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The generics pharmaceutical industry is a rapidly evolving market carrying the promise of reducing long term healthcare costs. For our fourth annual conference on Super Generics & Patent Busting, we at SMi are drawing on the successful meetings of the last four years to develop a forum where the ‘hot’ topics of this year can be focussed upon.

Those active in this area will know that this meeting is particularly well timed due to recent events concerning controversial patent issues and legal battles contesting the patent protection of high profile pharmaceutical products.

This conference represents an excellent opportunity to discuss current issues regarding patent protection and patent busting strategies. It will also highlight the latest advances R&D and technology in the field of generic and super generic pharmaceuticals. Other topics such as the formation of strategic partnerships and licensing agreements will also be discussed.

Conference programme

9:00 Registration and Coffee

9:30 Chairman's Opening Remarks

Simon Cohen

Simon Cohen, Partner, Taylor Joynson Garrett

9:40 THE EVOLUTION OF THE GENERIC PHARMACEUTICALS MARKET

Robert S Milanese

Robert S Milanese, President, National Association of Pharmaceutical Manufacturers

  • Generic drugs: lowering healthcare expenditure
  • The impact of drug prices on patients
  • Drugs due to come off patent
  • Brand-drug company tactics to ensure that generics do not get marketed
  • Future predictions for the generic drug market
  • 10:20 THE UK PERSPECTIVE ON THE GENERICS MARKET

    Dr Helen Jenkins

    Dr Helen Jenkins, Director, OXERA

  • Generics and the NHS strategic objectives
  • The supply chain and obtaining value for money
  • The relationships between markets for generic and branded proprietary drugs
  • Generic brand value
  • 11:00 Morning Coffee

    11:20 SUPER GENERIC PHARMACEUTICALS

    Dr Peter Sandmeier

    Dr Peter Sandmeier, Managing Director, Losan Pharma

  • Improved Bioavailability (up to doubling)
  • Improved gastric tolerance
  • Improved compliance
  • Improved chemical and physical stability
  • 12:00 OPTIMISING YOUR GENERIC ONCOLOGY DRUG PORTFOLIO

    Dr Jean-Francois Loumeau

    Dr Jean-Francois Loumeau, Director, Business Development, Faulding Pharmaceuticals

  • The increasing demand for generic oncology drugs
  • Oncology drugs due to come off patent
  • Trends in the market for generic oncology pharmaceuticals
  • Integrating current market issues into your portfolio strategy
  • Identifying licensing opportunities
  • 12:40 Networking Lunch

    14:00 OUTSOURCING DEVELOPMENT

    Dr David Goodman

    Dr David Goodman, Executive Vice President, Pharmascience

  • Economical alternatives for early access to European markets
  • Benefits of conducting development outside the EU
  • Analysis of patent status and patent busting strategies
  • Beating patents through process and formulation concepts
  • Complete solutions: from R&D and product supply to regulatory affairs
  • 14:40 Afternoon Tea

    15:00 ENHANCING THE THERAPEUTIC ACTION OF COMPOUNDS THROUGH DRUG DELIVERY

    Dr Krishna Vishnupad

    Dr Krishna Vishnupad, Vice President, Research and Development, Eurand

  • Choosing the optimum system
  • Targeted drug delivery
  • Improved drug absorption
  • Overcoming multiple-drug resistance
  • Valuing delivery systems
  • 15:40 USING ADDTM TECHNOLOGY TO DIFFERENTIATE PULMONARY DELIVERED GENERIC DRUGS

    Jonathan Rigby

    Jonathan Rigby, Business Development Executive, Profile Therapeutics

  • The market for respiratory pharmaceuticals
  • The market for systemic pharmaceutical delivered via the lung
  • Using a range of AAD devices to differentiate generic drugs
  • Using ProDose TM technology to lock the drug and the device together
  • 17:00 Chairman's Closing Remarks and Close of Day One

    17:10 Networking Drinks Reception for Speakers and Delegates

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Peter Bakker

    Peter Bakker, Director Strategic Marketing, Pharmachemie

    9:10 THE CLAMOUR FOR DATA PROTECTION

    Dr Howard Rosenberg

    Dr Howard Rosenberg, Head of Patents and Raw Material Sourcing, Merck Generics

  • A fair balance?
  • Fair competition?
  • 'Unfair commercial use'.....by whom?
  • 9:40 PATENT PROTECTION STRATEGIES CURRENTLY IN FORCE

    Jenny Berg

    Jenny Berg, Business Analyst, Datamonitor

  • Setting the scene: number of patent expiries affecting high-selling products by 2005
  • Existing patent protection strategies for pharmaceutical companies: maximising regulatory benefits, adding value to products, defending patent rights, competing post-patent expiry, lifecycle management
  • Gaps in current practice: are pharmaceutical companies using the available strategies to their full potential?
  • Case studies of patent protection strategies for blockbuster products and their fit with best practice
  • 10:20 INTELLECTUAL PROPERTY RIGHTS AND STRATEGIES FOR GENERICS AND SUPER GENERICS

    Dr Andrea Wayda

    Dr Andrea Wayda, Partner, Pharma Intellectual Property, Morgan and Finnegan

  • The pros and cons of using protest or re-examination procedures to attack patent validity in the U.S. patent office
  • How to level the playing field for generic manufacturers when litigating against the branded pharmaceutical company
  • Recent political and legal developments in the US effort to institute quick approval procedures for generic versions of biologics
  • 11:00 Morning Coffee

    11:20 LEGAL UPDATE

    Marjan Noor

    Marjan Noor, Solicitor, Taylor Joynson Garrett

  • Second medical use patents – potential for revocation : American Home Products –v- Novartis (27 July 2000); Lilly ICOS LLC –v- Pfizer Limited (8 November 2000)
  • Volume based strategies to combat parallel imports : EU Court of First Instance decision in the Bayer case (26 October 2000)
  • Patent dispute tactics: actionable threats
  • 12:00 IDENTIFYING AND CHALLENGING INVALID PATENTS

    George Lombardi

    George Lombardi, Partner, Winston and Strawn

  • Identifying invalid patents
  • The risks of patent challenges
  • Product protection strategies: double patenting
  • Successful patent challenges: Prozac
  • How do patent challenges affect the future of the pharmaceutical industry?
  • 12:40 SUCCESSFUL PATENT BUSTING

    Martin Zeiger

    Martin Zeiger, Senior Vice President, Strategic Business Development and General Counsel, Barr Laboratories

  • What makes a patent invalid?
  • Predicting the timing and outcome of FDA decisions on patent challenges
  • Models for patent challenges
  • Successful challenges: Tamoxifen and Ciprofloxacin
  • The effect of patent challenges on the generic pharmaceuticals market
  • 14:40 MARKETING BRANDED GENERIC PHARMACEUTICALS

    Ian Troup

    Ian Troup, President and COO, Upsher-Smith

  • What are “branded generics”?
  • Advantages for primary healthcare groups
  • Branded generics currently on the market
  • Meeting and anticipating the changing needs of consumers
  • Marketing a broad spectrum of branded generic drugs
  • 15:20 Afternoon Tea

    15:40 IMPROVING THE MARKETING POTENTIAL OF GENERIC PHARMACEUTICALS WITH DRUG DELIVERY SYSTEMS

    Dr Ad Van Dooren

    Dr Ad Van Dooren, Sales Manager, Banner Pharmacaps Europe

  • Types of drug delivery approaches
  • Identifying drug delivery opportunities
  • Integrating drug delivery systems into your marketing strategy
  • Case study: gel cap systems
  • 16:20 BUSINESS STRATEGIES IN THE GENERIC PHARMACEUTICAL INDUSTRY

    Dr John Siebert

    Dr John Siebert, President and Chief Executive Officer, CIMA LABS

  • Assessing your capabilities
  • Out-licensing technology for third party products
  • Identifying partners
  • Strategic partnerships with shard development and profitability
  • 17:00 Chairman's Closing Remarks and Close of Conference

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    Workshops

    Adding Value Through Drug Delivery Systems
    Workshop

    Adding Value Through Drug Delivery Systems

    The Hatton, at etc. venues
    25th April 2001
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    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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