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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. , 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 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 Medical Center