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Building on the success of previous events, SMi 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

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 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

    Ha Kung Wong

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

    - 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.
     

    11:40 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”
     
  • 12:20 Networking Lunch

    13:20 Do biosimilars really need Real World Evidence?

    Anita Burrell

    Anita Burrell, Founder and CEO, Anita Burrell Consulting
    View Bio

  • 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 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
  • 14:40 Afternoon Tea

    15:10 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
     
  • 15:50 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
  • 16:30 PANEL: How sustainable is the biosimilars market?

  • 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?
  • Richard Dicicco

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

    Anita Burrell

    Anita Burrell, Founder and CEO, Anita Burrell Consulting
    View Bio

    Christina Yunis

    Christina Yunis, Global Biosimilars Market Development Lead, Pfizer

    17:10 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?

    Richard Dicicco

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

  • Do you target the emerging market first?
  • Considerations and strategies when choosing which biosimilar to include in your pipeline
  • Venturing out of monoclonal antibody biosimilars
  • 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, Senior Director, Amneal Pharmaceuticals
    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 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 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
  • 14:00 Biosimilars – can they all survive?

    Steinar Madsen

    Steinar Madsen, Medical Director, Norwegian Medicines Agency

  • Will the first biosimilar always win?
  • Switching – is there a cost limit?
  • From biosimilars to biosimilars in practice – problem or solution? 
  •  

     

    14:40 Afternoon Tea

    15:10 A case study of development for biosimilars

    Magdalena Leszczyniecka

    Magdalena Leszczyniecka, Founder and CEO, STCBiologics Inc

  • The strategy of development used
  • Scientific issues encountered during development
  • How the scientific issues can be circumvented in order to streamline development
  • The process of approval

    Magdalena Leszczyniecka, President and CEO, STC Biologics

  • 15:50 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
     

    16:30 PANEL: Forecasting uptake of biosimilars entering the market: Points to consider

  • How can biosimilars differentiate themselves when clinical differentiation isn’t possible? How much will manufacturing quality and reliability of supply matter?
  • What levers are the most successful at encouraging biosimilar adoption?
  • The changing balance of decision-making power across stakeholder 
  • Richard Dicicco

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

    Nigel Rulewski

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

    Edric Engert

    Edric Engert, Managing Director , Abraxeolus Consulting
    View Bio

    17:10 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    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

    Anita Burrell is a dynamic, passionate and infectiously enthusiastic consultant focused on improving patient outcomes through pharmaceutical innovation. She is also an adjunct assistant professor at Rutgers University and a regular speaker in the industry on health economics, market access and mHealth.

    Anita has 23 years of leadership experience in the pharmaceutical industry in a wide variety of roles and geographies. As the Global Project Lead for Aubagio, the oral MS therapy from Genzyme, she was able to bring Aubagio to market over eight months ahead of schedule becoming the second oral therapy to market in the USA and EU. Aubagio is the fastest growing MS product in the US and the #1 product in the Genzyme/Sanofi portfolio with revenue of €1.6B in 2017.

    As a consultant Anita has helped companies to:
    Understand market dynamics and payer behavior in diabetes and MS
    Design big data platforms to deliver value in terms of regional sales variations
    Develop predictive models to inform HTA submissions
    Understand the implications of digital health and possibilities to use behavioural economics

    Anita holds a BA (Hons) in Economics from the University of Stirling, an M.A. in Economics from Dalhousie University, Nova Scotia, Canada, and a Masters in Business Administration from Kingston University, Surrey UK. She speaks French at an advanced level.

    For more insight visit https://www.linkedin.com/in/anitaburrell
     

    Arun Nataraj

    Senior Director, Amneal Pharmaceuticals
    Arun  Nataraj

    Arun Nataraj has over 17 years of Business Development & Licensing experience in the Pharma Industry. After spending a decade in pharma manufacturing organizations, most recently at Lonza, where his roles included leading licensing for Lonza’s leading mammalian expression system, Arun then switched over to the “buy side” by joining Amneal Pharma, where he worked until recently, and led BD&L activities for the US market. During his career, Arun has completed over a hundred transactions, from In/Out Licensing of Products & Technology Platforms; Technology Transfers; Manufacturing agreements for Products & Devices; and Commercial Distribution Arrangements. Arun has a PhD in Molecular Biology from the MD Anderson Cancer Center and an MBA from Cornell University.

    Catherine Soo

    Senior Clinical Evaluator, Health Canada
    Catherine Soo

    Catherine Soo holds a PhD in Pharmacology and joined Health Canada in 2011 as a Regulatory Project Manager in the Therapeutic Products Directorate (TPD), Health Products and Food Branch. Shortly after joining, she moved into a review position within the Bureau of Pharmaceutical Sciences, TPD, where she focused on the review of generic pharmaceuticals. Since 2015, Catherine has been working in the Biologics and Genetic Therapies Directorate as a Senior Clinical Evaluator on the review of biologics products, including biosimilars. Catherine therefore has extensive experience in the review of bioequivalence and comparative bioavailability studies in both the pharmaceutical and biologics areas, as well as knowledge of the regulatory requirements for filing.

    Christina Yunis

    Global Biosimilars Market Development Lead, Pfizer
    Christina Yunis

    Christopher Loh

    Partner, FITZPATRICK, CELLA, HARPER & SCINTO
    Christopher Loh

    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.
     

    Edric Engert

    Managing Director , Abraxeolus Consulting
    Edric Engert

    Edric Engert is Managing Director of Abraxeolus Consulting and has over 20 years of experience in the healthcare industry. He offers problem solving leadership and expertise in such areas as strategy, its operationalization, business development/in-licensing, portfolio strategy, selection, and management, operational improvement programs and turnarounds, and M&A. He has advised a broad range of clients in such industries as Biosimilars, Generics, Branded Pharmaceuticals, API, Healthcare Information Exchanges, distributors, trade associations, and not-for-profit agencies.

    Prior roles included Head of the Biosimilars Business at Teva, leading Generics portfolio, BD, strategy, and API sourcing at companies like Sandoz and Teva, and consultant at McKinsey & Company’s health care practice. Edric holds an MBA from Wharton and a BS in Mathematics from MIT.
     

    Ha Kung Wong

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

    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

    Magdalena Leszczyniecka

    Founder and CEO, STCBiologics Inc
    Magdalena Leszczyniecka

    Nigel Rulewski

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

    Dr Nigel Rulewski MD, DCH, DRCOG is Vice President and Head of the Biosimilar Center of Excellence at IQVIA. Dr Rulewski has over 25 years of experience in the pharmaceutical industry.
    He has been involved in all stages of development of biosimilar products for approval in the US, EU and major global markets. Prior to joining IQVIA, Dr. Rulewski served as Chief Medical Officer at Astra USA, Fisons, Serono, Procept and ArQule. He has managed FDA Advisory Committee meetings, and interacted with the FDA on numerous drug development projects in diverse therapeutic areas resulting in seven successful US approvals. He also served as a consultant working in venture capital in the US funding biotech startup companies. During the development of the AIDS crisis, Dr. Rulewski was media trained and acted as a company spokesperson on sensitive drug development issues handling both press and TV interviews. He received his medical training at St Bartholomew’s Medical School, University of London and completed post graduate training in Obstetrics and Gynecology, (Diploma in Child Health, Royal College of Physicians) and Pediatrics
     

    Peter Waibel

    Head of US Patent Litigation, Novartis
    Peter Waibel

    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>

    Sarfaraz Niazi

    Founder, Karyo Biologics, LLC
    Sarfaraz Niazi

    Prof. Sarfaraz K. Niazi, Founding Chairman of Karyo Biologics, Founder and Ex-Executive Chairman of Adello Biologics, and Adj. Professor of Biopharmaceutical Sciences, University of Illinois, has developed several biosimilar products, written 50+ major textbooks and handbooks, authored 100+ research papers, and owns the largest number of bioprocessing patents. He is a major contributor to the the BPCIA and the FDA guidance that followed. Dr. Niazi’s Citizen Petitions on bioequivalence testing and biosimilar development have been accepted by the FDA. www.niazi.com; www.karyobio.com; niazi@niazi.com

    Steinar Madsen

    Medical Director, Norwegian Medicines Agency
    Steinar Madsen

    Official Media Partner

    Supporters

    Workshops

    Decoding How Stakeholders May Drive Biosimilar Adoption
    Workshop

    Decoding How Stakeholders May Drive Biosimilar Adoption

    Renaissance Woodbridge Hotel
    13th 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.

    HOTEL BOOKING FORM

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

    Download

    News Article on Celltrion

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    Speaker Interview Edric Engert, Abraxeolus Consulting

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    Speaker Interview HoUng Kim, Celltrion Healthcare

    Download

    Speaker Interview Catherine Soo, Health Canada

    Download

    The FDA’s infographic on the biosimilar development process

    Download

    2018 Brochure

    Download

    2017 Speaker Presentation from KARYO BIOLOGICS

    Download

    2017 Speaker Presentation from PlantForm Corporation®

    Download

    2017 Speaker Presentation from profecyINTEL, LLC

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    2017 Speaker Presentation from COVANCE

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    2017 Speaker Presentation Zuckerman Spaeder

    Download

    2017 Speaker Presentation from Sandoz

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    Speaker Interview with Anita Burrell, Anita Burrell Consulting

    Download

    Speaker Interview with Sarfaraz Niazi, Founder, Karyo Biologics

    Download

    Press Release on FDA Biosimilar Action Plan

    Download

    Speaker Interview Hillel Cohen, SANDOZ

    Download

    2018 Speakers

    Download

    2018 Agenda

    Download

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    http://www.farmavita.net/

    Farmavita Net is professional community and network of pharmaceutical licensing and business development executives, innovators and researchers
    Farmavita.Net is the pharmaceutical licensing, technology transfer and regulatory affairs network. We are managing the marketplace of offers and demand for pharmaceutical Dossiers, know-how and technologies. Members of Farmavita.Net network usually find a number of attractive solutions for business development, alliances, joint ventures, co-development and co-marketing of pharmaceutical products. Farmavita.Net is not just a pure Internet portal. We manage a number of regional associates. We are connecting the dynamic network of few hundreds members / pharmaceutical companies interested in license-in and license-out opportunities.

    Media Partners


    Labcompare

    Supporters
    http://www.labcompare.com

    Labcompare is a product of American Laboratory, and is already included in the AL logo on your website. I have attached the standalone Labcompare logo and info is below, but if you do add this one separately, could you exchange the American Lab logo with the one attached? For laboratory managers and researcher scientists across analytical chemistry and applied sciences who need to find product solutions, advice, and access scientific tools. Labcompare provides an industry-leading, comprehensive, online resource of product information to support the laboratory’s needs. Labcompare supports every step of the buying journey by focusing on core and new product technology, supplies, tips, and buyer’s guides.


    ASD MEDIA

    Supporters
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
    • Find companies and organizations; www.asdsource.com
    • Distribute news globally. www.asdwire.com
    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

    For more detailed information please contact with: ASD MEDIA
    Stefan.koopman@asdmedia.nl


    Biocompare

    Supporters
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    Bentham Science

    Supporters
    http://www.benthamscience.com/

    Bentham Science Publishers is a major STM journal publisher of 130 plus print and online journal. Out of these, 40 journals have already registered good IMPACT FACTORS as per Journal Citation Reports® 2017. These titles have extensive readership mostly in Europe and North America. For a detailed profile please visit our website at http://www.benthamscience.com. Besides, Bentham Science publishes eBooks in all areas of Science, Technology and Medicine. Our eBooks provide professionals, academicians, corporate researchers, graduates and undergraduates worldwide with the most current information in their subject areas of interest. Our eBooks are also available in the ePub and Kindle formats besides the PDF edition here http://ebooks.benthamscience.com/. Bentham is offering attendees of this conference discounts on its publication. For more information click here


    American Laboratory

    Supporters
    http://www.americanlaboratory.com

    For laboratory managers and researchers utilizing analytical chemistry and its applications, seeking knowledge on new technologies, methods, applications, and products, the American Laboratory® publication platform provides comprehensive technology coverage for laboratory professionals at all stages of their careers. Unlike single-channel publications, American Laboratory® is a multidisciplinary resource that engages scientists through print, digital, mobile, multimedia, and social channels to provide practical information and solutions for cutting-edge results. American Laboratory® serves the need of global community of laboratory professionals for communicating relevant technical advances and insights. Globally, American Laboratory® reaches out to subscribers by offering digital distribution plus premium print in North America. Digital communications utilize internet, mobile and social channels.


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Open Chemistry

    Supporters
    http://www.openchemistry.com

    Open Chemistry (IF - 1.425) is a peer-reviewed, open access journal that publishes original research, reviews and short communications in the fields of chemistry in an ongoing way. Our central goal is to provide a hub for researchers working across all subjects to present their discoveries, and to be a forum for the discussion of the important issues in the field.


    Pharmaceutical Outsourcing

    Supporters
    http://www.pharmoutsourcing.com

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


    Gate2Biotech

    Supporters
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    pharmaphorum

    Supporters
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    Mednous

    Supporters
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    American Pharmaceutical Review

    Supporters
    http://www.americanpharmaceuticalreview.com

    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


    Technology Networks

    Supporters
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com

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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, 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

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    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
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