GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Guidelines For Investigator Initiated Study Proposa...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

problem, with average positive margin rates of 10% ...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America


Methods:
Study Design               This will be a...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Statistical Analysis       Student t-tests will be ...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

          biochemical recurrence in relation to ner...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Kings College                                      ...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

1990-1991                Clinical Fellow (Urology),...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Executive Committee - Chicago Urological Society - ...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Department of Community Health Sciences            ...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

The AMC is the oldest mountaineering/conservation o...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

The Irving J. Shapiro Award - Dedicated to a physic...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America


Principal Investigator: David M. Albala, M.D.: Lap...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Principal Investigator: David M. Albala, M.D., Opti...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Urology                                            ...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Laparoscopic Urology - Tulane University Medical Sc...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Albala, D.M., Turk, M.T., Fulmer, B.R., et al: Peri...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

for the management of ureteral and ureteropelvic ju...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Monk, T.G., Albala, D.M., Diaz, Y., Clayman, R.V., ...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Albala, D.M.: Clayman, R.V.: Commentary: Percutaneo...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Fulmer, B., Turk, T., Albala, D.M., et al.: Extraco...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America


Kumar, U. and Albala, D.M.: Urinary Tract Obstruct...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Albala, D.M.: Stenting Prior to ESWL - Complication...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America


McKay, T. and Albala, D.M.: Laparoscopic Ureteral ...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Medical College of Virginia, Richmond, Virginia—Lap...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Dartmouth-Hitchcock Medical Center, Hanover, New Ha...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

The Mellineum Urological Meeting, Delhi, India, Nov...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America


14th World Congress of Endourology and Shock Wave ...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Curso Internacional - Advances in Urologia, Hospita...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

Appendix B: Curriculum Vitae of James O. L’Esperanc...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America


Appendix C: Curriculum Vitae of Jeffrey C. Sung

 ...
GlaxoSmithKline
Clinical Development & Medical Affairs, North America

6/96-9/96          Research Intern
                ...
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Dutasteride GSK proposal.doc.doc

  1. 1. GlaxoSmithKline Clinical Development & Medical Affairs, North America Guidelines For Investigator Initiated Study Proposals Prior to submitting a complete protocol, please submit a letter of intent or brief study proposal. A multi-disciplinary committee reviews all submissions. Proposals not adhering to the appropriate format will not be reviewed. Following review of the study proposal, the investigator will be notified whether the proposed research study will be supported. The committee may recommend changes to the protocol or may request further information before a final decision is made. The investigator must comply with all regulatory requirements (including IRB approval and filing a Sponsor-Investigator IND, when needed). The letter of intent or brief study proposal should be directed to the appropriate GSK contact. Electronic versions are preferred. Communication with the GSK contact prior to submission, to determine whether the proposed study is of interest and/or duplicates current projects, is advised. Your proposal should include the following information: Name of Investigator: David M. Albala, M.D. Name of Sub-Investigators Involved In The Conduct of The Proposed Study: James O. L’Esperance, M.D. Jeffrey C. Sung Name of Institution: Duke University Medical Center Division of Urology Address of Institution: Box 3457 Medical Center Durham, NC 27710 Phone:919 668 6401 FAX: 919 681 7423 Email: albal002@mc.duke.edu Title of Proposal: The Effect of Two Weeks of Dutasteride Pretreatment on Blood Loss and Surgical Margins in Radical Prostatectomy Scientific Rationale for Study / Scientific Study Objectives: Blood loss during radical prostatectomy is a major cause of surgical morbidity that may result in longer hospital stays and increased expense. In literature reviews, the retropubic approach, which is currently the most common, has been associated with blood losses ranging from 500 to 7700 mL and transfusion rates of 26.2% to 89%1,2,17. Even the laparascopic approach, which is generally associated with the least blood loss, has been found in large series to carry an average blood loss of 380 ml and a transfusion rate of 4.9%16. The transfusion of allogenic blood products carries the additional risks of HIV, Hepatitis C and transfusion reactions. Recent studies have shown that pretreatment with 5-a-reductase inhibitors, ranging from 2 weeks to 4 months, reduces blood loss in transurethral prostatectomy (TURP)4,5,6. However, no studies have investigated the potential for 5-a-reductase inhibitors to reduce blood loss in radical prostatectomy. With only 2 to 3 mm of periprostatic tissue between the prostate and other pelvic structures, positive surgical margins following radical prostatectomy for prostate cancer also remain a major 1
  2. 2. GlaxoSmithKline Clinical Development & Medical Affairs, North America problem, with average positive margin rates of 10% to 30% following radical retropubic prostatectomy8,9,10,11. Positive surgical margins are associated with higher rates of biochemical, local and systemic progression11,13, and frequently require radiation therapy that can lead to erectile dysfunction, incontinence, rectal symptoms, hematuria and bladder symptoms. Recent studies have shown that 5-a-reductase inhibitors may have a role in the prevention and adjuvant treatment of prostate cancer14,15. Nevertheless, no studies have looked at pretreatment with 5-a- reductase inhibitors to reduce the frequency of positive margins in prostate cancer. The objectives of this study are twofold: to examine the effect of 2 weeks of pretreatment with dutasteride on intraoperative blood loss and positive margin rates in radical prostatectomy. Two weeks of pretreatment should be enough to garner the benefits of dutasteride, without delaying surgical therapy. 2
  3. 3. GlaxoSmithKline Clinical Development & Medical Affairs, North America Methods: Study Design This will be a double-blind, randomized, placebo-controlled, single- center, parallel group pilot study approved by the local institutional review board. After screening and providing written informed consent, all patients with prostate cancer who are scheduled for radical prostatectomy will be randomly allocated to receive pretreatment with either dutasteride 0.5 mg once daily or placebo for 2 weeks before radical prostatectomy. A routine hematologic analysis will be performed immediately pre-operatively, post-operatively in the recovery room and the next morning. A prostate-specific antigen measurement will also be performed prior to pretreatment. Estimated blood loss during surgery will be calculated in the standard fashion. All specimens will be sent to pathology for analysis of tumor volume and margin status following surgery. The weight and volume of the resected prostate will also be noted along with the volume of tumor and margin status. Inclusion / Exclusion Patients will be included if they have prostate cancer and are scheduled for open or laparoscopic radical prostatectomy. Patients on aspirin will be included. Patients with renal impairment, defined as serum creatinine greater than 150 umol/L, will be excluded due to its effect on blood clotting. Number of Patients This study will contain a total of 50 patients with 25 patients in each arm. Projected Enrollment Proposed start date – November 2003 Timeline (proposed Anticipated finish date – November 2004 start date, proposed Anticipated enrollment rate – 4 to 5 patients per month finish date, anticipated enrollment rate) Drug Dose 0.5 mg dutasteride once daily for 2 weeks preoperatively and continued (doses, dosing, at 0.5 mg once daily for 1 week postoperatively frequency, duration) Study Endpoints/ The study will be concluded after 50 patients have completed 2 weeks Objectives of pretreatment with dutasteride or placebo and have undergone radical prostatectomy. Data Analysis: Study Variables Intraoperative blood loss (Clinical procedures, Pre-operative hemoglobin levels and hematocrit laboratory tests, safety Post-operative recovery room hemoglobin levels and hematocrit assessments) Next morning hemoglobin levels and hematocrit Units of blood transfused if any Resected prostate volume and weight Pre-operative PSA Surgical margins as assessed by pathologist Outcome Parameters / The primary endpoints will be measurement of intraoperative blood Analytical Endpoints loss, transfusion rates, tumor weight and volume, and pathological assessment of surgical margins. 3
  4. 4. GlaxoSmithKline Clinical Development & Medical Affairs, North America Statistical Analysis Student t-tests will be used to evaluate differences in the means of Plan continuous variables. Chi-square tests will be used to analyze categorical variables. Publication / Presentation Plan: A manuscript will be prepared for submission to a professional journal. Estimated Study Budget/Requested Support from GSK (per patient cost, study medication, other supplies): Funding requested from any other source? No:__X___Yes:____If yes, give details (e.g. specify if another portion of the study budget is to be covered by a NIH grant): Note – Please attach your current curriculum vitae Investigator Signature _______________________________________ Date _____________________ References: 1. Ness PM, Walsh PC, Zahurak M, Baldwin ML, Piantadosi S. Prostate cancer recurrence in radical surgery patients receiving autologous or homologous blood. Transfusion. 1992;32:31-36. 2. Oefelein MG, Colangelo LA, Rademaker AW, McVary KT. Intraoperative blood loss and prognosis in prostate cancer patients undergoing radical retropubic prostatectomy. J Urol. 1995;154(2, pt 1):442-447. 3. Nuttall GA. Cragun MD. Hill DL. Morris TJ. Decker PA. Blute ML. Patterson DE. Warner DO. Radical retropubic prostatectomy and blood transfusion. Mayo Clinic Proceedings. 77(12):1301-5, 2002 Dec. 4. Donohue JF. Sharma H. Abraham R. Natalwala S. Thomas DR. Foster MC. Transurethral prostate resection and bleeding: a randomized, placebo controlled trial of role of finasteride for decreasing operative blood loss. Journal of Urology. 168(5):2024-6, 2002 Nov. 5. Sandfeldt L. Bailey DM. Hahn RG. Blood loss during transurethral resection of the prostate after 3 months of treatment with finasteride. Urology. 58(6):972-6, 2001 Dec. 6. Hagerty JA. Ginsberg PC. Harmon JD. Harkaway RC. Pretreatment with finasteride decreases perioperative bleeding associated with transurethral resection of the prostate. Urology. 55(5):684-9, 2000 May. 7. Parek G. Shevchuk M, ArmenakasThe effect of finasteride on the expression of vascular endothelial growth factor and microvessel density: a possible mechanism for decreased prostatic bleeding in treated patients. J. Urol. 2003 Jan; 169(1):20-3 8. Wieder JA, Soloway MS: Incidence, etiology, location, prevention and treatment of positive surgical margins after radical prostatectomy for prostate cancer. J Urol 160:299-315, 1998 9. Watson RB, Civantos F, Soloway MS: Positive surgical margins with radical prostatectomy: Detailed pathologic analysis and prognosis. Urology 48:80-90, 1996 10. Steele GS, Richie JP: Understanding and avoiding positive margins in prostate cancer. AUA Update Series 20:1-8, 2001 11. Cheng L, Darson ME, Bergstralh EJ, et al: Correlation of margin status and extraprostatic extension with progression of prostate carcinoma. Cancer 86:1775-1782, 1999 12. Sofer M. Hamilton-Nelson KL. Schlesselman JJ. Soloway MS. Risk of positive margins and 4
  5. 5. GlaxoSmithKline Clinical Development & Medical Affairs, North America biochemical recurrence in relation to nerve-sparing radical prostatectomy. Journal of Clinical Oncology. 20(7):1853-8, 2002 Apr 1 13. Catalona WJ, Smith DS: 5-year tumor recurrence rates after anatomical radical retropubic prostatectomy for prostate cancer. J Urol 152:1837-1842, 1994 14. Thompson IM, Goodman PJ, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med. 2003 July 17; 349 (3):215-24 15. Andriole G. Lieber M. Smith J. Soloway M. Schroeder F. Kadmon D. DeKernion J. Rajfer J. Boake R. Crawford D. et al. Treatment with finasteride following radical prostatectomy for prostate cancer. [Clinical Trial. Journal Article. Randomized Controlled Trial] Urology. 45(3):491-7, 1995 Mar. 16. Guillonneau B. Rozet F. Cathelineau X. Lay F. Barret E. Doublet JD. Baumert H. Vallancien G. Perioperative complications of laparoscopic radical prostatectomy: the Montsouris 3-year experience. [Journal Article] Journal of Urology. 167(1):51-6, 2002 Jan. 17. Salomon L. Levrel O. de la Taille A. Anastasiadis AG. Saint F. Zaki S. Vordos D. Cicco A. Olsson LE. Hoznek A. Chopin D. Abbou CC. Radical prostatectomy by the retropubic, perineal and laparoscopic approach: 12 years of experience in one center. [Journal Article] European Urology. 42(2):104-10; discussion 110-1, 2002 Aug. Appendix A: Curriculum Vitae of David M. Albala CURRICULUM VITAE NAME: David Mois Albala, M.D., F.A.C.S. HOME ADDRESS: OFFICE ADDRESS: 904 Bayberry Drive Duke University Medical Center Chapel Hill, NC 27517 Department of Surgery (919) 942-9415 Division of Urology E-mail: dmalbala@aol.com DUMC Box 3457 Rm. 1112 Green Zone Davison Bldg. Trent Drive Durham, NC 27710 (919) 684-5416 (Direct Line) (919) 681-7423 (Fax) E-mail: albal002@mc.duke.edu WIFE: Francine A. Salerno 10/23/99 DATE AND PLACE OF BIRTH: December 29, 1955; Chicago, IL SOCIAL SECURITY NUMBER: 035-40-5462 EDUCATION: Michigan State University M.D. College of Human Medicine June 1983 East Lansing, Michigan 48824 Brown University Program in Medicine Student Providence, Rhode Island 02912 1979 - 1981 Lafayette College A.B. Honors in Geology Easton, Pennsylvania 18042 June 1978 Harvard University Visiting Scholar Cambridge, Massachusetts 02138 1977 5
  6. 6. GlaxoSmithKline Clinical Development & Medical Affairs, North America Kings College English Speaking Union Taunton, Somerset, England Scholarship, 1974 POST DOCTORAL TRAINING: 1990 - 1991 Fellow in Endourology and Stone Disease, Barnes Hospital, Washington University School of Medicine, St. Louis, Missouri 63108 (under the direction of Ralph V. Clayman, M.D.) 1989 - 1990 Chief Resident, Urology, Dartmouth-Hitchcock Medical Center Hanover, New Hampshire 03756 1989 Senior Resident, Pediatric Urology, Massachusetts (Jan-March) General Hospital Boston, Massachusetts 02114 (under the direction of Patricia K. Donahoe, MD) 1988 - 1989 Senior Resident, Urology, Dartmouth-Hitchcock Medical Center Hanover, New Hampshire 03756 1987 - 1988 Research Resident, Urology, Dartmouth-Hitchcock Medical Center Hanover, New Hampshire 03756 (area of concentration: drug-induced nephrolithiasis) 1986 - 1987 Junior Resident, Urology, Dartmouth-Hitchcock Medical Center Hanover, New Hampshire 03756 1984 - 1985 Junior Resident, General Surgery, Dartmouth-Hitchcock Medical Center Hanover, New Hampshire 03756 1983 -1984 Intern, General Surgery, Dartmouth-Hitchcock Medical Center Hanover, New Hampshire 03756 ACADEMIC APPOINTMENT: 2001-Present Professor, Divison of Urology, Duke University Medical Center, Durham, North Carolina 27710 2001-Present Staff Urologist, Veterans Administration Hospital, Durham, North Carolina 27710 1999-2001 Professor, Department of Urology and Radiology, Loyola University, Strich School of Medicine, Maywood, Illinois 60153 1991-2001 Staff Urologist, Veterans Administration Hospital Hines, Illinois 60141 1994.1999 Associate Professor, Department of Urology, Loyola University, Stritch School of Medicine, Maywood, Illinois 60153 1995-1996 Associate Professor, Department of Urology, George Washington Medical Center, Washington, DC 20008 1992.1994 Assistant Professor, Department of Urology, Loyola University Stritch School of Medicine, Maywood, Illinois 60153 1991-1992 Instructor, Department of Urology, Loyola University Stritch School of Medicine, Maywood, Illinois 60153 6
  7. 7. GlaxoSmithKline Clinical Development & Medical Affairs, North America 1990-1991 Clinical Fellow (Urology), Washington University School of Medicine, St. Louis, Missouri 63110 1989-1990 Clinical Instructor (Urology), Dartmouth Medical School, Hanover, New Hampshire 03756 FELLOWSHIP DIRECTOR: 2001-Present Co-Director of the Duke University Endourology Fellowship Program, approved by the Endourological Society 1996-2001 Director of The Loyola University Endourology Fellowship Program, approved by the Endourological Society LICENSURE/CERTIFICATION: State of North Carolina, 2001-current (2002-01164) State of New Hampshire, 1984 - 2002 (#7609) State of Illinois, 1991-2002 (036-083171) State of New York, 1993 - 1995 (193729) State of Vermont, 1984 - 1998 (#42-0007234) State of Missouri, 1990-1991 (T-17094) State of Massachusetts, 1989 - 1990 (#967768) Basic Cardiac Life Support - 1984 - current Advanced Trauma Life Support - 1984 - current Advanced Cardiac Life Support Instructor - 1986 - current Advanced Life Support - 1985 - current Federal Licensing Examination (FLEX) - 1984 Extracorporeal Shock Wave Lithotripsy (Dornier)- Mass. General Hosp. 1989 Extracorporeal Shock Wave Lithotripsy (Lithostar) - Barnes Hospital - 1990 Urological Laser Certification - Pulse-Dye, Nd-Yag, Indigo, Holmium, CO2-1991 American Board of Urology (Parts I and II) - certified- 1994; re-certified 2001 PROFESSIONAL MEMBERSHIPS/COMMITTEES: Admissions Committee—Duke University Medical School—2002-present American Medical Foundation - 2000 -present American Urological Association - 1986-present American College of Surgeons (Fellow) - 1988 -present American Medical Association - 1988-present American Association for the Advancement of Science - 1989-present American Public Health Association - 1985-present Endourological Society - 1990-present Society for Minimally Invasive Therapy - 1991-present American Association of Clinical Urologists - 1992-present Society of University Urologists - 1992-present Societe Internationale d'Urologie - 1993-present Society for Urology and Engineering - 1992 - present Medical Advisory Committee - American Telemedicine - 1993-present Admission Committee - Loyola Stritch School of Medicine 1994-2001 Medical Record Committee - Loyola University Med. Ctr. - 1993-2001 Surgical Pathology Committee Loyola University Med. Ctr. - 1992-2001 Health Policy Committee, American Urological Association - 1995-1998, 2000-2001 Chicago Urological Society - 1991-2001 7
  8. 8. GlaxoSmithKline Clinical Development & Medical Affairs, North America Executive Committee - Chicago Urological Society - 1996-2001 Illinois State Urological Society - 1991 -2001 Loyola University Physician Foundation (LUPF) Board Member - 1997-2000 Medical Advisory Committee - Day Surgi Center - 1993-1996 Blood Usage Committee - Loyola University Med. Ctr. - 1992-1998 Grafton County Medical Society - 1986-1990 New Hampshire Urological Society - 1986-1990 Appalachian Mountain Club - Search and Rescue Committee - 1983-1990 Health Advisory Committee - Vermont March of Dimes - 1989-1990 EMPLOYMENT: Division of Urology Professor of Urology Duke University Medical Center 2001-Present Room 1112, Green Zone, DUMC Box 3457 Durham, NC 27710 Director of minimally invasive urologic surgery at a large academic teaching hospital. Involved with endoscopic and laparoscopic surgery, patient care, and resident/medical student education. Engaged in all aspects of laparoscopic and endourological research. Department of Urology Instructor in Urology Loyola University Medical Center 1991-1992 Stritch School of Medicine Assistant Professor of Urology 2160 South First Avenue 1992-1994 Maywood, Illinois 60153 Associate Professor of Urology 1994-1999 Professor of Urology and Radiology 1999-2001 Responsible for the Endourology service at an academic teaching hospital. Involved with endoscopic and laparoscopic surgery, patient care, and resident/medical student education. Currently engaged in laparoscopic and ureteral healing research, as well as uses of fibrin glue in urology. White House Fellowship Office White House Fellow 712 Jackson Place, NW 1995 - 1996 Washington, DC 20503 Served as a special assistant to the Secretary of Transportation, Federico Pena. Responsible for writing speeches, drafting and reviewing proposed legislation answering Congressional inquiries, chairing meeting and conducting briefings. Participated with the Secretary and administration heads on matters pertaining to project plans and policies. Worked on health related issues in the Department of Transportation, both classified and unclassified. Department of Urologic Surgery Endourology Fellow Washington University School of Medicine 1990 - 1991 4960 Children's Place St. Louis, Missouri 63110 Served as the Extracorporeal Shockwave Lithotripsy (ESWL)/Endourology fellow. Responsibilities included patient care, surgery, medical student/resident teaching and research in laparoscopic surgical techniques. 8
  9. 9. GlaxoSmithKline Clinical Development & Medical Affairs, North America Department of Community Health Sciences Special Assistant to the Aga Khan University and Medical College Chairman P.O. Box 3500 Karachio-5, Pakistan 1985 - 1986 Assisted the departmental chairman in managing a complex agenda in a highly dynamic environment - facilitated administrative, academic, and external activities and relationships including developing proposals for external support. Participated in teaching, fieldwork, and direct patient care. Involved in developing primary health care programs for the squatter settlements in urban Karachi. Mount Ascutney Hospital, Windsor, Vermont Emergency Room Northeast Rehab. Hospital, Salem New Hampshire Physician Brattleboro Hospital, Brattleboro, Vermont 1985 - 1991 Rockingham Hospital, Bellows Falls, Vermont Served as a physician in the emergency room. Responsibilities included direct patient care and providing emergency services to the hospital in-patients. Served as a coordinator of the emergency room physician at Mount Ascutney Hospital for four years and served as coordinator of physicians at Northeast Rehabilitation Hospital for five years. Rhode Island Hospital Laboratory Assistant Department of Pathology 1980 Providence, Rhode Island 02945 Assisted in various aspects of surgical and anatomical pathology. Duties included sectioning tissues for various microscopic examinations, photography, and autopsies. Rhode Island Department of Health Researcher Division of Epidemiology, Room 105 1979 (summer) Health Building Providence, Rhode Island 02908 Involved in a rubella research program involving college-aged women. Responsibilities included assessing the impact of a new Rhode Island state law, setting up immunization programs, and handling problems that developed. Brandt Associates, Inc. Laboratory Technician P.O. Box 81 1978 - 1979 Martins Creek, Pennsylvania 18063 Involved in various aspects of water and wastewater testing from the chemical and biological standpoints. Duties included designing a quality control system for the lab, data interpretation, computer work, and routine analyses. Lafayette College Laboratory Instructor Department of Geology 1976 - 1978 Easton, Pennsylvania 18042 Served as a laboratory instructor in an upper level geology course (mineralogy). Responsible for setting up demonstrations, giving lectures, and writing exams. Appalachian Mountain Club Hutmaster/Hutboy Pinkham Notch Camp 1973 - 1976 Summers Gorham, New Hampshire 03581 Involved in operating a mountain hostel in the White Mountains. Duties included packing food supplies, cooking for up to ninety guests, developing mountain education programs and mountain rescue programs. 9
  10. 10. GlaxoSmithKline Clinical Development & Medical Affairs, North America The AMC is the oldest mountaineering/conservation organization in the country. I also worked at their main office in Boston, Massachusetts. AWARDS/DISTINCTIONS: Adolph A. Kutzman Visiting Professor (Cedars-Sinai Medical Center), Los Angeles, CA, November, 2002 Guest Professor, Chi Mei Medical Center, Tainan, Taiwan, May, 2002. Visiting Professor, University of Arkansas Medical Center, April , 2002. Visiting Professor, Medical University of South Carolina (Kenneth M. Lynch Memorial Visiting Professorship), Charleston, South Carolina, November, 2001. Visiting Professor, Singapore General Hospital, Singapore, September, 2001. Visiting Professor, Medical College of Wisconsin, June, 2001. Visiting Professor, Italian Urological Association, Sardenia, Italy, May, 2001. Visiting Professor, Pakistan Urological Association, Karachi, Pakistan, February, 2001. Selected as one of the “Top Doctors in the Chicago Area” as chosen by their peers. Chicago Magazine, January, 2001. Selected as one of the “Best Doctors in America” by peers. Castle Connolly Medical Ltd., Chicago, Illinois, January 2001. Visiting Professor, Icelandic Urological Association, Reykjavik, Iceland, October 2000. 2000 Pfizer/American Urological Association, Visiting Professorship in Urology, June, 2000. Selected as an Outstanding Physician in the Chicago Metropolitan Area: How to Find The Doctors: Chicago Metropolitan Area, Castle Connolly Medical Ltd, Chicago, IL, March, 2000. Visiting Professor, San Diego Naval Hospital, San Diego, California, July, 1999. The Irving J. Shapiro Award - Dedicated to a physician who has performed outstanding service in the urogram conference of the Chicago Urological Society. April, 1999. Visiting Professor, University of Miami, Miami, Florida, March, 1999. Selected as one of the “Top Doctors in the Chicago Area” as chosen by their peers. Chicago Magazine, January, 1997. The Irving J. Shapiro Award - Dedicated to a physician who has performed outstanding service in the urogram conference of the Chicago Urological Society. April, 1997. Judge - The 29th Annual Washington Urological Society’s Resident Scholars Conference, Washington, D.C., February, 1996. White House Fellowship - Selected to spend a year in Washington, D.C. as a special assistant to Federico Pena. June, 1995. Alf H. Gunderson, M.D. Memorial Lecturer - Selected to deliver this memorial lecture at the Gunderson Clinic, LaCrosse, Wisconsin, September, 1995. 10
  11. 11. GlaxoSmithKline Clinical Development & Medical Affairs, North America The Irving J. Shapiro Award - Dedicated to a physician who has performed outstanding service in the urogram conference of the Chicago Urological Society. April, 1995. Visiting Professor, University, University of Florida, Gainesville Fl., March, 1995. Visiting Professor, Tulane University, New Orleans, LA, November, 1994. Visiting Professor, University of California, San Diego, CA, October, 1992. American College of Surgeons Cine-Clinic Award - Laparoscopic Adrenalectomy, October, 1994. Video Urology Award - Laparoscopic Adrenalectomy, August, 1994 Endourological Society Resident/Fellow Award - 2nd place: "Extracorporeal Shock Wave Lithotripsy (ESWL) for Ureteral Calculi: To Stint or Not to Stint." June, 1991. New Hampshire Chapter of the American College of Surgeons Best Trauma paper: "Urological Injury and Assessment in Patients with Pelvic Fractures." January, 1989. New Hampshire Chapter of the American College of Surgeons Best Trauma paper: "Bladder Rupture: A Review of 42 Cases." March, 1988. Awarded the Yoshioka Japan Hospital Association Fellowship (through the International Hospital Federation) to study primary health care programs in selected third world cities. US $4,000 March, 1986. Medical Expedition to eastern Nepal with the Johns Hopkins University and the Woodlands Institute. Involved in a health survey of a village in eastern Nepal as well as in developing a field clinic. April, 1983. GRANTS: Photocure Grant. Principal Investigator: David M. Albala, M.D. Principal Investigator: David M. Albala, M.D.: A Randomized, Comparative, Post-Market Evaluation of Symptoms and Discomfort Associated with an Indwelling Ureteral Stent. Awarded $7,000 by Boston Scientific Corporation, Natick, Massachusetts, February, 2001. Principal Investigator: David M. Albala, M.D.: Flow Characteristics of the Lithostent. Awarded $20,000 by ACMI/Circon, Inc., Norwalk, Connecticut, January, 2001. Principal Investigator: David M. Albala, M.D. : Vaginal Thermotherapy for the Treatment of Urinary Incontinence. Awarded $30,000 by SURX, Pleasanton, California, September, 2000. Principal Investigator: David M. Albala, M.D.: Medstone STS-T Lithotriptor. Awarded $25,000 by Medstone, Inc., San Francisco, California, May, 2000. Principal Investigator: David M. Albala, M.D.: Nephro-Step : A New Device for Percutaneous Access. Awarded $5,000 by Innerdyne, San Francisco, California, March 2000. Principal Investigator: David M. Albala, M.D.: A New Laparoscopic Procedure for the Treatment of Urinary Incontinence. Awarded $50,000 by SURX, Pleasanton, California, April, 1999. Principal Investigator: David M. Albala, M.D.: A New Ureteral Stent. Awarded $10,000 by ACMI/Circon Inc., Norwalk, Connecticut, February, 1998 Principal Investigator: David M. Albala, M.D.: Thermotherapy Treatment for Benign Prostatic Hypertrophy. Awarded $75,000 by Thermatrix, Chicago, Illinois, January, 1997. 11
  12. 12. GlaxoSmithKline Clinical Development & Medical Affairs, North America Principal Investigator: David M. Albala, M.D.: Laparoscopic Ureteral Reanastomosis using Fibrin Glue. Awarded $15,000 by The National Kidney Foundation of Illinois. Chicago, Illinois, November, 1992. Principal Investigator: David M. Albala, M.D.: Contact Nd: YAG Laser Prostatectomy in the Canine Model. Awarded $12,000 by Surgical Laser Technology, Oaks, Pennsylvania. June, 1992. Principal Investigator: David M. Albala, M.D., Co-Investigator: Mansel Kevwitch, M.D.; Laparoscopic Ureteral Reanastomosis Awarded $5,000 by Ethicon Endosurgical Institute, Cincinnati, Ohio. March, 1992. Principal Investigator: Department of Community Health Sciences, Aga Khan University and Medical College; The Aga Khan University Scholars in Community Health Sciences: A Career Development Program for Physicians and Nurses in Pakistan. Co-authored with Dr. John Bryant. Awarded C $1,110,000 by the Canadian International Development Agency, Canada, for a four-year project. November 1986. Principal Investigator: Department of Community Health Sciences, Aga Khan University and Medical College; A Proposal for a Primary Health Care Pilot Program in the Northern Areas of Pakistan. Co- authored with Dr. John Bryant, Dr. Eugene Boostrom, and Ms. Shameela Karmali. Awarded US $302,467 by the Aga Khan Foundation, Geneva and USAID, Washington, D. C. for a two-year project. July, 1986. Principal Investigator: Department of Community Health Sciences, Aga Khan University and Medical College; A Proposal for Studying Health and Health Services and for Developing Initiatives in Thatta District. Co-authored with Dr. John Bryant. Awarded C $253,416 by the International Development Research Center, Canada for a three-year study. September, 1986. Principal Investigator: Department of Community Health Sciences, Aga Khan University and Medical College; The Sequential Development of Primary Health Care Modules in Katchi Abadies and Other Low Income Settlements of Urban Karachi. Co-authored with Dr. John Bryant. Awarded US $503,147 by the Aga Khan Foundation, Geneva, for a three-year study. February, 1986. RESEARCH PROJECTS: Principal Investigator: David M. Albala, M.D., Lower Pole II: A Prospective Randomized Trial of Ureteroscopy and Percutaneous Nephrostolithotomy for Lower Pole Nephrolitiasis. Study conducted at Loyola University Medical Center and Duke University Medical Center, 2000-present. Principal Investigator: David M. Albala, M.D., Flow Characteristics of the Lithostent. Study conducted at Loyola University Medical Center 2000 - 2001. Principal Investigator: David M. Albala, M.D., A Randomized, Comparative, Post-Market Evaluation of Symptoms and Discomfort Associated with an Indwelling Ureteral Stent. Study conducted at Loyola University Medical Center and other academic medical centers, 2000 - 2001. Principal Investigator: David M. Albala, M.D., Medstone STS-T: A Multi-institutional Study. Study conducted at Loyola University Medical Center and other academic medical centers, 2000 - 2001. Principal Investigator: David M. Albala, M.D., Vaginal Thermotherapy for the Treatment of Urinary Incontinence. Study conducted at Loyola University Medical Center, 2000 - 2001. Principal Investigator: David M. Albala, M.D., Thermotherapy Treatment for Benign Prostatic Hypertrophy (Multi-Institutional Randomized Study). Study conducted at Loyola University Medical Center and other academic medical centers, 1998 - 2000. 12
  13. 13. GlaxoSmithKline Clinical Development & Medical Affairs, North America Principal Investigator: David M. Albala, M.D., Optimal Therapy for Middle and Distal Calculi (Multi- Institutional Randomized Study) Study conducted at LUMC and other academic medical centers, 1995 - 2000. Principal Investigator: David M. Albala, M.D., Lower Pole I: A Prospective Randomized Trial of Extracorporeal Shock Wave Lithotripsy and Percutaneous Nephrostolithotomy for Lower Pole Nephrolithiasis. Study conducted at Loyola University Medical Center and other academic medical centers, 1997 – 2000. Principal Investigator: David M. Albala, M.D., A New Laparoscopic Procedure for the Treatment of Urinary Incontinence. Study conducted at Loyola University Medical Center and other academic medical centers, 1999 - 2000. Principal Investigator: David M. Albala, M.D., Evaluation of a New Model Ureteral Stent. Study conducted at Loyola University Medical Center. 1999 - 2000. Principal Investigator: David M. Albala, M.D., Direx Tripter X1 Lithotripter: Fragmentation of Upper Urinary Stones. (FDA Trial - Project # 0051) Study conducted at LUMC, 1992-1996. Principal Investigator: David M. Albala, M.D., Leonard Gomella, M.D. and Douglas Milam, M.D.: Contact Nd: YAG Laser Prostatectomy in the Canine Model. (Surgical Laser Technology, Inc. Study #B243-0). Study conducted at LUMC, 1992-1993. Principal Investigator: David M. Albala, M.D. Fluoroscopically Controlled Incision of Upper Urinary Tract Strictures. (Applied Urology, Inc Study #C91-002) Study conducted at LUMC, 1991-1993. Principal Investigator: Stuart M. Selikowitz, M.D. Co-Investigator: David M. Albala, M.D. Informed Patient Decision-Making in Patients with BPH: Pilot Project. A pilot benign prostate hypertrophy informed patient decision-making program (IPDP) conducted at the Veterans Administration Hospital, White River Junction, VT, in conjunction with the Dartmouth Medical School Department of Community Medicine, 1989 - 1991. Principal Investigator: John A. Heaney, M.D. Co-Investigator: David M. Albala, M.D. Phase III - Patient preference and quality of life in metastatic prostate carcinoma: Zoladex versus orchiectomy. (Stuart Pharmaceuticals ZOL - 7-624-3) - Study conducted at Dartmouth-Hitchcock Medical Center, 1987 - 1990. Principal Investigator: John A. Heaney, M.D. Co-Investigator: David M. Albala, M.D. Phase III - Long- term efficacy and safety of Terazosin in the treatment of the symptoms of benign prostatic hypertrophy. (Abbott Laboratory Protocol Number M87-006) - Study conducted at Dartmouth-Hitchcock Medical Center, 1987 - 1990. JOURNALS: EDITORIAL BOARD: Journal of Endourology – Editorial Board 2001 - present Urology Index & Reviews - Editor 1997 – present Current Opinion in Urology-Editorial Board 2001- present Techniques in Urology - Editor in Chief* 1994 – 2002 *Techniques in Urology was accepted in Medline in 1996, two years after its inception. JOURNALS: REVIEWER/ABSTRACTOR 13
  14. 14. GlaxoSmithKline Clinical Development & Medical Affairs, North America Urology 1994 - present Obstetrics and Gynecology 1994 - present Journal of Urology 1992- present Journal of Endourology 1990 - present Surgery, Gynecology, and Obstetrics 1990 – present British Journal of Urology 2000-present COURSES: PROGRAM DIRECTOR Hand Assisted Laparoscopic Urological Surgery—Duke University Medical Center, March 2002; April 2002; May 2002; June 2002; August 2002; September 2002; October 2002; November 2002; December 2002; January 2003; April 2003. Urological Laparoscopy-American College of Surgeons Clinical Congress, October, 2001. Hand Assisted Laparoscopic Urological Surgery - Loyola University Medical Center, August, 2000; September, 2000; October, 2000; December 2000; January 2001; March, 2001; April, 2001; September, 2001. Management Strategies for the Treatment of UPJ Obstruction - American Urological Association, June, 1998; June 1999. New Horizons in Urology - Loyola University Medical Center; February, 1992; October, 1992; May, 1993. FACULTY Laparoscopic Urological Surgery—American Urological Association Annual Review Course (Chicago), March 2002; May 2003. Annual International Course on Urological Laparoscopic Surgery, Medical University of Ribeirao Preto, Brazil, July 2001; September, 2001. Hand-Assisted Laparoscopy- American Urological Association; February, 2001. Hand- Assisted Laparoscopic Urological Surgery - Ethicon Endosurgical Institute; November, 2000; May, 2001; October 2001; March 2002. Laparoscopic Urology - Brazilian Urological Association; November, 2000. Frontiers in Endourology - Washington University School of Medicine; June, 1991; June, 1992; July, 1994. Lasers and Laparoscopy in Urology - New Jersey Laser Institute; September, 1991. Laparoscopic Surgery - University of Minnesota Medical Center; October, 1991. Minimally Invasive Surgery - Thomas Jefferson Medical School; May, 1992; July, 1992; August 1995. Laparoscopic Surgery - Harvard Medical School; April, 1992. 14
  15. 15. GlaxoSmithKline Clinical Development & Medical Affairs, North America Laparoscopic Urology - Tulane University Medical School; November, 1991; February, 1992; May, 1992, March, 1993, September 1993, November 1994. Laparoscopy in Urology - New York University Medical School; December, 1991; March, 1992; June, 1992; December, 1992; May 1993, July 1994. Laparoscopic Urology - Cornell University Medical Center; February, 1992; May, 1992; September, 1992, March, 1993; October, 1993; May, 1994. Laparoscopic Urology - Georgetown University Medical School; March, 1992. Laparoscopic Urology - Dartmouth-Hitchcock Medical Center; January, 1992. Laparoscopy - American Urological Association- October, 1992; May 1993, May 1994, January, 1995, May, 1995. Advanced Laparoscopy - American Urological Association; March, 1993. Lasers in Urology - Cornell University Medical Center, February, 1994; April, 1994. PUBLICATIONS: ARTICLES: Dahm, P., Paulson, D., and Albala, D.M.: Management of Retained Retractor During Radical Perineal Prostatectomy. Journal of Urology 159:1085, 2003. Albala, D.M., Turk, M.T., Fulmer, B.R., et al: Office -Based Transurethral Microwave Thermotherapy (TUMT) using the Thermatrix TMX-2000. Journal of Endourology 16:57, 2002. Fulmer, B., Sakamoto, K., Albala, D.M., et al.: Acute and Long-Term Outcome of Radiofrequency Bladder Neck Suspension. Journal of Urology 167:141, 2002. Fulmer, B.R., Turk, M.T. and Albala, D.M. : Editorial: Retroperitoneoscopic Adrenalectomy: Lateral Approach. Journal of Endourology 15:505, 2001. Sadowski, E.A., Salomon, C.G, Wojcik, E.M. and Albala, D.M.: Fibroma of the Testicular Tunics: An Unusual Extratesticular Intrascrotal Mass. Journal of Ultrasound Medicine 20:1245, 2001. Kumar, U. and Albala, D.M.: Laparoscopic Approach to Adrenal Carcinoma. Journal of Endourology 15: 339,2001. Albala, D.M., Assimos, D.G., Clayman, R.V. et al: Lower Pole I: A Prospective Randomized Trial of Extracorporeal Shockwave Lithotripsy and Percutaneous Nephrostolithotomy for Lower Pole Nephrolithiasis—Initial Results. Journal of Urology 166:2072, 2001. Kumar, U., Dickerson, A., Sakamoto, K., Albala, D.M., and Turk, T.M.T. : Effects of Fibrin Glue on Injured Rabbit Ureter. Journal of Endourology: 15: 205, 2001. Kumar, U. and Albala, D.M.: Techniques in Intracorporeal Tissue Approximately: Suturing, Newer Tissue Adhesives and Microclips. Urologic Clinics of North America 28:15, 2001 Galen, D.I., Abbott, K., Albala, D.M. et al: Radiofrequency Bladder Neck Suspension: Long Term Results Using a Laparoscopic Approach. Obstetrics and Gynecology 97:49, 2001. Kumar, U. and Albala, D.M.: Fibrin Glue Applications in Urology. Current Urology Review, 2:79, 2001. 15
  16. 16. GlaxoSmithKline Clinical Development & Medical Affairs, North America Albala, D.M., Turk, M.T., Fulmer, B.R., et al: Periurethral Transurethral Microwave Thermotherapy (P- TUMT) for the Treatment of BPH: An Interim 1 year Safety and Efficacy Analysis Using the Thermatrix TMX - 2000. Techniques in Urology 6:288, 2000. Kumar, U. and Albala, D.M.: Simple Nephrectomy: Transperitoneal Approach. Journal of Endourology 14:10, 2000. Wolf, J.S., Marcovich, R., Albala, D.M. et al: Survey of Neuromuscular Injuries to the Patient and Surgeon During Urologic Laparoscopic Surgery. Urology 55:831, 2000. Albala, D.M., Rassweiler, J., Winfield, H.N. et al: Controversial Cases in Endourology. , Rassweiler, J., Winfield, H.N. et al: Controversial Cases in Endourology. Journal of Endourology 14:541, 200. Fulmer, B.R., Turk, M.T. and Albala, D.M.: Complications of Retrograde Balloon Cautery Endopyelotomy Journal of Urology 165: 542, 2000 Turk, T.M.T., Koleski, F., Wojcik, E., Jahoda, A., and Albala, D.M.: Use of Epidermal Growth Factor and Collegen Synthesis Inhibition As Adjuvant to Healing of Ureteral Anastomosis. Journal of Endourology 14:145, 2000. Koleski, F., Turk, T.M.T., Jahoda, A., and Albala,D.M.: Grooved Ureteral Stent: Preliminary Evaluation. Journal of Endourology 14:2, 2000. Koleski, F., Turk, T.M.T., and Albala, D.M.: Laparoscopic Adrenalectomy. AUA News 4:3, 1999. Koleski, F., Turk, T.M.T., Orwega, M., Borge, M., and Albala D.M.: Splenosis as a cause for Testicular pain - Laparoscopic Management. Journal of Endourology 13:373, 1999. Koleski, F., Turk, T.M.T, and Albala, D.M.: Update on Endourology and Laparoscopic Urology. Chicago Medicine 102:17, 1999. Koleski, F., Turk, T.M.T., and Albala D.M.: Carcinosarcoma of the Prostate. World Journal of Urology 17:316, 1999 Albala, D.M.: Review of Campbells Urology, Doody’s Review 3:26, 1999 Turk,T.M.T., Koleski, F.C., and Albala D.M.: Incidence of Urolithasis in Cystectomy Patients after Intestinal Conduit or Continent Urinary Diversion. World Journal of Urology 17:305,1999 Jahoda, A.E., Albala, D.M., Dries, D.J., and Kovacs E.J.: Fibrin Sealant Inhibits Connective Tissue Deposition in a Murine Model of Peritoneal Adhesions. Surgery 125:53, 1999. Herrell, S.D., Jahoda, A.E., Husain, A.N., and Albala, D.M.: The Laparoscopic Cooling Sheath: A Novel Device for Hypothermic Preservation of the Kidney During Temporary Renal Artery Occlusion. Journal of Endourology 12:155, 1998. Gill, I.S., Clayman, R.V., and Albala D.M. et.al: Retroperitoneal and Pelvic Extraperitoneal Laparoscopy: An International Perspective, Urology 52:566, 1998 Kim, F.J., Herrell, S.D., Jahoda, A.E., Albala, D.M.: Complications of Acucise Endopyelotomy. Journal of Endourology 12:433, 1998. Gomella, C., Loft, M., Hirsch, I., Albala, D.M., Manyak, M., Sosa, E., and Stone, N.: Laparoscopic Urologic Surgery: Outcome Assessment. Journal of Laparoscopic and Advanced Surgical Techniques 7:77, 1997. Preminger, G.M., Clayman, R.V., Nakada, S.Y., Babayan, R.K., Albala, D.M., Fuchs, G.J., Smith, A.D. A multicenter clinical trial investigating the use of a fluoroscopically controlled cutting balloon catheter 16
  17. 17. GlaxoSmithKline Clinical Development & Medical Affairs, North America for the management of ureteral and ureteropelvic junction obstruction. Journal of Urology 157:1625, 1997. Gomella, L.G., Abdel-Meguid, T.A., Lofti, M.A., Hirsch, I.H., Albala, D.M., Manyak, M., Kozminski, M., Sosa, E., Stone, N.N. Laparoscopic Urologic Outcome Assessment. Journal of Laparoendoscopic & Advanced Surgical Techniques. Part A. 7:77, 1997. Albala, D.M.: Contact Laser Vaporization of the Prostate for Benign Prostatic Hypertrophy. Monographs in Urology 8:92, 1997 Gerber, G., Jahoda, A., Bales, G., and Albala, D.M.: Transurethral Vaporization of the Prostate in the Treatment of Bladder Outlet Obstruction at Two University Hospitals. Techniques in Urology 3:25, 1997. Ferrer, F., MacGillivray, D., Malchoff, C., Albala, D.M., and Schickman, S.J.: Bilateral Laparoscopic Adrenalectomy for Adrenocorticotropic-Dependent Cushing’s Syndrome. Journal of Urology 157:16, 1997. Mendoza, D., Neuman, R., Albala, D.M., Cohen, M., et al: Laparoscopic Complications in Markedly Obese Urologic Patients (A Multi-Institutional Review). Urology 48:562, 1996. Brown, J., Albala, D.M., and Jahoda, A.: Laparoscopic Surgery for Advanced Lesions. Seminars in Surgical Oncology 12:96, 1996. Albala, D.M., Brown, J., and Jahoda, A.J.: Laparoscopic Adrenalectomy. Seminars in Surgical Oncology 14:216, 1996. Seilkowitz S. and Albala, D.M.: A Method of Exposing the Vesicourethral Anastomotic Site During Radical Prostatectomy. Journal of Urology. 154:1461, 1995. Albala D.M., Jahoda, A.E., McKay, T.C., and Castelli, M.: Ureteral Reanastomosis Using Fibrin Glue. Journal of Pelvic Surgery 1:49,1995. Albala DM., Galal HA., and Gomella LA: Laparoscopic Pelvic Lymph Node Dissection for Prostate Cancer. Atlas of the Urologic Clinics of North America, 3:43, 1995. Kerbl, K., Clayman, R., McDougall, E.M., Gill, I.S., Wilson B.S., Chandhoke, P.S., Albala, D.M., Kavoussi, L.R.: Transperitoneal Nephrectomy For Benign Disease Of The Kidney: A Comparison of Laparoscopic And Open Surgical Techniques. Urology 43: 607,1994. Anderson, K., Keetch, D., Albala, D.M., Chandhoke, P., McClennan, B. and Clayman, R.V.: Optimal Therapy for the Distal Ureteral Stone: Lithotripsy vs. Ureteroscopy. Journal of Urology . 152:62, 1994. Gomella, L.G., Lotfi, M.A., Milam. V., Albala, D.M., and Reagan G: Contact Laser Vaporization Of The Prostate For Benign Prostatic hypertrophy. Progress in Biomedical Optics, 2129:73, 1994. Albala, D.M.: Laparoscopic Nephrectomy and Adrenalectomy. Seminars in Surgical Oncology 10:417, 1994. Gomella L.G., and Albala, D.M.: Laparoscopic Urology Surgery 1994. British Journal of Urology 74:267, 1994. Albala, D.M., Prien, E.L. and Galal, H.A.: Urolithiasis as a Hazard of Sulfonamide Therapy. Journal of Endourology 8:401, 1994. Albala, D.M., Richardson, J.R., and Heaney, J.A.: Diuretic Renal Scan: Is It Always Reliable. Journal of Endourology. 8:405, 1994. 17
  18. 18. GlaxoSmithKline Clinical Development & Medical Affairs, North America Monk, T.G., Albala, D.M., Diaz, Y., Clayman, R.V., and White, C.F., Topical EMLA Analgesia: Effects on Pain Response and Analgesic Requirement During Lithotripsy Procedures. Anesthesia and Analgesia. 79:506, 1994. McKay, T.C., Albala, D.M. and Gehrin, B.: Laparoscopic Ureteral Reanastomosis Using Fibrin Glue. Journal of Urology 152:1637, 1994. McKay, T.M., Albala, D.M., Sendelbah, K. and Gattuso, P.: Cytomegalovirus Prostatitis: Case Report and Review of the Literature. International Urology and Nephrology. 26:535, 1994. Albala, D.M.: How to Approach the Problematic Ureteral Stone. Contemporary Urology 5:64,1993. Klutke, J. Kavoussi, L.R., Albala, D.M., and Clayman, R.V., Laparoscopic Treatment of Ureteral Obstruction Secondary to Ovarian Remnant Syndrome, Journal of Urology. 149:827, 1993. Kerbl, K., Figenshau, R., Clayman, R., Chandhoke, P., Kavoussi, L., Albala, D.M. and Stone, A.: Retroperitoneal Laparoscopic Nephrectomy: Laboratory and Clinical Experience. Journal of Endourology 7:23, 1993. Klutke, J., Kavoussi, L., Albala, D.M., Clayman, R.: Laparoscopic Treatment of Ureteral Obstruction Secondary to Ovarian Remnant Syndrome. Journal of Urology 149:827, 1993. Albala, D.M., Kevwitch, M.K. and Waters, W.B.: Treatment of Persistent Lymphatic Drainage after Laparoscopic Pelvic Lymph Node Dissection and Radical Retropubic Prostatectomy. Journal of Endourology 7:337, 1993. Kavoussi, L.R., Albala, D.M., and Clayman, R.V.: Outcome of Secondary Ureteropelvic Junction Obstruction Failures. British Journal of Urology 72:157, 1993. Gagner, M., Lacroix A., Prinz R., Bolter E., Albala, D.M. Potvin, C., and Hamet, P: Early Experience with Laparoscopic Approach for Adrenalectomy. Surgery 114:1120, 1993. Albala, D.M., Schuessler, W.W., and Vancaille, T.G.: Laparoscopic Bladder Neck Suspension. Journal of Endourology, 6:137, 1992. Clayman, R.V., Kavoussi, L.R., Soper, N.J., Albala, D.M., Figenshau, R.S., and Chandhoke, P.S. Laparoscopic Nephrectomy: Review of the Initial 10 Cases. Journal of Endourology 6:127, 1992. Chandhoke, P.S., Albala, D.M. and Clayman, R.V.: Long Term Comparison and Renal Function in Patients with Solitary and/or Renal Insufficiency Undergoing ESWL or Percutaneous Nephrolithotomy, Journal of Urology. 147:1226, 1992. Clayman, R.V., Kavoussi, L.R., McDougall, E.M., Soper, N.J., Figenshau, R.S., Chandhoke, P.S. and Albala, D.M.: Laparoscopic Nephrectomy: A Review of 16 Cases. Surg. Laparoscopy and Endoscopy 2:29, 1992. Albala, D.M., Kavoussi, L.R., and Clayman, R.V: Laparoscopic Nephrectomy. Seminars in Urology, 10:146, 1992. Kavoussi, L.R., Albala, D.M., Basler, J.W., Apte, S. and Clayman, R.V.: Percutaneous Management of Urolithiasis During Pregnancy. Journal of Urology. 148:1069, 1992. Albala, D.M. Schuessler W.W., and Vancaillie, T.G.: Laparoscopic Bladder Suspension For The Treatment Of Stress Incontinence. Seminars in Urology 10:222, 1992. Meretyk S., Albala, D.M., Clayman R.V., Denstedt, J. and Kavoussi, L.R: Endoureterotomy For The Treatment Of Ureteral Strictures. Journal of Urology 147:1502, 1992. 18
  19. 19. GlaxoSmithKline Clinical Development & Medical Affairs, North America Albala, D.M.: Clayman, R.V.: Commentary: Percutaneous Nephrolithotomy An Approach to Branded and Staghorn Renal Calculi. Journal of Lithotripsy and Stone Disease, 3:182, 1991. Albala, D.M. and Richardson, J.R., Jr: Diagnosis and Treatment of Bladder Rupture: A Review of 42 Cases. Rhode Island Medical Journal, 74:133, 1991. Albala, D.M., Richardson, J.R., and Heaney, J.A.: Urological Injury and Assessment in Patients with Pelvic Fractures. Rhode Island Medical Journal, 74:128, 1991. Huntsman, W.T., and Albala, D.M.: Cardiac Tamponade as an Unusual Presentation of Lung Cancer: A Case Report and Review of the Literature. Clinical Cardiology, 14:529, 1991. Figenshau, R.S., Albala, D.M., Clayman, R.V., Kavoussi, L.R., Chandhoke, P.S., and Stone, A.M.: Laparoscopic Nephroureterectomy: Initial laboratory Experience, Minimally Invasive Therapy, 1:93, 1991. Albala, D.M., Meretyk, S. and Clayman, R.V.: Extracorporeal Shock Wave Lithotripsy (ESWL) for Ureteral Calculi: To Stint or Not to Stint, Journal of Endourology, 5:277, 1991. Albala, D.M., Chung, C.J., Sueoka, B.L., Memoli, V.A., and Heaney, J.A.: Hemorrhagic Myelolipoma of the Adrenal Gland After Blunt Trauma. Urology, 38:559, 1991. Clayman, R.V., Kavoussi,, L.R., Figenshau, R.S., Chandhoke, P.S., and Albala, D.M.: Laparoscopic Nephroureterectomy: Initial Clinical Case Report. Journal of Laparoendoscopic Surgery, 1:343, 1991. Albala, D.M., Danaher, J., and Huntsman, W.T.: Ventriculoperitoneal Shunt Migration Into the Scrotum. The American Surgeon, 55:685, 1989. Albala, D.M. and Danaher, J.W.: Thank you, Sahib. Dartmouth Medical School Alumni Magazine, Winter 1987. Albala, D.M.: Primary Health Care in Bangkok. World Hospitals, 23:1, 1987. Albala, D.M., Faisel, A., Fikree, F. and Bryant, J.: The Educational Programs of the Aga Khan University Department of Community Health Sciences. Specialist, 2:25, 1986. Albala, D.M., Quershi, F.A. and Karim, M.S.: A Comparison of Health and Socioeconomic Indicators in the Townships of Orangi and Karimabad. Journal of Pakistan Medical Association, 36:9, 1986 Albala, D.M.: Healing the Sick in Pakistan, Special two-part article in The Valley News, West Lebanon, NH October 1986. Albala, D.M., Huntsman, W.T. and Crichlow, R.W.: Gallstone Ileus. Surgical Rounds, 8:93, 1985. Albala, D.M., and Taylor-Ide, D.: Water Quality and Diarrheal Diseases in a Rural Community of Eastern Nepal. Journal of the Institute of Medicine, 7:13, 1985. Albala, D.M., Bromley, B., Culver, J., et al: Medical Report from Isolated Communities in Sankhuwsabha District - Kosi Zone. Journal of the Institute of Medicine, 7:21, 1985. Albala, D.M.: The Spirit of Nepal. Lafayette College Alumni Magazine, Summer, 1985 Albala, D.M. and Schamel, S.: Water Quality of the Martins Creek Drainage Basin. Proceedings of the Pennsylvania Academy of Sciences, 53:101, 1979. SUBMITTED: 19
  20. 20. GlaxoSmithKline Clinical Development & Medical Affairs, North America Fulmer, B., Turk, T., Albala, D.M., et al.: Extracorporeal Shock Wave Lithotripsy with the Medstone STS-T (Transportable) Electrohydraulic Lithotripter: Experience with 370 Cases. Journal of Endourology. Albala, D.M., Del Guidice, P., Coombs, D.W., and Colburn, R.: Temporal Correlation Between Toxic Plasma and Urinary Inorganic Fluoride Levels and Urinary PGE2 in the Ewe. Canadian Journal of Anesthesia. Toselli, C.V., Fleming, C., Albala, D.M., and Selikowitz, S.M.: A Decision Analytic Approach to the Management of Clinical Stage I Non-Seminomatous Germ Cell Testicular Tumors. Techniques in Urology. Griffin, J., Hatch, D. and Albala, D.M.: Laparoscopic Replacement of CAPD Catheters. Journal of Urology. Jahoda, J., Simon, S., Albala, D.M., et al.: Systemic Effects of Intraparenchymal Injection of Fibrin Sealant for Renal Lacerations. Journal of Urology. BOOKS (Editors) Atlas of Endourology Albala, D.M., and Grasso, M.,: (Eds.) Raven Press, New York, NY, 1999. Textbook of Endourology, Albala, D.M., Sosa, E.R., Perlmutter, A.B. and Jenkins, A., (Eds.), W. B. Saunders, Cambridge, Mass., 1996. BOOKS (Assistant Editor) Five Minute Urological Consult, Gomella, L.G. (Ed), Lippencott-Raven Press, New York, N.Y.,2000. Laparoscopic Urologic Surgery, Gomella, L.G., Kozminski, M., Winfield, H.N., (Eds.), Raven Press, New York, NY, 1993. BOOK CHAPTERS/MONOGRAPHS: Albala, D.M.: Laparoscopic Hand-Assisted Nephrectomy. Hemal, A.K. (Ed). Contemporary Trends in Laparoscopic Urologic Surgery, B.I. Churchill Livingston, New Delhi, 2002. Kumar, U. and Albala, D.M.: Fibrin Sealants in Urology. Minimally Invasive Therapies in Urology, Marcel Decker, New York, 2001. Martins, A.C. and Albala, D.M.: Prostate and Hormones. Martins, A.C. (Ed) Benign Prostate Diseases, FAEPA – Hospital das Clinicas de Ribeirao Preto, Ribeiro Preto, Brazil, 2001. Koleski, F.C. and Albala, D.M.: Acute Urinary Retention. Mulhall, J.P. (Ed). Contemporary Diagnosis and Management of Urologic Emergencies, Handbooks in Health Care Co., Newtown, Pennsylvania, 2001. Koleski, F.C. and Albala, D.M.: Laparoscopia Equipamento Castilho, L.C. (Ed). Laparoscopia Urologica. LPC Comunicacoes, Sao Paulo, Brazil, 2000. Koleski, F.C. and Albala, D.M.: Cirurgia do Ureter. Castilho, L.C. (Ed). Laparoscopia Urologica, LPC Comunicacoes, Sao Paulo, Brazil, 2000. Kumar, U. and Albala, D.M.: Radionucleotide Imaging. Levine, D. (Ed) Urology Pearls of Wisdom Boston Medical Publishing, Boston, Mass., 2000. Kumar, U. and Albala, D.M.: Urinary Tract Infections. Levine, D. (Ed) Urology Pearls of Wisdom Boston Medical Publishing, Boston, Mass., 2000. 20
  21. 21. GlaxoSmithKline Clinical Development & Medical Affairs, North America Kumar, U. and Albala, D.M.: Urinary Tract Obstruction. Levine, D. (Ed) Urology Pearls of Wisdom Boston Medical Publishing, Boston, Mass., 2000. Albala, D.M., and Koleski, F.: Nephrolithiasis. Gomella, L.G. (Ed). Five Minute Urology Consult, Raven-Lippencott Press, New York, N.Y., 2000. Albala, D.M.: Backpacking to the Capital. McCrea Curnen, M., Spiro, H., and St. James, D. (Eds) Doctors Afield Yale University Press, New Haven, Ct., 1999. Kumar, U. and Albala, D.M.: History of Laparoscopy and Laparoscopic Instrumentation. Hemal, A.K. (Ed). Laparoscopic Surgery in Urology, B.I. Churchill Livingstone, New Delhi, India, 1999 Kumar, U. and Albala, D.M.: Hand Assisted Laparoscopic Surgery in Oncology. Hemal, A.K. (Ed). Laparoscopic Surgery in Urology, B.I. Churchill Livingstone, New Delhi, India, 1999 Albala, D.M.: Laparoscopic Adrenalectomy. In Glenn, J (Ed). Urologic Surgery, J.B. Lippincott, Philadelphia, PA, 1998. Albala, D.M.: Laparoscopic Adrenalectomy. In Albala, D.M., Sosa, E.R., Perlmutter, A.B and Jenkins, A., (Eds) Textbook of Endourology. W.B. Saunders, Cambridge, Mass, 1996. Albala, D.M., and Isacksen, R.: Laparoscopic Bladder Neck Suspension. In Albala, D.M., Sosa ER, Perlmutter, AB., and Jenkins A., (Eds). Textbook of Endourology. W.B. Saunders, Cambridge, Mass, 1996. Albala, D.M., and Brown JP: Endopyelotomy For The Treatment Of Ureteropelvic Junction Obstruction. In Rous, S.N. (Ed) 1995 Urology Annual East Norwalk, CT Appleton & Lange 1995. Albala, D.M.: Laparoscopic Adrenalectomy, In Smith, A.J. (Ed) Smith=s Endourology Textbook, St. Louis, Quality Medical Publish, Inc. 1995. Isacksen, R., Albala, J.C., Jahoda A.E., and Albala, D.M.: Legal Issues in Laparoscopy In Smith, A.J., (Ed) Smith=s Endourology Textbook. St. Louis, Quality Medical Publish, Inc. 1995. Albala, D.M., Chandhoke, P.S., and Clayman, R.V.: Ureterorenoscopy: Urolithiasis. In Krane, R., Siroky, M., and Fitzpatrick, J. (Eds.) Clinical Urology. Philadelphia, PA: J.B. Lippincott Company, 1994. Albala, D.M.: Postoperative Laparoscopic Care. In Soper, N., Oden, R., Clayman, R. and McDougal, E. (Eds.) Essentials of Laparoscopy St. Louis: Quality Medical Publishing, Inc., 1994. Albala, D.M.: Laparoscopic Nephrectomy. In Steichen F.M., Welter R, (Eds.) Minimally Invasive Surgery and New Technology. St Louis: Quality Medical Publishing, Inc., 1994. Albala, D.M.: Vesicoureteral Reflux in Adults. In Seidmon, J., Hanno, P. and Kaufman, J. (Eds.), Current Urologic Therapy, W.B. Saunders Company, Cambridge, Mass., 1993. Albala, D.M.: Laparoscopic Surgery in Urology. In Roig, JMS (Eds.) Progress in Urology 1993. Barcelona, Spain: Support Med Publishing, 1993. Albala, D.M. and Prinz, R.: Retroperitoneal Evaluation and Resection of Adrenal Masses. In Rosin, D. and Greene, F. (Eds.) Minimal Access Surgical Oncology. Radcliffe Medical Press, New York, NY, 1993 Albala, D.M.: Preparing for an International Meeting. In St. James, D. (Ed.), Writing and Speaking for Excellence: A Practical Guide for Physicians, Jones and Bartlett, Boston, Mass., 1993. 21
  22. 22. GlaxoSmithKline Clinical Development & Medical Affairs, North America Albala, D.M.: Stenting Prior to ESWL - Complications. In Smith, A.D. (Ed.) Controversies in Endourology, W.B. Saunders Company, Cambridge, Mass., 1993. Albala, D.M. and Kavoussi, L.R.: Laparoscopic Ureteral Surgery. In Das, S. and Crawford, D., (Ed.) Laparoscopic Urology, Orlando, FL, W. B. Saunders Company, 1993. Albala, D.M., Vancaille, T.G., and Schuessler, W.W.: Suspension of the Bladder Neck Using the Laparoscope. In Gomella, L., Kozminski, M. and Winfield, H. (Eds.) Laparoscopic Urologic Surgery, New York, N.Y., Raven Press, 1993. Albala, D.M.: Postoperative Laparoscopic Care. In Clayman, R. and McDougall, E., (Eds.) Laparoscopic Urology, St. Louis, MO, Quality Medical Publishers, 1992. Meretyk, S., Albala, D.M., Kavoussi, L., and Clayman, R.V.: Endosurgery: Non-Calculus Applications in the Upper Urinary Tract. In Stamey, T.A. (Ed.) Monographs in Urology. Montverde, FL: Medical Directions Publishing Company, 1991, Volume 12, No. 4. Albala, D.M., Prien, E.L., Jr., and Heaney, J.A.: Drug-Induced Urinary Lithiasis. In Rous, S.N. (Ed.) 1990 Urology Annual. East Norwalk, CT., Appleton & Lange, 1990, pp. 255-266. VIDEOTAPES: Fulmer, B.R., Turk, T.M.T. and Albala, D.M.: Nephro-Step for Percutaneous Access (10 minutes), 2001 Albala, D.M.: Urological Laparoscopy: Hand-Assisted Nephrectomy, Adrenalectomy and Radical Prostatectomy. (15 minutes), 2001. Fulmer, B.R., Turk, T.M.T. and Albala, D.M.: Hand - Assisted Nephrectomy using the Intromitt. (10 minutes), 2000. Albala, D.M., Turk, T.M.T. and Fulmer, B.R.: Nephro-Step: A New Device for Percutaneous Access. (8 minutes), 2000. Kumar, U., Dickerson, A. and Albala, D.M.: Transurethral Resection of the Prostate using the Marberger Loop. (8 minutes), 2000. Albala, D.M., Turk, T.M.T., and Koleski, F.: Percutaneous Nephrolithotomy: Our Surgical Technique (10 minutes), 1999. Albala, D.M., and Thomas, R.: Laparoscopic Adrenalectomy: A Step-by-Step Approach (12 minutes), 1997. Herrell, D., Jahoda, A., and Albala, D.M.: The Use of Fibrin Glue in Urology (14 minutes), 1996. Albala, D.M. and Jahoda A.J.: Electrosurgical Vaporization of the Prostate - A New Procedure (10 minutes), 1995. Albala, DM and Flanigan, RF: Laparoscopic Adrenalectomy. American College of Cine Clinics (14 minutes), 1994. Isacksen, RM, Jordan G, Albala, DM, and Winslow, B: Laparoscopy in Children (10 minutes), 1994 Albala, D.M. and Prinz, R.: Laparoscopic Adrenalectomy, Video Journal of General Surgery, Volume 2, No. 1, (12 minutes), 1993. Asbury, J.A. and Albala, D.M.: Laparoscopic Renal Cyst Surgery (9 minutes), 1993. Isacksen, R.M. and Albala, D.M.: The Role of Laparoscopy in Undescended Testes. (8 minutes), 1993. 22
  23. 23. GlaxoSmithKline Clinical Development & Medical Affairs, North America McKay, T. and Albala, D.M.: Laparoscopic Ureteral Reanastomosis Using Fibrin Glue (9 minutes), 1993. Albala, D.M. and Prinz, R.: Laparoscopic Adrenalectomy for Cushings Disease (10 minutes), 1993. Albala, D.M. and Prinz, R.: Laparoscopic Adrenalectomy (8 minutes), 1992. Kinzler, G.J. and Albala, D.M.: Laparoscopic Drainage of the Post Transplant Lymphocele (10 minutes), 1992. Albala, D.M. and Kinzler, G.J.: Laparoscopic Placement of a Difficult Continuous Ambulatory Peritoneal Dialysis (CAPD) Catheter (9 minutes), 1992. Albala, D.M., Kevwitch, M.K. and Gehrin, B.: Acucise Endopyelotomy - A New Surgical Procedure (9 minutes), 1992. Kavoussi, L.R., Clayman, R.V., Figenshau, R.S., Soper, N.J., Chandhoke, P.S. and Albala, D.M.: Laparoscopic Nephrectomy: Initial Clinical Experience with a New Surgical Technique, (10 minutes), 1992. Kavoussi, L.R., Albala, D.M, and Clayman, R.V., Laparoscopic Ureterolysis, (10 minutes), 1992. Albala, D. M., Figenshau, R.S., Chandhoke, P.S., Kavoussi, L.V., and Clayman, R.V.: Potential Complications of Laparoscopic Surgery, (10 minutes), 1991. Kavoussi, L.V., Albala, D.M., and Clayman, R.V.: Laparoscopic Ureterolysis, A New Surgical Approach (8 minutes), 1991. Kavoussi, L.V., Albala, D.M., and Figenshau, R.S., and Clayman, R.V., Organ Entrapment Systems for Tissue Removal, (9 minutes), 1991. Chandhoke, P.S., Clayman, R.V., Albala, D.M., Figenshau, R.S. and Kavoussi, L.R.: Acucise Endopyelotomy: Initial Clinical Experience (10 minutes), 1991. Figenshau, R.S., Clayman, R.V., Kavoussi, L.R., Chandhoke, P.S., and Albala, D.M.,: Laparoscopic Nephrectomy, (12 minutes), 1990. Kavoussi, L.R., Clayman, R.V., Albala, D.M, Chandhoke, P.S., Figenshau, R.S, and Stone, A.M., Laparoscopic Nephrectomy, (10 minutes), 1990. Albala, D.M., Chandhoke, P.J., Figenshau, R.S., and Clayman, R.C.: Clinical Applications of Flexible Ureteronephroscopy (11 minutes) 1990. OPERATIVE DEMONSTRATIONS: St. Petersburg Hospital, St. Petersburg, Florida—Laparoscopic Hand-Assisted Nephrectomy, December 2002 Baptist Hospital, Louisville, Kentucky—Laparoscopic Hand-Assisted Nephrectomy, November 2002 Champlain Valley Physician’s Hospital, Plattsburg, New York—Laparoscopic Hand- Assisted Nephrectomy, May 2002. Louisville General Hospital, Louisville, Kentucky—Laparoscopic Hand-Assisted Nephrectomy, May, 2002 23
  24. 24. GlaxoSmithKline Clinical Development & Medical Affairs, North America Medical College of Virginia, Richmond, Virginia—Laparoscopic Hand-Assisted Nephrectomy, April, 2002 All India Institute of Medical Sciences, New Delhi, India—Laparoscopic Hand-Assisted Nephrectomy, April, 2002 Singapore General Hospital, Singapore - Laparoscopic Hand-Assisted Nephrectomy, September, 2001 University of Ribeirao Preto, Brazil – Laparoscopic Hand-Assisted Nephrectomy, July, 2001. Keesler Air Force Hospital, Biloxi, Mississippi – Bilateral Laparoscopic Hand-Assisted Nephrectomy, July, 2001. Ankara General Hospital, Ankara, Turkey – Accucise Endopyelotomy, May,2001. Caligary Hospital, Caligary, Sardenia, Italy – Laparoscopic Hand-Assisted Nephrectomy, Accuccise Endopyelotomy, May, 2001. Peoria Medical Center, Peoria, Illinois - Laparoscopic Hand-Assisted Nephrectomy, January, 2001. Iceland Urological Association, Reykjavik, Iceland - Laparoscopic Hand- Assisted Nephrectomy, October, 2000. 18th World Congress on Endourology and ESWL 16th Basic Research Symposium, Sao Paolo, Brazil- Acucise Endopyelotomy, September, 2000. Rhine Medical Center, Lepitz Germany - Laparoscopic Andrenalectomy, June, 2000. Coimbatore Urological Association, Coimbatore, India - Laparoscopic Hand-Assisted Nephrectomy, June, 2000. All India Institute of Medical Sciences, New Delhi, India - Laparoscopic Hand-Assisted Nephrectomy, November, 1999. Lake Charles Medical Center, Lake Charles, Louisiana - Laparoscopic Adrenalectomy, July, 1999. San Diego Naval Hospital, San Diego, California - Laparoscopic Hand-Assisted Nephrectomy, July, 1999. Panipat Medical Center, Panipat, India - Ureteroscopy, Percutaneous Nephrolithotomy, December, 1998. All India Institute of Medical Sciences, New Delhi, India - Ureteroscopy, Endopyelotomy, December, 1998. Christian Medical College and Hospital, Vellore, India - Ureteroscopy, Endopyelotomy, Laparoscopic Nephrectomy, December, 1998. Tulane University Medical Center, New Orleans, Louisiana - Laparoscopic Adrenalectomy, October, 1997. George Washington University Medical Center, Washington D.C. - Laparoscopic Nephrectomy, April, 1996. Cornell University/New York Hospital, New York, New York - Laparoscopic Adrenalectomy, December, 1995. National Institute of Health, Bethesda, Maryland - Laparoscopic Adrenalectomy, March, 1995. 24
  25. 25. GlaxoSmithKline Clinical Development & Medical Affairs, North America Dartmouth-Hitchcock Medical Center, Hanover, New Hampshire - Laparoscopic Pelvic Lymph Node Dissection, October 1994. Medical College of Wisconsin, Milwaukee, Wisconsin - Laparoscopic Pelvic Lymph Node Dissection, September, 1994. Hospital La Fe, Barcelona, Spain - Laparoscopic Nephrectomy, September, 1992. University of California at San Diego, San Diego, California - Ureteroscopy, Laparoscopic Pelvic Lymph Node Dissection, October, 1992. Cochin Hospitaux, Paris, France - Laparoscopic Nephrectomy, September, 1992. Massachusetts General Hospital, Boston, Massachusetts - Laparoscopic Nephrectomy, August, 1992. INVITED PRESENTATIONS: Duke Winter Urologic Forum, Steamboat Springs, Colorado, February, 2003. 14th Annual Urology Symposium, Fort Lauderdale, Flordia, February, 2003. International College of Surgeons Meeting, Taipei, China, November, 2002. 20th World Congress on Endourology and ESWL, Geneva, Italy, October 2002. New York American Urological Association Annual Meeting, Madrid, Spain, September, 2002. All India Institute of Medical Science, New Delhi, India, April, 2002. Mexican Urological Association Annual Meeting, Mexico City, Mexico, February 2002. 19th World Congress on Endourology and ESWL, Bangkok, Thailand, November 2001. Singapore General Hospital, Singapore, September, 2001. Society of Pelvic Surgeons, Oslo, Norway, July, 2001. University of Rebeirao Preto, Rebeirao Preto, Brazil, July, 2001. 96th American Urological Association Annual Meeting, Anaheim, California, June, 2001. Ankara Urological Association, Ankara, Turkey, May, 2001. Italian Urological Association, Caligary (Sardinia), Italy, May 2001. Henry Ford Hospital (Grand Rounds), Detroit, Michigan, March 2001 Wayne State University (Grand Rounds), Detroit, Michigan, March 2001 Fourth International Symposium on Urology, Nephrology and Transplantation, Sindh Institute of Urology and Transplantation, Karachi, Pakistan, February, 2001. 48th Annual James C. Kimbrough Urological Seminar, San Diego, California, January, 2001. Societe of International Urology, Singapore, November, 2000. 25
  26. 26. GlaxoSmithKline Clinical Development & Medical Affairs, North America The Mellineum Urological Meeting, Delhi, India, November, 2000. The 27th Annual Egyptian Urological Meeting, Cairo, Egypt, October, 2000. Iceland Urological Association, Reykjavik, Iceland, October, 2000. 18th World Congress on Endourology and ESWL, Sao Paolo, Brazil, September, 2000. Coimbatore Urological Association, Coimbatore, India, June, 2000. 95th American Urological Associates Annual Meeting, Atlanta, Georgia, May, 2000. Video Urology 2000: 12th World Congress of Videourology, Goa, India, March, 2000. All India Institute of Medical Sciences, New Delhi, India, November, 1999. Kentucky Urological Association , Louisville, Kentucky, November, 1999. Circon/ACMI Annual Meeting, Tampa, Florida, November, 1999. 17th World Congress of Endourology of Shock Wave Lithotripsy, Athens, Greece, September 1999. Specialty Review in Urology, Chicago, Illinois, April 1993, 1994, 1995, 1996, 1997,1998, 1999, 2000, 2001. Timely Topics in Urology, Loyola University, Maywood, Illinois, June 1999. 94th American Urologic Association Annual Meeting, Dallas, Texas, April, 1999. 23rd Annual James McDonald Urological Seminar, Scottsdale, Arizona, March 1999. University of Miami, Challenging Cases in Urology, Miami Florida, February, 1999. All India Institute of Medical Sciences, New Delhi, India, December, 1998. Christian Medical College and Hospital, Vellore, India, December, 1998. 16th World Congress of Endourology of Shock Wave Lithotripsy, New York, New York, September, 1998 Wayne State University Grand Rounds, Detroit, Michigan, August, 1998. Mississippi/Alabama Urological Society Meeting, Biloxi, Mississippi, August, 1998. 93rd American Urological Association Annual Meeting, San Diego, California, May 1998 Tampa Urological Association Meeting, Tampa, Florida, March, 1998. American College of Surgeons 84th Clinical Congress, American College of Surgeons, Orlando, Florida, October, 1998. 15th World Congress of Endourology and Shock Wave Lithotripsy, Edinburgh, Scotland, September, 1997. 92nd American Urologist Association Annual Meeting, New Orleans, Louisiana, April, 1997. The 44th Annual James C. Kimbrough Urological Seminar, Scottsdale, Arizona, December, 1996. The 1st International Pan Arab Endolaparoscopic Urology Congress, Cairo, Egypt, November, 1996. 26
  27. 27. GlaxoSmithKline Clinical Development & Medical Affairs, North America 14th World Congress of Endourology and Shock Wave Lithotripsy, Melbourne, Australia, November, 1996. American College of Surgeons - 82nd Clinical Congress, American College of Surgeons, San Francisco, California, October, 1996. North Central American Urological Association Annual Meeting, Tucson, Arizona, September, 1996. Alumni Meeting of the White House Fellows, Annapolis, Maryland, June, 1996 George Washington University Trauma Lecture, Washington DC, February, 1996. University of California San Diego - Tissue Sealants: Current Practice, Future Uses. San Diego, California, April, 1995. Uniformed Services University of the Health Sciences - Potential Uses of Fibrin Sealants, Bethesda, Maryland, December, 1994. 13th World Congress of Endourology and Shock Wave Lithotripsy, Jerusalem, Israel, November, 1995. Alf H. Gunderson Memorial Lecture, Gunderson Clinic, LaCrosse, Wisconsin, September, 1995 90th American Urological Association Meeting, Las Vegas, Nevada April, 1995. XII Annual Urology Conference, Gainesville, Florida, March 1995. 12th World Congress of Endourology and Shock Wave Lithotripsy, St. Louis, Missouri, December 1994. American College of Surgeons - 80th Clinical Congress, Chicago, Illinois, October, 1994. North Central American Urological Association Annual Meeting, Boca Raton, Florida, September, 1994. Society of Pelvic Surgeons Annual Meeting, Chicago, Illinois, September, 1994. Basic Science Course in Urology, American Urological Association Charlottesville, Virginia, June, 1993; June, 1994; June 1995, June 1996, June 1997, June 1998, June 1999. 91st American Urological Association Meeting, San Francisco, California, May 1994. 5th Internal Meeting - Society for Minimally Invasive Therapy, Orlando, Florida, November, 1993. 11th World Congress on Endourology and ESWL, Florence, Italy, October, 1993. 35th World Congress of International Society of Surgery, Hong Kong, August 1993. Urological Association of Pennsylvania and Maryland Urological Society - New Technologies in Urology, Baltimore, Maryland June, 1993. 90th American Urological Association Meeting, San Antonio, Texas May, 1993. 17th Annual Clinical Problems in Urology, Northwestern University Chicago, Illinois, April, 1993. Society of Surgical Oncology Annual Meeting, Los Angeles, California, March, 1993. 27
  28. 28. GlaxoSmithKline Clinical Development & Medical Affairs, North America Curso Internacional - Advances in Urologia, Hospital La Fe, Barcelona, Spain, March, 1993. Minimally Invasive Surgery in Oncology Symposium, M.D. Anderson Cancer Center, Houston, Texas, December, 1992. Surgical Grand Rounds, Cornell University - New York Hospital, New York, N.Y., December, 1992. Hospital Universitario De Caracas, Caracas, Venezuela, November, 1992. Society for Minimally Invasive Therapy: 4th International Meeting, Dublin, Ireland. November, 1992. American College of Surgeons - 78th Clinical Congress, New Orleans, Louisiana, October, 1992. San Diego Urological Society, San Diego, California, October, 1992. Minimally Invasive Surgery and New Technology. 2nd European Congress of Viscero - Synthesis, Luxemburg, September, 1992. 10th World Congress on Endourology and ESWL, Singapore, September, 1992. Group Hospitalier - Cochin, Hospitaux de Paris, Paris, France, June, 1992. 90th American Urological Association Annual Meeting, Washington, DC., June 1992. American Lithotripsy Society Annual Meeting, Orlando, Florida, October 1991. Society for Minimally Invasive Therapy: 3rd International Meeting, Boston, Massachusetts, June, 1991. Curso Internacional - Advances en Urologia, Hospital La Fe, Valencia, Spain, March, 1992. Videourology 91: 3rd World Congress of Videourology, Hakone, Japan, July, 1991. 9th World Congress on Endourology and ESWL, Vienna, Austriam, June 1991. 89th American Urological Association Annual Meeting, Toronto, Canada, June, 1991. International Anesthesia Research Society Meeting, San Antonio, Texas, April, 1990. Society for Medical Decision Making Boston, Massachusetts, March 1990. 88th American Urological Association Annual Meeting, New Orleans, Louisiana, May 1990. New England Section of the American Urological Association, Bermuda, October, 1988. New England Section of the American Urological Association, Montreal, Canada, October. 1997. Tri-State Meeting of the Maine, Vermont and New Hampshire Chapters of the Americal College of Surgeons, Sugarloaf, Maine, February, 1987. 1st Annual Symposium of the Abbassi Shaheed Hospital, Karachi, Pakistan, February, 1986. 116th Annual American Public Health Association Meeting, Las Vegas, Nevada, November, 1986. 23rd Annual Symposium of the Jinnah Postgraduate Medical Center, Karachi, Pakistan, November, 1985. 28
  29. 29. GlaxoSmithKline Clinical Development & Medical Affairs, North America Appendix B: Curriculum Vitae of James O. L’Esperance 29
  30. 30. GlaxoSmithKline Clinical Development & Medical Affairs, North America Appendix C: Curriculum Vitae of Jeffrey C. Sung JEFFREY SUNG 103 Mayfield Circle (919) 395-1001 Durham, NC 27705 jeffrey.sung@duke.edu Education 2000.2005 DUKE UNIVERSITY, School of Medicine and The Fuqua School of Business, Durham, NC Candidate for the degrees of Doctor of Medicine and Master of Business Administration, May 2005. Honors: Albert Schweitzer Fellow, Marshall and Sarah Pickens Scholarship Medical School Admissions Committee (Interviewer). Alternative Career Paths in Medicine (Founder). Christian Medical and Dental Association (Student Leader). Special Olympics Volunteer. Health Care Club. 1996.2000 STANFORD UNIVERSITY, Stanford, CA B.A.S. in Economics and Biology with Distinction. Honors: Phi Beta Kappa. Asian-American Students Association (Issues Chair). Alternative Spring Break (Course and Trip Senior Leader). Intervarsity Christian Fellowship. Experience 10/02-03/03 A.M. Pappas and Associates Intern, Venture Fund Management • Reviewed business plans for value as potential investment opportunities, evaluating in terms of technology, market opportunity, management and finance strategy • Completed competitive analyses, cash flow analyses and preliminary due diligence reports • Presented companies to investment team at weekly investment meetings • Participated in lead generation and in new company presentations 2001.2002 STANFORD UNIVERSITY, Stanford, CA Resident Assistant • Organized educational and social events. • Facilitated dorm meetings. • Mediated student conflicts. • Counseled residents on academic and personal issues. 1998.1999 VA HOSPITAL UROLOGY DEPARTMENT, Menlo Park, CA Research Assistant • Analyzed efficacy of FDG PET scans in the diagnosis and staging of advanced prostate cancer. • Compared prostate cancer grades and treatments with survival rates in patients over the age of 70. 6/99-9/99 STANFORD ECONOMICS DEPARTMENT, Stanford, CA Research Intern • Compared funding of state education programs from 1970 to 1990. • Developed mathematical algorithms to describe state programs. • Conducted primary and literature research on state education laws. 6/97-9/97 M.D. ANDERSON CANCER CENTER, Houston, TX 30
  31. 31. GlaxoSmithKline Clinical Development & Medical Affairs, North America 6/96-9/96 Research Intern • Designed immunostaining procedure for detection of mutant MMAC1 gene in malignant cancers. • Analyzed efficacy of antisense TGF-α as an anti-tumorigenic agent in glioma cells. Publications Sung JC, Kabalin JN, Terris MK. Prostate cancer detection, characterization, and clinical outcomes in men aged 70 years and older referred for transrectal ultrasound and prostate biopsies. Urology. 2000 Aug 1;56(2):295-301. Sung, J., Espiritu, J.I., Segall, G.M., and Terris, M.K.: Flurodeoxyglucose Positron Emission Tomography Studies in Diagnosis and Staging of Clinically Advanced Prostate Cancer. BJU International 2003 Jul;92(1):24-7. 31

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