Module 21: Clinical Research & Emerging Therapies

Throughout this program, we have focused on mastering the complexities of current specialty pharmacy practice – navigating access barriers, optimizing complex regimens, managing high-touch patient care, and leveraging sophisticated technology. You have honed the skills needed to excel in today’s demanding environment.

This module marks a significant pivot. We now look beyond established therapies and operational workflows to explore the dynamic and rapidly evolving landscape where specialty pharmacy intersects with clinical research and the development of truly novel treatments. The skills you’ve acquired in managing complex patients, handling high-cost biologics, and meticulously documenting clinical data position you uniquely at the forefront of medical innovation.

We will delve into the critical role specialty pharmacies play in supporting clinical trials, managing investigational drugs under stringent FDA regulations, and contributing vital real-world data to shape our understanding of drug performance. Furthermore, we will venture into the operational intricacies of the next generation of therapeutics – gene, cell, and mRNA therapies – demanding entirely new levels of logistical precision and clinical oversight. This module elevates your perspective from executing established protocols to actively participating in the discovery and delivery of tomorrow’s cures.