Molecular bioanalysis considerations along the drug development journey
Tuesday 24 June 2025
07:00 [PDT] 10:00 [EDT] 15:00 [BST]
Alternative time zones
Transitioning from the pre-clinical to the clinical space.
This presentation outlines molecular bioanalysis considerations, such as assay design to support cell and gene therapies. A forward-thinking approach leads to several gained efficiencies that are usually missed in early study design or due to segmented pre-clinical and clinical teams. The key is defining context-of-use when planning these studies for the end goal — clinical translation. Successful programs leverage building methods for both pre-clinical and clinical use. Here, we highlight assay differences in cell versus gene therapies and lessons learned.
What will you learn?
- Considerations for packaging/building methods for both pre-clinical and clinical use
- Assay context-of-use: qPCR versus ddPCR platforms and other design modalities
- Leveraging expertise and capabilities to better prepare for the end goal — clinical translation
Who may this interest?
- Cell and gene therapy developers and researchers
- Biopharmaceutical scientists involved in drug development and testing
- Molecular bioanalytical scientists working in both pre-clinical and clinical settings
Keith Rennier
Scientist, Molecular Bioanalysis
Labcorp Bioanalytical Services (IN, USA)
Dr Keith Rennier has more than 13 years of biomedical research and development expertise in PCR, cell-based assays, signal transduction pathways and flow cytometry. His research has primarily focused on cellular mechanotransduction, tumor immunology and cancer biology.
He earned a PhD in Biomedical Engineering from Purdue University (IN, USA) in 2015. As a postdoctoral research fellow at Washington University in St. Louis (MO, USA), Keith focused on assay development to delineate key oncogenic signaling pathways and immune cell recruitment in human tumors.
After his fellowship, Keith joined Labcorp in 2020. Currently working as part of Labcorp Biopharmaceutical CMC Services’ biodistribution group, Keith serves as the scientific point of contact for internal and external GLP/GCP projects and leads the scientific teams to meet client expectations and project deliverables. Keith provides scientific oversight to ensure the successful development, validation and execution of preclinical- and clinical-stage biodistribution and vector shedding studies.
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