Developing Therapies for Patients

CRES 703 Subject & Catalog Number

Description

This course delivers a deep, clinically oriented dive into the science, strategy, and practice of clinical development, focusing on bringing new pharmaceutical treatments and devices from concept to market. By examining core scientific principles and research methodologies, students will learn how to conduct thorough benefit-risk assessments, craft comprehensive clinical development plans (CDPs), and formulate precise target product profiles (TPPs) that guide the strategic direction of a drug's lifecycle. 

The curriculum also delves into the nuanced regulatory environments, primarily of the United States but also other parts of the world, empowering participants to navigate complex approval pathways with confidence. Beyond regulatory considerations, the program covers critical aspects of commercialization, including patent protections, pricing strategies, market access, and lifecycle management; equipping students with the skills to develop a medicine that will optimize its market potential and sustain its value. Throughout the course, learners will develop the analytical mindset and practical expertise needed to successfully plan and execute the development of innovative treatments that address unmet medical needs and ultimately improve patient outcomes.