Jiaqi Wang

Since February 2023, I have been responsible for the IIT clinical trials of several new AAV drugs. The specific work content is as follows:
• Modify the IIT plan
• Communicate with researchers to formulate the next clinical trial plan
• Statistically analyze the patient's efficacy
• Write a summary report
• Prepare IND application materials, such as formulating an IND plan, writing IB, CRF, etc.
• Answer questions raised by regulatory agencies, and have communicated with FDA and CDE so far
All the projects I am currently responsible for have successfully obtained IND approvals from FDA and CDE. Among them, NGGT001 is a drug developed for a rare ophthalmic disease, Bietti crystalline retinopathy, for which there is currently no effective treatment. During the IND application process, the FDA raised concerns about the safety of the drug, mainly based on adverse reactions observed in animal experiments. To this end, I had two in-depth communications with the FDA, and by fully citing the actual clinical data in the IIT study, I successfully eliminated their concerns and finally obtained approval.
NGGT002 is a drug developed for another rare metabolic disease, phenylketonuria (PKU). Because the drug is administered systemically, regulators are particularly concerned about its safety. To this end, I wrote a detailed risk management plan, which clearly listed the risks that may arise during the study and provided corresponding response plans to ensure that the safety of the drug is fully evaluated. In addition, I was also responsible for writing the IIT trial protocol for NGGT006. NGGT006 is mainly used to treat patients with homozygous familial hypercholesterolemia (HoFH). At present, all dose groups in this IIT study have completed enrollment and dosing, with only three cases of extended dosing remaining. As the project I am currently responsible for, the preliminary research results of NGGT006 have been determined to be presented in an oral presentation at the EAS conference in 2025, and more clinical data are planned to be disclosed at the ESC conference in 2025. Since systemic administration of AAV usually requires the use of glucocorticoids, during the IIT trial of NGGT006, I discussed and determined the application plan of glucocorticoids with the researchers. While promoting the IIT study of NGGT006, I also completed the CDE application for NGGT007 and successfully obtained the IND approval.

I worked in the psychiatric department of a hospital for 22 months, with nearly one year spent in the psychiatric emergency department. During this time, I treated a large number of patients with acute psychiatric disorders, including schizophrenia, severe depression, suicidal tendencies, and self-harming behaviors. In my role, I frequently collaborated with the police, judges, fire departments, emergency services, and doctors from specialized psychiatric hospitals to ensure that patients received timely and effective interventions and treatment.

I participated in the standardized residency training program in China and chose psychiatry as my specialty. During the training, my rotations were primarily focused on psychiatry and neurology, with additional rotations in internal medicine to comprehensively enhance my clinical skills and professional knowledge.

I was responsible for assisting the hospital in preparing for the re-evaluation of its status as a tertiary hospital in Shanghai and directly reported the progress to the chief executive. My specific responsibilities included: thoroughly interpreting the evaluation criteria set by Shanghai's healthcare authorities, assisting various departments in organizing and clarifying management documents, overseeing the development and improvement of job responsibilities, promoting the standardization of staff training processes while ensuring the completeness of related records, and reviewing the management ledgers of each department to ensure that the hospital's management practices met the evaluation requirements.