4th ICH-M7/QSAR Workshop

ICH-M7 QSAR/Expert Judgment Workshop - iGenotox Challenge Prediction –

The 4th ICH-M7/QSAR Workshop will be held on November 19 in ACEM/JEMS 2019 from November 18 to 20 in Tokyo. Please see the ACEM/JEMS 2019 web site for the detailed information and registration http://www.acem-jems2019.jp/. We will discuss QSAR expert judgment for Ames mutagenicity (Part I) as well as purge factor approach for the control of potential impurities in pharmaceuticals (Part II). Simultaneous interpretation between English and Japanese will be provided in the Workshop.

Part I will include exercises for ambiguous QSAR outcomes with 20 query substances. You can obtain the excel file of the chemical structures here (20 Substances). We welcome your submission of expert judgments with any of these substances, and may appoint you as a speaker of an interesting approach. Try this exercise and return the results to the workshop organizer (e-mail below) by September 10th.

Part I: QSAR prediction and expert judgment for Ames mutagenicity

Chairs: Kiyohiro Hashimoto, Masamitsu Honma

    9:00- 9:05  Introduction: Kiyohiro Hashimoto (Takeda)

    9:05- 9:25  Ames/QSAR International Challenge Project; Masamitsu Honma (NIHS)

    9:25- 9:45  Actions of PhiAS-Contract research and consultation support of ICH M7/QSAR for pharmaceutical

          companies-: Tsukasa Kikuno (PhiAS)

    9:45- 9:55  Overview of expert judgments with 20 substances: Masayuki Mishima (Chugai)

    9:55-10:15  Case studies of the expert judgment: TBD

   10:15-10:45 Undertaking expert review under the ICH M7 guidelines: Chris Barber (Lhasa)

   10:45-11:15 Effective expert review strategy for ICH M7 assessments: Roustem Saiakhov(MultiCASE)

   11:30-12:00 Handling out-of-domain and indeterminate results as part of ICH M7 recommended (Q)SAR

          analyses. A Leadscope perspective: Manuela Pavan (Innovatune)

   12:00-12:10 Discussion and summary: Chris Barber (Lhasa)

Part II: Control of impurities in pharmaceuticals by purge factor

Chairs: Junichi Fukuchi, Masayuki Mishima

   12:10-12:15 Introduction: Junichi Fukuchi (PMDA)

   12:15-12:30 Control strategy for potential mutagenic impurities in the synthesis of drug substance,

          Sakuramil mock case study: Yusuke Nagato (FUJIFILM)

   12:30-12:45 Case study, use of purge factor to evaluate regulatory starting material: Hiroshi Iwamura (Chugai)

   12:45-13:15 Use of Mirabilis based purge calculations to understand MI related risk and control

          strategy options – case study examples (including management of N-Nitrosamines):

          Andrew Teasdale (Astrazeneca)

Closing: Masamitsu Honma (NIHS)

4th ICH-M7/QSAR Workshop Organizer

Masayuki Mishima (Chugai Pharmaceutical); mishimamsy@chugai-pharm.co.jp

Last update; Aug. 2019

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