Clinical Supplies Management, Inc., USA
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.
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.