LGBT Cancer Project

Fundación de Investigación

Center Information

Michelle Echeandia
Clinical Operations Director
Fundación de Investigación
998 Ave Munoz Rivera
San Juan 00927-4807
Puerto Rico
787-722-1248
787-721-6098 (fax)
mecheandia@fdipr.com
www.fundaciondeinvestigacion.com
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Contact Center

FDI is located at 998 Ave Munoz Rivera, San Juan PR

Currently Enrolling Trials

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Therapeutic Areas

Cardiology/Vascular Diseases
Endocrinology
Family Medicine
Gastroenterology
Healthy Volunteers
Hematology
Hepatology (Liver, Pancreatic, Gall Bladder)
Immunology
Infections and Infectious Diseases
Internal Medicine
Musculoskeletal
Nephrology
Oncology
Pharmacology/Toxicology
Pulmonary/Respiratory Diseases
Rheumatology
Urology
Vaccines

Center Overview

Located in San Juan, Puerto Rico, Fundación de Investigación (FDI) is a clinical research center with state-of-the-art facilities that comprise medical treatment for multiple conditions, a 30-bed phase I unit, an in-house bioanalytical laboratory, multispecialty experienced personnel, and the latest in medical technology. We have successfully completed hundreds of FDA-regulated clinical trials sponsored by numerous pharmaceutical companies. Our site has enrolled thousands of patients in chronic hepatitis C clinical trials alone.

We are also an active medical care facility for patients with diverse medical ailments including liver diseases; metabolic disorders such as diabetes, hypertension and lipidemias; oncology and hematology, neurologic, musculoskeletal and infectious diseases. Our facilities include nurse stations, medical offices, exam rooms and chemotherapy or infusion chairs. We also have a complete research pharmacy with a clean room for the preparation of chemotherapy and investigational drugs.

At FDI, patients receive their primary medical care, and many of them participate in our clinical trials. This active medical care clinic model provides us with a robust pool of potential subjects for our clinical trials and has been instrumental in our enrollment successes. For our patients, the combination of the best available therapies with expert physician care and access to clinical trials with drugs under investigation broadens their chance of achieving the best medical outcomes.

Performance Metrics

Number of Studies Conducted: +350
Number of Studies Actually Completed: +300
Regulatory Submission Turn-Around Time: 14 Business Day(s)
Average Percent of Total Patients Randomized: 85%

Clinical Research Experience

FDI has over 20 years of continuous research experience. Our staff has published over 150 manuscripts in prestigious journals such as The New England Journal of Medicine, Hepatology, Journal of Hepatology, and the Journal of Clinical Gastroenterology and presented hundreds of abstracts at medical conferences. We have been instrumental in the development and approval process of several drugs against chronic hepatitis C. Our founder and medical director, Dr. Maribel Rodríguez-Torres, was influential in the approval of pegIFN-2a and RBV for co-infected patients with HCV and HIV in 2003. She also conducted the first trial in the world in which 6 patients received a combination of Telaprevir/peflFN and RBV for HCV therapy.

FDI has research experience in other therapeutic areas including hematology/oncology, heaptology, pulmonology, rheumatology, musculoskeletal, infectious diseases, vaccines, nephrology, internal medicine, innmunology, cardiology, endocrinology, gastroenterology, healthy volunteers and urology.

FDI has an excellent reputation as a top clinical trial enroller. Treating patients at our facilities enables us to screen and recruit appropriate candidates for our clinical trials. We have a history of high enrollment rates in most HCV and oncology studies performed at our facilities. In case of any difficulty finding adequate subjects for a clinical trial, we organize and conduct aggressive outreach activities to boost those numbers.

Following is a list of Pharmaceutical Sponsors, Clinical Research Organizations and Institutional Review Boards, that Fundacion has worked with.

Clinical Trial Sponsors

  • Abbott
  • Amgen
  • Anadys Pharmaceuticals
  • Astra Zeneca
  • Bristol Myers Squibb
  • Eximias Pharmaceuticals
  • Forrest Research Institute
  • GlaxoSmithKline
  • Human Genome Sciences
  • Idenix Pharmaceuticals
  • Idera Pharmaceuticals
  • Intarcia Pharmaceuticals
  • Intermune
  • Merck Sharp
  • Novartis Pharmaceuticals
  • Pharmasset
  • Pfizer
  • Procter & Gamble
  • Roche Laboratories
  • Sanofi-aventis
  • SciClone Pharmaceuticals
  • Tibotec Pharmaceuticals
  • Valeant Pharmaceuticals
  • Vertex Pharmaceuticals
  • Virochem Pharma
  • Wyeth Pharmaceuticals

Clinical Research Organizations (CRO)

  • CATO Research
  • Covance
  • Duke Clinical Research Institute
  • ICON
  • Kendle International
  • Medifacts International
  • Parexel
  • Pharmaceutical Research Associates (PRA)
  • Pharmanet
  • Phase to Phase Clinical
  • PPD Development
  • Quintiles
  • SC Liver Research Consortium

Institutional Review Boards (IRB)

  • Chesapeake Review Board
  • Coast IRB
  • Copernicus Group IRB
  • Ethical Review Committee
  • IRB Ponce School of Medicine
  • IRB UPR Medical Science Campus
  • Quorum Review Board
  • Research Consultants Review Committee
  • Western Institutional Review Board (WIRB)

Facility Description

Located in San Juan, Puerto Rico, Fundación de Investigación (FDI) is a clinical research center with state-of-the-art facilities that comprise medical treatment for multiple conditions, a 30-bed phase I unit, an in-house bioanalytical laboratory, multispecialty experienced personnel, and the latest in medical technology.

We are also an active medical care facility for patients with diverse medical ailments including liver diseases; metabolic disorders such as diabetes, hypertension and lipidemias; oncology and hematology, neurologic, musculoskeletal and infectious diseases. Our facilities include nurse stations, medical offices, exam rooms and chemotherapy or infusion chairs. We also have a complete research pharmacy with a clean room for the preparation of chemotherapy and investigational drugs.

Sublevel:

  • Bioanalytical laboratory facilities
  • AgilentHPLC(1290)-MS/MS(6460) equipments for drug analysis
  • Biosafety hood (Class II Type B2)
  • Chemical Hood
  • Centrifuges (refrigerated)
  • Centrifuges (ambient)
  • Microcentrifuge
  • Analytical balances
  • Vortex system
  • Tube rotator system
  • Freezers (-20°C, -80°C)
  • Refrigerators
  • Ultrapure water system
  • Thermomixer
  • Autoclave system
  • Savant system concentrator

First floor:

  • Ambulatory Clinics
  • Liver Disease Clinic
  • Hematology-Oncology Clinic
  • Rheumatology Clinic
  • Diabetes and Metabolic Diseases Clinic
  • Infectious Diseases Clinic
  • Neurology Clinic
  • Dermatology Clinic
  • Pain Management Clinic
  • 7 Seats for Chemotherapy
  • 2 Nurse Stations
  • 6 Medical Offices
  • 4 Exam Rooms

Second Floor:

  • Clinical Research Facilities
  • 7 Clinical Research Coordinators Offices
  • 2 Physician and Exam Rooms
  • 4 Seats for Blood Draws
  • 2 Bathrooms for urine collection
  • Laboratory for sample preparation
  • Centrifuge (refrigerated)
  • Centrifuge (ambient)
  • Freezer (-80°C)
  • Freezer (-20°C)
  • Refrigerators
  • 8 Seats for PK studies, up to 12 hours
  • Security room for drug storage
  • 48 spaces for drug storage (ambient)
  • 4 refrigerators (4°C)
  • Conference Room
  • Regulatory Office
  • Regulatory Document Room
  • Data Entry Room
  • Monitors Office (8 spaces)

Third Floor:

  • Clinical Research Facilities
  • 4 bunk beds
  • 22 beds
  • Refrigerator
  • Entertainment room for subjects
  • Computer facilities
  • Big Screen Plasma TV
  • Library
  • 4 Seats for blood drawing
  • Healthmeter mechanical Physician Scales
  • ECG telemetry system (12 – lead, Mortara)
  • ECG machines (12 – lead)
  • Elance Monitor ECG, RESP, NIBP, SPO2, TEMP
  • Laboratory for sample preparation
  • Centrifuge (refrigerated)
  • Centrifuge (ambient)
  • Freezer (-80°C)
  • Freezer (-20°C)

Infrastructure:

  • Back up electric generator for the whole building
  • Backup air conditioning for sensitive areas (drug storage and laboratories)
  • Parking facilities
  • Excellent public transportation
  • Transportation upon request provided by us to patients on Clinical Trials
  • High speed internet access (T1)
  • Long term blood and tissue storage
  • Security systems for all the building
  • Excellent public transportation

Our 30-bed phase I unit is the only one in the Caribbean and one of the few in South America. Our phase I unit has state-of-the-art monitoring technology that includes remote telemetry and sophisticated software designed to manage phase I trials.

Fundación de Investigación has conducted trials with confinement duration of up to 16 days, including multiple intensive pharmacokinetic and pharmacodynamic trials as SAD and MAD for many molecules. We also conduct hepatic impairment and drug-to-drug interaction studies. We have a database of normal volunteers and the capability to conduct all kinds of early studies in both normal volunteers and patients. Our phase I unit’s experienced staff and facilities allow the trials to be conducted without interruption 7 days a week.

Bio Lab
Fundacion Bioanalytical Laboratory (FBL) is a unit of Fundacion de Investigacion de Puerto Rico that specialize in qualitative and quantitative analysis of chemical and biological pharmaceutical compounds. We provide added value to our customers by advising on the scientific and regulatory situations that could arise in the development of these compounds. We are a one-stop facility where customers can perform Phase 1 and Phase 2 studies in the same facilities including the pharmacokinetics and pharmacodynamics assessment. This strategy provides faster results for companies for decision taking before embarking with additional cohorts in the development of the products.

We provide to our customers not only scientific but also clinical expertise in the development of pharmaceutical products. Our scientists have extensive experience in the development and validation of bioanalytical methods in the determination of small molecules and their metabolites. In addition, we are capable of performing sample analysis for pharmacokinetics/toxicokinetics of pre-clinical and clinical samples. FBL has the latest analytical equipment to quantify pharmaceutical compounds and metabolites with an extraordinary turn-around time. Two Ultra performance liquid chromatographs (Agilent 1290) coupled to two tandem mass spectrometers (Agilent 6460 QQQ) are available.

Investigator Experience

EXECUTIVE LEADERSHIP

Maribel Rodriguez-Torres
Founder, President and Chief Medical Officer

Maribel Rodriguez-Torres, Founder, President and Chief Medical Officer at Fundación de Investigación, earned her medical degree from the UPR School of Medicine in San Juan on 1975. She completed her internship and Internal Medicine residency at the UDH and her Gastroenterology fellowship at the UPR School of Medicine. Dr. Rodriguez-Torres is certified as a Clinical Principal Investigator and is an Assistant Professor of Medicine at Ponce School of Medicine in Ponce, Puerto Rico. She was a voting member of the Antiviral Drugs Advisory Committee of the US Food and Drug Administration from 2004 to 2008. Her clinical interests include: Hepatitis C infection in Latinos, including those with HIV co-infection, as well as new anti-HCV therapies. Dr. Rodriguez-Torres is recognized as a key opinion leader in Hepatology and one of the most important investigators working with oral agents for Chronic Hepatitis C.

Dr. Rodriguez-Torres is a speaker and frequent presenter on HCV therapy at society meetings, as well as national and international conferences. Her dedication to the Latino patients is underscored by her key participation as the main investigator in the first and only multicenter, national, prospective study in Latino patients with Chronic Hepatitis C.

Her goal of developing a state-of-the-art research center was fulfilled this past July, when Fundación de Investigación moved to their new 20,000 square feet facility, and expanded research to other therapeutic areas. The center has the only Phase 1 unit in Puerto Rico, and the only Bio-analytical Laboratory. This new facility has unique software interfaces in order to be able to conduct any early clinical study. The Bioanalytical Laboratory will allow Fundación de Investigación to conduct their own studies, including pre-clinical and basic science research in areas of interest as nanoparticles, genetics and drug development.

Dr. Jose F. Rodriguez-Orengo
Chief Scientific Officer & Bioanalytical Laboratory Director
Email: jrodrigiez@fdipr.com

Dr. Rodriguez-Orengo obtained his BS with concentration in chemistry (Magna Cum Laude) from the University of Puerto Rico, Rio Piedras Campus in 1985. He was awarded a Minority Biomedical Research Program Award in 1983 to perform his undergraduate Research. As an undergraduate student presented several times including national meetings. He moved to Texas A&M University obtaining his Ph.D. in chemistry in 1989. He obtained various scholarships and fellowships from the Puerto Rico government, the University of Puerto Rico, Hispanic Fund and the Robert Welch Foundation. In 1989. Dr. Rodriguez-Orengo has over 55 peer-reviewed articles.

In 2009, joined Fundacion de Investigacion de Diego, a private clinical research center to foster more research in Puerto Rico. In 2011, returned to the Department of Biochemistry where he is member of the Academic Senate and Graduate Coordinator. With Dr. Raul Mayo designed the graduate course entitled: From Mendel to Collins: History and Philosophy of the Genetic Code. He was named Acting Chancellor at the UPR-Medical Sciences Campus from May 2013 until Jan 2014. Dr. Rodriguez Orengo leads the state-of-the-art Bioanalytical laboratory at FDI where multiple analytical assays have been developed and validated complimenting FDI clinic to become a one-stop-shop for pharmaceutical companies. Numerous investigator initiated research projects are underway at FDI. As FDI new CEO, he has the vision of integration and collaboration among different entities towards a common goal of promoting Puerto Rico as a premier location for clinical research.

Dr. Irvin M. Maldonado-Rivera
Chief Operating Officer (COO)
Email: imaldonado@fdipr.com

Dr. Irvin Maldonado obtained his Ph.D. in Biomedical Sciences from Ponce School of Medicine in 2006. Rapidly he moved to San Juan Bautista School of Medicine where he obtained multiple administration trainings and became the director of the Biochemistry and Pharmacology Department. His administrative skills along with his grantsmanship knowledge gave him the opportunity to become the Associated Dean of Biomedical Sciences and Research. As a Dean he was awarded with the prestigious National Institutes of Health’s EARDA grant and the Disadvantaged Students Scholarship of Health Resources and Services Administration. In addition, Dr. Maldonado has received several private and non-private grants and he was the main contributor of the recently awarded Title V grant of the US Department of Education In SJBSOM.

In September of 2014, he joined Fundación de Investigación (FDI), as the Chief Operating Officer (COO). Dr. Maldonado is promoting a culture of high performance and continuous improvement that values learning and a commitment to quality. Dr. Maldonado is also contributing to the development of various strategic goals and objectives as well as the overall management. Dr. Maldonado is part of the Epidemiology, Biomedical and Clinical Research team at FDI, in which he supports his colleagues in the development of research proposals.

Grisell Ortíz-Lasanta, MD
Associate Clinical Director
Internal Medicine
Email: gortiz@fdipr.com

Grisell Ortiz-Lasanta, Associate Clinical Director, Sub-Investigator and Principal Investigator at Fundación de Investigación earned her medical degree from the UPR School of Medicine in San Juan on 2004. She completed her internship and Internal Medicine residency at the UPR School of Medicine. Dr. Ortiz-Lasanta is a member of the American College of Physician and was a student member of the American Chemical Society on 1997. Her clinical interests include: Hepatitis C in the Latino population, Hypertension and Diabetes. Dr. Ortiz-Lasanta has been conducting research since 2007 and is trained under Good Clinical Practices. She has been reviewer of different Journals including: Annals of Hepatology and Journal of medical Virology.

Michelle Echeandia
Clinical Operations Director
Email: mecheandia@fdipr.com

Michelle Echeandia obtained her bachelor’s degree in Science with concentration in Biology in the University of Puerto Rico. She then made her post bachelors degree in Medical Technology in the University of Puerto Rico-Medical Science Campus followed by a master’s degree in Molecular Biology in the Interamerican University of PR.

She started in FDI in 2006 as a clinical Study Coordinator for trials in different therapeutic areas as hepatitis C and oncology, and also conducted phase I trials with pharmacokinetics and pharmacogenetics specialty and experience. Then she created and directed the Quality Control Program where she implemented different operational standards and in-house audit programs. Since 2011 she has become part of the executive team in FDI as the Clinical Operations Director where she supervises daily operational procedures at the center and part of the clinical team. She is in charge of the ongoing process of all clinical trials including phase I, II, III and IV trials, budget negotiations and contracts as well as programming monitor’s and auditor’s visits from different sponsors and FDA. Actually she is also Co-Director of the Quality Control Program and team she helped to design. She also collaborated in different manuscripts and abstracts directed by our founder Dr. Maribel Rodríguez-Torres.

Staff Expertise


Investigators using ECG telemetry system
(12 – lead, Mortara)


Phase I Unit


Bioanalytical Laboratory Facilities

FDI has a growing, dynamic and enthusiastic staff that includes physicians of different specialties such as internal medicine, hepatology, gastroenterology, oncology, endocrinology, family medicine, pediatrics, infectious diseases, neurology, psychiatry and basic science. We also employ Ph.D.s in chemistry, biochemistry and pharmacy; multiple masters’ and bachelors’ in medical technology, graduate nurses, research nurses, research assistants, physician assistants, educators and accountants. We contract all the necessary personnel required to conduct clinical trials quickly and efficiently.

Our staff understands the seriousness and importance of our work and knows that only the best patient care and research conduct is acceptable. These professionals have great pride in FDI’s achievements and in our mission to contribute to the development of innovative medicines that improve our patients’ health and quality of life.

Patient Demographics

Latino Population

Fundación de Investigación (FDI) is recognized as a center for excellence in medical care and a premier site for research on Latino patients. Our patients have a positive attitude toward clinical research and are responsible and compliant with study procedures. Our location in Puerto Rico and our medical care treatment model allow easy access to a good pool of Latino patients for clinical trial participation. Latinos have a high prevalence of many infectious, neurologic and chronic diseases including metabolic diseases and cancer. The plethora of medical conditions seen in this population guarantees that our Latino patients are willing to participate in various disease trials. As the largest minority group in the United States, regulatory agencies such as the FDA require this ethnicity’s representation in trials relating to most medical conditions.

Other Information

The Puerto Rico Government offers an attractive set of incentives to the pharmaceutical industry that invest in research and development in our island. By engaging FDI to conduct any clinical trial, sponsors may be eligible to receive tax credits from the Puerto Rico Treasury Department. Through the Economic Incentives for the Development of Puerto Rico Act (Act 73 of May 28, 2008) your company can obtain up to 50 percent tax credit on every dollar invested on your clinical research contract with us. These tax credits could be used against your local tax liabilities or may be sold or transferred to an entity with tax liabilities in Puerto Rico.

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.