Clinical Development Readiness

Overview

CortexBio offers strategic guidance and hands-on support to optimise your clinical development journey, leveraging specialised expertise in rare and metabolic diseases. We help companies navigate the complex landscape of clinical development, from early planning through execution and regulatory submission.

Our Approach

We strike a balance between scientific rigour and practical implementation to create development plans that maximise efficiency and minimise risk. Our services include:

·      Target Product Profile Development: Create comprehensive Target Product Profiles (TPPs) that align your clinical development with commercial goals and patient needs.

·      Clinical Development Strategy: Design optimal development pathways that balance scientific, regulatory, and commercial considerations.

·      Study Design Optimisation: Develop innovative clinical trial designs tailored to rare and metabolic diseases, including adaptive trials and platform approaches.

·      Chemistry, Manufacturing, and Controls (CMC) Readiness: Ensure your CMC strategy keeps pace with accelerated clinical timelines through the FDA's CDRP program and other approaches.

Benefits

·      Accelerated development timelines through strategic planning and regulatory alignment

·      Enhanced probability of success through optimised trial designs

·      Improved resource allocation through clear development roadmaps

·      Greater alignment between clinical, regulatory, and commercial objectives

Why CortexBio

Our "metabolic mosaic" approach uniquely positions us to identify shared mechanisms between rare diseases and ageing, thereby opening up novel clinical development strategies. Dr. Martini-Drew's experience leading cross-functional teams in global pharmaceutical companies provides practical insights into successful clinical development approaches.