“medical breakthroughs for tomorrow”. our vision through our highly specialized phase i...
TRANSCRIPT
“Medical Breakthroughs for Tomorrow”
Our Vision
Through our highly specialized Phase I facility, MRA Clinical Research provides the pharmaceutical industry with precise clinical trial assessments and quality data in the early phase development arena.
Overview Neuroscience
Dr. Bruce Kohrman Dr. Timothy Grant
Psychiatry Dr. Americo F. Padilla Dr. Rafael Rivas-Vazquez Dr. Gustavo J. Rey
Sleep Disorders Dr. Timothy Grant Dr. Howard Schwartz
Pediatric Dr. Americo F. Padilla Dr. Adriana M. Castro
Vaccines Dr. Eric Sheldon
Women’s Health Dr. Robert Feldman
Multi-specialty Phase I site conducting clinical trials in special populations and healthy volunteers Medical Director: Dr. Patricia Pardo Dermatology
Dr. Robert Goddard Gastroenterology
Dr. Howard Schwartz Dr. Harris Goldberg
Nutrition/Endocrinology Dr. Diane Krieger
Rheumatology Dr. Eric Sheldon Dr. Jaime Pachon Dr. Margarita Garces
Our Phase I Unit uniquely: Provides high-level
medical oversight of special populations and healthy volunteers
Exceeds at executing complex, highly-detailed clinical trials
Phase I Facility Description 11,000 Square Feet 50 beds Central Nursing Stations Multiple units configured for
gender privacy Multiple activity areas Facility layout allows for
isolation of different populations, if needed
24-hour lab turnaround Customized meals by
registered dietitians
Less than ¼ mile from nearest hospital, South Miami Hospital
Security Cameras throughout the
facility Restricted Access via key
cards Closed-Circuit Flat Panel TVs Entertainment Internet access via desktops &
Wi-Fi
Clinical Capabilities Equipment:
Multiple Freezers (-70°C & -20°C)
ECG EEG Refrigerated Centrifuges Cardiac Monitoring Echocardiography Endoscopy DEXA Scanner Digital X-Ray Polysomnography (PSG) Spirometry Compounding Scale Biosafety Level 2 Hood
Emergency Equipment: Fully Equipped Crash
Cart Intubation Capababilites
on-site 2 Defibrillators Oxygen Tank Pull Cord Emergency
Service installed in bathrooms
Emergency Room located less than 100 yards from unit
Phase I Unit Director
Dr. Patricia Pardo is Board Certified in Internal Medicine and an APPI Certified Physician Investigator
Completed her training at UM/Jackson Memorial Hospital
Former faculty member at University of Miami’s School of Medicine
Has participated in the conduct of over 100 clinical trials
Director of Operations
Ms. Janeen Rosales, BS, CCRC has 10 years experience in the Phase I-IV clinical research arena
Previous experience in Project Management and Business Development
Research Staff Between MRA and our Phase I unit, we have
over 60 experienced study coordinators 38 are ACRP Certified
Our study coordinators are: CITI Certified NIH Certified BLS Certified
In addition, 4 Project Managers are responsible for overseeing the study and being the primary point of contact for sponsors. Project Managers are ACRP Certified
30 years or more Linda Camp, MA*
20-30 years Vivian Rosales*
15-20 years Maria Heimer* Margarita Mederos
10-15 years Mirnaya Alabaci* Isabel Pino, ARNP-BC* Marlene Piloto Linda Nannini, LPN* Teresa L. Wright, CCRP
5-10 years: Ilka Morales* Sharon Oxford, CDT Meredith Arguelles, LPN* Terry Piedra* Surisaday Mederos, MA* Thelma Beltran, LPN* Noris Peraita* Gisela Cortina Edith Bethencourt* Elsa V. Esquen Maria Gomez
Our Dedicated Staff
* = denotes CCRC Certification
5-10 years (continued): Janeen Rosales, BS* Douglas Kalman, PhD, RD* Jack Mesa, MCP Elaine Martino Ricardo Aleman, BA* Martha Quinones Jose Garcia, BHSA Maura Quinones Samantha Feldman, MS, RD,
CDE* Krizia Vidiella Ann Kramer Alexandra Galvis Anita Puras*
Karin Miranda* Melissa Gonzalez * Marysol Cassola Lori Feldman, RD* Beatriz Rivera
* = denotes CCRC Certification
In addition, many of our staff have gone on to pursue health-care related degrees, internships, and residencies: George Sanchez, MD Ivette Hernandez, RN Naime Reyno-Ramos, RN Yelenia Reyno, RN Noris Peraita, RN Surisaday Mederos, completing RN degree Poliana Ayala, completing RN degree Melissa DeCastro, MS in Speech Pathology Rodrigo Velasco, completing MD degree Kristin Irmiter, completing MD degree Christina De La Vega, completing MD degree
Client Relations Over the years, we have established strong business
relationships with various pharmaceutical companies, such as: Amgen Eli Lilly & Co. Merck Novartis Pfizer Roche Shire Wyeth
Special Populations Arthritis
Osteoarthritis Rheumatoid
ADHD Adult Pediatric
Depression Diabetes
Type II Elderly Healthy Volunteers Hepatic Hypertension
Lupus Obesity Parkinson’s Pediatrics Post-Menopausal Psoriasis Renal
Subject Safety Step-Wise Systematic Training ACLS Certified Staff must be present at all
times Protocol-Specific Training prior to study start Specialty-tailored physician coverage Less than 1500 hundred feet to nearest ER
Phase I Experience
Food Interaction Pharmacokinetics Dose Ranging Drug-to-Drug Interaction Jet Lag Polysomnography Cardiac Safety Narcotic Safety Endoscopic Safety Bioavailability/ Bioequivalency
Phase I Experience Have conducted over 40 studies in various
therapeutic areas, in which we achieved the following: Consistently met enrollment goals Excellent subject retention (over 90%) Frequent requests for additional cohorts
Recent Phase I Trials
Pediatrics: Open-Label, Dose-escalating safety, tolerability,
Pharmacokinetics and cardiovascular safety study including Holter Monitoring and Serial Orthostatic Values in adolescents with ADHD
Open-Label, Randomized, Single and Multiple Dosing PK study in children and adolescents with ADHD
Biologics: Single-Ascending Dose study of the safety, tolerability, PK and
PD administered to subjects with Rheumatoid Arthritis
Single-Ascending Dose study of the safety, tolerability, PK, and PD administered to subjects with Lupus
Multiple-Ascending Dose 9-month study of the safety, tolerability, PK and PD of IP following IV infusion in patients with Allergic Rhinitis
Multiple-Ascending Dose study of the safety, tolerability, PK, PD and efficacy of the IP administered Subcutaneously or Intravenously to Subjects With Psoriasis
Multiple-Ascending Dose study safety and tolerability in subjects with Psoriasis Vulgaris
Recent Phase I Trials cont’d
Hepatic: Single Dose Study to evaluate the PK, safety, and
tolerability of IP in Subjects with Hepatic Impairment and Normal Hepatic Function
Healthy Volunteers: Single Dose study of the safety, tolerability, PK, and
PD of IP in Healthy Subjects
Multiple-Dose Study to evaluate the safety, tolerability, PK, and PD of IP in Healthy Subjects
Recent Phase I Trials cont’d
Neurology: Dose-Ranging study to assess safety, efficacy,
tolerability, and Pharmacokinetics in subjects with Parkinson’s Disease
Vaccines: Have enrolled over 1,100 subjects since 2008 Conducted trials involving:
Seasonal Influenza H5N1 Influenza (Avian Influenza) H1N1 Influenza (Swine Influenza) Typhoid Fever Japanese Encephalitis Smallpox West Nile Virus Meningitis Plague
Recent Phase I Trials cont’d
Consumer Packaged Goods / OTC Switch Experience Over the past 20 years, MRA Investigators have
conducted clinical trials in the later stage and post-market arenas, including consumer packaged goods such as: OTC Migraine OTC Pain Smoking Cessation Patches Sleep Aids Allergy Preparations Laxatives OTC Heartburn
Regulatory Regulatory Document
Package Review Finance/Marketing
Coordination IBC Submissions IRB Submissions
Central IRB Local IRB
Turnaround within 3-5 business days
Contracts/Budgets Process Finance Director reviews
contract & budget with CEO
Budget Negotiation Budget Approval Contract Execution Patient Stipend to
Regulatory and Marketing Departments
Turnaround within 5 business days
Marketing/Advertising Create Site-Specific
Advertisements Print Radio Television Internet
In-house radio & video production
Guerrilla Marketing Social Networking
Media Buys Response Analysis
Recruitment
Potential Subjects are recruited through: Advertising in local media and Internet Call Center Guerrilla Marketing Database of over 30,000 Potential Subjects
Security: Password Protection & Encryption
Retention
Careful pre-screening, early subject education
Establish good rapport with subjects Follow-Up Phone Contacts to see how
subject is doing and remind them of next visit
Upfront Quality Assurance
Standardized process that begins upon initial receipt of the protocol
Goal is to ensure excellent quality and establish a cohesive process that integrates all departments
All study team members are required to participate
Laboratory
With over 20 years Phase I experience, the Laboratory Manager, Ms. Neiner Enriquez, is responsible for: Evaluating protocol to establish laboratory needs upon initial
receipt Attending SIV Coordinating with resource manager to generate calendar of
events Preparing pertinent logs & requisition forms Preparing laboratory kits needed throughout the study Shipping & Packaging specimens Sample retention
Pharmacy & IP Storage
Security Measures Registered Pharmacists Compounding
Pharmacists Biosafety Certified Hood Randomization
Dedicated Fax line
IV Infusions Sample Retention TempGuards
Quality Assurance
SOPs Policies & Procedures Sponsor/FDA Audit
Preparation Standardization Real-time QA Upfront/Backend QA Site Training
Site Training
In an effort to have the most current knowledge available to our research staff, many forms of training are held each year:
- GCP training- Training Sessions for ACRP
Certification Exam- Research Assistant Training
for new employees- HIPAA Training- Investigator’s Lunch and
Learn Series
Electronic Data Capture
Our staff is trained in Multiple EDC systems Data Entry usually occurs within 24 hours of
seeing the subject Quality Control
- Subject’s source document is reviewed prior to and during data entry
- Data Clarifications are answered within 24 hours of receipt
Conclusion Our ability to excel in conducting complex
clinical trials is due to our:- Highly-trained clinical staff- Multi-specialty physicians on-site and on-call- High Investigator Involvement- Access to a diverse patient population- Outstanding recruitment/retention capability
Key Medical Contacts Medical Director: Howard I. Schwartz, MD
Phone: (305) 598-3125 Email: [email protected]
Medical Director: Eric A. Sheldon, MD Phone: (305) 598-3125 Email: [email protected]
Phase I Unit Director: Patricia Pardo, MD Phone: (305) 722-0970 Email: [email protected]
Director of Operations: Janeen Rosales, BS, CCRC Phone: (305) 403-3860 ext. 4102 Email: [email protected]
Key Contacts Business Development, Phase I:
Director: Douglas Kalman, PhD, RD Phone: (305) 666-2368 Email: [email protected]
Mark Morrison Phone: (919) 787-9528 Email: [email protected]
Business Development, Phase I-IV: Director: Teresa L. Wright, CCRP
Phone: (305) 279-0015 ext. 4223 Email: [email protected]