From the Agenda

Challenges in Assessing Therapeutic Equivalence of Nano-Similars

2016-11-23 15:00:00

Dr Beat Flühmann

Global Regulatory Science Lead® & Director

Dr. Flühmann is a Pharmacist by training and holds a PhD in molecular biology from ETH Zürich,

Switzerland on “Structural analysis and characterization of cell surface receptors” and a MBA of the

University of St Gallen Switzerland. He was working in various position in the field of pharmaceuticals and

functional nutrition. He was Deputy Department Head of a R&D department for 8 years. Dr. Flühmann was

leading a global multidisciplinary research and development team at Roche/DSM nutritional products

developing novel compounds for the prevention and treatment of diabetes. At Vifor Fresenius Medical

Care Renal Pharma Ltd Dr. Flühmann was acting as Global Brand Director defining the global strategic

product plans across all functions (medical, marketing, market research, regulatory, life cycle

management, logistics) and ensuring the operational execution. A strong life cycle plan to maintain market

leadership against generics was successfully implemented to increase sales despite introduction of

generics and additional originator products. In his current position Dr. Flühmann is Global Lead Regulatory

Science with a main interest in regulatory aspects of nanomedicines. He is Steering Committee Member

of the Non-Biological Complex Drugs Working Group hosted at Lygature a non for profit organization. The

Non-Biological Complex Drugs Working Group has been set up to discuss appropriate and harmonized

science-based approval and post-approval standards for nanosimilars to ensure patient safety and benefit

with Non Biological Complex Drugs (NBCDs). The working group engages in activities to disseminate the

corresponding scientific evidence to authorities, experts, health care providers. Moreover the group is

involved in scientific education and training on the above mentioned topics to relevant stakeholders. He is

as well advisory board member of the GoNanoBioMat project a multinational research project in the field

of nanomedicine.