Workshop 2 – Clinical Trials for Advanced Therapies
Date: 24 July (Friday) 12:20 – 13:50 (GMT+8)
Venue: www.bioasiataiwan.com / Online event platform
Dr. Kush Dhody, Senior Vice President of Clinical Operations for Amarex Clinical Research, is a seasoned clinical research professional with academic, clinical, and pharmaceutical research experience spanning over more than 15 years. Dr. Dhody has managed Phase I-IV studies within a contract research organization (CRO) environment and for mid-to-large sized pharmaceutical and biotechnology companies. He has also served as a study site investigator.
Dr. Dhody provides the strategic direction for the implementation and execution of clinical trials and oversees the operational delivery of clinical study programs. He works extensively in the areas of oncology, infectious diseases and wound healing.
Dr. Dhody has held several leadership positions in clinical operations and in drug development activities to conduct/execute clinical development programs from the Investigational New Drug (IND) submission through filing of New Drug Application (NDA). While serving as Clinical Program Director for several New Chemical Entities (NCE) development projects, he has a highly successful track record of managing diverse cross-functional teams from data management, biometrics, regulatory affairs, clinical compliance, pharmacovigilance, and liaison with investigators and clinical site staff to achieve overall project delivery.
Dr. Dhody has written/developed 20+ clinical trial protocols, ranging from early phase studies, complex PK/PD (pharmacokinetic/pharmacodynamic), adaptive clinical trials, through later phase randomized Phase III clinical trials and prepared several individual and integrated study reports and co-lead teams in preparation of comprehensive integrated analysis of the safety and effectiveness of a study drug (ISSs/ISEs).
Dr. Dhody earned his Doctor of Medicine (MD equivalent) degree from the University of Pune in India, and his Master of Science in Clinical Research from Cranfield University in the UK. He has an ACRP certification as a Clinical Research Professional.
Speech title & Synopsis
Clinical trials in oncology have traditionally focused on the treatment of cancer based on the anatomic location of the primary tumor in the body. Traditional 3+3 Design followed by bayesian experimental design are the most common dose escalation study design among the traditional oncology study designs.
Cancer treatment has made significant strides toward the promise of personalized medicine and use of blood-based biomarkers such as circulating tumor cells have shown great potential in the management of cancer. Immune therapeutic drugs are a unique group among the novel targeted therapies that are under development for cancer treatment to work against tumors that possess specific somatic mutations. Understanding of the genomic alterations in multiple tumor types would help identify potentially actionable genomic changes independent of tumor histology.
This webinar focuses on the different options pertaining to clinical trial strategies such as studies including adaptive designs with innovative endpoints, umbrella or basket designs as key to advancing precision medicine, as well as the challenges of accurately interpreting traditional survival analyses in the era of personalized cancer immunotherapies.