Programme - All timings are Swedish time (CET). Exact timings and parts of agenda may be subject to change
09.00 - 09.10 Welcome: Presentation of chairs, agenda, meeting logistics and technical point person
Axel Pähler (Roche), Emre Isin (Servier), Lars Weidolf (AstraZeneca), Markus Walles (Novartis)
09.10 - 09.30 Presentation 1: Cold Quantitation of metabolites in Discovery/need for early radiolabel before IND
Lars Weidolf, Emre Isin, Markus Walles, Axel Pähler
09.30 - 10.00 Presentation 2: Application of Cyclic Ion Mobility mass spectrometry application for BT
David Higton (Waters)
10.00 - 10.20 Presentation 3: Computational prediction of xenobiotic metabolism (focus on AI/machine learning methods)
Prof. Johannes Kirchmair (University of Vienna)
10.20 - 10.30 Break
10.30 - 11.00 Breakout (Group will be divided into 3 sub teams):
1. Future needs in BT (software and hardware, addressing new modalities)
Markus Walles, Christian Lanshöft (Novartis)
2. New discovery advances (e.g. response normalization),
Emre Isin, Claude Delatour (UCB)
3. Need for radiolabel before IND
Axel Pähler, Lars Weidolf
11.00 - 11.30 Breakout: Discuss outsourcing needs for Biotransformation studies 
11.30 - 12.30 Feedback/discussion from morning breakout sessions 
12.30 - 13.00 Lunch break
13.00 - 13.30 Presentation 4: Genotox risk assessment of metabolites and qualification of impurities using metabolite data
Andreas Zeller (Roche), Andreas Brink (Roche), Lars Weidolf
13.30 - 14.00 Breakout: Share thoughts about the proposed strategies
14.00 - 14.30 Presentation 5: Ozanimod metabolism-Qualification of disproportionate metabolites
Sekhar Surapeni (BMS)
14.30 - 15.00 Presentation 6: EFPIA initiative to qualify mixed matrix methodology for metabolite exposure comparison across species
Alexander David James (Novartis)
15.00 - 15.30 Presentation 7: Regulatory aspects of MIST (influence of disease, ethnicity and ppb)
Axel Pähler
15.30 - 16.00 Breakout: How can we best avoid surprises regarding biotransformation in late development? Cold clinical MetID vs early human ADME using radiolabel?
16.00 - 16.45 Feedback from afternoon breakout sessions
16.45 - 17.00 Feedback on workshop/Collect topics for next workshop
17.00 Meeting closure