Transcript Slide 1

“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
Multi-specialty Phase I site
conducting clinical trials in
special populations and healthy
volunteers
Medical Director: Dr. Patricia Pardo
 Dermatology
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Dr. Bruce Kohrman
 Dr. Timothy Grant
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Psychiatry
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Dr. Americo F. Padilla
Dr. Rafael Rivas-Vazquez
 Dr. Gustavo J. Rey
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Dr. Robert Goddard
Sleep Disorders
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 Gastroenterology
 Dr. Howard Schwartz
 Dr. Harris Goldberg
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 Nutrition/Endocrinology
 Dr. Diane Krieger
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 Rheumatology
 Dr. Eric Sheldon
 Dr. Jaime Pachon
 Dr. Margarita Garces
Neuroscience
Pediatric
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Dr. Americo F. Padilla
Dr. Adriana M. Castro
Vaccines
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Dr. Timothy Grant
Dr. Howard Schwartz
Dr. Eric Sheldon
Women’s Health
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Dr. Robert Feldman
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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
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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
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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
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Equipment:
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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
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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
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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
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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
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Between MRA and our Phase I unit, we have
over 60 experienced study coordinators
 38
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are ACRP Certified
Our study coordinators are:
 CITI Certified
 NIH Certified
 BLS
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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
Our Dedicated Staff
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30 years or more
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20-30 years
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Vivian Rosales*
15-20 years
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Linda Camp, MA*
Maria Heimer*
Margarita Mederos
10-15 years
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Mirnaya Alabaci*
Isabel Pino, ARNP-BC*
Marlene Piloto
Linda Nannini, LPN*
Teresa L. Wright, CCRP
* = denotes CCRC Certification
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5-10 years:
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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
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5-10 years (continued):
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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*
* = denotes CCRC Certification
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Karin Miranda*
Melissa Gonzalez *
Marysol Cassola
Lori Feldman, RD*
Beatriz Rivera
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In addition, many of our staff have gone on to
pursue health-care related degrees, internships,
and residencies:
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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
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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
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Arthritis
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ADHD
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Adult
Pediatric
Depression
Diabetes
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Osteoarthritis
Rheumatoid
Type II
Elderly
Healthy Volunteers
Hepatic
Hypertension
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Lupus
Obesity
Parkinson’s
Pediatrics
Post-Menopausal
Psoriasis
Renal
Subject Safety
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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
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Food Interaction
Pharmacokinetics
Dose Ranging
Drug-to-Drug Interaction
Jet Lag
Polysomnography
Cardiac Safety
Narcotic Safety
Endoscopic Safety
Bioavailability/
Bioequivalency
Phase I Experience
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Have conducted over 40 studies in various
therapeutic areas, in which we achieved
the following:
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Consistently met enrollment goals
 Excellent subject retention (over 90%)
 Frequent requests for additional cohorts
Recent Phase I Trials
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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
Recent Phase I Trials cont’d
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Biologics:
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Single-Ascending Dose study of the safety, tolerability, PK and PD
administered to subjects with Rheumatoid Arthritis
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Single-Ascending Dose study of the safety, tolerability, PK, and
PD administered to subjects with Lupus
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Multiple-Ascending Dose 9-month study of the safety, tolerability,
PK and PD of IP following IV infusion in patients with Allergic
Rhinitis
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Multiple-Ascending Dose study of the safety, tolerability, PK, PD
and efficacy of the IP administered Subcutaneously or
Intravenously to Subjects With Psoriasis
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Multiple-Ascending Dose study safety and tolerability in subjects
with Psoriasis Vulgaris
Recent Phase I Trials cont’d
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Hepatic:
 Single
Dose Study to evaluate the PK, safety, and
tolerability of IP in Subjects with Hepatic Impairment
and Normal Hepatic Function
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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
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Neurology:
 Dose-Ranging
study to assess safety, efficacy,
tolerability, and Pharmacokinetics in subjects with
Parkinson’s Disease
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Vaccines:
 Have enrolled over 1,100 subjects
 Conducted trials involving:
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Seasonal Influenza
H5N1 Influenza (Avian Influenza)
H1N1 Influenza (Swine Influenza)
Typhoid Fever
Japanese Encephalitis
Smallpox
West Nile Virus
Meningitis
Plague
since 2008
Consumer Packaged Goods / OTC
Switch Experience
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Over the past 20 years, MRA Investigators have
conducted clinical trials in the later stage and postmarket arenas, including consumer packaged goods
such as:
 OTC Migraine
 OTC Pain
 Smoking Cessation Patches
 Sleep Aids
 Allergy Preparations
 Laxatives
 OTC Heartburn
Regulatory
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Regulatory Document
Package Review
Finance/Marketing
Coordination
IBC Submissions
IRB Submissions
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Central IRB
Local IRB
Turnaround within 3-5
business days
Contracts/Budgets Process
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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
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Create Site-Specific
Advertisements
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In-house radio & video
production
Guerrilla Marketing
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Print
Radio
Television
Internet
Social Networking
Media Buys
Response Analysis
Recruitment
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Potential Subjects are recruited through:
 Advertising
in local media and Internet
 Call
Center
 Guerrilla Marketing
 Database of over 30,000 Potential Subjects
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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
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Upfront Quality Assurance
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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
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With over 20 years Phase I experience, the Laboratory
Manager, Ms. Neiner Enriquez, is responsible for:
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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
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Security Measures
Registered Pharmacists
Compounding
Pharmacists
Biosafety Certified Hood
Randomization
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Dedicated Fax line
IV Infusions
Sample Retention
TempGuards
Quality Assurance
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SOPs
Policies & Procedures
Sponsor/FDA Audit
Preparation
Standardization
Real-time QA
Upfront/Backend QA
Site Training
Site Training
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In an effort to have the most
current knowledge available
to our research staff, many
forms of training are held
each year:
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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
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Our staff is trained in Multiple EDC systems
Data Entry usually occurs within 24 hours of
seeing the subject
Quality Control
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Subject’s source document is reviewed prior to and
during data entry
Data Clarifications are answered within 24 hours of
receipt
Conclusion
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Our ability to excel in conducting complex
clinical trials is due to our:
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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
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Medical Director: Howard I. Schwartz, MD
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Medical Director: Eric A. Sheldon, MD
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Phone: (305) 598-3125
Email: [email protected]
Phase I Unit Director: Patricia Pardo, MD
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Phone: (305) 598-3125
Email: [email protected]
Phone: (305) 722-0970
Email: [email protected]
Director of Operations: Janeen Rosales, BS, CCRC
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Phone: (305) 403-3860 ext. 4102
Email: [email protected]
Key Contacts
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Business Development, Phase I:
 Director:
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Phone: (305) 666-2368
Email: [email protected]
 Mark
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Douglas Kalman, PhD, RD
Morrison
Phone: (919) 787-9528
Email: [email protected]
Business Development, Phase I-IV:
 Director:
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Teresa L. Wright, CCRP
Phone: (305) 279-0015 ext. 4223
Email: [email protected]