IndianaUniversitySchool of Medicine

Thomas A. Gardner, M.D.

535 N. Barnhill Dr. Indianapolis, IN 46202

NAME:Gardner, Thomas

EDUCATION:

UNDERGRADUATE:

The GeorgeWashingtonUniversity

Columbian College of Arts and Science

Washington, D.C.

1986, B.A.“with Distinction”

Major:Computer Science / Statistics

GRADUATE:

The GeorgeWashingtonUniversity

School of Medicine

Washington, D.C.

1990, M.D.

POSTDOCTORAL:

1990-1991Intern, General Surgery

New York Hospital-Cornell Medical Center, New York, NY

Breast and Thoracic SurgeryRotations-MemorialSloan-KetteringCancerCenter

1991-1992Resident, General Surgery

New York Hospital-Cornell Medical Center, New York, NY

Thoracic SurgeryRotations-MemorialSloan-KetteringCancerCenter

1992-1995Resident, Urology

New York Hospital-Cornell Medical Center, New York, NY

Urologic SurgeryRotation-MemorialSloan-KetteringCancerCenter

1993Research Rotation

New York Hospital-Cornell Medical Center, New York, NY

Urologic Oncology Lab (Director: Neil H. Bander) and Male Reproductive

Microsurgery & Reconstructive Training Lab (Director Marc Goldstein)

1992-1996Lecturer and Clinical Instructor

Cornell University Medical College-Physician Assistant Program, New York,NY

1995-1996Chief Resident, Urology

New York Hospital-Cornell Medical Center, New York, NY

1996-1998Urologic Oncology Research Fellowship

Cancer Biology/Gene Therapy

Lab Director: Leland W. K. Chung, Ph.D.

Department of Urology, Molecular Urology and Therapeutics Program,

University of VirginiaHealthSciencesCenter

Charlottesville, VA

ACADEMIC APPOINTMENTS: (Inclusive dates.)

1998-1999Assistant Professor of Research

Department of Urology, Molecular Urology and Therapeutics Program,

University of VirginiaHealthSciencesCenter,

Charlottesville, VA

1999-2001Visiting Assistant Professor

Department of Urology, Molecular Urology and Therapeutics Program,

University of VirginiaHealthSciencesCenter,

Charlottesville, VA

1999-2005Assistant Professor of Urology,

IndianaUniversity,School of Medicine

Indianapolis, IN

1999 -2005Assistant Professorof Microbiology and Immunology

IndianaUniversity,School of Medicine

Indianapolis, IN

2005-PresentAssociate Professor of Urology with Tenure,

IndianaUniversity, School of Medicine

Indianapolis, IN

2005-PresentAssociate Professor of Microbiology and Immunology

IndianaUniversity, School of Medicine

Indianapolis, IN

HOSPITAL APPOINTMENTS:

1999 – Present Attending Urologist

IndianaUniversityMedical Center, Indianapolis, IN

1999 - PresentUrology Staff Surgeon and Service Chief (1999-2007)

Department of Surgery,WishardMemorialHospital,

Indianapolis, IN

1999 - PresentUrology Staff Surgeon, Department of Surgery

VAMC and Methodist Hospital,Clarian North, Clarian West,

Indianapolis, IN

OTHER APPOINTMENTS AND PROFESSIONAL CONSULTANTSHIPS:

DirectGene, Inc., Founder, Scientific Advisory Board, Clinical and
Research Consultant (1998 –2003)

Advagen, Inc., Scientific Advisory Board (2003-2004)

Focus Surgery, Inc., HIFU Proctor, Clinical and Scientific

Consultant for SBIR Grant (2001-present)

Amgen, Inc., Prostate Cancer Advisory Board Meetings (2000-2001)

Pfizer Speaker Bureau (2002-Present)

AstraZeneca LP Prostate Cancer Lecture Bureau (2003-Present)

Endocare, Inc., Proctor Kidney Cryotherapy (2003-Present)

Intuitive Surgery, Proctor Laparoscopic Robotic Surgery (2004-Present)

GSK Speaker Bureau (2002 - Present)

AMS Proctor (2005-Present)

SPECIALTY BOARD STATUS:

Diplomate, National Board of Medical Examiners - Part I, II, III Completed 1991

Diplomate, American Board of Urology - Part I 1996, Part II 2002

Recertified - 2009

LICENSURE AND CERTIFICATION:

1991-PresentNew YorkState Medical License (In-Active)

1997-PresentVirginiaState Medical License(Active)

1999-PresentIndianaState Medical License(Active)

PROFESSIONAL ORGANIZATIONS:

American Urological Association - Associate Member

Young Urologist Committee –Member

North Central Section - Member

American Society of Gene Therapy - Member

Society of Basic Urologic Research - Member

Society of Laparoendoscopic Surgeons - Member

Hoosier Oncology Group (HOG) - Member

Eastern Cooperative Oncology Group (ECOG) - Member

American Medical Association - Member

American Association for the Advancement of Science - Member

Phi Delta Epsilon Medical Fraternity

American Medical Student Association

Alpha Epsilon Delta Pre-Medical Honor Society

HONORS AND AWARDS:

In Rank Intramural Award Total $2,500

In Rank Extramural Award Total $277,500

1982Reagents Scholarship-New York Board of Reagents

1982-1986Board of TrusteesHonorScholarship-GeorgeWashingtonUniversity

1995Andlinger Fellowship Award-The American Austrian Foundation

1996-1998American Foundation of Urologic Disease Research Scholar Award

1996CaPCURE Research Award-Co-Investigator (PI-Chung, LWK)

1997CaPCURE Research Award ($100,000)

1998 AUA Annual Essay Contest Co-First Prize in Research Category ($ 1,000)

1999CaPCURE Research Award ($100,000)

1999VICAL Best Abstract Award – 1999 Cancer Gene Therapy Meeting ($ 2,500)

2000CaPCURE Research Award ($100,000)

2000-2002NY Academy of Medicine Edwin Beer Award ($ 75,000)

2002AUA Annual Best Video Award – Honorable Mention

2004IndianaUniversity Trustee Teaching Award ($ 2,500)

TEACHING ASSIGNMENTS SINCE APPOINTMENT

Formal Course Instruction:

Medical Students

Course Number Course Information

X601Introductions to Clinical Medicine- II - Urology Section

Sophomore Lecture (100 students) Series in Urology

Role – Urology Section Director and Lecturer, I organize 4 lectures per year (2 hours), Write Exam Questions

Organize the Didactic Examination of Male Genitalia 4 X 4 hour Sessions)

L700 Urology Core Clerkship 1999-2002Senior Students –

(Average 3-4 Senior Students Per Month) Prior to 2002 all senior student were required to rotate through the urology service and attend 4 one hour lectures every other week for a majority of the year. I would generally give one of the 4 lectures half of the time.

L897Urology Senior Elective (IU or Non-IU) (1- 4 senior students per month from July to October). These students would rotate on the urology service attend clinics and operative procedures.

L804Urology Research Elective (1-2 students per year, spending time in the research lab or clinical research project

S700Surgical Core Rotation –

Director Lecturer - Urology Surgical Subspecialty

2002 – Present All 3rd year students attend 3 hours of lectures, I give 2 of the 3. Nine series of lectures are given for the year.

I also developed the lecture series and arranged the rotation schedule for the student when urology became part of this course. L700 and overlapped for one year with S700.

Graduate Student

Course Number Course Information

J854Spring 2004Course Title: Hematopoiesis –

Lecture Title: Vaccine Trials for Urologic Cancer

Students: 8-12

Format: Lecture(1 hr) and Small Group Discussion (1.5 Hrs)

J828 Fall2004 Course Title: Virology

Lecture Title: Adenovirus and Parvovirus

Students: 8-12

Format: Lecture (1 hr) and Small Group Discussion (1.5 Hrs)

J802 Course Title: Microbiology and Immunology Summer Research Rotation. (1 to 2 Graduate students pending 1 month in the lab.)

2002 Philip Abosh

2003 Juan Jimenez and

Student Mentoring:

Formal

Phillip Abosh 2002 – Present Ph.D Committee – Member

Juan Jimenez 2004 – Present Ph.D. Advisor and Mentor for F31-CA106215-01

Joseph Klink 2004 – Academic Advisor – Interested in Urology

Informal

I have mentored Medical Students, Residents and Fellows throughout my career at IU.

T. Shirakawa, MD, PhD 1998-9 at UVA, now at KobeUniversity as Assistant Prof.

M. Moghaddam, MD2000-2002, now Assistant Professor in Iran

A Mosharafa, M.D. 2003-2004 now Assistant Professor in Epypt

SP Raikwar, Ph.D 2002-2005 now Assistant Scientist ,Univ. of Wisconsin

JA Jiménez2002-Present MD/PhD Student (PhD Advisor)

M Mellon2006-2008

CME Courses Taught

2000MiniMedicalSchool- Gene Therapy and Prostate Cancer

Location: University Place

Sponsor Dean’s Office

CME Course Title: “The 8Th Annual Family Practice Update

Date: June 1, 2002

Location: UniversityPlaceConferenceCenter

Sponsor:IndianaUniversity, School of Medicine, Division of CME

Title “Prostate Disorders, Diagnosis and Treatment”

CME Course Title: “Sexual HealthHospital Symposia” –Half-Day CME Program

Date: September 27, 2003

Location: IndianaUniversityMedicalCenter

Sponsor: BostonUniversitySchool of Medicine and National Foundation for Sexual Health Medicine

Title: “Low Testosterone and Your Male Patients: Correlates, Symptoms and Treatments”

CME Course Title: “Men’s Health Issues Update”- Half Day CME Program

Date: March 19, 2004

Location: UniversityPlaceConferenceCenter

Sponsor: IndianaUniversity, School of Medicine, Division of CME

Title: “Benign Prostatic Hypertrophy: Update on Diagnoses and Medical Management”

CME Course Title:“Latest Develop in Urology for Primary Care Physicians”,

Date: April 24, 2004

Location: MarriotKingsgateConferenceCenter

Sponsor: Lecture Titles “Latest Advances in Diagnosing and Treating Erectile Dysfunction”And “Case Study: ED and Men’s Sexual Health: Importance of Asking”

CME Lecture Title: “Erectile Dysfunction 2004 Update”

Date: June 24, 2004

Location: IndianPalace, Indianapolis, INUniversityPlaceConferenceCenter

Sponsor: VAMC, Division of CME

CME Lecture Title: “Kidney Masses: Evaluation and Treatment”

Date November 12, 2004

Location: HolidayInnConfCenter

Sponsor: Urology Nursing Society Inc.

CME Lecture Titles: “2004 Treatment for Metastatic Prostate Cancer”, “HIFU and Cryotyherpy for Prostate Cancer” and “Gene Therapy for Prostate Cancer”

Date: September 23, 2004

Location: University of Minnesota, Center for Prostate Cancer Symposium

CME Lecture Titles: “2009 Prostate Cancer Update"

Date: July 21, 2009

Location: Union Hospital, Evansville IN

Clinical Teaching

Clinical instruction of medical students, residents and fellows is conducted during my clinical activities at UniversityHospital, Wishard and VA Medical Center. In 1999 - 2001 a majority of my clinical teaching occurred at WishardMemorialHospital at which time I almost independently supported the clinical activities of the Urology Service. From 2002 until present I spend 1.5 days seeing patients in the clinic and 2.5 days in the operating room.

PROFESSIONAL SERVICE:

(1) Service to the discipline

(a) State and Regional,

Public Service Announcements, Prostate Cancer

TV (Channel 13, RTV6, Health Beat)

Radio (Sound of Medicine)

CME and non-CME Lectures thought the State and Region

(b) National and international [list public offices, committees, organizations];

National Grant Reviews

2001 - DOD – CDMRP Prostate Cancer Research Program (PCRP)

2002 - DOD – CDMRP (PCRP) – Molecular Biology and Genetics

2002 - DOD – CDMRP (PCRP) – Consortium Award

2003 – NIH/NCI - R 03-124 NIAID

2005 - DOD – CDMRP (PCRP) – Clinical Trials Award

2006- DOD- CDMRP (PCRP)-Clinical & Experimental Therapeutics-1

International Grant Review

2002 - Canadian Institutes of Health Research – External reviewer

2003 – Fonds zur Frderung der wissenschaftlichen Forschung (FWF)

Austrian Science Fund- External Reviewer

International Consultant

KoreaUniversity - Gene Therapy Research Program

KobeUniversity - Gene Therapy Research Program

(2) service to patients/clients and related clinical institutions;

  1. “Phase I Study of Ad-OC-TK Plus Valacyclovir for the Treatment of Metastatic Recurrent Prostate Cancer” Sponsor Investigator, Status Closed, PI Gardner, Co-PI Chung.
  2. “Clinical Investigation of High Intensity FocusedUltrasound (HIFU) For the Treatment of Benign Prostatic Hyperplasia (BPH)” Sponsor FocusSurgery, Status Open (6/8/93), PI Gardner, Co-PI: Birhle, Foster, Shalhav, Koch.
  3. “Cox II Inhibitors in the Treatment of Bladder Cancer” Sponsor NIH, Open (12/9/01) PI- Foster, Co-PI: Bihrle, Gardner, Koch.
  4. “Phase III Randomized, Double- Blind Study of DFMO vs. Placebo In Low Grade superficial Bladder Cancer” Sponsor ILEX Onc., Status Open (3/17/99) PI- Foster Co-PI: Bihrle, Gardner, Koch, Mulcahy, Shalhav, Williams
  5. “The Selenium and Vitamin E Chemoprevention Trial(SELECT)” Sponsor NCI, Status Open(7/2/01) PI Koch Co-PI: Foster, Gardner
  6. Feasibility Study for Organ Confined Prostate Cancer Treatment with HIFU Using SONABLATE™ System Sponsor FocusSurgery, Status Open(7/25/01) PI – Koch; Co-PI: Gardner
  7. Feasibility Study for Locally Recurrent Prostate Cancer Treatment Using SONABLATE™ System Sponsor FocusSurgery, Status Open(5/14/01) PI – Koch; Co-PI: Gardner
  8. A Multicenter, Phase IIb, Four Arm, Dose Finding, Randomized, Placebo Controlled Study to Determine The Long Term Prostate Cancer Chemoprevention Efficacy and Safety Of 20mg, 40 mg, and 60 mg Daily of GTX-006 in Men with High Grade Prostate Intraepithelial Neoplasia (PIN) Sponsor GTx; Status Open(7/2/01); PI- Koch; Co-PI: Bihrle, Foster, Gardner, Mulcahy
  9. A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy With Autologous Antigen Presenting Cells Loaded With PA2024 (Provenge, AOC8015) in Asymptomatic Subjects With Gleason Sum Less than or Equal to 7, Metastatic, Androgen Independent Prostatic Adenocarcinomas.Sponsor Dendreon Corp. [D9902]PI Gardner
  10. An Open Label, Single Arm Trial of Immunotherapy with Autologous Antigen Presenting Cells Loaded with PA2024 (APC8015F) for Subjects with Objective Disease Progression and Disease-Related Pain on Trial D9902 Part B PI: Thomas A. Gardner
  11. A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer. PI Thomas A. Gardner
  12. A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of IC351(LY450190) Administered "On Demand" to Patients with Erectile Dysfunction Following Bilateral Nerve-Sparing Radical Retropubic Prostatectomy, PROTOCOL H6D-MC-LVCI Sponsor Lilly, Status Pending, PI Mulcahy, Co-PI: Gardner, Koch

Investigational New Drug/RAC Applications

  1. BB-IND 8115 - Adenovirus Vector (Ad-OC-TK, BioReliance) Expressing Thymidine Kinase Gene Under Regulation of an Osteocalcin Promoter and Valacyclovir (PI Gardner TA)
  2. RAC #-276 - Phase I Study of Ad-OC-TK Plus Valacyclovir for the Treatment of Metastatic Recurrent Prostate Cancer (PI Gardner TA)
  3. RAC #-426 - Phase I Study of Ad-OC-E1a for the Treatment of Metastatic Recurrent Prostate Cancer (PI Gardner TA)

Patent(s)

  1. 6,342,384 (1/29/02) Production of adenoviral vectors using serum-free suspension cell culture in a hollow fiber system.

Patents Pending

  1. MN - promoter based gene therapy for the treatment of malignancies.
  2. ß-HCH promoter based gene therapy for testicular malignancies.

(3) Community service (Prostate Cancer Support Group Presentations)

(1)US TOO Charlottesville Chapter, Charlottesville, VA 4/97

(2)US TOO of the Valley, Waynesboro, VA 2/98

(3)Man-to-Man (ACS-Sponsored) Lynchburg Chapter, Lynchburg, VA 10/97

(4)US TOO Richmond Chapter, Richmond, VA 3/98

(5)US TOO Charlottesville Chapter, Charlottesville, VA 4/98

(6)Man-to-Man (ACS-Sponsored), Roanoke, VA 4/98

(7)US TOO Annual Regional Directors Meeting, Chicago, IL 10/98

(8)US TOO of the Valley, Waynesboro, VA 2/99

(9)US TOO Charlottesville Chapter, Charlottesville, VA 4/99

(10)Man-to-Man (ACS-Sponsored) Lynchburg Chapter, Lynchburg, VA 4/99

(11)US TOO Richmond Chapter, Richmond, VA 6/99

(12)Man-to-Man (ACS-Sponsored) – St. VincentHospital, Indianapolis, IN, 9/99

(13)Man-to-Man (ACS-Sponsored) – St. VincentHospital, Indianapolis, IN 1/00

(14)Man-to-Man (ACS-Sponsored) – St. VincentHospital, Indianapolis, IN 1/01

(15)Man-to-Man (ACS-Sponsored) – St. VincentHospital, Indianapolis, IN 1/02

(16)Man-to-Man (ACS-Sponsored) – St. VincentHospital, Indianapolis, IN 1/03

(17)Man-to-Man (ACS-Sponsored) – St. VincentHospital, Indianapolis, IN 1/04

(18)Man-to-Man (ACS-Sponsored) – St. VincentHospital, Indianapolis, IN 1/05

(19)Man-to-Man (ACS-Sponsored) – St. VincentHospital, Indianapolis, IN 1/06

(20)Man-to-Man (ACS-Sponsored) – St. Vincent Hospital, Indianapolis, IN 1/07

UNIVERSITY SERVICE:

(1)university administrative service

Executive Council of WishardMemorialHospital - Member

Operating RoomCommitteeWishardMemorialHospital - Member

IUMG-SC Wishard Specialty Group - Member

Urology Clinic Redesign Team of WishardMemorialHospital - Member

(2) university committee service

(a) departmental,

WaltherOncologyCenter, Member

WaltherOncologyCenter, Internal Advisory Board Member

(b) school,

NIHCancerCenter Scientific Review Committee (SRC) - Member

NIH GCRC Advisory Committee - Member

Institutional Review Board - Alternate Member

IndianaUniversityCancerCenter – Member Experimental Therapeutics

IUCC Bone Cancer Working Group - Member

Clinical Research Strategic Planning Committee - Member

Radiation Oncology Chair Search Committee- Member

Cancer Center Director Search Commitee -Member

(c) campus,

Research III Strategic Planning Committee

(d)system [list name of committee, nature of participation, duration];

(3)student service [list student group, position/role, duration, formal-informal counseling

Not applicable

OTHER PROFESSIONAL ACTIVITIES:

Editorial Boards/ Journal Reviews

1997 – Reviewer - Journal of Urology

1997 – Reviewer – Investigative Urology

1998 – Editor - Gene Therapy and Molecular Biology

1999 – Editor - Tumor Targeting

2001 – Reviewer – Journal of Experimental Therapeutics

2001 – Reviewer – Molecular Therapy

2002 – Reviewer – Cancer Research

2002 – Reviewer - Urology

2002 – Reviewer – Cancer Research

Invited Presentations/Lectureships/Grand Rounds

  1. Gardner TA, Li PS, Lopez M, Wright EJ, Goldstein M. Microsurgical vasoepididymostomy: Which technique is best? The Department of Urology Grand Rounds, General Hospital, Salzburg, Austria, February 1995.
  2. Gardner TA, Kaneda Y, Liu D, Ko SC, Ginsberg RJ, Burt M, Kao C, Chung LWK. Gene therapy for the treatment of sarcoma. Thoracic Service Grand Rounds-Department of Surgery-Memorial Sloan-Kettering Cancer Center, New York, NY, March 1998.
  3. Gardner TA, Ko SC, Kao C, Shirakawa T, Cheon J, Gotoh A, Wu TT, Sikes RA, Zhau HE, Cui Q, Balian G, Chung LWK. Exploiting stromal-epithial interaction for model development and new strategies of gene therapy for prostate cancer and osteosarcoma metastases. International Conference on Gene Therapy, Crete, Greece, August 1998.
  4. Gardner TA, KoSC, Kao C, Cheon J, Shirakawa T, Chung LWK. Tumor-restricted adenoviral gene therapy applied to osteosarcoma and prostate cancer. ColdSpringHarbor Laboratory’s Meeting on Vector targeting strategies for therapeutic gene delivery, March 1999.
  5. Gardner TA, KoSC, Kao C, Chung LWK. Ad-OC-TK gene therapy for the treatment of metastatic osteosarcoma. Pediatric Oncology Service Grand Rounds-Department of Medicine-Memorial Sloan-Kettering Cancer Center, New York, NY, June 1999.
  6. Gardner TA. Gene therapy for the treatment of urologic malignancies. Clinical Science Symposia at the 32nd Annual Meeting of American Society of Nephrology, Miami, FL, November 1999.
  7. Gardner TA. “High Intensity Focused Ultrasound for Localized and Recurrent Prostate Cancer” Grand Rounds, Department of Urology, University of Michigan, August, 2000.
  8. Gardner TA. “Results of a Phase I Trial of Ad-OC-TK/VAL for Metastatic and Recurrent Prostate Cancer.” Prostate Cancer SPORE Lectureship, Department of Urology, University of Michigan, August, 2000.
  9. Gardner TA. Genetics underlying urologic malignancies. Fourth Uro-Oncology Conference, Lake Louise, Alberta, Canada, February 24-28, 2001.
  10. Gardner TA. “Basic gene therapy for the uro-oncologists”. Fourth Uro-Oncology Conference, Lake Louise, Alberta, Canada, February 24-28, 2001.
  11. Gardner TA. “Gene therapy approaches for metastatic prostate and kidney cancer.” Grand Rounds, Dept. of Urology, New York Hospital-Cornell Medical Center, NY, March 21, 2001.
  12. Gardner TA, “Gene Therapy for Osteosarcoma” CTEP sponsored “Biology of Childhood Osteogenic Sarcoma and Potential Targets for Therapeutic Development. BethesdaMD, November 29-30, 2001.
  13. Gardner TA, “Gene Therapy, What is it?” State of the Art lecture at NCS of AUA 2001 ChicagoIL, January 17, 2002.
  14. Gardner TA, “Chasing the Cash to Find the Cure” American Marketing Association, South BendIN, January 24, 2002.
  15. Gardner TA, “Treatment Options for Advanced and Recurrent Prostate Cancer:Vaccines and Thermal Therapy” Community Cancer Care Quarterly Seminars, April 29th, 2004.
  16. Gardner TA, Visiting Professor – ProstateCancerSymposiumUniversity of Minnesota, September 23,2004
  17. Gardner TA, “Gene Therapy, What is it?” State of the Art lecture at NCS of AUA 2004 , October 15, 2004.

Personal CME and non CME Clinical and Research Activity

2000 – 2004 325 hours Departmental and IU CME Credits

1999 – 2004 175 hours CME Credits fromMeeting

New clinical techniques acquired and incorporated in to clinical practice

*Each of these techniques required formal training (online up to two day hands on courses) and proctoring leading authority in the procedure.

1.High Intensity Focused Ultrasound for Prostate

2.Advanced Laparoscopy

  1. DaVinci Robotic Laparoscopy

4.Kidney Cryotherapy

5.Prostate Cryotherapy

6.Transurethral Microwave Thermal Therapy

7.Transurethral Needle Ablation of Prostate

8.Interstim Sacral Nerve Implantation

9.TVT, TOT, TVT-O Urethral Sling Procedures

GRANTS AND FELLOWSHIPS: