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Areas of expertise: Early oncology clinical development; oncology registration studies; Oncology translation medicine; development of companion diagnostics for patient selection; solid tumors; oncology orphan indications; immune-oncology studies; clinical development plan; global clinical studies including EU, Australia, Japan, and China
Jerry has 20+ years of oncology global clinical development experience with expanding leadership responsibilities; strategy development from First-in-Human to Proof-of-Concept to pivotal registration studies; hands-on global clinical studies from IND (phase 1) to NDA enabling (phase 2/3); worked on multiple solid tumor indications and orphan indications; Health authority interactions (FDA CDER, CDRH, EMA); working experience in the Asia Pacific and China; hands-on global clinical operation with CROs; collaborated with multiple line functions on medical monitoring, ongoing and final analysis of clinical data/summary.
Jerry has led global clinical studies using the Bayesian logistic regression model in phase 1 and phase 2 studies. She has interacted with a network of investigators for various oncology clinical studies in different tumor indications. Working in big pharma based in the US and in Europe, as well as in small start-up biotech companies in China, she has guided organizations and teams on process improvement and setting up standard working practices to efficiently execute clinical studies. She has spent 2 and a half years working in a CRO supporting projects in the US, EU, and the Asia Pacific.
Jerry graduated from Sun-yet San university of Medical Sciences in China and received her Ph.D. in biophysics and MS in Clinical Research Methods in Albert Einstein College of Medicine in the US.