Home
overview
In 2006 the Generics Industry has grown by 13%, and with $80 Billion worth of branded drugs coming off patent in the next 3 years, generics companies are expected to gain massive market share in the pharmaceutical arena.
Yet as competition intensifies, adapting to the changing pace has become vital;
  • Identifying opportunities in multiple markets,
  • Diversifying product portfolio,
  • Incorporating regulatory changes and overcoming legal hurdles,
SMi's 10th Annual Generics, Supergenerics & Patent Strategies Conference brings together Vice Presidents, Directors and Heads of the world's leading generics companies to discuss key critical issues:
   
Q: What core R&D strategies are implemented by the world's largest generics company?
STREAMLINING RESEARCH AND PRODUCT DEVELOPMENT - Maintaining leadership in the Generic industry
Amir Elstein, Vice President, Global Resources, Teva
    
Q: How to diversify business strategies towards patentable drugs?
DIRECTING RESEARCH AND DEVELOPMENT TOWARDS PATENTABLE PRODUCTS - Broadening activity beyond the generics market
Dr Uday Saxena, Chief Scientific Officer, Dr Reddy Laboratories
    
Q: What are the business prospects in Bio-Generics?
HARNESSING BIO-GENERIC OPPORTUNITIES TO PERPETUATE GROWTH - Prospects for Biogenerics
Dr Salah Ahmed, Senior Vice President, Research & Development, Barr Laboratories
     
Q: How to gear towards competition in the emerging Asian markets?
THE CHALLENGE FROM INDIA - Pathways into a booming market
Dr Brian Tempest, Chief Mentor & Executive Vice President, Ranbaxy
      
Q: Will regulatory changes affect the profitability of authorized generics?
APPROVED GENERICS IN LIGHT OF REGULATORY CHANGES - An insight to the shifts in incentives in authorized generics
Heather Bresch, Senior Vice President, Strategic Corporate Development, Mylan Laboratories
     
This is an exceptional occasion to engage with the industry's decision-making experts:
  • William F. Haddad, Chairman & Chief Executive Officer, Biogenerics Inc.
  • Stefan Sveinsson, Executive Vice President, Research & Development, Actavis
  • Dr Aleksandar Danilovski, Senior Director, Vertical Integration, Global Research & Development, PLIVA
  • Stuart A. Williams, Chief Legal Officer, Mylan Laboratories
  • Warwick Smith, Director, British Generics Manufacturers Association (BMGA)
  • Neil Greenblum, Senior Managing Partner, Greenblum & Bernstein PLC
  • H. Keeto Sabharwal, Partner, Blank Rome LLP

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

William Haddad

William Haddad, Chariman and Chief Executive Officer, Biogenerics

9:10 MAINTAINING LEADERSHIP IN THE GENERIC INDUSTRY

Amir Elstein

Amir Elstein, Executive Vice President, Global Resources , TEVA

  • Facing patent expiry, hurdles and strategies
  • Facing Diversified competition and multinational generics
  • Expanding the technology scope and opportunities and prospects in Biogenerics
  • 9:50 HARNESSING BIO-GENERIC OPPORTUNITIES TO PERPETUATE GROWTH

  • Product development issues: characterization, bio-similarity, immunogenicity and stability
  • New challenges in the technological and regulatory fronts
  • Addressing business issues: market acceptability, competition and uncertainty
  • New collaborative paradigms for the generic industry: acquisition, licensing and joint-ventures
  • Salah Ahmed

    Salah Ahmed, Senior Vice President, Research & Development , Barr Laboratories

    Domagoj  Runac

    Domagoj Runac, Senior Director, Biologics Research and Development, PLIVA R&D

    10:30 Morning Coffee

    11:00 PORTFOLIO MANAGEMENT AND PRODUCT DEVELOPMENT IN A GROWING GENERICS ENVIRONMENT

    Stefan Sveinsson

    Stefan Sveinsson, Executive Vice President, Research & Development, Actavis

  • Product selection and target outline
  • Increasing efficiency in generic drug development
  • Reshaping the business strategies through mergers and acquisitions
  • Product launching strategies
  • 11:40 NOVEL APPROACH TO PRESERVING LONGEVITY OF NEW AND CURRENT BETA-LACTAM ANTIBIOTICS

    Nora Kaarela

    Nora Kaarela, Chief Executive Officer, IPSAT Therapies

    12:20 Networking Lunch

    13:50 LICENSING AS A GROWTH MECHANISM

    Paul Ranson

    Paul Ranson, Partner, Intellectual Property, Stringer Saul

  • Regulation and IP framework
  • Financial structures
  • Warranties and liabilities
  • Resolving friction points: liabilities and disputes
  • 14:30 OPPORTUNITIES AND CHALLENGES FROM INDIA

    Brian Tempest

    Brian Tempest, Chief Mentor and Executive Vice President, Ranbaxy Laboratories

  • The emergence of Asia : projected growth and intensifying competition
  • The advantages of the Indian generics market
  • Utilizing India as a global strategic asset
  • Examining the possible downsides to the India scenario
  • 15:10 Afternoon Tea

    15:40 THE WAXMAN-SCHUMER-CLINTON ACCESS TO LIFE SAVING MEDICINE ACT AND RELATED LEGISLATION

    William Haddad

    William Haddad, Chariman and Chief Executive Officer, Biogenerics

  • Emerging differences with Drug Price Competition Act and section 505 (b)
  • Comparison to the EU developing regulation
  • How is “therapeutic interchange ability” achieved?
  • Shifting the balance from structured political decision-making to reviewing the scientific information
  • 16:20 HANDLING INFRINGEMENT DISPUTES IN THE US

    Stuart Williams

    Stuart Williams, Chief Legal Officer , Mylan Laboratories

  • Modelling the cost of litigation, and structuring the financial benefits of the deal
  • Demonstrating patent invalidness: lessons learned
  • Negotiating the terms of the settlement
  • 17:00 KEEPING GENERIC COMPETITION AT BAY

    Duncan Curley

    Duncan Curley, Partner, McDermott, Will & Emery

  • Overview of the legal framework for SPCs in Europe
  • Gliadel case study: SPCs for new formulations of known drugs
  • Reviewing case-in-point litigation
  • Future prospects
  • 17:40 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Duncan Curley

    Duncan Curley, Partner, McDermott, Will & Emery

    9:10 APPROVED GENERICS IN LIGHT OF REGULATORY CHANGES

    Heather Bresch

    Heather Bresch, Senior Vice President, Strategic Corporate Development, Mylan Laboratories

  • The Preserve Access to Affordable Generics act
  • The 2007 amendments to the US Medicade rebate rules
  • The implications on authorized Generics, and the ambiguity that arises
  • 9:50 THE ACHILLES HEEL OF THE NAME BRANDS

    Neil Greenblum

    Neil Greenblum, Senior Managing Partner , Greenblum & Berstein PLC

  • Improper Orange Book Listing and Baseless Litigation
  • Name Brands’ Abuse of Discovery and Litigation Delay
  • Awards of Attorneys’ Fees
  • Alternative Attorney Fee Arrangements
  • The Role of Class Action Suits: Authorized Generics and Collusive Agreements
  • 10:30 Morning Coffee

    11:00 FORMING A SUPERGENERIC: PROSPECTS IN SPECIALITY AND INNOVATIVE PHARMA

    Brian Lovatt

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

  • Reformulation and drug delivery strategies
  • Driving the business strategy through mergers & acquisitions
  • R&D shifts towards NCEs
  • 11:40 CHALLENGES AND PROSPECTS OF ACCESSING DRUG SUBSTANCE FOR GENERIC COMPANIES

    Aleksandar Danilovski

    Aleksandar Danilovski, Senior Director, Vertical Integration, Global Research & Development, PLIVA Research Institute

  • Key success factors for Generic companies: where do Active Pharmaceutical Ingredients fit?
  • Effective access to the drug substance for generic companies
  • Differentiated approach to access the drug substance: achieving a better balance
  • Supply and value chain
  • 12:20 Networking Lunch

    13:50 CONSOLIDATING FORCES IN THE GENERICS MARKET

    Charles R Wolfe Jr

    Charles R Wolfe Jr, Partner & Chair, IP, Blank Rome L L P

  • Evaluation the costs and rewards in a prospective venture
  • Legal issues to consider when constructing a deal
  • Executing mergers and acquisitions – the legal perspective
  • 14:30 KEY STRATEGIES FOR SAFE LAUNCH OF GENERIC PHARMACEUTICALS IN EUROPE

  • Interim measures available in Europe for patentees to prevent launch: comparing the UK, Germany, France and other European markets
  • Interim injunctions - recent authorities and how interim injunctions can be avoided
  • Cross-undertakings as to damages - can it ever compensate for being kept off the market?
  • Simon Cohen

    Simon Cohen, Partner, Taylor Wessing

    Nigel Stoate

    Nigel Stoate, Partner, Taylor Wessing

    15:10 Afternoon Tea

    15:40 PERFORMING BIOEQUIVALENCE STUDIES USING INNOVATIVE OR HISTORICALLY COMMON APPROACHES

  • Conducting a pilot study: timing and methods
  • Choosing the correct sample size
  • Reformulation based on results analysis
  • When to perform additional data analysis and how
  • Dr Murray  Ducharme

    Dr Murray Ducharme, Vice President, , Allied Research International

    Dr Murray Ducharme

    Dr Murray Ducharme, Vice President,Scientific Affairs, Allied Research International

    16:20 TAKING THE GUESS WORK OUT OF GENERIC PRICING

    Charles Joynson

    Charles Joynson, Chief Executive Officer, Wavedata

  • Traditional methods of forecasting and pricing
  • Long term patterns in generic pricing
  • Developing models to predict generic prices
  • Applying models to other markets
  • How reimbursement influences generic prices
  • Is there a link between reimbursement, bounces and seasonality? 
  • 17:00 PRICE EROSION DUE TO DRUG REIMBURSEMENT

    Warwick Smith

    Warwick Smith, Director, British Generic Manufacturers' Association

  • Balancing high penetration rates with reductions in margins of profit
  • Lessons learned from the implementation of the new reimbursement system
  • Regulating the competition between patent-expired drugs and their generic equivalents
  • 17:40 Chairman’s Closing Remarks and Close of Day One

    +

    Workshops

    Successfully Litigating Method of Use Patents
    Workshop

    Successfully Litigating Method of Use Patents

    Crowne Plaza Hotel - The City
    16th May 2007
    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

    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.