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|John P Neal|
|PCRS Network LLC, USA|
|Keynote: J Clin Trials|
|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 taking 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 the last eighteen months, the author will provide insights and predictions of some disruptive changes coming to the clinical research enterprise. The author 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. The author will address all this and more in this timely presentation.|
John P Neal has over 30 years of experience as an entrepreneur and has provided services to biotech and pharmaceutical companies via his various businesses since 1985. He is the Founder and Chairman of PCRS Network LLC, and a leading independent research site network. He is a frequent speaker at industry conferences, writes the PCRS blog, and serves on the Board of Trustees of the Association of Clinical Research Professionals, the industry’s largest professional membership organization. Prior to founding PCRS, he served as the COO and CFO of a multi-site clinical research company, which he helped grow from a single site in 2004 to 5 sites in 2007 by establishing privately operated clinical trial offices at community hospitals.
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