Standardised Lab Manual for bioanalytical

support in clinical studies :

Introducing the harmonised Lab Manual

Introduction to the Workshop

Philip Timmerman (for EBF)

05 February 2014

NH Sablon Hotel, Brussels

Welcome to Brussels

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EBF

EBF was founded in 2006 at the initiative of 12

pharmaceutical companies, all having

bioanalytical lab activities in Europe.

The goal of forming our Forum was to create a

platform for discussions of science, day-to-day

procedures, business tools, technologies and

last but not least regulatory issues

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Mission

Our mission is to share, discuss, optimize and seek alignment on a broad array of bioanalytical topics including science, procedures, business tools and technology, and regulatory issues.

Internal discussions within EBF aim to recommend or influence opinions/procedures towards our members, business partners, regulatory bodies and any other stakeholders.

Going forward, EBF is providing guidance and recommendations to the European and Global bioanalytical community

Finally, provide development opportunities for EU based scientist by joining cross company collaborations and contributions to peer reviewed journals, international meetings and symposia.

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EBF Today, EBF counts 53 member, or the vast majority

(global and EU based Pharma and CRO) companies

with regulated bioanalysis activities in EU.

Since 2006, EBF has organized 9 international

symposia (Barcelona, Brussels), 3 workshops and has

published over 20 papers (scientific or recommendation

on process), covering all areas of regulated bioanalysis

with major impact.

More info on:

http://www.europeanbioanalysisforum.eu/

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Where does the EBF interest on lab

manuals started?

The internal EBF organization (83 experts from

53 companies) discusses many aspects of

bioanalysis in Topic teams almost on a day to

day basis.

Currently about 20 of these teams are active.

Topics discussed are related to general

bioanalysis processes and regulations, topics

connecting with stakeholders or more science

oriented topics involving the chromatography

(LC-MS) or ligand binding assay community.

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TT-12

TT-12: Clinical Multi Center Trials

Topic Team started in 2011 with 12 EBF

companies on board to prepare the work.

Desired Outcome:

– Get agreement in BA community on the real and

perceived issues in bioanalytical support of MCT

– Create awareness with our customers and service

providers on bioanalytical interactions in MCT

– After understanding the landscape Team identified one

important tangible deliverable from 2012 onwards:

propose a standard lab manual for sample management

in clinical trials (with focus on MCT) to improve overall

quality of trial and save on costs

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Why this meeting?

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Share internal discussions within EBF on proposing a standard lab manual

Learn from all stakeholders on what is working and what isn’t

Get input from all stakeholders in clinical trail management in our proposal and fine tune lab manual

Get buy-in to promote the standardized lab manual as a starting template general use in bioanalytical sample logistics of clinical trials

How did we define our stakeholders?

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Everybody we thought that from far or close by can impact the chain of custody from sampling to arrival at the bioanalytical facility….

And, unless you showed up as a tourist opportunity to visit Brussels, we were probably right..

12:00 - 13:00 Welcome lunch

13:00 - 13:10 Introduction to the workshop

Philip Timmerman (Janssen R&D, for EBF)

13:10 - 13:30 A case study: temperature control

Stuart McDougall (Covance, for EBF TT-38)

13:30 - 14:00 Introducing the harmonized manual

Richard Abbott (Shire, for EBF)

14:00 - 15:00 Session 1: Input and comments from Clinical PK

Bart Remmerie (Janssen R&D)

Donna-Michelle Smith (Cancer Research UK Cambridge)

15:00 - 15:30 coffee break

15:30 - 16:30 Session 2: Input and comments from Sample Logistics

Jean-Guy de Gruben (World Courier)

Scott Vincent (A4P)

16:30 - 17:30 Session 3: Input from study monitors

Tammy Harter (Covance) Peter van Amsterdam replacing Hanneke van Assche (Abbott)

17:30 - 19:00 Complementary cocktail reception: the Belgian Beer tour

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05 FEB

In practice

In each session, 2 industry speakers, experienced in

working with lab manuals, will share comments and

give input/propose enhancements on the EBF lab

manual. Their 15 min. presentations will be followed

by a 30 minute plenary discussion.

Each session will be moderated by both presenters

and an EBF experts involved in building the manual.

– Richard Abbott

– Jeff Long

– Carina Ekstrom

– Rebecca Sleigh

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17:30-19:00 Reception

Belgium, Beer country by excellence

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Be aware…….

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08:00 - 08:30 Morning coffee and pastries

08:30 - 09:30 Session 4: Input and comments from clinical operations

Julia Gall (CRS)

Marten Harbers replacing Helen Pruim (PRA)

09:30 - 10:30 Session 5: Input and comments from a phase-1 unit

Els Jacob (Janssen R&D)

Berry Everts (QPS)

10:30 - 11:00 Coffee break

11:00 - 12:30 Session 6: Input and comments from central labs

Gerrit Schönicke replacing Bärbel Wilke (LKF)

Natalie Rossignol replacing Marina Sinkovic-Vaugeois (Covance CL)

12:30 - 13:30 Lunch

13:30 - 14:00 Session 7: Perspective from regulatory and health authorities

David Butler (Quotient, for RQA)

14:00 - 15:00 Workshop discussion: refining the harmonized lab manual

Moderators: Stuart, Richard, Philip

15:00 - 15:30 Next steps: promoting the use of the harmonized lab manual

Philip, Stuart, Richard

15:30 - 16:00 coffee, pastries and adjourn

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06 FEB

Looking forward to your active

interaction!

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Did we reach our goal?

Congratulations….although EBF has a

good track record in engaging people, this

LM Workshop is maybe the EBF meeting

with the most intense discussions.

But the work is not done

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Actions and learnings from the meeting

Consider 2 track approach o Lab manual template for HV Phase-1 trials

o Lab manual template for CL coordinated (MCT) trials

Team in front/parallel of next 2 teams:

o common principles and practice…from there

split into two subteams: 1. HV trials

» Include comments from the meeting

» Identify a small team, including non BA experts

2. CL coordinated (MCT) trials

» Include comments from the meeting

» Identify a small team, including non BA experts

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Timelines

Q1/beginning of Q2-2014

– Updated both documents

– Via regular TCs

E.o. Q2/Q3-2014

– Rapid communication/editorial in a relevant paper (the target audience)

– Make both manuals available on our website

– Start socializing the manuals

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In the mean time

PDF of all slides will be shared with delegates of this meeting via e-mail

EBF can load slides on their website if we feel this stimulates the discussion in industry

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