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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;

FEATURED SPEAKERS

Don Stewart

Don Stewart

CEO, PlantForm Corp
Hillel Cohen

Hillel Cohen

Executive Director, Scientific Affairs, Sandoz Inc

Anita Burrell

Founder and CEO, Anita Burrell Consulting
Anita Burrell

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.

HoUng Kim

Senior Director, Celltrion Inc.
HoUng Kim

Richard Dicicco

Chairman, Harvest Moon Pharmaceuticals USA, Inc.
Richard Dicicco

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

Media Partners


The Medicine Maker

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The Medicine Maker


Samedan

Official Media Partner
http://www.samedanltd.com/magazine/13.

International Clinical Trials (ICT) is a quarterly magazine edited by Dr Graham Hughes, and written by specialists at the forefront of clinical research. ICT’s coverage of operational developments ranges from adaptive designs in early phase trials through to post marketing research. ICT’s targeted readership consists of key decision makers across the pharmaceutical and biotech industries, along with contract partners and consultants. The magazine is distributed to pharmaceutical professionals in Europe and North America, and is accessed globally online. Read the latest issues, explore the ICT archive and subscribe at www.samedanltd.com/magazine/13.


Pharma Journalist

Official Media Partner
http://www.pharmajournalist.com

Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


World Pharma News

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http://www.worldpharmanews.com/


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Technology Networks

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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


Gate2Biotech

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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.


Pharmalicensing

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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.


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.


ASD MEDIA

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http://www.asd-network.com

Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
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  • Find companies and organizations; www.asdsource.com
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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


Mednous

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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

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Renaissance Woodbridge Hotel

515 US Highway 1 South
Iselin 08830
USA

Renaissance Woodbridge Hotel

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

HOTEL BOOKING FORM

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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