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Building on the success of previous events, SMi proudly announces the return of its 4th annual Biosimilars North America Conference, taking place on November 15 and 16, 2017 in Iselin, New Jersey.

The first biosimilar product launched in the US in 2015. Currently there are only 4 biosimilar products approved but the North Americas market continues to grow and has become highly lucrative. As such, pharmaceutical companies continue to find ways to differentiate their products in such a saturated market. Thus, Biosimilars North America 2017 will provide an intelligent meeting to explore novel and innovative strategies to advance biosimilar development, and ensure optimal market access and commercialization opportunities whilst complying with evolving regulatory requirements.

This year, the conference will also explore significant developmental topics within the sector including the impact of FDA’s newly implemented biosimilar interchangeability guidelines, the US market access landscape, and biosimilars of orphan drugs.
 

 

  • Hear Sandoz talk on the FDA issuing the long awaited biosimilar interchangeability guidance
  • Explore complex Biosimilars and new technologies from MedImmune
  • Learn how to combat the legal, policy and commercial obstacles to the development and launch of Biosimilars with Momenta Pharmaceuticals
  • Gain insights from FUJIFIlM Diosynth Biotechnologies on Biosimilar latest development strategies and successfully bringing biosimilars to market
  • Examine the drug product and formulation developmentconsiderations for biosimilars with Oncobiologics Inc

Abzena; AmerisourceBergen; Amgen; Antares Pharma; Ares-Trading (Merck); Bionovis; Boehringer Ingelheim; Challand Biosimilar Consulting; EGeen International Corporation; Eli Lilly and Company; FFF Enterprise; Gan & Lee Pharmaceuticals USA Co.; GPhA (Generic Pharmaceutcal Association); Kim & Chang; Lupin Pharmaceuticals; Lupin Pharmaceuticals Inc; Lupin Pharmaceuticals, Inc.; Medimmune Inc; Merck; Merck AND Co Ltd; Myoderm; Norwegian Medicines Agency; Oncobiologics; Orygen Biotecnologia Ltda; Pfizer; Pfizer Global Pharmaceuticals; Pfizer Inc; Pfizer Inc.; Pfizer, Inc; Prescient Healthcare Group; SAI MedPartners; Samsung BioLogics; Sandoz; Sandoz Inc; Sandoz Inc.; Sandoz Pharmaceuticals; Schwegman Lundberg Woessner; Teva Pharmaceuticals; Teva Pharmaceuticals USA; UBC - An Express Scripts Company; Vizient Inc.; Wyatt Health Management; ZS Associates;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Richard Dicicco

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

9:10 The Road to biosimilars: Reaching our destination with the patient in mind

Chrys Kokino

Chrys Kokino, Global Commercial Head, Mylan Inc

  • Road Today: Lessons learned from EU and RoW as we look towards US launches
  • Detours: New guidelines, naming, reimbursement, interchangeability
  • Road Ahead: Keeping the patient and other stakeholders in mind
  • 9:50 From biosimilar approval to biogenerics in clinical practice

    Steinar Madsen

    Steinar Madsen, Medical Director, Norwegian Medicines Agency
    View Bio

  • Attitudes and acceptance
  • Uptake in clinical practice – the European experience
  • Nor-Switch study and other clinical trials
  • Switching is already there – do we need interchangeability?
  • 10:30 Morning Coffee

    11:00 How to ensure optimal market access for biosimilars

    Gary C Cupit

    Gary C Cupit, President & CEO, Sapphire Therapeutics

  • The economics of biosimilars
  • How should we price biosimilars?
  • What can be done by payers to ensure long term savings?
  • 11:40 Building a biologics empire: Being both the originator and biosimilar Innovator

    Mkaya Mwamburi

    Mkaya Mwamburi, Founder, President and CEO, profecyINTEL, LLC

  • It’s not a conflicting scene - complimenting your portfolio with both original biologics and biosimilars
  • The story behind - from technical capabilities to branding
  • What’s the best approach and how to hedge?
  • 12:20 Networking Lunch

    13:30 Biosimilars of orphan drugs: The case study of biosimilar Eculizumab

    Richard Dicicco

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

  • Eculizumab global market data
  • Cost and development risk requires a change in extrapolation strategy
  • Defining the target quality profile and critical quality attributes
  • The right patient assistance program is necessary for biosimilar orphans
  • 14:10 Drug product and formulation development considerations for biosimilars

    Hiten Gutka

    Hiten Gutka, Principal Scientist Formulation Development Biosimilar Development, Oncobiologics

  • Considerations in development of formulation and Drug Product for Biosimilars
  • Excipient quality and influence on biosimilar drug product quality and stability, Container closure effect on stability of biosimilar drug product
  • Similarity assessment and the role of formulation and drug product.
  • 14:50 Afternoon Tea

    15:20 Functional similarity assessment

    Rajani Srikakulam

    Rajani Srikakulam, Principal Scientist, Oncobiologics

  • What is the importance of functional assays/ bioassays in biosimilar development? Why does one need functional assays in addition to an in-depth structural characterization?
  • What bioassays are appropriate for a given biosimilar? How does one determine what assays are necessary and when are they needed?
  • Diversity of bioassay methodologies – how to select the appropriate methodology for the purpose
  • Tiering of functional attributes based on mechanism of action and known clinical relevance
  • 16:00 Dyadic’s C1 Expression System, a potential CHO Stopper

    Ronen  Tchelet

    Ronen Tchelet, VP Research & Business Development, Dyadic Nederland B V

    16:40 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 Bioinnovations: speed to market biosimilars.

    Sarfaraz Niazi

    Sarfaraz Niazi, Adjunct Professor, Department of Biopharmaceutical Sciences, UIC College of Pharmacy

  • Minimising bioprocessing steps, environment controls and cleaning validation.
  • Continuous manufacturing, scale-free lots, ready tech transfer
  • Addressing unique challenges in biosimilars development
  •  

    9:50 Understanding the U.S. market access landscape for biosimilars

    John Carlsen

    John Carlsen, Vice President, Covance Inc

  • Review key CMS policy developments for biosimilars (e.g., Medicare guidance, coding decisions, payment policies) and understand the potential impact on commercial payers' policies
  • Highlight coding and Medicare payment for currently available biosimilar products, understand the link between coding/payment and pricing, and discuss what this means for biosimilars approved in the future
  • Gain insight into how commercial payers are covering and managing biosimilars, as well as the resulting impact on patient access to competing innovator products (based on original research conducted by Covance)
  • Assess the implications for reimbursement hubs, patient assistance programs, and other customer support resources

     

  • 10:30 Morning Coffee

    11:00 Targeted Biobetters: Tissue Specific Delivery Using Caveolae Technology Improves Drug Efficacy

    Ruchi Gupta

    Ruchi Gupta, Senior Scientist, MedImmune

  • Current bio-therapeutics focus on the molecular targets expressed on cells/tumors. Inspite of increased antigen expression on the targeted organ, less than 10% of the IV administrated biologics can reach the diseased tissues.
  • Tissue targeting using caveolae proteins can allow for specific delivery to organs of interest within minutes to hours.
  • This talk will focus on caveolae technology to specifically deliver to lungs and kidneys and improve drug efficacy.
  • This technology can achieve markedly improved efficacy of drugs in several diseases including fibrosis, COPD, infections as well as tumors.
  • 11:40 Opportunities for biosimilar and biobetter drugs in Brazil

    Don  Stewart

    Don Stewart , CEO, PlantForm Corp

  • Establishing Partnerships
  • Funding Scenarios
  • Technology Transfer and Manufacturing

     

  • 12:20 Networking Lunch

    13:30 Legal, Policy and Commercial Obstacles to the development and launch of Biosimilars

    Bruce Leicher

    Bruce Leicher, Sr. Vice President and General Counsel, Momenta Pharmaceuticals

  • The use of Public Policy and Guidance to Promote Evergreening of Reference Products
  • Restricted access to reference products and REMS Abuse
  • 14:10 Amgen v. Sandoz: the U.S. Supreme Court’s First Foray into the BPCIA

    Carlos Angulo

    Carlos Angulo, Partner, Zuckerman Spaeder LLP

  • The Court’s BPCIA “patent dance” decision
  • The Court’s decision on the BPCIA’s “notice of commercial marketing” provision
  • How will the Court’s holdings affect biosimilars development going forward?
  • 14:50 Afternoon Tea

    15:20 FDA issues long awaited biosimilar interchangeability guidance

    Cindy Cao

    Cindy Cao, Executive Director & Head of US Regulatory Affairs for Biopharmaceuticals, Sandoz Inc

  • The impact of the new guidelines
  • Interchangeability: Considerations for a single switch vs. multiple switches
  • Engaging with your stakeholders - how will switching work?
  • 16:00 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Bruce Leicher

    Bruce Leicher

    Sr. Vice President and General Counsel, Momenta Pharmaceuticals
    Chrys Kokino

    Chrys Kokino

    Global Commercial Head, Mylan Inc
    Cindy Cao

    Cindy Cao

    Executive Director & Head of US Regulatory Affairs for Biopharmaceuticals, Sandoz Inc
    Richard Dicicco

    Richard Dicicco

    Chairman, Harvest Moon Pharmaceuticals USA, Inc.
    Sarfaraz Niazi

    Sarfaraz Niazi

    Adjunct Professor, Department of Biopharmaceutical Sciences, UIC College of Pharmacy

    Bruce Leicher

    Sr. Vice President and General Counsel, Momenta Pharmaceuticals
    Bruce Leicher

    Carlos Angulo

    Partner, Zuckerman Spaeder LLP
    Carlos Angulo

    Chrys Kokino

    Global Commercial Head, Mylan Inc
    Chrys Kokino

    Cindy Cao

    Executive Director & Head of US Regulatory Affairs for Biopharmaceuticals, Sandoz Inc
    Cindy Cao

    Don Stewart

    CEO, PlantForm Corp
    Don  Stewart

    Gary C Cupit

    President & CEO, Sapphire Therapeutics
    Gary C Cupit

    Hiten Gutka

    Principal Scientist Formulation Development Biosimilar Development, Oncobiologics
    Hiten Gutka

    John Carlsen

    Vice President, Covance Inc
    John Carlsen

    Mkaya Mwamburi

    Founder, President and CEO, profecyINTEL, LLC
    Mkaya Mwamburi

    Rajani Srikakulam

    Principal Scientist, Oncobiologics
    Rajani Srikakulam

    Richard Dicicco

    Chairman, Harvest Moon Pharmaceuticals USA, Inc.
    Richard Dicicco

    Ronen Tchelet

    VP Research & Business Development, Dyadic Nederland B V
    Ronen  Tchelet

    Ruchi Gupta

    Senior Scientist, MedImmune
    Ruchi Gupta

    Sarfaraz Niazi

    Adjunct Professor, Department of Biopharmaceutical Sciences, UIC College of Pharmacy
    Sarfaraz Niazi

    Steinar Madsen

    Medical Director, Norwegian Medicines Agency
    Steinar Madsen

    Dr. Steinar Madsen is medical director at the Norwegian Medicines Agency. He has been working with generic substitution since it was introduced in Norway in 2001 and with biosimilars since 2006. He is member and previously chairman of the committee for generic substitution at the Agency. Dr. Madsen is engaged in the drug information service, with a special interest in the safe and cost-effective use of drugs. He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology.

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    Workshops

    Biosimilar Development and the Establishment of Biosimilarity
    Workshop

    Biosimilar Development and the Establishment of Biosimilarity

    Renaissance Woodbridge Hotel
    14th November 2017
    Iselin, USA

    Clinical Strategy for Orphan and Non-Orphan Biosimilars Development
    Workshop

    Clinical Strategy for Orphan and Non-Orphan Biosimilars Development

    Renaissance Woodbridge Hotel
    14th November 2017
    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.

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    Preliminary Attendee List - Biosimilars North America

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    Interview with PlantForm - Don Stewart

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    Attendee List - SMi Pharma USA Week 2017

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    Interview with Pfenex - Patrick Lucy

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    Past Attendees - Biosimilars North America 2016

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    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830
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    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.

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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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