Ildiko Csiki
Chief Medical Officer Geneos Therapeutics
Dr. Ildiko Csiki is an oncology drug development leader, currently serving as the Chief Medical Officer for Geneos Therapeutics with more than 20 years of experience spanning academia, biotech, and pharma. She has held senior leadership roles in academia including at U Penn and City of Hope as the Chief Commercial and R&D Officer and was a global development had for Keytruda in GI Oncology at Merck. She completed an executive program Wharton focused on healthcare innovation. Her work focuses on personalised and precision oncology and access to therapies for patients.
Seminars
As neoantigen therapies advance into clinical development, optimising clinical trial design and operational setup becomes critical to ensuring scientific validity, regulatory alignment, and overall programme success. Careful planning of endpoints, patient stratification strategies, biomarker integration, manufacturing timelines, and site coordination is essential to minimise delays, control costs, and generate robust, interpretable data. This workshop will provide an in-depth exploration of best practices in clinical trial setup to equip you with the strategic and operational insights needed to execute streamlined, data-driven, and successful trials.
This workshop will gather experts to discuss:
- Design robust trial protocols to successfully meet regulatory requirements
- Align manufacturing timelines and supply chain logistics with clinical trial sites to ensure timely treatment delivery
- Optimise patient selection approaches to improve response rates and meet primary endpoints
- Generate mechanistic insights through immune monitoring and translational biomarker analysis
- Navigate varying regulatory requirements to support smoother global trial execution
- Clinical learnings from GT-30, including the favourable safety profile observed with a personalised neoantigen immunotherapy regimen even in advanced hepatocellular carcinoma patients treated in combination with pembrolizumab
- The scientific and development rationale for moving into GT-31, an adjuvant monotherapy study in hepatocellular carcinoma patients with no active radiographic disease, where lower tumour burden and immune priming may provide a stronger setting for benefit
- Key design considerations for personalised neoantigen trials in hepatocellular carcinoma, including novel endpoint strategy, surveillance and recurrence assessment, feasibility of individualised manufacturing, and how to generate a package that is both clinically meaningful and developmentally scalable
