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Building on previous success, SMi proudly announces the return of 3rd Annual Biosimilars USA  conference to New Jersey in November 2016!

It's without doubts that the biosimilars market present lucrative opportunities for pharmaceuticals and biotech companies. Over the last 12 months, market participants have witnessed revolutionary steps in the US to facilitate commercialization. While FDA has just announced the acceptance of Amgen's Biologics License Application (BLA) for ABP 501*, Biocon** is also set to seek US FDA approval which the addressable market is worth more than $30 billion.

It's now time for industry colleagues to act, and to act fast to seize such opportunities. The 3rd A nnual Biosimilars USA meeting will update you with the latest market developments and regulatory updates to ensure you stay at the forefront of this evolving market! 

*http://prn.to/1Xt0ECL

**http://bit.ly/2455uuv

Join us today  to:

  • Hear latest regulatory updates for smooth and speedy  approval
  • Learn successful biosimilar case studies to reshape your business model
  • Dissect regional market growth opportunities - where should you go next ?
  • Network with like-minded senior experts and engage in interactive debates

 

CEOs, Chiefs, VPs, Directors, Principals, Heads, Managers of:

  • Biosimilars/ Biobetters
  • Portfolio Management & Strategy
  • CSO
  • Alliance Management
  • Business Development
  • Regulatory Affairs
  • Commercial
  • Planning

or anyone working with Biosimilars and Biobetters from pharmaceutical, biotechs and solution providers.

Abzena, Alston & Bird LLP, Apobiologix, Austrian Agency for Health & Food Safety, Bespak, Bio Outsource, Boehringer Ingelheim Pharmaceuticals, Inc., Bristows, Dr. Reddy's Laboratories, Formycon AG, Genentech, Harvest Moon Pharmaceuticals, Hospira,  IMS Health Inc., Johnson & Johnson, Janssen, Medimmune, Merck, Merck Serono, Norwegian Medicines Agency, Oncobiologics, PAREXEL, Samsung Bioepis, Sandoz AG, Sandoz Inc., Schwegman Lundberg Woessner, Selecta Biosciences, STC Biologics Inc., Teva Pharmaceuticals, Wyatt Health Management and many more! 

Conference programme

8:00 Registration & Coffee

8:30 Chairman's Opening Remarks

Richard Dicicco

Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.

8:40 What to Expect? Regulatory Agency's Update on Biosimilars Application

Hillel Cohen

Hillel Cohen, Executive Director, Scientific Affairs, Sandoz Inc

  • Health authority perspectives on regulation of biosimilars (US, EU and other regions)
    > Totality of evidence
    > Data expectations
    > Naming
    > Labeling
    > Substitution and interchangeability
  • Extrapolation is a reality
  • Are immunogenicity concerns about biosimilars scientifically valid?
  • Can a company develop a single global biosimilar application?
  • 9:20 Regulatory Concerns for Interchangeability - Time to Define and Clarify

    Gustavo Grampp

    Gustavo Grampp, Director R&D Policy, Biosimilars, Amgen Inc.

  • What's in a name? Differentiating European and US terms and policies
  • What are the concerns? Medically-guided switching vs. pharmacy substitution
  • What's the standard? Survey of perspectives from policy makers and industry
  • What's next? Labelling, naming and pharmacy practice
  • 10:00 Put Aside Your Status as a Generic, Biosimilar, Innovator or Sponsor? How Can You Beat the Big Guys? (Part 1)

    Robin Chadwick

    Robin Chadwick, Principal, Schwegman Lundberg Woessner

    Albin James Nelson

    Albin James Nelson, Senior Shareholder, Schwegman Lundberg Woessner

  • Barriers to market
    > Difficulties and dead-ends of R&D to make a biological
    > Obtaining FDA/State/EP and/or Asian Governments' regulatory approval
    > Cost and patent considerations
  • How to overcome?
    > Search and identify patents early - prepare in advance of BPCIA
    > Thorough evaluation of cost of bioequivalent work vs new biological with full clinical data
    > Do not be a Lemming: Avoid running as a 'herd' off the edge of a cliff
  • 10:50 Morning Coffee & Networking Break

    11:20 Biosimilars – Lessons Learned in Europe

    Steinar Madsen

    Steinar Madsen, Medical Director, Norwegian Medicines Agency

  • What decides uptake in clinical practice?
  • From biosimilar to biogeneric?
  • The future of biosimilars?
  • 12:00 The Engineering Scenario for Biosimilar Antibodies in Brazil

    Andrew Simpson

    Andrew Simpson, Scientific Director, Orygen Biotechnologia S/A

  • Public sector vs. private sector
  • Local manufacturing
  • 12:40 Networking Lunch

    13:50 Overview of Biosimilars Industry in China

    Jianguo Yang

    Jianguo Yang, CEO, Abpro Corporation -- China

  • Globalization of biosimilar from China to the rest of the world
  • Biosimilar development trend in China
  • Challenges and opportunities in China
  • 14:30 Development of Biosimilars in South Korea

    Kevin Kyumin Lee

    Kevin Kyumin Lee, Partner, Kim & Chang

  • Overview and current trend of the biosimilars industry in Korea
  • Regulatory approval of biosimilars in Korea
  • Patent disputes related to biosimilars in Korea
  • 15:10 Afternoon Tea & Networking Break

    15:40 Why Successful Commercialization of Biosimilars is Important to Vizient

    L. Ross Day, R.Ph. D.P.

    L. Ross Day, R.Ph. D.P., Director of Pharmacy, Sourcing Operations, Vizient Inc.

  • What is Vizient and who do we represent (50% of the US Acute Care Hospitals and 25% of Non-Acute Providers)
  • The size of biological spend in Vizient hospitals and the potential impact for biosimilar price reductions
  • Vizient's efforts to educate providers (hospitals and physicians) regarding myths that must be overcome to ensure successful commercialization of biosimilars
  • 16:20 Building a Biologics Empire - Being both the Originator and Biosimilar Innovator

    17:00 Panel Discussion: Who's the Ultimate Winner? Biosimilars vs. Biobetters

    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 USA, Inc.

    9:10 Looking for Fingerprints

    9:50 The Importance of Early Immunogenicity and Product Quality Assessment (PQA) in Biosimilar Development

    Laura Perry

    Laura Perry, Director of Scientific Affairs – Cell Line Development, Abzena

  • Understanding the causes and variations of immunogenicity between biosimilars and originators
  • Case study: EPO vs infliximab switching experiences
  • Methods for preclinical immunogenicity and PQA for early comparative analysis
  • De-risking approaches for biosimilars and biobetters
  • 10:30 Characterization of Innovator and Biosimilar Antibody Molecules

    T. Shantha Raju

    T. Shantha Raju, Scientific Director, Biologics Research, Janssen Pharmaceuticals, Inc.

  • Analytical characterization
  • Novel methods to distinguish
  • Clinical relevance of differences
  • 11:10 Morning Coffee & Networking Break

    11:40 How to Build a Convincing Business Case and Sustainable Model for Biosimilar mAbs

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc.

  • mAb development and manufacturing cost drivers are declining
  • How to price and how low can you go: Case study of mAb development cost 2007 - present
  • Market access strategy and lifecycle: Case study of post-approval launch mistakes
  • Can biosimilars be a sustainable business at current variable costs?
  • 12:20 Industry Partnerships: Key Success Factors in Biosimilar Space

    Catherine Godrecka-Bareau

    Catherine Godrecka-Bareau, Director Strategy & Portfolio Management, Biosimilars, EMD Serono

  • Stand-alone situation: High R&D costs, unclear regulatory pathways, uncertain business model, incomplete portfolios
  • We will win together through innovative partnership models
  • Case study: Airline industry - high fixed costs but low marginal costs
  • Translation to the biosimilar space
  • 13:00 Networking Lunch

    14:00 Biosimilars – From Aspiration to Operations

    Edric Engert

    Edric Engert, SVP Biosimilars, Teva Pharmaceuticals

  • Corporate strategy
  • Portfolio strategy
  • Organizational implications
  • 14:40 Considerations for Commercial Success

    Molly Burich

    Molly Burich, Associate Director, Public Policy of Biosimilars, Pipeline, Reimbursement , Boehringer Ingelheim Pharmaceuticals, Inc

  • Engaging key stakeholders to drive biosimilar adoption

  • The big question of reimbursement of biosimilars in the US - what is the future and challenges?

  • 15:20 Afternoon Tea

    15:50 Addressing the Clinical Risks of Switching

    Daniel Alvarez

    Daniel Alvarez, Senior Director, Asset Lead Biosimilars Research Development Unit, Pfizer Inc.

  • Types of switching, let's talk the same language

  • Considerations when switching to biosimilars - what are the risks?

  • Do we have data support switching?

  • How to transition from reference product to biosimilars?

  • 16:30 Marketing and Distribution – Keys to Success

    17:00 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Catherine Godrecka-Bareau

    Catherine Godrecka-Bareau

    Director Strategy & Portfolio Management, Biosimilars, EMD Serono
    Molly Burich

    Molly Burich

    Associate Director, Public Policy of Biosimilars, Pipeline, Reimbursement , Boehringer Ingelheim Pharmaceuticals, Inc
    Richard Dicicco

    Richard Dicicco

    Chairman, Harvest Moon Pharmaceuticals USA, Inc.

    Albin James Nelson

    Senior Shareholder, Schwegman Lundberg Woessner
    Albin James Nelson

    Andrew Simpson

    Scientific Director, Orygen Biotechnologia S/A
    Andrew Simpson

    Catherine Godrecka-Bareau

    Director Strategy & Portfolio Management, Biosimilars, EMD Serono
    Catherine Godrecka-Bareau

    Daniel Alvarez

    Senior Director, Asset Lead Biosimilars Research Development Unit, Pfizer Inc.
    Daniel Alvarez

    Edric Engert

    SVP Biosimilars, Teva Pharmaceuticals
    Edric Engert

    Gustavo Grampp

    Director R&D Policy, Biosimilars, Amgen Inc.
    Gustavo Grampp

    Hillel Cohen

    Executive Director, Scientific Affairs, Sandoz Inc
    Hillel Cohen

    Jianguo Yang

    CEO, Abpro Corporation -- China
    Jianguo Yang

    Kevin Kyumin Lee

    Partner, Kim & Chang
    Kevin Kyumin Lee

    L. Ross Day, R.Ph. D.P.

    Director of Pharmacy, Sourcing Operations, Vizient Inc.
    L. Ross Day, R.Ph. D.P.

    Laura Perry

    Director of Scientific Affairs – Cell Line Development, Abzena
    Laura Perry

    Mkaya Mwamburi

    Vice President of Health Economics & Outcomes Research, Market Access Solutions
    Mkaya Mwamburi

    Mkaya Mwamburi MD, PhD, MA (Econ), is Vice President of Health Economics & Outcomes Research and heads the HEOR practice area. Mkaya is an HEOR specialist and evidence strategist with extensive experience in consulting for pharmaceutical industry leading health economic modeling, systematic reviews, and value determination and communication projects among others. He also has experience in the clinical trial analysis of oncology and immunology products and has published extensively in this space.
     

    Molly Burich

    Associate Director, Public Policy of Biosimilars, Pipeline, Reimbursement , Boehringer Ingelheim Pharmaceuticals, Inc
    Molly Burich

    Richard Dicicco

    Chairman, Harvest Moon Pharmaceuticals USA, Inc.
    Richard Dicicco

    Robin Chadwick

    Principal, Schwegman Lundberg Woessner
    Robin Chadwick

    Steinar Madsen

    Medical Director, Norwegian Medicines Agency
    Steinar Madsen

    T. Shantha Raju

    Scientific Director, Biologics Research, Janssen Pharmaceuticals, Inc.
    T. Shantha Raju

    Sponsors and Exhibitors

    Workshops

    Biosimilars : Considerations for Optimizing Access and Price
    Workshop

    Biosimilars : Considerations for Optimizing Access and Price

    Renaissance Woodbridge Hotel
    15th November 2016
    Iselin, USA

    VENUE

    Renaissance Woodbridge Hotel

    515 US Highway 1 South, Iselin, New Jersey, USA

    Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

    HOTEL BOOKING FORM

    Sponsors and Exhibitors


    Abzena

    Sponsors and Exhibitors
    http://www.abzena.com

    Abzena offers a suite of complementary services and technologies. Its range of technologies include immunogenicity assessment, antibody drug conjugation, protein engineering, PEGylation, cell line development , GMP manufacturing and a range of bespoke assays to enables the development of better biopharmaceuticals which will have a greater chance of reaching the market.


    Schwegman, Lundberg & Woessner

    Sponsors and Exhibitors
    http://www.slwip.com

    The Schwegman firm is dedicated to obtaining strong patents while innovating how IP law is practiced. Schwegman developed proprietary systems, allowing us to deliver high quality work, remaining cost competitive. Schwegman attorneys have robust backgrounds across a spectrum of technology areas, working with diverse clients, including corporations, universities, and start-ups.

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    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830
    USA

    Renaissance Woodbridge Hotel

    Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

    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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