Kayoko C.

Served as a sole Clinical Trial Manager overseeing a global open-label, multicenter Phase 1 dose escalation study in subjects with relapsed/refractory chronic lymphocytic leukemia or Richter syndrome.

Collaborated extensively Zogenix Japan to contribute to the Phase III long-term safety study for Fintepla. Led PMDA inspection readiness activities and provided operational leadership for study closeout activities globally.

Contributed to the Phase 1/2 Study for Patients With Advanced Solid Tumors, RET Fusion- Positive Solid Tumors, and Medullary Thyroid Cancer, encompassing dose escalation to dose expansion of selpercatinib which received a breakthrough designation from the FDA. Supported FDA, EMA, and PMDA inspection readiness of clinical trial for selpercatinib and the successful NDA submission of selpercatinib, resulting in FDA approval received on 08May2020, EMA approval received on 02Nov2021, and PMDA approval received on 27Sep2021. In collaboration with Sr. Clinical Trial Manager, contributed to the selection of multiple central laboratory vendors, budget review, CRO selection and site feasibility for Pirtobrutinib global phase III study for Chronic Lymphocytic Leukemia patients. Demonstrated proficiency in site feasibility and startup activities across North America, Europe, the Middle East, and Asia Pacific regions in a global, Phase III trial.

In collaboration with the Clinical Trial Manager, contributed to the operational execution of clinical studies to ensure timely delivery, within budget, and with high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs. Responsibilities included participation in cross-functional study teams and oversight of CRO teams and vendors. Led Investigator’s meeting in Japan.

I was responsible in pediatric growth hormone deficiency study, which involves reviewing monitoring visit report form CRO and assisting with conducting site feasibility and associated tracking. Experience at Versartis, Inc Reviewing Monitoring Visit Report (MVR), which is written in Japanese. CRO management based on MVR review findings, resolution and escalation. Participating in feasibility and/or site identification activities. Assisting the Project Team with the day-to-day management of clinical studies.

I was responsible for study in a oncology Phase I and Phase IIb studies, which involves managing CROs for reviewing trial reports, reviewing and collecting documents for TMF, reviewing clinical invoices, and managing clinical and drug and non-drug clinical supplies.

I was responsible for study start up in a Global Phase II study, which involves managing CROs for site feasibility and site selection and ensuring the effective and efficient delivery of country/region operational information and oversight in accordance with ICH-GCP standards, SOPs, local operating guidelines and local regulatory requirements.

I work in a strong team consisting of multiple CRAs, and I work closely with each clinical trial to foster communication and facilitate teamwork in seeing clinical trials to a successful finish. I am responsible for conducting site initiation and intramonitoring visits with a focus on Phase III clinical trials. I ensure clinical trials are conducted in compliance with protocols, ICH-GCP procedures and PPD and sponsor company SOPs. My responsibilities includ site monitoring, site management, site administration, and regulatory management for clinical studies according to ICH-GCP. I am involved in all aspects of training, monitoring, and communication in clinical trials as well as in site closure. I train clinical site staff to ensure protocol and regulatory compliance and I train investigators how to report adverse events. I maintain the supplies of investigational products and equipment used on-site during trials and develop action plans to improve documentation quality onsite. I also manage patient enrollment, including tracking and monitoring enrollment at sites and initiating additional recruitment strategies as required. I monitor sites to detect unreported adverse events and keep track of adverse event follow-up data. I also ensure accuracy and completeness of data collected by sites and track all deviations from the protocol throughout the entire trial. Finally, I a responsible for site closure including keeping track of and collecting unopened investigational products and equipment and collecting final patient data. I communicate with each vendor and manage sites to ensure documents from vendors such as HCRI, DCRI, assisTek, AG Mednet, and IVRS are completed correctly. I use several EDC systems including Oracle Clinical and Medidata RAVE applications.

At Sanofi, I was responsible for conducting site initiation, intermediate monitoring and site closure visits with a focus on Phase I and Phase III clinical trials. I ensured clinical trials were conducted in compliance with protocols and J-GCP and ICH-GCP procedures. I also monitored compliance and any deviations as required. I participated in Phase III cardiovascular disease clinical trials, which were conducted throughout Japan. My responsibilities also included site management and CRO management. I also participated in phase III diabetes and phase I oncology clinical trials.

At UCLA, I worked at the Brain Research Institute for Dr. Eain Cornford, PhD. In my work at UCLA, I utilized immunoliposomes via gene-replacement and enzyme replacement therapy to treat a knock-out mouse model for Lafora's disease. I also prepared rat anti-mouse monoclonal antibodies and assisted with nick translation to make P32-labeled lacZ plasmids, injections, tissue extractions and preparation of tissues for immunocytochemistry. Other skills I picked up at UCLA include column chromatography, pegylated immunoliposome synthesis, and purification. I also routinely performed amylase and amyloglucosidase enzyme assays and glucose and maltose assays. Finally, I took part in mouse behavioral studies.

Publication at UCLA: Bacillus simplex, a little known PGPB with anti-fungal activity, alters pea legume root architecture and nodule morphology when coinoculated with Rhizobium leguminosarum bv. viciae http://www.mdpi.com/journal/agronomy/special_issues/Biocontrol_plant_Microorganisms

Prepared for undergraduate studies before transferring to UCLA.