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Drug Research and Development for Adults Across the Older Age Span
The Era of COVID-19 and Beyond
The National Academies of Sciences, Engineering and Medicine
Sven Stegemann Professor for Patient Centric Drug Development and Manufacturing Graz University of Technology
K1 Competence Center - Initiated by the Federal Ministry of Transport, Innovation and Technology (BMVIT) and the Federal Ministry of Science, Research and Economy (BMWFW). Funded by the Austrian Research Promotion Agency (FFG), Land Steiermark and the Styrian Business Promotion Agency (SFG). The context of drug development and healthcare technology
Covid-19 Quality, Safety and efficacy Special patient populations patient Special Policies and Regulations Policies
Development Clinical trials clinical and Scientific (incl PFDD) (incl pediatrics & geriatrics) provision Healthcare evidence Discovery Dev. & clinical trail Patients & Fast track, break through & orphan Technology New modalities Innovation (CAR-T cells) (wearable diagnostics, Digital health programs telemed) Use & generate scientific and clinical evidence directly to patients e.g. Remdesivir, SARS-CoV2 vaccine, digital healthcare, new clinical trials design,... Agenda – August 6, 2020 – 12.00 pm – 1.30 pm Opening remarks by panel moderator, European perspective SVEN STEGEMANN
Lessons learned from COVID-19 (12.00 – 1.00 pm) U.S. regulatory changes Digitization of medicine HARPREET SINGH ERIC TOPOL Division Director (Acting) Founder and Director U.S. Food and Drug Administration, Division of Oncology 2 Scripps Research Translational Institute Infectious disease perspective Patient perspective JOHN POWERS BEVERLY CANIN Senior Medical Scientist Patient Advocate Leidos Biomedical Research Cancer and Aging Research Group Telehealth / Physician perspective ERIKA RAMSDALE Panel discussion (1.00 – 1.30 pm) Assistant Professor University of Rochester Medical Center