Total Research Group, LLC

Experience

1. Duke University/Boehringer Ingelheim – Principle Investigator – Phase 3, A Multicenter International Randomized Parallel Group Double-Blind Placebo-Controlled Clinical Trial of XXX Once Daily To Assess Cardio-Renal Outcomes In Patients With Chronic Kidney Disease. (EMPA-Kidney)

2. Retrophin, Inc. – Principal Investigator – Phase 3, A Randomized, Multicenter, Double-Blind, Parallel, Active-Control Study of the Effects of XXX, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS)

3. Ardelyx, Inc. – Principal Investigator -Phase 3, A Long-Term, Open Label Study to Evaluate the Ability of XXX Alone or in Combination with Sevelamer to Treat to Goal Serum Phosphorus in Patients with ESRD on Dialysis.

4. Astra Zeneca - Principal-Investigator - A Phase 3: Amendment 3 to Clinical Study. A Multicenter, Randomized, Double blind, placebo-controlled study Evaluating the Safety and Efficacy of XXX for the Treatment of Anemia in Chronic CKD Patients not on dialysis

5. OPKO Renal Division – Principal Investigator – Mineral and Bone Disorder in Pre-dialysis: A Real-World Assessment of Risk and Effectiveness of Current SHPT Treatment Approaches (MBD-AWARE)

6. Akebia, Inc – Principal Investigator – Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral XXX for the Correction of Anemia in Subjects with Non-Dialysis-Dependent Chronic Kidney Disease.

7. Akebia, Inc – Principal Investigator – Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral XXX for the Maintenance Treatment of Anemia in Subjects with Non-Dialysis-Dependent Chronic Kidney Disease.

8. Ardelyx, Inc. – Principal Investigator - A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of XXX as Adjunctive Therapy to Phosphate Binder Therapy in End Stage Renal Disease subjects with Hyperphosphatemia.

9. Akebia, Inc. – Principal Investigator – Phase 2, Randomized, Open-Label, Active-Controlled, Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics study of Oral XXX for the Treatment of Anemia in Hemodialysis Subjects Converting from Epoitin alfa.

10. Ardelyx, Inc. – Principal Investigator - A Phase 3, Open Label Study with a 12-Week, Placebo-Controlled, Randomized Withdrawal Period Followed by an Open Label
Long Term Safety Extension to Evaluate the Safety and Efficacy of
XXX to Treat Hyperphosphatemia in End-Stage Renal Disease
Patients on Hemodialysis and Peritoneal Dialysis.

11. GlaxoSmithKline - Principal-Investigator – A open-label (sponsor-blind), randomized, active controlled, parallel-group, multi-center study to evaluate the efficacy and safety of XXX compared to recombinant human erythropoietin in subjects with anemia associated with CKD who are initiating dialysis.

12. GlaxoSmithKline - Principal-Investigator - A phase 3 randomized, open-label (sponsor-blind), active controlled, event driven study in non-dialysis subjects with anemia associated

with chronic kidney disease to evaluate the safety and efficacy of XXX compared to darbepoetin alfa

13. GlaxoSmithKline - Principal-Investigator - A phase 3 randomized, open-label (sponsor-blind), active controlled, event driven study in dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of XXX compared to recombinant human erythropoietin, following a switch from erythropoietin-stimulating agents

14. Astra-Zeneca - Principal-Investigator - A Phase 3: multicenter, randomized, double blind, placebo-controlled study evaluating the safety and Efficacy of XXX for the Treatment of Anemia in Chronic CKD Patients not on dialysis

15. Zoll LLC - Principal-Investigator - Wearable cardioverter defibrillator in hemodialysis patients (WED-HED) study

16. Astra-Zeneca Principal-Investigator - A phase 3, multicenter, randomized, double blind placebo-controlled study in anemic patients with CKD 3, 4, or 5 not on dialysis.

17. Takeda Corporation - Principal-Investigator - XXX a phase 3 selective inhibitor xanthine oxidase in patients with renal impairment

18. Genkyotex - Principal-Investigator - A double-blind randomized placebo controlled, Phase 2 evaluating the safety and efficacy of oral XXX in patients with type 2 diabetes and albuminuria

19. Ciba-Geigy Corp - Principal-Investigator - Pilot Bioavailability study evaluating a single dose of oral solution XXX given on four separate occasions

20. Pfizer Labs - Principal-Investigator - Phase 1 double blind placebo controlled single dose study to establish toleration and pharmacokinetics of XXX

21. Pfizer Labs - Principal-Investigator - A phase 1 study of the bioequivalence of the research and proposed commercial pediatric formulations of XXX.

22. Pfizer Labs - Principal-Investigator - A phase 1 study of the bioequivalence of the research and proposed commercial tablet formulations of XXX.

23. Syntex Research - Principal-Investigator - Safety and pharmacokinetic study of a single intravenous dose of XXX.

24. Duramed Pharmaceuticals - Principal-Investigator - Comparative randomized 2-way crossover bioavailability study of XXX and Upjohn methylprednisolone

25. Pfizer Labs - Principal-Investigator - Single dose study of XXX in obese otherwise healthy volunteers.

26. Pfizer Labs - Principal-Investigator - Phase 1 study comparing the bioequivalence of sertraline commercial tablet and capsule with XXX research capsule

27. Pfizer Labs - Principal-Investigator - Phase 1 double-blind, placebo controlled single dose study to establish toleration, pharmacokinetics and bioavailability of XXX.

28. Bristol-Myers - Principal-Investigator - A multi-dose human safety and pharmacokinetic study of XXX.

Research interests

See Curriculum Vitae for full details:

MEDICAL STAFF EXECUTIVE POSITIONS
Coral Gables Hospital (Tenet)
Physician Advisor
Medical Staff President
Board of Trustees Member
Medical Executive Board
Governing Board Member

COMMUNITY POSITIONS

Miami Rescue Mission – Board Member 2015 - Present

Team Physician - University of Miami Hurricanes 1995 - 2010

Disease areas

• Other

End Stage Renal Diseas, Chronic Kidney Disease, Diabetes,

Other information

See curriculum vitae for details.

Documents