Home
overview

SMi are proud to introduce their fourth annual Biosimilars & Biobetters conference due to met on the 1 & 2 October 2013 in London. This conference aims to build on the progress made in the previous extremely successful meetings; further developing the ideas and strategies that have been made over the past twelve months.


Biological therapeutics promises to be a radical step forward for many pharmaceutical companies pipelines; patent expiry dates are playing an important role in why many pharma companies are pushing for innovative steps to be taken in this field. Following on from our huge 2012 event, we aim to bring together pharma, biotech, CROs with regulatory bodies and legal experts to explain the advantages and disadvantages of a hugely lucrative but young market.
 

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.

  • Discover guidelines issues by regulatory bodies such as the FDA & EMEA and how they impact your business model
  • Understand market access pathways and see case studies on successful products
  • Hear from the development process from pre-clinical focus from pharma doing the research
  • Learn from expert legal opinions on intellectual property and patent protection programmes
  • Evaluate global research co-operation producing blockbuster Biosimilars
  • Develop clinical plan for biosimilar and biobetter drug design for your clinical trial - When is the right time to proceed
  • Intellectual Property
  • Legislation and Policy Advice
  • Business Development
  • Licensing
  • Manufacturing
  • APIs
  • Bioequivalence
  • Drug and Safety Assessment
  • Market Strategy
  • Regulatory Affairs

 

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 A clinical pharmacologist’s view of Biosimilars

Malcolm Mitchell

Malcolm Mitchell, Director, BioPharmaceuticals, Eli Lilly & Co

  • PK and/or PD
  • Population to Study
  • Design of Study
  • 3-way comparison-a need too far
  • 9:50 Biosimilar guidelines in the USA: Why industry has not yet filed a 351k

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

  • Summary of the USA Law
  • FDA’s non-legal barriers for filing a 351k
  • Deficiencies of the FDA Published Guidelines
  • FDA’s Scientific Advice
  • Best strategies to avoid the pathway and still be reimbursed by payers with physician and patients’ acceptance
  • 10:30 Morning Coffee

    11:00 Pfizer Biosimilars Update: Where are we? What does the future hold?

    Josh Adelson

    Josh Adelson, Director, Commercial Development, Business Development Biosimilars, Pfizer

    11:40 Biosimilars: naming, substitution and interchangeability

    Rodeina Challand

    Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs,, PRA International

  • Naming and traceability
  • Pharmacovigilance considerations
  • Current status with substitution and Interchangeability
  • Regulatory framework
  • US state Biosimilar bills
  • Study designs: can it be done?
  • 12:20 Networking Lunch

    13:50 How to encourage physicians and patients to use biosimilars

    Steinar Madsen

    Steinar Madsen, Medical Director, Norwegian Medicines Agency

  • Physicians and patients views on biosimilars
  • Which information is needed?
  • Who will decide?
  • 14:30 Biotech patenting and litigation

    Thomas Klein

    Thomas Klein, European and Swiss Patent Attorney, Roche

  • Patenting strategies for biotech molecules
  • Litigation strategies, in particular in emerging markets
  • Case study
  • 15:10 BioSuperiors: an alternative concept between NBEs and Biosimilars

    Franzpeter Bracht

    Franzpeter Bracht, Chief Financial & Business Officer, Glycotope GmbH

  • Difference between Biobetters and BioSuperiors: Biosuperiors have to show a significant clinical benefit
  • BioSuperiors: Better in regard to cost x risk vs. potential reward compared to NBEs as well as BioSimilars
  • Example for a BioSuperior already at the market and based on glycooptimisation: Aranesp™
  • Example from Glycotopes Pipeline: CetuGEX ™
  • 15:40 Afternoon Tea

    16:10 Avoiding injunctions in biologics patent litigation

    Christopher Stothers

    Christopher Stothers, Partner, Arnold and Porter

    Compulsory licences?
    Ethical or public health imperatives?
    Competition law?
    Strategic litigation

    16:50 UK patent litigation on biologics

    Dominic Adair

    Dominic Adair, Senior Associate, Bristows

  • An overview of recent cases, including MedImmune v Novartis and Lilly v HGS
  • The litigation pitfalls of broad claim drafting
  • Issues surrounding SPCs
  • Predictions for litigation involving biosimilars
  • 17:30 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 Linking performance to strategy in the pharmaceutical emerging markets

    Yahia Elsadek

    Yahia Elsadek, Consultant , Elsadek Consulting

  • Measuring tangible or intangible assets
  • Limitations of relying only on financial measures
  • Characteristics of a good PMS
  • The emergence of the BSC
  • Linking multiple scorecard measures to a single strategy
  • Experience with BSC implementation
  • Key success  factors for the BSC implementation
  • 9:50 Biosimilars: an analysis of EU product approvals

    Gary Walsh

    Gary Walsh, Professor Industrial Biochemistry, University Of Limerick

  • Sourced primarily from regulatory documentation, this work analyzes in detail the regulatory data that underpinned the approval of authorized biosimilars in the EU
  • The data is contextualized in terms of biosimilar guidelines
  • The duration of regulatory consideration of biosimilar applications to those of additional biopharmaceutical applications received within the same timeframe is compared.
  • Likely further developments in EU biosimilar regulatory policy is considered
  • 10:30 Morning Coffee

    11:00 Sustained delivery: A Simple Route to BioBetter

    Paul Ashton

    Paul Ashton, President & CEO, pSivida

  • Controlled Delivery
  • Bioerodible
  • Simple Formulation
  • 11:40 Speeding map to clinic: A predetermined mab process template for your biosimilar

    Jennifer Campbell

    Jennifer Campbell, Director World Wide Biosimilars Program, Merck Millipore

  • Predefined process parameters in a mab template
  • Minimising process design
  • Ensuring process robustness
  • Case study: Down stream process development
  • 12:20 EU Legal developments and strategies for Biosimilars

    Liz Fuller

    Liz Fuller, Partner, Bird & Bird

  • EU legislation framework and case law
  • Key questions and strategic issues
  • Looking into the future: upcoming developments, revision of the guidelines and next steps
  • 13:00 Networking Lunch

    14:00 Market Access issues for Biosimilars

    Brian Lovatt

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

  • Pricing and Reimbursement
  • Health Technology Assessment
  • Guidelines Listing
  • Prescriber Preference
  • 14:40 Follow-On Biologics : Differences (& Similarities!) between BioSimilars and BioBetters - A Regulatory Perspective.

    Amanda Gibbons

    Amanda Gibbons, Director, Voisin Consulting Life Sciences

  • Present real-case examples of biobetters currently in development
  • Discuss what differentiates biobetters from biosimilars and also highlight some similarities
  • Envisage potential developments in the definition of a regulatory framework for biobetters
  • 15:20 Afternoon Tea

    15:40 Assessing the needs of biosimilars and biobetters from a regulatory perspective

    Isabel Zwart

    Isabel Zwart, Senior Consultant, Parexel International

  • The differences in regulatory pathways for biosimilars and biobetters
  • How similar is similar? Do minor product modifications negate the biosimilar paradigm?
  • Can reduced development programs support the approval of biobetters?
  • What options exist for biobetters, and what are the likely regulatory implications?
  • 16:20 Key factors in the generating of anti-drug antibody responses including the importance of T cell help

    Matthew Baker

    Matthew Baker, CEO & CSO, Antitope

  • Data showing the benefits of assessing drug immunogenicity by measuring induction of CD4+ T cell responses
  • Comparison of innovator and biosimilar products for the capacity to induce T cell responses in vitro
  • CMC related factors that can modulate T cell activation
  • 17:00 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Josh Adelson

    Josh Adelson

    Director, Commercial Development, Business Development Biosimilars, Pfizer
    Thomas Klein

    Thomas Klein

    European and Swiss Patent Attorney, Roche

    Amanda Gibbons

    Director, Voisin Consulting Life Sciences
    Amanda Gibbons

    Brian Lovatt

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

    Christopher Stothers

    Partner, Arnold and Porter
    Christopher Stothers

    Dominic Adair

    Senior Associate, Bristows
    Dominic Adair

    Franzpeter Bracht

    Chief Financial & Business Officer, Glycotope GmbH
    Franzpeter Bracht

    Gary Walsh

    Professor Industrial Biochemistry, University Of Limerick
    Gary Walsh

    Isabel Zwart

    Senior Consultant, Parexel International
    Isabel Zwart

    Jennifer Campbell

    Director World Wide Biosimilars Program, Merck Millipore
    Jennifer Campbell

    Josh Adelson

    Director, Commercial Development, Business Development Biosimilars, Pfizer
    Josh Adelson

    Liz Fuller

    Partner, Bird & Bird
    Liz Fuller

    Malcolm Mitchell

    Director, BioPharmaceuticals, Eli Lilly & Co
    Malcolm Mitchell

    Matthew Baker

    CEO & CSO, Antitope
    Matthew Baker

    Paul Ashton

    President & CEO, pSivida
    Paul Ashton

    Richard Dicicco

    Chairman, Harvest Moon Pharmaceuticals
    Richard Dicicco

    Rodeina Challand

    Executive Director, Biosimilars Development, Scientific Affairs,, PRA International
    Rodeina Challand

    Steinar Madsen

    Medical Director, Norwegian Medicines Agency
    Steinar Madsen

    Thomas Klein

    European and Swiss Patent Attorney, Roche
    Thomas Klein

    Yahia Elsadek

    Consultant , Elsadek Consulting
    Yahia Elsadek

    Workshops

    Biosimilars, the commercial reality
    Workshop

    Biosimilars, the commercial reality

    Marriott Regents Park
    3rd October 2013
    London, United Kingdom

    Marriott Regents Park

    128 King Henry's Road
    London NW3 3ST
    United Kingdom

    Marriott Regents Park

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.