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Biosimilar Development and the Establishment of Biosimilarity
November 14, 2017
Biosimilar Development and the Establishment of Biosimilarity

The purpose of this forum is to discuss strategies for dealing with the evolutionary process that occurs across the product development lifecycle, especially as it pertains to the development of biosimilars. Phase-appropriate requirements for release, characterization and stability of materials will be discussed. Establishment of biosimilarity, based on a thorough analytical characterization of the product and process, will also be addressed.

Workshop LEADER

keynote-img

David Lin

Senior Consultant, Biologics Consulting

Dr. lin received a BA in Biochemistry from
the University of Pennsylvania in 1984; a PhD
in Organic Chemistry from the University of
Maryland in 1989; and received a Masters
Degree in Business Administration from the
University of Maryland’s RH Smith School of Business in 2002.
From 1997-2001 he was a Chemistry Reviewer in the Division
of Reproductive and Urologic Drug Products, Center for
Drug Evaluation and Research (CDER), FDA, and in 2001
became the Team Leader in the same Division. He had
been serving as the acting Deputy Division Director in the
Division of New Drug Chemistry III (DNDCIII), Offi ce of New
Drug Chemistry since 2003, and was promoted in 2004 to
the acting Division Director.
As a Senior Consultant at Biologics Consulting, Dr. Lin utilizes
his drug quality (CM&C) scientifi c and regulatory expertise,
along with business administration training, to assist clients
in areas of drug development including Global CM&C
development planning for drugs and biotechnological/
biological drugs, Assisting clients in the development of
analytical methodology and design of stability testing
protocols and representing clients in interactions with FDA.

Biologics Consulting

Biologics Consulting is a full-service regulatory and product development consulting fi rm for Biologics, Pharmaceuticals and Medical devices, supporting companies large and small seeking to bring innovative, safe and effective products to the market within the US

Workshop agenda

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8:30

Registration & Coffee

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9:00

Regulatory strategy and requirements in biosimilar development

David Lin, Senior Consultant, Biologics Consulting

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9:30

High level overview of formulation development for biosimilars

Hiten Gutka

Hiten Gutka, Principal Scientist Formulation Development Biosimilar Development, Oncobiologics

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10:00

Morning Coffee

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10:30

Analytical development and the establishment of the release profi le

Amber Fradkin

Amber Fradkin, Director Particle Characterization Core Facility, KBI Biopharma

clock

11:30

Selection and limitations of extended characterization techniques for the establishment of biosimilarity

Brent  Kendrick

Brent Kendrick, CSO, Elion Labs LLC

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12:00

Statistics and the formal comparability exercise

Jose Ramirez

Jose Ramirez, Consultant, Amgen

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12:30

Close of Workshop

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

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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, 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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