SOT 2022 – Continuous Education Course

Professor Ruth Roberts

Professor Ruth Roberts will be presenting at the SOT 2022 Continuous Education (CE) Programme Course in the session entitled ‘Safety Evaluation Strategies in Drug Discovery: From Target Assessment to Identification of Drug Candidates’.  This CE course will take a chronological look at drug discovery toxicology from target identification through to candidate de-risking and early in vivo studies.  Ruth will kick off the session with her talk entitled ‘Target Safety Assessments: Knowledge is Power’.

Running in San Diego on Sunday 27th of March 2022 from 8:15 AM to 12:00 Noon, this CE course is part of a programme offering a wide range of courses covering established knowledge and new developments in toxicology and related disciplines.  The courses will be delivered live at the SOT Annual Meeting taking place next year form March 27th to the 31st.

Anyone registered on a course will:

  • Earn CE credit for professional certification and licensing.
  • Expand your knowledge of novel concepts and methods.
  • Learn from an array of regulatory, industry, and academic perspectives.
  • Receive CE course materials digitally weeks before the course.


Drug discovery toxicology starts at the very beginning, when a new target is proposed for entry into the portfolio. After confirmation of the target, the discovery toxicologist will serve as an integral member in lead optimization and candidate selection for progression into GLP toxicology studies. A lead candidate is selected through rigorous in silico and in vitro screening and subsequent in vivo pilot toxicology studies that enable a preliminary assessment of safety.

In this course, the speakers will provide a comprehensive overview of the target toxicity evaluation, chemical series and compound de-risking strategies, and approaches leading to lead identification and the first in vivo pilot toxicology studies. The identification of any potential liabilities associated with the target and their relevance for the patient population and indication contributes to the decision to invest in the exploration of a particular target.

After the decision is made to drug a chosen target, the discovery toxicologist will become a critical member of the early discovery team, where the selection of lead compounds will be discussed to finally enable the identification of a candidate to take into GLP toxicology studies. To select a molecule with a safety profile that provides an optimal chance of clinical success, strategies are developed by selecting a panel of in silico, in vitro, and in vivo experiments.

How these in silico and in vitro strategies are developed to provide optimal chemical series and compound de-risking will be discussed. Other presentations will focus on the in vivo experiments where PK/PD modelling and ideally early human dose predictions are needed to drive decisions on dosing frequency and dose selection. Early in vivo pilot toxicology studies will be discussed, with a focus on their design, interpretation, and impact.

The course will conclude with an interactive investigative toxicology case study session where different case studies will be discussed with the audience. While this session focuses on strategies for small molecules, the overall concepts, approaches, and technologies are generally informative for biotherapeutics and new chemical modalities.


The course will be chaired by Marie Lemper from UCB S.A. and Satoko Kakiuchi-Kiyota from Genentech Inc.


There will be five presentations given during this course:

Target Safety Assessments: Knowledge Is Power

Ruth Roberts, ApconiX, Cheshire, United Kingdom.

Chemical Series and Compound De-risking: What Do We Focus on and Why?

Nigel Greene, AstraZeneca, Waltham, MA.

Pharmacokinetics as an Integral Part of Early Drug Development

Sabrinia Crouch, Neurocrine Biosciences Inc., San Diego, CA.

Early In Vivo Pilot Toxicology Studies in Drug Discovery: Study Designs, Strategies, and Objectives Jonathan Maher, Theravance Biopharma, South San Francisco, CA.

Discovery Toxicology Case Studies: An Interactive Session

Satoko Kakiuchi-Kiyota, Genentech Inc., South San Francisco, CA; and Brandon Jeffy, Takeda Pharmaceutical Company Limited, San Diego, CA.

Find out more about Continuing Education at SOT

Members of the ApconIX team will be attending the SOT Annual Meeting and we will be exhibiting at the ToxExpo between March 28th and 30th 2022.

Please come and see Dr Laurence Bishop, Dr Michael Morton, Professor Ruth Roberts, Dr Richard Knight, Dr James Sidaway, Dr Andrew Winkley, Dr Claire Sadler, Dr Paul Duffy and Dr Kimberly Rockley who will all be there to welcome you at the conference and on our Booth #2028.