Free Webinar | Getting Back to Work – Strategies to Prepare for the Reopening of Halted Clinical Trials
June 30, 2020 | 11:00 am-12:00 pm EDT
Reopening halted trials and moving onto the new normal requires careful consideration of key topics in clinical research, including remote ratings and rater training, mixing modes of data capture for regulatory submission, data analytics to track the direct and indirect impact of COVID-19, and more. So where do we go from here? Join this educational and interactive virtual panel featuring Deb Phillips, Senior Director, Clinical Operations at Sunovion, alongside thought leaders from Signant Health for a practical look at what sponsors are doing now to mitigate disruption and prepare for the future.
11:00 Chairperson’s Remarks
Amir Kalali, MD, Executive Advisor for Global Strategy, Signant Health
11:05 Case Study: The Impact of COVID on Our Trials and How We Proceed from Here
Deb Phillips, Senior Director, Clinical Operations, Sunovion
11:15 Remote Ratings and Training, Now and in the Future
Dan DeBonis, Principal, Endpoint Solutions, Signant Health
11:25 Mixing Modes of Data Capture for Regulatory Submission
Bill Byrom, PhD, Vice President, Product Strategy & Innovation, Signant Health
11:35 Data Analytics to Track the Impact of COVID
Alan Kott, MUDr, Clinical Vice President and Practice Lead, Data Analytics, Signant Health
11:45 Open Panel Discussion: The Road Ahead
Moderator: Amir Kalali, MD, Executive Advisor for Global Strategy, Signant Health
Amir Kalali, MD
Executive Advisor for Global Strategy, Signant Health
Dr. Kalali helps identify innovative technologies to support the evolution of Bracket’s growth. In addition, Dr. Kalali will assist in the acceleration of growth in Bracket’s CNS product lines in other fields of medicine. He is Professor of Psychiatry at University of California San Diego, Editor of the journal Innovations in Clinical Neuroscience, and the Lead Editor of the book Essential CNS Drug Development, published by Cambridge University Press. He has authored over 150 peer-reviewed publications. Recognized globally as a leader in drug development and healthcare with an emphasis on innovation, collaboration, and the intersection with new technology, Dr. Kalali was the Founding Chairman of the Executive Committee of the International Society for CNS Drug Development (ISCDD), a founding member of the International Society for CNS Clinical Trials and Methodology (ISCTM), where he serves on Executive Committee, the Scientific Committee, and previously chaired the Membership and Publication Committees. He is also a founder and Co- Chair of the Scientific Program Committee of the CNS Summit, and serves on the Scientific Program Committee of the American College of Neuropsychopharmacology. Dr. Kalali regularly presents at national and international scientific meetings, and lectures frequently on drug development, innovation, technology, digital medicine and health. He is an advisor to the Center for Digital Transformation at the Paul Merage School of Business at the University of California, Irvine. Dr. Kalali earned his medical degree from the University of London and completed his psychiatry training at University College and Middlesex School of Medicine, University of London.
Senior Director, Clinical Operations, Sunovion
Debra Phillips is the Executive Director and Acting Head of Global Clinical Operations at Sunovion Pharmaceuticals, Inc., which is focused on the innovative application of science and medicine to help people with serious psychiatric, neurological, and respiratory conditions. With 30 years of experience in clinical research, Debra has held positions at a Contract Research Organization as well as at both large and mid-sized pharmaceutical companies. She has been a key contributor to numerous successful global clinical programs, as well as, the registration of medicines in the therapeutic areas of CNS and Neurology. Debra oversees and directs a team of clinical research professionals with expertise in clinical trial execution and analytic monitoring oversight.
Principal Endpoint Solutions, Signant Health
Dan DeBonis is one of the pioneers in the field of study data analytics and quality control. He was the founder of Concordant Rater Systems in 2001, which became part of Bracket in 2010. Throughout his career at Concordant and Bracket, he has designed and implemented technology driven data monitoring solutions for trials ranging from pivotal worldwide programs to NIMH studies. Dan is a graduate of Yale University.
Bill Byrom, PhD
Vice President, Product Strategy & Innovation, Signant Health
Bill serves as Vice President of product strategy and innovation at Signant Health, where he also leads a team of ePRO scientists. He has worked in the Pharmaceutical industry for 30 years and is the author of over 70 publications and two industry textbooks on electronic patient-reported outcomes (ePRO). His recent scientific work includes the use of wearable technology and bring-your-own-device (BYOD) eCOA in clinical trials. Bill recently served as Vice Director of the C-PATH ePRO Consortium, and is an active member of the DIA Study Endpoints Community where he leads a cross-disciplinary group on the use of endpoints derived from wearable devices to support labelling claims and regulatory decision making. Bill provides independent eClinical commentary via LinkedIn (http://uk.linkedin.com/pub/bill-byrom/5/697/713) and Twitter (@billbyrom).
Alan Kott, MUDr
Clinical Vice President and Practice Lead, Data Analytics, Signant Health
Dr. Kott is based in CRF Bracket’s Prague office. Having led the development of the Data Analytics Program for Bracket, he has overseen the design and reporting of data analytics in multiple large schizophrenia studies. For the past seven years, he has also provided training to investigators as an Expert Trainer. Dr. Kott has been responsible for the design and implementation of multiple in-study data quality programs and served as a Product Business Owner for Rater Reliability Statistical Measures Application. Prior to Bracket, Dr. Kott worked as a house officer in Psychiatry at General Teaching Hospital, Department of Psychiatry, and as an Assistant Professor at Charles University, 1st Medical Faculty - Department of Psychiatry, in Prague. Dr. Kott has a Medicinae Universae Doctor (MUDr) from Charles University.