Bioanalytical fit-for-purpose solutions for preclinical and clinical development
Wednesday, December 7, 2022 11:15-11:45 am ET
Biomarkers and PK/PD-studies play key roles in the drug development process with the potential to improve success rate and reduce uncertainty in regulatory decisions.
Through case studies based on real-life challenges, in this webinar we will discuss:
- How to tailor the bioanalytical strategy to fit the study needs and
- How to ensure a successful method validation outcome
Speaker: Carmen Herrera Hidalgo, Ph.D., Mercodia
Updating Regulated Assays in Anticipation of ICH M10
Wednesday, December 14, 2022 1:15-1:45 pm ET
The adoption of ICH M10 will introduce several operational changes in the regulated bioanalytical laboratory. While most of these changes are minor, depending upon the stage of development for a drug discovery program, they will need to be incorporated into the bioanalytical assay for future sample analysis. Among these changes are significant differences in the handling of dilution QCs during sample analysis, alterations to the placement of the mid-level QC in the analytical range, universal adoption of multi-aliquot stability QCs and specific instructions for validation experiment requirements for co-administered compounds. None of these changes represents major alterations to the bioanalytical assay; however, any change to a regulated method will warrant consideration and likely some level of validation. If additional validation is required, a priori acceptance criteria need to be established to demonstrate that the changes to the method to bring it into compliance with the ICH M10 guidance do not impact the integrity of the previously collected data or the integrity of any upcoming analysis.
Speaker: Jennifer Zimmer, Ph.D., Alturas Analytics
Analysis of Oligonucleotide Therapeutic Candidates by Antisense Capture with High-Resolution Mass Spectrometry
Wednesday, February 8 11:15-11:45 am ET
Therapies based on oligonucleotides (OGN) often require multiple bioanalytical assay formats to measure the active pharmaceutical ingredient in tissues and fluids. Hybridization ELISA is used to measure the levels in fluids such as cerebral spinal fluid or plasma because the concentrations can be too low to detect with liquid chromatography mass spectrometry (LCMS). The levels in tissues are commonly measured by LC-MS/MS or LC-high resolution MS (LC-HRMS) as they are greater than liquid matrices. Regulatory agencies and innovators increasingly want to monitor additional components in OGN assays including glycoforms, shortmers, payloads, and other non-OGN constructs. The challenges are that hybridization ELISA lacks the specificity to monitor multiple components and LC-MS lacks the sensitivity to measure components in clinically relevant liquid matrices. We employed antisense capture to clean up and concentrate the samples to gain the sensitivity on the mass spectrometer to have quantitation limits comparable to hybridization ELISA. In this talk, the design of the capture probes will be discussed as well as the capture efficiency across various shortmer lengths and OGNs containing covalently attached small molecules.
Speaker: Liam Moran, Ph.D., Charles River