About Med-XU
Med-XU was launched in 2008 in cooperation with Xavier University and a distinguished board of Advisors that include leaders in the areas of pharmaceutical consulting, regulatory affairs, clinical research, quality assurance, FDA readiness, and risk management.
Based in Cincinnati, Ohio, Med-XU is committed to fostering the critical thinking that is necessary to help advance our industry through impactful change, as evidenced by the following initiatives:
- FDA/Xavier Medical Device Conference (Past Conference: Medcon 2010) hosted by Xavier May 3-6, 2011. The powerful Strategic Committee of Industry Experts, Current FDA personnel and prominent ex-FDA personnel (including two former national medical device experts, and 1 GHTF representative), are bringing in global regulators and top industry experts to help advance the industry through Quality, Regulatory and Clincial challenges.
- FDA/Xavier Global Outsourcing Conference (Past Conference: GOC 2010), hosted by Xavier Oct. 2-5, 2011. This unique conference is bringing together client companies, contractors and regulators to resolve the issues on both sides. The diverse Strategic Committee is working to create a very dynamic experience to address the hottest industry issues, such as: 3rd Party Auditing, the new FDA guidance for outsourcing, and Supply Chain Transparency/Pedigree.
Our Team
Members of Med-XU are subject matter experts in the following areas:
- FDA readiness
- ICH guidelines
- Trends and issues within the pharmaceutical industry
- Analytical training
- Regulatory Affairs
- Clinical Research
- Quality Assurance
- OOS (Out of Specification) training
- Risk Management
Contact Us.
For more information, please contact Marla A. Phillips, Ph.D., Director of Med-XU at (513) 745-3073 or via email.
About Our Director
Marla A. Phillips, Ph.D.
Dr. Phillips joined Xavier University in 2008 as the Founder and Director of Med-XU. Working in the pharmaceutical industry since 1996 – Dr. Phillips was initially in industry, then consulting, and now academia. Med-XU is an organization with the ultimate goal of increased patient safety through enhanced awareness and compliance within the FDA Regulated Industries. Advanced educational opportunities for industry professionals, in combination with the identification and development of cutting-edge solutions for pertinent industry challenges, result in maximum global impact.
As Director of Med-XU, Dr. Phillips is also a Global Compliance Consultant for the Pharmaceutical Industry on issues related to quality assurance, manufacturing operations (API, non-sterile and sterile products), packaging operations, testing, stability program management, regulatory agency inspection readiness, technical document review, liaison to the FDA, and responding to the FDA. Prior to joining Xavier, Dr. Phillips worked with ex-FDA inspectors for over 3 years to provide world-class consulting to pharmaceutical companies ranging in size from Big Pharma to Virtual Pharma.
Dr. Phillips started in the industry in 1996 when she was employed by Merck & Co. as a Senior Project Chemist involved in global new product launches, technology transfers, and technical support. In 1998 Dr. Phillips became Manager of Merck’s largest and most complex QC laboratory, located in Philadelphia. This role involved method transfers, method improvement, new product launches, technical support, stability program management, FDA readiness, and managing FDA inspections. In 2000, Dr. Phillips became the Head of Quality Operations at the Merck North Carolina facility, and was responsible for manufacturing, packaging, testing, joint venture relations, contract packaging operations, management of the North American stability program, liaison for the site to the FDA, and managing FDA inspections.
Dr. 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.
Our Board Download PDF list 
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Len Brzozowski Lori Carlson Robert Coleman Steve Eastham Karl Fricke, Ph.D. |
Jeffrey Gelwicks, Ph.D. Barbara Hopkins, Ph.D. Marla Phillips, Ph.D. John Simmons, Ph.D. |
