Dr. René Dathe

Development Driving xRNA, Radioligand and Gene & Cell Therapy combination products as well as Due Diligence Accountable for QA team based in Austria, Germany, India, Switzerland and US

Global Drug Development End-to-End Digital Quality organization for Digital Therapeutics, Connected Health & Software as Medical Devices portfolio for Development projects & commercial Franchise. Accountable for teams in Germany, India and Switzerland.

Global Drug Development: Accountable for the Quality of Medical Devices and Combination products of the Global Sandoz Biosimilar portfolio (Immunology, Oncology and Endocrinology Franchise) with teams in Austria, China and Germany. Foster Connected Health and Digital therapeutic solutions. Heading Diversity & Inclusion ERG Asia Business Forum Council including Asia Business Mentoring program and Due Diligence.

Novartis Technical Operations: Leading Quality Shared Function for Quality teams in Austria, Germany and Switzerland, aligning technical development, and manufacturing operations for Biological Drug Device Combination Products to ensure regulatory compliance and operational efficiency. Accountable for all Quality Management Systems/SOPs concerning ISO 13485:2016, 21 CFR 820/Part 4 for Medical Devices and Combination Products including Audit and Supplier Management, QMS, Compliance and Risk Management.

Global Device Development Unit: Managing Alliance projects in Sanofi/Regeneron alliance (Cardiovascular & Metabolic, Immunology & Inflammation and Oncology Franchises). Leading Development, submission, design transfer, launch support and LCM of auto-injectors for therapeutic monoclonal antibodies (Praluent, Dupixent and Kevzara) as Biologicals. Responsible as PMO for Design control, DHF, Usability & Risk with strong experience in managing CMC, CROs and CMO activities, co-authored BLA and MAA documents.

Global R&D Diabetes Division: Research on active pharmaceutical ingredients against Diabetes metabolic disorders small molecules and Biologicals in Global Diabetes R&D organisation

Digital Chemistry Group: Digital organic-electrochemical research and development of organic LEDs (Digital Display and optical nanotechnology)

Inventive problem solving concepts (TRIZ) for drug-device combination products, Development of group process interactions, Psychological group behavior analysis with SYMLOG; Thesis: “Process and efficiency of applying the TRIZ methodology to medical device innovations”

International strategy and Sales management, International Entrepreneurship; thesis: „Success strategies in the researched-based pharmaceutical industry after patent cliff 2013”

Organische Chemie, Polymerchemie, Technische Chemie; Thesis: „Aufbau einer Lösungsspray-Blitzvakuumpyrolyse-Apparatur“