Memorial Sloan Kettering Cancer Center and
`Weill Cornell Medical College
`Curriculum vitae and Bibliography
`
`
`
`Kenneth Ho-ming Yu, MD, MSc
`MSKCC
`300 East 66th Street
`NY, NY 10065
`646-888-4188
`646-888-4255
`YuK1@mskcc.org
`
`Date of preparation: July 15th, 2016
`A.
`GENERAL INFORMATION
`
`1.
`2.
`
`
`Name/Degree(s)
`Institution Name, Office address:
`
`Office telephone:
`Office fax:
`Email:
`
`
`
`3.
`
`B.
`
`Degree
`
`EDUCATIONAL BACKGROUND
`
`Institution name and location
`
`Dates attended
`
`Harvard University, Cambridge, MA
`Johns Hopkins University, Baltimore, MD
`University of Pennsylvania, Philadelphia, PA
`
`1991-1995
`1995-1999
`2005-2009
`
`Year Awarded
`
`1995
`1999
`2009
`
`PROFESSIONAL POSITIONS AND EMPLOYMENT
`
`Post-doctoral training including residency/fellowship
`
`B.A.
`M.D.
`M.Sc.
`
`
`
`C.
`
`1.
`
`Title
`
`Institution name and location
`
`Hospital of the University of Pennsylvania,
`Philadelphia, PA
`Hospital of the University of Pennsylvania,
`Philadelphia, PA
`Fellow, Hematology and Oncology Hospital of the University of Pennsylvania,
`Philadelphia, PA
`
`Medical Intern
`
`Medical Resident
`
`
`2.
`
`Title
`
`Academic positions (teaching and research)
`
`
`Institution name and location
`
`University of Pennsylvania, Philadelphia, PA
`Institute for Translational Medicine and
`Therapeutics, University of Pennsylvania
`University of Pennsylvania, Philadelphia, PA
`Center for Cancer Pharmacology, University of
`
`Research Associate in Medicine
`Research Scholar
`
`Instructor in Medicine
`Associate Laboratory Director
`
`
`
`Dates
`
`1999-2000
`
`2000-2002
`
`2002-2005
`
`Dates
`
`07/05-09/05
`07/05-12/09
`
`09/05-7/10
`2008-7/10
`
`1
`
`Roxane Labs., Inc.
`Exhibit 1004
`Page 001
`
`

`
`Assistant Member
`Assistant Professor
`Adjunct Assistant Professor
`Clinical Fellow
`
`Pennsylvania, Philadelphia, PA
`Memorial Sloan Kettering Cancer Center, NY
`Weill Cornell Medical College
`University of Pennsylvania, Philadelphia, PA
`Cold Spring Harbor Laboratory, Cold Spring
`Harbor, NY
`
`7/10-present
`7/10-present
`7/11-present
`9/12-present
`
`
`Hospital positions (e.g., attending physician)
`
`
`
`
`
`
`
`Institution name and location
`
`
`
`3.
`
`Title
`
`Attending Physician
`
`Assistant Attending Physician
`
`of
`Abramson Cancer Center, Division
`the
`Hematology-Oncology, Hospital
`of
`University
`of Pennsylvania, Presbyterian
`Medical Center and the Philadelphia VAMC
`Memorial Hospital for Cancer & Allied Diseases,
`Department of Medicine, NY
`
`Dates
`
`2005-7/10
`
`7/10-present
`
`Other Employment
`None
`
`Breaks in academic or medically-related employment of one month or longer
`None
`
`LICENSURE, BOARD CERTIFICATION, MALPRACTICE
`
`Licensure
`
`State
`NY
`PA
`
`
`
`DEA:
`NPI:
`
`Number
`257085
`419942
`
`Number
`BY8049048
`1073554440
`
`Board Certification(s)
`Full Name of Board
`Diplomate, American Board of
`Internal Medicine
`Diplomate, ABIM, Medical Oncology
`
`
`
`
`
`Malpractice insurance
`
`Date of issue
`05/14/2010
`06/26/2002
`
`Date of issue
`
`
`
`Date of expiration
`04/30/2016
`12/31/2010
`
`Date of expiration
`5/31/2016
`
`
`Candidate #
`216229
`
`Year passed
`2002
`
`Year expires/d
`2012
`
`216229
`
`2005
`
`2025
`
`Do you have Malpractice insurance? Yes
`Name of Provider:
`MSK Insurance, US, Inc
`Premiums paid by:
`Memorial Sloan Kettering Cancer Center
`
`2
`
`
`4.
`
`
`5.
`
`
`
`D.
`
`1.
`
`
`
`2.
`
`
`3.
`
`
`
`
`
`Roxane Labs., Inc.
`Exhibit 1004
`Page 002
`
`

`
`
`E. PROFESSIONAL MEMBERSHIPS
`
`
`Member/officer/other
`
`Member
`Member
`Member
`Member
`
`Name of Organization
`
`American Society of Clinical Oncology
`American Association of Cancer Research
`American Gastroenterology Association
`American Society for Mass Spectrometry
`
`
`F. HONORS AND AWARDS
`
`
` Name of award
`
`Thomas T. Hoopes Prize, Harvard University, for excellence in an
`undergraduate senior thesis
`Magna cum laude with highest honors, Harvard University
`ACS Institutional Grant, Johns Hopkins School of Medicine
`Research Scholar, Institute for Translational Medicine and Therapeutics,
`University of Pennsylvania
`Bernard L. Schwartz Designated Research Award in Pancreatic Cancer, AGA
`Foundation for Digestive Health and Nutrition
`
`Dates
`
`2003-Present
`2003-2012
`2005-2011
`2008-2012
`
`Date awarded
`
`1995
`
`1995
`1996
`2005
`
`2006
`
`
`G.
`
`
`INSTITUTIONAL/HOSPITAL AFFILIATION
`
`Primary Hospital Affiliation: Memorial Hospital for Cancer and Allied Diseases
`None
`Other Hospital Affiliations:
`Other Institutional Affiliations: Weill Cornell Medical College
`University of Pennsylvania
`Cold Spring Harbor Laboratory
`
`
`H.
`
`
`EMPLOYMENT STATUS
`
`Name of Employer(s): Memorial Sloan Kettering Cancer Center
`Employment Status: Full-time salaried
`
`
`
`
`
`CURRENT AND PAST INSTITUTIONAL RESPONSIBILITIES AND EFFORT
`I.
`
`Teaching/Mentoring (e.g., specific teaching and mentoring activities, courses taught, dates)
`1.
`Activity
`Dates
`
`2006-2008
`
`Lecturer, Frontiers in Medicine: Gastroenterology Course, University of
`Pennsylvania School of Medicine. Lecture to 4th year medical students
`regarding emerging biomedical research topics in gastroenterology.
`Lecturer, Tutorial Seminar Series in Pharmacology, Department of Radiation
`Oncology, University of Pennsylvania School of Medicine. Lecturing to
`
`2006-6/2010
`
`3
`
`Roxane Labs., Inc.
`Exhibit 1004
`Page 003
`
`

`
`2007
`
`2008-Present
`
`2009-6/10
`
`2008-6/10
`
`
`
`8/2012
`
`
`
`1/2014
`2/2014
`4/2015
`7/14/15
`
`
`Dates
`
`2003-6/10
`
`2005-6/10
`
`7/10-Present
`
`Dates
`
`2010-Present
`2014-Present
`
`Radiation Oncology residents, core curriculum.
`Lecturer, Frontiers in Medicine: Cancer Pharmacology Course, University of
`Pennsylvania School of Medicine. Lecture to 4th year medical students
`regarding emerging biomedical research topics in pharmacology.
`Co-Director, Frontiers in Medicine: Cancer Pharmacology Course,
`University of Pennsylvania School of Medicine. Direct class for 4th year
`medical students, discussing emerging biomedical research topics in
`pharmacology.
`Lecturer, Fellowship Didactic Lecture Series, Division of
`Hematology/Oncology, University of Pennsylvania School of Medicine.
`Lecturing to Hematology/Oncology fellows, core curriculum.
`Associate Director, Laboratory of Ian Blair, Ph.D., Center for Cancer
`Pharmacology, University of Pennsylvania. Laboratory research mentoring
`of undergraduate students, graduate students and post-doctoral fellows.
`GI Oncology International Videolinked Conference, Case Presentation:
`“Management of a Patient Diagnosed with Pancreatic Cancer and
`Myelodysplastic Syndrome”
`Cornell/MSKCC, inpatient housestaff lecture on Pancreatic Cancer
`Cornell/MSKCC, inpatient intern morning report
`Lecturer, Radiation Oncology Didactic Lecture Series, MSKCC
`Lecturer, Hematology/Oncology Grand Rounds, MSKCC
`
`
`
`2.
`
`
`Clinical Care
`
`Activity
`
`Attending Physician in Oncology, Philadelphia VAMC. Management and
`treatment of GI Oncology patients.
`Attending Physician, Abramson Cancer Center, University of Pennsylvania.
`Management and treatment of GI Oncology patients.
`Physician, GI Oncology Division, MSKCC. Management and treatment of
`GI Oncology patients.
`
`
`3.
`
`
`Administrative duties
`
`Activity
`
`Member, Pancreatic Cancer Working Group, MSKCC
`Member, The David M. Rubenstein Center for Pancreatic Cancer Research
`
`
`4.
`
`Research Summary
`My research has two focuses: the development of novel therapeutics and biomarkers in
`pancreatic cancer. Development of novel therapeutics involves the conduct of translational and
`
`Research
`
`
`
`4
`
`Roxane Labs., Inc.
`Exhibit 1004
`Page 004
`
`

`
`therapeutic clinical trials in pancreatic cancer. Development of biomarkers involves the study of
`proteomics, metabolomics and circulating tumor cells (CTCs). These biomarkers have the
`potential to be used as tools for individualized cancer treatment and for developing novel
`therapeutics in pancreatic cancer. I have the expertise, leadership and motivation necessary to
`successfully carry out the described research. I have experience in proteomics and translational
`research with specific training and expertise in key research areas. As a hematology/oncology
`fellow at Penn, I developed innovative mass spectrometry and proteomic techniques for
`identifying serum biomarkers of pancreatic cancer. As the PI on numerous University and
`Foundation funded grants, an NIH K08 career development award and an NIH R01 research
`award, I have further developed these approaches. I have successfully administered these
`projects (e.g. staffing, research protections, budget), written and carried out IRB-approved
`translational research protocols, collaborated with other researchers, and authored several peer-
`reviewed publications from each project. As a result of these previous experiences, I am aware of
`the importance of frequent communication among project members and of constructing a
`realistic research plan, timeline, and budget. Current research builds logically upon my prior
`work and is currently funded via an NIH R01 research award and Foundation research awards
`focused on pancreatic cancer. I have chosen collaborators who provide specific expertise in
`clinical research (Dr. Eileen O’Reilly), expertise in mass spectrometry (Dr. Ian Blair and Dr.
`Paul Tempst), expertise in pancreatic cancer biology (Dr. David Tuveson), expertise in CTCs
`and gene expression profiling (Dr. Mark Ricigliano), expertise in clinical trial design (Dr.
`Marinela Capanu) and systems biology and gene expression modeling (Dr. Nathan Price). In
`summary, I have a demonstrated record of successful and productive research projects in an area
`of high relevance for the NIH, NCI and MSKCC.
`
`Protocol
`IRB #10-210: A Phase II, Open-Label, Multicenter Study to Evaluate the
`Antitumor Efficacy of CO-1.01 for Infusion as Second-Line Therapy for
`Gemcitabine-Refractory Patients with Stage IV Pancreatic Adenocarcinoma and
`No Tumor hENT1 Expression
`IRB #11-141: Feasibility of Obtaining and Characterizing Circulating
`Tumorigenic Cells in Patients with Pancreatic Adenocarcinoma
`IRB #12-036: A Phase Ib, Open-label, Multi-center, Dose Escalation, Safety and
`Tolerability Study of LDE225 in Combination with Gemcitabine in Patients with
`Locally Advanced or Metastatic Pancreatic Adenocarcinoma
`IRB #12-078: A Phase I-II, Two-Part, Multicenter Study to Evaluate the Safety
`and Efficacy of M402 in Combination with Gemcitabine in Patients with
`Metastatic Pancreatic Cancer
`IRB #12-234: A Phase Ib/2 Study of OMP-59R5 in Combination with
`Gemcitabine in Subjects with Previously Untreated Stage IV Pancreatic Cancer
`IRB #14-039: A Two Stage Pilot Study Of Single Dose PEGPH20 And
`Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical
`Resection
`IRB #14-120: A Phase III, Multicenter, Open-Label, Randomized Study of nab-
`Paclitaxel Plus Gemicitabine Versus Gemicitabine Alone As Adjuvant Therapy
`in Subjects with Surgically Resected Pancreatic Adenocarcinoma
`IRB #14-190: A Randomized, Double-Blind, Phase 3 Study of the JAK1/2
`
`
`
`Co-PI
`
`Role
`Co-PI
`
`PI
`
`PI
`
`Co-PI
`
`Co-PI
`
`PI
`
`
`
`Co-PI
`
`
`
`5
`
`Roxane Labs., Inc.
`Exhibit 1004
`Page 005
`
`

`
`
`
`PI
`PI
`
`Inhibitor Ruxolitinib or Placebo in Combination With Capecitabine in Subjects
`With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed
`or Are Intolerant to First-Line Chemotherapy (The JANUS 2 Study)
`IRB #15-064: Screening Test for the Early Detection of Pancreatic Cancer
`IRB #15-065: Protease Biomarkers of Early Pancreatic Ductal Adenocarcinoma
`
`
`
`Summary of the above time and effort
`
`
`
`Teaching/Mentoring
`Clinical Care
`Administration
`Research
`TOTAL
`
`Current Percent
`Effort (%)
`
`
`60%
`
`40%
`100%
`
`Does the activity involve
`WCMC students and/or
`researchers? (Y/N)
`
`Y
`
`Y
`
`Does the activity involve
`MSKCC trainees and/or
`researchers? (Y/N)
`
`Y
`
`Y
`
`
`J.
`RESEARCH SUPPORT
`ACTIVE
`1. Research Award. Lustgarten Foundation. (07/01/14-06/30/16) Principal Investigator (10%). A Phase 0,
`Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic
`Adenocarcinoma Prior To Surgical Resection. The major goals of this award are to establish a new
`approach to drug development and understand disease biology in pancreatic cancer.
`2. Research Award. Weizmann - Rising Tide Translational Cancer Research Fund. (08/01/15 – 07/31/17)
`Co-PI. Targeting the human pancreatic cancer microenvironment utilizing integrated imaging modalities
`and novel anti-protease inhibitors. The major goals of this award are to study and to develop novel
`therapies targeting the pancreatic tumor microenvironment.
`3. Investigator Sponsored Trial, Halozyme Therapeutics (04/01/16 – 03/31/18). Principal Investigator
`(10%). Pilot Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced
`Pancreatic Adenocarcinoma. The major goals of this award are to establish safety and efficacy of this
`novel treatment approach in advanced pancreatic cancer.
`4. 1R01CA202762-01, Yu (Principal Investigator), 07/01/16-06/30/21. Pharmacogenomic and circulating
`tumor cell approach to individualized treatment of pancreatic cancer. The major goals of this award are to
`develop a clinical assay to guide treatment of pancreatic cancer and to establish tools to accelerate
`development of new therapies.
`
`
`
`COMPLETED (within past three years)
`
`1. NIEHS K08 ES019615-01 (1/11-12/13). Principal Investigator (75%). Biomarkers of exposure and
`response to environmental tobacco smoke in the pancreas. The major goals of this award are to develop
`and implement novel biomarkers for pancreatic cancer and the relationship with environmental tobacco
`smoke. No cost extension through 12/31/14.
`2. Research Award. Jeffrey Rosenzweig Foundation for Pancreatic Cancer Research (07/11-06/13).
`$50,000/year. Principal Investigator. Screening test for the early detection of pancreatic cancer. The
`
`
`
`6
`
`Roxane Labs., Inc.
`Exhibit 1004
`Page 006
`
`

`
`major goals of this award are to develop and implement novel biomarkers for the early detection of
`pancreatic cancer.
`3. Research Award. National Pancreas Foundation (07/11-06/12). $40,000/year. Principal Investigator.
`Screening test for the early detection of pancreatic cancer. The major goals of this award are to develop
`and implement novel biomarkers for the early detection of pancreatic cancer.
`4. Pilot Project Grant. Center of Excellence in Environmental Toxicology, University of Pennsylvania
`(1/10-12/10). $20,000/year. Principal Investigator (1%). Environmental Exposures and Biomarkers of
`Pancreatic Cancer. The major goals of this award are to identify and implement novel biomarkers of
`environmental exposures in pancreatic cancer.
`5. Research Fellowship, Institute for Translation Medicine and Therapeutics, University of Pennsylvania
`(9/05-9/08). Salary support up to $90,000 per year for a total of three years. The positions are open to
`individuals nearing the end of their clinical fellowship program at PENN or junior faculty within the first
`three years of their academic appointment. The goals of the program are to provide salary support to
`individuals that will facilitate protected time for the pursuit of research activities and to provide didactic
`training in research methodology. A required component of this fellowship will be completion of the
`Masters of Science in Translational Research.
`6. Bernard L. Schwartz Designated Research Award in Pancreatic Cancer. AGA Foundation for Digestive
`Health and Nutrition (7/06-6/09). $75,000/year. Principal Investigator. Proteomic Approaches to Tumor
`Marker Discovery in Pancreatic Cancer. The major goals of this award are to develop and implement
`novel methods for biomarker discovery in pancreatic cancer.
`
`EXTRAMURAL PROFESSIONAL RESPONSIBILITIES
`
`(e.g., Invited lectures, Journal reviewer, NIH study section, etc)
`
`
`
`Lecture and venue
`Yu KH, Rustgi AK, Blair IA.: Identification of Differentially Expressed
`Proteins in Pancreatic Cancer Serum Using Differential Gel Electrophoresis.
`Minisymposium, Annual Meeting of the AACR.
`Yu KH: Discoveries of serum biomarkers for the early detection of
`pancreatic cancer using proteomic approaches. The Center for Molecular
`Studies in Digestive and Liver Diseases and GI Division 7th Annual
`Conference and Retreat, Philadelphia, PA.
`Yu KH: Application of differential gel electrophoresis and tandem mass
`spectrometry to serum biomarker discovery in pancreatic cancer. GE
`Healthcare, Protein Analysis Seminar Series, Philadelphia, PA.
`Yu KH: Advances in the treatment of Gastrointestinal Carcinoid Tumors.
`Focus on Gastrointestinal Cancers, Abramson Cancer Center, Philadelphia,
`PA.
`Yu KH: Biomarker targeted proteomics. Center for Molecular Studies in
`Digestive and Liver Diseases, Advances
`in Technology seminar,
`Philadelphia, PA.
`Yu KH: Advances in the treatment of Rectal Cancer.
` Focus on
`Gastrointestinal Cancers, Abramson Cancer Center, Philadelphia, PA.
`Yu KH: Environmental Exposures and Biomarkers of Pancreatic Cancer.
`2010 Pilot Project Award Presentations, Center of Excellence
`in
`
`K.
`
`
`Invited lectures
`Date
`04/2005
`
`
`
`05/11/2006
`
`
`
`09/20/2006
`
`
`
`03/14/2008
`
`
`
`10/20/2009
`
`
`
`03/26/2010
`
`02/17/2011
`
`
`
`
`7
`
`Roxane Labs., Inc.
`Exhibit 1004
`Page 007
`
`

`
`Environmental Toxicology, University of Pennsylvania, Philadelphia, PA.
`Yu KH: Biomarker Discovery in Pancreatic Cancer. Cold Spring Harbor
`Laboratory, Cold Spring Harbor, NY, Aug. 1st, 2012.
`Yu, KH: Approaches to Pancreatic Cancer. Inspire2Live Banbury
`Conference, Cold Spring Harbor Laboratory, Cold Spring Harbor, NY.
`Sangar V, Ricigliano M, O’Reilly EM, Abou-Alfa GK, Lowery M, Saltz LB,
`Crotty J, Gary K, Branham A, Yin J, Yu KH: Use of Pharmacogenomic
`Modeling in Pancreatic Cancer for Prediction of Chemotherapy Response
`and Resistance. Presenter, Oral presentation, 2013 Gastrointestinal Cancers
`Symposium, ASCO, San Francisco, CA.
`Yu KH: Pancreatic Cancer. Invited speaker and panel discussant. 22nd
`Annual Meeting, New York Biotechnology Association, New York, NY.
`Yu KH, Sangar V, Ricigliano M, Hidalgo M, Abou-Alfa GK, Lowery M,
`Saltz LB, Crotty J, Gary K, Branham A, Yin J, O’Reilly EM. Use of
`pharmacogenomic modeling
`in pancreatic cancer for prediction of
`chemotherapy response and resistance. Poster discussion, 2013 ASCO
`Annual Meeting, Chicago, IL.
`Yu KH: Invited faculty and lecturer: “Clinical Trials in Pancreatic Cancer.”
`Foundations of Pancreatic Cancer Banbury Workshop, Cold Spring Harbor
`Laboratory, Lloyd Harbor, NY.
`Yu KH: Visiting Professor and Keynote speaker, Medical College of
`Wisconsin, Research Day.
`Yu KH, Tseng JF, O’Reilly EM: ASCO University Tumor Board,
`Pancreatic Cancer
`Yu KH: Invited speaker, Regional Summit on Practical and Emerging
`Trends in Pancreatic Cancer. Chicago, IL.
`Yu KH: Pancreatic Cancer: The Current State and Future of Research.
`Discussant, Oral Abstract Session: GI (Noncolorectal) Cancer, 2015 ASCO
`Annual Meeting, Chicago, IL.
`Yu KH: Invited faculty and lecturer: “Clinical trial development and
`precision medicine.” Workshop on Pancreatic Cancer, 2015 Cold Spring
`Harbor Laboratory Banbury Seminars, Lloyd Harbor, NY.
`Yu KH:
` Invited speaker: “ASCO Highlights: Pancreatic Cancer.”
`Hematology/Oncology Grand Rounds, Memorial Sloan Kettering Cancer
`Center, NY, NY.
`Yu KH: Invited speaker: “Pharmacogenomic modeling to predict treatment
`response in pancreatic cancer.” UAB/UMN GI/Pancreas Cancer SPORE
`Workshop, NCI Shady Grove Campus, Rockville, MD.
`Yu KH: Invited speaker, Division of Hematology/Oncology Grand Rounds,
`Columbia University Medical Center
`
`
`08/01/2012
`
`09/15/2012
`
`01/24/2013
`
`
`
`05/30/2013
`
`06/03/2013
`
`
`
`07/01/2013
`
`
`
`10/18/13
`
`01/01/14
`
`09/13/14
`
`05/31/15
`
`
`
`06/24-30/15
`
`
`
`07/14/2015
`
`
`07/31/2015
`
`05/18/2016
`
`
`
`
`Editorial responsibilities
`Date
`Journal name (ad hoc reviewer vs Editorial Board with position as applicable)
`Ad hoc reviewer: Journal of Proteome Research
`2007-Present
`Ad hoc reviewer: Gastroenterology
`2007-Present
`Ad hoc reviewer: Proteomics
`2008-Present
`Ad hoc reviewer: BMC Cancer
`2010-Present
`
`
`
`8
`
`Roxane Labs., Inc.
`Exhibit 1004
`Page 008
`
`

`
`2011-Present
`2011-Present
`2011-Present
`2011-Present
`2011-Present
`2012-Present
`2012-Present
`2012-Present
`2012-Present
`
`
`Ad hoc reviewer: Journal of Gastrointestinal Cancer
`Ad hoc reviewer: Drugs of the Future
`Ad hoc reviewer: Cancer Chemotherapy and Pharmacology
`Ad hoc reviewer: Pancreatology
`Ad hoc reviewer: Cancer Chemotherapy and Pharmacology
`Ad hoc reviewer: Bioanalysis
`Ad hoc reviewer: Oncogene
`Ad hoc reviewer: Journal of Surgical Oncology
`Associated Editor, Journal of Integrated OMICS
`
`
`
`Study section peer review activities
`Date
`Activity
`2011-2015
`Ad hoc reviewer, Environmental Health Sciences Review Committee
`
`(EHSRC), National Institute of Environmental Health Sciences (NIEHS/NIH)
`2013-Present
`Peer reviewer, Pancreatic Cancer UK Research Innovation Fund
`2013-Present
`Review Committee member, Canada Foundation for Innovation, Leaders
`
`Opportunity Fund.
`2015
`Peer reviewer, Institut National du Cancer (NCI of France)
`
`2012-2015
`
`
`Other consultant activities or positions
`Date
`Activity
`2011-2014
`Data Safety Monitoring Committee, Dasatinib Added to Gemcitabine for
`Subjects With Locally-advanced Pancreatic Cancer, NCT01395017
`Data Safety Monitoring Committee Chairman, Study of Sativex® Oromucosal
`Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced
`Cancer, NCT01424566
`
`
`L.
`
`
`
`
`
`
`BIBLIOGRAPHY
`
`1. Peer-Reviewed Articles
`
`1. Paul DL, Yu KH, Bruzzone R, Gimlich RL, Goodenough DA.: Expression of a dominant negative
`inhibitor of intercellular communication in the early Xenopus embryo causes delamination and
`extrusion of cells. Development. 121(2):371-81, Feb. 1995. PMID: 7768179
`2. Yu KH, Weng LJ, Fu S, Piantadosi S, Gore SD.: Augmentation of phenylbutyrate-induced
`differentiation of myeloid leukemia cells using all-trans retinoic acid. Leukemia. 13(8):1258-65,
`Aug. 1999. PMID: 10450755
`3. DiGiuseppe JA, Weng LJ, Yu KH, Fu S, Kastan MB, Samid D, Gore SD.: Phenylbutyrate-
`induced G1 arrest and apoptosis in myeloid leukemia cells: structure-function analysis. Leukemia.
`13(8):1243-53, Aug. 1999. PMID: 10450753
`4. Yocum AK, Yu KH, Oe T, Blair IA.: Effect of Immunoaffinity Depletion of Human Serum
`During Proteomic Investigations. Journal of Proteome Research. 2005 Sep-Oct;4(5):1722-31.
`PMID: 16212426
`5. Yu KH, Rustgi AK, Blair IA.: Characterization of Proteins in Human Pancreatic Cancer Serum
`Using Differential Gel Electrophoresis and Tandem Mass Spectrometry. Journal of Proteome
`Research. 2005 Sep-Oct;4(5):1742-51. PMID: 16212428
`
`9
`
`Roxane Labs., Inc.
`Exhibit 1004
`Page 009
`
`

`
`6. Yu KH, Barry CG, Austin D, Busch CM, Sangar V, Rustgi AK, Blair IA.: Stable Isotope Dilution
`Multidimensional Liquid Chromatography-Tandem Mass Spectrometry for Pancreatic Cancer
`Serum Biomarker Discovery. Journal of Proteome Research. 2009 Mar;8(3):1565-76. PMCID:
`PMC2652408
`7. Ciccimaro E, Hanks SK, Yu KH, Blair IA: Absolute Quantification of Phosphorylation on the
`Kinase Activation Loop of Cellular Focal Adhesion Kinase by Stable Isotope Dilution Liquid
`Chromatography/Mass Spectrometry. Analytical Chemistry. 2009 May 1;81(9):3304-13. PMID:
`19354260. PMCID: PMC2706532
`8. Shah SJ, Yu KH, Sangar V, Parry SI, Blair IA: Identification and Quantification of Preterm Birth
`Biomarkers in Human Cervicovaginal Fluid by Liquid Chromatography/Tandem Mass
`Spectrometry. Journal of Proteome Research. 2009 May;8(5):2407-17. PMID: 19354260. PMCID:
`PMC2729452
`9. Rangiah K, Wong MT, Sangar V, Austin D, Tétreault MP, Rustgi AK, Blair IA, Yu KH:
`Biomarker Discovery in Colon Cancer Using a Differential Secreted Proteome Approach. Journal
`of Proteome Research. 2009 Nov;8(11):5153-64. PMID: 19769411. PMCID: PMC2783939
`10. Wehr AY, Furth EE, Sangar V, Blair IA, Yu KH: Analysis of the Human Pancreatic Stellate Cell
`Secreted Proteome. Pancreas. Pancreas. 2011 May;40(4):557-66. PMID: 21499210. PMCID:
`PMC3086313
`11. DeNicola GM, Karreth FA, Wei C, Frese K, Gopinathan A, Mangal D, Yu KH, Blair IA, Tuveson
`DA.: Reduction of intracellular redox state by K-RasG12D promotes tumorigenesis. Nature. 2011
`Jul 6;475(7354):106-9. PMID: 21734707. PMCID: PMC3404470
`12. Wehr AY, Hwang WT, Blair IA, Yu KH: Relative Quantification of Serum Proteins from
`Pancreatic Ductal Adenocarcinoma Patients by Stable Isotope Dilution Liquid Chromatography-
`Mass Spectrometry. Journal of Proteome Research. 2012 Mar 2;11(3):1749-58. PMID: 22264027.
`PMCID: PMC3292696
`13. Epstein AS, Volandes AE, Chen LY, Gary KA, Li Y, Agre P, Meier DE, Levin TT, Reidy DL,
`Meng RD, Segal NH, Yu KH, Abou-Alfa GK, Janjigian YY, Kelsen DP, O'Reilly EM: A
`Randomized Controlled Trial of a Cardiopulmonary Resuscitation Video in Advance Care
`Planning for Progressive Pancreas and Hepatobiliary Cancer Patients. J Palliat Med. 2013
`Jun;16(6):623-31. PMID: 23725233
`14. Lewis GH, Wang H, Bellizzi AM, Klein AP, Askin FB, Westra WH, Ende L, Schulick RD,
`Wolfgang CL, Cameron JL, O’Reilly EM, Yu KH, Hruban RH: Prognosis of Minimally Invasive
`Carcinoma Arising in Mucinous Cystic Neoplasms of the Pancreas. Am J Surg Pathol. 2013
`Apr;37(4):601-5. PMID: 23388125. PMCID: PMC3596434
`15. Lee JK, Capanu M, O’Reilly EM, Ma J, Chou JF, Shia J, Katz SS, Gansukh B, Reidy-Lagunes D,
`Segal N, Yu KH, Chung K-Y, Saltz LB, Abou-Alfa GK: A phase II study of gemcitabine and
`cisplatin plus sorafenib in patients with advanced biliary adenocarcinomas. British Journal of
`Cancer. 2013 Aug 20;109(4):915-9. PMID: 23900219. PMCID: PMC3749586
`16. Li D, Pant S, Ryan DP, Laheru D, Bahary N, Dragovich T, Hosein PJ, Rolfe L, Saif MW, LaValle
`J, Yu KH, Lowery MA, Allen A, O'Reilly EM: A phase II, open-label, multicenter study to
`evaluate the antitumor efficacy of CO-1.01 as second-line therapy for gemcitabine-refractory
`patients with stage IV pancreatic adenocarcinoma and negative tumor hENT1 expression.
`Pancreatology. 2014 Sep-Oct;14(5):398-402. PMID: 25278310
`17. Yu KH, Ricigliano M, Hidalgo M, Abou-Alfa GK, Lowery MA, Saltz LB, Crotty JF, Gary K,
`Cooper B, Lapidus R, Sadowska M, O'Reilly EM: Pharmacogenomic Modeling of Circulating
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`Tumor and Invasive Cells for Prediction of Chemotherapy Response and Resistance in Pancreatic
`Cancer. Clinical Cancer Research. 2014 Oct 15;20(20):5281-9. PMID: 25107917
`18. Boj SF, Hwang C-I, Baker LA, Chio IIC, Engle DD, Corbo V, Jager M, Ponz-Sarvise M, Tiriac H,
`Spector MS, Gracanin A, Oni T, Yu KH, van Boxtel R, Huch M, Rivera KD, Wilson JP, Feigin
`ME, Ohlund D, Handly-Santana A, Ardito-Abraham CM, Ludwig M, Elyada E, Alagesan B, Biffi
`G, Yordanov GN, Delcuze B, Creighton B, Wright K, Park Y, Morsink FHM, Molenaar IQ,
`Rinkes IHB, Cuppen E, Hao Y, Jin Y, Nijman IJ, Iacobuzio-Donahue C, Leach SD, Pappin DJ,
`Hammell M, Klimstra DS, Basturk O, Hruban RH, Offerhaus GJ, Vries RGJ, Clevers H, Tuveson
`DT: Organoid Models of Human and Mouse Ductal Pancreatic Cancer. Cell. 2015 Jan 15;160(1-
`2):324-38. Epub 2014 Dec 31. PMID: 25557080
`19. Li D, Capanu M, Yu KH, Lowery MA, Kelsen DP, O’Reilly EM: Treatment, Outcomes and
`Clinical Trial Participation in Elderly Patients with Metastatic Pancreas Adenocarcinoma. Clinical
`Colorectal Cancer. 2015 May 22. PMID: 26072442
`20. Salo-Mullen EE, O’Reilly EM, Kelsen D, Ashraf A, Lowery M, Yu KH, Reidy D, Epstein A,
`Lincoln A, Saldia A, Jacobs LM, Rau-Murthy R, Zhang L, Kurtz R, Saltz L, Offit K, Robson M,
`Stadler ZK: Identification of Germline Genetic Mutations in Pancreatic Cancer Patients. Cancer.
`2015 Dec 15;121(24):4382-8. PMID: 26440929
`21. Hicks AM, Chou J, Capanu M, Lowery MA, Yu KH, O'Reilly EM: Pancreas Adenocarcinoma:
`Ascites, Clinical Manifestations, and Management Implications. Clin Colorectal Cancer. 2016
`May 7. PMID: 27262896
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`2. Books, book chapters and reviews
`
`1. Hewitt MR, Yu KH: Treatment update for metastatic pancreatic cancer. Community Oncology.
`3(7):428-30. 2006.
`2. Yu KH, Ahmad N. Adenocarcinoma of the Pancreas: Diagnosis and Evaluation. Endosocopic
`Oncology: Gastrointestinal Endoscopy and Cancer Management, 1st Edition. Faigel D, Kochman
`ML, eds. Totowa, NJ: Humana Press, 2006.
`3. Hung KE, Yu KH: Proteomic Approaches to Cancer Biomarkers. Gastroenterology. 2010
`Jan;138(1):46-51.e1. PMID: 19931265. PMCID: PMC2873613
`4. Lowery MA, Kelsen DP, Stadler ZK, Yu KH, Janjigian YY, Ludwig E, D’Adamo DR, Salo-
`Mullen E, Robson ME, Allen PJ, Kurtz RC, O’Reilly EM: An Emerging Entity: Pancreatic
`Adenocarcinoma Associated with a Known BRCA Mutation: Clinical Descriptors, Treatment
`Implications and Future Directions. Oncologist. 2011;16(10):1397-402. PMID: 21934105.
`PMCID: PMC3228075
`5. Lowery MA, Klimstra DS, Shia J, Yu KH, Allen P, Brennan EM, O’Reilly EM.: Acinar Cell
`Carcinoma of the Pancreas: New Genetic and Treatment Insights into a Rare Malignancy.
`2011;16(12):1714-20. PMID: 22042785. PMCID: PMC3248770
`6. Won E, Yu KH, Shamseddine A, Saltz L, Mukherjee D, Haydar A, El-Olayan A, Temraz S,
`Naghy M, Makanjoula D, O’Reilly EM, Abou-Alfa GK: Gastrointestinal Cancer Educational
`Case Series: Management of a Patient Diagnosed with Pancreatic Cancer and Myelodysplastic
`Syndrome. Gastrointest Cancer Res. 2013 Mar;6(2):56-60. PMID: 23745160. PMCID:
`PMC3674464
`7. Cavalcante L, Kelsen D, Yu KH: Multimodality therapy in Pancreatic Adenocarcinoma. Current
`Pharmaceutical Design. 2014 Oct 22;20(42):6697-701. PMID: 25341941
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`8. Yu KH: Pharmacogenomic modeling in pancreatic cancer—response. Clinical Cancer Research.
`2015 Mar 15;21(6):1498. PMID: 25770296
`9. Ponz-Sarvise M, Tuveson DT, Yu KH: Mouse models of pancreatic ductal adenocarcinoma.
`Hematol Oncol Clin North Am. 2015 Aug;29(4):609-17. doi: 10.1016/j.hoc.2015.04.010. Epub
`2015 Jun 11. Review. PMID: 26226900.
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`Date: __7/15/2016___________________
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`______________________________________
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`Signature:
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