David Burkholder, PhD has more than 30 years of Pharmaceutical Industry experience in clinical research, medical writing, medical education, and communications programming. The first 12 years were in Product Development and Clinical Research at major pharmaceutical companies including Pfizer and Bayer. He then started and led a clinical research organization (CRO). Dr. Burkholder’s clinical research career began in clinical pharmacology and progressed to the management of all phases of new drug development. He was responsible for writing numerous study protocols, reports and submissions to regulatory agencies. Dr. Burkholder managed the submission and regulatory review process of a major NDA that included extensive interactions with the FDA.Dr. Burkholder broadened his experience significantly by moving to the Communications and Medical Education Business. The next 13 years were focused on developing medical education and communications programs with emphasis on Opinion Leader Development to support major product launches (Captopril®, Pravachol®, Glucophage®, Avandia®). This work emphasized in-depth clinical/scientific content development and high quality editorial output. Twelve years ago (2003) Dr. Burkholder launched PD Pharma Consulting to provide free-lance medical writing and medical education services.Specialties: Wide-ranging background in clinical trials, biochemistry, cell and molecular biology and genetics facilitates rapid up-to-speed time in new therapeutic areas. Motivation to learn and interest in new topics results in no charge to clients for the basic topic learning curve. Extensive experience working with foremost opinion leaders facilitates relationship building for clients and efficient incorporation of expert knowledge into projects.