029 - "Purpose" with Marla Phillips

On This Episode, I was joined by Marla Phillips of Pathway for Patient Health. Marla and I discuss:  Pathway for Patient Health Training the Next Generations - What students can do?  Quality for the 21st Century  Chief Quality Officer Forum  FDA/Industry Collaborations  How Xavier Health Came to be and the Future of Xavier Health  Supply by Design  The importance of doing things with purpose  -------------------------------------------------------------  Pathway for Patient Health: Link  Pathway for Patient Health Quality Science Program : Link  Pathway for Patient Health Hiring Portal: Link  Good Supply Practices/Supply by Design: Link 1 & Link 2  USP <1083> GOOD DISTRIBUTION PRACTICES—SUPPLY CHAIN INTEGRITY: Link  Future of Xavier Health: Link  -----------------------------------------------------------------  Marla Phillips PhD founded Pathway for Patient Health in 2018, and leads cultural, quality and supply chain initiatives with regulators and industry professionals for the betterment of patient health around the world. Phillips is a frequently invited speaker for major industry association conferences across the country each year, including the PDA/FDA Joint Regulatory Conference, AdvaMed Medtech Conference, Cold Chain Global Forum, USP, IPEC, and the FDA’s own Association of Food and Drug Officials. In 2008, Phillips founded, Xavier Health at Xavier University. In this role, Phillips was asked to co-lead with FDA the CDRH Case for Quality metrics initiative from 2014-2016, which culminated in work that continues to support the Case for Quality program.  She led the Good Supply Practices (GSP) initiative with the FDA Office of the Commissioner, CDER, pharmaceutical and medical device professionals, and suppliers, which has been published for global industry adoption. Additionally, Phillips founded the FDA/Xavier PharmaLink Conference, FDA/Xavier MedCon Conference, AI Summit and Combination Products Summit for global regulators and industry professionals.  Phillips began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She has expertise in leading FDA inspections and readiness, quality, analytical testing and validation, supply chain, stability program management, process validation, manufacturing, and packaging operations. Phillips holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.