Your Questions, Answered
Answers to common questions about translational strategy, biomarker development, and due diligence.
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End-to-end strategic advisory services across two primary pillars: Data Package Development & Review (Due diligence, Regulatory filing document, IND, IB review) and Translational Medicine & Diagnostics (Clinical biomarker strategy and integration, RP2D considerations, Patient stratification/ selection approach, CDx, Operational logistics).
Dedicated time in supporting local STEM & Career Mentorship initiatives. -
While I support assets across development, the ideal time for engagement is during late preclinical planning or early clinical design. Establishing a robust translational, biomarker, and data packaging strategy early avoids costly downstream protocol amendments and focuses on establishing asset value (mechanistic data, efficacy data) within expected resource.
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Having navigated both biotech and established pharma partners, I understand the cultural and operational gap, as well as expectations at both sides of the due diligence table. Being fluent to translate lean, agile biotech practicalities into the rigorous, highly structured data frameworks that major pharmaceutical partners expect during evaluation and governance reviews is the major differentiator.
Digital biomarker advancement through AI/ML-assisted model development is another area passionately working on.
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Therapeutic Areas: Oncology (Adult & Pediatric), Metabolic Dysfunction (MASLD), Neurology (ALS), Nephrology (IgAN), and Ophthalmology (dAMD).
Therapeutic Modalities: Small molecules, Biologics (including ADCs, antibodies, and bispecifics), and oligonucleotides (siRNA, ASO) -
Translational medicine bridges the gap between preclinical knowledge to human clinical efficacy. By defining clear proof-of-mechanism and proof-of-concept biomarkers early, I support sponsors to establish data-driven decision and implement strategies to capture early signs of efficacy and biological activities.
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Collaborative, transparent, and straightforward.
I see my role as a facilitator and enhancer in the drug development process, translating ideas to test in the clinic efficiently.