The worldwide generics industry has seen strong growth in recent times as the demand for affordable treatment has increased worldwide. In addition to this, numerous branded-drug patent expirations, the prospect of generic biotechnology drugs and a favourable regulatory environment is providing a huge opportunity for the sector to expand further.

Join us for SMi's 13th annual Generics, Super-Generics and Patent Strategies and discover the future of the generics market. Hear experts in the field discuss the latest patent strategies, regulatory updates and growth strategies that will be key to the future of the industry.

For speaker opportunities, contact smiproduction@smi-online.co.uk

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  • Examine the legal framework and litigation mechanics in both the EU and US 
  • Latest legislative and regulatory updates in generics and biosimilars
  • Identify key growth areas and methods to take advantage of these
  • M&A activities and their implications
  • New business models
  • Emerging markets
  • R&D in generics

Bill Haddad
Chairman & CEO 

John Beighton
Generics Industry Consultant

See the full lineup...



From generics manufacturers:

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

From pharmaceutical innovators:

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

Industry stakeholders:

  • Patent attorneys
  • Intellectual Property experts
  • Branding specialists




Crowne Plaza St James Hotel

45-51 Buckingham Gate
 Tel: +44 (0) 207 834 6655
Fax: +44 (0) 207 6307
 Crowne Plaza St James Hotel

Crowne Plaza St James London is a traditional deluxe hotel right in the heart of the city, perfectly situated for all your business and leisure needs. In the heart of Westminster, it is just a stone's throw away from Buckingham Palace, The Houses of Parliament, the London Eye and Victoria Station.  

The hotel boasts three excellent restaurants. Bistro 51 with British and European cuisine, the Michelin Starred Indian restaurant Quilon serving south coastal Indian food and Bank Westminster with a modern British menu.

A beautiful, award-winning, courtyard garden surrounds the Victorian buildings of the Crowne Plaza London St James - a peaceful oasis in the centre of London.

Crowne Plaza St James


Book your accommodation at SMi discounted rates by:

SMi discounted rates include Continental Breakfast & VAT
  • £ 205.63 / Standard room / night for single occupancy
  • £ 229.13 Executive  room / night for single occupancy


Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Bill Haddad

Bill Haddad, Chariman & Chief Executive Officer, Biogenerics

9:10 The Acquisition of Generic Companies by Big Pharma

  • Why there is so much activity
  • Attractiveness of emerging markets
  • Innovation Model versus Diversified Strategy
  • Where does IP come into it?
  • Brian Tempest

    Brian Tempest, Chairman, Hale & Tempest

    Brian Tempest

    Brian Tempest, Chairman, Hale & Tempest

    9:50 Pharmaceutical Products Protection and Patenting Strategies in China

    Qinghong Xu

    Qinghong Xu, Partner, Lung Tin International Patent & Trademark Agent

  • Protecting products via obtaining strong patents
  • Protecting products via regulatory exclusivities
  • Invalidating patents via invalidation activities
  • Enforcing patents via administrative procedures and judicial actions
  • 10:30 Morning Coffee

    11:00 Developments in US Law and its Effects on Litigation under the Hatch-Waxman Act

    Joseph  Reisman

    Joseph Reisman, Partner, Knobbe, Martens, Olson & Bear LLP

  • New legislations and regulations
  • Case law developments
  • Effect on patent challenges
  • Permissible settlement structures
  • 11:40 EU Intellectual Property Agenda

    Duncan Curley

    Duncan Curley, Director, Innovate Legal

  • Growth in the EU
  • Patents and SPCs: Legal Update
  • Review of major cases: escitalopram, olanzapine
  • EU Patent Strategies
  • 12:20 Networking Lunch

    13:20 An Update on Data Protection and Recent Patent Developments

    Elisabeth Berthet-Maillols

    Elisabeth Berthet-Maillols, Lawyer, Armengaud-Guerlain Law Firm

  • How data protection and patents are used to block generics?
  • Which strategies are set up in the both sides?
  • Relevant case law updates
  • 14:00 Pharmaceutical Patent Intelligence

    Martin Paltnoi

    Martin Paltnoi, CEO, MPA Business Services Ltd

  • Significance of upcoming expiries
  • Regulatory considerations and limitations
  • Paediatric extensions: taking into account US vs. EU
  • Illustrative case studies
  • 14:40 Market Access Issues

    Brian Lovatt

    Brian Lovatt, Managing Director & Chief Executive, Vision Healthcare Consultancy Ltd

  • The augmented value proposition
  • Biosimilar prices down or ?
  • Price - Volume - Value - Profit
  • 15:20 Afternoon Tea

    15:50 Pharmacovigilance for Generics

    Nawab Qizilbash

    Nawab Qizilbash, Director, OXON Epidemiology

  • Challenges
  • Unique aspects applicable to generics
  • Operational considerations: responsibilities and options available
  • Case study: post-approval safety studies (PASS) and generics
  • Case study: commercial strategies in entering the Spanish market
  • 16:40 The Future of Biosimilars

    Bill Haddad

    Bill Haddad, Chariman & Chief Executive Officer, Biogenerics

  • Post Eshoo / Waxman update - the status of biosimilars
  • Current and European concerns
  • Opportunities
  • Developing markets
  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

    9:10 Biosimilar Development Costs & the Future Global Biosimilars Market

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

  • Why biosimilar profits are difficult in EU
  • Differing guidelines and laws
  • Where the profits are
  • Specifics on how to make a profit
  • Impact on the future global biosimilars market
  • 9:50 Pharmaceutical Gateway Concept

    Peter Hartnack

    Peter Hartnack, General Manager, Bactimm | Farmalyse

  • Background
  • Benefits in efficiency, efficacy & traceability
  • Cost comparisons
  • 10:30 Morning Coffee

    11:00 Engineering Controlled-Release Formulations for Supergeneric Products

    Celal Albayrak

    Celal Albayrak, CEO and Founder, Alrise Biosystems GMBH

  • Application of encapsulation technology for both hydrophilic and hydrophobic drugs independent of the molecule size
  • Rationale for controlled-release depot formulations
  • Advantages of ImSus® technology
  • Field of application
  • 11:40 Supergenerics - Threat or Opportunity?

    Malcolm Ross

    Malcolm Ross, CEO, Generapharm

  • What constitutes a supergeneric
  • Supergeneric possibilities
  • Combination products
  • New dosage forms
  • The barriers to developing supergenerics
  • Commercial considerations for generic companies
  • Case study: Zolpidem
  • 12:20 Networking Lunch

    13:20 Strategies for Success

    Peter Wittner

    Peter Wittner, Senior Consultant, Interpharm Consultancy

  • Which markets?
  • Generic biologics situation
  • Mergers, acquisitions and the options for smaller companies
  • EU Sectoral Inquiry & US FTC review
  • 14:00 Entering the Emerging Markets

    Hordur Thorallsson

    Hordur Thorallsson, Executive Vice President of Emerging Markets, Actavis

  • Entry strategies
  • Pitfalls and barrier
  • Opportunities and growth prospects
  • 14:40 Commercial Strategies in Today's Financial Climate

  • Already stretched healthcare provision hit even harder as a result of financial crisis
  • How are payers addressing current constraints?
  • Are traditional models of pricing and reimbursement under threat?
  • Are current models of generics sales and marketing still appropriate?
  • Commercial dilemmas that generics companies are currently facing will become more acute
  • How can generics companies adapt to, respond to or even lead this evolving process?
  • John Beighton

    John Beighton, Consultant, Generics Industry

    15:20 Chairman’s Closing Remarks and Afternoon Tea



    Strategic Portfolio Planning for Generic Drugs

    Strategic Portfolio Planning for Generic Drugs

    Crowne Plaza Hotel - St James
    12th May 2010
    London, United Kingdom

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James



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    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.


    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.


    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.


    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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