Panel Discussion: To What Extent are In Vivo Models Relevant Purely in Evaluating Toxicity & Target Engagement?
Time: 11:30 am
day: Conference Day One Track A
Details:
- Highlighting the need for robust toxicity and bioavailability data showcased in vivo systems
- Critically evaluating the ability of animal models to predict drug efficacy in treating ALS patients, and the relevance of target engagement data in vivo with different modalities of treatment (including gene therapies)
- Navigating regulator perspective across FDA, EMA and more to the credence placed on animal and human cell data
- Determining to what degree in vitro models can provide robust efficacy data for regulators and to determine clinical efficacy, what in vivo data might be necessary to prove efficacy and safety
