Biography
Biography: John P. Neal
Abstract
From the make-up of the study pipeline to how studies are conducted, the Clinical Research industry is changing. Pressure to reduce the time and costs required to take new drugs and devices from the lab to market, patients advocating for quicker access to novel new treatments, and technology advances are driving changes in systems, processes, and strategies. Based on discussions and interviews with numerous Senior Executives with Drug and Device companies, CRO’s, IRBs, and the FDA over a the last eighteen months, Mr. Neal will provide insights and predictions of some disruptive changes coming to the clinical research enterprise. Mr. Neal will address the primary drivers of the changes that are coming, share quotes from notable figures involved in Clinical Research, including Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), and elaborate on eighteen specific predictions of changes coming, and shed light on what the changes mean for study sponsors, CROs, IRB, and the Investigators and clinical research staff employed at Sites. Since he first presented his predictions in April 2016 at the ACRP Annual Expo and Conference, many of his predictions have already come true. The changes coming will affect everyone from the lab to the clinical research Site, and everyone in between. Many positions will change dramatically; others will simply disappear. Mr. Neal will address all this and more in this timely presentation.