Suzette Girgis
Vice President & Head of Global Clinical Pharmacology & Pharmacometrics Jazz Pharmaceuticals
Strong drug development experience (more than 25 years) in small molecule, cell therapy and biologics (including bispecifics such as BCMA, GPRC5D & HER2) at early and late stage of development, including filing and registration across different therapeutic areas with emphasis on oncology. Expert in applying quantitative medicine approaches for strategic decision making and selecting the dose regimen for First in Human and the Proof of Concept studies. Solid clinical experience in study execution and data interpretation. Strong managerial and mentoring experience. Influential leadership skills. Oversee the clinical pharmacology strategy of oncology and neuroscience compounds. Significant contributions to various compounds submissions (such as Ziihera, Tecvayli, Talvey, Velcade, Dacogen, Nulojix). Due Diligence activities. Business and operation strategies. Hold 3 patents (teclistamab, talquetamab, soluble BCMA).
Seminars
- Implementing evidence-based step-up dosing regimens to reduce the cytokine response, allowing for higher target doses while minimizing the risk of severe CRS and ICANS
- Transitioning to Modified MABEL models that utilize real-time PD markers to identify the optimal biological dose
- Ensuring escalation decisions are based on anti-tumor activity rather than just circulating drug levels
Join this workshop to bridge the critical gap between preclinical promise and clinical reality, where the focus shifts from molecular potency to the power of a translational data package
- Discussing ideal assays for bankable safety data beyond TCRs, such as cytokine release assays and tissue models
- Evaluating the translational impact of Fc-silencing or Fcengineering on systemic inflammation and half-life in a nonanimal context
- Discussing the current gap in translational models for ICANS/ neurotoxicity and whether specialized neuro models are ready for IND inclusion
- Deep diving into how TCE developers are harnessing the modified MABEL approach to avoid ‘sub-therapeutic’ dose escalation and save cohorts
- Discussing how unexpected clinical outcomes should trigger new in vitro or ex vivo studies
