Design and conduct of clinical trials – a primer

Time: September 23th, Saturday, 9pm-10pm, EST (Sunday, September 24th, 9 am to 10 am Beijing Time)

Abstract: Clinical trials are a critical component in drug development and commercialization. The regulatory approval and commercial success of an active product depends, to a large extent, on the sound clinical trial strategy and efficient trial conduct. This seminar will provide a basic framework on the key elements in the design and conduct of clinical trials. Clinical trial design is based on a comprehensive understanding of the molecule under investigation such as the molecular profile, the target, preclinical data, and any relevant preliminary clinical data. A thorough understanding of potential indication in terms of the unmet medical needs, the current medical practice and the competitive environment are also critical consideration. For pivotal trials intended for regulatory approval, expertise in regulatory policies, guidance, precedents, and input from regulatory agencies are required to ensure that clinical data collected from the trial will support drug approval if trial endpoints and objectives are met. Some specific paramters are considered in a trial strategy such as patient population, endpoints, sample size and power, and approaches to data analysis. The strategy of a clinical trial guide clinical trial conduct, which is reflected in the clinical trial protocol, which is the most important document in clinical trials. The development of a clinical protocol is a multi-disciplinary efforts that includes product background information, trial design details, and trial execution instruction/guidance. Significant planning is essential to the initiation and conduct of a clinical trial, which is governed by the ethical and regulatory principles described in Good Clinical Practice (GCP) and ICH guidelines. Some of the key areas in clinical trial conduct are study site/investigator identification and selection, trial initiation, conduct, monitoring, safety reporting, data collection, analysis, and reporting, and eventually data submission to the regulatory agency and publication of the clinical data.

Speaker: Dr. Yong-Jiang Hei

Dr. Hei is the Chief Medical Officer (CMO) at Ambrx responsible for the clinical development strategy and clinical operations to support commercialization of Ambrx’s pipeline including antibody-drug conjugates (ADCs) and CD3-based biospecifics. Prior to Ambrx, Dr. Hei worked at Amgen for more than 9 years as the Executive Medical Director in oncology global development and medical affairs in the capacity of global development leaders for several oncology pipeline molecules and marketed products including small molecules such as motesanib as well as biologics such as conatumumab and Vectibix. Additionally, during his tenure at Amgen, Dr. Hei was assigned the role of the medical head in China where he built the clinical medical teams and established product development and clinical operations capabilities for Amgen China. Before Amgen, Dr. Hei worked for Roche Laboratories, Inc., and Novartis oncology as the US Medical Director for Roche, and Senior Global Brand Medical Director/Executive Director for Novartis Oncology where he led the development and execution of medical plans and expanded the investigator-initiated clinical research. In addition, Dr. Hei supported regulatory filings and submissions at the FDA, PMDA (Japan) EMA, and the Chinese FDA (cFDA). Dr. Hei received his medical degree from Shihezi Medical College in China, and graduate degrees from the West China University of Medical Sciences (M.Sc) and the University of British Columbia in Canada (Ph.D.).

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