Day 1 :
Lotus Health, USA
Keynote: The emergence of neurotherapeutics
Time : 10:30-11:00
Randall J Bjork is a Neurologist from North Dakota who has been in practice for over three decades, mostly in Colorado, emphasizing humane and ethical dementia care. He was involved in dementia treatment research from the early days of Cognex. He has conducted research with Aricept treatment and MRS evaluation in Down-Alzheimer patients. He is involved in a multi-center ketamine treatment protocol of treatment-resistant depression and post-traumatic stress disorder. He has lectured worldwide, contributed to the literature of cardiac arrest, stroke, myoclonus, Alzheimer disease, prionoses and has recently published a children's book, The ABCs of You, Volume I, available on Amazon.
From the time of the Glorious Age of Egypt, neurological function has been a source of fascination in those with the wherewithal to observe and contemplate. Imhotep was, in fact, the first to document his obsession with the implications of lesions to the brain and spine. He introduced the concept of triage in his observations, contemplations and formulations. Pythagoras theorized that the brain was the seat of the mind and thought, shaping Greco-Roman thinking. IbnSina was the greatest thinker of the Golden Arabian Age, discussing the relationship of the obvious physical, inobvious metaphysical and immortality. Great minds over the millennia have refined our thinking to lead us to our conference here in Dubai. Some of those great minds will be discussed and the evolution of therapies for the brain and mind will be presented in an historical overview, with a view to a potentially revolutionary future in neurotherapeutics. We are on the verge of a New Era in the treatment and prevention of the most worrisome affliction of mankind: dementia.
FB2D Clinical Research Consulting Inc., Canada
Time : 11:00-11:30
Farida Dabouz holds a PhD in Statistics with a broad industry experience as well as academic international oncology group in Europe and Canada. In addition to her many accomplishments in Biostatistics/Data Management at Sanofi and BCIRG, she also leverages her experience in “data quality” on applying innovative approaches in the field of biostatistics, data management and medical writing to improve data processing. She has a strong experience in training site investigators and operational teams, covering all data aspects, mainly demystifying statistics in clinical trials. She is Certified/Active Member of SOCRA and SCDM education committee, providing webinars and online courses.
Clinical trials are conducted on all new medicines and devices. Regulators will only approve a new medicine or device if these trials, together with other research data, demonstrate it has a favorable risk: benefit profile. Historically, the majority of patients recruited into clinical trials for medicine development have been from Western Europe and the US. However, clinical trials are increasingly recruiting patients from other countries, including developing countries. Also, the landscape for clinical trials has continued to evolve and change over the last twenty years. Clinical trials have become more complicated but not more efficient. The increased complexity of today’s clinical trials is associated with reduced patient enrollment and retention, higher risk for protocol amendments, and longer and more costly clinical trials. Clinical trials are used to assess the benefits and harms of interventions in health care, and if conducted properly, the risk of bias is minimized, particularly bias in selection of patient populations, endpoints and analysis. There is, however, considerable evidence that clinical trials are not always well reported. The usefulness of a Clinical Study Report (CSR) depends on the clarity with which it details the relevance of its, participants, outcomes, and design to the real world practice. ICH E3 is guidance on how to present the results in order to provide a level of details that will enable a secondary evaluation i.e. an assessment by regulatory authorities of the conducted analysis and conclusions drawn. ICH E9 is guidance on the content of the Statistical Analysis Plan (SAP) and presents recommendations for information to be included in key sections of CSR. A well written and complete research protocol is essential for a high quality study and avoids problems during the study. Clear and unambiguous SAP minimizes the risk of bias in the analysis and provides detailed statistical methodology used as well as the definition of Tables, Figures and Listings (TFLs) to be included in the CSR. Clear, complete and concise CSR streamlines regulatory review, publishing and facilitate the use of study results in real word.
Stockholm University, Sweden
Keynote: Efficiency enhancement of neuropsychological evaluation - Short forms of Wechsler Adult Intelligence Scale, 4th Ed. (WAIS-IV) seven-and four-subtest models
Time : 11:45-12:15