BIO Asia–Taiwan 2021 亞洲生技大會

BIO Asia–Taiwan 2021 亞洲生技大會

講師

Jennifer Mao

Session 11 – Advances in Cell & Gene Therapies

Date:23 July (Friday)
Time:  10:40 – 12:10 (GMT+8)

Jennifer Mao

VP, Clinical Operations, Greater China
IQVIA RDS(Shanghai)Co., Ltd


Current responsibilities
Direct clinical operations for IQVIA GRC to ensure projects are appropriately resourced and delivered to meet project needs. Work with country/region leadership in formulating effective strategic goals and objectives for GRC and assures operational alignment with priorities of the organization and sustainable growth of business in GRC market.
 
Profile overview
● Over 20 years of experience in clinical operations strategy, delivery excellence and project management
● Joined IQVIA in 2004 and toke various leadership position in IQVIA GRC RDS
● Prior experience includes working in Hong Kong and Canada in the area of pharma research and develop 

Areas of expertise
● Clinical operation and project management
● Operational excellence and quality management
● Talent and Performance management
● Strategy planning 

Education
● M. Sc, University of Alberta, Edmonton, Canada 

Past experience
● Research Scientist, New Era Nutrition Inc, Canada
● Clinical Trial Manager, Chinese University of Hong Kong

Speech title & Synopsis

Decentralized Clinical Trial Facilities Gene-therapy LTFU

Gene therapy can achieve therapeutic effect by causing permanent or long-term changes in human body, which may increase unpredictable risks such as delayed adverse reactions. In order to evaluate and reduce the risk of late-onset adverse reactions, and to understand the change of treatment effect with time, it is necessary to carry out long-term follow-up for the subjects who received gene therapy clinical trials. Regulatory authorities have issued relevant guidelines for long-term follow-up after administration of gene therapy products.
 
The challenge is that the long-term follow-up will bring great burden to the subjects, make them easy to drop off halfway, and the project cost is huge. IQVIA's patient-centric decentralized clinical trial model uses DCT platform conduct re-mote follow up visits, leverage the resources of local HCP and home health nurses surrounding subjects, medical records uploading in DCT platform to facilitate data collection, thus eliminating the burden of subject visits, making it easier to collect long-term treatment effect and safety data, and making gene therapy long-term follow-up more simple and efficient.

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