programma hulp -

Challenging the Current Paradigm for ADA Testing

21-22 September 2023, NH Málaga, Spain

The draft agenda of the meeting can be found in this link: PDF of program.
Changes in the draft agenda will be announced regularly and uploaded on the website as the agenda crystalizes further.

EBF – Focus Workshop draft agenda

Current Analysis of Immunogenicity: Best Practices and Regulatory Hurdles

27-28 September 2016 , Lisbon
The Altis Grand Hotel, Lisbon, Portugal

draft agenda – Version 28JUN2016

26-Sep-2016
17:00-19:00	Registration desk opens
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27-Sep-2016
07:30	Registration desk opens
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08.45-09.00	Welcome and aim of the meeting
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09:00-10.10	The current landscape and future challenges on immunogenicity
09:00–09:30	The current regulatory landscape on immunogenicity
	(Michaela Golob, on behalf of the EBF)
09:30–09:50	EMA view on immunogenicity regulations
	(Venke Skibeli, Avd. for legemiddelutredning, Norway)
09:50–10:10	Awaiting confirmation – Regulatory Feedback session 2
	(presenter tbc – from HA – US)
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10:10–10:40	Coffee break & networking
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10:40–12.30	A rapidly changing regulatory environment
10:40–11:00	EBF’s feedback to the EMA and FDA draft guidance
	(Jo Goodman, on behalf of the EBF)
11:00–12:30	Panel discussion
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12:30–13:30	Lunch
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13:30–15:30	Challenges of drug tolerance and interferences
13:30–13:45	Case study 1 – Strategies for improving ADA assay sensitivity, when high
	drug or target concentrations cause interference
	(James Munday, Covance)
13:45–14:00	Case study 2 – Overcoming drug & target interference in ADA and NAb assays
	(Robert Nelson, Novimmune)
14:00–14:15	Case study 3: Reflections on the use of acid treatment for improving drug
	tolerance in ADA assays
	(Nicoline Videbæk, NovoNordisk)
14:15–14:30	Case study 4 – title tbc
	(Thomas Emrich, F. Hoffmann La Roche)
14:30–15:30	Panel discussion
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15:30–16:00	Tea break
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16:00–18:00	Alternatives for NAb assessment
16:00–16:30	Strategies to assess the neutralizing capacity of Biopharmaceuticals
	(Daniel Kramer, Sanofi)
16:30–17:00	Strategies to determine assay format for the assessment of neutralizing
	Antibody responses to biotherapeutics
	(Jim McNally, Merck Serono, on behalf of the AAPS Immunogenicity DG)
17:00–18:00	Panel discussion
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18:00	End Day 1
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28-Sep-2016
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09:00–13:00	Cut-point setting in ADA and NAb assays
09:00–09:30	Title tbc
	(Simon Cowen, LGC)
09:30–10:30	Title tbc
	(Viswanath Devanarayan, Abbvie)
10:30–11:00	Coffee break & networking
11:00–11:20	Pitfalls in cut-point setting
	(Timo Piironen, Syrinx Bioanalytics)
11:20–11:40	Title tbc
	(Denise Sickert, Novartis)
11:40–13:00	Panel discussion
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13:00–14:00	Lunch
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14:00–15:00	Closing focus workshop panel discussion
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15:00–15:30	Tea break
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15:30–16:00	Summary, conclusion and next steps
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16:00	Adjourn

Program