ABOUT CLINICAL PHARMACOLOGY OF MIAMI

Clinical Pharmacology of Miami (CPMI) was founded to serve a real need for a high quality clinical research unit. We have the experience and facility to conduct safe, precise, well controlled clinical research with new and existing drugs.

The dedication of the staff at CPMI led by Dr Lasseter, Vice President and Medical Director, Stacy Dilzer, President, and Cooper Shamblen, VP of Clinical Operations, is evident in the success of CPMI.  Together they have a strong clinical resume with over 100+ years of research experience.

  • • Screening Department / Interview / Exam Rooms / Prescreening lab & more
  • • Out-patient department
  • • Secure and monitored PK sample processing laboratory
  • • Secure temperature alarm monitored -20 and -70C freezers
  • • Secure alarm monitored pharmacy department
  • • Secure and monitored CRF / Record rooms
  • • Secure Entryways
  • • Standby Generator
  • • 120 clinical research beds
  • • 3 large PK bedded rooms
  • • 6 private research rooms (2 plus beds each)
  • • 2 very spacious recreational areas for volunteers
  • • Supervised Internet access areas for subjects
  • • Entire facility monitored by clinical staff, onsite 24 hours a day 7 days a week
  • • Security Video Monitor Recording 24 hours a day, 7 days a week
  • • Executive suites
  • • Conference rooms
  • • Record review rooms with monitors’ work areas
  • • Study coordinator / offices
  • • Women’s health examination areas and ultrasound equipment
  • • Data entry / regulatory affairs department
  • • Entire facility handicap accessible
  • • Spacious private parking
  • • QTc Clinical trial ECG monitored research areas equipped with individual telemetry units

The CPMI Research Unit and location was carefully considered. Our facility was meticulously custom designed and constructed, employing all the knowledge of our experience. We are convinced that our 120 bed research unit is “State of the Art”. We are equipped with the experience, expertise and the research unit facility to meet the individual needs of each sponsor and research protocol.

The 24,000 square foot facility is not a hospital, it is not a hotel, it is not an ICU, but it is a custom designed Clinical Pharmacology Research Unit.

CPMI uses a validated environmental monitoring system to ensure the quality and integrity of all pharmacy room temperatures, refrigerated / frozen drugs and samples stored within the CPMI research facility.

Security Cameras are stratigically placed throughout the CPMI research facility, both inside and outside, to monitor and record all activity 24 hours a day, 7 days a week. Entry and Exit doors, including fire exits, are alarmed with audible sirens at all times to secure controlled access to and from CPMI.

Separation between volunteer inpatient and outpatient areas are strictly secured with locked doors accessible only by staff members with swipe-cards / push-button security codes.

Clinical Pharmacology of Miami is protected by a stand-by 40k watt natural gas generator. In the event of loss of Florida Power & Light power to the building, the strong, but quiet generator automatically detects the loss and starts providing power to all essential portions of the facility.

This includes: all the refrigerators, freezers, centrifuges, and security monitoring equipment. The natural gas supply allows the generator to work without interruption for an extended period of time.

Kenneth C. Lasseter, M.D

Kenneth C. Lasseter, M.D., is the Vice President and Medical Director of Clinical Pharmacology of Miami, LLC. Dr. Lasseter is a clinical pharmacologist certified by the American Board of Clinical Pharmacology, and is board eligible in Cardiology and Internal Medicine. Over the past 38 years, he has served as Principal Investigator on over 1,800 clinical trials and has contributed to approximately 60 successful NDAs. Dr. Lasseter has published over 300 articles and abstracts in the area of clinical pharmacology, and continues to be active in studies pertaining to development of safe and effective new drugs. Dr. Lasseter truly has a national and international reputation as an outstanding clinical pharmacologist and Principal Investigator.

Dr. Lasseter began his research career while at the University of Miami, School of Medicine. He has served as an Assistant and Associate Professor of Pharmacology and Medicine at the University of Miami, School of Medicine, and as an Adjunct Professor of Pharmacology at the University of Miami Miller School of Medicine. He is a frequent lecturer for post-graduate courses and medical programs. Dr. Lasseter earned his doctorate degree from the University College of Medicine in Gainesville, Florida. He completed his residency at University of Kentucky in Lexington, Kentucky and a postdoctoral fellowship in Clinical Pharmacology and Cardiology at the University of Miami School of Medicine, Miami, Florida.

Antoinette Sulpizi, M.D

Dr. Sulpizi attended Medical School at the College of Medicine and Dentistry of New Jersey, graduating with the MD degree in 1981. She completed her fellowship in Cardiology at the Medical College of Pennsylvania in 1987. Dr. Sulpizi is board certified in internal medicine, and a Fellow of the American College of Cardiology. She has over 25 years of experience in the medical field, and now serves as one of the Investigators at Clinical Pharmacology of Miami.

Pablo Suso, PHARMD. RPH

Dr. Suso attended the University of Florida School of Pharmacy, graduating with a Doctorate in Pharmacy – Cum Laude in 2009. Previously, he attained a Bachelor of Science in Biological Science – Cum Laude at Florida International University in 1998. Pablo worked as an Associate Research Coordinator at CPA from 2002 – 2004. Dr. Suso was a Sterile Product Supervisor at a central-county Hospital and a Clinical Pharmacist at a University Hospital. His experience as a Clinical Pharmacist and as a Associate Research Coordinator make him an excellent Research Pharmacist. Born in Spain he immigrated to the USA at the age of 6, he is fluent in English and Spanish.

RSVP (Research Subject Verification Program) is a web based central database used to track the dosing dates of Phase 1 research subjects to prevent them from participating in multiple research trials simultaneously and from by-passing required protocol wash-out periods. Recently, Clinical Pharmacology of Miami, along with other Phase 1 research sites in South Florida, agreed to report the dose taken date(s) of subjects participating in Phase 1 drug studies to RSVP. By reporting these dates, sites on RSVP can access the subject registry at the time of screening to help determine the last time a potential participant received dosing of investigational medication. The subjects are identified by digitizing their fingerprint which generates a unique 9 digit number. The result of implementing RSVP, is that cleaner subject populations are selected for studies. Sponsors that contract sites using RSVP know their data comes by way of subjects that undergo thorough screening measures to eliminate participation in more than one study simultaneously or before an appropriate washout.
For more information, please visit: WWW.CLINICALRSVP.COM

The staff of CPMI has maintained within our database, an extensive population of healthy males and females 18-80 years of age. The size of this population varies from 2000 to 3000 subjects. Dr. Lasseter has successfully been the Principal Investigator of approximately 1400 healthy male and female research studies.

Hepatically Impaired

The staff of CPMI has maintained a population of patients with Hepatic Impairment for a number of years. These patients are divided into two categories; Disease due to alcohol abuse and disease not due to alcohol abuse. NonAlcoholic Steatohepatitis (NASH) is a form of fatty liver disease and not due to alcohol use and the other is known as cirrhotic patients and a direct result of alcohol abuse and are classified as either Child-Pugh A or Child-Pugh B. Our ability to recruit Child-Pugh C (severely impaired) patients is limited only by the fact that these subjects are usually quite sick and not able to participate in studies. Historically the size of database varied for this population but averaged between 30 -50 patients at any given time. We have recently began an active outreach and collaboration effort with a group of physicians who are interested in referring this population to us for these trials.
Nevertheless, our population of patients has allowed us to complete a number of FDA mandated studies every year according to the guidance that they have published.

 

GUIDANCE FOR INDUSTRY

Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling http://clinicalpharmacologyofmiami.com/wp-content/uploads/2014/03/Pharmacokinetics-in-Patients-with-Impaired-Hepatic-Function.pdf

Renally Impaired

The staff of CPMI has maintained a population of patients with Renal Impairment for a number of years. Most of these patients result from our intensive screening programs and are classified as either mild (GFR 50-80 ml/min) or moderately (GFR 20-50 ml/min} impaired. Our ability to recruit severely impaired patients (GFR less than 30 ml/min) is limited by the fact that most of these subjects go on a transplant list and are placed on dialysis in our community but we still have been able to identify and study enough of these subjects every year to complete a number of FDA mandated studies according to the guidance that they have published. Studies with ESRD patients requires collaboration with a dialysis center or other investigator.

 

GUIDANCE FOR INDUSTRY

Pharmacokinetics in Patients with Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and Labeling 1998 US Food and Drug Administration

http://clinicalpharmacologyofmiami.com/wp-content/uploads/2014/03/Pharmacokinetics-in-Patients-with-Impaired-Renal-Function.pdf

Hypertensive

CPMI has maintained am active database of patients with Hypertension. We have successfully performed skip phase 1 studies with antihypertensive drugs confining hypertensive patients for first time in man exposures. The Hypertensive patients age ranges from 35 to 80 years. Dr. Lasseter has successfully been the Principal Investigator of approximately 70 Hypertensive research studies.

Geriatric Subjects

With the evolution of baby boomers, Miami and South Florida specifically, has an ever-growing geriatric population. CPMI has capitalized on this opportunity to build our database. The age range starts at 65 years to 85+ years of age. Obviously the higher the age, the more difficult it is to recruit subjects so we try to maintain contact with the older subjects. Dr. Lasseter has successfully been the Principal Investigator of 38 Geriatric research studies.

 

GUIDANCE FOR INDUSTRY

Studies in Support of Special Populations: Geriatrics 1994 US Food and Drug Administration ICH-E7

http://clinicalpharmacologyofmiami.com/wp-content/uploads/2014/03/Studies-in-Support-of-Special-Populations-Geriatrics.pdf

Diabetic Subjects

We have a culturally diverse database of subjects with Diabetes. Most of our Diabetic patients are Type II maintained on a oral hypoglycemic agent or Insulin or are diet-controlled. Dr. Lasseter has successfully been the Principal Investigator of approximately 30 Diabetic research studies.

Obese Subjects

We have maintained our database and have significant access to Obese subjects. The subjects BMI range is greater than 35. Dr. Lasseter has successfully been the Principal Investigator and at least 10 Obese research studies.

First In Human Studies

The staff and investigators at Clinical Pharmacology of Miami have extensive experience with designing and implementing “First in Man” studies. This is one of the most critical steps in the entire drug development process. Competence at this point is important so that a potential blockbuster drug that can save lives and prevent suffering will not be erroneously discarded and that a potentially unsafe drug is not continued in the research pipeline needlessly costing millions of dollars and exposing countless research subjects to unnecessary risk. Clinical Pharmacology of Miami can help with avoiding these pitfalls by helping design and implement studies according to sound scientific principles.

 

GUIDANCE FOR INDUSTRY

 

Estimating the Maximum Safe Starting Doses in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers 2005 US Food and Drug Administration

https://www.fda.gov/downloads/drugs/guidances/ucm078932.pdf

Cardiac Safety

CPMI has an ICU-like unit for the conduct of Thorough QT/QTc studies under the guidance of the E14 document promulgated by ICH and the FDA Guidance for Industry. Containing up to 48 beds in a single large room, the unit is specifically designed to allow control of all environmental factors that might adversely influence a thorough QT/QTc study. By controlling Temperature, humidity, noise levels and other conditions, we are able to have better control of factors that may cause variation in the data collected in these difficult to control cardiovascular studies. Even though most data in the unit is collected with either 12 lead holter recordings (such as Mortara H-12+) or other 12 lead collection machines, we also have flexibly to include bedside monitoring including pulse oximetry, ECG, vital signs and ready access to emergency equipment if needed. Thus we are able to offer our clients a fully equipped cardiovascular research unit that can be focused on repolarization studies.

 

GUIDANCE FOR INDUSTRY

E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs 2005 US Food and Drug Administration

http://clinicalpharmacologyofmiami.com/wp-content/uploads/2014/03/E14-Clinical-Evaluation-of-QTQTc-Interval-Prolongation-and-Proarrhythmic-Potential-for-Non-Antiarrhythmic-Drugs.pdf

Reprints

Dr. Lasseter has been Principal Investigator of approximately 1800 clinical studies (over past 40+ years) of the safety and efficacy and mechanisms of action of Phase I, II and III drugs as well as bioavailability and pharmacokinetic studies in normal subjects and in special populations. Numerous clinical studies have been successfully audited by sponsoring institution audit teams and by Food and Drug Administration Audit Teams. Virtually all studies have been conducted under auspices of active IND applications and approximately 60 successful NDA’s have contained data generated by these studies. These include:
RSVP (Research Subject Verification Program) is a web based central database used to track the dosing dates of Phase 1 research subjects to prevent them from participating in multiple research trials simultaneously and from by-passing required protocol wash-out periods. Recently, Clinical Pharmacology of Miami, along with other Phase 1 research sites in South Florida, agreed to report the dose taken date(s) of subjects participating in Phase 1 drug studies to RSVP. By reporting these dates, sites on RSVP can access the subject registry at the time of screening to help determine the last time a potential participant received dosing of investigational medication. The subjects are identified by digitizing their fingerprint which generates a unique 9 digit number. The result of implementing RSVP, is that cleaner subject populations are selected for studies. Sponsors that contract sites using RSVP know their data comes by way of subjects that undergo thorough screening measures to eliminate participation in more than one study simultaneously or before an appropriate washout.
acrovastine, alendronate, amiloride, amrinone, arbutamine, atenolol, benzazepril, candesartan cilexetil, carteolol, caspofungin, ciprofloxacin, dofetilide, enalapril, encainide, eplerenone, recombinant erythropoietin, etodolac, famotidine, felodipine, finasteride, flecanide, fosinopril, galantamine, grepafloxacin, indapamide, irbesartan, leucovorin, lisinopril, losartan, meropenem, milrinone, moexepril, montelukast, nefazodone, nimodipine, nisoldipine, nitroprusside, nizatidine, oxaprozin, penbutalol, pinacidil, piperacillin, piroxicam, prazosin, ramipril, 13-cis retinoic acid, rofecoxib, sinemet CR, sirolimus, sitagliptin, sulindac, tegaserod, timolol, terazocin, tocanide, trandolapril, valsartan, venlafaxin, zafirlukast, zolmitriptan and zolpidem.