Panel Discussion: Developing TPD Study Design for Preclinical Safety Assessment of Degraders
Time: 8:15 am
day: Day 1
Details:
• Are current guidelines for assessing the safety of small-molecule therapeutics adequate – are there TPD specific risks?
• What is the current decision-making framework for assessing TPD safety risks, e.g. how to assess off-target degradation risks in vitro, and how to select preclinical safety species?
• Should safety assessment of PROTACs and Molecular Glues be different?
• TPDs fall within the regulatory framework of small molecules, yet there are differences between small molecules and TPDs – what are those differences and what developers need to think about differently? What are some additional considerations for nonclinical safety evaluation of TPDs?
• What are current nonclinical safety hurdles of TPDs and how to address them?
• “We’ve generated the data, now what? What to do with all the data? – challenges in data interpretation for decision making.
