WORKSHOP DAY - TUESDAY 1ST DECEMBER 2020
9:30 am-11:30 am
Preclinical PK/PD analysis is increasingly being included in regulatory submissions. In this workshop we will focus on PK/PD principles for both small and large molecule IO candidates that can assist in the selection/optimisation of doses/dose regimens, including prediction of human efficacious doses. The workshop will provide examples of how PK/PD principles can assist in partially explaining why many candidates don’t behave the same way in the clinic as in preclinical models.
Clinical Pharmacometrics, Biostatistics, Data Science Senior Research Fellow
University of Manchester
Using Software to Tackle the In Vivo Reproducibility Crisis & Address the 3R
12.00pm - 3.00pm
In this workshop we will discuss:
- The impact of irreproducibility in pre-clinical in vivo research
- How irreproducibility can directly impact our ability to adhere to the three Rs
- The importance of user-focused design when implementing a solution aimed at improving reproducibility
- How Overwatch in vivo study management software can improve reproducibility in your organization via the implementation of modern technologies. This will include hands-on experience
Looking at the Big Picture in Preclinical Translation
3:50 pm-5:30 pm
- Gain clarity and understanding on useful and realistic end points to translate your immune-oncology therapy into the clinic; what are regulators and internal/external stakeholders looking for?
- Guide your preclinical strategy to accelerate the success of your therapeutic pipeline and de-risk clinical trials.
- How to harmonize preclinical studies with the translational science of early clinical development
Vice President - Translational Biology