8:00 am Check-In & Coffee
9:00 am Workshop A: Selecting an ADC Target Receptor to Reduce On-Target Off-Tumor Toxicities
Synopsis
Discovering a way to direct more of your ADC towards the tumor and less onto the organ of toxicity and off-tumor receptor sites will allow for a huge increase of your ADC candidates’ therapeutic index. Take part in this deep dive into ADC target selection to learn how to select the correct target receptor, resulting in reduced on-target off-tumor toxicities.
What you will gain from this session:
- A deeper understanding of target liability assessment for ADCs to discover the optimal binding location.
- Navigating the tumor microenvironment to release payload in the appropriate area.
- Choosing an appropriate target receptor to bind to, in order to reduce off-target toxicities and recruit the correct enzymes to cleave the linker.
- Understanding how to alter the binding and affinity of your antibody to not cause toxicities through disruption of critical interactions, but to still obtain your desired pharmacologic effect.
12:00 pm Lunch Break & Networking
1:00 pm Workshop B: Regulatory Expectations – Testing ADC Toxicity & Designing Experiments in Accordance to Obtain IND and BLA Approval
Synopsis
With the common goal of developing ADCs with the highest therapeutic index, the industry is gradually shifting away from traditional ADCs and testing methods and towards novel approaches, such as a reduction in animal testing and newer payload and mechanistic technologies. From these advances, a question has to be asked – what are the regulatory standpoints on these novel methods? Join this workshop to gain a further understanding the regulatory requirements when designing your GLP study to achieve both IND and BLA regulatory approval.
What this Workshop Will Cover:
- Regulatory opinions on a variety of topics, such as a push to reduce animal testing, introduction of more advanced in vitro technologies, and novel payload strategies.
- Understanding what is expected from GLP studies for a greater alignment with regulatory expectations.
- How will moving away from NHP testing be feasible from a regulatory perspective and what can aid in that progression.
4:00 pm Goodbye & End of Workshops
Companies That Attended the 2023 Workshop Day:
