Day 1 :
Keynote Forum
Michael Bernstein
Clinical Supplies Management, Inc., USA
Keynote: Patient Centricity – A Patient Perspective
Biography:
Michael Bernstein is Vice President of Global Compliance and Risk Management at Clinical Supplies Management, Inc. He is responsible for the oversight of CSM's global compliance, risk management, process excellence and quality programs. He has over 28 years of Compliance experience in the pharmaceutical industry. Prior to joining CSM, he held various R&D, Manufacturing and Global Compliance positions during his 26-years at Merck & Co. Inc.
Abstract:
Patient Centricity is a popular topic recently. Recent initiatives such as the FDA Patient-Focused Drug Development Program and the Patient Representative Program are focused on getting patients more involved with the drug development process. Patients are becoming more involved with their care and want to be in control of their life and manage their condition. This is especially true with the younger generation of patients with chronic diseases who must balance the demands of their illness with that of work and their families. Understanding a patient’s experience with their illness and what they value most will be very important for a successful clinical study. The presenter will share real life experiences with patients and care-givers that have been involved in recent clinical trials to better understand what Patient Centricity means to them and how we can do better as an industry to focus on the needs of patients.
Keynote Forum
Jody Ehrhardt
Ehrhardt Clinical Research, USA
Keynote: Why Conferences and Continued Training Really Matter
Biography:
Jody M Ehrhardt is a certified clinical research coordinator with over 20 years of experience in the clinical research industry. Throughout her career she has worked in phase I-IV human trials as a clinical research coordinator, data coordinator, project manager, and Director of Research Services. She also consults for a major animal pharmaceutical company as a regulatory and development specialist. In 2012 she used the experience she gained from working in numerous roles, therapies and industries and founded her own clinical research facility.
Abstract:
According to the Alliance for Continuing Education in Health Professionals, continuing education has been proven effective at improving patient outcomes and saving lives. Further, continuing education helps bridge the gap between what was learned after completing traditional education and current medical advancements and policy directives. As clinical research professionals we need, now more than ever, to seek out continued training in order to stay successful in our industry. Opportunities such as this conference give us the tools we need to stay relevant in our chosen profession. Through conferences and continued training we can achieve better outcomes in our clinical trials, maintain or establish our expertise within our industry and community, and better serve our customers (our sponsors, CROs, and volunteer.) Continued training also results in personal gains. Individuals who continually seek out and complete training enjoy higher job satisfaction, increased confidence in their daily tasks, and higher salaries.
Keynote Forum
Stephen Hsu
Augusta University, USA
Keynote: Phase II clinical trials using formulations of compounds derived from tea plant for restoration of salivary function and treating herpes labialis
Biography:
Stephen Hsu has obtained his PhD degree from the University of Cincinnati. He spent four years at Memorial Sloan-Kettering Cancer Center prior to a 4-year career change as a TV Sports Anchor for ESPN International while teaching at the National University of Singapore. He is a tenured Professor at Georgia Regents University and serves as Course Directors for Nutrition and Biochemistry. He has published more than 60 research articles and 8 books/book chapters. His contribution in translational studies on the benefits of green tea was recognized with multiple awards such as Georgia Bio Innovation Award and IADR/GSK Innovation in Oral Care Award.
Abstract:
Previous in vitro and in vivo studies indicated that catechins from the tea plant (Camellia sinensis) possess multi-beneficial effects including a therapeutic effect for herpes simplex virus infections and restoration of salivary functions. To test the efficacy of formulations developed for treating herpes labialis and managing xerostomia, AverTeaX and MighTeaFlow, respectively, two separate double blind, placebo controlled, randomized clinical trials were design and conducted in two dental institutions located in the US and China. For the AverTeaX herpes labialis trial, the results demonstrated significant reduction of clinical episode duration (median 4.5 days, range 1-11 days vs. 9 days, p=0.003) and shortened blistering/ulceration stages within an episode from a median of 3 days to 1 day (p=0.0003). Patient’s quality of life was also improved and no adverse effect was reported. It is concluded that AverTeaX formulation containing lipophilic catechins inhibited herpes simplex labialis infection effectively with clinical significance. For the MighTeaFlow xerostomia trial, after 8 weeks of therapy of lozenges containing either MighTeaFlow formula with green tea catechins or a placebo, the catechin-containing MighTeaFlow formula resulted in a statistically significant increase in un-stimulated (3.8-fold) and stimulated (2.1-fold) saliva output verses baseline. In contrast, the xylitol-containing placebo failed to modulate saliva output. The results demonstrate that the catechin-containing MighTeaFlow formula partially restored salivary function in xerostomia patients and provided an objective improvement in saliva output. In conclusion, food additive natural compounds derived from tea plant are suitable for medicinal use to provide significantly higher efficacy than currently available medications or OTC products.