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Building on the success of previous events, SAE Media Group proudly announces the return of its 5th Annual Biosimilars USA Conference, taking place in New Jersey on the 14th and 15th November 2018.

This fifth event in the series will gather a global audience of biosimilar experts and industry-thought leaders to discuss biosimilar manufacturing and commercialization considerations specific to the U.S..

On March 7th, 2018, the U.S.-FDA’s Commissioner, Scott Gottlieb, MD, announced that Biosimilar medicines are now a top priority for the FDA. Join us this November to learn how to take advantage of the FDA’s focus on biosimilars, accelerate your biosimilar pipeline and achieve FDA approval.

This year's conference will home-in on how to circumvent regulatory hindrances and expediting the approvals process for your biosimilars pipeline. Experience will be drawn from a range of expert perspectives, to allow you to benchmark your business practices and learn how to streamline your processes.

Hear from a selection of carefully handpicked keynote addresses and case studies presented to you by top manufacturing and leading distributors of market approved biosimilars, as they offer a unique insight into the areas of manufacturing, commercialization, device design, uptake, switching, interchangeability, and regulations.

“If we’re serious about seeing the market for biosimilars take shape, it’s going to require a payment system that gives products that are currently in the pipeline a chance to enter the market once they’re approved…. The FDA will do its part by laying out an efficient path for showing how biosimilar products can demonstrate interchangeability with their branded counterparts. But we can solve only one part of this equation.”

- Quote from Scott Gottlieb, MD, Commissioner of Food and Drugs Speech titled “Capturing the Benefits of Competition for Patients” Full transcript can be found here.

  • Hear about recent caselaw which will help you to navigate changes occurring in the BPCIA litigation
  • Assess challenges to gaining the FDA’s Interchangeability status and debate, is it worth it?
  • Consider different device design options
  • Explore routes to take if your biosimilar has a better formulation and/or administration than the originator
  • Discuss the FDA’s CMC finger print comparability that requires a minimum of 10 batches for statistical considerations
  • Examine whether more batches lead to better clinical trial outcomes
  • Learn how to meet high GMP compliance when manufacturing outside of the US
  • Analyze whether the biosimilar industry can provide co-payments and other healthcare benefits to patients to successfully complete with originators
  • Discover how to get onto patient formularies, and the important role pharmacy benefit manages have in achieving this

 

Alexion Pharmaceuticals, Inc.; Algorithme Pharma | An Altasciences Company; Amerisourcebergen; AmeriSourceBergen (ION Solutions); BiologicTx; Bio-Rad; Choate, Hall & Stewart LLP; Covance Inc; Dyadic Nederland B V; FFF Enterprise; Fortress Biotech; GaBI Journal ; Grifols; Harvest Moon Pharmaceuticals USA, Inc.; Janssen , Johnson & Johnson; Karyo Biologics, LLC; Lupin Pharmaceuticals; Lupin Pharmaceuticals, Inc.; Luye Pharma; Luye Pharma Group; Market Access Solutions; MedImmune; Merck; Momenta Pharmaceuticals; Mylan Inc; Norwegian Medicines Agency; Oncobiologics; Paragon; Pfizer; PlantForm Corp; QuintilesIMS; SAI MedPartners; Sandoz; Sandoz Biopharmaceuticals; Sandoz Inc; Sanofi-Aventis; Sapphire Therapeutics; Schiff Hardin LLP; Slack Incorporated; Teva Pharmaceuticals USA; The ABIS Group; The Center for Biosimilars; Ulteemit BioConsulting; VCN Health; ZS Associates; Zuckerman Spaeder LLP;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Michel  Mikhail

Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars, Independant Consultant

9:10 Sustainability is key to realizing the benefit biosimilars offer to patients, physicians, payers and healthcare systems

Christina Yunis

Christina Yunis, Global Biosimilars Market Development Lead, Pfizer

  • Biosimilars is a very dynamic market and not only from a competitive environment perspective, but the Intellectual Property (IP), Policy and Regulatory Environment will continue to evolve.
  • There are 5 main ingredients to achieving a vibrant, sustainable environment for biosimilars that benefits patients, healthcare systems and industry:
    o Fair and early access to market,
    o appropriate pricing,
    o biosimilars from several competitors on the market,
    o broad insurance coverage, and
    o educated and supportive physicians and patients.
  • As an industry, we must unite to ensure health systems are ready to realise the potential of biosimilars in the US, and around the world
     
  • 9:50 New Dance Moves: How recent caselaw has reshaped the BPCIA patent dance

    A discussion looking at several of the recent US case law rulings that have significantly altered the canonical timeline for BPCIA litigation, and how biosimilars makers can potentially navigate those changes
    A discussion on how the Amgen v. Sandoz Supreme Court case has opened the door to bypassing the patent dance and accelerating the time period for pre-launch declaratory judgment litigation
    A discussion on the potential for pre-launch damages litigation, as were awarded in the Amgen v. Hospira district court decision
    A discussion on how, whether and when to disclose biosimilar manufacturing info, as was the subject of the Amgen v. Hospira Fed Cir decision
    A discussion on the recent skirmishes in California over choice of venue, as in the pending Amgen v. Genentech and Celltrion v. Genentech matters
    A discussion of the FDA’s process for approving biosimilar applications, and how the FDA’s approval timeline syncs up (or does not) with the BPCIA’s “expected” litigation timeline 
     
     

    Christopher Loh

    Christopher Loh, Partner, FITZPATRICK, CELLA, HARPER & SCINTO

    Peter Waibel

    Peter Waibel, Head of US Patent Litigation, Novartis

    10:30 Morning Coffee

    11:00 Hasta La Vista, Baby”: The Impact of IPRs and PGRs on Biologic Products

    - IPR and PGR process, strategic differences between those and district court litigation
    - Statistics demonstrating the particular impact of these venues on biologic products
    - General strategy as to how to prepare for them from both the BLA holder and aBLA filer perspective.
     

    Ha Kung Wong

    Ha Kung Wong, Partner, New York, FITZPATRICK, CELLA, HARPER & SCINTO

    John Kirkland

    John Kirkland, Director, Alkermes, Inc.

    11:40 Rationalising FDA guidance on Biosimilars – Expediting approvals and acceptance

    Sarfaraz Niazi

    Sarfaraz Niazi, Founder, Karyo Biologics, LLC
    View Bio

  •  FDA to eliminate bridging test, make statistical equivalence criteria clinically relevant and allow in vitro immunogenicity where available
  • The FDA, the prescribers and the payers jointly promote the use of biosimilars as first choice for new patients, given that there is no clinically meaningful difference
  • The developers to concentrate on fingerprint like similarity rather than offering to do studies in patients
     
  • 12:20 Networking Lunch

    13:20 Risk evaluation of Biosimilars and downstream implications for operations and commercialization

    Edric Engert

    Edric Engert, Managing Director , Abraxeolus Consulting
    View Bio

    •             External risks that are systemic to Biosimilars and internal risks that each Biosimilar firm likely faces
    •             Understanding the approaches needed for operations and commercialization in both planning and execution
    •             Examples of key drivers, incentives, and what components must be known and considered with example quantification of resulting market dynamics
    •             An outline of resulting to-do's that any Biosimilar firm engaged in commercialization needs to cover to be successful in their launch and beyond
     

    14:00 Switching form Reference Biologics to Biosimilars

    Hillel Cohen

    Hillel Cohen, Executive Director, Scientific Affairs, Sandoz Inc
    View Bio

  • Scientific literature was reviewed from 1993 to June 30, 2017 to identify publications that described switching from reference biologic to a biosimilar
  • Ninety studies were identified, involving 7 molecules used to treat 14 disease indications, enrolling a total of 14,225 individuals
  • The great majority of studies did not report differences in safety, efficacy or immunogenicity
  • The results suggest a low risk of either a safety concern or loss of efficacy after switching to a biosimilar
  • 14:40 Afternoon Tea

    15:20 Biosimilars Interchangeability: The Draft Regulatory Guidance in the USA

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars, Independant Consultant

    16:00 PANEL: How sustainable is the biosimilars market?

    Christina Yunis

    Christina Yunis, Global Biosimilars Market Development Lead, Pfizer

  • Where is the market heading?
  • Who will be the relevant players and where will they be based globally?
  • Will we see a migration of manufactures to low cost countries as we did with generics?
  • What are the short and long-term gains?
  • In 10 years’ time, will there still be a market that can make profit?
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars, Independant Consultant

    9:10 Recent Expected and Unexpected Developments in Biosimilar Drug Development

    Nigel Rulewski

    Nigel Rulewski, Vice President, Head Biosimilar Center of Excellence, IQVIA
    View Bio

  • US interchangeability requirements in the US
  • Use of Next Generational Tools and novel paradigms to accelerate the clinical development cycle
  • Steps that innovator companies have taken to block biosimilar development
  • Steps being taken to erode the “patent dance” in the US
  • The potential for using a global reference comparator
  • The possibility of abbreviating the biosimilar development pathway
  • The emergence and ramifications of the ‘Nocebo Effect”
     
  • 9:50 Developing biosimilars with a tobacco plant expression system

    Don Stewart

    Don Stewart , CEO, PlantForm Corp
    View Bio

  • Drug production using plant based and other expression systems 
  • Regulatory environment for non-traditional expression systems
  • Partnerships using alternative expression systems to develop biosimilars and biobetters
  • 10:30 Morning Coffee

    11:00 In-licensing biosimilars: Best practices for completing diligence and executing the contract successfully

    Arun  Nataraj

    Arun Nataraj, Business Development and Licensing Executive , Vermont Biosynthetics LLC
    View Bio

    • Gap analysis in the data during due diligence and Partners plans to address them. FDA correspondence following Pre-IND and pre-BLA meetings
    • The importance of outside consultants and their role in due diligence
    • Structuring a deal to de-risk your investment until there is confidence in the program
    • Critical contractual issues that need to be negotiated in a favourable manner (to you)

    11:40 Canadian Regulatory Perspective on Biosimilars

    Catherine Soo

    Catherine Soo, Senior Clinical Evaluator, Health Canada
    View Bio

  • Regulatory Framework – the Canadian Food and Drugs Act and Regulations and Health Canada’s Guidance Documents on the Information and Submission Requirements for Biosimilars
  • Clinical requirements for biosimilar drug submissions
  • Intersect of Patented Medicines and the approval process for Biosimilars
  • Roles of the Federal versus Provincial Jurisdictions
  • Authorised/marketed Biosimilars in Canada
  • 12:20 Networking Lunch

    13:20 Biosimilars – can they all survive?

    13:20 Do biosimilars really need Real World Evidence?

    Anita Burrell

    Anita Burrell, VP, Global Market Access, Eversana
    View Bio

    14:00 Roles of Biosimilars in Patients Access to Biologic Treatments

    HoUng Kim

    HoUng Kim, Head of Strategy and Operations Division , Celltrion Healthcare Co, LTD.

    • Improving patient access
    • Biologics in earlier stage
    • Impact of biosimilars in oncology

    14:40 PANEL: Forecasting uptake of biosimilars entering the market: Points to consider

    Nigel Rulewski

    Nigel Rulewski, Vice President, Head Biosimilar Center of Excellence, IQVIA
    View Bio

    Edric Engert

    Edric Engert, Managing Director , Abraxeolus Consulting
    View Bio

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars, Independant Consultant

    15:40 Chairman’s Closing Remarks and Close of Day Two

    +

    VP, Global Market Access
    Eversana
    Business Development and Licensing Executive
    Vermont Biosynthetics LLC
    Senior Clinical Evaluator
    Health Canada
    Global Biosimilars Market Development Lead
    Pfizer
    Partner
    FITZPATRICK, CELLA, HARPER & SCINTO
    CEO
    PlantForm Corp
    Managing Director
    Abraxeolus Consulting
    Partner, New York
    FITZPATRICK, CELLA, HARPER & SCINTO
    Executive Director, Scientific Affairs
    Sandoz Inc
    Head of Strategy and Operations Division
    Celltrion Healthcare Co, LTD.
    Director
    Alkermes, Inc.
    International Expert in Regulatory Affairs, International Expert in Biosimilars
    Independant Consultant
    Vice President, Head Biosimilar Center of Excellence
    IQVIA
    Head of US Patent Litigation
    Novartis
    Founder
    Karyo Biologics, LLC
    Medical Director
    Norwegian Medicines Agency

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    Workshops

    Decoding How Stakeholders May Drive Biosimilar Adoption
    Workshop

    Decoding How Stakeholders May Drive Biosimilar Adoption

    Renaissance Woodbridge Hotel
    13 November 2018
    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.

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Biosimilars USA 2018 Attendee List

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    Speaker Interview with Christopher E. Loh, FITZPATRICK, CELLA, HARPER & SCINTO

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    News Article on Celltrion

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    Speaker Interview Edric Engert, Abraxeolus Consulting

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    Speaker Interview HoUng Kim, Celltrion Healthcare

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    Speaker Interview Catherine Soo, Health Canada

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    The FDA’s infographic on the biosimilar development process

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    2018 Brochure

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    2017 Speaker Presentation from KARYO BIOLOGICS

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    2017 Speaker Presentation from PlantForm Corporation®

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    2017 Speaker Presentation from profecyINTEL, LLC

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    2017 Speaker Presentation from COVANCE

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    2017 Speaker Presentation Zuckerman Spaeder

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    2017 Speaker Presentation from Sandoz

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    Speaker Interview with Anita Burrell, Anita Burrell Consulting

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    Speaker Interview with Sarfaraz Niazi, Founder, Karyo Biologics

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    Press Release on FDA Biosimilar Action Plan

    Download

    Speaker Interview Hillel Cohen, SANDOZ

    Download

    2018 Speakers

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    2018 Agenda

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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.

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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, SAE Media 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@saemediagroup.com

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    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
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