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
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
- Debating the reality on the ground for biotechs still being pushed for NHP data and managing the gap between progressive policy and conservative reviewer feedback
- Discussing perspectives from the EU, US and Asia around the strategic burden of conducting redundant animal studies to satisfy geographically distinct regulation
- Exploring how smaller biotechs ca balance high cost of NHP studies against the need for convincing data to secure funding, even when alternative models might gain FDA approval
- Discovery and engineering approaches for generating highly selective pHLA-targeted binders.
- Preclinical evaluation strategies, including functional activity, specificity, and safety assessment.
- Key learnings from advancing pHLA-targeted therapies from nonclinical development into the clinic, and implications for next-generation programs
