Yuan Lin Email and Phone Number

Senior scientist in AbbVie's CMC-biological analytics team in Irvine site Manage cell based potency assay and in vivo animal assay.Responsible for assay development, qualification/validation, cross validation, transfer, testing for biologics development.Wrote SOP, protocol, study report, investigation report and passed QA approval. Support DS, DP, QA, regulatory groups in IND, clinical and BLA stages.

• Pre IND translational research on non-clinical analytical and functional characterization of antibody products, using SPR, ELISA, Flow, PCR and various functional in vitro and in vivo ssays.• Work on Amgen’s oncology and immunology projects, covering in vitro and in vivo assay development, extrapolation, qualification and testing. • Support project management from initial PQAA QTPP CQA study plan assessment to study report finalization and regulatory writing on Module 2 and Module 4. • Support regulatory writing, reviewing and filing.• Manage internal lab and external CRO for antibody assay testing.

• Managed multiple industry-sponsor research combo projects, responsible for experiment design, assay development, execution and reporting. • Led a research team for cancer immunotherapy research, using FACS, ELISA and in vivo syngeneic model of cancer. • Demonstrated anti-cancer efficacy of adenosine receptor inhibitor combo with PD1 inhibitor or IDO inhibitor. Established cancer models, evaluated response by in vivo imaging, ELISA and flow.• Exanimated PI3K-delta inhibition in the development of regulatory and central memory T cell in vitro and test its anti-cancer efficacy in vivo. • Evaluated MDSC, T cells inhibition by genetically modified adenosine receptor in vivo.

• Supported phase 1 clinical trial of genetically modified dendritic cell therapy with chemokine CCL21 (DC-CCL21) for the immunotherapy of late stage lung cancer patients. Isolated PBMC from patient and ex vivo culture of DC. Measured immune response in patients by ELISA and flow cytometry. • Demonstrated anti-cancer efficacy in preclinical animal test of polymer delivered DC-CCL21 cancer immunotherapy. • Developed and synthesized PCL/PLCL polymer for local cisplatin and CCL21 release combined with low dose radiation treatment in vivo. • Performed cancer metastasis/EMT basic research on HNSCC.

Investigated glutamate transporter in disease model of neuro-degenerative diseases, chronic pain, IBS, IBD, epilepsy and stroke. Developed glutamate transporter activator as a novel anesthesia medication.