Standardised Lab Manual for bioanalytical support in clinical studies : Introducing the harmonised Lab Manual. Introduction to the Workshop

Transcription

1 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

2 Welcome to Brussels 10-Feb

3 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 10-Feb

4 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. 10-Feb

5 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: 10-Feb

6 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. TT

7 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 10-Feb

8 Why this meeting? 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 10/02/

9 How did we define our stakeholders? 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.. 10/02/

10 12:00-13:00 Welcome lunch 05 FEB 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 10-Feb

11 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 10-Feb

12 17:30-19:00 Reception Belgium, Beer country by excellence 10-Feb

13 Be aware. 10/02/

14 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 06 FEB 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 10-Feb

15 Looking forward to your active interaction! 10-Feb

16 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 16

17 Actions and learnings from the meeting Consider 2 track approach o o Lab manual template for HV Phase-1 trials 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 17

18 Timelines Q1/beginning of Q Updated both documents Via regular TCs E.o. Q2/Q Rapid communication/editorial in a relevant paper (the target audience) Make both manuals available on our website Start socializing the manuals 18

19 In the mean time PDF of all slides will be shared with delegates of this meeting via EBF can load slides on their website if we feel this stimulates the discussion in industry 19