Maria Li （李敏）

Xellar Biosystems is a Wet Artificial Intelligence (AI) biotechnology company, combining machine learning and AI with large-scale wet-lab experiments, tackling the most challenging problem in modern drug discovery – harnessing the complexity of human biology to accelerate drug discovery and development.

Medicilon Preclinical Research (Shanghai) LLC, a subsidiary of Shanghai Medicilon Inc., established in 2008-2010 by a joint venture between Medicilon and MPI, and now is a China's leading CRO in preclinical research. Medicilon Preclinical Research with a focus on preclinical pharmacokinetics and safety evaluation research, animal experiment facilities have been accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), and has obtained NMPA GLP and FDA GLP certification. TFM Office is responsible for the whole operation of the facility, to assist the Testing Facility Management (TFM) to handle the daily operation, oversee the testing facility management office, ensuring that all GLPs and SOPs are followed by appropriate personnel. From Jun. 2022, while responsible for the Project Management Department of Medicilon, I also concurrently served as TFM Office Director, who was responsible for assisting TFM in charge of the daily operation management of the entire facility, I had cooperated with company executives to complete the review application after rectification of newly added items, the finalization and binding of three copies of inspection application after the first certification and rectification of new facilities, mail the work, and complete the online application for newly added items and new facilities in the service hall of China Food and Drug Administration at the same time; On April 20, 2023, we had obtained the GLP certification of the NMPA for the newly added facilities at Nanhui Park. In addition, Medicilon obtained two GLP certification approvals for the reproductive toxicity test (Stage III) and the carcinogenicity test qualification. Medicilon also passed the three-year regular review of NMPA drug GLP.

Medicilon is one of the professional preclinical CRO in China, we are dedicated to help clients developing their research and discovery programs from a burst of ideas all the way to the Investigational New Drug (IND) filing phase. Our service span across medicinal chemistry, biology, API synthesis, CMC and preclinical studies. We focus on providing an exceptional client-centered experience and advancing the drug discovery process. Until now, there are more than 100 cases successfully gained certifications for Phase I clinical trials. Our research team is capable of, but not limited to the medicinal research of small molecule chemicals, antibody, PROTAC, ADC, CAR-T, etc. Project Management dept.’s responsibility is to establish project management system/SOPs to track project progress and help assure that critical deadlines are met. Monitor project scope, schedule and costs to ensure all remain on track per contract. Familiarize and understand various aspects of analytical development activities for research development. Regularly interact with management team including department head and various laboratory heads and project analytical leads. Facilitate management team meetings and coordinates cross-functional team meetings. Keep detailed records and follow up on action items to ensure timely execution. Responsible for driving cross-functional alignment to strategic plans and goals;

Shanghai Syn-The-All Pharmaceutical Co. Ltd. (“STA”) is a wholly owned subsidiary of WuXi AppTec which provides an integrated platform with “end-to-end” small molecule APIs/intermediates development and manufacturing capabilities from preclinical to commercial stages. We proudly support over 100 life-science clients worldwide and manufacture over 100 APIs per year. STA is World Leading Process Development & API Manufacturing CDMO: 1. “End-to-end” platform for APIs and advanced intermediates provides “one-stop” solution from preclinical to commercial; 2. World largest small molecule process R&D organization; 3. The only Chinese CMO who’s producing commercial NCE APIs approved in US, Canada, EU, Switzerland, China, Japan, Australia and New Zealand; 4. Experienced. Fast. Flexible. As a Senior Project Manager of Business Operations in STA, I serve for many large pharmaceutical companies, handling clients’ RFPs/RFQs, and negotiate with client for our proposals, try to push the projects to late stage, and then to commercial manufacture projects. Internally, we communicate with the Directors of PRDs and make the process move smoothly to the end, and externally, we contact clients for project updates. We coordinate with clients, our BDs and PRDs, QA/QC team, EX/IM team, legal and accounting to make sure every project finished successfully.

Ark Pharm, founded in 2007, is a Chicago based CRO company providing drug discovery & development services to worldwide clients. We do contract research, custom synthesis and bulk intermediates. As a Key Account Manager, I handle all the sales related issues like taking inquiries, giving quotations, identifying suppliers, and following up for orders of famous international pharmaceutical companies. Moreover, I am also good at international business development, using my special skills to contact research group leaders to find some FTE/NFTE/Bulk projects. On Mar 22, 2014, I had passed the Project Management Professional examination, successfully leaded many projects as a PMP until now. From Jun 1 to Sep 1 of 2014, I had a chance to work in Ark Pharm headquarter, in IL, USA, and attended 248th ACS meeting in San Francisco in Aug 2014. Meanwhile, as a PMP, I could handle all those projects and coordinate with internal and external suppliers, QC/QA managers and warehouse for timely deliveries & quality related issues, then for timely shipment for our customers.

More than 4 years, I had serviced for Shanghai ChemPartner Company. As a team leader, I took part in both the synthetic chemistry and new targets designing. Our customers are from many famous international pharmaceutical companies, like Merk, GSK, Lilly etc. Because of outstanding performance and teamwork, I have received awards for many times from both the inner-company and outer-company. For example, in August 14, 2009, I got a Silver Award level from GSK for the large scale synthesis of a complex diastereomeric mixture, followed by organization of the chiral separation to give the four diastereomers in excellent yield and chiral purity. In June 4, 2010, I got an Outstanding Teamwork Award from Lilly for the hard work and high productivity of our group.

When working in National Center for Drug Screening, as a principal chemist, I took part in many international projects including: Study on a nonpeptidic agonist of glucagon-like peptide 1 (GLP-1) receptors; Research on NeuromedinU(NmU) project; The synthesis and modification of LAP antagonists; Research on melatonin receptor antagonist; Develop systematic structural modification of a selective androgen receptor (AR) modulators; We usually communicated with our international partners using TC or email, and we discussed our research progress and problems openly and freely. Besides, they often visited us and gave a lot of help for us. As the principal of our chemical group, I usually took responsibility as a host.

During studying for Master Degree, my main research subject was the total synthesis of Duloxetine Hydrochloride and its analogues. We also optimized its synthetic scheme in order to adapt the need of industry. Besides, I studied the herbal medicine during my bachelor degree. My investigation subject was the study of API from Rabdosia rubescens(Hemsl.) Hara, a traditional Chinese medicine used for therapy of cancer, so I am also very familiar with TCM and phytochemistry.