EBF
EBF Focus
15-16 SEPTEMBER 2022 - NH Malaga, Spain
Managing GCP in Regulated Bioanalysis

29-30 SEPTEMBER 2022 – NH Malaga, Spain
Biomarkers/CoU - Sharing Experience through Examples

 

Program

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10:40–11:00 EBF’s feedback to the EMA and FDA draft guidance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