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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


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 programme

8:30 Registration & Coffee

9:00 Regulatory strategy and requirements in biosimilar development

David Lin

David Lin, Senior Consultant, Biologics Consulting
View Bio

9:30 High level overview of formulation development for biosimilars

Hiten Gutka

Hiten Gutka, Principal Scientist Formulation Development Biosimilar Development, Oncobiologics

10:00 Morning Coffee

10:30 Analytical development and the establishment of the release profi le

Amber Fradkin

Amber Fradkin, Director Particle Characterization Core Facility, KBI Biopharma

11:30 Selection and limitations of extended characterization techniques for the establishment of biosimilarity

Brent  Kendrick

Brent Kendrick, CSO, Elion Labs LLC

12:00 Statistics and the formal comparability exercise

Jose Ramirez

Jose Ramirez, Consultant, Amgen

12:30 Close of Workshop


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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, 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.


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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