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The assay requirements for rapid decision making with licenced biotherapeutics in clinical practice can be very different from the best practice applied during regulated studies. The growing trend for TDM (therapeutic drug monitoring) with biotherapeutics has highlighted the need for harmonisation of assays and associated data throughout the lifecycle of a given drug.

In this workshop, an overview of historical approaches to validating methods to quantify biopharmaceuticals and to detect, monitor, and characterise anti-drug antibodies will be presented. The current best practices, terminology, and future insights for standardisation of methods and associated technological developments will be discussed.
 

Join us today to learn about the latest trends and developments for quantifying biotherapeutics and monitoring anti-drug antibodies in the context of assay harmonisation, associated challenges and possible solutions.

 

Chiefs, Directors, Heads, Principals, Managers of:

Immunology/ Immunogenicity
PK/PD
Pharmacokinetics
Bioanalysis
Chemistry
Biologics
Drug Discovery & Development
Scientist
and anyone who works in the related subject within pharmaceutical and biotech companies.
 

Workshop LEADER

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Hishani Kirby

Founder & Director, Hishany Kirby Associates Ltd

Spanning over 25years in the biopharmaceutical industry, Hishani has gained wide experience in the development of biopharmaceutical products. This has been mainly with Mab and Mab based fragments, where she has utilised her extensive protein analytical and bioanalytical expertise, in the characterisation and measurement of complex biotherapeutics. Having gained her PhD and following two postdoctoral positions at the University of London, Hishani continued her career at Celltech in Mab therapeutics and latterly, at UCB, Hishani was responsible for providing expert guidance on bioanalytical strategy in PK, PD and immunogenicity in support of the company’s portfolio from discovery through to post licencing phases of development, as well as leading the team responsible for execution of analytical and bioanalytical services.
Grappling with the issues of unwanted immunogenicity of biotherapeutics to provide a fit for purpose, clinically relevant approach to immunogenicity risk assessment to benefit both the patient and payor is a key area of interest which Hishani has promoted through her positions on the executive committees of the European immunogenicity platform (E-I-P) and IMI.
(www.abirisk.eu)
More recently, Hishani has formed her own consulting company providing expertise in scientific aspects of bioanalysis (PK,PD biomarkers), immunogenicity risk assessment and testing strategies, and in regulatory considerations in biopharmaceutical development. Her strengths are in designing and implementing practical/innovative analytical solutions to enable rapid decision making through development to post license life cycle management.
 

Hishany Kirby Associates Ltd

Hishani Kirby , PhD, Founder & Director, Hishani Kirby Associates Ltd

Spanning over 25years in the biopharmaceutical industry, Hishani has gained wide experience in the development of biopharmaceutical products. This has been mainly with Mab and Mab based fragments, where she has utilised her extensive protein analytical and bioanalytical expertise, in the characterisation and measurement of complex biotherapeutics. Having gained her PhD and following two postdoctoral positions at the University of London, Hishani continued her career at Celltech in Mab therapeutics and latterly, at UCB. As Senior Director and Head of department at UCB, Hishani was responsible for providing expert guidance on bioanalytical strategy in PK, PD and immunogenicity in support of the company’s portfolio from discovery through to post licencing phases of development, as well as leading the team responsible for execution of analytical and bioanalytical services.

Grappling with the issues of unwanted immunogenicity of biotherapeutics to provide a fit for purpose, clinically relevant approach to immunogenicity risk assessment to benefit both the patient and payor is a key area of interest which Hishani has promoted through her positions on the executive committees of the European immunogenicity platform (E-I-P) and IMI.
(www.abirisk.eu)

More recently, Hishani has formed her own consulting company providing expertise in scientific aspects of bioanalysis (PK,PD biomarkers), immunogenicity risk assessment and testing strategies, and in regulatory considerations in biopharmaceutical development. Her strengths are in designing and implementing practical/innovative analytical solutions to enable rapid decision making through development to post license life cycle management.
 

Dan Sikkema, PhD, Executive Director Clinical Immunology, GSK

Dan Sikkema joined GlaxoSmithKline (GSK) as Executive Director and Head of the Clinical Immunology group in BioPharm R&D in August 2010. He studied the regulation of Iron-Repressible Outer Membrane Proteins of Yersinia pestis, the causative agent of bubonic plague, for 4 years at Michigan State University during his PhD in Microbiology and Public Health. Between finishing at Michigan State University and starting at GSK he spent 4 years at the State University of New York Medical School as a post-doctoral fellow and Research Assistant Professor (Infectious Diseases) investigating vaccine candidates for otitis media caused by Haemophilus influenzae, followed by positions of increasing responsibility at Bristol-Myers Squibb (4 yrs), Wyeth Vaccines (10 yrs), Merck Vaccines and Biologics (4 yrs), and Sanofi Pasteur (2 yrs). In his career, he has contributed to the clinical immunology and microbiology assessments leading to licensure of Prev(e)nar, Meningitec, Gardasil, Rotavax, ProQuad, and Zostavax, and has worked extensively with the World Health Organization, US Centers for Disease Control, National Institute for Biological Standards and Controls, US FDA, and EMA. Now at GSK he is heading the Immunogenicity and Clinical Immunology group assessing immunogenicity of administered biotherapeutics and the quantitation of target-engaged biomarkers in the clinical setting, as well as leading the Innovative Medicines Initiative (www.abirisk.eu) to further understand the underlying mechanisms and basic biology around induction of immunogenicity to biotherapeutics and their clinical relevance. July 1, 2015, he assumed the Chair Elect position for Division V at American Society for Microbiology.
 

Workshop programme

8:30 Registration & Coffee

9:00 Workshop Leaders Introduction

Hishani Kirby

Hishani Kirby, Founder & Director, Hishany Kirby Associates Ltd
View Bio

Daniel  Sikkema

Daniel Sikkema, Head BioPharma Clinical Immunology, GSK

9:10 Overview of historical approaches for drug and ADA measurement: Fit for purpose?

10:30 Morning Coffee

11:00 Looking beyond - technological developments

12:00 Q&A

12:30 Closing Remarks from Workshop Leader and End of Workshop

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Holiday Inn Kensington Forum

97 Cromwell Road
London SW7 4DN
United Kingdom

Holiday Inn Kensington Forum

Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

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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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