Moving from concept to clinic
Advancing a novel therapy from discovery to first-in-human studies requires both scientific rigor and a cohesive long-range plan.
Strategic Clinical Development
As a strategic advisor, I help emerging biotech and pharma teams translate early discoveries into structured development strategies that align preclinical, manufacturing, and clinical plans, anticipate regulatory expectations, and support investor confidence.
For Entheon Biomedical, a therapeutics startup looking to develop a novel addiction treatment, my initial focus was compiling data and identifying gaps in preclinical studies to assess the feasibility of a clinical trial. As the program matured, I took on the role of Chief Science Officer and began working closely with interdisciplinary teams and advisors around the world to advance a comprehensive and efficient IND/CTA strategy. This included selecting the right clinical site, conducting preclinical assays, organizing GMP manufacturing activities, drafting clinical protocols and compound dossiers, and integrating a novel biomarker program, all within a complex regulatory environment. The effort resulted in the accelerated approval of a phase 1 clinical trial which was subsequently sold to an acquiring company.
