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Following on from the success of our past events, SMi's third Biosimilars and Biobetters conference will build upon the progress made in previous meetings and further develop the ideas and strategies that were debated and discussed. In particular how industry players will face regulatory challenges in approval of follow on biologics, rising development costs, threat from competition and a similar if not bigger challenge to that seen in marketing of innovator drugs.

There will be case studies from those who are both developing and distributing follow on biologics. With analysis of key trends in biologic pipelines, methods in clinical trials for biosimilar approval, a review of emerging markets, assessment of biosimilar manufacturing, post approval strategy and future forecasting for follow on biologics.

SMi's Biosimilars and Biobetters event will provide up to date information from key opinion leaders in the biologics industry with discussion and debate and opportunities for networking between CROs, CMOs, law firms, regulatory bodies, pharma and biotechs.

This exciting event will present attendees with the perfect forum to discuss the rising development cost of biosimilars and successful marketing and pricing strategies, with a focus on case studies from those who are both developing and distributing follow on biologics. With more in depth guidelines being issued by regulatory bodies on the development of biosimilars, this event is not to be missed!

Testimonials from our successful 2011 event:

"Complicated processes made clear!" - Abbott

"Great speakers with interesting contributions" - Genentech


Discover the impact of recent guidelines issued by regulatory bodies such as the FDA and EMEA
Develop plans and methods for biosimilar and biobetter drug design and clinical testing
Learn about new variations in global regulatory strategies for biosimilar development
Evaluate current and future developments in intellectual property and patent protection
Hear from industry and academia on the development process from a pre-clinical perspective
Consider market access pathways and learn from past success stories
Understand and make the most of opportunities for long term growth in follow on biologics
Network and learn from key opinion leaders from the field
 

SMi's 3rd annual Biosimilars and Biobetters Conference will build on the success of our previous events and bring together a unique mix of senior executives from the industry, academia and the public sector and will provide an unrivalled forum for problem-solving discussion and debate.

This event is unmissable for Chief Executives, Executive Directors, Vice Presidents, Heads and Team Leaders from:

  • Intellectual Property
  • Legislation and Policy Advice
  • Business Development
  • Licensing
  • Manufacturing
  • APIs
  • Bioequivalence
  • Drug and Safety Assessment
  • Market Strategy
  • Regulatory Affairs

Attendees at previous SMi's Biosimilar events include senior representatives from: Ablynx; Armengaud-Guerlain; Arnold and Porter; AstraZeneca; Atheln Biomed; BRG; Bristows; Brockmeyer Biopharma GmbH; Business Insights; Crown CRO; Edenbiodesign Ltd; Eli Lilly; Flamel Technologies; Fresenius Kabi Deutschland GmbH; Frontline Pharma Consulting Ltd; Genentech; GenericsWeb; GlaxoSmithKline; Glycotope GmbH; Harvest Moon Pharmaceuticals; I B R Inc Institute For Biopharmaceutical Research; IDDI; IMS Health; Interpharm Consultancy; JustPharmaReports; Medical Industry Week; Medimmune; Menarini; Merck; Pinsent Masons; PolyTherics Ltd.; Roche; Ropes & Gray; Sanofi-Aventis; Takeda Pharmaceuticals; Technology Networks; TRISKEL Integrated Services S.A; UCB;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Richard Dicicco

Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

9:10 Overview of Biosimilar development process: Opportunities and challenges from a pre-clinical perspective

Ezogelin Oflazoglu

Ezogelin Oflazoglu, Executive Director, Sr. Project Leader MBV Biologics PPM, Merck Research Laboratories

• Global Trends in Antibody Development
• MSD strategy to win: Biosimilars, Biobetters and Novel Mechanisms
• Introduction to biosimilars and biosimilar development process
• Overview of EMA and FDA biosimilar guidelines
• Challenges faced during biosimilar development
• Potential Actions to mitigate biosimilar development challenges

9:50 The future of biosimilars in specific emerging markets

Richard Dicicco

Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

• Current biosimilar sales in specific emerging markets
• Issues for growth: changing regulatory requirements; protectionism; counter-detailing, MNC competition
• Future biosimilar sales in specific emerging markets

10:30 Morning Coffee

11:00 Development of biosimilar monoclonal antibodies: opportunities and challenges

Sandy Eisen

Sandy Eisen, Previously Chief Medical Officer, Teva Pharmaceuticals Europe from March 2006 to March 2011, Frontline Pharma Consulting Ltd

• Introduction to monoclonal biosimilars; are there any special requirements for the demonstration of biosimilarity?
• Biosimilars and monoclonals in Europe; progress since 2005
• The biosimilar monoclonal commercial opportunity
• Comparing the EU and US biosimilars laws and guidelines
• What are the key challenges for the clinical development, registration and commercialisation of biosimilar monoclonal antibodies

11:40 Biosimilars for recombinant human insulin and insulin glargine

Heinz Haenel

Heinz Haenel , Senior Project Director, Sanofi-Aventis

  • Considerations of batch-to-batch consistency, product stability and clinical safety
  • Focus on immunogenicity
  • Market access in developing countries
  • Defining non-innovator biologics
  • 12:20 Networking Lunch

    13:50 Panel discussion: biosimilars vs. biobetters, so which is the better strategy?

    • Initial return of investment (ROI)
    • Gaining a competitive edge
    • An accelerated approval process
    • Innovator responses to the threat of competition

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

    David Szymkowski

    David Szymkowski, Senior Director, Biotherapeutics, Xencor

    14:30 Clinical approach to biosimilar development

    Andrew Rankin

    Andrew Rankin, Vice President, Emerging Pharmaceuticals, Prescient Life Sciences (Former Head of Clinical Development, Teva)

    • Pharmacokinetic studies of approved biosimilars
    • Implementing comparative clinical trials
    • Demonstrating therapeutic equivalence
    • Clinical programs for the evolving global regulatory environment 

    15:10 Afternoon Tea

    15:40 Marketing Biosimilars in the EU

    Paul Greenland

    Paul Greenland, Director of Biosimilar Marketing, Hospira UK Limited

    • Overview of the developing Biosimilar business in EU
    • Key learnings in the early markets
    • Nivestim : a case study of a Biosimilar GCSF
    • Future opportunities and challenges

    16:20 Global market analysis of follow on biologics

    Peter Wittner

    Peter Wittner, Senior Consultant, Interpharm Consultancy

    • Opportunities for long term growth
    • Competition across emerging and established markets
    • Transition from monopoly to oligopoly
    • Innovator responses to competitor threats

    17:00 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 Generating a biosuperiors pipeline through Fc engineering: a low-risk approach to improving the performance of therapeutic antibodies

    David Szymkowski

    David Szymkowski, Senior Director, Biotherapeutics, Xencor

    • Advantages and disadvantages of developing biosuperior vs. biosimilar biologics
    • Strategies to improve half-life and potency
    • Multiple case studies of antibodies and Fc fusion therapeutics will be presented

    9:50 Forecasting the future of biosimilars

    Ashleigh Wake

    Ashleigh Wake, Biotechnology Program Manager, Intertek Pharmaceutical Services Manch

  • Considerations for Physiochemical, Structural and Biological Characterisation
  • 10:30 Morning Coffee

    11:00 Methods for biobetter development

    Steve		 Brocchini

    Steve Brocchini , CSO , PolyTherics Ltd.

    • Pegylation for less frequent injections
    • Ultra potent antibodies and ligand traps
    • Bispecific antibodies for dual activity
    • Glycoengineering to increase potency

    11:40 Minimising patent risk

    Christopher Stothers

    Christopher Stothers, Partner, Arnold and Porter

    • Why is patent risk higher for biopharmaceuticals than traditional small molecules?
    • Identifying the patent risk
    • Clearing the way - negotiating tactics
    • Clearing the way - litigation tactics

    12:20 Networking Lunch

    13:50 Variations in global regulatory strategy for biosimilars

    Judith Macdonald

    Judith Macdonald, Director, Worldwide Regulatory Strategy, Pfizer Inc

    • European, US, and Rest of World regulatory environments

    14:30 Biosimilars safety: experience to date

    Marite Ode

    Marite Ode, Clinical Development Manager, Sandoz

    • Increased use of Biosimilars (experience of one company)
    • Pharmacovigilance of Biologics
    • Safety Risk Management
    • Managing patients & physicians concerns

    15:10 Afternoon Tea

    15:40 Innovation in generics: is it applicable?

    Nicola Travierso

    Nicola Travierso, General Manager, ntc pharma

    • Generic market: Patent expiration of a host of Blockbuster drugs in the next 5 years versus austerity measures through Europe in the health sector
    • Current market scenario and expected health measures: increase need and Limited resources
    • Innovation in Generics, a way to maintain the growth
    • Innovation: Inside/Outside the Company, Organization, Products and Services

    16:20 Pricing and reimbursement of biosimilars

    Brian Lovatt

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

  • How should biosimilars be priced compared to their originators?
  • Considering effective incentives
  • Evaluating rebating practices
  • Effective market access strategies
  • 17:00 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Andrew Rankin

    Andrew Rankin

    Vice President, Emerging Pharmaceuticals, Prescient Life Sciences (Former Head of Clinical Development, Teva)
    Ezogelin Oflazoglu

    Ezogelin Oflazoglu

    Executive Director, Sr. Project Leader MBV Biologics PPM, Merck Research Laboratories
    Heinz Haenel

    Heinz Haenel

    Senior Project Director, Sanofi-Aventis
    Judith Macdonald

    Judith Macdonald

    Director, Worldwide Regulatory Strategy, Pfizer Inc

    Andrew Rankin

    Vice President, Emerging Pharmaceuticals, Prescient Life Sciences (Former Head of Clinical Development, Teva)
    Andrew Rankin

    Ashleigh Wake

    Biotechnology Program Manager, Intertek Pharmaceutical Services Manch
    Ashleigh Wake

    Brian Lovatt

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

    Christopher Stothers

    Partner, Arnold and Porter
    Christopher Stothers

    David Szymkowski

    Senior Director, Biotherapeutics, Xencor
    David Szymkowski

    Ezogelin Oflazoglu

    Executive Director, Sr. Project Leader MBV Biologics PPM, Merck Research Laboratories
    Ezogelin Oflazoglu

    Harvinder Popli

    Director and Head In-Licensing, Ranbaxy
    Harvinder Popli

    Heinz Haenel

    Senior Project Director, Sanofi-Aventis
    Heinz Haenel

    Judith Macdonald

    Director, Worldwide Regulatory Strategy, Pfizer Inc
    Judith Macdonald

    Lincoln Tsang

    Partner, Arnold and Porter
    Lincoln Tsang

    Marite Ode

    Clinical Development Manager, Sandoz
    Marite Ode

    Nicola Travierso

    General Manager, ntc pharma
    Nicola Travierso

    Paul Greenland

    Director of Biosimilar Marketing, Hospira UK Limited
    Paul Greenland

    Peter Wittner

    Senior Consultant, Interpharm Consultancy
    Peter Wittner

    Richard Dicicco

    Chairman, Harvest Moon Pharmaceuticals
    Richard Dicicco

    Sandy Eisen

    Previously Chief Medical Officer, Teva Pharmaceuticals Europe from March 2006 to March 2011, Frontline Pharma Consulting Ltd
    Sandy Eisen

    Steve Brocchini

    CSO , PolyTherics Ltd.
    Steve		 Brocchini

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    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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