Paula Ladwig is a principal developer with the Clinical Mass Spectrometry Development Laboratory, developing and validating LDT protein assays. She is an associate in the Department of Laboratory Medicine and Pathology at Mayo Clinic in Rochester, MN. Paula believes that mass spec can be a robust, powerful tool for a high volume clinical lab and as such mentors and speaks on the development and validation of quality lab developed tests; utilizing her work with proteins by mass spec as powerful examples. Paula has developed and published methods for the quantitation of monoclonal antibody therapeutics both by peptide and intact methods that have been successfully translated and implemented into a clinical laboratory. Paula is ASCP certified as a Medical Technologist. Paula has completed AACC’s Clinical Laboratory Leadership and Management Certificate Program, has been awarded both AACC NACB Distinguished Abstract Award and Outstanding Speaker Award. Paula is a volunteer for CLSI and is currently the Chair of the Expert Panel on Evaluation Protocols. Paula holds a Master’s Degree in Biochemistry and Structural Biology from the Mayo Clinic Graduate School.