Translational Consulting & Partnerships

Mitigating the Risk of Clinical Oncology Failures

Oncology therapeutics show the lowest approval probability of all major disease classes, with 95% of candidates failing during clinical phases (Wong, Siah & Lo, 2019). This represents a massive financial and clinical burden for developers. Over 90% of these failures are driven by a lack of efficacy or safety issues in the clinic (Sun et al., 2022), which are often detectable earlier with systems biology profiling.

Yatiri Bio partners directly with biopharma developers to integrate proteomics and cellular efficacy modeling into Phase I/II trial designs.

We act as a specialized translational Contract Research Organization (CRO). By reviewing preclinical data, mapping the target's active network, and screening cell models, we outline a comprehensive strategy to enrich trials with patients carrying responsive proteomic profiles.

Custom Consultation Pillars

Our translational consulting engagements are structured around three primary project pillars:

• Biomarker-Driven Trial Design: Drafting patient selection protocols, defining sample acquisition timelines, and structuring clinical assays (such as MRM mass-spectrometry or ELISA endpoints) for clinical runs.
• Kinase Pathway Mapping & Combinations: Predicting potential escape routes and bypass mechanisms to design rationale-based combination therapy protocols.
• Companion Diagnostic (CDx) Regulatory Alignment: Mapping analytical validation scopes to FDA companion diagnostic requirements (such as Investigational Device Exemptions - IDE).