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Approaches to standardising assays for measuring drug levels and anti drug antibodies to biotherapeutics
15 June 2016
Approaches to standardising assays for measuring drug levels and anti drug antibodies to biotherapeutics

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.
 

Workshop LEADER

keynote-img

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 agenda

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8:30

Registration & Coffee

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9:00

Workshop Leaders Introduction

Hishani Kirby, Founder & Director, Hishany Kirby Associates Ltd

Daniel  Sikkema

Daniel Sikkema, Head BioPharma Clinical Immunology, GSK

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9:10

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

  • Which format?
  • What are the parameters?
  • Constraints and challenges
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    10:30

    Morning Coffee

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    11:00

    Looking beyond - technological developments

  • Future standardization of methods
  • Advanced quantification techniques for biotherapeutics and application on immunogenicity
  • Associated challenges and solutions
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    12:00

    Q&A

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    12:30

    Closing Remarks from Workshop Leader and End of Workshop

    VENUE

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    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. 

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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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