Patient-Focused Drug Development

Overview

CortexBio helps pharmaceutical and biotech companies implement effective patient-focused drug development (PFDD) strategies that meaningfully incorporate patient experiences throughout the therapeutic development lifecycle. Our approach aligns with evolving regulatory guidance while delivering authentic patient insights that enhance product development and innovation.

Our Approach

We provide comprehensive support for integrating the patient voice into drug development, from early research through regulatory approval and beyond.  Our services include:

·      Patient Experience Data Collection: Design and implement systematic approaches to gather robust patient insights that meet regulatory standards.

·      PFDD Meeting Support: Facilitate FDA Patient Listening Sessions and externally led PFDD meetings that illuminate the patients' experiences.

·      Endpoint Strategy Development: Create meaningful endpoint strategies that capture outcomes important to patients.

·      Benefit-Risk Assessment: Incorporate patient preferences into benefit-risk frameworks that align with the perspectives of regulators and payers.

Benefits

·      Stronger regulatory submissions with meaningful patient experience data

·      More patient-relevant clinical trial designs and endpoints

·      Enhanced product value through alignment with patient priorities

·      Accelerated regulatory reviews through well-documented patient insights

Why CortexBio

Our integrated approach to rare and metabolic diseases offers a unique perspective on patient experiences throughout the lifespan. By connecting insights from diverse patient populations, we help companies develop more comprehensive patient-focused disease-driven development (PFDD) strategies that address the full spectrum of patient needs.