Lei Wang, M.D. Email & Phone Number

Berlin, Germany; Cairo, Egypt; Heidelberg, Germany

Heidelberg, Baden-Württemberg, Germany

• Driving a comprehensive characterization of a cellular product by advanced high-throughput technologies to fulfill authority requirements, apply new patents and provide evidence for treating autoimmune disease• Established, modified and overseed the quality control system including functional cellular potency assays, enabling to meet the large-scale production• Designed analytical method validation and supervised cross-functional teams to conduct, document, analyze and report the validation• Drafted the complete ATMP application and persuaded EMA’s CAT, successfully obtaining the ATMP classification• Prepared and supported the application of phase II clinical trial, receiving the permission by the national authority

Heidelberg Area, Germany

• Planed and executed logistics studies, demonstrating the feasibility of the centralized manufacturing hub model to reduce cost and boost revenue for the business investments• Devised and optimized a new manufacturing process step-by-step, broadening the product indication from living to deceased organ transplantation• Improved and simplified the manufacturing process for saving time and man power• Answered the authorities’ questions (EMA, FDA and PEI) from the scientific and manufacturing aspects, and updated the IB and IMPD accordingly• Connected a potential investment partner and organized several meetings

Heidelberg Area, Germany

• Developed and performed functional cellular assays, delivering the results of potency assay to complete phase I clinical trial• Created and maintained SOPs, leading to consistent performance and easy transition• Manufactured the cellular product in GMP lab

Heidelberg Area, Germany

• Leading team of 3 doctoral fellows working in CAR-T cells to optimize CAR vector and to develop novel combinational strategies to enhance clinical efficacy with less side effects and received 2 awards in EBMT• Supervising 1 doctoral fellow to establish strategic pipelines, resulting in identification of 6 biological signatures of SR-aGvHD by immune profiling and machine learning-based advanced analysis• (Co-) authored 40 peer-reviewed publications with a total impact factor of 324 in the field of cellular immunotherapy and guided 2 students to successfully receive doctoral degree with magna cum laude and received 2 awards in ASH and DGHO• Designed and implemented quality controls and stability study to fulfill authority requirements, supporting our team to obtain authority permission and conduct Germany’s first academic phase I clinical trial of CAR-T cells• Participated and supported 3 phase I clinical trials through immunomonitoring, managing and analyzing data

中国 江苏 南京

• Evaluated patients’ symptoms initially, followed by diagnosing, documenting, treating and managing over 100 patients• Managed difficult conversations to smoothly deliver unfortunate news to patients and relatives• Educated senior medical students by giving lectures and supervised over 20 interns in the clinical practice

中国 江苏 南京

teach Clinical Diagnostics

中国 江苏 南京

中国 江苏 南京

Intern, All Clinical Depts.

中国 新疆 乌鲁木齐

Intern, Dept. of Orthopedics

Clinical And Industrial Drug Development

Activities and Societies: Clinical Development Strategies: Beyond Clinical Trials

Doctor Of Medicine - Md, Cellular Immunotherapy

• Developed multicolor flow cytometry methods for in-depth monitoring of patient samples undergoing ECP therapy, the first FDA-approved.

Master Of Internal Medicine, Haematology

Bachelor Of Clinical Medicine, Clinical Medicine