Lillian Yengi, PhD — Preclinical and Clinical Biomarker Development
Lilian Yengi is a pharmaceutical scientist and leader with over 20 years of experience in drug discovery and development ranging from small molecules to gene/cellular therapy and antibody linked oligonucleotides.
She has extensive experience in leading teams and projects in preclinical development (ADME & safety), translational biomarkers, assay development and validation, and management of contract research organizations (CROs), with additional experience in authoring regulatory documents including Pre-INDs, INDs, CTAs, MAAs and BLAs.
Lillian is an expert at adapting traditional paradigms to new and unconventional drug development platforms. Her functional expertise includes:
- Guidance on preclinical strategies to support advancement of drug candidates to the clinic.
- Guide clinical biomarker development, assay development and validation in alignment with clinical ‘Context-of-Use’.
- Evaluate CROs for PK/PD and toxicology studies, assay development and validation.
- Generate and execute on preclinical study protocols.
- Evaluation and prioritization of prognostic & pharmacodynamic assessments.
- Manage and oversee external work at CROs, including data analysis and interpretation.
- Work with clinical teams to incorporate biomarker plans into clinical protocols.
- Train clinical investigators on biomarker assessments.
- Author/review relevant sections of regulatory documents.
