`
`PART I: General Information
`
`DATE PREPARED:
`
`June 1, 2016
`
`Name:
`
`A. Oliver Sartor, M.D
`
`Home Address:
`
`1511 Dufossat Street, New Orleans, LA 70115
`
`E-Mail and Cell:
`
`osartor@tulane.edu and 504-355-7970
`
`Citations:
`
`h-index= 53 (per Google Scholar)
`13,215 citations
`
`Education:
`1977 B.A.
`1982 M.D.
`
`Postdoctoral Training:
`1982-1983
`
`1983-1984
`1984-1986
`1986-1989
` 1989-1990
`
`Colorado College, Colorado Springs, CO
`Tulane University School of Medicine, New Orleans, LA
`
`Intern in Pediatrics, University of Pennsylvania Pediatrics Program,
`Children’s Hospital of Philadelphia, Philadelphia, PA
`Intern in Medicine, Tulane University School of Medicine
`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
`
`1993-1998
`
`1998-2006
`
`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
`Patricia Powers Strong Professor of Oncology (with tenure), Louisiana
`State University School of Medicine, New Orleans, LA
`Associate Professor of Medicine, Dana-Farber Cancer Institute, Harvard
`Medical School, Boston, MA
`Piltz Professor for Cancer Research and Professor of Medicine and
`Urology (with tenure), Tulane Medical School, New Orleans, LA
`C.E. and Bernadine Laborde Professor for Cancer Research
`Professor of Medicine and Urology (with tenure), Medical Director,
`Tulane Cancer Center, Tulane University School of Medicine, New
`Orleans, LA
`
`2006-2007
`
`2008-2010
`
`2010-
`
`Licensure and Certification:
`1985-
`Louisiana Medical Licensure
`1986-lifetime
`American Board of Internal Medicine Certificate
`
`1
`
`AVENTIS EXHIBIT 2180
`Mylan v. Aventis IPR2016-00712
`
`
`
`American Board of Internal Medicine, Medical Oncology Certificate
`Maryland Medical Licensures
`Virginia Medical Licensures
`Massachusetts Medical Licensure
`
`1989-lifetime
`1986-1993
`1988-1990
` 2006-2008
`
`Hospital Appointments:
`1990-1993
`Attending Physician, NIH Clinical Center, Bethesda, MD
`1993-1998
`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
`
`1993-1998
`1998-2006
`
`1998-2006
`2006-2007
`2006-2007
`2008-
`
`Hospital and Health Care Organization Service Responsibilities:
` 1998-2006
`Head, LSU Oncology Services, Medical Center Louisiana, New Orleans
` 2010-
`Medical Director, Tulane Cancer Center, Tulane University Hospital and
`Clinics, New Orleans, LA
`
`1998-2006
`
`2002-2006
`
`2006-2007
`
`
`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
`
`
`
`2010-
`2013-
`
`Selected Committees and Assignments:
`1993-1998
`Genitourinary Cancer Committee, Member, Southwestern Oncology
`Group
`Institutional Review Board, Member, Louisiana State University School
`of Medicine
`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
`
`1995-1998
`
`1996-1998
`
`1997-1998
`
`1998-2006
`
`1999-2002
`
`
`
`2
`
`
`
`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-
`2013-
`2014-
`2014
`
`Teaching Assignments:
`1990-1993
`
`1990-1993
`
`1993-1998
`
`
`
`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
`LCRC (Louisiana Cancer Research Consortium) Finance Committee
`Ad hoc advisor to the FDA on prostate cancer matters
`Ad hoc Consultant to Botswana Government on National Cancer Plan
`
`
`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)
`
`3
`
`
`
`1993-1998
`
`1998-2005
`
`1998-2005
`
`2006-2007
`
` 2006-2007
`
` 2008-
`
`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 (students, 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
`(students, residents, fellows)
`
`
`Selected 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
`University of South Alabama, Cancer Center External Advisory Board
`
`
`
`
`
` 2000-2004
` 2000-2006
` 2004-2006
`
` 2004-2011
` 2006-2011
` 2010-
` 2012-
` 2013-
` 2014-
` 2015-
`
`Selected Advisory 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)
` 1996-1997
`Janssen (USA)
` 1996-1998
`Berlex (German)
` 2003-2009
`GPC Biotech (German)
` 2003-2004
`Atrix Laboratories (USA)
` 2003-2005
`Bracco (Italy)
` 2004-2007
`Negma-Lerads (France)
` 2004-2005
`Abbott (USA)
`Sanofi (France)
` 2004-
` 2004-
`Dendreon
`
`
`
`
`
`
`
`
`
`
`
`4
`
`
`
`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)
`Janssen
`Bavarian-Nordic
`OncoCell MDX
`Cellectar
`Active Biotech
`Imaginab
`Progenics
`AstraZeneca
`
`
`
` 2005
` 2005
` 2005
` 2005-2006
` 2006-2007
` 2006
` 2006-2007
` 2006-2013
` 2006-2010
` 2006
` 2007
` 2007-2012
` 2007-2008
` 2007-
` 2007
` 2007-2013
` 2008
` 2008-2014
` 2009
` 2009-2012
` 2009-2011
` 2009-2011
` 2009-
` 2009-2011
` 2009-
` 2010
` 2010-2013
` 2010-
` 2010-2011
` 2011-
` 2011-
` 2013
` 2014
` 2014
` 2015-
` 2015-
` 2015-
`
`
`Independent Data Safety and Monitoring Committee Assignments:
`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, 2010-2013
`
`2007-2009
`2006-2012
`2008-2010
`
`2008-2013
`
`
`
`5
`
`
`
`2009-2012
`
`2009-2011
`
`2010-2014
`2010-2012
`2011-
`
`2011-2015
`2012-2014
`
`2013-
`2013-
`2014-
`2014-
`2015-
`2015-
`
`Special NCI Service:
`2005 and 2008
`
`2014-
`
`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 Docetaxel Phase III
`Trial.
`Chairman, IDMC, OncoGenex OGX-011 and Cabazitaxel Phase III 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/enzalutamide
`Chairman, IDMC, AstraZeneca Danube phase III trial with MEDI4736
`
`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
`
`
`Community Activities and Services 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
`
` 2002
`
`2004-2006
`
`
`
`6
`
`
`
`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
`Komen Foundation, New Orleans, Board Member
`Tulane CME Advisory Committee
`Audubon Board, State of Louisiana
`
`
`
`
`
`2005-2008
`2005-2013
`2006-2008
`2008-2011
`2011-
`2014-
`
`Selected Professional Societies:
` ~1988-
`American Society for Clinical Oncology
` ~1990-2010
`American Association for Cancer Research
` ~1994-
`American Urological Association
` ~1998-
`Society of Urologic Oncology
` ~2002-2010
`Society of Basic Urological Research
`
`Selected Editorial Boards:
`1999-2001
`The Prostate Journal
`2002-
`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)
`The Oncologist
`
`2003-2006
`2011-
`2011-2015
`2012-
`2012-
`
`
`Editor-in-Chief:
`1997-1999
`2002-2005
`
`2006-
`
`
`Selected Reviewer:
` 1993-
` 1995-
` 1998-
` 1998-
` 1999-
` 2000-
` 2004-
` 2006-
` 2006-
` 2007-
` 2008-
` 2008-
` 2009-
` 2009-
`
`
`
`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.
`
`Clinical Genitourinary Cancer (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
`Lancet Oncology
`Prostate Cancer and Prostatic Disease
`
`
`
`
`
`7
`
`
`
`Journal of Clinical Investigation
`The Oncologist
`Clinical Cancer Research
`
` 2013-
` 2013-
` 2014-
`
`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
`Reviewer, Movember Foundation
`
`1998-
`
`2006-2013
`
`2006-2010
`
`2008-2009
`
`2010-
`2015-
`
`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 (by that organization)
`New Orleans “Best Doctors” every year, by local New Orleans magazine
`
`
`PART II: Research, Teaching, and Clinical Contributions
`
`A. Narrative Report
`There is much that preceded 1998, but I will start there. 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
`8
`
`
`
`
`
`Stanley S. Scott Cancer Center grew considerably by every metric (grants/philanthropy/clinical).
`Growth was a consequence of increased resources that enabled 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, who were also critical
`leaders of this process.
`
`Management of the aforementioned activities were 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 during my years as
`Cancer Center Director at LSU.
`
` I
`
` have been a principal investigator or co-principal investigator (and author on the peer-reviewed
`manuscripts) on five pivotal multi-institutional trials that lead directly to FDA approvals. These are
`the trials that change practice and these to me are critical for progress in our field. Samarium-153
`lexidronam (Quadramet), two formulations of leuprolide acetate (30 mg and 45 mg Eligard),
`cabazitaxel (Jevtana), and radium-223 (Xofigo) are the agents studied in these phase III trials. For
`the samarium-153 and leuprolide 30 mg manuscripts, I was the first author. For the cabazitaxel and
`radium-223 manuscripts, I was the senior author. For the leuprolide 45 mg, I was the second author.
`The leuprolide trials were not evaluating a new drug, but simply a new delivery system. The
`radium-223, cabazitazel, and samarium-153 phase III trials contributed to approval for new
`chemical entities. The radium-223 trial lead to the approval for the first alpha-particle emitter. I
`suspect more will follow.
`
` I
`
` have chaired and continue to chair and participate in various independent data monitoring
`committees (IDMC). These are critical aspects of large pivotal clinical trials. Four of the pivotal
`trials have lead to FDA approvals including sipuleucel-T, axitinib, and enzalutamide (twice).
`Multiple other pivotal trials are in progress, which if positive, could lead to 4 additional FDA
`approvals.
`
`Direct teaching and mentoring of various trainees including hematology-oncology or oncology
`fellows, residents, and medical students has occurred at NCI, LSU, Harvard, and Tulane. Teaching
`has always been an important portion of my duties
`
`As part of the LSU 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.
`
`9
`
`
`
`
`
` 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 served as co-PI (with Dr. Mathew Freedman) on a project in
`the Harvard SPORE submission in prostate cancer (Kantoff-PI). This was funded but because of the
`change in location to Tulane, I relinquished the SPORE project to a DFCI investigator. I am
`currently International Co-PI on the FIRSTANA phase III trial with cabazitaxel and docataxel and a
`number of other trials that are in process or about to begin.
`
` I
`
` serve as the Medical Oncology Chairman of the GU Committee of RTOG (now NRG). I served as
`national co-PI on RTOG 0521, RTOG 0621, and RTOG 0622.
`
`Philanthropy has been a focus of mine, especially since coming to Tulane. We now have four
`separate and distinct events that raise funds for prostate cancer research and these independent but
`mutually inter-dependent events are critical for our mission. Experiences in the philanthropic arena
`have been an area marked by personal and professional growth.
`
` I
`
`PI
`
`PI
`
` have served on a number of financial committees and financial advisory situations. In some cases
`these are predominantly strategic, in others these have been predominantly operational. I have
`served on a family company, the Lane Company, as a Board of Director member since 1998. This
`company was founded in 1924 by my great-grandfather and remains entirely family controlled
`today. Our focus is on agriculture, commercial real-estate, and minerals. I have also served as a
`committee member on various health care related financial committees at LSU, Tulane, and the
`Louisiana Cancer Research Consortium.
`
`B. Selected Funding Information
`PI
` 1993-1994
`NIH contract
`
` Serum Sample and Patient Demographic Data on Elderly
`
`Males Without Prostate Cancer
`Site-PI
`1993-1998
`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
`Cytogen
`Site-PI
`
` 1994-1995
`
`
`
` 1995-1996
`
` 1995-1996
`
`
`
`
`
` 1995-1997
`
`
`
` 1995-1998
`
`
`
` 1995-1998
`
` 1995-1998
`
`
`
`10
`
`
`
`
`
`
`
` 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
`
`
`
`Open-Label Study of Intravenously Administered 153Sm-EDTMP (CYT-424)
`for the Treatment of Patients with Bone Pain- Secondary Metastatic
`Carcinoma
`Schering-Plough Site PI
`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
`Janssen & Kyowa Site-PI
`Protocol for a Phase II Study of KW2189 for the Treatment of Advanced
`Renal Cell carcinoma
`Ligand Pharmaceuticals Site-PI
`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
`
`Cytogen
`
` Site-PI
`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
`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 Site-PI
`Estramustine Phosphate in Advanced Prostate Cancer
`PI
`Baptist Community Ministries/Daughters of Charity
`Partners in Health: The Breast and Cervical Health Cooperative
`ASPH/CDC
`Co-PI
` Geographic Information Systems and Prostate Cancer
`
`Atrix
`
`
` Site-PI
`LA-2575 for hormonally Sensitive Prostate Cancer
`Medarex
`
` Site-PI
`MDX-010 With and Without Docetaxel in Hormone-Refractory Prostate
`Cancer
` Site-PI
`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
`
`Co-PI
`PI
`
`11
`
`
`
`PI
`
`
`
`Funding for Cancer Control Personnel
`
`
`
`GlaxoSmithKline
` Site-PI
` 2004-2006
`Dutasteride in Recurrent Prostate Cancer
`
`
`
`sanofi
` 2004-2006
`COMPARE – Registry for Recurrent Prostate Cancer
`
`
`
`CDC
` 2004-2006
`Cancer Prevention and Control in High Risk Families
`
`
`
`GlaxoSmithKline (GSK)
`
` 2008-
`TARP randomized clinical trial
`
`
`
`Sanofi
`
`
` 2007-2009
`TROPIC randomized clinical trial (XRP-6258)
`
`
`
`co-PI
`Prostate SPORE project 2 co-PI
` 2007-2008
`Genetic and Clinical characterization of the 8q24 risk locus
`
`
`
`Cougar Biotechnology
`Site-PI
` 2008-
`
`Randomized Abiraterone post-docetaxel (Cougar 301)
`
`
`
`AstraZeneca
`
` 2008-
`
`ENTHUSE study (ZD4054 versus placebo in M0 prostatate)
`
`
`
`Cougar Biotechnology
` 2009-
`
`Randomized Abiraterone pre-docetaxel (Cougar 302)
`
`
`
`Site PI
` 2009- Algeta
`
` ALSYMPCA (Alpharadin randomized study in prostate cancer)
` 2010-
`Many trials and past grants have not been listed simply due to volume.
`
`
`There are too many list.
`
`Current NIH funding in which I am a sub-investigator or co-PI.
` 2015-
`
`
`
`
`
`
`
`5U10CA021661-32 (Curran)
`
`
`
`
`
`
`
`
`
`
`
`
`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).
`
`Site-PI
`
`Site PI
`
`Site PI
`
`Site PI
`
`Site-PI
`
`Site-PI
`
`
`
`
`
`
`
`01/06-date
`0.12 calendar
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 1
`
` R01 CA188609-01 (Dong)
`
`
`
`
`NIH/NHLBI
`
`
`$207,500 per year
`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)
`
`
`
`
`
`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
`
` 09/01/14-8/31/19
`
` 0.6 calendar
`
`
`
`
`
`
`08/01/13-7/31/18
`0.01 calendar after cuts
`
`
`
`
`
`12
`
`
`
`
`
`
`
`
`
`
`
`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, fo