Home
Generics & Supergenerics
11 May - 12 May 2009
Generics & Supergenerics

Conference Overview

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, SAE Media Group 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
  • Alexandre Williams, Director of Business Development, Ethypharm
  • Rahul Garella, Senior VP - EU Business, Glenmark Generics

Conference agenda

clock

8:30

Registration & Coffee

clock

9:00

Chairman's Opening Remarks

Milena Izmirlieva

Milena Izmirlieva, Senior Analyst, IHS Global Insight

clock

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
  • clock

    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
  • clock

    10:30

    Morning Coffee

    clock

    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
  • clock

    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
  • clock

    12:20

    Networking Lunch

    clock

    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
  • clock

    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
  • clock

    15:00

    Afternoon Tea

    clock

    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
  • clock

    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 
  • clock

    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?
  • clock

    17:20

    Chairman’s Closing Remarks and Close of Day One

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Milena Izmirlieva

    Milena Izmirlieva, Senior Analyst, IHS Global Insight

    clock

    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
  • clock

    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
  • clock

    10:30

    Morning Coffee

    clock

    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
  • clock

    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
  • clock

    12:20

    Networking Lunch

    clock

    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
  • clock

    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
  • clock

    15:00

    Afternoon Tea

    clock

    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
  • clock

    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
  • clock

    16:40

    Chairman’s Closing Remarks and Close of Conference

    Workshops

    Introduction to Intellectual Property & Generics
    Workshop

    Introduction to Intellectual Property & Generics

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

    Advanced Patent Busting
    Workshop

    Advanced Patent Busting

    Crowne Plaza Hotel - St James
    13 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

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download

    Title


    Description

    Download

    Title


    Description

    Video



    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

    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@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 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@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