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The change in the generics industry competitive landscape is driving the evolution of traditional business operating models. Companies are seeking further competitive advantage through innovation, differentiation and enhanced quality of products, striving for smarter, more profitable business models, cost effectiveness and faster routes to market. Traditional pharmaceutical innovators are coupling with generic manufacturers to better serve the healthcare sector with more companies like Novartis launching or acquiring generics arms to their businesses.

With more than 30 drugs coming off-patent in the next 3-5 years, this will open up serious competition from the generics alternatives. Pharmaceutical innovators strive to protect their intellectual property and product brands by extending patents, whilst generic producers fight to occupy the new space in the market, capitalising on the new opportunities. As a result, the generics space is pitched for fundamental growth with revenues reaching more than $84bn by 2010.

With this back-drop, SMi announces the 12th annual Generics & Super-generics conference. Holistic and controversial in its theme, the 2009 conference agenda aims to tackle the business and profitability issues and challenges faced by the generic manufacturers, but at the same time offering patent protection, intellectual property and patentability advice to the pharmaceutical innovators.

Speakers are the generics players - presenting case studies & evaluating business models; key consultants, analysts and external experts - outlining policy, regulation and providing strategic tips around the challenges that this market faces.

Topics that will be covered include:

  • Intellectual Property protection: patentability, patent extensions and exclusivity
  • Ever-greening strategies
  • Protection strategies whether you are branded or generic
  • Blockbuster drugs due for patent expiration come 2012
  • Profitability models
  • Emerging markets and improved generics
  • The changing generics business model in the competitive climate
  • Market expansion strategies
  • Biosimilars: Regulatory, scientific and commercial aspects
  • Innovation and differentiation
  • Ways to capitalise on patent and product brands
  • Patent busting strategies
  • Reduction of portfolio risk
  • Patent Life Cycle Management

The changing landscape of the generics market means that more pharmaceutical companies are entering the generics space. Existing manufacturers need to work harder and smarter to protect their market share.

  • Learn how to capitalizing on close to patent expiration of branded drugs, extending the life cycle of your products
  • Reduce portfolio risk by developing re-formulations and extended uses for existing products
  • Tackle intellectual property and brand protection
  • Develop market growth expansion strategies
  • Evaluate existing business profitability models in the generics market
  • Differentiate yourselves from your competitors
  • Formulate patent busting strategies
  • Weigh up emerging market opportunities
  • Attend the in-depth post-conference workshops on intellectual property protection and patentability and patent busting options.

There will also be ample time for networking with peers during lunch and all of the refreshment breaks.

From pharmaceutical innovators:

  • Patent, Directors and Managers
  • Directors of Intellectual Property
  • Brand Directors and Managers
  • Product Directors and Managers
  • Directors of Business Development

From generics manufacturers:

  • Business Development leaders
  • Presidents and CEOs
  • Commercial Directors
  • Operations Directors
  • Driectors of R&D
  • Managing Directors

All other generics industry stakeholders

  • Patent attorneys
  • Intellectual Property experts
  • Branding specialists

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Milena Izmirlieva

Milena Izmirlieva, Senior Analyst, IHS Global Insight

9:10 GENERICS AND SUPERGENERICS: THE NEW PRODUCT PROMOTION PARADIGM

Milena Izmirlieva

Milena Izmirlieva, Senior Analyst, IHS Global Insight

  • Pricing and reimbursement pressures and generics promotion needs
  • Current experience with promotion of branded generics
  • Generics promotion under threat in light of the Conte vs. Wyeth ruling in United States 
  • Outlook and implications for generics promotion going forward
  • 9:50 THE MARKET FOR BIOSIMILARS: EVOLUTION AND POLICY OPTIONS AN ECONOMIST'S PERSPECTIVE

    Adrian Towse

    Adrian Towse, Director, Office Of Health Economics

  • Treating biosimilar markets differently - a progression to biogenerics?
  • The substitutability/Interchangeability issue
  • The importance of patient safety year and outcome data
  • An Economic Framework and predictions on price trajectories
  • Options for payers to get value for money
  • 10:30 Morning Coffee

    11:00 DEFINING THE CRITERIA FOR PATENTABILITY, PATENT EXTENSIONS & EXCLUSIVITY

    Duncan Curley

    Duncan Curley, Director, Innovate Legal

  • Ascertaining the likely success of patent applications
  • What's new and innovative?
  • Modifications and extensions to patents
  • European supplementary protection certificates
  • 11:40 PATENT EXPIRATION ANALYSIS OF BLOCKBUSTERS IN 2009-2012

    Martin Paltnoi

    Martin Paltnoi, CEO, MPA Business Services

  • Protection of intellectual property
  • Date exclusivity and marketing exclusivity
  • Patent exclusivity
  • Patent term extensions: Hatch-Waxman Act
  • Supplementary protection certificates - Europe
  • Re-inventions of the same product with new applications to extend the brand
  • 12:20 Networking Lunch

    13:40 EUROPEAN COMMISSION'S SECTOR INQUIRY INTO PHARMACEUTICALS

    Sune Larsen

    Sune Larsen, Case Handler, European Commission – DG Competition

  • Background of the sector inquiry
  • Preliminary findings
  • Current status of the sector inquiry
  • 14:20 USING INFORMATION TO BUILD EFFECTIVE PATENT STRATEGIES

    Leighton Howard

    Leighton Howard, Managing Director, GenericsWeb

  • Life cycle management by Innovators
  • The new threat: patenting by generics
  • When does the patent really expire?
  • Difficulties in finding and tracking patents
  • 15:00 Afternoon Tea

    15:20 CLINICAL DEVELOPMENT STRATEGY FOR BIOSIMILARS

    Partha Ghosh

    Partha Ghosh, Director and Service Lead, Early Stage Drug Development, PAREXEL International

  • Are biologicals amenable to generic development?
  • Regulatory environment
  • Early development studies
  • Efficacy and safety data
  • The way ahead
  • 16:00 MARKET & ENTRY STRATEGY IN ORAL DDS GENERIC

    Alexandre Williams

    Alexandre Williams, Director of Business Development, Ethypharm

  • Change in the Oral DDS Generic market
  • Competitivity, Profitability, Predictability Challenges
  • Generics as market strategy for generic companies 
  • 16:40 GENERIC SUBSTITUTION IN THE UK – THE NEW PPRS AGREEMENT

    Dermot Glynn

    Dermot Glynn, Chairman, Europe Economics

  • The case for generic substitution
  • Possible arrangements
  • The risks
  • Rationale under the new PPRS - would price reductions for branded out of patent medicines make more sense?
  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Milena Izmirlieva

    Milena Izmirlieva, Senior Analyst, IHS Global Insight

    9:10 PROTECTION STRATEGIES

    Howard Rosenberg

    Howard Rosenberg, Scientific Advisor, Frommer, Lawrence and Haug LLP

  • Is it thicket, clusters, picket fences or just can't see the wood for the trees?!
  • Patent strategies/issues for both brand and generic.. fair or foul
  • Data protection 3yrs, 5yrs, 8ys, 10yrs, 8+2+1 or should it be just old hat?!
  • Data protection methods and the issues
  • 9:50 DEVELOPING SYNERGIES WITH THE ACTIVE PHARMACEUTICAL INGREDIENT SUPPLIER FOR STRONGER PROTECTION STRATEGIES

    Carla Vozone

    Carla Vozone, Business Development Director, Hovione PharmaScience

  • Creating value by partnering with the API manufacturer in the search for innovation or patent challenge strategies
  • Capitalizing from the know-how, capabilities, supply-chain network and geographic access accessible from the API manufacturer
  • Building the bridge between API development and drug product development; sharing risks and rewards
  • Case studies exemplifying the buyer/supplier integration process for maximization of value
  • 10:30 Morning Coffee

    11:00 GENERICS: THINKS SMALL, WIN BIG! WHY YESTERDAY'S GROWTH MANTRA WILL NOT WORK

    Rahul Garella

    Rahul Garella, Vice President - EU Business, Glenmark Pharmaceuticals

  • Examining how the generics Industry is in transition
  • Re-examining the traditional Growth models
  • Why the paths of innovative pharma and generics will increasingly criss-cross
  • What makes for a successful Pharma company of tomorrow
  • Glenmark and its model for differentiation in generics
  • 11:40 BIO-SIMILARS & BIO-EQUIVALENCE PROGRAMMES

    Murray Ducharme

    Murray Ducharme, Chief Science Officer, Cetero Research

  • New scientific bioequivalence guidelines
  • Harmonization between countries, challenges & improvements
  • What’s new for Generic biologics?
  • How to conduct a bioequivalence program from a global scientific and regulatory point of view
  • 12:20 Networking Lunch

    13:40 A CANADIAN VIEW ON GENERICS

    Sibylle Graf

    Sibylle Graf, Senior Director, Business Development Europe, Pharmascience

  • Key developments on the Canadian generic market
  • Differences in Canadian versus European legislation
  • Challenges for a medium sized generic manufacturer
  • Growth strategies and business models
  • 14:20 PROTECTING THE SAFETY OF YOUR GENERIC

    Nawab Qizilbash

    Nawab Qizilbash, Honorary Senior Lecturer in Epidemiology, Imperial College London

  • Ensuring a ‘safe’ passage for your bibliographic submission
  • Risk management plans
  • Pharmacovigilance responsibilities
  • 15:00 Afternoon Tea

    15:20 THE FUTURE OF THE GENERICS SPACE

    Brian Tempest

    Brian Tempest, Chairman ex-CEO, Hale & Tempest; Ranbaxy

  • Big pharma in transition
  • Changes to the generic marketplace
  • M&A activity including big pharma - generics
  • The future role of Asia
  • 16:00 PATENT LITIGATION - THE INDIAN SCENARIO

    Rajeshwari Hariharan

    Rajeshwari Hariharan, Senior Partner, K&S Partners

  • Impact of recent novartis case
  • Learnings from the recent Cipla-Roche case
  • Tips and strategies for from a generic's perspective
  • 16:40 Chairman’s Closing Remarks and Close of Conference

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    Workshops

    Introduction to Intellectual Property & Generics
    Workshop

    Introduction to Intellectual Property & Generics

    Crowne Plaza Hotel - St James
    13th May 2009
    London, United Kingdom

    Advanced Patent Busting
    Workshop

    Advanced Patent Busting

    Crowne Plaza Hotel - St James
    13th May 2009
    London, United Kingdom

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

    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:

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    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.

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    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.

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