Gary Scott Friedlander, M.D. Urological Consultants, P.A. A Division of Chesapeake Urology Associates, LLC

Transcription

1 Gary Scott Friedlander, M.D. Urological Consultants, P.A. A Division of Chesapeake Urology Associates, LLC 9420 Key West Ave, Suite 420, Rockville, MD University Blvd, West, Suite 516, Wheaton, MD Office Phone Office Fax Credentials: 1995 Diplomate American Board of Urology Education: Emory University, Atlanta, Georgia Georgetown University School of Medicine, Washington, District of Columbia Residency: Washington Hospital Center-Surgery, Washington, District of Columbia Internship: Washington Hospital Center-Urology, Washington, District of Columbia Work Experience: 1993 Present Private Practice Urological Consultants, P.A., Rockville, Maryland 1989 Present Investigator Washington Hospital Center, Washington, District of Columbia Hospital Affiliations: Chairman, Shady Grove Adventist Hospital Urology Section, Rockville, Maryland 1993 Present Member, Shady Grove Adventist Hospital, Rockville, Maryland 1993 Present Member, Montgomery General Hospital, Olney, Maryland 1993 Present Member, Holy Cross Hospital, Silver Spring, Maryland Professional Affiliations: 1993 Present Member, American Urological Association

2 Research Activities: Urology-Benign Prostatic Hypertrophy 1. A Phase III Study of the Efficacy and Safety of XXXXX in Subjects with Symptomatic Benign Prostatic Hyperplasia (BPH). 2. A Long-Term, Open Label Extension Trial Evaluating the Safety and Efficacy of XXXXX in Subjects with Benign Prostatic Hyperplasia (BPH). 3. A Multi-Center, Double-Blind, Double-Dummy, Randomized, Placebo and XXXXX Controlled Parallel Group Study to Assess the Efficacy and Safety of XXXXX in Subjects with Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction. 4. A Double-Blind Placebo-Controlled, Parallel-Group Safety and Efficacy Study Evaluating Three Dose Regimens of XXXXX, a Selective Alpha-Adrenergic Antagonist, in the Treatment of Benign Prostatic Hyperplasia. 5. A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Two Dosing Regimens of XXXXX in Subjects with Symptomatic Benign Prostatic Hyperplasia. 6. A Randomized, Double-Blind, Placebo Controlled, Two-Year, Parallel Group Study of the Efficacy and Safety of XXXXX 0.5mg in the Treatment and Prevention of Progression of Benign Prostatic Hyperplasia. 7. A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Efficacy and Safety of XXXXX in the Treatment and Modification of Progression of Benign Prostatic Hyperplasia. Urology-Bladder Cancer 8. Phase III Randomized, Double-Blind Study of XXXXX vs. Placebo in Low Grade Superficial Bladder Cancer. Urology-Erectile Dysfunction 9. A Multicenter, Open Label, Flexible Dose Study to Investigate the Use Patterns of XXXXX (XXXXX) and the Ability of Investigators to Further Optimize Subject Satisfaction with XXXXX Through Customized Instruction. 10. A Phase III At Home Use Study Evaluating the Efficacy and Safety of Escalating Doses of XXXXX 2, 3, and 4 mg in the Treatment of Patients with Erectile Dysfunction. 11. A Phase III, Six-Month, Long-Term, Open-Label, Flexible Dose, Safety Extension Study of XXXXX Tablets (2, 3, and 4 mg) in the Treatment of Male Erectile Dysfunction. 12. A Randomised, Double-Blind, Multi-Centre, Fixed Dose, Parallel-Group Twelve Month Study to Investigate the Safety and Tolerability of XXXXX in the Treatment of Patients with Erectile Dysfunction in Comparison with XXXXX. 13. A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Fixed-Dose, Parallel Group, 6-Month Comparison Study to Investigate the Efficacy and Safety of XXXXX in Males with Erectile Dysfunction. 14. An Open-Label Study to Evaluate the Efficacy and Safety of XXXXX

3 Administered On Demand to Men of Various Populations with Erectile Dysfunction. 15. A Phase III, Double-Blind, Randomized Parallel Study Evaluating the Safety and Efficacy of XXXXX Sublingual (2 and 3 mg) in the Treatment of Male Erectile Dysfunction. 16. A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Phase III Trial of the Efficacy and Safety of XXXXX in Male Patients with Erectile Dysfunction. 17. An Open-Label, Parallel Design, Twelve Month Phase III Trial of the Safety and Efficacy of XXXXX in Male Patients with Erectile Dysfunction. Urology-Prostate Cancer 18. A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of XXXXX mg XXXXX in Men with Metastatic, Hormone- Refractory Prostate Cancer. 19. A Phase III Extension Study to Evaluate the Safety of XXXXX mg XXXXX in Men with Hormone-Refractory Prostate Cancer. 20. A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of XXXXX mg XXXXX in Men with Non-Metastatic, Hormone- Refractory Prostate Cancer. 21. A Phase III, Multicenter, Open-Label, Randomized Study of XXXXX Vs. XXXXX Plus Daily XXXXX in Patients with Prostate Cancer Who Are Candidates for Initial Hormonal Therapy. 22. A Phase III, Randomized Multicenter, Placebo-Controlled, Double-Blind Clinical Trial to Study the Efficacy and Safety of XXXXX for the Treatment of Hot Flashes Following Surgical or Chemical Castration of Prostate Cancer Patients and Its Impact on the Quality of Life in These Patients. 23. Phase III, Open-Label, Randomized, Parallel, Active-Control Study to Evaluate Efficacy and Safety of XXXXX in Patients with Advanced Prostate Cancer. 24. A Phase III, Multicenter, Open-Label Randomized Study of XXXXX Vs. XXXXX in Patients with Prostate Cancer Who Are Candidates for Initial Hormonal Therapy. 25. A Rollover, Multicenter, Open-Label, Maintenance Study of Patients with Prostate Cancer Who Were Previously Treated with XXXXX 50 mg or 100 mg IM. 26. A 12 Month, Open-Label, Fixed-Dose Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Endocrine Efficacy of Two Doses of XXXXX 45 mg in Patients with Advanced Prostate Cancer. 27. A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of XXXXX 0.5 mg Administered Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer. 28. A Randomized, Double-Blind, Placebo-Controlled, Multicenter Efficacy and Safety Study of XXXXX for the Prevention of Bone Fractures in Men with Prostate Cancer on Androgen Deprivation Therapy.

4 29. A Multicenter, Phase IIIb, Four Arm, Dose Finding, Randomized, Placebo- Controlled Study to Determine the Long Term Prostate Cancer Chemoprevention Efficacy and Safety of 20 mg, 40 mg & 60 mg Daily of XXXXX in Men with High Grade Prostatic Intraepithelial Neoplasia (PIN). Urology-Prostatitis 30. A Double-Blind, Randomized, Placebo-Controlled Trial of XXXXX for the Treatment of Chronic Non-Bacterial Prostatitis. 31. A Randomized, Double-Blind, Multicenter, Phase III Study of XXXXX and XXXXX in the Treatment of Chronic Bacterial Prostatitis. Urology-Urinary Incontinence 32. Double-Blind, Placebo Controlled Study of XXXXX in Subjects with Symptoms of Overactive Bladder of Urgency, Frequency and Urinary Incontinence. 33. Open-Label Extension Study of Sustained Release XXXXX in Subjects with Symptoms of Overactive Bladder. 34. A Multicenter, Double-Blind, Placebo-Controlled Study of 20 mg, Twice Daily XXXXX for 12 Weeks Followed by a 9-Month, Open-Label Treatment Phase in Patients with Overactive Bladder. 35. A Dose-Range Study to Evaluate XXXXX, XXXXX and XXXXX When Administered to Female Subjects with Unstable Bladder Conditions. 36. A 12-Week Safety and Efficacy Study of XXXXX Versus Placebo in Subjects with Overactive Bladder. 37. XXXXX in Patients with Urge Urinary Incontinence: A 12-Week Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study with a 12-Week Open- Label, Dose-Titration, Safety Extension. 38. A Multi-Center, Double-Blind, Placebo-Controlled, Dose-Titration Study of XXXXX in Patients with Overactive Bladder. 39. Open-Label Study of the Efficacy and Safety of 5 and 10 mg XXXXX in Patients with Overactive Bladder Symptoms. 40. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of XXXXX in Patients Years of Age with Symptoms of Overactive Bladder. 41. A Multicenter, Randomized, Double-Blind, Study to Evaluate the Safety and Efficacy of XXXXX Vaginal Ring Releasing 4 mg/day Versus 6 mg/day Versus Placebo in Women Diagnosed with Overactive Bladder Who Have Symptoms of Predominant or Pure Urge Incontinence, Urgency and Frequency. 42. Open-Label Safety and Dose Conversion/Determination Study of XXXXX for Urge Urinary Incontinence. 43. Comparison of the Efficacy and Tolerability of XXXXX and XXXXX in the Treatment of Overactive Bladder. 44. A 52-Week Extension Study to Evaluate Long-Term Safety of Oral XXXXX in Subjects with Overactive Bladder. 45. A Randomized Double-Blind, Placebo-Controlled, Parallel-Group, Fixed- Dose, Multicenter Study to Assess Efficacy and Safety of Daily Oral Administration of XXXXX Versus Placebo in Male and Female Subjects with

5 Overactive Bladder. 46. A 6-Week, Double-Blind, Placebo Controlled, Randomized, Parallel Group, Multicenter, Multidose Study of the Efficacy and Safety of XXXXX in Patients with Overactive Bladder Symptoms of Increased Urinary Frequency, Urgency and Urge Incontinence. 47. A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel- Group Study Assessing the Efficacy and Safety of XXXXX in Postmenopausal Women with Urinary Incontinence.

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