Panel Discussion
Monday, September 22
06:10 PM - 06:55 PM
Live in Berlin
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As pharmaceutical manufacturers face rising cost pressures, supply chain disruptions, and increasing demands for efficiency, the industry must rethink its approach to operational excellence. A holistic strategy—one that integrates innovative business models, digitalization, and resilient supply chains—is essential to navigating these challenges. From supply chain resilience in an era of geopolitical uncertainty to the role of new ownership models like Dynamic Shared Ownership (DSO), panelists will discuss how companies can optimize efficiency while remaining agile and competitive. In this session, you will learn more about:
Timo Flessner, Senior Vice President, has broad operational and senior management experience in pharmaceutical R&D, manufacturing & Product Supply.
Since June 2024 he takes the role as the Manufacturing API & Medical Devices Lead at Bayer Pharma Product Supply. The portfolio in API and MD manufacturing, is rich in diversity and complexity, spans across 11 global sites. MD adds to his former responsibility and brings new challenges as change, fostering collaboration, and setting new benchmarks in the supply of active pharmaceutical ingredients and a diverse portfolio of medical devices.
Since October 2020 he took responsibility for the Global API (Active Pharmaceutical Ingredient) Product Supply organization. The main focus is on API supply for clinical studies as well as launch & the longer-term commercial life-cycle of a broad product portfolio.
In the previous role he was the Site Manager for the Pharma site in Wuppertal - which is the founding place of Bayer & includes Pharma R&D and API Product Supply operations. Before he was the Site Manager for the Bayer Supply Center Bergkamen as well as the Supply organization in Berlin-Charlottenburg. Before moving into the site manager responsibilities he was heading Global Chemical Development with a focus on the development of chemical & technological processes to ensure API supply concepts & security for preclinical, clinical studies, submission & launch.
From 2000-2011 he held various positions of increasing responsibility in Bayer´s / Bayer HealthCare’s Global Drug Discovery (Head of chemistry labs, Chief of staff for PH Research and PH R&D, Director & Head of a Medicinal Chemistry Department).
In addition to his responsibilities at Bayer he is a non-executive advisor for start-up companies and a lecturer at the University of Hannover since 2015 (Making Drugs: Research, Development & Industrialization of API). His strong ambition for sustainability drove him into a supporter role for the Circular Valley initiative. In an additional assignment he is a member of the board of the GDCh (2016-2024). Apart from the professional level he is active in voluntary work, e.g. in an initiative in Wuppertal that supports the city & people in need. He is married and a proud father of two sons.
He holds a PhD in Chemistry. He was educated at the Universities of Oldenburg, Hannover and Paris-Sud (Diploma in Chemistry). He received his PhD with Prof. E. Winterfeldt in 1999 from the University of Hannover. He worked as a Postdoc in the group of Prof. C.-H. Wong at the Scripps Research Institute in San Diego.
Rebecca has worked with ERP and MES systems and NN global supply chain for + 15 years. She was a business process specialist and super user of SAP, before she became a Solution Architect on a global ERP/MES implementation for all NN production sites (+20 sites). Currently, she is responsible for the direction and development of the MES Solution in NN as the MES Product Manager and System Architect and member of the leadership team in NN MES CoE. She is a member of BioPhorum’s MES of the Future work stream since 2022 and contributor to white papers regarding Interfaces and data. She is a passionate music lover, a mother of two, and hobby chef and visual artist.
I’m a visionary who is intrigued by the technological developments in the MES arena and how we in the industry can adopt and benefit from these developments. I’m a tech sceptic and I do not get swept away by tech fads as I want to understand and analyze how the adaptation can help us move forward. I’m fascinated by the human and organizational change that follows digitalization and technology transfer, and I’m passionate about enabling the human creativity by using IT and OT systems.
Over 15 years experience in Pharmaceutical Technology, 14 years thereof in industry, including:
- experience in New Product Launches (e.g. Bavencio, Mavenclad)
- experience in leading international technical project teams
- experience in global development teams
- experience in development, optimisation and scale-up of manufacturing processes
- know-how in creating regulatory dossiers (IMPD, IND, CTD, eCTD)
- know-how in Quality by Design (QbD)
- experience in In-Vitro In-Vivo Correlations (IVIVC)
Brian DiVasta is Director for Computer System Validation for ElevateBio for 4+ years. There his specialties are computer validation and quality assurance. Before his position at ElevateBio he was with Sanofi for 8+ years as Associate Director, ITS Compliance.
Senior professional and leader with more than 20+ years of experience in biotech/pharmaceutical industry with proven track record of organizational development, strategic planning and execution; within clinical and commercial manufacturing, product and technology development, CMC project management in GMP environment. Expertise in technology transfer, process validation and optimization of biologics/chemical drug substances and drug product and finished goods.