Han-Yu Chuang Email & Phone Number

San Diego, Ca, Us

Sevenoaks, Gb

Edinburgh, Gb

San Diego, California, Us

San Diego, California, Us

Phoenix, Arizona, Us

- Provided expert consultation to the executive team on strategic planning for product and market development of cutting-edge “omics” diagnostic assays in veterinary medicine- Provided technical consultation to a team of genomics platform developers, bioinformaticians, and software engineers in the creation, testing, maintenance, and versioning of veterinary clinical “omic” diagnostic pipelines, assays, and laboratory information systems underneath of SearchLight DNA

Palo Alto, California, Us

- Partnered with Product Management to develop multi-year technology product roadmap and carried P&L responsibilities for R&D operation and project implementation- Led cross-functional project teams to design and develop oncology platforms for “smart” liquid and tissue biopsies, extending the technology stack from genome only to multiomics including methylome and transcriptome, for MRD and therapy selection- Supported biopharma solutions for translational science and biomarker discovery1. Launched ctDNA genomic and methylation profiling (Guardant Infinity) from the ground up to CLIA operational2. Responsible for bioinformatics and technology development support to biopharma service projects and collaborated with Business Development and Medical Affairs in pre- and post- sales activity to facilitate strategic partnership with biopharma clients- Provided post-market sustaining and upgrade1. Collaborated with Medical Affairs in KOL engagement for CF/CV/CU data analysis in MRD and novel methylation biomarkers (e.g. promoter methylation)2. Collaborated with Laboratory Directors and Regulatory Affairs in upgrading minimal residual disease monitoring products to Infinity Platform for improved detection limit and quantification (Guardant Reveal)3. Collaborated with Operation and Enterprise Software in transferring CGP LDT testing volume to Infinity Platform for operational efficiency towards CoGs reduction (G360 LDT)4. Collaborated with Clinical Development and obtained FDA approval for follow-on CDx biomarkers (G360 CDx)5. Collaborated with Technology Transfer to set up G360 solutions in partners’ labs in Europe, Japan, and China6. Collaborated with Operation and Laboratory Directors in supporting clinical reporting of liquid and tissue oncology tests- Led a global team of 160+ scientists and engineers for Bioinformatics, Software, Assay, and Automation Development and executed 7 departmental reorganizations in 2 years to enhance R&D operational efficiency

Palo Alto, California, Us

San Diego, California, Us

- Responsible for building up the informatics team, attracting and growing talents, and planning for project timeline and resource allocation- Led a team of bioinformaticians, biostatisticians, and software engineers in the development of statistical analyses, bioinformatics methods, and informatics systems for clinical test optimization with fetal cell based technology and next-generation sequencing (NGS) for comprehensive non-invasive prenatal testing- Evaluated and architected end-to-end data infrastructure to support high-volume clinical tests with cloud computing- Provided technical leadership in the design and analysis of complex experiments during research and development- Devised statistical modelling on technology requirements to fulfill the LDT roadmap- Collaborated with external teams and manage vendor relationship to deliver startup milestones fast with quality

Switzerland 🇨🇭 , Ch

- Led ~30 bioinfomaticians and biostaticians across six Roche sites in 3 continents to support research and early development, rigorous product development process, and post-launch product care for NIPT and reproductive health, oncology molecular diagnostics, and NGS library prep and target enrichment solutions- Led bioinformatics product development for IVD grade end-to-end clinical sequencing solutions and LDT component kits- Led bioinformatics support in product development for alternative high-throughput molecular profiling platforms- Led bioinformatics and biostatics data analysis to support medical and scientific collaboration for prenatal care and oncology- Planned budget for bioinformatics development with the understanding of interplay between product development timeline and strategic priorities

Switzerland 🇨🇭 , Ch

- Stabilized a team of bioinformaticians, biostatisticians, and software engineers during the key personnel departure (post Ariosa acquisition)- Represented Software and Bioinformatics function in lifecycle teams to mitigate project risks, prioritize resource utilization, and increase employee engagement- Worked with Software and Bioinformatics leadership team on improving organizational operation efficiency- Proposed sustainable solutions to senior management on IVD kit expansion and new NGS testing menu in CLIA lab portfolio planning- Led bioinformatics support in product development projects of end-to-end solutions for next-generation Harmony NIPT tests- Led bioinformatics support in product development for alternative high-throughput molecular profiling platforms - Led biostatistical analysis on Harmony on-market microarray products to provide quality monitoring for CLIA lab operation and reagent manufacturing, to support NIPT medical affair collaboration, and to address technical questions from regulatory submission in US and outside- Led bioinformatics support to validate Avenio ctDNA and FFPE products and launch for oncology pharma services in CLIA - Led bioinformatics support in collaboration with pharma partners on minimal residual disease monitoring and personalized cancer vaccine

San Diego, Ca, Us

- Represented Illumina in FDA-led consortia effort SEQC2 as the main contact for all working group involvement in WGS, targeted seq, methyl-seq, and bioinfo- Led Illumina KOL collaboration with Human Vaccine Project for affordable immune repertoire sequencing, with Zhongshan hospitals in Shanghai China for immuno oncology biomarker identification, and with Shanghai CDC for microbial sequencing- Served as Illumina’s technical ambassador to interact with China government bodies including CFDA and NCCL and gave scientific talks in industry meetings- Interacted with pharma partners, reference/LDT labs, and regulatory bodies in the CDx development to bridge gaps in technical understanding, lab practice, and clinical trial needs- Engaged customers as subject matter experts in marketing activity and addressed customer feedback on Illumina products

San Diego, Ca, Us

- Designed and launched TruSight Tumor 170 (hybrid capture based)- Selected and built a team of bioinformatics scientists. Developed direct reports in to front-line functional/project managers- Proposed NGS products in portfolio planning to senior management for where and what to penetrate the oncology markets next- Scouted and evaluated internal and external technology development for next product planning- Interacted with pharma partners in the CDx development to bridge gaps in technical understanding and trial needs - Advocated the strength of Oncology products to customers and address customer feedback- Led bioinformatics support in NGS assay development and validation as well as informatics optimization for cancer diagnosis using both tissue biopsy and liquid biopsy- Led algorithm development on digital error correction, somatic variant calling, copy number alteration, gene fusion calling, and splice variant calling on FFPE tissues and cell free nucleic acids, given molecular characteristics in different assays, like amplicon vs. shotgun sequencing- Led design and optimization effort for primers, probes, and unique molecular identifiers used in multiplex PCR and hybrid capture based NGS diagnostics for small variant calling, amplification detection, and gene fusion identification- Led pipeline development for automatic data quality analysis to speed up assay development for NGS diagnostics on DNA and RNA libraries from FFPE tissues and cell free nucleic acids- Filed patent applications during product development and collaboration projects- Drafted key concepts in validation strategies for FDA pre-submission- Worked as core team in product development to discuss risk mitigation and provide expert opinions for subteam leads from business development, marketing, pharma alliance, assay, software, quality, manufacturing, regulatory, and IVD to develop gene-panel NGS diagnostics, using multiplex PCR amplicon or hybridization capture, at clinically grade

San Diego, Ca, Us

Group lead for oncology algorithms and applicationsDesigned and launched Illumina's TruSight Tumor 15 (multiplex PCR based)

San Diego, Ca, Us

San Diego, Ca, Us

- Coordinated Marketing and R&D teams to facilitate new offering in human genome sequencing service- Defined quantitative metrics and develop infrastructure softwares to benchmark NGS data quality- Performed competitive analysis on internal products and platforms to third party technologies such as SOLiD, Complete Genomics, PacBio, and Ion Torrent- Provided guidance on sample prep kit development as well as on informatics pipelines- Facilitated long reads strategies for structural variant calling, haplotying, and genome assembly- Created marketing materials of competitive analysis across technologies - Addressed customers’ requests on data quality analysis in pre- and post- sale inquiries- Mentored junior team members

San Diego, Ca, Us

Phd, Bioinformatics And Systems Biology

Bs, Ms, Computer Science And Informatics Engineering