Yi Zhang, Ph.D.

CONTACT INFORMTAION

Address:   San Diego, CA 92127

Email:   yzharng@mironcol.com

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Summary of Qualifcations

  • A statistician/scientist/clinical researcher with extensive experience in molecular diagnostics, pharmaceutical, and biotechnology industries. 
     

  • Unique background with a combination of training in oncology, molecular biology, statistics and bioinformatics. 
     

  • My creative work on key clinical studies laid critical foundation for Biotheranostics to establish as a successful commercial entity in the fiercely competitive breast cancer diagnostic market, with sales revenue increasing from zero to 25 million in 2 years.
     

  • Exceptional statistical expertise in genomics and clinical research (generalized linear & nonlinear models, linear mixed models, survival analysis, supervised & non-supervised learning, permutation, bootstrapping, cross-validation, etc) well recognized in the field.
     

  • Strategic leadership in the design and analysis of clinical utility studies for oncology biomarkers. 
     

  • Track record of accomplishment across biomarker discovery, translational research & clinical development, demonstrated by strong publications in high profile journals including Lancet, Lancet Oncology, Journal of Clinical Oncology, Annals of Oncology, Journal of the National Cancer Institute, PNAS, Clinical Cancer Research, etc. 
     

  • Guest speaker at domestic and international meetings. 
     

  • Network of influential collaborators.

Education

PH.D., Genetics

North Carolina State University, Raleigh, NC

M.S., Statistics

PH.D., Genetics

B.S. Genetics

National Wuhan University, Wuhan, China

Professional Experience

Biotheranostics, INC, A Hologic Company, San Diego, CA

4.2011 - present

​Senior Director, Biostatistics & Computational Biology:

  • Provide biostatistics and functional leadership in the clinical development of two key company products Breast Cancer Index and CancerTYPE ID, as well as in the operation of CLIA certified CAP accredited clinical laboratory and in assay development for Research laboratory.
     

  • As a functional lead in clinical development, provide strategic input in the design of clinical studies to build clinical utilities for company products, which led to successful inclusion of Breast Cancer Index in the National Comprehensive Cancer Network (NCCN) breast cancer guideline as the only predictive biomarker for extended endocrine therapy.
     

  • Assume biostatistics leadership in the preparation of preIDE and 510K submission for Breast Cancer Index and CancerTYPE ID. In collaboration with Research lab, designed and analyzed key analytic studies, including reproducibility/precision, limit of detection, minimum input requirement, and stability studies.
     

  • My creative statistical analysis of the NCIC CTG MA.17 study strategically changed Breast Cancer Index from a prognostic biomarker to the only predictive biomarker in the fiercely competitive breast cancer diagnostic market for the prediction of clinical benefit of extended endocrine therapy for estrogen receptor positive breast cancer patients. This work provided foundation to transform Biotheranostics to a commercially successful company with a molecular diagnostic test with differentiated clinical utility. 
     

  • Proposed and implemented endpoint-adaptive design for the pivotal clinical study with the aTTom trial, which strategically saved this critical clinical study from failure and allowed Biotheranostics to achieve ultimate success with the study.
     

  • Led the collaboration with investigators from Royal Marsden Hospital to evaluate Breast Cancer Index for late disease recurrence in the pivotal Arimidex, Tamoxifen, Alone or Combination (ATAC) trial on a head-to-head comparison with the market leading breast cancer assay Oncotype DX. Implemented a critical improvement in Breast Cancer Index algorithm and an amendment in Statistical Analysis Plan that led to successful completion of the trial, which demonstrated the superiority of Breast Cancer Index over Oncotype DX for late disease recurrence and the ability of Breast Cancer Index as the only predictive biomarker for superior efficacy of anastrozole over tamoxifen.
     

  • Spearheaded the implementation of statistical process control (SPC) in the CLIA laboratory for commercial assays, which facilitated successful approval of CAP inspection.
     

  • Performed critical examination and major improvement for CancerTYPE ID algorithm in an urgent short period of time before unblinding of a pivotal clinical study, resulting in a successful validation of the test with performance exceeding the expectation.
     

  • Led due diligence to evaluate potential business opportunities for Biotheranostics.

PFIZER, INC, San Diego, CA

7.2010 – 3.2011

​Translational Medicine Consultant:

  • Provided support in the design, implementation and analysis of mechanism of action studies with a JAK inhibitor (tofacitinib) in phase 1/2 clinical trials in ophthalmology therapeutic area, characterizing clinical efficacy endpoints and biomarkers in tear film and ocular surface cells from dry eye patients.
     

  • Contributed to the design, execution and analysis of preclinical studies to define and validate alternative indications for JAK inhibitor.

AMYLIN PHARMACEUTICALS, San Diego, CA

3.2010- 7.2010

​Pirincipal Statistician:

  • As the non-clinical statistical lead, provided statistical support to departments/functional lines across the company, including Research, Pharmaceutical R&D, In vivo Pharmacology, Assay Development, etc. 
     

  • Conducted experimental design and statistical analysis in the area of PK/PD, cell-based bioassay, compound screening, drug combination synergy, product development, quality control, etc, to ensure customer benefits from high quality analytic approaches.

VERIDEX, LLC, A JOHNSON & JOHNSON COMPANY, La Jolla, CA

11.2003 – 3.2010

5.2006 – 3.2010

12.2002 – 5.2006

Principal Scientist:​

Senior Scientist:

  • As the head of biostatistics/bioinformatics group, managed biomarker discovery projects in oncology area for risk prediction in breast, colorectal, lung and prostate cancers, using a variety of genomic technologies including gene expression profiling, high-resolution SNP microarrays for copy number analysis, Illumina targeted DASL arrays for FFPE samples and RT-PCR etc.
     

  • Responsible for all phases of biomarker discovery from experimental design, algorithm development and marker discovery, internal and external validations to final marker nomination, helped build a strong molecular diagnostics pipeline with novel contents that address unmet clinical needs in oncology.
     

  • Collaborated with J&J pharmaceutical division on developing companion diagnostic biomarkers for therapeutic responses of a J&J investigational compound (Zarnestra) for patient selection in relapsed and refractory acute myelogenous leukemia, with the aim to integrate the biomarkers into clinical studies.
     

  • Worked with Nuvera Biosciences, MD Anderson and Erasmus Medical Center to integrate 3 breast cancer tests (prognostics, endocrine-response and chemo-response) into one diagnostic assay to be commercialized in a CLIA reference laboratory. Performed due diligence, verification and validation of the partner company’s tests, streamlined and standardized the analysis of 3 different tests, conducted experimental design and data analysis for equivalence studies among different laboratories. 
     

  • Managed the first large-scale targeted next generation sequencing (NGS) project in J&J using Illumina technology for mutation detection in oncology, managed external CRO to develop an enhanced protocol to allow both target chromosome region enrichment and multiplexing feasible.
     

  • Initiated/Maintained external collaborations with academic and medical centers on biomarker discovery and clinical validation projects including study/protocol design, data collection and analysis.
     

  • Supervised and trained junior level scientists, built a stellar bioinformatics team renowned for its outstanding capability in genomic data analysis within J&J.
     

  • Evaluated emerging genomic technologies including Illumina whole genome (WG) DASL arrays, WG methylation arrays, WG microRNA profiling and GoldenGate Mehtylation Cancer Panel Arrays, etc.
     

  • Provided ad hoc statistical support for the product development group and clinical & regulatory groups.
     

  • Awards received during tenure:

    • Ortho Clinical Diagnostics Publication of The Year Award (2008)

    • Johnson & Johnson Global Leadership Profile Award (2006)

    • Veridex GOLD ENCORE Award (2006)

    • Veridex STAR Award (2005)

AXCELL BIOSCIENCES, Newtown, PA

7.2001 – 11.2002

​Bioinformatics Scientist:

  • Designed and implemented a comprehensive and integrative platform using Perl/CGI for in-house data mining of the company’s proprietary protein interaction database that is crucial for research and business establishment in a biotech industrial setting. 
     

  • Implemented a computational algorithm to search for potential novel ligands from public databases based on position specific scoring matrices (PSSM) using the in-house domain-ligand affinity data as the weighting scheme.
     

  • Employed a robust algorithm to automate the screening and flow of high quality affinity data from LIMS into production protein interaction database (ORACLE), which significantly increased the pipeline throughput.