The Importance of Holistic Sterile Drug Product Development

This webcast highlights typical challenges experienced during the development and commercialization of sterile drug products.

Register Free: https://www.pharmtech.com/pt_w/holistic-drug-development

Event Overview:

This webcast highlights typical challenges experienced during the development and commercialization of sterile drug products containing, for example, therapeutic modalities of biological or ATMP types. Interdependencies of formulation, packaging, device and process are also highlighted. At the end of this webcast, we hope this knowledge can be used to help you design a holistic roadmap and strategy to ensure a successful registration and commercialization of a differentiated, efficient, safe and well-usable sterile medicine.

Key Learning Objectives:

• Understand challenges associated with development and commercialization of sterile drug products.
• Learn about interdependencies of formulations, packaging, devices and processes.
• Master how to design your development pathway and roadmap to ensure a successful drug product, ensuring quality, efficacy, safety, patient usability and product competitiveness.

Who Should Attend:

• CEOs
• CMC / product team leaders
• R&D managers
• R&D scientists
• Regulatory Affairs specialists
• Formulation Development Scientists & managers
• Drug Product Scientists & managers
• Analytical Scientists & manager
• Sterile Production managers
• CMC Consultants

Speaker:

Prof. Dr. Hanns-Christian Mahler
Chief Enablement Officer (CEO) & Board Member
ten23 health AG, Basel, Switzerland

Dr. Hanns-Christian Mahler is the Founder, CEO and board member of ten23 health AG, the human-centric and sustainable pharmaceutical development partner.

From 2015 until mid-2021, Dr. Mahler built and led the Drug Product Services business unit at Lonza AG, a leading service provider for the Pharma and Biotech industry. Prior to this position, he worked at Hoffmann-LaRoche (Basel), leading Pharmaceutical Development and Supplies, Biologics EU, and played a role in building up Formulation R&D for biologics at Roche (2005-2015). From 2000-2005, Dr. Mahler worked at Merck KGaA, Darmstadt, Germany, as a principal formulation scientist. He was also a lab manager for Protein Formulation Development and Clinical Trial Manufacturing and the CMC team leader for Erbitux.

Dr. Mahler studied Pharmacy at the University of Mainz, Germany. He holds a Ph.D. in Toxicology from the Institute of Pharmacy, University of Mainz, and obtained his venia legendi (german Habilitation) from the University of Frankfurt/Germany in 2010.

He was elected an AAPS Fellow in November 2013, nominated extraordinary Professor for Pharmaceutical Technology in November 2015, received the PDA Distinguished Service Award in 2018 and the APV 2022 Award for Outstanding Achievements in Pharmaceutical Sciences, and was included in the Medicine Maker Power List in 2022 and 2023. Dr. Mahler is a top 10 leader in biopharmaceuticals, and is amongst the most influential people making the most impact in the drug-making space.

Register Free: https://www.pharmtech.com/pt_w/holistic-drug-development