`
`PART I: General Information
`
`DATE PREPARED:
`
`February 23, 2016
`
`Name:
`
`A. Oliver Sartor, M.D
`
`Home Address:
`
`1511 Dufossat Street, New Orleans, LA 70115
`
`Work E-Mail:
`
`osartor@tulane.edu
`
`Citations:
`
`h-index= 52 (per Google Scholar)
`12,188 citations
`
`Place of Birth:
`
`Shreveport, LA
`
`Education:
`1977 B.A.
`1982 M.D.
`
`Postdoctoral Training:
`1982-1983
`
`1983-1984
`1984-1985
`
`1985-1986
`
`1986-1989
`1989-1990
`
`Colorado College, Colorado Springs, CO
`Tulane University School of Medicine, New Orleans, LA
`
`Intern in Pediatrics, Children’s Hospital of Philadelphia, University of
`Pennsylvania Pediatrics Program, Philadelphia, PA
`Intern in Medicine, Tulane University School of Medicine
`Junior Resident, Internal Medicine, Tulane University School of
`Medicine
`Senior Resident, Internal Medicine, Tulane University School of
`Medicine
`Fellow in Medical Oncology, National Cancer Institute, Bethesda, MD
`Senior Staff Fellow, Laboratory of Cellular Development and Oncology,
`National Institutes of Dental Research, Bethesda, MD
`
`Licensure and Certification:
`1985-
`Louisiana Medical Licensure
`1986-lifetime
`American Board of Internal Medicine Certificate
`1989-lifetime
`American Board of Internal Medicine, Medical Oncology Certificate
`1986-1993
`Maryland Medical Licensures
`1988-1990
`Virginia Medical Licensures
`2006-2008
`Massachusetts Medical Licensure
`
`Academic Appointments:
`1990-1993
`Senior Investigator, Clinical Pharmacology Branch, National Cancer
`Institute, Bethesda, MD
`Associate Professor of Medicine (with tenure), Section of
`Hematology/Oncology, Departments of Medicine and Urology, Louisiana
`State University School of Medicine, Shreveport, LA
`
`1993-1998
`
`1
`
`AVENTIS EXHIBIT 2002
`Mylan v. Aventis, IPR2016-00712
`
`
`
`1998-2006
`
`2002-2006
`
`2006-2007
`
`2007-2008
`
`2008-2010
`
`2010-
`
`Patricia Powers Strong Professor of Oncology (with tenure), Louisiana
`State University School of Medicine, New Orleans, LA
`Adjunct Clinical Professor of Medicine, Tulane University School of
`Medicine, New Orleans, LA
`Associate Professor of Medicine, Dana-Farber Cancer Institute, Harvard
`Medical School, Boston, MA
`Lecturer, Dana-Farber Cancer Institute, Harvard Medical School, Boston,
`MA
`Piltz Endowed Professor of Cancer Research in Depts. of Medicine and
`Urology, Professor of Medicine and Urology (with tenure), Tulane
`Medical School, New Orleans, LA
`C.E. and Bernadine Laborde Professor of Cancer Research and Medical
`Director, Tulane Cancer Center (with tenure)
`
`Hospital Appointments:
`1990-1993
`1993-1998
`
`1993-1998
`1998-2006
`
`1998-2006
`2006-2007
`2006-2007
`2008-
`
`Attending Physician, NIH Clinical Center, Bethesda, MD
`Attending Physician, Louisiana State University Hospital, Shreveport,
`LA
`Attending Physician, Willis-Knighton Hospital, Shreveport, LA
`Attending Physician, Medical Center of Louisiana at New Orleans, New
`Orleans, LA
`Attending Physician, Memorial Medical Center, New Orleans, LA
`Attending Physician, Dana Farber Cancer Institute, Boston, MA
`Attending Physician, Brigham and Women’s Hospital, Boston, MA
`Attending Physician, Tulane University Hospital, New Orleans, LA
`
`Hospital and Health Care Organization Service Responsibilities:
`1998-2006
`Head, LSU Oncology Services, Medical Center Louisiana, New Orleans
`2009-
`Medical Director, Oncology, Tulane Hospital and Clinics, New Orleans
`
`1998-2006
`
`2002-2006
`
`Major Administrative Responsibilities:
`1998-2006
`Chief, Hematology/Oncology Section, Department of Medicine,
`Louisiana State University School of Medicine
`Director, Stanley S. Scott Cancer Center, Louisiana State University
`Health Sciences Center
`Co-Director, Louisiana Cancer Research Consortium (comprised of both
`Louisiana State University Health Sciences Center in New Orleans and
`Tulane Health Sciences Center, New Orleans, LA)
`Director, Clinical Trials Unit, Lank Center for Genitourinary Oncology,
`Dana Farber Cancer Institute
`Medical Director, Tulane Cancer Center
`Board Member, Louisiana Cancer Research Consortium
`
`2006-2007
`
`2010-
`2013-
`
`Major Committee Assignments:
`1993-1998
`Genitourinary Cancer Committee, Member, Southwestern Oncology
`Group
`Institutional Review Board, Member, Louisiana State University School
`of Medicine
`
`1995-1998
`
`2
`
`
`
`1996-1998
`
`1997-1998
`
`1998-2006
`
`1999-2002
`
`2000-2002
`
`2001-2005
`
`2003-2009
`
`2003-2005
`
`2003-2006
`2003-2006
`
`2003-2006
`
`2005-2006
`
`2006-
`
`2006-
`
`2008-
`
`2008-2010
`2009-
`2010-
`2010-
`2012-
`
`2013
`
`2013-
`
`2013-
`2013-
`2014-
`2014-
`
`Medical School Admissions Committee, Member, Louisiana State
`University School of Medicine
`Institutional Review Board, Chairman, Louisiana State University School
`of Medicine
`Louisiana Cancer and Lung Trust Fund Board, Member, (Board
`Appointed by the Governor of Louisiana)
`Promotion and Tenure Committee, Member, Department of Medicine,
`Louisiana State University Health Sciences Center
`Promotion and Tenure Committee, Chairman, Department of Medicine,
`Louisiana State University Health Sciences Center
`Clinical Faculty Advisory Committee to the LSU Health Care Network,
`member, Louisiana State University Health Sciences Center
`The Comprehensive Multicenter Prostate Adenocarcinoma Registry
`(COMPARE), Co-Chairman, sponsored by sanofi-aventis.
`Louisiana Cancer and Lung Trust Fund Board, Chairman, 2004 (Board
`Appointed by the Governor of Louisiana)
`Executive Committee, Member, Louisiana Cancer Control Partnership
`Finance Committee, Member, LSU Health Care Network (organization
`responsible for overall billing and collections at the LSU Medical School,
`New Orleans)
`Contracts Committee, Member, LSU Health Care Network (responsible
`for insurance/managed care contracting at the LSU Medical School, New
`Orleans)
`Investment Strategic Planning Committee, ad hoc Member, LSU Health
`Sciences Center Foundation (LSU endowment investments)
`Medical Oncology, Co-Chairman, Genitourinary Cancer Committee,
`Radiation Therapy Oncology Group (RTOG), Now NRG
`Medical Oncology Committee, Radiation Therapy Oncology Group
`(RTOG), Now NRG
`Louisiana Cancer and Lung Trust Fund Board, (Board Appointed by the
`Governor of Louisiana)
`Institutional Review Board member, Tulane Medical School
`LCRC TURC (Tissue Utilization Research Committee) Committee
`Tulane Cancer Center Executive Committee
`Chairman, Tulane Cancer Center Strategic Planning Committee
`Promotion and Honors Committee, Tulane Medical School (handles both
`promotion and tenure decisions School Wide)
`FDA Public Workshop Panelist: Clinical Trial Design Issues - Drug &
`Device Development for Localized Prostate Cancer
`MEDCAC (Medicare Evidence Development & Coverage Advisory
`Committee) Panel Member (health and Human Services)
`Chairman, Commission on Cancer Committee at Tulane
`LCRC (Louisiana Cancer Research Consortium) Board of Directors
`Ad hoc advisor to the FDA on prostate cancer matters
`Ad hoc Consultant to Botswana Government on National Cancer Plan
`
`3
`
`
`
`Teaching leadership:
`1990-1993
`
`1990-1993
`
`1993-1998
`
`1993-1998
`
`1998-2005
`
`1998-2005
`
`2006-2007
`
`2006-2007
`
`2008-
`
`Medical Oncology Attending, National Cancer Institute, Bethesda, MD,
`inpatient oncology service ~2 months/year (fellows)
`Medical Oncology Attending, National Cancer Institute, Bethesda, MD,
`outpatient oncology clinics, 12 months/year (fellows)
`Medical Oncology Attending, LSU Medical School and VA Medical
`Center, Shreveport, LA,
`inpatient oncology service ~2 months/year
`(fellows, residents, students)
`Medical Oncology Attending, outpatient oncology attending, LSU
`Medical School and VA Medical Center, Shreveport, LA, outpatient
`oncology service, 12 months/year (fellows, residents a portion of the
`time)
`Medical Oncology Attending, LSU Medical School, New Orleans, LA,
`inpatient oncology service ~2 months/year (fellows, residents, students)
`Medical Oncology Attending, outpatient oncology attending, LSU
`Medical School, New Orleans, LA, outpatient oncology service, 12
`months/year (fellows, residents a portion of the time)
`Medical Oncology Attending, Solid Tumor Service, Brigham & Women's
`Hospital, Boston, MA, 4-6 weeks/year (residents)
`Medical Oncology Attending, outpatient GU oncology clinics, Dana-
`Farber Cancer Institute, Boston, MA, 12 months/year (fellows, a portion
`of the time)
`Tulane Cancer Center Attending, Inpatient and outpatient services
`
`2000-2004
`2000-2006
`2004-2006
`
`Scientific Advisory Boards:
`1999-
`Center for Prostate Disease Research-Walter Reed Hospital & US
`Department of Defense, Washington, DC
`Atrix Laboratories, Ft. Collins, CO
`Metastatin Pharmaceuticals, Washington, DC
`Patient Advocates Against Advanced Cancer (PAACT),
`Grand Rapids, MI
`Theralogix, Rockville, MD
`Prostate Cancer Prevention Trial P01
`Bellicum
`Mt. Sinai Tisch Cancer Center External Scientific Advisory Board
`Biscayne Pharmaceuticals
`AJCC staging committee (8th edition) for male genital expert panel
`
`2004-2011
`2006-2011
`2010-
`2012-
`2013-
`2014-
`
`Miscellaneous ad hoc Advisory Boards and Consultant Agreements:
`1993
`Henri-Beaufour Institute (France)
`1993-1995
`Immunex (USA)
`1995
`DuPont (USA)
`1996
`Schering (USA)
`1996-2008
`Cytogen (USA)
`1996
`Debiopharm (Swiss)
`1996
`Janssen (USA)
`1996-1998
`Berlex (German)
`2003-2009
`GPC Biotech (German)
`
`4
`
`
`
`2003-2004
`2003-2005
`2004-2007
`2004-2005
`2004-
`2004-
`2005
`2005
`2005
`2005-2006
`2006-2007
`2006
`2006-2007
`2006
`2006-2010
`2006
`2007
`2007-
`2007-2008
`2007-
`2007
`2007-
`2008
`2008-
`2009
`2009-2012
`2009-2011
`2009-2011
`2009-
`2009-2011
`2009-
`2010
`2010-
`2011-
`2010-2011
`2011-
`
`Atrix Laboratories (USA)
`Bracco (Italy)
`Negma-Lerads (France)
`Abbott (USA)
`sanofi (France)
`Dendreon
`Novacea (USA)
`Astella (Japan)
`Novartis (Swiss)
`Spectrum Pharmaceuticals (USA)
`QLT, Inc. (Canada)
`Roche (Swiss)
`Sermo (USA)
`TEVA (Israel)
`GlaxoSmithKline (UK)
`General Electric (USA)
`Cleveland Biolabs (USA)
`Pfizer (USA)
`Ausio Pharmaceuticals, LLC (USA)
`OncoGenex (Canada)
`Bind Biosciences (USA)
`Algeta (Norway)
`EUSA (USA)
`Tolmar (Argentina)
`Ascenta (USA)
`Takeda (Japan)
`Celgene
`BMS
`Medivation
`Amgen
`Bellicum
`ExonHit
`Exelixis
`Bayer
`Centocor (JNJ)
`List truncated as it became too numerous to detail
`
`2007-2009
`2006-2012
`2008-2010
`
`Independent Data Safety and Monitoring Committees:
`2004-2009
`Chairman, IDMC, Dendreon, Provenge Vaccine Trial 9902B phase III
`IMPACT study
`Chairman, Dendreon, Provenge Vaccine Trial PO-7 Study
`IDMC (sole member), OncoGenex, OGX-427-01 Trial
`Chairman, IDMC, Pfizer, A6181120 (Phase III study in hormone-
`refractory prostate cancer with sunitinib/prednisone versus prednisone
`IDMC, Pfizer, A4061032 (Phase III Trial of axitinib in metastatic renal
`cancer). Chairman, 2010-
`
`2008-2013
`
`5
`
`
`
`2009-2012
`
`2009-2011
`
`2010-2014
`2010-2012
`2011-
`
`2011-2015
`2012-
`2013-
`2014-
`2014-
`2015-
`
`IDMC member, Celgene, Phase III MAINSAIL Study (Evaluation of
`efficacy and safety of docetaxel and prednisone with or without
`lenalidomide in subjects with castrate-resistant prostate cancer)
`Chairman, IDMC, Medivation, Affirm Phase III trial in castrate-
`refractory Prostate Cancer with MDV3100 versus Placebo
`Chairman, IDMC, OncoGenex/TEVA, OGX-011 and Docetaxel Trial
`Chairman, IDMC, Medivation Affirm Trial in Prostate Cancer
`Chairman, IDMC, Bavarian-Nordic, PROSTVAC-VF TRICOM Phase III
`trial
`Chairman, IDMC, Astellas, trial, Phase II randomized TERRAIN
`Chairman, IDMC, OncoGenex/TEVA. OGX-011 and Cabazitaxel Trial
`Chairman, IDMC, Aragon/JNJ phase III trial ARN-509-003
`Chairman, IDMC, Medivation phase III trial enzalutamide (PROSPER)
`Chairman, IDMC, TOPARP (Royal Marsden), phase II with olaparib
`Chairman, IDMC, Tokai phase III trial with galeterone
`
`Special NCI Service:
`2005 and 2008
`
`2014-
`
`Site Reviewer/Advisor: National Cancer Institute (NCI) Intramural
`Medical Oncology Prostate Cancer Program
`National Cancer Institute (NCI) Board of Scientific Counselors, Clinical
`Sciences and Epidemiology
`
`1998-2006, 2008
`1999
`
`2001
`
`2002
`
`2002
`
`Community Service Related to Professional Work:
`1998, 2002-2005
`Executive Committee, “Key to the Cure” Fundraiser, Saks Fifth Avenue,
`New Orleans, LA
`Komen Foundation, New Orleans Chapter, Board of Directors
`Louisiana Legislative Act 1357: Provides for health insurance coverage
`of certain cancer patients participating in federally sponsored clinical
`trials. Worked with Rep. Clarkson and testified for Legislative
`Committees, co-wrote legislation
`Louisiana Legislative Act 1116: Access to Mammography Act. Worked
`with Rep. Clarkson and testified for Legislative Committees, co-wrote
`legislation
`Louisiana Legislative Act 41 (2002 Special Session): Louisiana Cancer
`Research Consortium. Co-wrote legislation: Worked with Senate
`President, John Hainkel and Representative Mitch Landrieu; testified for
`various Legislative Committees.
`Louisiana Legislative Act 19: Tobacco Tax: Increased tax on cigarettes:
`Funds from three cents per pack of each cigarette sold in the state
`directed to support the Louisiana Cancer Research Consortium. Worked
`with Senate President, John Hainkel and Representative Mitch Landrieu;
`testified for various Legislative Committees and co-wrote legislation with
`Dr. Roy Weiner of Tulane.
`Operations Co-Chair, Hope Lodge New Orleans, American Cancer
`Society Project
`Advisory Board to the Honorary Consul from Louisiana to Canada
`PER Continuing Medical Education Advisory Board, Dallas, TX
`Medical Advisory Committee, Massachusetts Prostate Cancer Coalition
`
`2004-2006
`
`2005-2008
`2005-
`2006-2008
`
`6
`
`
`
`2008-2011
`2011-
`2014-
`
`Komen Foundation, New Orleans, Board Member
`Tulane CME Advisory Committee
`Audubon Board, State of Louisiana
`
`Professional Societies:
`~1987-
`~1990-2010
`~1994-
`~1998-
`~2002-2010
`
`Editorial Boards:
`1999-2001
`2002-2009
`2002-
`
`2003-2006
`2011-
`2011-
`2012-
`2012-
`
`Editor-in-Chief:
`1997-1999
`2002-2005
`
`2003-2004
`2006-
`
`Reviewer:
`~1993-
`~1995-
`~1998-
`~1998-
`~1999-
`~2000-
`~2004-
`2006-
`2006-
`2007-
`2008-
`2008-
`2008
`2009-
`2009-
`
`American Society for Clinical Oncology
`American Association for Cancer Research
`American Urological Association
`Society of Urologic Oncology
`Society of Basic Urological Research
`
`The Prostate Journal
`Clinical Prostate Cancer/Clinical Genitourinary Oncology
`CURE (Periodical for cancer patients: CURE has won multiple awards
`including Top 10 magazine launches in the USA, 2002; silver and gold
`Eddies Award for editorial excellence for consumer health magazine
`category, circulation between 250,000-500,000) .
`Urology
`Asian Journal of Andrology
`Journal of the Louisiana State Medical Society
`Personalized Medicine in Oncology (PMO)
`International Journal of Targeted Therapies (IJTT)
`
`Advances in Prostate Cancer, PER Publications, Dallas, TX (CME)
`Clinical Prostate Cancer (peer-reviewed, MEDLINE listed). Note: name
`change in 2006 to Clinical Genitourinary Cancer.
`New Urology (CME)
`Clinical Genitourinary Cancer (Co-Chief Editor, peer-reviewed and
`MEDLINE listed)
`
`Journal of the National Cancer Institute
`Journal of Clinical Oncology
`Journal of Urology
`Urology
`The Prostate
`Cancer
`International Journal of Cancer
`Asian Journal of Andrology
`Clinical Cancer Research
`New England Journal of Medicine
`Cancer Investigation
`British Journal of Urology International
`Molecular Cancer Therapeutics
`Lancet Oncology
`Prostate Cancer and Prostatic Disease
`
`7
`
`
`
`2013-
`2013-
`2014-
`
`Journal of Clinical investigation
`The Oncologist
`Clinical Cancer Research
`
`1998-
`
`2006-2013
`
`National Study Sections: (CDC, NIH, DOD)
`1996-1998
`Centers for Disease Control, Chronic Disease Program, member
`1998-2004
`Department of Defense-Prostate Cancer Study Section in
`Epidemiology/Behavioral Sciences, member
`Ad hoc member of various PO1s, P20s, U54s, U56s, and P30s study
`sections. Reviewer of NCI designated cancer center grants-P30s at Fred
`Hutchinson-University of Washington, Seattle, WA and University of
`Pennsylvania, Philadelphia, PA
`Prostate Cancer Integration Panel, US Department of Defense (DOD):
`Oversees all peer-reviewed DOD funding for prostate cancer research in
`the United States
`Elected to Executive Committee of the Prostate Cancer Integration Panel,
`US Department of Defense (DOD)
`Chairman for 2008-2009, Prostate Cancer Integration Panel, US
`Department of Defense (DOD)
`Reviewer, Prostate Cancer Foundation
`
`2006-2010
`
`2008-2009
`
`2010-
`
`Awards and Honors:
`1981
`
`1982
`1982
`
`1982
`
`1985
`
`1985
`
`2002-2005
`2004
`2005-
`2008-
`
`Alpha Omega Alpha (Springtime selectee and President of Tulane AOA
`Chapter)
`New Orleans Pediatric Society Award for outstanding ability in Pediatrics
`Hymen S. Mayerson Award for exceptional academic and/or research
`achievement in physiology as a medical student
`C.V. Mosby Book Award for outstanding scholarship as a medical
`student
`Outstanding teaching resident, Department of Medicine, Tulane Medical
`School
`First place prize for scientific presentation at the La. Chapter of the
`American College of Physicians
`New Orleans "Best Doctors", by local New Orleans magazine
`Spirit Award Recipient, American Cancer Society, New Orleans, LA
`Best Doctors in America
`New Orleans “Best Doctors”, by local New Orleans magazine
`
`PART II: Research, Teaching, and Clinical Contributions
`
`A. Narrative Report
`In 1998 I was appointed as the Patricia Powers Strong Professor of Oncology, Chief of
`Hematology-Oncology, and Director of the Stanley S. Scott Cancer Center at Louisiana State
`University (LSU) Health Sciences Center in New Orleans. As a consequence of these positions and
`their attached responsibilities, I had broad purview over the development and coordination of basic,
`clinical, and epidemiologic cancer research at the largest Health Sciences Center in the State of
`Louisiana. From 1998-2005, the Stanley S. Scott Cancer Center grew considerably by every metric
`(grants/philanthropy/clinical). Growth was a consequence of increased resources that enabled
`8
`
`
`
`investments in both faculty recruitment and equipment. These resources (approximately $10 million
`per year net to LSU) were primarily derived from 1) The Tobacco Settlement Funds from the
`Attorneys General settlement against tobacco companies and 2) A new state-wide Tobacco Tax
`dedicated to the establishment of the Louisiana Cancer Research Consortium (a legislatively
`established collaborative effort between the LSU and Tulane Health Sciences Centers). The tobacco
`tax and the collaborative effort between LSU and Tulane were the result of an intense and
`successful lobbying effort that Roy Weiner (Tulane) and I helped to lead in 2002. Full credit for
`these efforts must be given to the (now deceased) Senate President John Hainkel, Representative
`Mitch Landrieu, and Tulane Cancer Center Director Roy Weiner who were also critical leaders of
`this process.
`
`Management of the aforementioned activities had essentially been a full time job, however I
`continued to see patients in the clinic, teach, attend in the hospital, and focus my research efforts
`predominantly on clinical and translational aspects of advanced prostate cancer. Over the past
`several years, as a consequence of collaborative arrangements, I have been a principal investigator
`or co-principal investigator (and author on the peer-reviewed manuscripts) on five pivotal multi-
`institutional trials that have lead to FDA approvals. This includes samarium-153 lexidronam
`(Quadramet), two formulations of leuprolide acetate (30 mg and 45 mg Eligard), cabazitaxel
`(Jevtana), and radium-223 (Xofigo).
`
`I have chaired and continue to chair and participate in various independent data monitoring
`committees (IDMC). These are critical aspects of large clinical trials. Four of the pivotal trials have
`lead to FDA approvals including sipuleucel-T, axitinib, and enzalutamide (twice).
`
`Direct teaching and mentoring of hematology-oncology fellows, medical residents, and medical
`students at LSU, Harvard, and Tulane have also occurred on a regular basis.
`
`As part of the Cancer Center’s outreach programs in Louisiana, I was instrumental in establishing,
`promoting, and funding both community- and hospital-based educational programs promoting early
`detection of cancer. These programs have particularly targeted low income and minority
`populations in the state of Louisiana. Federal, Foundation, and State Legislative grants were
`obtained for the establishment of cancer-focused early detection programs, not only in New
`Orleans, bit also throughout the state. As Chairman of the Governor-appointed Louisiana Cancer
`and Lung Trust Fund Board, I was instrumental in establishing and funding new state-wide
`collaborations between CDC funded programs, Komen Foundation funded programs, and multiple
`practice sites.
`
`I returned to New Orleans after serving at the Dana-Farber/Harvard Cancer Center from March,
`2006-November, 2007. At Dana-Farber I served as head of the clinical trials group in the Lank
`Genitourinary Oncology Program. I also served as co-Chair of the Registry in PSA Rising after
`Local Therapy in Prostate Cancer (COMPARE Registry). I have served as co-PI (with Dr. Mathew
`Freedman) on a project in the Harvard SPORE submission in prostate cancer (Kantoff-PI). This was
`favorably scored and funding occurred but because of the change in location to Tulane, I have
`relinquished this grant to a Harvard investigator. I am an International Co-PI on the FIRSTANA
`phase III trial with cabazitaxel and doectaxel and a number of other trials as well that are in process
`or about to begin.
`
`9
`
`
`
`I serve as the Medical Oncology Co-Chairman of the GU Committee of RTOG (now NRG). I serve
`as national co-PI on RTOG 0521, RTOG 0622, and also on RTOG trial 0621.
`
`1993-1998
`
`B. Selected Funding Information
`1993-1994
`NIH contract
`Serum Sample and Patient Demographic Data on Elderly
`Males Without Prostate Cancer
`Site-PI
`Parke-Davis
`Study of Suramin vs. Placebo in Patients with Metastatic Hormone
`Refractory Disease
`Louisiana Cancer & Lung Trust Fund
`A Pilot Study for the Early Detection of Prostate
`in African Americans with a Familial Risk of the Disease
`Louisiana Cancer & Lung Trust Fund
`Developing Prevention Programs for African American Men
`Site-PI
`Matrix
`A Pilot Study to Evaluate the Histologic Response to CDDF-e Therapeutic
`Implant (MPI 5010) Administered Prior to Radical Prostatectomy in Patients
`with Stage A, B, or C Prostatic Carcinoma
`PI
`CDC-Demonstration Project
`Developing Prostate Cancer Early Detection Demonstration Program
`SWOG
`Site-PI
`Prostate Cancer Prevention Trial
`Site-PI
`Cytogen
`Study of Intravenously Administered 111In-Capromab Pendetide in the
`Evaluation of Patients with Prostate Cancer
`Site-PI
`Cytogen
`Open-Label Study of Intravenously Administered 153Sm-EDTMP (CYT-424)
`for the Treatment of Patients with Bone Pain- Secondary Metastatic
`Carcinoma
`Site PI
`Schering-Plough
`Comparative Study of the Clinical Efficacy of Two Dosing Regimens of
`EULEXIN
`Site-PI
`Janssen
`A Phase III Trial to compare the efficacy and the tolerability of Liarozole
`Versus prednisone in Patients with Relapsed Hormone-Resistant Prostate
`Cancer
`Site-PI
`Zeneca
`A Randomized Double-Blind Comparative Trial of Bicalutamide versus
`Placebo in Patients with Early Prostate Cancer
`Site-PI
`Janssen & Kyowa
`Protocol for a Phase II Study of KW2189 for the Treatment of Advanced
`Renal Cell carcinoma
`Ligand Pharmaceuticals
`A Multicenter Phase 2 Evaluation of a Combination Therapy of
`TARGRETIN oral capsules (LGD1069) and INTRON A (Interferon-alfa-2b)
`in Patients with Advanced Renal Cell Carcinoma
`Site-PI
`Cytogen
`Phase II Study of Ascending Multiple Dose 153Sm-lexidronam (Quadramet)
`in Combination with Total Androgen Blockade for the Treatment of Patients
`with Stage D2 Prostate Carcinoma
`
`PI
`
`PI
`
`PI
`
`Site-PI
`
`10
`
`1994-1995
`
`1995-1996
`
`1995-1996
`
`1995-1997
`
`1995-1998
`
`1995-1998
`
`1995-1998
`
`1995-1998
`
`1996-1998
`
`1996-1998
`
`1996-1998
`
`1996-1998
`
`1996-1998
`
`
`
`1997-1998
`
`1997-1998
`
`1997-1998
`
`1998-2002
`
`1998-2000
`
`2000-2002
`
`2000-2003
`
`2000-2004
`
`2001-2004
`
`2002-2006
`
`2002-2006
`
`2002-2005
`
`2003-2006
`2003-2006
`
`2004-2006
`
`2004-2006
`
`2004-2006
`
`2008-
`
`2007-2009
`
`2007-2008
`
`2008-
`
`2008-
`
`2009-
`
`2009-
`
`2010-
`2015-
`
`PI
`
`Site-PI
`
`PI
`
`Co-PI
`
`Site-PI
`
`Site-PI
`
`Site PI
`CaPCURE Foundation Award
`Clinical Utility of Determining the Androgen Receptor Polymorphism.
`Lilly
`Site-PI
`Phase I Clinical and Pharmacological Evaluation of Escalating Doses of
`LY320236 Administered in Patients with Metastatic Prostate Cancer
`Abbott
`Site-PI
`A Phase II, Double-Blind Comparison of the Safety and Efficacy of ABT-
`627 versus Placebo in Subjects with Symptomatic Hormone Refractory
`Prostate Cancer
`NCI/ P20
`Cancer Center Planning Grant
`Pharmacia & Upjohn
`Estramustine Phosphate in Advanced Prostate Cancer
`Baptist Community Ministries/Daughters of Charity
`Partners in Health: The Breast and Cervical Health Cooperative
`ASPH/CDC
`Geographic Information Systems and Prostate Cancer
`Atrix
`LA-2575 for hormonally Sensitive Prostate Cancer
`Site-PI
`Medarex
`MDX-010 With and Without Docetaxel in Hormone-Refractory Prostate
`Cancer
`GPC-Biotech
`JM-216 in Hormone Refractory Prostate Cancer
`PI
`HRSA
`Design and Construction of a Cancer Prevention and Research Facility
`Atrix
`Site-PI
`LA-2580 in Hormonally Sensitive Prostate Cancer
`Louisiana Cancer Research Consortium
`Department of Energy
`Funding for Cancer Control Personnel
`GlaxoSmithKline
`Dutasteride in Recurrent Prostate Cancer
`sanofi
`COMPARE – Registry for Recurrent Prostate Cancer
`CDC
`Cancer Prevention and Control in High Risk Families
`GlaxoSmithKline (GSK)
`TARP randomized clinical trial
`Sanofi
`TROPIC randomized clinical trial (XRP-6258)
`Prostate SPORE project 2 co-PI
`Genetic and Clinical characterization of the 8q24 risk locus
`Cougar Biotechnology
`Randomized Abiraterone post-docetaxel (Cougar 301)
`AstraZeneca
`ENTHUSE study (ZD4054 versus placebo in M0 prostatate)
`Cougar Biotechnology
`Randomized Abiraterone pre-docetaxel (Cougar 302)
`Site PI
`Algeta
`ALSYMPCA (Alpharadin randomized study in prostate cancer)
`Many trials and some grants have not been listed simply due to volume.
`current NIH funding in which I am a sub-investigator or co-PI.
`
`Co-PI
`PI
`
`Site-PI
`
`Site-PI
`
`Site PI
`
`Site PI
`
`Site PI
`
`co-PI
`
`Site-PI
`
`Site-PI
`
`Site-PI
`
`11
`
`
`
`5U10CA021661-32 (Curran)
`
`01/06-date
`0.12 calendar
`
`NIH/ American College of Radiology
`Major goal: To formulate, design, monitor, and have input in all Radiation Therapy Oncology
`Group (RTOG, now NRG) trials that use a drug in addition to radiation (for trials involving
`prostate, bladder, and renal cancer).
`
`1 R01 CA188609-01 (Dong)
`
`09/01/14-8/31/19
`0.6 calendar
`
`NIH/NHLBI
`$207,500
`An inevitable mechanism of resistance to androgen-directed therapy.
`Major goal: To determine the mechanism by which androgen-directed therapies increase the
`expression of androgen receptor splice variants and the mechanism by which androgen receptor
`splice variants regulate target-gene expression.
`
`1UH 2TR000928-01 (Abdel-Mageed)
`
`08/01/13-7/31/18
`0.3 calendar
`
`NIH/NCATS
`$500,000
`Targeting Tumor-Derived exRNA-Containing Microvesicles by High Throughput Screening.
`Major goal: To screen human approved drugs (~4,000) to identify lead compounds that inhibit
`biogenesis and release of exosomes by tumor cells and uptake by stem cells procured from
`prostate cancer patients. The ultimate goal is to circumvent clonal expansion of tumors at
`primary and metastatic sites in patients with advanced disease.
`
`C. Report of Clinical Activities
`In terms of clinical services, for the past 22 years I attended on the inpatient oncology services,
`typically 2-3 months per year. These attending services have occurred in the context of teams
`that included fellows alone (at the NCI), or a combination of medical students, house officers,
`and fellows for oncology services at Louisiana State University affiliated hospitals. In addition,
`I have regularly had oncology fellows participate in my clinics. At the NCI, I supervised the
`fellows in the prostate cancer clinic from 1990-1993 and this clinic consistently had
`approximately 8 fellows per clinic. At LSU, the clinics were configured differently and fellows
`electively rotated through my clinic focusing on genitourinary oncology. Each year several
`fellows would rotate through for a total of 3-6 fellows per year while on the faculty at LSU and
`at Tulane this is an option as well. I never ceased seeing patients and attending on the inpatient
`services despite numerous administrative responsibilities. While in Boston, I was integrated into
`the teaching and attending rotations at Dana Farber Cancer Institute and the Brigham and
`Women's hospital both in the attending and conference schedules. At Tulane, I am rotating on
`the general oncology service approximately two months per year and attending in clinics twice
`weekly.
`
`1. Description of clinical practice
`
`My current clinical practice has been based at Tulane Cancer Center and the Tulane urology
`multi-disciplinary clinic. I focus on urologic malignancies and have nearly 90% of my patients
`12
`
`
`
`with prostate cancer. I am now involved with a wide variety of protocols covering both
`translational issues and advanced treatments. I see about 50 patients per week with urological
`malignancies in clinic using a nurse practitioner, junior faculty, and a physician assistant.
`
`2. Patient Load
`
`I see 25-50 patients per week with urologic malignancies, about 3-5 new patients per week.
`Currently about 1000 patients, mostly prostate cancer, are under my care.
`
`3. Clinical Contributions
`
`My clinical contributions are documented within the overall context of my publications.
`Particularly noteworthy in my mind is having been a lead author on two studies that have been
`pivotal in terms of FDA approvals for new drug applications (NDAs). These studies included a
`new radio-isotopic treatment for bone metastases in prostate cancer (Quadramet), as well as a
`new formulation for hormonal treatment of prostate cancer (4 month Eligard). I was co-PI on
`the TROPIC trial which was positive for survival and lead to an FDA approval. I've been
`involved in a wide variety of clinical and translational investigations over the last 22 years, as
`detailed within my publications and abstracts. At this time I am a national PI or Co-PI on 4
`separate prostate cancer studies.
`
`4. Other relevant information about clinical role
`
`I have been recognized with several clinical awards while in Boston and New Orleans for my
`patient care including the Spirit Award by the American Cancer Society and named to "Best
`Doctors" by various publications. In 2005-2014, I was named as one the "Best Doctors in
`America" by Best Doctors, Inc. This is based upon a peer survey (according to that
`organization).
`
`Invited Lectures and various presentations
`
`Over the past 25 years I have given literally hundreds of invited lectures and presentations at
`meetings. To list them would be impossibly long.
`
`I have kept a catalog of the countries in which I have lectured. These countries include at least 27
`(that I can remember): Canada, USA, Mexico, Honduras, Costa Rica, Panama, Colombia, Brazil,
`United Kingdom, France, Italy, Spain, Portugal, Switzerland, Germany, Austria, The Netherlands,
`Norway, Sweden, Finland, South Africa, Botswana, Singapore, Malaysia, Japan, South Korea, and
`Australia.
`
`The ASCO (American Society of Clinical Oncology) and ASCO Genitourinary Cancers, AUA
`(American Urological Association), ESMO (European Society of Medical Oncology), the Prostate
`Cancer Foundation, and EAU (European Association of Urology) meetings are regularly attended. I
`have given hundreds of presentations at these meetings.
`
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`Publications:
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`18.
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`Spirtes MA, Gerber AR, Wood KS, Sartor AO, and Christenson CW. The effect of MIF-I on in
`vitro cGMP production in a particulate rat brain fraction. Neuropharmacology 1980; 19:687-89
`Spirtes MA, Woods KS, Sartor AO, Gerber AR, and Wheeler WF. The in vitro effects of L-
`Prolyl L-Leucyl glycinamide (MIF-I) on the guanylate cyclase system of a rat brain
`mitochondrial fraction. Neuropeptides 1981; 1:391-400
`Sartor O and Bowers CY. Hypothalamic hypophysiotropic hormones: Generalizations,
`concepts, and mechanisms. Rational Drug Therapy 1983; 17(7):1-6.
`Sartor O, Bowers CY, and Chang D. Parallel studies of His-D-Trp-Ala-Trp-D-Phe-Lys-NH2
`and hpGRF-44-NH2 in rat primary pituitary cell monolayer culture. Endocrinology 1985;
`116:952-57
`Sartor O, Bowers CY, Reynolds GA, and Momany FA. Variables determining the GH response
`of His-D-Trp-Ala-Trp-D-Phe-Lys-NH2 in the rat. Endocrinology 1985: 117:1441-47
`Sartor O and Sander GE. Unusual variant of eosinophilic fascitis. Southern Med J 1985;
`78:1387-89
`Sartor O and Anday E. Campylobacter jejuni enteritis in a premature neonate. Southern Med J
`1987; 80:1593-94
`Lebacq-Verheyden AM, Krystal G, Sartor O, Way J, and Battey JF. The rat prepro-gastrin
`releasing peptide gene is transcribed from two initiation sites in the brain. Mol Endocrinol 1988;
`2:556-63
`Battey JF, Lebacq-Verheyden AM, Krystal G, Markowitz S, Sartor O, and Way J. Expression,
`regulation, and post-translational processing of the human prepro-gastrin releasing peptid