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Over 15 years of industry experience in small molecules, biologics, and gene therapies drug development. Experience in neurological diseases, CVMET, hematology, rare diseases. Co-authored IND/CTA submissions and global regulatory interactions. Extensive experience in integrating preclinical and clinical biomarker strategy through working across Research and Development organizations. Scientific and technical expertise in implementing translational biomarker, PK and immunogenicity strategy in pre-clinical, Phase 1-3 studies. Key driver for Biomarker-based clinical endpoint design and execution. Organized and invited speakers for multiple national/international conferences on biomarkers and precision medicine Demonstrated track record in building high-performing teams from inception, and leading cross-functional teams. Led by example and by enabling and inspiring others. Recognized leadership roles in external professional organizations (AAPS and SAPA). 35+peer-reviewed publications and book chapters, 6 US patents.. Authors of industry white papers on large molecule and biomarker bioanalysis. Authors of industry white papers on large molecule and biomarker bioanalysis.
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Executive Director, Biomarkers And Precision MedicinePassage Bio Jul 2021 - PresentPhiladelphia, Pennsylvania, UsResponsible for building a high performing Biomarkers and Precision Medicine team from the inception. Drive the integration of biomarker, PK and immunogenicity strategy with the overall clinical development plan for the company portfolio. Oversee the direction, planning, execution of all activities as they related to clinical diagnostics, biomarkers, PK/PD and immunogenicity studies. Lead the Biomarkers and Precision Medicine team for all IND/CTA submissions and on-going global regulatory interactions.
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Senior Director, Biomarkers And Precision MedicinePassage Bio May 2020 - Jul 2021Philadelphia, Pennsylvania, Us
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Associate DirectorRegeneron Pharmaceuticals, Inc. Jul 2016 - May 2020Tarrytown, New York, UsResponsible for the design and implementation of biomarker strategy and generation of high-quality data enabling dose selection and early efficacy reading for multiple complement-mediated rare diseases (FIH to Phase 3). Provide strategic leadership for discovery and early cardiovascular programs and influence cross-functional teams to enable biomarker guided target validation, disease indication selection and patient stratification.. Spearhead multiple precision medicine focused clinical experimental science studies with external research institutes and clinical centers for understanding new disease indication, PK/PD relations and de-risking programs. Responsible for developing and implementing a company-level strategy which ensures that biomarker and clinical diagnostic assays are validated for the Context of Use and meet regulatory requirements. -
Senior Research Investigator IiBristol-Myers Squibb Mar 2012 - Jul 2016Lawrence Township, Nj, UsDevelop and execute bioanalytical strategy. Supervise fit-for-purpose biomarker method development and validation by internal staff and at CROs in support of immuno-oncology, immunology and cardiovascular disease studies. Provide strategic and technical input on bioanalytical plan, resource requirement and timeline for FIH and PoC studies. Issue, review and approve reports on method development, validation and study reports. People management, direct and matrix reports -
Senior Research BiologistMerck Feb 2007 - Dec 2011Rahway, New Jersey, UsProject lead for developing a 2nd generation fully human monoclonal antibodies for PCSK9. Coordinated efforts of cross-division sub-teams including antibody production, bioanalytical and DMPK teams. Lead primary functional screen for antibodies for PCSK9. Responsible for establishing several robust and sensitive ELISA-based pharmacodynamics and target engagement biomarker assays. Developed biomarker assays supporting multiple Hypertension and Heart Failure targets, including a GCMS-based 15NO2 assay as a translatable biomarker for Nitric Oxide metabolism to support clinical studies, and a novel radio-ligand binding assay for an ion channel target. Nominated novel targets for validation and lead identification. Initiated cross-divisional collaboration to create genetically engineered rodent models for target validation. -
Research Assistant ProfessorUt Southwestern Medical Center At Dallas 2001 - 2007Dallas, Texas, UsResearch focus: Role of Akt and FOXO transcriptional factors in cardiac hypertrophy and heart failure; cardiac aging.
Yan G. Ni Skills
Yan G. Ni Education Details
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Yale School Of MedicinePostdoctoral Training -
Uc IrvineNeuroscience
Frequently Asked Questions about Yan G. Ni
What company does Yan G. Ni work for?
Yan G. Ni works for Passage Bio
What is Yan G. Ni's role at the current company?
Yan G. Ni's current role is Gene Therapy Precision and Translational Medicine.
What is Yan G. Ni's email address?
Yan G. Ni's email address is ya****@****ron.com
What is Yan G. Ni's direct phone number?
Yan G. Ni's direct phone number is +190899*****
What schools did Yan G. Ni attend?
Yan G. Ni attended Yale School Of Medicine, Uc Irvine.
What are some of Yan G. Ni's interests?
Yan G. Ni has interest in Science And Technology.
What skills is Yan G. Ni known for?
Yan G. Ni has skills like Drug Discovery, Biomarkers, Drug Development, Assay Development, Biochemistry, Translational Medicine, Biomarker Discovery, Clinical Development, Biotechnology, Cro, Bioanalysis, Monoclonal Antibodies.
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