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Focus Workshop Slides 2016 June

Program of EBF Workshop  “Bringing Assay Validation and Analysis of Biomarkers into Practice”  June 9-10, 2016

PDF renditions of the powerpoint presentations can be viewed and downloaded from this page by clicking the specific point on the program. The program itself can be viewed and downloaded by clicking here

08.45-09.00 Welcome and aim of the meeting – Plenary 
09:00-10.30 A developing regulated environment for Biomarker Assay Validation – Plenary
09:00–09:25 Overview and comparison of current approaches to Biomarker assay
validations in drug development and diagnostics.
(John Allinson, on behalf of the EBF)
09:25–09:50 Biomarker Assay Validation – a status update on the EBF Recommendation
and discussions in Industry.
(Marianne Scheel Fjording, on behalf of the EBF)
09:50–10:10 Biomarker Assay Validation – are we asking the right questions and can we optimize
the scientific Pharma/CRO interface.
(Philip Timmerman, on behalf of the EBF)
10:10–10:30 Panel discussion: how to integrate the different expectations into solid regulatory strategy?
(Moderators & Panelists: Begoña Barroso, John Smeraglia and Session presenters)
10:30–11:00 Coffee break
workshop sessions
Note: each 90 minute (breakout) session will consist of 4 parts:
·       Preparing for the analysis: Integrating project info, PK, PD, aspects of
         biology/pharmacology , link to healthy volunteers/target population (15 min.)
·       Analytical challenges – assay criteria – Assay development and validation (15 min.)
·       How have/will data be(en) used in the project (15 min.)
·       Panel discussion: what would you have done differently, how and why? (45 min.)
11:00–12.30 Morning Workshop session – Plenary
11:00–12:30 To spike or not to spike? The value of spiking recombinant proteins for the validation
of biomarker methods.
(Liz Hickford, UCB BioPharma)
12:30–13:30 Lunch
Presentation – Plenary
13:30–14:15 Biomarker driven early phase oncology clinical trials; challenges in the real world.
(Sidath Katugampola, CRUK Centre for Drug Development)
14:15–14:30 Logistic break – change rooms to go into breakout
14:30-16:00 Afternoon Workshop session – Breakout
14:30–16:00 4 Beta hydroxycholesterol, an emerging biomarker on hepatic CYP3A4 activity
with the potential of predicting Drug-Drug Interactions.
4β-Hydroxycholesterol, an endogenous marker of CYP3A activity
  (Ulf  Diczfalusy, Karolinska Institutet)
– 4β-Hydroxycholesterol as an Emerging Endogenous Biomarker of Hepatic CYP3A
  (Hamza Kandoussi, BMS)
– Data from 4β-hydroxycholesterol in clinical development projects
  (Cecilia Arfvidsson, AstraZeneca)
14:30–16:00 Development of an early stage Biomarker within discovery: considerations for assay
(Adrian Freeman, Envigo)
16:00–16:30 Tea break
16:30-18:00 Afternoon Workshop session – Plenary
 16:30-18:00 Integrating an exploratory BM in an early clinical stage in Pharma R&D.
(Ulrich Kunz, Boehringer-Ingelheim)
Morning Workshop – Plenary
09:00–10:30 Verification and validation of an efficacy biomarker during early clinical development.
(Robert Nelson, Novimmune)  
10:30–11:15 Coffee break
Presentation – Plenary
11:15–12:00 Integrating Biomarker data into projects. Overcome Challenge and develop
partnership to maximize value.
(John Allinson, LGC)  
12:00–12:30 feedback and summary from the workshop sessions (20 minutes)
Introduction to the planery closing panel discussion (10 minutes)
12:30–13:30 Lunch
13:30–15:00 Closing Panel discussion – Plenary
Bringing Assay Validation and Analysis of Biomarkers into Practice – Development
of biomarkers strategy/hypothesis, incl.
• Interaction within discovery, preclinical and clinical colleagues to understand Mode of
  Action, PK/PD, and how effect translate into clinical
• How understanding biology impacts sampling strategies and the assay validation criteria
Moderators: conference organizers and presenters
15:00–15:30 Tea break
15:30–16:00 Summary, conclusion and next steps. 
16:00 Adjourn