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Why attend this event

Drawing on the strength of SMi's successful Generics, Supergenerics and Patent Strategies conference series, we are proud to present our inaugural Biosimilars & Biobetters: Aligning Business & Science for Success.

According to a recent report published by Biophoenix, in 2009 the biosimilar-susceptible segment of the biologic market was worth US$63 billion and by 2013 biosimilars could generate a total market of $5.6 billion. The key driver to biosimilar development is the expiry of patents across the older leading biologics and with many of these products beginning to come off patent between 2015 and 2016 this industry is set to grow at a significant pace.

Biosimilars have attracted a great deal of interest recently and are seen by some as the new generic frontier. It is widely thought that lower levels of competition will lead to higher margins in an industry notorious for its generally low margins on commodity generics. Payer pressure is expected to drive uptake, particularly in the German, UK and US markets.

The EU has led the way in bringing biosimilars safely to market in establishing an approval process for biosimilars, with many biosimilars already marketed. Recent developments have seen the United States establish a long awaited abbreviated approval pathway for biosimilar  products and this will have major implications for both innovators and current biosimilar manufacturers.

Biosimilar manufacturers are also looking to strengthen their long term strategy, with many developing or acquiring technologies to produce improved biologics (or 'biobetters') to help compete against second generation innovator biologic drugs. Many believe that biobetters, with their improved characteristics are a more exciting and favourable proposition than biosimilars - will offer medical advantages along with a better price.

Hear experts in this field discuss the latest developments in legislation, regulation, technology and emerging commercial strategies to succeed in this highly competitive market.
 

Why not attend the associated pre-conference workshop as well?

Associated with the conference there will be a half-day interactive workshop on "Biosimilars: Understanding the Regulatory Processes and the Commercial Realities", taking place on 21st September.  It will cover overview of the Biosimilars picture across the world and provide insight into the regulatory and commercial situation, now and in the future. This will be led by Peter Wittner, Senior Consultant at Interpharm Consultancy.  To see more information about the workshop, please see the workshop page.


Keen to see the detailed programme?  Click here.

Want to download the brochure?  Click here.

Want to register your place? Click here.

Make a group booking - discounts apply

 


 

key topics include

  • Worldwide regulatory updates
  • The developing U.S. follow-on biologics framework
  • The challenges in biosimilar commercialisation
  • Legal and IP developments
  • Biosimilar and biobetter monoclonal antibodies
  • Opportunities to drive a long term commercial strategy
  • Effectively leveraging licensing opportunities
  • Biosimilar quality aspects

 


 
 hear keynote addresses from

Rahul Padhye 
Head, Corporate Development
Reliance Life Sciences

Huub Schellekens
Professor, Department of Pharmaceutical Sciences & Innovation Studies
Utrecht University

 


speaker lineup includes

David Szymkowski
Senior Director of Biotherapeutics
Xencor 

Huub Schellekens
Professor
Department of Pharmaceutical Sciences and Innovation Studies
Utrecht University

Matthias Hoepfner
VP, Head GRA Global CMC & Change Management
Bayer Schering Pharma


See the full lineup...

 

Syringe and biosimilar drug 


 who should attend

 Members of Board, Vice President, Directors, Heads and Senior Managers involved in:

  • Analytics
  • Business Development
  • Business Strategy
  • Corporate Development Strategy
  • Commercial Affairs
  • Intellectual Property
  • Marketing & Sales
  • Medical Affairs
  • New Product Development
  • Legal Affairs
  • Preclinical and Clinical Development
  • Product Development
  • Regulatory Affairs
  • Pricing and Reimbursement
  • Research and Development
  • Quality Assurance
  • Scientific Affairs
  • Strategic Planning
  • Strategic Sourcing
  • Strategy

  venue details

Crowne Plaza London – The City

19 New Bridge Street  EC4V 6DB

Tel: +44 (0) 870 4009 190    Fax: +44 (0) 207 4388 080

Crowne Plaza London – The City is a modern and stylish hotel right in the heart of the city, perfectly situated for all your business and leisure needs. Set back from the north bank of the River Thames, it is just a stones throw away from Blackfriars station.

The Crowne Plaza London – The City hotel is ideally located within easy access of some of the city’s most famous tourist attractions: The British Airways London Eye, St Paul’s Cathedral, Millennium Bridge, Tate Modern and West End theatres

 

London City (LCY) 

Distance: 10 KM / 6.21 MI W

Approx. taxi Fee: £37.00 (GBP)

Time by taxi: 20 minutes

Time by train: 35 minutes  

London Heathrow (LHR)  

Distance: 30 KM / 18.64 MI E

Approx. taxi Fee: £48.00 (GBP)

Time by taxi: 40 minutes

Time by train: 55 minutes  

London Gatwick (LGW)  

Distance: 38 KM / 23.61 MI SE

Approx. taxi Fee: £78.00 (GBP)

Time by taxi: 1 hour

Time by train: 1 hour

Book your accommodation at SMi discounted rates by calling us on +44 (0)870 9090 713, sending a fax to +44 (0)870 9090 714 or emailing hotels@smi-online.co.uk

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Alan Sheppard

Alan Sheppard, Global Head Generics, Thought Leadership, IMS Health

9:10 Biosimilars - A global opportunity?

Alan Sheppard

Alan Sheppard, Global Head Generics, Thought Leadership, IMS Health

  • Current market penetration of biosimilars
  • Players and payers
  • Growth potential
  • 9:50 Improving biosimilar delivery systems to compete with second-gen innovator products

    Keith Powell

    Keith Powell, CEO, PolyTherics Ltd.

  • History of PEGylated biologics and comparing PEGylation to competing technologies
  • Choosing the best chemistry and the right-sized PEG
  • Process optimisation and benefits
  • Succeeding in a challenging market
  • 10:30 Morning Coffee

    11:00 The developing biosimilars regulatory framework in the U.S.

    Dutch Chung

    Dutch Chung, Associate, Wilson Sonsini Goodrich & Rosati

  • Review of U.S. statutory framework for handling biosimilar patent litigation
  • Impact on strategies for biosimilars product patenting
  • Strategies for biosimilars patent litigation and resolution in the U.S.
  • 11:40 EU guidelines and biosimilar development strategies

    Peter Gaskin

    Peter Gaskin, Principal Consultant, Aptuit

  • Latest guidelines and recommendations
  • Adopting the right development strategy
  • Ensuring guideline compliance
  • Illustrative case study
  • 12:20 Networking Lunch

    13:30 EU legal developments and strategies for biosimilar medicines

  • New legislation/developments
  • Case law affecting biosimilars and bio-betters
  • Biosimilar patent disputes and best processes to handle them
  • Impact of special patent resolution procedures and potential patent strategies
  • Frank Landolt

    Frank Landolt, VP Intellectual Property and Legal, Ablynx
    View Bio

    Marc Martens

    Marc Martens, Senior Associate, Bird & Bird

    14:10 Biosimilars as a new business opportunity

    Anjan Selz

    Anjan Selz, CEO, FINox AG

  • Analyzing the business case through SWOT
  • Finding remedies to threats and weaknesses
  • Creating value for patients and shareholders
  • 14:50 Afternoon Tea

    15:20 Clinical comparability and European biosimilar regulations

    Huub Schellekens

    Huub Schellekens, Professor, Department of Pharmaceutical Sciences and Innovation Studies, Utrecht University

  • Quality differences between biosimilars and reference drug products
  • Equivalence margins, usefulness and discrepancies
  • Withdrawn biosimilars and important aspects
  • Should the biosimilar pathway be restricted only to biologics?
  • 16:00 Leveraging biosimilars licensing opportunities

    Rahul Padhye

    Rahul Padhye, Head, Corporate Development, Reliance Life Sciences

  • Opportunities in Biosimilars market
  • Commercialisation strategies/options for biosimilars
  • Licensing Deal - objectives, process, examples and key learnings
  • Reliance Life Sciences - overview, biosimilars business brief
  • 16:40 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    David Szymkowski

    David Szymkowski, Senior Director, Biotherapeutics, Xencor

    9:10 Biosimilars in the clinic

    David Goldsmith

    David Goldsmith, Consultant Nephrologist, St Thomas' Hospital

  • The changing physician outlook
  • Lingering concerns
  • The decision to substitute a biosimilar for a reference
  • Policies and economic pressures
  • 9:50 EMA guidelines for biosimilar monoclonal antibodies

    Robert Blakie

    Robert Blakie, Director of Regulatory Affairs and General Manager (UK), Era Consulting (UK) Limited

  • Immunogenicity assessment annexe to existing guidelines
  • Level of similarity required - demonstrating further features
  • Clinical development and study design
  • mAb categorisation
  • Authorise as stand-alone or biosimilar and the evidence requirements
  • 10:30 Morning Coffee

    11:00 Developing "biosuperior" monoclonal antibodies

    David Szymkowski

    David Szymkowski, Senior Director, Biotherapeutics, Xencor

  • Building biosuperiors based on leading mAbs & Fc fusions
  • A novel approach to develop fully human antibodies with enhanced in vivo activity
  • Commercial realities and strategies for innovators
  • Illustrative case studies and results
  • 11:40 Biosimilar quality aspects

    Jean-Yves le Cotonnec

    Jean-Yves le Cotonnec, Managing Partner. Founder & CEO, TRISKEL Integrated Services S.A

  • Clinical relevance of differences
  • Demonstrating comparability
  • Bioassays to complement physicochemical methods
  • Variability of biosimilars, is this acceptable?
  • 12:20 Networking Lunch

    13:50 Biosimilar CMC development - an innovator's point of view

    Matthias Hoepfner

    Matthias Hoepfner, VP, Head GRA Global CMC & Change Management, Bayer Schering Pharma

    Reference characterisation
    Importance of comparability - how similar is similar?
    Factors introducing unpredictability

    14:30 Interactive Panel Discussion

    Topics including:

  • The market rationale for biosimilars - are they worth it?
  • Biosimilar or biobetter?
  • Developing regulatory and legislative perspectives
  • What about safety? Can biosimilars actually be registered on reduced clinical dataset
  • Sustainability and future industry directions
  •  

    Rahul Padhye

    Rahul Padhye, Head, Corporate Development, Reliance Life Sciences

    Matthias Hoepfner

    Matthias Hoepfner, VP, Head GRA Global CMC & Change Management, Bayer Schering Pharma

    David Szymkowski

    David Szymkowski, Senior Director, Biotherapeutics, Xencor

    15:10 Immunogenicity of biosimilars and biobetters

    Matthew Baker

    Matthew Baker, CEO & CSO, Antitope

  • Properties determining immunogenicity
  • Effects on efficacy, clearance and distribution
  • Unknown factors
  • Illustrative case studies in unwanted immunogenicity
  • Designing and generating biobetters to avoid immunogenicity
  • 15:50 Chairman’s Closing Remarks

    16:00 Afternoon Tea

    16:30 Close of Conference

    +

    Workshops

    Biosimilars: Understanding the Regulatory Processes and the Commercial Realities
    Workshop

    Biosimilars: Understanding the Regulatory Processes and the Commercial Realities

    Crowne Plaza - The City
    21st September 2010
    London, United Kingdom

    Crowne Plaza - The City

    19 New Bridge Road
    London EC4V 6DB
    United Kingdom

    Crowne Plaza - The City

    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.

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    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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