Program Training day

Critical reagents for LBA

13 MAY 2018
17:00	Registration desk opens
18:00 – 19:00	Welcome reception – Altis Hotel
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14 MAY 2018
07:30	Registration desk opens
08:45 – 09:00	Welcome and introduction
09:00 – 10:30	Session 1 – Critical reagents for PK assays: general & regulatory framework
09:00 – 09:15	Introduction to the session – Susanne Pihl (on behalf of the EBF)
09:15 – 09:45	Update on the guidelines and current practice in industry
	Michaela Golob (on behalf of the EBF)
09:45 – 10:15	The EBF decision tree on CR for PK assays, in perspective of current industry practices
	Susanne Pihl (on behalf of the EBF)
10:15 – 10:30	Q&A
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10:30 – 11:00	Coffee break & networking
11:00 – 12:30	Session 2 – Case studies on alternative approaches to manage critical reagents (PK assays)
11:00 – 11:20	Case study: The importance of quality critical reagents for the entire developmental life cycle of a biopharmaceutical: A PK Case Study
	Andrew Mayer (GlaxoSmithKline)
11:20 – 11:40	Characterization of critical reagents – FB from the AAPS ADA community
	Jonathan Haulenbeek (BMS, on behalf of the AAPS)
11:40 – 12:00	Critical reagents for PK assessment – How reagent characteristics can impact your result interpretation
	Thomas Emrich (Roche Pharma Research and Early Development)
12:00 – 12:30	Expert panel discussion
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12:30 – 13:30	Lunch
13:30 – 15:00	Session 3 – Critical reagents for immunogenicity assays – general & regulatory framework
13:30 – 13:45	Introduction to the session – Birgit Jaitner (on behalf of the EBF)
13:45 – 14:05	Update on the guidelines and current practice in industry
	Jo Goodman (on behalf of the EBF)
14:05 – 14:40	Recommendations on CR for immunogenicity assays, in perspective of current industry practices
	Barry van der Strate (on behalf of the EBF)
14:40 – 15:00	Q&A
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15:00 – 15:40	Coffee break & networking
15:40 – 17:15	Session 4 – Case studies on alternatives approaches to manage critical reagents (immunogenicity assays)
15:40 – 16:00	Qualification of new lots of critical reagents for IG assays: Some practical examples
	Lydia Michaut (Novartis)
16:00 – 16:20	Management of an ADA critical reagent issue during a clinical study support
	Laurent Vermet (Sanofi)
16:20 – 16:40	ADA Case study: Generation and characterization of critical reagents supporting immunogenicity assays: Case studies on how to navigate challenging drug modalities
	Terri Caiazzo (Pfizer)
16:40 – 17:15	Expert panel discussion
17:15 – 17:30	Closing Questions & Answers session
	Panel of presenters answering delegate’s pre-submitted questions
17:30	Adjourn