Focus Workshop Slides 2019 May
Program of EBF Focus Workshop “ICH M10 – Public consultation & Industry Feedback Towards a Science based Global Bioanalytical Guideline”
May 20-22, 2019
PDF renditions of the powerpoint presentations given at the Focus Workshop can be viewed and downloaded from this page. The program itself can be viewed and downloaded by clicking here
Monday 20 May | ||
08:25 | 08:30 | Welcome, aim of the meeting |
08:30 | 10:00 | Plenary session 1 |
Introduction, objective, background and scope of the Guideline | ||
Comparison of draft ICH M10 with exisiting Guidance/Guidelines | ||
08:30 | 09:30 | Comparison of draft ICH M10 with exisiting Guidance/Guidelines |
EMA/MHLW – presenter: Joanne Goodman (AstraZeneca) | ||
NMPA(China) – presenter: Fan Jin (Covance, on behalf of the CBF) | ||
FDA 2018 – presenter: Boris Gorovits (Pfizer, on behalf of the AAPS) | ||
09:30 | 10:00 | Scope of ICH M10 – learnings from EBF Strategy Meeting, ICH M3 (R2) and metabolite quantification |
presenter: Philip Timmerman (EBF) | ||
10:00 | 10:30 | Coffee break |
10:30 | 12:20 | Plenary session 2 |
Did we consider the world around us? | ||
10:30 | 10:35 | Introduction in the session |
presenter: Michaela Golob (Nuvisan) | ||
10:35 | 10:50 | 3Rs and surrogate matrix |
presenter: James Lawrence (Envigo) | ||
10:50 | 11:10 | Clinical vs. Preclinical |
presenter: Eric Woolf (MSD) | ||
11:10 | 11:25 | Informed consent and GCP |
presenter: Cecilia Arfvidsson (AstraZeneca) | ||
11:25 | 11:40 | The Value of Decision-based acceptance criteria! |
presenter: Magnus Knutsson (Ferring) | ||
11:40 | 12:20 | Panel Discussion – including stakeholders from PK/TK and representatives of the UK-MHRA |
12:20 | 12:40 | Introduction to Tuesday workshops |
General introduction: aim of the workshops Philip Timmerman, EBF | ||
A. Dried Matrix Methods (introduction by Enaksha Wickremsinhe, Lilly) | ||
B. New or Alternative Technologies (introduction by Scott Summerfield, GlaxoSmithKline) | ||
C. Commercial and Diagnostic Kits (introduction by Arno Kromminga, Bioagilytix) | ||
12:40 | 13:40 | Lunch break |
13:40 | 14:10 | ICH M10: a global harmonised BMV Guideline |
presenter: Brian Booth (CDER) (Video/TC-link) | ||
14:10 | 15:40 | Plenary session 3 |
General principles of method development/Validation, Partial and cross validation | ||
14:10 | 14:20 | Introduction in the session |
presenter: Magnus Knutsson (Ferring) | ||
14:20 | 14:40 | Method Development |
presenter: Marco Michi (Aptuit) | ||
14:40 | 15:00 | Full & Partial Validation – LBA and CHROM |
presenter: Mark Arnold (Covance) | ||
15:00 | 15:20 | Cross validation |
presenter: Tom Verhaeghe (Janssen R&D) | ||
15:20 | 15:40 | Panel discussion |
15:40 | 16:10 | Coffee break |
16:10 | 18:00 | Plenary session 4: common themes in stability assessment |
16:10 | 16:20 | Introduction in the session |
presenter: Faye Vazvaei (MSD) | ||
16:20 | 16:40 | General Principles of Stability Testing |
presenter: Stuart McDougall (Arcinova) | ||
16:40 | 16:55 | Benchtop and F/T |
presenter: Tim Sangster (Charles River) | ||
16:55 | 17:10 | Blood stability testing |
presenter: Johannes Stanta (Covance) | ||
17:10 | 17:25 | F/T and LT stability testing: intra- or extrapolation? |
presenter: Susanne Pihl (Ascendis) | ||
17:25 | 18:00 | Day 1 closing panel discussion |
Tuesday 21 May | ||
08:30 | 10:00 | Focussed parallel sessions (duration: 90 minutes approx.) |
A. Dried Matrix Methods (moderated by Enaksha Wickremsinhe, Lilly) | ||
B. New or Alternative Technologies (moderated by Scott Summerfield, GlaxoSmithKline) | ||
C. Commercial and Diagnostic Kits (moderated by Arno Kromminga, Bioagilytix) | ||
10:00 | 10:30 | Coffee break |
10:30 | 17:30 | Tuesday Breakout sessions: Chromatography |
Key Validation parameters for chromatography assays will be discussed. The sessions will include short or full presentations on selectivity, specificity, Matrix Effect, Cal curve, A&P, QCs, Carry-over, stability assessment, dilution integrity, reinjections and extraction recovery, Acceptance Criteria for an Analytical Run, calibration range reanalysis & reinjection of study samples, (re)integration of chromatograms – some panel discussions may include input from PK/TK stakeholders. | ||
10:30 | 12:20 | Breakout session 1: Chromatography |
10:30 | 10:40 | Introduction to the morning session |
presenter: Magnus Knutsson (Ferring) | ||
10:40 | 11:00 | Guideline paragraphs anticipated of not needing a discussion |
presenter: Johannes Stanta (Covance) | ||
11:00 | 11:10 | Considerations from the JBF for general requirements (with focus on Chromatographic assays) |
presenter: Masanari Mabuchi (Mitsubishi Tanabe Pharma, on behalf of the JBF) | ||
11:10 | 11:30 | Considerations on reference standards for chromatographic assays |
presenter: Amanda Wilson (AstraZeneca) | ||
11:30 | 11:50 | Haemolysed/hyperlipidaemic – matrix effects |
presenter: Steve White (GlaxoSmithKline) | ||
11:50 | 12:20 | Panel discussion |
12:20 | 13:30 | Lunch break |
13:30 | 15:20 | Breakout session 2: Chromatography |
13:30 | 13:40 | Introduction to the afternoon session |
presenter: Johannes Stanta (Covance) | ||
13:40 | 14:00 | Stability assessment: considerations on FDC |
presenter: Eric Woolf (MSD) | ||
14:00 | 14:20 | Considerations on specificity and selectivity for MS/MS assays |
presenter: Tim Sangster (Charles River) | ||
14:20 | 14:30 | Value of Dilution QC in batch analysis |
presenter: Stuart McDougall (Arcinova) | ||
14:30 | 14:50 | QC samples – considerations on geometric vs. arithmetic placement of the midQC |
presenter: Peter van Amsterdam (Abbott Healthcare Products) | ||
14:50 | 15:20 | Panel discussion |
15:20 | 16:00 | Coffee break |
16:00 | 17:30 | Breakout session 3: Chromatography |
16:00 | 16:20 | Considerations on re-injection |
presenter: Amanda Wilson (AstraZeneca) | ||
16:20 | 16:40 | Considerations from the JBF for requirements specific to chromatographic assays |
presenter: Masanari Mabuchi (Mitsubishi Tanabe Pharma, on behalf of the JBF) | ||
16:40 | 17:00 | Documentation & Glossary – Specific to Chromatographic assays |
presenter: Tom Verhaeghe (Janssen R&D) | ||
17:00 | 17:30 | Closing Panel discussion CHROM |
10:30 | 17:30 | Tuesday Breakout session: Ligand Binding Assays |
Key Validation parameters for LBA will be discussed. The sessions will include short or full presentations on selectivity, specificity, Cal curve, A&P, QCs, Carry over, stability assessment, dilution linearity, Parallelism, Minimum Required Dilution, Free/total and Hook Effect, Acceptance Criteria for an Analytical Run, calibration range, reanalysis of study samples – some panel discussions may include input from PK/TK stakeholders. | ||
10:30 | 12:20 | Breakout session 1: LBA |
10:30 | 10:40 | Introduction to the session |
presenter: Robert Nelson (Novimmune) | ||
10:40 | 11:00 | Guideline paragraphs anticipated of not needing a discussion |
presenter: Robert Nelson (Novimmune) | ||
11:00 | 11:20 | Considerations for reference standards and key reagents |
presenter: Johanna Mora (BMS) | ||
11:20 | 11:40 | Scientific aspects for the use of surrogate matrix in calibration, dilution and QC |
presenter: Roland Staack (Roche) | ||
11:40 | 11:50 | Analytes that are also Endogenous Compounds – Focus on LBA |
presenter: Birgitte Buur Rasmussen (Ferring) | ||
11:50 | 12:20 | Panel discussion |
12:20 | 13:30 | Lunch break |
13:30 | 15:20 | Breakout session 2: LBA |
13:30 | 13:40 | Introduction to the afternoon session |
presenter: Joanne Goodman (AstraZeneca) | ||
13:40 | 14:00 | Stability assessments |
presenter: Michaele Golob (Nuvisan) | ||
14:00 | 14:20 | Considerations on calibration range during validation & sample analysis |
presenter: Anna Laurén (SVAR) | ||
14:20 | 14:40 | Specificity and Selectivity |
presenter: Wibke Lembke (Janssen Biologics) | ||
14:40 | 15:20 | Panel discussion |
15:20 | 16:00 | Coffee break |
16:00 | 17:30 | Breakout session 3: LBA |
16:00 | 16:20 | Partial validation and/or Dilution linearity & Parallelism |
presenter: Robert Nelson (Novimmune) | ||
16:20 | 16:40 | Documentation & glossary – Specific to LBA |
presenter: Stephen Williams (Charles River) | ||
16:40 | 17:30 | Closing panel discussion LBA |
Wednesday 22 May | ||
08:30 | 09:50 | Plenary session 4 |
ISR, general aspects of Documentation for Validation and Bioanalytical Reports and Glossary | ||
08:30 | 08:50 | ISR |
presenter: Morten A. Kall (Lundbeck) | ||
08:50 | 09:10 | General aspects of Documentation & Glossary for Validation and Bioanalytical Report |
presenter: Steve White (GlaxoSmithKline) | ||
09:10 | 09:30 | Repeat Analysis |
presenter: Mark Arnold (Covance) and Boris Gorovits (Pfizer) | ||
09:30 | 09:50 | Panel dicsussion |
09:50 | 10:20 | Plenary session 5 |
FB from interactive discussions during workshops on day 2 (10 min each) | ||
A. Dried Matrix Methods (feedback by Enaksha Wickremsinhe, Lilly) | ||
B. New or Alternative Technologies (feedback by Scott Summerfield, GlaxoSmithKline) | ||
C. Commercial and Diagnostic Kits (feedback by Arno Kromminga, Bioagilytix) | ||
10:20 | 11:00 | Coffee break |
11:00 | 13:00 | Summarising the 2 days – our FB to EWG & Wrap up |
Panel, including Brian Booth (CDER) (Video/TC-link) | ||
13:00 | Adjourn |