The different parts of the nervous system (or CNS for short), including the brain and spinal cord, and the peripheral nervous system, are important drug targets for many serious diseases affecting human health. As the body’s processing center, the CNS is responsible for all functions of our bodies, including thoughts, emotions, memories, and behaviors. Unsurprisingly, drugs working on the CNS are subject to stringent regulatory requirements, and specialized safety assessments are often mandated. To confirm CNS activity without safety concerns, dedicated nonclinical and early phase clinical studies, with relevant endpoints and biomarkers, and supporting bioanalysis, are needed; and drug manufacturing must be carefully managed via rigorous handling and production processes.

Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely sharing of data at every step of the drug development plan, and facilitate agile, flexible decision-making and planning.

CHAPTERS:

- 1:22 — Introduction

- 3:53 — Preclinical Safety and Toxicity Testing of CNS-Active Molecules

- 12:28 — Preclinical Case Study

- 15:11 — Manufacturing CNS-Active Drugs for Trials and Commercialization

- 21:48 — CDMO Case Study

- 24:39 — Maximizing Early Phase Clinical Trials of CNS-Active Drugs

- 34:02 — Clinical Case Study

- 36:27 — Bioanalysis for CNS Drug Development (Preclinical to Phase IV)

- 42:26 Altasciences' CNS Center of Excellence