Panel Discussion: Securing Regulatory Buy-In for Precision Psychiatry: What is the Regulatory View on Targeting More Precise Patient Subtypes & How Will This Effect Drug Labels?
Time: 3:00 pm
day: Day Two PM
Details:
- What is the regulatory guidance on how to use biomarkers and outcome measures to identify and target specific patient populations?
- Do regulators believe it is feasible to develop a selective population initially to confirm the treatment’s utility?
- How are trial enrichment criteria going to translate in the real world and affect indication statements?
- What are the risks and pitfalls of going after a biologically informed population? E.g. depression vs MDD vs anhedonia
- Trial design associated with selecting a subtype: What are the statistical considerations here?
