time to understand the generics industry and market. SMi’s 11th annual Generics, Supergenerics and Patent Strategies conference is a great opportunity for those attempting to do just that. Key issues to be addressed at the conference will include:

  • Why do markets like Ireland, Belgium and Spain have such low generic uptake in comparison to others such as Germany or the UK?
  • Discover how generic competition affects pricing and reimbursement for both generic and innovative producers
  • Future prospects for the EU and US generics market
  • The latest IP developments
  • The challenge of China and India – each country’s market, industrial potential and intellectual property and regulatory environment analysed in depth.

Confirmed speaker include:

  • Zhijun Jiang, Vice President, Head of European Research and Development, Barr Laboratories
  • Rahul Garella, Vice President, API Business, Glenmark Pharmaceuticals
  • William Haddad, Chairman and CEO, Biogenerics
  • Brian Tempest, Chief Mentor and Executive Vice Chairman - recently retired and now Non-Executive Director, Ranbaxy Laboratories
  • Aleksandar Danilovski, Senior Director, Head of Global API R&D, Pliva Research and Development
  • Milena Izmirlieva, Senior Analyst, Global Insight
  • Albin J. Nelson, Partner, Schwegman, Lundberg, Woessner IP
  • Nora Kareela, CEO, Ipsat Therapies
  • Deborah Taylor, Market Development Manager, Colorcon
  • Malcolm Ross, CEO, Generapharm
  • Duncan Curley, Director, Innovate Legal
  • Nawab Qizilbash, Director, Oxon Clinical Epidemiology
  • Brian Lovatt, Managing Director and Cheif Executive, Vision Healthcare
  • Henning Blume, CEO, SocraTec
  • Paul Ranson, Parter, Fasken Martineau Stringer Saul LLC

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Brian Tempest

Brian Tempest, Chief Mentor and Executive Vice Chairman, Ranbaxy Laboratories Ltd

9:10 OPENING KEYNOTE – PERSPECTIVES ON THE FUTURE OF THE GENERICS INDUSTRY

Zhijun  Jiang

Zhijun Jiang , Vice President, Head of European Research and Development, Barr Laboratories Inc

  • Can the generics industry keep up its phenomenal growth in coming years?
  • New technological innovations and their effect on the market
  • Regulatory and intellectual property challenges and opportunities in coming years
  • Globalisation of the pharmaceutical market means a national outlook is no longer possible
  • Falling profit margins for production in the US are leading to new opportunities in Europe and Asia
  • The emergence of China and India
  • 9:50 PROSPECTS FOR BIOSIMILARS

    Bill Haddad

    Bill Haddad, Chairman & Chief Executive Officer, Biogenerics

  • What biologics are, their challenges and their potential for generic manufacturers
  • Bioequivalence studies and market approval for biosimilar molecules
  • The serious contenders in the biogenerics market
  • Strategies for success in the biosimilars market
  • Understanding how the biogenerics market will differ from the normal generics market
  • 10:30 Morning Coffee

    11:00 IPSAT THERAPIES CASE STUDY

    Grahaem Brown

    Grahaem Brown, Chief Medical Officer, IPSAT Therapies

    11:40 THE GENERIC VS BRANDED ENVIRONMENT IN THE US

  • The branded vs. generic war in the US!
  • Litigation and legislation influence on victories in the war
  • PTO tinkering
  • Does the branded need the generic and vice versa?
  • Is the branded pipeline dry in the US?
  • Patents as a sword for competitive advantage in the US
  • Albin J Nelson

    Albin J Nelson, Senior Shareholder (Partner), Schwegman, Lundberg, Woessner IP

    Gary Speier

    Gary Speier, Partner, Schwegman, Lundberg, Woessner IP

    12:20 Networking Lunch

    13:50 COLLABORATIONS IN GENERICS MANUFACTURE

    Rahul Garella

    Rahul Garella, Vice President, API Business, Glenmark Generics Europe

  • A review of recent merger and acquisition activity
  • Tendencies towards outsourcing of production and the impact on the industry
  • Alliance management in generics deals – some case studies
  • 15:10 Afternoon Tea

    15:40 SUPERGENERICS, THE MISSED OPPORTUNITY

    Malcolm Ross

    Malcolm Ross, Chief Executive Officer, Generapharm

  • Definition of a supergeneric
  • Regulatory aspects
  • Generic successes
  • Missed opportunities
  • Supergenerics or life cycle management
  • Factors involved in the success or failure of a supergeneric
  • 16:20 LICENSING AS A GROWTH MECHANISM

    Paul Ranson

    Paul Ranson, Partner, Fasken Martineau Stringer Saul L L P

    17:40 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Bill Haddad

    Bill Haddad, Chairman & Chief Executive Officer, Biogenerics

    9:10 OUTSOURCING OF PRODUCTION – CASE STUDY

    Alexandar Danilovski

    Alexandar Danilovski, Senior Director, Head of Global API R&D, Pliva

  • Origin Paradigm: Traditional APIs ("small-molecule) vs. recombinant proteins (rDNA APIs)
  • Making the decision: to outsource or to be vertically integrated
  • Choosing a location; setting up from scratch, acquiring or partnering (alliance management)?
  • The differing legal and regulatory framework
  • Lessons from the successes and failures (strategic importance of API availability)
  • 9:50 IMPROVING PRODUCTS AND MARKET POSITION USING INNOVATIVE TABLET DESIGN

    Deborah Taylor

    Deborah Taylor, Market Development Manager, Brand Enhancement Services , Colorcon

  • Improving patient compliance – making the tablet easier to handle and swallow through shape and finish
  • Reducing medication errors through too many tablets looking the same
  • Opportunities for branding in an increasingly competitive market – case studies
  • Introducing easier to recognise markings, again improving compliance
  • 10:30 Morning Coffee

    11:40 IP AND REGULATORY LANDSCAPE FOR GENERICS IN THE EU

    Duncan  Curley

    Duncan Curley , Director, Innovate Legal

  • Update on recent patent cases: atorvastatin, perindopril, escitalopram
  • SPCs and paediatric extensions - latest developments
  • Impact of TRIPs and the Doha Declaration
  • 12:20 Networking Lunch

    13:50 PANEL DISCUSSION - THE IMPACT OF ASIA

    Brian Tempest

    Brian Tempest, Chief Mentor and Executive Vice Chairman, Ranbaxy Laboratories Ltd

    Milena Izmirlieva

    Milena Izmirlieva , Senior Analyst, Global Insight

    14:30 FOCUS ON INDIA

    Brian Tempest

    Brian Tempest, Chief Mentor and Executive Vice Chairman, Ranbaxy Laboratories Ltd

  • Advantages of India
  • Future crystal ball
  • M&A and private equity
  • Challenges of India
  • 15:10 Afternoon Tea

    15:40 GENERICS AND BIOSIMILARS IN INDIA AND CHINA

    Milena Izmirlieva

    Milena Izmirlieva , Senior Analyst, Global Insight

  • Generics pricing and reimbursement in India and China
  • Competitive Overview
  • Looking to the future of generics P&R in India and China
  • India v. China on the biosimilars manufacturing front
  • 16:20 FOCUS ON PRICING AND REIMBURSEMENT

    Brian Lovatt

    Brian Lovatt, Managing Director & Chief Executive, Vision International Healthcare

  • A review of pricing in European states
  • How parallel trade impacts on pricing structures
  • Prices in the US and other nations
  • Devising a pricing strategy to put you ahead of the game
  • Differential pricing
  • Future trends in reimbursement for generics
  • 17:00 Chairman’s Closing Remarks and Close of Day Two

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    Workshops

    Patent Issues in The Development of Biosimilar Medicines
    Workshop

    Patent Issues in The Development of Biosimilar Medicines

    Crowne Plaza Hotel - The City
    14th May 2008
    London, United Kingdom

    Crowne Plaza Hotel - The City

    19 New Bridge Street
    London EC4V 6DB
    United Kingdom

    Crowne Plaza Hotel - The City

    HOTEL BOOKING FORM

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    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

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