The pharmaceutical and biopharmaceutical industry has never demanded more of the next generation than it does today. Accelerating technologies, evolving regulatory landscapes, and unrelenting pressure to bring safe, effective therapies to patients faster will fall on the shoulders of the workforce of the future. ISPE understands this and has built a robust, multi-tiered pathway for those who...
The pharmaceutical industry has always promised meaningful work: molecules that become medicines, processes that protect patients, and careers built on rigor and purpose. Yet for ISPE student Chapter members and Emerging Leaders approaching graduation, breaking into that world has never felt more daunting.
The revised EU GMP Annex 1 has placed renewed emphasis on developing a holistic approach to contamination control: leveraging barrier technologies, automation, rapid microbial methods and proactive management of airflow patterns, compelling manufacturers to rethink how aseptic systems are designed, qualified, and operated. With these evolving regulatory expectations and growing complexity in...
The journey of an ISPE Emerging Leader is one defined less by titles and more by growth, resilience, and the willingness to learn. Over the past several years, I’ve come to recognize a set of lessons that continue to guide my own path and the paths of many peers in the ISPE Emerging Leader community.
Advances in pharmaceutical regulation and pharmaceutical technology don’t always coincide. Each advancement moves on its own schedule, driven by its own unique forces. But sometimes there is a synergy, when advances in technology can help regulators to achieve their objectives and changes in regulation come at just the right time to enable a technology to be impactful. This interplay between...
Globally, there is an increase in approved advanced therapy medicinal products (ATMPs), with thousands of therapies currently in various stages of pre-clinical and clinical development.
