IO Translational
Consultancy, Translational Research & Translational Medicine in Cancer Immunology & Immunotherapy Research
Accelerating Biotech Success through Translational Research
What I Provide
As a consultant, I specialize in delivering end-to-end support for biotech and early-phase clinical trials, with a strong focus on cancer immunotherapy and translational research. My mission is to help you navigate the complexities of drug development with tailored, expert-driven solutions.
Comprehensive Services Include:
- Biomarker Strategy Expertise: Developing biomarker strategies for PK/PD endpoints, selecting robust candidates for companion diagnostics, and designing gating strategies and biomarker panels for advanced flow cytometry. I also specialize in selecting protein biomarkers tailored for XMAP Luminex technology to ensure targeted and impactful assay outcomes.
- CRO Selection & Oversight: Supporting the selection and management of Contract Research Organizations (CROs) for preclinical and clinical studies, including RFP preparation, bid defense, and SOW negotiation and review.
- Central Lab Management: Guiding central lab selection and oversight, drafting and revising laboratory manuals to streamline processes, and ensuring alignment with trial-specific requirements.
- Regulatory & Quality Assurance: Drafting SOPs and ensuring compliance with GCP/GLP standards to maintain regulatory rigor and data integrity throughout your projects.
- LIMS Implementation: Deploying and managing Laboratory Information Management Systems for enhanced operational efficiency, data tracking, and regulatory compliance.
- Data Analysis Collaboration: Partnering with leading data analysis CROs to provide reliable and actionable interpretations of complex datasets.
By combining technical expertise with strategic insight, I help biotech organizations transform innovation into impactful clinical outcomes. Let’s collaborate to bring your breakthrough therapies closer to patients.