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 Syringe and biosimilar drug

SMi Presents their 2nd annual conference on...

Biosimilars and Biobetters:

Aligning business & science for success

About the conference:

Following the success of our inaugural event, SMi’s second Biosimilars and Biobetters conference shall build upon the progress made in last year’s meeting and  further develop the ideas and strategies that were debated and discussed. Specifically, how can the pharma and generics industries best approach the rapidly emerging and developing biosimilar market? How are policy makers shaping the contours of this new generic frontier, and what implications to they have for current biologic drug development and patent protection?


With billions of dollars worth of biologic drugs going off patent in the next decade, this industry in set to expand at an intensive rate, and the importance of being fully informed of how you and your business will be affected is paramount. By the same token, the rewards of playing an important role in the development of biosimilars, or “Follow On Biologics”, are potentially substantial.

At this conference you can expect to learn about a comprehensive range of pivotal issues in this area, not just relating to the development of the US regulatory pathway and the early steps of the EMA, but also the scientific developmental agenda of major players in the fledgling industry, the unique and exiting position of mAbs in this new arena, how Biobetters and Biosuperiors could challenge second generation biologics, and analysis of global biosimilars pricings structure.

Presented by leading industry figures and stakeholders, this event is an unmissable opportunity to gather vital information and contacts to work towards an optimal position in the biosimilars market.

 | Register Your Place |

Key Topics Addressed:

  • The developing regulatory framework in advanced and developing markets
  • The specific commercial, legal and scientific development of monoclonal antibodies
  • Differentiated biosimilars: Debating their true value and potential
  • Critical issues in demonstrating biosimilarity and maintaining diligent quality control
  • Opportunities to drive a long term commercial strategy
  • CMC in biosimilar development

Interested in speaking at the conference?  Contact the Conference Producer.

For sponsorship and exhibition opportunities, Contact our Sponsorship Department.

 

 

Testimonials from last year:

“Great conference, right size and mix of people” - Senior manager, Biogen Idec

“Very well organised, excellent time keeping [...] excellent choice of topic covered” - Patent Editor, IMS Health

 

Who is chairing this event?

Day One

Alan Sheppard

Global Head Generics, Thought Leadership

IMS Health

Day Two

Richard DiCicco

Chairman

Harvest Moon Pharmaceuticals

 

Who is speaking at this event?

 

 

  • Peter De Veene, Deputy European Qualified Person for Pharmacovigilance Roche
  • Anne Dollard Deputy, General Counsel and Chief Patent Counsel, Takeda
  • Ross Lobell, Vice President Regulatory Affairs, MedImmune
  • Anita Varma, Partner, Ropes and Gray
  • Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals
  • Camilla Balleny, Partner, Pinsent Masons LLP
  • Christopher Stothers, Counsel, Intellectual Property & Antitrust Litigation, Arnold & Porter (UK) LLP
  • Harvinder Popli Director and Head In- Licensing Ranbaxy Labs
  • Jean-Yves le Cotonnec Managing Partner, Founder & CEO TRISKEL Integrated Services S.A.
  • Elisabeth Berthet Lawyer at the Paris Bar Armengaud-Guerlain
  • Louis-Christian Clauss Senior Consultant  Health Care Atheln Biomed
  • Frank Scappaticci Associate Group Medical Director Genentech
  • Alan Sheppard Global Head Generics, Thought Leadership IMS Health
  • Richard Littlewood Founding Partner Applied Strategic LLP
  • Carsten Brockmeyer MD Brockmeyer Biopharma
  • Hans-Martin Mueller Associate Director, Biotech Development Merck

 

CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:

 

  • Analytics
  • Business Development
  • Business Strategy
  • Corporate Development Strategy
  • Commercial Affairs
  • Intellectual Property
  • Marketing & Sales
  • Medical Affairs
  • New Product Development
  • Legal Affairs
  • CMC

 

  • Preclinical and Clinical Development
  • Product Development
  • Regulatory Affairs
  • Pricing and Reimbursement
  • Research and Development
  • Biologic Production
  • Quality Assurance
  • Scientific Affairs
  • Strategic Planning
  • Strategic Sourcing

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 The market for biosimilars: unravelling the mystery

Alan Sheppard

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

  • Although the biosimilars launched to date have started to gain market share this is variable by molecule and country.
  • Is it the molecule or the country which will decide success?
  • Will it be payer or prescriber who has the final say?
  • 9:40 The EMA scientific advice compared with EMA guidelines

  • Conclusions from the EMA biosimilars mAb guideline text
  • How the guidelines can differ from scientific advice
  • Possible future mAb guidelines
  • How to achieve the best dossier from scientific advice
  • Sandy Eisen

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

    10:30 Morning Coffee

    11:00 Industry interpretation the new guideline on biosimilar mAbs

  • Overview of the new mAb biosimilar guideline
  • What scientific advice can we expect from the EMA following the guideline release?
  • Clinical requirements with examples for some well known mAbs
  • What to expect in term of Statistical requirements?
  • Size of patients population to be recruited
  • A look into clinical and non-clinical concerns surrounding the guideline
  • Cost of development and timelines
  • What this regulation will mean for industry, and more specially, for the European Biosimilar market
  • Louis-Christian Clauss

    Louis-Christian Clauss , Senior Consultant Health Care, Atheln Biomed

    11:40 Next generation monoclonal antibody development and clinical challenges with biosimilar drug development

    Frank Scappaticci

    Frank Scappaticci, Associate Group Medical Director, Genentech

  • The advancement of Monoclonal antibody technology and the enhancement of oncologic disease therapy by next generation antibody drugs
  • Promising early clinical studies and growing interest
  • The clinical challenges in the biosimilar drug development: manufacturing, preclinical testing, and clinical trial implementation
  • 12:20 Networking Lunch

    13:30 EU litigation considerations and update

  • Litigation strategy in the EU including an update on the proposed European Patents Court
  • Settlements and overview of the impact of the Pharmaceutical Sector Inquiry
  • Need for regulatory and patent coordination and an update on SPC issues
  • Recent case law relating to biotech products
  • Christopher Stothers

    Christopher Stothers, Counsel, Arnold and Porter (UK) LLP

    Camilla Balleny

    Camilla Balleny, Partner, Pinsent Masons

    14:10 The Ins And Outs Of The Biosimilar Regulatory Pathway

    Anita Varma

    Anita Varma, Partner, Ropes & Gray

  • An overview of the statutory framework
  • An overview of the FDA hearings to implement the Abbreviated Biologics Pathway
  • Some considerations:
  • Prosecution strategy in view of the legislation
  • Licensing considerations in view of the legislation
  • Diligencing your portfolio to get ready for a biosimilars challenge
  • 14:50 The developing biosimilars regulatory framework in the U.S.

    Ross Lobell

    Ross Lobell, Vice President, Regulatory Affairs, Medimmune

  • Current status – Developments since March 2010
  • The exclusivity debate
  • FDA guidance
  • Data requirements & exclusivity periods
  • 15:30 Afternoon Tea

    15:50 US patent issues in biosimilars

    Anne Dollard

    Anne Dollard, Chief Patent Counsel, Deputy General Counsel, Takeda Pharmaceuticals

  • What strategies are innovator companies using to extend exclusivity and fend off competition?
  • Revaluating technology in-licensed from universities and Strategic alliances with companies
  • Considering where to file suit and conduct a jurisdictional analysis
  • The FDA’s guidelines for biosimilars
  • Anti-competitive and unfair methods of competition, including patent settlements, and patent pools
  • 16:10 Biosimilars: patent protection issues

  • Why biotech patents are difficult to enforce?
  • Could biotech patents be easier circumvented compared to chemical product patents?
  • Biotech product and SPC : how to define a “biotech product" and how to apply the  “one SPC per product” rule?
  • What about the USA legislation on follow-on biologics (“FOBs”)?
  • Elisabeth Berthet-Maillols

    Elisabeth Berthet-Maillols, Lawyer at the Paris Bar, Armengaud-Guerlain

    16:50 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 Maintaining a consistent quality standard of Biosimilars

    Jean-Yves le Cotonnec

    Jean-Yves le Cotonnec, Managing Director, TRISKEL Integrated Services S.A

  • Detection and data analysis for immunogenicity of biopharmaceutical products
  • Strategy and development
  • Demonstrating comparability to regulators
  • Future considerations
  • 9:50 From Imitation to Innovation – Biosimilars are not Generics

    Carsten Brockmeyer

    Carsten Brockmeyer, Founder, Brockmeyer Biopharma GmbH

  • The future of the global biosimilar market
  • From differentiated Biosimilars to Biobetters
  • Successful development plans for Biosimilars, enhanced Biosimilars, and Biobetters
  • What are the must consider elements to any biosimilar development plan
  • Critical difference in the development for a Biosimilar, enhanced Biosimilar, and Biobetter
  • Manufacturing and Capacity Considerations for Biosimilars
  • Will there be enough capacity?
  • Can there be a global supply for a global market?
  • How much can modern biomanufacturing contribute to reduced costs?
  • 10:30 Morning Coffee

    11:00 Making things last longer for less

  • What makes a biobetter?
  • Classical biologics versus antibody molecules
  • How can biobetters be really better?
  • Use of modern biotech versus classical products
  • Making things better for the patient
  • Jeff Edwards

    Jeff Edwards, Director of Alliance Management, PolyTherics Ltd.

    11:40 Pharmacovigilance & biosimilar monoclonal antibodies: practical considerations

    Peter De Veene

    Peter De Veene, EU Qualified Person for Pharmacovigilance, Roche

  • Why are monoclonal antibodies different?
  • Substitution and interchangeability: potential effects on PV
  • Extrapolation and labelling: how to ensure that patients and prescribers get the right information?
  • 12:20 Networking Lunch

    13:30 Factors to be considered for Biosimilar CMC development

    Hans-Martin Mueller

    Hans-Martin Mueller, Associate Director, Biotech Development, Merck

  • Reference characterisation
  • Importance of comparability - how similar is similar?
  • Factors introducing unpredictability
  • 14:10 Biosimilar sales forecast in seven unregulated markets in 2016: How large is the opportunity?

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

  • Current biosimilar sales in the emerging markets of Brazil, Russia, India, China, South Korea, Turkey and Mexico (BRICKTM)
  • Issues for growth: regulatory requirements; protectionism; MNC competition
  • Future emerging markets (BRICKTM): dominant players, biosimilars in rural areas, and how the market size will change in 2016
  • 14:50 Chairman’s Closing Remarks and Close of Day Two

    15:00 Afternoon Tea

    +

    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.

     

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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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