The Brave New World of eCOA in Neuroscience

Gary Sachs, MD, Clinical Vice President, CRF Bracket, Associate Professor of Psychiatry, Harvard Medical School

Dr. Gary Sachs is the Therapeutic Area Leader in bipolar disease and mood disorders at Bracket. He previously co-founded Concordant Rater Systems, a specialty provider of technologies to improve CNS clinical research. Dr. Sachs is a recognized expert clinical trialist with extensive experience in rater training and the methodologies of mood and anxiety disorder research. He has been instrumental in developing technology-based solutions for randomized controlled trials that identify correlates of high placebo response, improve signal detection and reduce the risk of failed trials.

Dr. Sachs is the founder and director of the Bipolar Clinic and Research Program at Massachusetts General Hospital (MGH) and is an Associate Professor of Psychiatry at Harvard Medical School. After graduating from the University of Pennsylvania and the University of Maryland Medical School, he completed his residency at MGH. His areas of academic interest include psychopharmacology, chronobiology, bipolar mood disorder and development of pragmatic measure-based practice guidelines.

Dr. Sachs is Chair of the National Alliance on Mental Illness Scientific Advisory Board and serves on the Scientific Advisory Board of the Depression and Bipolar Support Alliance. He has authored over 200 articles, abstracts, books and book chapters.

Alan Kott, MUDr., Clinical Vice President, Data Analytics, CRF Bracket

Dr. Alan Kott is based in Bracket’s Prague office and until recently was Senior Clinical Manager for Europe. 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.

Bill Byrom, PhD, Vice President, Product Strategy and Innovation, CRF Bracket

Bill Byrom, PhD, leads product strategy and innovation. He has worked in the pharmaceutical industry for over 25 years in various positions within clinical development for pharmaceutical companies including Boots, Knoll and Zeneca. Bill has served as a product strategy leader within eClinical technology companies and CROs including ClinPhone, PAREXEL Informatics and ICON. He is the author of over 70 publications, including two industry textbooks on electronic patient-reported outcomes (ePRO). His recent scientific work includes consensus guidelines on the implementation of wearable and mobile sensor technology in clinical trials, and scientific validation supporting the use of bring-your-own-device (BYOD) ePRO in clinical trials. Bill has served two years as Vice Director of the Critical Path Institute’s ePRO Consortium and is an active member of the Drug Information Association (DIA) as an Annual Meeting Steering group member and within the Study Endpoints Community. Bill is visiting senior research fellow at Nottingham Trent University’s Medical Design Research group.

Bill holds a Doctor of Philosophy (PhD) in Mathematical Modelling and Simulation from the University of Strathclyde and a Bachelor of Science from the University of Nottingham.

Denis Curtin, PhD, Principal, eCOA and Patient Engagement, CRF Bracket

Denis Curtin is Principal, eCOA and Patient Engagement, in the Science and Medicine practice at CRF Bracket. Previously, he co-founded mProve Health, a mobile device-based software solutions company specializing in clinical research and commercial healthcare, which was acquired by Bracket in 2017. Dr. Curtin’s experience also includes more than twenty years in pharmaceutical industry roles leading drug and vaccine clinical development and commercial brand management; product lifecycle and franchise portfolio strategic planning; and clinical trial design and management. At CRF Bracket, he advises the company’s leadership in scientific matters, and oversees the development of company research capabilities, evidence for commercialized research products, and communication of product offerings to scientific and customer communities.