Central Lab Best Practices in Vaccine Clinical Trials: Insights from China and Indonesia

Date: July 9,2024

Agenda:

14:00-14:05   Welcome Remarks & Introduction of the speaker(s) and attendees

14:05-14:25    How to evaluate a central lab?

14:25-14:45    Application of pseudovirus technology in evaluating new outbreaks of infectious diseases

14:45-15:05   Introduction of Indonesia central lab landscape and biological sample management & exportation

15:05-15:20    Biological sample importation to China

15:20-15:25    Q&A

15:25-15:30    Closing Remarks

Speakers introduction：

• Mr. Wa Zhang

Wa Zhang, QA Manager, Beijing Xiaotong Mingda Technology Co. With nearly 10 years of experience in pharmaceutical/device preclinical and clinical trial industry, he has served multinational and local preclinical CROs as well as domestic pharmaceutical companies, responsible for quality assurance and system set-up, training, vendor management, computerised system establishment and validation. Currently he is responsible for auditing GLP labs, clinical labs, central pathology and imaging suppliers and computerised system compliance.

In 2018, he was qualified as a Certified GLP Quality Assurance Specialist by the Society for Quality Assurance (SQA), and serves as a member of SQA Computerised Validation and IT Compliance, SQA Computerised Validation Initiative Committee (CVIC) member (2023). Member of the instructor panel for the China Quality Assurance Association (CQAF) Season 1 Supplier Audit Training Course.

• Ms. Jiajing Wu

Jiajing Wu, PhD from NIFDC, Technical Director of Beijing Yunling Biotechnology Co., Ltd, has long been engaged in the evaluation of vaccines for new and outbreaks of infectious diseases and major infectious diseases, and has constructed a variety of pseudoviruses including COVID-19, Chikungunya viruses, Rabies viruses and so on, which provide important tools for the prevention and control of new and outbreaks of infectious viruses, and the evaluation of related vaccines and therapeutic products.

Since 2017, she has published more than 30 SCI articles as the first author or co-first author in international influential journals, such as Cell, STTT, and Nature Microbiology, with a cumulative impact factor of more than 300. The constructed pseudoviruses of COVID-19 and the neutralising antibody detection method based on the pseudoviruses have been included in the "Technical Guidelines for the Development of Vaccines for the Prevention of COVID-19 (Try out)“, which provide powerful evaluation tools for domestic Institutes and companies with vaccines or therapeutic products.

• Mr. Erizal Sugiono

Dr Erizal obtained his pharmacist from University of Padjajaran in 2001, Master from Hasanuddin University in 2008, and PhD from Hasanuddin University in 2013. In addition, he took courses in audit, project management, and management.

During his working career, he served several positions Including Head of Laboratory of Prodia Clinical Lab (Denpasar, Bali), Clinical Operations Manager, and Director of Prodia Diacro Laboratories (Prodia CRO). He is also a member of the Indonesia Association for the Study of Medicinals (IASMED) and Prodia Research and Education Institute (PERI).

He has been involved in more than 100 clinical studies either as Project Manager or Project Director. The project includes studies in nutritional, herbal medicines, vaccines, medicines, and medical devices, in various therapeutic areas.  Besides his role in clinical studies, he is also responsible for overall company operations, including mergers and acquisitions.

• Mr. Made Putra Semadhi

Mr. Made Putra Semadhi is a doctor of pharmacy from Padjadjaran University, Indonesia. He has experiences in laboratory quality management, laboratory referral services, and managing the central laboratory support for clinical trial in more than 30 projects. He is currently working as Lab Director and Central Lab Manager in Prodia Laboratory, the largest clinical laboratory in Indonesia, for over 10 years.

• Ms. Peipei Nie

Ms. Peipei Nie, Senior Manager of KingMyLab, Master of Biochemistry and Molecular Biology, joined KingMed in June 2011 and has served as Project Supervisor, Project Manager, Senior Operations Manager and Senior Project Manager. She has more than 10 years of experience in customised design of project solutions and project management. During her tenure, she has been responsible for the overall management and coordination of a number of projects related to COVID-19 vaccines and HPV vaccines. She is good at cross-departmental collaboration and process control, project risk assessment and risk management.

Original links：https://mp.weixin.qq.com/s/2QeKs16SoNom_bziUYaNWg