`William Patrick McGuire III, MD
`
`Practice Location:
`
`Virginia Commonwealth University
`1201 E Marshall St
`l11h Floor, Room 210
`Richmond VA 23298
`Phone:804-828-4642
`Fax:: 804-628-5920
`Mobi le:410-409-1394
`email: wpmcguire@vcu.edu
`Languages: English, French
`
`Education:
`
`9/62-6/66
`
`7/66-6171
`
`7/66-6171
`
`B.S., Chemistry, Emory University
`Atlanta, GA
`
`M.S., Anatomy/Cell Biology, Baylor College of Medicine
`Houston, TX
`
`M.D ., Baylor College of Medicine
`Houston, TX
`
`Post Graduate Education and Training:
`
`7171-6172
`
`7172-6173
`
`7173-6179
`
`Intern, Internal Medicine
`Yale New Haven Medical Center
`New Haven, CT
`
`Resident, Internal Medicine
`Yale-New Haven Medical Center
`New Haven, CT
`
`Clinical Associate, Medicine Branch
`Division of Cancer Treatment
`National Cancer Institute
`National Institutes of Health
`Bethesda, MD
`
`1
`
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Helsinn Healithcare S.A., et al.
`U.S. Patent No. 8,729,094
`Reddy Exhibit 1 022
`
`Exh. 1022
`
`
`
`Military Service:
`
`7173-6179
`
`7176-6177
`
`1979-Present
`
`7177-6178
`
`7178-6179
`
`Academic Appointments:
`
`Commander, U.S. Public Health Service
`
`Senior Investigator, Clinical Investigations Branch
`Division of Cancer Treatment
`National Cancer Institute
`National Institutes of Health
`
`Lt. Commander, U.S. Public Health Service
`lnacti ve Reserves
`
`Acting Chief, Clinical Investigations Branch,
`Cancer Therapy Evaluation Program-Division of Cancer Treatment
`National Cancer Institute, National Institutes of Health
`Bethesda, Maryland
`
`Head, Medicine Section, Clinical Investigations Branch
`Cancer Therapy Evaluation Program-Division of Cancer Treatment
`National Cancer Institute, National lnsti tutes of Health
`Bethesda, Maryland
`
`7179-6/82
`
`7179-6/82
`
`7179-6/85
`
`7/82-6/85
`
`7/85-6/93
`
`Assistant Professor of Medicine
`University of lllinois at Chicago
`Chicago, IL
`
`Associate Director for Clinical Programs,
`Illinois Comprehensive Cancer Center
`Chicago, IL
`
`Chief, Section of Medical Oncology
`Department of Medicine
`University of Illinois at Chicago
`Chicago, lllinois
`
`Associate Professor of Clinical Medicine
`University of lllinois at Chicago
`Chicago, lllinois
`
`Associate Professor of Oncology
`The Johns Hopkins University School of Medicine
`Baltimore, Maryland
`
`2
`
`Exh. 1022
`
`
`
`7/86-6/93
`
`7/90-6/93
`
`7/90-6/93
`
`7/93-2/97
`
`7/97-6/03
`
`7/03-9114
`
`2/98-12/00
`
`1/01-8/12
`
`8/12-8/14
`
`Associate Professor of Otolaryngology, Head and Neck Surgery
`The Johns Hopkins University
`School of Medicine
`Baltimore, Maryland
`
`Associate Professor of Medicine
`The Johns Hopkins University
`School of Medicine
`Baltimore, Maryland
`
`Associate Professor of Gynecology and Obstetrics
`The Johns Hopkins University
`School of Medicine
`Baltimore, Maryland
`
`Professor of Medicine
`Emory University
`Atlanta, Georgia
`
`Clinical Professor of Medicine
`University of Mississippi School of Medicine
`Jackson, Mississippi
`
`Clinical Professor of Medicine
`The Lombardi Cancer Center
`Georgetown University
`Washington, DC
`
`Director, Chemotherapy Services
`Gynecologic Oncology Center
`Mercy Medical Center
`Baltimore, Maryland 21202
`
`Director, Cancer Center
`Franklin Square Medical Center
`9103 Franklin Square Drive, Suite 2200
`Baltimore, Maryland 21237
`
`Medical Director, Gynecologic Cancer Outreach
`Inova Fairlax Hospital
`3300 Gallows Road
`Falls Church, Virginia 22042
`
`3
`
`Exh. 1022
`
`
`
`12/14-Present
`
`12/14-Present
`
`Certifications:
`
`1971
`
`1972
`
`1974
`
`1974
`
`1976
`
`1979
`
`1982
`
`1993
`
`2012
`
`Active Medical Licensures:
`
`Professor of Medicine
`Department of Internal Medicine
`Virginia Commonwealth University
`Richmond, Virginia 23298
`
`Director, Phase I Solid Tumor Program
`Massey Cancer Center
`Richmond, Virginia, 23298
`
`License to Practice Medicine
`State of Texas
`
`License to Practice Medicine
`State of Connecticut
`
`License to Practice Medicine
`State of Maryland
`
`Diplomat
`American Board of Internal Medicine
`
`License to Practice Medicine
`District of Columbia
`
`License to Practice Medicine
`State of Dlinois
`
`Diplomat
`Sub-specialty of Oncology
`American Board of Internal Medicine
`
`License to Practice Medicine
`State of Georgia
`
`License to Practice Medicine
`State of Virginia
`
`Maryland Lie. No.
`UPIN#
`NCI Investigational Drug #
`Texas Lie. No.
`NPI#
`Virginia Lie No
`
`Dl6801
`E10864
`9113
`D8344
`184 126 9222
`0101251554
`
`4
`
`Exh. 1022
`
`
`
`Membership in Professional Societies:
`
`1974
`
`1978
`
`1979
`
`1983
`
`1989
`
`1990
`
`1990
`
`1996
`
`1997
`
`2001
`
`American Society of Clinical Oncology
`
`International Association for the Study of Lung Cancer
`
`Gynecologic Oncology Group
`
`American Federation for Clinical Research
`
`Charter Councilor, Southern Association for Oncology (SAO)
`
`International Gynecologic Cancer Society
`
`Southern Association for Oncology's Education Committee (SAO)
`
`National Association for the Advancement of Science
`
`Society of Gynecologic Oncology
`
`European Society of Medica] Oncology
`
`Honors and Awards:
`
`1970
`
`1978
`
`1979-83
`
`1999
`
`Consultant Appointments:
`
`1982-2000
`
`1983-85
`
`Alpha Omega Alpha
`
`PHS Medal of Commendation
`National Institutes of Health
`
`Nominated Teacher of the Year by Housestaff
`Department of Medicine
`University of lllinois
`
`Per Kolstad A ward
`Radium Hospital
`Oslo, Norway
`
`Member, New Agents Committee
`Gynecologic Oncology Group (GOG)
`
`Chairman, New Agents Committee
`lllinois Comprehensive Cancer Center
`Chicago, lllinois
`
`5
`
`Exh. 1022
`
`
`
`1984-2004
`
`1984-1990
`
`1986-2004
`
`1988-Present
`
`1987-2000
`
`1990-1994
`
`1991-2000
`
`1992, 1998
`
`1992-2000
`
`1995-2000
`
`1991-2000
`
`2000-2004
`
`2000-2010
`
`2000-2010
`
`Member, Protocol Committee
`Gynecologic Oncology Group (GOG)
`
`Chairman, Quality Control Committee
`Gynecologic Oncology Group (GOG)
`
`Member, Ovarian Cancer Committee
`Gynecologic Oncology Group (GOG)
`
`Member, Membership Committee
`Gynecologic Oncology Group (GOG)
`
`Chairman, Phase 1/Pilot Subcommittee
`Gynecologic Oncology Group (GOG)
`
`Member, Executive Committee
`Gynecologic Oncology Group (GOG)
`
`Chairman, Ancillary Data Subcommittee
`Gynecologic Oncology Group (GOG)
`
`Member, Program Committee
`American Society of Clinical Oncology (ASCO)
`
`Member, Committee on Human Research
`The American College of Obstetricians
`and Gynecologists
`
`Chairman, Developmental Therapeutics Committee
`Gynecologic Oncology Group (GOG)
`
`Chairman, Phase I Subcommittee
`Gynecologic Oncology Group (GOG)
`
`Co-chairman, Ovarian Cancer Committee
`Gynecologic Oncology Group (GOG)
`
`Member, Data and Safety Monitoring Board (DSMB)
`Gynecologic Oncology Group (GOC)
`
`Member, Data Monitoring Committee (DMC)
`Gynecologic Oncology Group (GOC)
`
`2000-2001
`
`Program Committee, Society of Gynecologic Oncologists (SGO)
`
`6
`
`Exh. 1022
`
`
`
`2006-2010
`
`2007-2008
`
`2001-Present
`
`Member, Gynecologic Cancer Advisory Committee
`American Cancer Society''s National Office
`
`Breast Cancer Task Force
`Society of Gynecologic Oncologists (SGO)
`
`Member, Phase I Commjttee
`Gynecologic Oncology Group (GOG)
`
`Local and National Services:
`
`1980-1982
`
`1981-1985
`
`1982-1983
`
`1982-1984
`
`1988-1993
`
`1989-1992
`
`1989-1992
`
`1993-1997
`
`1993-1997
`
`Member, Hospital Executive Committee
`Uruversity of lllinois
`Chicago, IT.-
`
`Vice Chairman, Pharmacy and Therapeutics Committee
`University of Ulinois
`Chicago, IT.-
`
`President, Illinois Comprehensive Cancer Center
`University of Ulinois
`Chicago, IL
`
`Chairman, Do Not Resuscitate Committee
`Uruversity of lllinois
`Chicago, IT.-
`
`Member, Oncology Information Network Committee
`The Johns Hopbns Oncology Center
`Baltimore, MD
`
`Director, Medical Oncology Fellowship Training Program
`The Johns Hopbns Oncology Center
`Baltimore, MD
`
`Chairman, Fellowship Selection Committee
`The Johns Hopbns Oncology Center
`Baltimore, MD
`
`Member, Pharmacy and Therapeutics Comrruttee
`Emory University Hospital
`Atlanta, GA
`
`Member, Promotions and Tenure Committee
`Emory Uruversity Hospital
`
`7
`
`Exh. 1022
`
`
`
`1994-1997
`
`1996-1997
`
`2001-2005
`
`2002-2010
`
`2004-2012
`
`2005-2012
`
`2001-2012
`
`2014-2014
`
`Atlanta, GA
`
`Cancer Research Review Commjttee
`Winship Cancer Center
`Emory University
`Altanta, GA
`
`Chairperson, Cancer Research Review Committee
`Winship Cancer Center
`Emory University
`Atlanta, GA
`
`Oncology Investigational Review Board
`Medstar Health
`Baltimore, MD
`
`Member, Medstar Research Institute Board
`Medstar HeaJth
`Baltimore, MD
`
`Member, Pharmacy and Therapeutics Committee
`Franklin Square Hospital Center
`Baltimore, MD
`
`Member, Quality Council
`Franklin Square Hospital Center
`Baltimore, MD
`
`Chairman, Cancer Committee
`Franklin Square Hospital Center
`Baltimore, MD
`
`Chairman, Research Oversight Committee
`Inova Cancer Center Research Institute
`
`Editorial Board:
`
`1987-1995
`
`1999-2000
`
`Physician Data Query
`
`Journal of the National Cancer Institute
`
`1988-1991, 1996-2003
`
`Journal of Clinical Oncology
`
`8
`
`Exh. 1022
`
`
`
`1991-2000, 2003-2007
`
`Gynecologic Oncology
`
`1995-1999
`
`2002-Present
`
`Clinical Cancer Research
`
`American Journal of Cancer
`
`Prior Advisory and Peer Review Committees:
`
`Have not served as a full member of any NIH advisory or peer review committee. Have served
`on some site visit committees in the past three years. Dates are approximate.
`
`1.
`2.
`3.
`4.
`5.
`
`June 1988
`Core Cancer Grant Site Visit- Mayo Clinic -
`Core Cancer Grant Site Visit- University of Wisconsin- April 1989
`POl Immunology Site Visit- Cleveland Clinic Foundation- March 1990.
`FDA Orphan Drug Committee - 2006-Present
`FDA Oncology Drug Advisory Committee Ad Hoc Member- June 2014
`
`Articles Published in Professional Journals:
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`McGuire WP. Production of a lupus-like nephritis in strain Af- mice by transplantation
`of autologous hepatocytes. Master's Thesis, Baylor College of Medicine, 1971.
`
`Myers CE, McGuire WP and Young RC. Adriamycin: amelioration of toxicity by
`Alpha-Tocopherol. Cancer Treat Rep 60(7):961-962, 1976.
`
`Myers CE, McGuire WP, Liss RH, lfrarn I, Grotzinger K and Young RC. Adriamycin:
`the role of lipid peroxidation in cardiac toxicity and tumor response. Science 197: 165-
`167, 1977.
`
`McGuire WP, Gretzinger K and Young RC. Alterations in 3H-thymidine incorporation
`into DNA and 3H-uridine incorporation into RNA induced by 5-azacytidine. Biochem
`Pharmacol 27(5):745-750, 1978.
`
`Muggia FM and McGuire WP. Adjuvant systemic therapy of lung cancer. Cancer Clin
`Trials 1(3):235-241, 1978.
`
`lhde DC, Robett s WC, MarT KC, McGuire WP, Levine AS and Young RC. Cardiac
`candidiasis in cancer patients. Cancer 41(6): 2364- 2371, 1978.
`
`McGuire WP. Prospective monitoring for anthracycline cardiotoxicity: An introduction.
`Cancer Treat Rep 62(6):885, 1978.
`
`9
`
`Exh. 1022
`
`
`
`8.
`
`9.
`
`Mikulski S, McGuire WP, Louie A, Chirigos M and Muggia FM. Immunotherapy of
`lung cancer. I. Review of clinical trials in non-small cell histologic types. Cancer Treat
`Rev 6(2):177-190, 1979.
`
`Mikulskj S, McGuire WP, Louie A, Chirigos M and Muggia FM. Immunotherapy of
`lung cancer. IT. Review of clinical trials in small cell carcinoma. Cancer Treat Rev
`6(3):125-130, 1979.
`
`10. Muggia FM, Rozencweig M, Staquet M and McGuire WP. Methodology of phase II
`clinical trials in cancer. Recent Results Cancer Res 70: 53-60, 1980.
`
`11.
`
`12.
`
`13.
`
`14.
`
`15.
`
`16.
`
`Gail MH, Oldham RK, Holmes EC, Wright PW, McGuire WP, Mountain CF, Lukeman
`JM, Feld R, Hill LD, Eagan RT, and Pearson FG. Early Effects of intrathoracic BCG
`therapy in patients with non-small cell stage I lung cancer: Data from a randomized
`double-blind controlled trial by the Lung Cancer Study Group. Cancer lmmunol
`Immunother 10:129-137, 1981.
`
`Lad TE, Nelson RB, Diekamp U, Kukla U , Sarma PR, LarsoTll CS, CmTie ET, Chawla
`MS, Tichier T , Zawila P and McGuire WP. Immediate vs. postponed combination
`chemotherapy for unresectable non-small cell lung cancer: A randomized trial. Cancer
`Treat Rep 65(11): 973-978, Nov-Dec 1981.
`
`Kukla U , Burrows D, Bressler Land McGuire WP. Bleomycin induced Raynaud's
`phenomenon. Arch Dermatol117(10):604, 1981.
`
`Diekamp U, Lad TE, McGuire WP. Postsurgical adjuvant chemotherapy: a review. Surg
`Annu. 13:31-52, 1981.
`
`Kukla U, Saltiel M and McGuire WP. Acute vascular episodes with therapy of
`carcinomas of the upper aerodigestive tract with bleomycin, vincristine, and cisplatinum.
`Cancer Treat Rep 66(2):369-370, 1982.
`
`Kukla U and McGuire WP. Heat-induced recall of bleomycin skin changes. Cancer
`50(1):2283-2284, December 1982.
`
`17. McGuire WP. Diffuse undifferentiated non-Hodgkin's lymphoma among homosexual
`males - United States. MMWR 31(21):277-279, 1982.
`
`18.
`
`19.
`
`Kamath S, Booth P, Lad TE, Kohrs MB and McGuire WP. Taste thresholds of patients
`with cancer of the esophagus. Cancer 52(2):386- 389, July 1983.
`
`Saltiel M and McGuire WP. Doxorubicin (Adriamycin).Cardiomyopathy - A Critical
`Review. West J Med 139(3):332-341, 1983.
`
`10
`
`Exh. 1022
`
`
`
`20. McGuire WP, Blough RR, Cobleigh MA, Johnson CM, Kukla U , Lad TB, Lanzotti VJ,
`Stiff PJ and Zawila P. Phase II trial of bisantrene for unresectable non-small cell
`bronchogenic carcinoma. Cancer Treat Rep 67(9):841-842, September 1983.
`
`21.
`
`22.
`
`23.
`
`24.
`
`25.
`
`26.
`
`27.
`
`28.
`
`29.
`
`30.
`
`31.
`
`32.
`
`Chen ML, McGuire WP, Lad TE and Chiou WL. A specific HPLC assay to determine
`the pharmacokinetics of methotrexate in patients. Int J Pharmacol Ther Toxicol 22(1): 1-
`6, 1984.
`
`Kukla U, Mantravadi RVP, Applebaum ELand McGuire WP. Pre-irradiation
`chemotherapy for advanced head and neck carcinomas. Arch Otolaryngol 1 10(2):78-81,
`1984.
`
`Cobleigh MA, Gallagher P A, Hill JH, Applebaum ELand McGuire WP. Growth of
`human squamous head and neck cancer in vitro. Amer J Path 115(3):397-402, 1984.
`
`Taylor SG, McGuire WP, Showel J, Houck W and Lad TE. A randomized comparison
`of high dose infusion methotrexate versus standard dose weekly therapy in head and neck
`squamous cancer. J Clio Oncol2(9):1006-1011 , 1984.
`
`Venkataraman M, Shevrin D, McGuire WP and Westerman MP. B lymphocyte changes
`in homosexual men with generalized lymphadenopathy. Diag Immuno12:197-202, 1984.
`
`Abramson EC, Kukreja SC, Shevrin DH, Lad TE, McGuire WP and Kukla U. A model
`for malignancy associated humoral hypercalcemia. Calcified Tissue lnt 36:563-567,1984.
`
`Kukla U , Abramson EC, McGuire WP, Shevrin DH, Lad TE and Kukreja SC. Cis-
`platinum treatment for malignancy-associated humoral hypercalcemia in an athymic
`mouse modet Calcified Tissue Int 36:559-562,1984.
`
`Bychkov V, Ghosh L, Lundine M, Manaligod JR, McGuire WP, and Rose C. Ovarian
`androblastoma metastatic to tonsil. J Surg Oncol47(4):275-279, 1984.
`
`Lad TE and McGuire WP. Conventional agents in lung cancer. Cancer Treat Rep
`68(3):568, 1984.
`
`Shevrin DH, Bressler LR, McGuire WP, Kukreja SC, Kukia U and Lad TE. Treatment
`of cancer-associated hypercalcemia with mithramycin and ora] etidronate disodium. Clio
`Pharm 4:204-205, 1985.
`
`Cobleigh MA, Hill JH, Gallagher PA, Kukia U, Lad TE, Shevrin DH, Applebaum EL and
`McGuire WP. A phase II study of Adriamycin in previously untreated squamous cell
`carcinoma of the head and neck. Cancer 56(11):2573-2575, 1985.
`
`Shevrin DH, McGuire WP, Lanzotti V, Krauss 5, Blough R, Cobleigh M, Johnson C,
`Lad T and Kukia LJ. Phase II trial of arninothiadiazole in advanced non-small cell lung
`cancer. Cancer Treat Rep 70(3):417 -418, 1986.
`
`11
`
`Exh. 1022
`
`
`
`33. McGuire WP, Blessing JA, DiSaia PJ and Buchsbaum HJ. Phase ll clinical trial of
`Acivicin in patients with advanced epithelial ovarian carcinoma: A Gynecologic
`Oncology Group study. Invest New Drugs, 4:49-52, 1986.
`
`34. McGuire WP, Blessing JA, Hatch K and DiSaia PJ. A Phase II study of CHIP in
`advanced squamous cell carcinoma of the cervix: A Gynecologic Oncology Group study.
`Invest New Drugs 4:181.-186, 1986.
`
`35.
`
`36.
`
`37.
`
`38.
`
`Rowinsky EK, McGuire WP, Anhalt OJ, Ettinger DS and Donehower RC.
`Hexamethylene bisacetamide (HMBA)-induced cutaneous vasculitis. Cancer Treat Rep
`71 :471-474, 1987.
`
`Cobleigh MA, Kennedy JL, Wong AC, Hill JH, Lindholm KM, Tiesenga JE, Kiang R,
`Applebaum EL and McGuire WP. Primary culture of squamous head and neck cancer
`with and without 3T3 fibroblasts and effect of clinical tumor characteristics on growth in
`vitro. Cancer 59(10):1732-8, 1.987.
`
`Rowin sky EK, Ettinger DS, McGuire WP, Noe DA, Groch ow LB and Donehower RC.
`Prolonged Infusion of Hexamethylene Bisacetarnide: A phase I and pharmacologic study.
`Cancer Res 47(21):5788-5795, 1987.
`
`Hantel A, Rowinsky EK, Noe DA, McGuire WP, Grochow LB, Vito BL, Ettinger DS
`and Donehower RC. Clinical and pharmacologic reappraisal of dichloromethot:rexate. J
`Natl Cancer Inst 80(19): 1547-1553, 1988.
`
`39. McGuire WP, Blessing JA and Berman MA. Phase ll Study ofEsorubicin (4'-
`deoxydoxorubicin) in advanced epithelial carcinoma of the ovary: A Gynecologic
`Oncology Group study. Invest New Drugs 7:33 3-336, 1989.
`
`40. McGuire WP, Blessing JA, Yordan E and Beecham J. Phase IT Study ofEsorubicin (4'-
`Deoxydoxombicin) in Advanced or metastatic squamous carcinoma of the uterine cervix:
`A Gynecologic Oncology Group study. Invest New Drugs 7(2-3):235-238, 1989.
`
`41.
`
`Grochow LB , Noe DA, Dole GB, Rowinsky EK, Ettinger DS, Graham ML, McGuire
`WP and Donehower RC. Phase I trial of trimetrexate glucuronate (NSC 352122) on a 5
`day nolus schedule: Clinical pharmacology and pharmacodynamics. J Natl Cancer Inst
`81(2):124-130, 1.989.
`
`42. McGuire WP, Rowinsky EK, Rosenshein NB, Grumbine FC, Ettinger DS, Armstrong
`DK and Donehower RC. Taxol: A unique antineoplastic agent with significant activity in
`advanced varian epithelial neoplasms. Ann lnt Med 111:273-279, 1989.
`
`43. McGuire WP, Arseneau J, Blessing JA, DiSaia PJ, Hatch KD, Given FT, Teng NH and
`Creasman WT. A randomized comparative trial of carboplatin and iproplatin in
`
`12
`
`Exh. 1022
`
`
`
`advanced squamous carcinoma of the uterine cervix: A Gynecologic Oncology Group
`study. J Clin Oncol7(10): 1462-1468, 1989.
`
`44. McGuire WP. Multi modal Treatment of Ovarian Cancer. J Nat! Cancer lnst 81:958-959,
`1989.
`
`45. McGuire WP and Abeloff MD. Carboplatin substitution for cisplatin in the treatment of
`ovarian carcinoma- A word of caution. J Nat! Cancer Inst 81(19):1438-1439, 1989.
`
`46.
`
`Sutton G, Blessing JA, Manetta A, Homesley HD and McGuire WP. Phase ll experience
`with ifosfamide/mesna in gynecologic malignancy. Preliminary report of the Gynecologic
`Oncology Group. Sem Onco116(3) 68-72, 1989.
`
`47. McGuire WP, Blessing JA, Hatch KD and Berman MD. Phase ll study of N-
`methylformamide (NSC 3051) in patients with advanced squamous cancer of the cervix:
`A Gynecologic Oncology Group study. Invest New Drugs. 8:187-192, 1990.
`
`48.
`
`Asbury R, Blessing J, McGuire WP, Hanjani P and Mortel R. Arninothiadiazole
`(NSC#4728) in patients with advanced carcinoma of the endometrium: ApPhase II study
`of the Gynecologic Oncology Group. Am J Clin Oncol. 13(1):39-41, 1990
`
`49. McGuire WP, Blessing JA, Berek JA and Munoz A. Phase II study of
`N-methylformamide (NSC 3051) in patients with advanced epithelial ovarian cancer: A
`Gynecologic Oncology Group study. Invest New Drugs. 8:183-186, 1990.
`
`50.
`
`51.
`
`52.
`
`53.
`
`54.
`
`Hantel A, Donehower R, Rowinsky E, Vance E, Clarke B, McGuire WP, Ettinger D and
`Grochow L. A phase I study and pharmacodynamics of proxantrone (NSC 349174), A
`new anthrapyrazole. Cancer Res 50:3284-3288, 1990.
`
`Noe DA, Row.insky EK, Shen HSL, Clarke BV, Grochow LB, McGuire WP, Hantel A,
`Adams DB, Abeloff MD, Ettinger DS, and Donehower RC. Phase I and pharrnacokinetic
`study of brequinar sodium (NSC 368390). Cancer Res 50:4595-4599, 1990.
`
`Bosserman G, McGuire DB, McGuire WP and Nicholls D. Multidisciplinary
`management of vascular access devices. Oncol Nurs Forum 17(6):879-886, 1990.
`
`Richtsmeier WJ, Koch WM, McGuire WP, Poole ME, ChangER. Phase I-II study of
`advanced head and neck squamous cell carcinoma patients treated withrecombinant
`human interferon gamma. Arch Otolaryngol Head Neck Surg 116:1271-1277, 1990.
`
`Rowinsky EK, Gilbert MR, McGuire WP, Noe DA, Grochow LB, Forastiere AA,
`Ettinger DS, Lubejko BG, Sartorius SE, Cornblath DR, Hendricks CB, and Donehower
`RC. Sequences of Taxol and cisplatin: A phase I and pharmacologic Sstudy. J Clin Oncol
`9:1692-1703, 1991.
`
`13
`
`Exh. 1022
`
`
`
`55.
`
`56.
`
`Rowinsky EK, McGuire WP, Guarnieri T, Fisherman JS, Ch1istian MC, Donehower RC.
`Cardiac disturbances during the administration of Ttaxol. J Clin Oncol 9:1704-1712,
`1991.
`
`Hendricks CB, Grochow LB, Rowinsky EK, Forastiere AA, McGuire WP, Ettinger DS,
`Sartorius 5, Lubejko B and Donehower RC. Phase I and pharmacokinetics study of
`hepsulfam (NSC 329680). Cancer Res 51:5781-5785, 1991.
`
`57. McGuire WP, Rowinsky EK. Old drugs revisited, new drugs, and experimental
`approaches in ovarian cancer therapy. Semin Oncol 18(3); 255-69, June 1991.
`
`58. Markman M, Berek JS, Blessing JA, McGuire WP, Bell J and Homesley HD.
`Characteristics of patients with small-volume residual ovarian cancer unresponsive to
`cisplatin-based intraperitoneal chemotherapy: Lessons learned from a Gynecologic
`Oncology Group phase II 'Irial of IP cisplatin and recombinant alpha-interferon. Gynecol
`Oncol45:3-8, 1992.
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`59.
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`60.
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`61.
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`62.
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`Schuchter LM, Wohlganger JA, Fishman EK, MacDermott ML, and McGuire WP.
`Sequential chemotherapy and immunotherapy for the treatment of metastatic melanoma.
`J lmmunother 12(4):272-276, 1992.
`
`Rowinsky EK, Grochow LB, Hendricks CB, Etdnger DS, Forastiere AA, Hurowitz LA,
`McGuire WP, Sartorius SE, Lubejko BG, Kaufmann SHand Donehower RC. Phase I
`and pharmacologic study of topotecan: A novel topoisomerase I inhibitor. J Clin Oncol
`10:647-656, 1992.
`
`Sutton GP, Blessing JA, Manetta A, Homesley H, McGuire WP. Gynecologic Oncology
`Groups studies with ifosfamide. Sem Oncol19(6 Suppl 12):31-34, 1992.
`
`Piantadosi SD and McGuire WP. Assessing the effect of response on survival in ovarian
`cancer. J Natl Cancer lnst 84:376-379, 1992.
`
`63. Windom HH, McGuire WP, Hamilton RG, and Adkinson NF. Anaphylaxis to
`carboplatin- A new platinum chemotherapeutic agent. J Allergy Clin Immunol 90(4):681-
`683, 1992.
`
`64.
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`65.
`
`Caldas C, Sitzmann J, Trimble CL, and McGuire WP. Synchronous mature teratoma of
`the ovary and liver: A case presenting eleven years following chemotherapy for immature
`teratoma. Gynecol Oncol 47(3):385-390, 1992.
`
`Rowinsky EK and McGuire WP. Taxol: Present status and future prospects. Contemp
`Oncol 2:29-36, 1992.
`
`66. McGuire WP. Ovarian cancer. Experimental chemotherapy. Hematol Oncol Clin North
`Am, 6(4); 927-40, 1992 ..
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`67. McGuire WP. Primary treatment of epithelial ovarian malignancies. Cancer 71:1541-
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`69.
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`71.
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`73.
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`74.
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`Peereboom DM, Donehower RC, Eisenhauer EA, McGuire WP, Onetto N, Hubbard JL,
`Piccart M, Gjarmi L, and Rowinsky EK. Successful retreatment with Taxol after major
`hypersensitivity reactions. J Clin One 11:885-890, 1993.
`
`Sutton GP, Blessing JA, DiSaia PJ, and McGuire WP. Phase ll study of ifosfamide and
`mesna in nonsquamous carcinoma of the cervix: A Gynecologic Oncology Group study.
`Gynecol Oncol49:48-50, 1993.
`
`Caldas C and McGuire WP. Paclitaxel (taxol) therapy in ovarian carcinoma. Semin
`Oncol20:50-55, 1993.
`
`Caldas C and McGuire WP. Taxol in epithelial ovarian cancer. J Natl Cancer lnst
`15:155-160, 1993.
`
`Arbuck SG, Strauss H, Rowinsky E, Christian M, Suffness M, Adams J, Oakes M,
`McGuire WP, Onetto N, Canetta R, Reed E, Gibbs H, Greenfield RA and Montello M.
`A reassessment of cardiac toxicity associated with Taxol. J Natl Cancer lnst 15:117-130,
`1993.
`
`Sutton G, Blessing J, McGuire WP, Patton T, and Look K. Phase II trial of ifosfamide
`and mesna in patients with advanced or recurrent squamous carcinoma of the cervix who
`never received chemotherapy: A Gynecologic Oncology Group study. Am J Obstet
`Gynecol 168:805-807, 1993.
`
`Thigpen JT, Brady MS, Omura GA, Creasman WT, McGuire WP, Hoskins WJ and
`Williams SD. Age as a prognostic factor in ovarian carcinoma: The Gynecologic
`Oncology Group experience. Cancer 71:606-614, 1993.
`
`75. McGuire WP. Taxol: A new drug with significant activity as a salvage therapy in
`advanced epithelial ovarian carcinoma. Gynecol Oncol51:78-85, 1993.
`
`76.
`
`Rowinsky EK, McGuire WP, Oonehower RC. The current status of Taxol. Prin Pract
`Gynecol Updates 1:1-16, 1993.
`
`77. Wu LT, Averbuch SO, Ball OW, de Bustros A, Baylin SB, and McGuire WP. Treatment
`of advanced medullary thyroid carcinoma with a combination of cyclophosphamide,
`vincristine and dacarbazine. Cancer 73:432-6, I 994.
`
`78.
`
`Hoskins WJ, McGuire WP, Brady MF, Homesley HD, Creasman WT, Berman M, Ball
`H, and Berek JS. The effect of diameter of largest residual disease after primary
`cytoreductive surgery on survival in patients with suboptimal residual epithelial ovarian
`carcinoma: Am J Obstet Gynecol170(4):974-980, 1984.
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`Exh. 1022
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`79.
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`80.
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`81.
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`82.
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`83.
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`84.
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`Sutton GP, Blessing JA, Homesley HD, McGuire WP and Adcock L. Phase II study of
`ifosfamide and mesna in refractory adenocarcinoma of the endometrium: A Gynecologic
`Oncology Group study. Cancer 73:1453-5, 1994.
`
`Caldas C, Morris LE, McGuire WP. Salvage therapy in epithelial ovarian cancer. Obstet
`Gynecol Clin North Am 21(1); 179-94,1994.
`
`Trimble EL, Arbuck SO, McGuire WP. Options for primary chemotherapy of epithelial
`ovarian cancer: Taxanes. Gynecol Oncol 55(3): 114-121, 1994.
`
`Hurwitz HI and McGuire WP. Primary chemotherapy in epithelial ovarian cancer.
`Obstet Gynecol Clin North Am 21(1):141-54, 1994.
`
`Caldas C, Monis LE, McGuire WP. Salvage therapy in epithelial ovarian cancer. Obstet
`Gynecol Clin North Am 21(1): 179-94, 1994.
`
`Thigpen T, Vance RB, McGuire WP, Hoskins WJ, Brady M. The role of paclitaxel in
`the management of coelomic epithelial carcinoma of the ovary: A review with emphasis
`on the Gynecologic Oncology Group experience. Sem Oncol;22(6):23-31, 1995
`
`85. McGuire WP. Early ovarian cancer: Treat now, later or never? Ann Oncol 6:865-866,
`1995.
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`86.
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`87.
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`88.
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`Qazi F and McGuire WP. The treatment of epithelial ovarian cancer. CA 45:88-101,
`1995.
`
`Horowitz IR, Copas PR, Aaronoff M, Spann CO, McGuire WP. Endometrial
`adenocarcinoma following endometrial ablation for postmenopausal bleeding. Gynecol
`Oncol56:460-463, 1995.
`
`Slichenmyer WJ, Donehower RC, Chen TL, Bowling MK, McGuire WP, and Rowinsky
`EK. Neutropenia and paclitaxel clearance rates: Comparative effects of pretreatment
`cimetidine versus famotidine. Cancer Chemother Pharmacol36:227-232, 1995.
`
`89. McGuire WP, Hoskins WJ, Brady MF, Homesley HD, Creasman WT, Berman ML, Ball
`H, Berek JS, and Woodward J. An assessment of dose intense therapy in suboptimally
`debulked ovarian cancer: A Gynecologic Oncology Group study. J Clin Oncol
`13(7):1589-99, 1.995.
`
`90. Wholey MH, Meyerrose EG, McGuire WP, Reinhardt MJ, Sostre S. Endobronchial
`lesion from metastatic ovarian carcinoma resulting in partial right mainstream obstruction
`demonstrated by lung scintigraphy. Clin Nucl Med 20(5); 465-6, 1995.
`
`91. McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, Clarke-
`Pearson DL, Davidson M. Cyclophosphamide and cisplatin compared with paclitaxel and
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`16
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`cisplatin in patients with stage Ill and stage IV ovarian cancer. N Engl 1 Med 334(1):1-6,
`1996.
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`92.
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`RustinG, Nelstrop A, McClean P, Brady M, McGuire WP, Hoskins W1, Mitchell H,
`Lambert H. Defining response of ovarian carcinoma to initial chemotherapy according to
`serum CA125. 1 Clin Oncol14:1545-1551, 1996.
`
`93. McGuire WP, Hoskins WJ, Brady MF, Kuceras PR, Partridge II EE, Look KY, Clarke-
`Pearson DL, Davidson M. Comparison of combination therapy with paclitaxel and
`cisplatin Versus cyclophosphamide and cisplatin in patients with suboptimal stage Ill and
`stage IV ovarian cancer: A Gynecologic Oncology Group study. Int J Gynecol Cancer
`6:1-7, 1996
`
`94. McGuire WP, Blessing JA, Moore D, Lentz SS , Photopoulos G. Paclitaxel Jhas Moderate
`activity in squamous cervix cancer: A Gynecologic Oncology Group study. J Clin Oncol
`14:792-795, 1996.
`
`95. McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Clark-Pearson DL,
`Davidson M .. Cyclophosphamide and cisplatin versus paclitaxel and cisplatin: a phase Ill
`randomized trial in patients with suboptimal stage ill/IV ovarian cancer. Semin Oncol 23
`(5 Suppl 12):40-47, 1996.
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`96.
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`Bookman MA, McGuire WP, Kilpatrick D, Keenan E, Hogan WM, Johnson SW,
`O'Dwyer P, Rowinsky E, Gallion H, Ozols RF. Carboplatin and paclitaxel in ovarian
`carcinoma: A phase I Study of the Gynecologic Oncology Group. J Clin Oncol 14:1895-
`1902, 1996.
`
`97. McGuire WP, Neugut A, Arikian S, Doyle J, Dezii C,. Analysis of the cost-effectiveness
`of paclitaxel as alternative combination therapy for advanced ovarian cancer. J Clin
`Oncol15:640-645, 1997.
`
`98. McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, Clarke-
`Pearson DL, Davidson M. Comparison of combination therapy with paclitaxel and
`cisplatin versus cyclophosphamjde and cisplatin in patients with suboptimal stagelli and
`stage IV ovarian cancer: A Gynecologic Oncology Group study. Sem Oncol 24
`(1 suppl 2):S2-13-S2-16, 1997.
`
`99. McGuire WP. How many more nails to seal the coffin of dose intensity? Ann Oncol
`8:311-3 13, 1997.
`
`100. Asbury R, Blessing JA, Reid GC and McGuire WP. A phase II trial of amonafide in
`patients with endometrial cancer. Am J Clin Oncol 21:406-407, 1998.
`
`101. McGuire WP. Chemotherapeutic management of ovarian cancer. Cancer Invest 15:29-
`30, 1997.
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`102. O'Reilly S, Fleming GF, Baker 5, Walczak JR, Bookman MA, McGuire WP, Schilder
`RJ, Alvarez RD, Armstrong DK, Horowitz JR. Ozols R, Rowinsky E. A phase I and
`pharmacologic trial of sequences of paclitaxel and topotecan in previously treated
`ovarian epithelial malignancies: A Gynecologic Oncology Group study. J Chn Oncol
`15:177-186, 1997.
`
`103. McGuire WP. Current aspects of adjuvant therapy of early stage ovarian cancer.
`Zentralbl Gynakol 120:93-97, 1998.
`
`104. McGuire WP. High-dose chemotherapy and autologous bone marrow or stem cell
`reconstitution for solid tumors. Curr Probl Cancer 22:133-180, 1998.
`
`105. McGuire WP and Ozols RF. Chemotherapy of advanced ovarian cancer. Semin Oncol
`25:340-348, 1998.
`
`106. Keane TE, El-Galley RE, Sun C, Petros JA, Dillahey D, Gomaa A, Graham SD, and
`McGuire WP. Camptothecin analogues/cisplatin:an effective treatment of advanced
`bladder cancer in a preclinical in vivo mouse system. J Urol 160:252-256, 1998.
`
`107. Markman M, Rose PG, Jones E, Horowitz IR, Kennedy A, Webster K, Belinson J, Fusco
`N, Fluellen L, Kuip B, Peterson G, McGuire WP. Ninety-six hour infusional paclitaxel
`as salvage therapy of ovarian cancer patients previously failing treatment with 3-hour or
`24-hour paclitaxel infusion regimens. J Clin Oncol 16(5); 1849-51, 1998.
`
`108. Robinson JB, Im DD, Logan L, McGuire WP, and Rosenshein NB. Extraovarian
`granulosa cell tumor. Gynecol Oncol 74:123-127, 1999.
`
`109. Bridgewater JA, Nelstrop AE, Rustin GJ, Gore ME, McGuire WP, and Hoskins WJ.
`Comparison of standard orCA 125 response criteria in patients with epithelial ovarian
`cancer treated with platinum or paclitaxel. J Clin Oncol 17:501-508, 1999.
`
`110. Berek JS, Bertelsen K, duBois A, Brady MF, Carmichael J, Eisenhauer E, Gore M,
`Grennian S, Hamilton TC, Hansen SW, Harper PG, Kaye SB, Luck HJ, Lund B,
`McGuire WP, Neijt JP, Ozols RF, Parmar M, Piccart-Gebhart MJ, van Rijswijk R,
`Rosenberg P, RustinG, Sessa C, Trope C, Tuxen MK, Vergote I, Vermorken JB and
`Willemse PHB. Advanced epithelial ovarian cancer: 1998 consensus statements. Ann
`Oncol10 (Suppl1):87-92, 1999.
`
`11 1. McGuire WP, Brady MF, and Ozols RF. The Gynecologic Oncology Group experience
`in ovarian cancer. Ann Oncol 10 (Suppl 1):29-34, 1999.
`
`112. Marrano NN, Blevins LS, Gal AA and McGuire WP. Pancreatic polypeptide
`hypersecretion associated with a neuroendocrine carcinoma of the gallbladder. Am J Med
`Sci 3 17:55-58, 1999.
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`113.
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`Piccart MJ and McGuire WP. ICON2 Trial. Lancet 353:587, 1999.
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`18
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`114. McGuire WP, Blessing JA, Bookman MA, Lentz SS and Dunton CJ. Topotecan has
`substantial antitumor activity as first-line salvage therapy in platinum-sensitive epithelial
`ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol 18:1062-1067, 2000.
`
`115. Berek JS, Bertelsen K, duBois A, Brady MF, Carmichael J, Eisenhauer EA, Gore M,
`Grenman 5, Hamilton TC, Hansen SW, Harper PG, Horvath G, Kaye SB, Luck HJ, Lund
`B, McGuire WP, Neijt JP,.