How Is the Excipient World Evolving Philippe Tschopp
Infusing GxPs Into Your Organization’s DNA Troy Fugate
Steve Galen has been involved in clinical trials for more than 27 years now, in various high-level positions. In this podcast episode, he will explain the different stages of the clinical trials and point out the most severe deficiencies in the industry and how to overcome there.
Information on good manufacturing practices (GMP) in the life science industry is scattered, vague and poorly organized. We have chosen to solve this problem by organizing the best possible GMP webinars and courses to ensure we deliver all the information you need in a concise, engaging and clear format. All events are free and open to anyone in the industry.
Steve has a Ph.D. in Engineering and more than 27 years of experience in Big Pharma and global CROs. He has run the CRO division of a life sciences company and held senior leadership positions in clinical operations, software development, risk-based monitoring, clinical data science, project management, drug development, and pharmaceutical manufacturing, including clinical trial drug supply. Steve has spent the last decade making clinical trial design and execution predictable, efficient, and transparent by applying his knowledge of engineering, manufacturing, clinical operations, math, and software development to large sets of clinical trial data. Steve asserts that a clinical trial is not an AI/ML "black box" but rather a set of characterizable and connected processes that predictably produces data, like a manufacturing line. Steve is keenly aware that ROI matters when designing and running trials. His approach makes it easy to determine ROI before committing to a course of action intended to improve trial performance.