Data standards, digitalization, and closing the reproducibility gap in biopharmaceutical R&D
Research, development, and manufacturing irreproducibility in biopharmaceutical drug development, as well as cell and gene therapy, has implications far beyond the obvious loss of time, resources, and investment. Irreproducible outcomes have a downstream and upstream impact on the development of innovative therapeutic drugs and advanced therapy medicinal products.
Join us for this event, where we will:
- Explore sources of irreproducibility and discuss efforts to address these problems, including the use of data standards and digitalization.
- Highlight a case study at a Contract Research Organization using digitalization to address reproducibility issues in cell-based testing for regulatory submissions, as well as a GMP potency assay release test of a commercially approved gene therapy product.
This event will take part in three sessions, followed by an expert panel discussion:
- Session 1: The price of irreproducibility presented by Leonard Freedman, Chief Science Officer at Frederick National Laboratory for Cancer Research
- Session 2: The critical role of standards presented by Steve Emrick, Director, Translational Informatics / Digital & Innovation at US Pharmacopeia (USP)
- Session 3: Digitalization – meeting the challenge head-on presented by Patrick Dentinger, Senior Vice President, Managing Director at Absorption Systems
- Q&A session and Panel discussion: Join the debate on the challenges of manufacturing irreproducibility in biopharmaceutical drug development and the impact of this has on the development of innovative therapeutic drugs and advanced therapy medicinal products.
Who should attend?
Scientists and laboratory managers Laboratory IT specialists QC directors