Jindian F.

Senior Principal Scientist, China Responsible Lead of Biomarker/Dx(Non-Onco TA) @ Johnson & Johnson

About

Translational Science(Including Clinical Biomarker/Diagnostics) across multiple TA(Onco, Immune, Neuroscience, Retinal, Vaccine, CVM) and multiple modality of biAbs, gene Rx, BiTE, SM, protein etc. 1) 11Y+ Clinical Biomarker development and discovery 2) 8Y+ CDx/IVD Development and Registration under design control 3) 15Y+ Hands-on Lab skill of Bioanalytical Assay/IVD development in-house and with CRO # 11Y+ Clinical Biomarker Development and Translational Research/Biomarker Discovery in Multiple TA of Oncology and CV (Amgen-Novartis), and Immune-Neuroscience-Retinal-Vaccine/Infection Disease(Janssen), to advance pivotal clinical development in MNC Pharms by endpoint data generation(Patient Inclusion/Primary-2nd-Exploratory) and translational conviction, leading regional biomarker and its analytical assay strategy, Lab development/transfer and validation, CRO/KOL selection/collaboration, clinical sample analysis, biomarker protocol/CSR and HA submission etc. Rich experience in translational research of target/pathogen Epi., biomarker discovery, vaccinology, nonclinical pharmacology(MoA/PD) by in-vivo/In-vitro assays, PDx/CDx model, pivotal preclinical PK/PD/ADA/RO assay etc.. Relevant understanding of biology on BiTE, bsAbs, gene Rx, AVC etc. # 8Y+ IVD R&D/CDx Development in regulated setting for precision medicine in MNC Pharma and clinical diagnostics in IVD biotech(MNC/Local). Hands-on skills of product full development under R&D design control(CE/FDA/CMDE) spanning from strategy formulating, Lab development, prototype/verification, clinical validation to agency BD/KDE dossier submission. Well understanding on industrialization, GMP/GCP and RA. Rich experience in global wise engagement with agency and partner #15Y+ bench skills of Bioanalytical Assay Development and Validation with deep understanding on regulatory guidance and industrial consensus for 1) Large Molecule Bioanalysis by assorted immunoassay(ELISA/MSD/SiMOA/CLIA/Luminex/Turbidimetric/Lateral Flow, Automation, Single Molecule Test), FACS/CyTOF and IHC, 2) Molecular Bioanalysis by NGS, qPCR/ddPCR, and 3) Cell-Based Assay by neutralization Ab testing(Vaccine, ADA), ELISpot etc. Many experiences on LC-MS/MS, Microbiology testing(MOPA, WGS, AST, Agglutination etc.), Ab generation, chromatograph and clinical chemistry etc. # COMMIT TO TEAM-WORK/WIN-WIN SUCCESS. Being Science-based and Self-motivation

Country

China

City

Minhang District

Industry

Pharmaceuticals

Skill

医学研究, 良好药品临床试验规范, Translational Research in Multiple TA(Onco, Immune, Vaccine, Neuroscience, CVM ), Clinical Biomarker Development, In Vitro Diagnostics (IVD), Companion Diagnostics (CDx), Biomarker Assay Development and Validation, CRO 管理, Clinical Sample Analysis, 新一代测序技术 (NGS), Biomarker Development , Drug Clinical Development, IVD Design Control , Immunoassay Development , Large Molecule Bioanalysis , Biomarker Lab Management

Experience

Senior Principal Scientist, China Responsible Lead of Biomarker/Dx(Non-Onco TA)

Johnson & Johnson

2020-9 - Present · 6 yrs 1 mo

中国上海市

China Responsible Lead on Clinical Biomarker/CDx Develop. and Translational Research focusing on Non-onco TA (Immune, NS, Retina/Gene Rx, Infection Disease/Vaccine, CVM) by pivotal trial(Ph3/2b) endpoints(Inclusion/Primary/2nd/Exploratory) data generation, CDx/Dx development through biomarker Lab/Dx partner selection, assays develop./transfer and validation, Biomarker/CDx Protocol/CSR and HA submission, Translational Evidence/Ph0, KOL/external collaboration etc. Responsible projects for IMM(IL-23R Antagonist, FcRn Ab for Autoimmune), NS(Tau Active Immune, Tau Ab, KOR/Dyn Inhibitor, FcRn Ab for gMG), Retinal Gene Rx(RPGR, sCD59), Vaccine(ExPEC9V(LPS)/RSV Ad26/HIV) etc.

Group Lead of Biomarker Technology and CDx

Amgen

2014-7 - 2020-9 · 6 yrs 3 mos

Shanghai,China

Clinical Biomarker and Diagnostic 1) CDx PROJECT LEAD on local diagnostics program. As a key member of China CDx strategy shaping and project implementation with local prospective of co-development design, agency engagement, partner evaluation, technology and regulation landscape. Projects executed including KRAS(LC),Omecamtiv Mecarbil(HFrEF), Lp(a) SiRNA(CV) and many early development in solid tumor 2) BIOMARKER ASSAY LEAD AND LAB MANAGER for pipelines biomarker clinical development by assay development/validation, assay localization/transferring, CRO outsourcing/monitoring and global cross-functional coordination. Lead innovative technology and platform exploration(CyTOF,ctDNA etc). Projects executed including Blincyto/BiTE Phase 3 exploratory study(ELISA), Repatha/ PCSK9 observational studies(ELISA/NGS) with PEACE cohort , HF biomarker discovery(Omics) in AMI/HF cohort and many RWE 3) Contributed many projects of translational research, preclinical PK/PD/Safety and cross functional early discovery 4) Lead biomarker operation on HGRAC, Biomarker P2 Lab build-up from scratch, Biobank Management, Site Biosafety committee member

Senior Scientist/Project Leader

bioMérieux

2012-7 - 2014-7 · 2 yrs 1 mo

Shanghai City, China

IVD Immunoassay Kit Research and Development. As R&D project leader to develop immunoassay IVD kit targeting pathogenic microbes under R&D full design control, including project proposal, Feasi.study, Optimi., PTB/PVB/clinical trial, R&D Docs for filling, quality docs for Industrialization, WHO/CFDA onsite inspection and Key vendor sourcing/audit; Close working with headquarter (France) project team and being granted internal-training on headquarter lab. Kit developed include Strep A Ag, H.pylori Ag, Norovirus Ag and Rotavirus Ag

Scientific Associate/Technical Expert

Novartis

2008-6 - 2012-6 · 4 yrs 1 mo

Shanghai City, China

Biomarker assay Development and Validation Biomarker immunoassay development/validation/automation/human clinical sample analysis/CRO outsourcing for drug development in regulation setting. Biomarkers developed and validated include IL-13/IL-8/IL-18/GRO Alpha/IL-2/TARC/Eotaxin/MDC/BNP/ANP /MBP etc. Participate in SOPs generation. Being Lab management representative and department HSE officer

Scientist

KHB (Kehua Biotech)

2005-6 - 2008-6 · 3 yrs 1 mo

Shanghai City, China

IVD Immunoassay kit GMP Manufacturing and Development 1)Key member to develop plate enzyme luminescent immunoassay platform with case of HBsAg and CEA IVD kits. Participated filing Docs generation, organizing clinical trial and receiving CFDA onsite inspection 2) As manufacturing staff for IVD EIA kits production including HIV Ab, HBV(5 kits) and tumor markers 3)Project lead to develop affiliated reagents for auto haematology analyser