Junxia W. Email & Phone Number

Belgium, Princeton Nj, Boston

Responsible for the development and execution of cell therapy strategies for immunotherapy, stem cell therapy and regenerative medicine programs, focusing on evaluating new technologies and developing next generation cellular therapy platform, such as induced Pluripotent Stem Cells (iPSC).Built a Cyto Innovation R&D pilot lab and group at Waltham, MA to allow for the development of new processes and methods for iPSC/regenerative medicine, evaluated new technologies and supported partnership… Show more Responsible for the development and execution of cell therapy strategies for immunotherapy, stem cell therapy and regenerative medicine programs, focusing on evaluating new technologies and developing next generation cellular therapy platform, such as induced Pluripotent Stem Cells (iPSC).Built a Cyto Innovation R&D pilot lab and group at Waltham, MA to allow for the development of new processes and methods for iPSC/regenerative medicine, evaluated new technologies and supported partnership with clients. Allied with matrixed teams across two R&D sites, established flow cytometry, single cell sorting, single cell cloning, 3D culture, high content imaging, functional genomics/NGS, bioinformatics, genome editing, PS cell line development, high dimensional analysis and statistics capabilities in house to perform correlative analyses. Show less

Achieved three successful US IND filings for cellular therapies including two CAR T cell therapies and one stem cell therapy (0 to 3). Built systems, processes and labs in support of CMC and Clinical Development of 8 cell and gene therapy programs for oncology and rare disease indications. Built and expanded an analytical organization to 3 teams to support process development, CMC in-process testing of Drug Substances and Drug Products, and post treatment biomarker studies… Show more Achieved three successful US IND filings for cellular therapies including two CAR T cell therapies and one stem cell therapy (0 to 3). Built systems, processes and labs in support of CMC and Clinical Development of 8 cell and gene therapy programs for oncology and rare disease indications. Built and expanded an analytical organization to 3 teams to support process development, CMC in-process testing of Drug Substances and Drug Products, and post treatment biomarker studies. Trained, and coached scientists for processes, product analytics, cGMP assays, CAP CLIA biomarker assay development, qualification, and validation. Trained Team leads and managers to manage projects, equipment and people to meet corporate objectives on time and on budget. Show less

Greater Boston Area

Strategic planning and management of analytical activities for preclinical and clinical Chimeric Antigen Receptor (CAR) T-cell programs and X-linked severe combined immunodeficiency (XSCID) stem cell gene therapy programs.Analytical Development and Clinical Science- Established in-house Analytical capability of Flow cytometry, ddPCR, qPCR, QC microbiology, protein, DNA, vector, and cell-based assays in support of the lot release and product characterization of GMP cellular… Show more Strategic planning and management of analytical activities for preclinical and clinical Chimeric Antigen Receptor (CAR) T-cell programs and X-linked severe combined immunodeficiency (XSCID) stem cell gene therapy programs.Analytical Development and Clinical Science- Established in-house Analytical capability of Flow cytometry, ddPCR, qPCR, QC microbiology, protein, DNA, vector, and cell-based assays in support of the lot release and product characterization of GMP cellular therapy products, CAR T-cell and stem cell process development, and clinical trials for biomarker.- Hired, trained and expanded analytical development team for technology transfer, analytical method development, qualification, validation.- Authored and reviewed analytical study protocols, reports, technology transfer documentations.CMC Regulatory - Authored and reviewed Regulatory document (IND, CMC analytics), supported regulatory submissions and responses.- Represented CMC analytical organization in meetings with regulatory agency (FDA). Cross-functional team- Collaborated effectively with Project Management, Quality, Clinical development, Process development, and Regulatory groups to meet company goals on time and on budget.Outsourcing - Managed the selection and interactions with CROs and other third party testing laboratories (non-GMP, GMP, CAP CLIA), and the oversight of phase-appropriate method transfer, method validation, testing plans, and data verification. Show less

Greater Boston Area

Preclinical safety evaluation of genome editing (CRISPR/Cas9) programs with a focus on immunogenicity.- Established in-house bioanalytical capability of ELISpot, Luminex, ELISA, Flow cytometry assays in support of immunogenicity studies in non-human primates and humans.- Hired, trained and mentored direct reports.- Designed and developed immunogenicity assays and workflows for AAV and CRISPR/Cas9 based therapeutics.- Managed interactions with CROs, internal and… Show more Preclinical safety evaluation of genome editing (CRISPR/Cas9) programs with a focus on immunogenicity.- Established in-house bioanalytical capability of ELISpot, Luminex, ELISA, Flow cytometry assays in support of immunogenicity studies in non-human primates and humans.- Hired, trained and mentored direct reports.- Designed and developed immunogenicity assays and workflows for AAV and CRISPR/Cas9 based therapeutics.- Managed interactions with CROs, internal and external collaborations. Show less

Greater Boston Area

Analytical development and clinical biomarker strategy to predict manufacturing success and/or clinical outcome for cellular therapy.

Greater Boston Area

Analytical Development and Quality Management- Designed and developed analytical assays and workflows for Chimeric Antigen Receptor (CAR) T-cell therapy (KYMRIA). - Spearheaded CyTOF projects for WBC/tumor characterization in cellular therapy clinical trials.- Managed quality standards and quality related issues.Project Management- Managed a project to build a new GMP facility for cellular therapy.

Greater Boston Area

Director: Carl Rosow, M.D.A teaching faculty - 2015 Principles of Pharmacology courseA teaching faculty - 2014 Principles of Pharmacology course

Greater Boston Area

Report to Peter Nigrovic, M.D. and Michael Brenner, M.D.Conducted research on novel biomarkers/targets for inflammatory arthritis.- Immunophenotypic studies of myeloid cells in patients using flow cytometry and CyTOF mass cytometry- Cell sorting and gene profiling using QPCR array- Expression of GFP tagged protein in differentiated myeloid cell lines- Evaluated in vitro effect of antibodies on human myeloid cell activation and migrationConducted research on… Show more Report to Peter Nigrovic, M.D. and Michael Brenner, M.D.Conducted research on novel biomarkers/targets for inflammatory arthritis.- Immunophenotypic studies of myeloid cells in patients using flow cytometry and CyTOF mass cytometry- Cell sorting and gene profiling using QPCR array- Expression of GFP tagged protein in differentiated myeloid cell lines- Evaluated in vitro effect of antibodies on human myeloid cell activation and migrationConducted research on IL-33/ST2 signaling pathway in mast cell-mediated diseases.- Human skin-derived mast cell culture- siRNA knockdown and signal transduction- Histopathological investigation using arthritis and infectious models Show less

Postdoctoral Fellow - Bwh, Bidmc, Immunology, Cancer Biology

Advisors: Peter Nigrovic, M.D., Roya Khosravi-Far, Ph.D. Conducted research on innate immune cell types in autoimmune diseases. Conducted.

Ph.D., Pharmacology - Shanghai Institute Of Materia Medica

Activities and Societies: Immunosuppressive agents, autoimmune disease/inflammation, bone marrow transplantation, arthritis, lupus, herb.

M.D., Medicine

1/1998 – 7/1999: Clinical rotations in Tianjin Third Central Hospital, Tianjin, China