Services

Extensive experience in CMC statistics, including biosimilarity, drug stability, dissolution, analytical methods, validation, and bioassay cut-points. Optimization and validation of pharmaceutical processes and analytical methods. Stability analyses and shelf life estimation. Sampling plan development. Application of Bayesian Methods in CMC. Cell culture monoclonal antibody process optimization and control. Monoclonal antibody purification and fluorochrome conjugation.
Bioassay development, optimization, analysis, and validation, from research to marketed products. Speaker at various national and international (Rome, London, Berlin, Mexico City) on bioassay topics, particularly statistical analysis of bioassay data. Design and analysis of test method and process validations. Use approaches to bioassay analysis and validation that are both state of the art and in accordance with regulatory and compendial guidances.
Manufacturing support, including development of commercial assay specifications, assay transfer, SOP development, and statistical process control (SPC).
Statistical leadership and support in personalized/precision medicine, including multiplex genomic diagnostic testing in oncology. Experienced in achieving ISO15189 accreditation in association with genomic analysis.