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DOWNLOAD A BROCHURE FOR A DETAILED AGENDA AND FULL SPEAKER LINE-UP FEATURING:

BOEHRINGER INGELHEIM, CELLTRION HEALTHCARE, QUINTILESIMS, MERCK GROUP, NORWEGIAN MEDICINES AGENCY, TEVA PHARMACEUTICALS, GEDEON RICHTER + MORE!


SMi Group are thrilled to present the 2017 8th annual conference on Biosimilars & Biobetters taking place on 27th & 28th September in Central London, UK.

As the patents for several innovator biologics expire, biopharmaceutical companies are taking the opportunity to develop more affordable forms creating a rapidly booming biosimilars market. However, as the field of biosimilars evolves, challenges in immunogenicity studies, securing market share, exclusivity and regulations still persist.

Join us this autumn to arm yourself with the key requirements and tools for successful market entry through strategic direction on commercialisation; insight into potential therapeutic areas; and critical updates on interchangeability guidelines and patient litigation.

A must attend for principle scientists and regulatory experts involved in biotechnology, market access and compliance, Biosimilars & Biobetters 2017 will capture expert insight by honing in on current market trends through to emerging opportunities and global developments.
 

http://bit.ly/2nP31Ut

  • Gain an overview of the latest developments in regulation to increase speed of entry and compliance through informed guidance on interchangeability laws, patient litigation and IP rules
  • Develop strategies for market access and expansion by identifying key changes and future projections in biosimilars
  • Evolve clinical developments through insight into orphan drugs, in-vitro functional assays and data extrapolation
  • Create a competitive edge through understanding the multifaceted field of "switching studies"
  • Hear case studies on biosimilars drug development from pre-clinical to clinical and the various testing required such as immunogenicity and bio-similarity tests
  • Discuss challenges and potential solutions in exclusivity and HCP acceptance
  • Get unique coverage of biobetters from companies specialising in this field


 

Job titles include:
CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, from the following roles:
-Biopharmaceuticals/ Biotherapeutics
-Follow on Biologics/Follow on Proteins/Biosimilars
-Biologics/Biotechnology/ Biogenerics
-Legal and Regulatory Affairs
-Intellectual Property
-Pricing and Reimbursement
-Clinical operations
-Regulatory Compliance
-Pharmacovigilance
- Drug Safety & Risk Management
-Quality Affairs/ Quality Control
-Drug Development
-Research & Development
-Portfolio Management
-Business Development
-Commercial Affairs and Strategic Planning

 

3SBio Pharmaceutical Group; Abzena; Anteris Medical GmbH; Austrian Agency for Health and Food Safety; Ayva Pharma; Biogen; Boehringer Ingelheim; Boehringer-Ingelheim ; Bristows LLC; Daiichi Sankyo; Envirotainer AB; F. Hoffmann-La Roche; Genmab; GlaxoSmithKline; Health Products Regulatory Authority; IMS Health; IMS Health UK; Libbs FarmacÛutica; LIFESCIENCES; Louise Leong ABPI; Lupin Limited; mAbxience; medac GmbH; Merck Group; Merck Serono; Mylan BGP Pharma Hellas ; Napp Pharmaceuticals Limitedá; Napp Pharmaceuticals Ltd; Norwegian Medicines Agency; Orygen Biotecnoloiga S/A; Pharma Circle; RJW & Partners Ltd; Samsung BioLogics; Sandoz International GmBH; Sanofi-Aventis; Sartorius Stedim BioOutsource; Schwegman Lundberg Woessner;

Conference programme

8:30 Registration & Coffee

9:00 Chairs' Opening Remarks

Michel  Mikhail

Michel Mikhail, International Expert in Biosimilars and Global Regulatory Affairs, Independent Consultant

Louis Boon

Louis Boon, Chief Scientific Officer, Bioceros

9:10 10 years of biosimilar experience in Europe – barriers and opportunities in a multi-stakeholder environment

Matthew  Turner

Matthew Turner, Global Medical Director Biosimilars, Merck Group

  • How biologics have transformed treatment options for patients suffering an array of disease from renal failure, to oncology
  • Biosimilars on the market over the last the last 10 years, patient access and affordability in emerging markets
  • skepticism amongst clinical professionals and concerns on cost of development versus price erosion
     
  • 9:50 Biosimilars - the second wave

    Sarah Rickwood

    Sarah Rickwood, Vice President, Head of European of Thought Leadership , QuintilesIMS

  • The use of biologics in Europe
  • Biosimilars in review
  • A European overview of present status of biosimilars
  • Current market analyses
  • Conclusions
     
  • 10:30 Morning Coffee

    11:00 First Biosimilar Approval in Osteoporosis

    Ildiko Aradi

    Ildiko Aradi, Head, Clinical Development of Biologics, Gedeon Richter

  • Key development steps for biosimilar teriparatide
  • Medical device aspects
  • Clinical development programme challenges of biosimilar teriparatide
  • Market access challenges
     
  • 11:40 The biosimilar business case

    Thomas  Sachnik

    Thomas Sachnik, Sr Manager Strategic Associate to the President & CEO Generics Europe , Teva Pharma BV

  • The profitability of the biosimilar business and its sustainability remains a major question mark for the corporate decision makers in pharma
  • The past has shown a variety of partnerships in the field driven by a high degree of uncertainty of the business model of biosimilars – While investments are high and returns uncertain, risk is shared by partnerships and collaborations along the entire value chain of biosimilars
  • Comparing the biosimilar waves, how will the business case change and how did and will the competitive landscape evolve?
     
  • 12:20 Networking Lunch

    13:30 Latest developments in strategies to bring biosimilars to the market

    Richard  Peck

    Richard Peck , Vice President Regulatory Affairs, Lupin (Europe)

  • Challenges and opportunities faced by manufacturers in developing biosimilars
  • How to overcome challenges, increase development success and optimise results
  • Techniques in bringing the next generation biosimilars to the market
  • Ensuring market share: product differentiation
  • 14:10 Round Table: China's biosimilars guideline and EU requirements

    Michel  Mikhail

    Michel Mikhail, International Expert in Biosimilars and Global Regulatory Affairs, Independent Consultant

    The Round Table will invite the panel of distinguished speakers to address the following topics:

  • China's biosimilars Guidelines: 2 years after - sharing experience from and with the audience
  • EU relaxing requirements: Introduction of global reference products in the overarching guidelines, 3R and reducing animal data, extrapolation of indications
  • Norswitch study and interchangeability vs US-Draft guidance on interchangeability and requirement for 3 times switch study.
     
  • 14:50 Afternoon Tea

    15:20 Modern biosimilar analytical methods

    Harish  Pai

    Harish Pai, Principal Scientific Manager, Biocon

  • Functional characterization is an area of immense importance
  • In-vitro methods need to be sensitive enough to pick up the differences in biosimilar assessment
  • Establishing totality of evidence based on the mechanism of action
  • Use of in-vitro functional assays for extrapolation of clinical indication
     
  • 16:00 Designing affordability: A cost by design approach to develop biosimilars

    Harish  Shandilya

    Harish Shandilya, Head, Global Product Development and Regulatory Affairs, Enzene Biosciences

  • Pragmatic approach for Biosimilars development
  • CQA based approach to define product, don’t worry about Non-CQAs. Define range by analyzing various lots of RMP and biosimilar
  • Adopting newer technologies: Continuous manufacturing - Eco Friendly manufacturing with reduced facility foot print/energy consumption
     
  • 16:40 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairs' Opening Remarks

    Michel  Mikhail

    Michel Mikhail, International Expert in Biosimilars and Global Regulatory Affairs, Independent Consultant

    Louis Boon

    Louis Boon, Chief Scientific Officer, Bioceros

    9:10 Celltrion Healthcare case study: evidence-based approach to meet the expectations of different stakeholders

    HoUng Kim

    HoUng Kim, Division Head Strategy and Operations, Celltrion Healthcare

  • The Challenges Gaining Approval
  • The perception shift from negative to positive based on clinical evidence
  • Stringent standard criteria to demonstrate biosimilarity leading to CT-P13 and CT-P10 EMA approval
  • Publishing Data on Clinical Studies
  • ARD requirement on sensitivity analysis
  • Successfully demonstrated similar response rate regardless of different statistical approaches
  • Future Landscape of Biosimilars
  • Patent expiry expected for top selling biologics within 2020
  • The tremendous expansion expected in biosimilar industry: the market expected to reach $60 Billion
  • Commitment towards personalised and convenient treatment via ADA kit and SC type of CT-P13
     

     

  • 9:50 FDA Interchangeability guideline: what does it mean to the industry?

    Rodeina Challand

    Rodeina Challand, Director, Challand Biosimilar Consulting

  • The importance of interchangeability: Patients and healthcare professionals
  • FDA Guidance on gaining interchangeable biosimilar approval - scope
  • Designing switching studies, choosing reference products and monitoring immune responses
  • Regulatory and operational challenges
  • Rest of the world status
  • 10:30 Morning Coffee

    11:00 Clinical data extrapolation in biosimilars development

    Bernd Liedert

    Bernd Liedert, Senior Clinical Program Leader Biosimilars, Boehringer Ingelheim

  • Across indications in immunology: Known, plausible and hypothetical modes of action
  • From metastatic to adjuvant: Across disease stages in oncology
  • Extrapolation of PK, immunogenicity and safety
  • The AIID community, anti-TNF biosimilars and extrapolation
  • Interchangeability by extrapolation
  • 11:40 When the market wants BioBetters – developing the next generation Anti-Neutropenic Factor

    Glenn Kazo

    Glenn Kazo, President, Prolong Pharmaceuticals

  • Neulasta is one of the most desirable targets for biosimilar development
  • Ongoing technical and market challenges to biosimilar versions of Neulasta 
  • A new paradigm—preventing neutropenia vs treating the condition
  • Commercial approach to developing ANF-RhoTM.
     
  • 12:20 Networking Lunch

    13:30 From biosimilars to biogenerics

    Steinar Madsen

    Steinar Madsen, Medical Director, Norwegian Medicines Agency

  • Attitudes and acceptance in clinical practice
  • Uptake in clinical practice
  • Nor-Switch study and other clinical trials
  • Switching and interchangeability
  • 14:10 SPOT and process modulation technology to reduce cost of goods (COGs) for biosimilar development

    Louis Boon

    Louis Boon, Chief Scientific Officer, Bioceros

  • Specific productivity increase by SPOT
  • Process modulation to meet CQAs
  • Costs of Goods reduction
  • Custom bio-assays
     
  • 14:50 Afternoon Tea

    15:20 When push comes to push back…Australia and the flaw in payer-driven substitution

    Stephen  Murby

    Stephen Murby, International Advisory Board Member, Alliance for Safe Biologic Medicines

  • Just as biologics are not chemicals so there is a need for new business models for biosimilars
  • Substitution of biosimilars is not the same as supervised clinical switching
  • Biosimilar pharmas & payers underestimate patients, prescribers and pharmacists at their risk
  • The key to access is confidence not cost
     
  • 16:00 Expiring patents- court cases and how these are developing

    Dominic Adair

    Dominic Adair, Partner, Bristows LLC

  • Expenses involved in development and whether these can be recovered in the current UK market
  • Overview of current IP laws in biosimilars and developments in patent expiry
  • Launching case against a biosimilar company
  • Case study of Abbvie vs Fujifilm- what might this mean for future litigation cases?
     
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Bernd Liedert

    Bernd Liedert

    Senior Clinical Program Leader Biosimilars, Boehringer Ingelheim
    Harish  Pai

    Harish Pai

    Principal Scientific Manager, Biocon
    HoUng Kim

    HoUng Kim

    Division Head Strategy and Operations, Celltrion Healthcare
    Ildiko Aradi

    Ildiko Aradi

    Head, Clinical Development of Biologics, Gedeon Richter
    Louis Boon

    Louis Boon

    Chief Scientific Officer, Bioceros
    Matthew  Turner

    Matthew Turner

    Global Medical Director Biosimilars, Merck Group
    Stephen  Murby

    Stephen Murby

    International Advisory Board Member, Alliance for Safe Biologic Medicines
    Thomas  Sachnik

    Thomas Sachnik

    Sr Manager Strategic Associate to the President & CEO Generics Europe , Teva Pharma BV

    Bernd Liedert

    Senior Clinical Program Leader Biosimilars, Boehringer Ingelheim
    Bernd Liedert

    Chris Teale

    Vice President Europe, GfK HealthCare
    Chris Teale

    Dominic Adair

    Partner, Bristows LLC
    Dominic Adair

    Glenn Kazo

    President, Prolong Pharmaceuticals
    Glenn Kazo

    Harish Pai

    Principal Scientific Manager, Biocon
    Harish  Pai

    Harish Shandilya

    Head, Global Product Development and Regulatory Affairs, Enzene Biosciences
    Harish  Shandilya

    HoUng Kim

    Division Head Strategy and Operations, Celltrion Healthcare
    HoUng Kim

    Ildiko Aradi

    Head, Clinical Development of Biologics, Gedeon Richter
    Ildiko Aradi

    Louis Boon

    Chief Scientific Officer, Bioceros
    Louis Boon

    Matthew Turner

    Global Medical Director Biosimilars, Merck Group
    Matthew  Turner

    Michel Mikhail

    International Expert in Biosimilars and Global Regulatory Affairs, Independent Consultant
    Michel  Mikhail

    Richard Peck

    Vice President Regulatory Affairs, Lupin (Europe)
    Richard  Peck

    Rodeina Challand

    Director, Challand Biosimilar Consulting
    Rodeina Challand

    Sarah Rickwood

    Vice President, Head of European of Thought Leadership , QuintilesIMS
    Sarah Rickwood

    Steinar Madsen

    Medical Director, Norwegian Medicines Agency
    Steinar Madsen

    Stephen Murby

    International Advisory Board Member, Alliance for Safe Biologic Medicines
    Stephen  Murby

    Thomas Sachnik

    Sr Manager Strategic Associate to the President & CEO Generics Europe , Teva Pharma BV
    Thomas  Sachnik

    Official Media Partner

    Official Online Media Partners

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    Workshops

    Establishing winning commercial strategies in markets where biosimilars are entering
    Workshop

    Establishing winning commercial strategies in markets where biosimilars are entering

    Holiday Inn Kensington Forum
    26th September 2017
    London, United Kingdom

    VENUE

    Holiday Inn Kensington Forum

    97 Cromwell Road , London, United Kingdom

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    HOTEL BOOKING FORM

    An Interview with Prolong Pharmaceuticals

    Download

    New Interview with Celltrion Healthcare Ahead of Biosimilars 2017

    Download

    Bioceros Q&A | An Interview with CSO and Founder, Dr Louis Boon

    Download

    Media Partners


    Generics Bulletin

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    Generics bulletin provides its subscribers with up-to-date commercial intelligence about business opportunities in the global generic medicines and biosimilars markets. Accurate and reliable news reports reveal the strategies of the world’s leading generics companies and analyse their business performance, plans and product portfolios. Patent and pricing issues, regulatory changes, government initiatives, market opportunities and industry consolidation provide the wider context for Generics bulletin’s comprehensive industry coverage. With subscribers in nearly 60 countries, Generics bulletin is read by senior executives in all of the world’s leading generics companies, as well as by industry watchers and those supplying active ingredients, goods and services to the global generic and biosimilar medicines industries.


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    Generics and Biosimilars Initiative (GaBI) was founded in 2008. GaBI aims to foster the worldwide efficient use of high quality and safe medicines at an affordable price, thus advancing and supporting the idea of accessible, affordable and sustainable health care. The objective of GaBI is to raise the scientific status of generic and biosimilar medicines, via well-documented and up-to-date information about generic and biosimilar medicines both in print (www.gabi-journal.net) and electronically (www.gabionline.net) in an open access format, providing high quality, scientifically sound and reliable information to healthcare professionals including physicians, pharmacists and nurses, consumers, drug developers, third-party payers, legislators and assessors; who are in need of a reliable, critical and independent source of information on all aspects of generic and biosimilar medicines. Subscribe to gain easy access of information on the latest scientific research and developments in generic and biosimilar medicines via GaBI Online to editorial@gabionline.net; or submit a manuscript to GaBI Journal to editorial@gabi-journal.net. GaBI’s mission – Building trust in cost-effective treatments


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    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

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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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    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




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