Ming Yan
Senior Principal Scientist, Dx Sciences and Partnership, Novartis Precision Medicine @ Novartis
About
Principal Scientist and Tech Lead at Novartis Precision Medicine with 9 years + experience in the Clinical Trial Assay (CTA) and Companion Diagnostics (CDx) development. Familiar with drug and CDx submission strategies in the global and U.S. markets. Experienced in the preparation and meeting with the FDA. In depth knowledge in Next Generation Sequencing (NGS), multi-plex qPCR, digital droplet PCR (ddPCR), and various sample types including human FFPE tissue to plasma. Certified Green Belt of Design For Six Sigma (DFSS). Detail orients with strong trouble shooting skills. Excellent communication skilling with strong leadership and collaboration. CDx and CTA Strategies: • CDx strategies for drug submission • CTA strategies for patient enrollment in the clinical trial setting • Bridging between the CDx and CTA • Follow up CDx strategies Technologies: • Next generation sequencing (NGS) • Liquid Biopsy & ctDNA • Digital Droplet PCR (ddPCR) • Reverse-Transcription PCR (RT-PCR) • Fluorescent in situ hybridization (FISH) • Immunohistochemistry (IHC) Biomarker Analysis: • Accurate detection of biomarkers • Correlation between patient outcomes and biomarkers • Biomarker definition and cutoff • Co-occurrent mutations • Biomarkers for acquired resistance • Biomarker strategy for clinical trials and submissions Partnership & Collaborations: • Partnership with external vendors for CDx development and approval • Partnership for follow up CDx • Study designs and contracts • Business relationship
United States
Cambridge
Pharmaceuticals
Assay Development, Molecular Biology, Biotechnology, Protein Chemistry, Drug Discovery, Lifesciences, Biochemistry, Cell Culture, Genomics, Cell Biology, HPLC, In Vitro, Immunology, PCR, DFSS Green Belt, Life Sciences, High-Performance Liquid Chromatography (HPLC), Polymerase Chain Reaction (PCR), FDA, Real-Time Polymerase Chain Reaction (qPCR)
Experience
Senior Principal Scientist, Dx Sciences and Partnership, Novartis Precision Medicine
Novartis
Boston, Massachusetts, United States
Principal Scientist, Dx Science and Partnership, Novartis Precision Medicine
Novartis
Boston, Massachusetts, United States
-Supporting the CDx submission of Breast Cancer drug in the U.S. and global countries.
Principal Scientist and Tech Lead
Novartis
Boston, Massachusetts, United States
Tech lead to support the biomarker strategy, CDx/CTA strategy and drug submission in the U.S. and global markets. • Co-authored the bridging study report for the primary CDx submission of a lung cancer drug in U.S. • Contributed to a key lung cancer drug submission and approval in Japan and other countries. • Contributed to the preparation of commercial launch material • Co-authored publications for multiple prestigious conferences, including posters to AACR-NCI-EORTC 2019, and AACR-ISALC 2020. • Led the efforts to evaluate vendors to support the follow up CDx strategy • Key contact person with external vendors • Mentoring junior associates by providing training and leadership support
Principal Scientist
Novartis
Boston, Massachusetts, United States
- Application of next generation sequencing technology on the hematology malignancies, including the minimal residual disease monitoring for acute myeloid leukemia (AML)
Principal Scientist and Team Lead
Novartis
Boston, Massachusetts, United States
- Establishing the next generation sequencing laboratory - coordinating personnel training - Led the feasibility studies to evaluate the next generation sequencing (NGS) for the detection of multiple lung cancer biomarkers
Senior Scientist
Novartis
Cambidge
Led the assay development and analytical validation a q-PCR assay as the CDx for melanoma drug. • Internal development of CTA and CDx assays under Design Control environment and FDA regulation to support Novartis drug submission • Using Design For Six Sigma methodology to optimize, characterize and determine key assay specifications • Providing key solution for qPCR instrument calibration strategy to support the globalization of companion diagnostic assays for Novartis drug clinical trials.
Senior Scientist
Beckman Coulter Diagnostics
Greater Boston Area
Developed molecular in-vitro diagnostic (IVD) assays based on marketing and client need, including Human Immunodeficiency Virus (HIV), Hepatitis C Virus ( HCV ), and Chlamydia trachomatis and Neisseria gonorrhoeae(CTNG) assays. • System integration of multiple qPCR assays into a fully automated, extraction-to-results IVD • Using Design For Six Sigma (DFSS) methodology to optimize critical assay components and provide key chemistry solutions • Profound knowledge and hands on experience in clinical sample handling. • Establishing SOPs to transfer technology from lab procedure to manufacture facility. • GLP workshop experience
Education
Harvard Medical School
Microbiology and Vaccine Development
Ming Yan's Contact Information
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