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With the prominence of the Pharmaceutical generics industry growing rapidly each year, it is becoming harder for Big Pharma to dismiss the threat that now exists to their business.

With over half of the current blockbuster drugs on the market with a value of £241 Billion due to expire within five years, there are incredible opportunities open to the existing and upcoming generic players. With even the largest of primary drug manufacturers starting to involve themselves in a serious way.

However despite the opportunities there are still numerous pitfalls. The generic marketplace is rife with litigation & patent infringement cases, Intellectual Property (IP) disputes, production authorisation challenges, and cut-throat competition.

SMi's conference aims to provide an insight into the complexity of the current commercial and legal landscapes surrounding the Generics marketplace, and to keep you up-to-date with future trends and developments.

 

Also running are two pre-conference workshops on Tuesday 10th May, 2011;

8.30am - 12.30pm

Valsartan: Negotiating the EU patent thicket for a blockbuster anti-hypertensive

Hosted by; Duncan Curley, Director, Innovate Legal

             

1.30pm - 5.30pm

Generics in the emerging markets:

Boom or bubble?

Hosted by; Paul Mendelsohn. CEO at Pharmawise
And co-hosted by; Frances Cloud, Founder, Pharmacloud

 

Interested in speaking at the conference?  

We are always on the look-out for new speakers and interested projects for our upcoming conferences.  Let us know if you would like to participate by emailing smiproduction@smi-online.co.uk

For event sponsorship and exhibiting opportunities, please contact sponsorshipdept@smi-online.co.uk 

 

The event will address;

  • Structural changes in the global generic marketplace
  • The development of Supergenerics
  • Investment opportunities in the generics industry
  • The regulatory and licensing landscape of the EU
  • Generics in emerging markets: Opportunities & challenges
  • Patent strategies and generic pharma sector: US, European and Indian perspective
  • The future of generics and reference pricing in Europe and its implications for the industry

 

 

 

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 
     

 


 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Richard Dicicco

Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

9:10 INVESTING IN GENERIC DRUG PRODUCTS THROUGH PERFECT PRODUCT SELECTION

Richard Dicicco

Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

  • Limited or no API availability is the critical factor
  • Balancing IP circumvention with formulation in product selection
  • Product complexity must limit the competition
  • Difficult studies to prove bioequivalence
  • NPV must be highly positive
  • 9:50 RECENT TRENDS IN EU COMPETITION POLICY

    Paul Csiszár

    Paul Csiszár, Director, Directorate, European Commission, Competition Directorate General

  • General Development of European Competition Law
  • Patent Settlements
  • AstraZeneca Judgment
  • 10:30 Morning Coffee

    11:00 FROM LOCAL PLAYER TO BE A GLOBAL PLAYER

    Ayhan Aslan

    Ayhan Aslan, Manager, International Commerce, MN Pharmaceuticals

  • TBA
  • 11:40 PATENTING PHARMACEUTICALS: THE EPO'S APPROACH TO THE CHALLENGE

    Enrico Luzzatto

    Enrico Luzzatto, Director, Pure and Applied Chemistry , European Patent Office

  • The European Patent Office and its main pharmacological department, the Joint Cluster PAOC.
  • The present situation at the EPO in the pharmaceutical field: trends, facts and figures
  • Recent changes in the procedure before the EPO: impact on parties
  • Patent strategies: what can the parties' do to help streamline the procedure
  • 12:20 Networking Lunch

    13:20 INSIGHT ON EU REGULATORY BODIES

    Martin Votava

    Martin Votava, Senior Lecturer, and CHMP Member (2007-2010), Charles Unversity Prague

  • Pitfalls of generic dossiers
  • Overview of CHMP and CMDh referrals
  • CHMP rules of procedure
  • 14:00 LAUNCHING A GENERIC PRODUCT ON THE EU MARKET: PATENT ISSUES

    Duncan Curley

    Duncan Curley, Director, Innovate Legal

  • Patent expiry dates and SPCs
  • How to anticipate paediatric extensions to SPCs
  • Dealing with 'use' claims
  • Case study: Losartan in the UK
  • 14:40 Afternoon Tea

    15:10 REGULATORY OPTIONS FOR GENERICS THROUGH DIFFERENT LICENSING POSSIBILITIES

    Ivanka Atanasova

    Ivanka Atanasova, Chief Expert, Bulgarian Drug Agency

  • Players and trends in the generic market
  • In-house development versus in-licensing: Pros and cons
  • Risk factors for consideration
  • Opportunities in development of supergenerics
  • 15:50 A NEW BUSINESS MODEL IS NEEDED TO ADEQUATELY SERVE EU GENERIC COMPANIES

    Ineke Braat

    Ineke Braat, CEO, Pan-Generika

  • On time delivery
  • Data exclusivity
  • DCP slots
  • Affordable prices
  • Critical mass of dossiers
  • 16:30 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 PATENT STRATEGIES AND GENERIC PHARMA SECTOR: US, EUROPEAN AND INDIAN PERSPECTIVE

    Aman Trehan

    Aman Trehan, Deputy General Manager, Intellectual Property, Cadila Health Care

  • Background of US, European and Indian patent system
  • Patent litigation landscape: US, Europe and India
  • Insight of global pharmaceutical market
  • Hatch Waxman Act and Indian pharma industry: Implications and future prospects
  • Impact of TRIPS on Indian patent system and Indian pharmaceutical sector: Opportunities and challenges
  • 9:50 IP CHALLENGES FOR GENERIC COMPANIES

    Lorna Brazell

    Lorna Brazell, Partner, Bird & Bird

  • Brief overview – EU Patent system
  • Patent strategies employed by Pharma companies
  • Delay tactics 
  • Data exclusivity vs. Data protection
  • Copyright and trademarks
  • 10:30 Morning Coffee

    11:00 GENERICS IN EMERGING MARKETS: MIDDLE EAST & NORTH AFRICA – OPPORTUNITIES & CHALLENGES

    Manoj Paruthi

    Manoj Paruthi, Head, Branded Generics, Hikma

  • MENA Markets Demographics – Dividend or Challenge?
  • Regulatory Challenges while working in MENA
  • Changing landscape  - Upcoming additional requirements
  • 11:40 INVESTMENT OPPORTUNITIES AND CHALLENGES IN THE GENERICS INDUSTRY FOR THE UK

    Pascal Brenneisen

    Pascal Brenneisen, Country Head, Sandoz UK

  • How to add value to customers - Clinicians, doctors, pharmacists, patients & commissioning bodies in the context of new Government policies
  • How to offer value for price
  • What are potential differentiating factors with focus on access to affordable medicines
  • 12:20 Networking Lunch

    13:20 EMERGING MARKETS BEYOND BRIC

    Bernd Stoiber

    Bernd Stoiber, Consultant, Lead Training (Ex Head of Mass Markets, Novartis)

  • An untapped opportunity
  • CIS, Vietnam, SSA
  • How innovators take the lead in Generics
  • 14:00 THE DEVELOPMENT OF SUPERGENERICS

    Deepak Murpani

    Deepak Murpani, Vice President, Product Development, Genepharm

  • Develop business strategies
  • What are Supergenerics?
  • Why are Supergenerics “super” than the generics – A scientific, IP and commercial perspective
  • Supergenerics – The shareholder’s perspective
  • How to identify Supergeneric opportunities?
  • Case studies – Challenges, approach and strategies
  • Future potential
  • 14:40 Afternoon Tea

    15:10 THE RISK OF ENTERING CHINA WITH BRANDED GENERICS IN 2011

    Margaret Hsiao

    Margaret Hsiao, President, Harvest Moon Pharmaceuticals

  • Overview of the Chinese market
  • Current pharmaceutical distribution process flow
  • Foreign entries into China pharmaceutical distribution
  • Impact of expanding healthcare access on branded generics
  • Leading multinationals in China
  • Insights and issues
  • 15:50 THE CHINESE PHARMACEUTICAL INDUSTRY APPROACHES EUROPE: OPPORTUNITIES & OBSTACLES

    Bruce Murdoch

    Bruce Murdoch, Commercial Director, Stravencon

  • Overview of the Chinese pharmaceutical landscape
  • API’s & Formulation Development
  • Small molecules & follow-on biologics
  • Alternative scenarios of market penetration
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    Workshops

    Valsartan: Negotiating the EU patent thicket for a blockbuster anti-hypertensive
    Workshop

    Valsartan: Negotiating the EU patent thicket for a blockbuster anti-hypertensive

    Millennium Gloucester Hotel
    10th May 2011
    London, United Kingdom

    Generics in the emerging markets: Boom or bubble?
    Workshop

    Generics in the emerging markets: Boom or bubble?

    Millennium Gloucester Hotel
    10th May 2011
    London, United Kingdom

    Millennium Gloucester Hotel

    Harrington Gardens
    London SW7 4LH
    United Kingdom

    Millennium Gloucester Hotel

    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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