On Tuesday May 14th, BioClinica will be hosting an all-day complimentary oncology symposium as part of their annual User Conference. The symposium will take place at the Hyatt Regency at Penn’s Landing in Philadelphia and will feature presentations from Key Opinion Leaders on the subjects of medical imaging and cardiac safety in cancer drug development. I am pleased to have the opportunity to co-chair this symposium with my new colleague, Dr. Michael O’Neal, Chief Medical Officer at BioClinica. This symposium is designed to benefit clinical trial professionals interested in learning more about the utility of medical imaging for oncology clinical trials, cardiac safety considerations for oncology drug development, and centralized core lab services for facilitating successful oncology clinical trials.
The first part of the symposium will focus on medical imaging for oncology studies, starting with a keynote address highlighting the growing number of oncology biomarkers as paradigms for drug discovery and clinical practice. Dr. Chaitan Divgi, the Director of Nuclear Medicine and PET at Columbia University will follow with a presentation on the applications of PET imaging in oncology studies. Dr. Divgi is an expert in PET imaging and has conducted immunoPET and radioimmunotherapy studies in a variety of solid tumors.
The symposium will then shift its focus to cardiac safety studies, which have become increasingly important components of clinical trials, especially when it comes to oncology drugs. Jeff Heilbraun will provide an introduction and overview to the unique challenges and considerations when assessing cardiovascular safety for anti-cancer therapies. He will also review recent developments in clinical research, regulatory trends, and study design associated with oncology drug development. Jeff is currently the Director of Strategic Business Development at BioClinica and has been active in the field of cardiac safety for over 20 years, focusing on the science and physiology behind cardiac safety and hemodynamics within pharmaceutical development.
The Oncology symposium will also feature a second keynote address to be delivered by Dr. Leonard Berlin of the NorthShore University Health System. Dr. Berlin is world renown for his lectures on the topics of radiologic malpractice and risk management and will talk about the increasing frequency of incidentaloma discovery using high-resolution computed tomography (CT), magnetic resonance imaging (MRI), and ultrasonography as it relates to patient health and medical malpractice.
Attendees of the symposium will also have the chance to better understand the many roles that an imaging core lab serves for oncology clinical trials and explore some of the common issues encountered when contracting their services. Dr. Michael O’Neal will talk about independent review for oncology clinical trials and discuss protocol development, site qualification, site compliance, and clinical data transfer. Dr. O’Neal is Chief Medical Officer at BioClinica and is responsible for managing the organizational planning and operational needs of the Medical Affairs department, as well as overseeing service quality, physician training, and process improvement at BioClinica.
Recently, the FDA’s Oncologic Drug Advisory Committee (ODAC) proposed an audit process for oncology clinical trials that would allow for primary imaging reads of solid tumors at investigator sites. In response to this regulatory update, the symposium will feature an Oxford Union style debate focused on the efficiency of centralized reads of oncology images. I am excited for the opportunity to moderate this debate featuring two prominent physicians; Dr. Phillip Lim, President of the Department of Radiology at Abington Memorial Hospital and Dr. Rajan Agarwal, Clinical Adjunct Professor of Nuclear Radiology at the University of Pennsylvania, and promises to shed light on the advantages and disadvantages of centralized reads for oncology images in clinical trials.
The BioClinica Oncology symposium brings together an impressive list of expert speakers from different disciplines to discuss imaging, cardiac safety, and core lab services relating to oncology studies. If you are a clinical professional with an interest in oncology clinical trials, this symposium should not be missed.
