Building on the success of previous events, SMi proudly announces the return of its 5th Annual Biosimilars North America 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..

Fresh form the press: 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.

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.

  • 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

Medical Directors, Scientific Directors, VP’s, Directors, Managers, Team Leaders, Partners, Consultants and Attorneys of:

Biosimilars, Biobetters, Biopharmaceuticals, Biostatistics, Business Alliances, Business Development, Clinical Operations, Commercial, Decision Analytics, Global Intelligence, Global Operations, Managed Markets and Trade Relations, Market assess, Marketing, Patient & Physician Services, R&D Policy, Regulatory Affairs, Scientific Affairs, and anyone else who works within the biosimilars industry!

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; 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; Therapeutic Proteins International, LLC; Ulteemit BioConsulting; VCN Health; ZS Associates; Zuckerman Spaeder LLP;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Richard Dicicco

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

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 Biosimilars wanted: a new priority for the FDA

    10:30 Morning Coffee

    11:00 Recent Expected and Unexpected Developments in Biosimilar Drug Development

    Nigel Rulewski

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

  • 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”
  • 11:40 The future of biosimilars and its roles

    HoUng Kim

    HoUng Kim, Senior Director, Celltrion Inc.

  • Who are we?
  • Physicians’ perspective on early introduction of biologics
  • The future and role of biosimilars
  • Reducing cost and increase patient access
  • 12:20 Networking Lunch

    13:20 Do biosimilars really need Real World Evidence?

    Anita Burrell

    Anita Burrell, Founder and CEO, Anita Burrell Consulting

  • What is Real World Evidence (RWE) and how is this different to trial data?
  • Recent trends in RWE: standards and regulatory inclusion
  • What does this mean for your market access issues?
  • Looking at ways to use RWE innovatively during development
  • 14:00 Patent Litigation Updates and Current BPCIA Litigation

    14:40 Afternoon Tea

    15:10 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
  • 15:50 Gaining FDA interchangeability status: is it worth it?

    16:30 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.
    View Bio

    9:10 Which biosimilars should you include in your pipeline?

    9:50 Alternative expression systems for production of biosimilars and biobetters

    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 to complete diligence successfully and key contractual terms to be addressed when executing the agreement

    Arun  Nataraj

    Arun Nataraj, Senior Director, Amneal Pharmaceuticals

    • 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 Dosage form and Formulation strategy for life cycle management of biosimilars

    Hiten Gutka

    Hiten Gutka, Principal Scientist Formulation Development Biosimilar Development, Oncobiologics
    View Bio

  • Presentation will review formulation and dosage form considerations for biosimilars – a review of currently approved biosimilars and their dosage forms
  • Presentation will focus on one or more case studies where it is essential to re-consider formulation changes and have a strategy for life cycle management for the approved biosimilar
  • 12:20 Networking Lunch

    13:20 How to meet high GMP compliance when manufacturing outside of the US

    14:00 US market uptake after redeeming and replacing Obamacare

    14:40 Afternoon Tea

    15:40 Co-payments and other healthcare benefits: Can the biosimilar industry provide?

    16:20 Forecasting uptake of biosimilars entering the market: Points to consider

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



    Don Stewart

    Don Stewart

    CEO, PlantForm Corp
    Hillel Cohen

    Hillel Cohen

    Executive Director, Scientific Affairs, Sandoz Inc
    Hiten Gutka

    Hiten Gutka

    Principal Scientist Formulation Development Biosimilar Development, Oncobiologics
    Richard Dicicco

    Richard Dicicco

    Chairman, Harvest Moon Pharmaceuticals USA, Inc.

    Anita Burrell

    Founder and CEO, Anita Burrell Consulting
    Anita Burrell

    Arun Nataraj

    Senior Director, Amneal Pharmaceuticals
    Arun  Nataraj

    Christina Yunis

    Global Biosimilars Market Development Lead, Pfizer
    Christina Yunis

    Don Stewart

    CEO, PlantForm Corp
    Don Stewart

    Don Stewart, PhD

    Dr. Stewart, an entrepreneur and scientist bringing 30 years’ experience in the biotechnology industry to this role. Dr. Stewart has founded a biotechnology company, PlantForm Corporation. At PlantForm Dr. Stewart has developed the company from a start-up, directing fundraising, the development of a strong intellectual property portfolio and implementation of partnerships with Pharmaceutical Companies, Government Organizations and Foundations.

    Previously, as the Director Research and Development for Cangene Corporation, Dr. Stewart was responsible for the company’s research and development group. Dr. Stewart led collaborative programs developing innovative and biosimilar drugs as medical countermeasures and as traditional therapeutics.

    Dr. Stewart graduated with a PhD from the University of London, UK and gained academic experience at the University of Alberta in Edmonton, Canada.

    Hillel Cohen

    Executive Director, Scientific Affairs, Sandoz Inc
    Hillel Cohen

    Dr. Hillel Cohen leads Scientific Affairs efforts for Sandoz in the Americas where he helps explain the science-based Sandoz and Novartis biosimilar policy positions to the healthcare community, the public, and health authorities. He has been active in field of biosimilars since 2002, when discussions about them were initiated in the US.

    Dr. Cohen has been active in biosimilar trade associations in a variety of roles, including leadership roles at the Biosimilars Forum and at the Biosimilars Council (a division of the Association for Affordable Medicines).

    Dr. Cohen has over 25 years of industry experience. He is an expert in regulatory science policy and biologic product development. Before joining Scientific Affairs at Sandoz, he was the Head of Global Strategic Labeling as well as the Head of Regulatory Affairs for the Americas at Novartis Vaccines. Hillel has held leadership positions in biotechnology QC, bioanalytical chemistry, and regulatory affairs at other firms.

    Dr. Cohen received a BA from NYU and a PhD in Biology from Dartmouth.

    Hiten Gutka

    Principal Scientist Formulation Development Biosimilar Development, Oncobiologics
    Hiten Gutka

    Dr. Hiten Gutka is a Principal Scientist Formulation Development at Oncobiologics Inc. He works on biosimilar drug product development. He worked on formulation and stabilization of novel insulin analogues at Thermalin Diabetes LLC. He did a co-op at Medimmune LLC in Gaithersburg, MD, in the Antibody Formulation and Drug Product Development group.

    Hiten got his PhD in Pharmacognosy (Pharmaceutical Biotechnology track) from University of Illinois at Chicago (UIC) College of Pharmacy, where he worked on characterization of Fructose 1,6-bisphosphatase II from pathogenic bacteria Mycobacterium tuberculosis.

     Between 2004 and 2008 he worked at Biocon and Reliance Biopharmaceuticals in India, wherein he was involved with analytical and pharmaceutical development of biosimilar Insulin and other biosimilars including cytokines and hormones. He got his Bachelors and Masters in Pharmaceutical Sciences from University Institute of Chemical Technology, Mumbai, India.

    HoUng Kim

    Senior Director, Celltrion Inc.
    HoUng Kim

    Richard Dicicco

    Chairman, Harvest Moon Pharmaceuticals USA, Inc.
    Richard Dicicco

    <p>Richard DiCicco co-founded Harvest Moon Pharmaceuticals USA, Inc. in 2007 with a proven pipeline of complex generic products. Harvest Moon Pharma develops manufactures, markets and exports complex generic and biosimilars. Biosimilars include second generation mAbs and fusion proteins: adalimumab, trastuzumab, bevacizumab, rituximab, infliximab, ranibizumab, tocilizumab, cetuximab, omalizumab, etanercept, abatacept and aflibercept all of which have been filed in the USA and Europe. Harvest Moon Pharma is now developing third wave mAbs natalizumab, eculixumab, golimumab, certolizumab, ustekinumab, pertuzimab, ipilimumab, denosumab, nivolumab, and pembrolizumab all in analytical comparability studies. These biosimilars are manufactured in the USA and comply with both FDA and EMA mAb revised guidelines. Mr. DiCicco is a member of the Editorial Board of the Journal of Generic Medicines.</p>

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    Renaissance Woodbridge Hotel
    13th November 2018
    Iselin, USA


    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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    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830

    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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    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.


    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.


    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.


    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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