Yuriko Mori, M.D., Ph.D.

acvtrt@r.postjobfree.com; 410-***-****; www.linkedin.com/in/YurikoMori

PROFESSIONAL PROFILE:

I am a geneticist with clinical experience and am specialized in DNA/RNA biomarker R&D, gastrointestinal oncology, and commercial laboratory management. My expertise includes:

Research design, execution, & analysis

Scientific expert’s review

DNA methylation and genome wide studies

Quality assurance

Technical writing (grants, articles, & SOPs)

Clinical data review & management

Statistics

Regulatory affairs

PROFESSIONAL EXPERIENCE

Principal Consultant, CLIA and Laboratory Operations 2016-current

Otto Consulting Group, Reisterstown, MD

Provide clients with CLIA laboratory set-up, license application, and audit preparation.

Provide clients with patient diagnostic test development and regulatory clearance.

CLIA Laboratory Manager & Technical Supervisor 2014-2016

CHI Center for Translational Research, Baltimore, MD

Established a high-complexity diagnostic laboratory within 11 months, from CLIA license application to a successful CMS audit without any citation.

Oversaw daily laboratory operations, personnel, documentation, purchasing, assay development and validation, regulatory affairs, quality control, and CAPA.

oValidated 2 LDTs for clinical service and reduced nonconformance by 75%.

Executed a commercial research project on NGS and earned $10K in revenue.

Participated in an internal R&D effort on plasma/urine cell-free DNA assays.

Assisted the CTR biorepository’s commercial service by project implementability assessment and audit of deliverables (specimen, data, and chain of custody records).

Visiting Assistant Professor / Research Associate 2012-2013

Johns Hopkins University of Medicine, Baltimore, MD

Conducted research on ell-free RNA- based cancer biomarker development.

Published 4 original research articles (including one last author article).

Supervised and trained 2 postdoctoral fellows.

Served as a peer-reviewer for 3 professional journals.

Assistant Professor 2006-2012

Johns Hopkins University of Medicine, Baltimore, MD

Led an epigenetics research laboratory focusing on cancer and inflammation. Project topics were stool DNA- based cancer biomarker development.

Received 4 research project grants as principal investigator (total direct cost: $600K).

Published 27 original research articles (including one first- and 4 last author articles).

Received a provisional biomarker patent and attracted a prospective industrial licensee.

Served as a peer-reviewer for >10 professional journals and 2 grant funding agencies.

Mentored and trained 5 postdoctoral fellows and 5 undergraduate students.

Organized an elective laboratory research program for Japanese medical school students and hosted 5 students in the Johns Hopkins University.

OTHER RELEVANT PROFESSIONAL EXPERIENCE

-Assistant Professor of Medicine, Gastroenterology

University of Maryland School of Medicine, Division of Gastroenterology; Baltimore, MD.

-Postdoctoral Research Fellow, Gastroenterology

University of Maryland School of Medicine, Division of Gastroenterology; Baltimore, MD.

-Fellow, Pulmonary Oncology

Tohoku University Institute of Development, Aging, and Cancer; Miyagi, Japan.

-Resident, Pulmonology

Tohoku University Institute of Development, Aging, and Cancer; Miyagi, Japan.

-Resident, Internal Medicine

Iwaki City Kyoritsu General Hospital; Miyagi, Japan.

EDUCATION

-PhD, Medical Science, Tohoku University Graduate School; Miyagi, Japan.

-MD, Tohoku University School of Medicine; Miyagi, Japan.

-Board eligible, American Board of Clinical Chemistry (ABCC).

CERTIFICATIONS

-Medical License, Ministry of Health, Labor, and Welfare; Japan (ID# 10342).

-Diplomate, Japanese Board of Medicine; Japan (ID# 348772).

PROFESSIONAL AFFILIATIONS

American Association for Cancer Research, Active Member.

SKILLS

-Administrative Skills:

•High-complexity CLIA laboratory setup: Policies and workflow development; SOP writing; medical informatics; assay performance validation; personnel training; facilities and instrument setup; preparation of CLIA license application; federal audit preparation.

•Regulated laboratory operations: Regulatory compliance management (CLIA-CMS, OSHA); test development and quality control; development and enforcement of corrective action plans; personnel management and training; client relations; ordering; recordkeeping.

•Research management: Study design; funding acquisition; scheduling; budgeting; team building; compliance management (IRB, OSHA, EPA); problem-solving; reporting.

•Commercial research project management: Implementability assessment; study design; sample procurement; laboratory process development; documentation system (e.g., chain of custody) development; project management; reporting; biospecimen QC; data QC; QA.

•Technical writing: Regulated technical documents (e.g., LDT validation study report); scientific papers; grant applications; oral scientific presentations; literature review.

•Scientific expert’s review: Grant applications; scientific articles; editorials.

-Translational Research Skills:

•Study design: Patient cohort design; clinical data extraction; case-control matching; power analysis.

•Biomarker evaluation: ROC curve analysis; sensitivity-specificity analysis; survival analysis; computation of multiple marker-based diagnostic scoring.

•Biospecimen: Chain of custody; QC of specimens and delivertives; PHI management; document review for case eligibility verification.

-Computational and Informatics Skills:

•On-line database mining: PubMed; OMIM; Entrez; BLAST; UCSC Genome Browser; Ensemble; GEO; COSMIC.

•Software: R; STATISTICA; EndNote; Adobe Acrobat; Adobe Photoshop

-Bench-top Laboratory Skills

• Molecular biological skills:

oBiospecimen processing: Nucleic acid extraction from fresh frozen, FFPE tissues; cfDNA extraction from plasma and urine; Laser capture micro-dissection.

oDNA/RNA: DNA methylation assays; DNA microarray; sequencing; pyrosequencing; real-time PCR; SNP and microsatellite marker genotyping; Northern blot; FISH.

oCloning: KO vector construction; targeted mutagenesis.

oProtein: Western blot; IHC; ChIP.

• Cell biological skills:

oMammalian cell culture and chemical treatment.

oTransfection of siRNAs and plasmid vectors.

oCell proliferation, migration, invasion, adhesion, apoptosis, and survival assays.

PATENTS PENDING

•Novel DNA hypermethylation diagnostic biomarkers for colorectal cancer: PCT/US2011/054781.

•Methods and compositions useful for diagnosing inflammatory bowel disease-associated neoplasia: 61/642,054.

GRANTS AWARDED AS THE PRINCIPAL INVESTIGATOR

1.Research Grant; Prevent Cancer Foundation ($80,000)

Preclinical development of colorectal cancer risk stratification marker (2011-2013).

2.Associated Membership Grant; Early Detection Research Network, NCI ($100,000)

DNA methylation markers for colon cancer diagnosis (2009-2012).

3.Research Grant; Wendy Will Case Cancer Fund ($30,000)

Age-associated DNA methylation in the colon (2010-2011).

4.Senior Research Award; Crohn’s and Colitis Foundation of America ($390,000)

A genome-wide search for novel methylation targets in inflammatory bowel disease associated colon cancer (2007-2010).

5.AGA Research Scholar Award; Foundation for Digestive Health and Nutrition ($195,000)

A global search of hypermethylated genes in colon cancer (2004-2008).

6.Intramural Pilot Project Award, University of Maryland School of Medicine ($15,000)

Functional Assessment of Novel Tumor Suppressor Gene Genes in Colon (2004-2005).

PEER-REVIEWED PUBLICATIONS

(Selected from 64 articles including 11 first author- and 5 last author articles)

1.Yang X, Song JH, Cheng Y, Wu W, Bhagat T, Yu Y, Abraham JM, Ibrahim S, Ravich W, Chander Roland B, Khashab M, Singh VK, Shin EJ, Yang X, Verma AK, Meltzer SJ, and Mori Y.

Long noncoding RNA HNF1A-AS1 regulates proliferation and migration in esophageal adenocarcinoma cells. Gut (2014).

2.Cheng Y, Jin Z., Agarwal R., Ma K, Yang J, Ibrahim S, Olaru AV, David S, Ashktorab H, Smoot DT, Duncan MD, Hutcheon DF, Meltzer SJ, and Mori Y.

LARP7 is a potential tumor suppressor gene in gastric cancer. Laboratory Investigation (2012).

3.Olaru AV, Cheng Y, Agarwal R, Yang J, David S, Yu W, Hutcheon DF, Harpaz N, Meltzer SJ, and Mori Y.

The lack of cancer-specific CpG island methylation in inflammatory bowel disease-associated colorectal cancers. Inflammatory Bowel Disease (2012).

4.Mori Y, et al.

Methylation microarray-based scanning identifies novel colorectal cancer biomarkers. Endocrine-related Cancer (2011).

5.Paun BC, Cheng Y, Young J, Leggett B, Meltzer SJ, and Mori Y.

Screening for microsatellite instability identifies frequent 3'-untranslated region mutation of the RB1-inducible coiled-coil 1 gene in colon tumor. PLoS ONE (2009).

6.David S, Kan T, Cheng Y, Agarwal R, Jin Z, and Mori Y.

The gastric endocrine peptide precursor gene tachykinin-1 is a target of epigenetic silencing in human gastric cancer. Biochemical Biophysical Research Communications (2009).

7.Mori Y et al.

A genome-wide search isolates somatostatin, tachykinin-1, and five other genes as targets of epigenetic silencing in human colon cancer. Gastroenterology (2006).

8.Mori Y et al.

Identification of genes uniquely involved in MSI-H colon carcinogenesis by expression profiling combined with epigenetic scanning. Cancer Research (2004).

INVITED TALKS AT INTERNATIONAL CONFERENCES

1.Invited Speaker, Frontiers in Cancer Prevention Research 2009, Houston TX. American Association for Cancer Research.

2.Invited Speaker, Epigenomics and Sequencing 2008 Meeting in Boston, MA. GeneExpression Systems, Inc.

3.Invited Lecturer/Panelist, 2007 Annual Quantitative PCR Meeting in San Diego, LA, Cambridge Healthtech Institute.

EDITORIAL BOARD & REVIEW PANEL MEMBER EXPERIENCE

Editorial Board: The Open Gastroenterology Journal until 2013.

Scientific Article Review Panel: 18 international biomedical journals including Cancer Research, Journal of Medical Genetics, Journal of Clinical Investigation, and Gastroenterology.

Grant Application Review Panel: Four extramural grant funding agencies in Europe.

PROGRAM BUILDING AND LEADERSHIP

Organizer, Basic Research Elective program at the Johns Hopkins Medicine Division of Gastroenterology (Tohoku University School of Medicine). 2006-2012

Basic investigator, the Meyerhoff Inflammatory bowel disease center, the Johns Hopkins University School of Medicine, Division of Gastroenterology & Hepatology. 2006-2012

Associate Member, The Early Detection Research Network (NCI). 2009-2012

Faculty Mentor, NIDDK STEP-UP program. 2010-2011

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