“Making a Difference for the Future”M I A M I R E S E A R C H A S S O C I A T E S

Full Service CRO Early Stage Operations: India Taiwan Netherlands Springfield, MO

Toxicology, Pre-Clinical, Bioanalysis, Biomarkers: Delaware

2013…MRA Joins QPS

MRA Operations

MRA Primary Campus Phase I Center Broward Research Group (Sister Site) Sleep Centers (Broward & Miami-Dade) Patient Recruitment Advertising Agency MRA Clinical Laboratory

Overview

MRA conducts approximately 75 trials/year Over 1500 trials successfully conducted since

1996 Nearly every therapeutic area except

Oncology Preferred provider agreements with Pfizer,

Sanofi and several major CRO’s Last 4 FDA audits did not result in a Form 483

Phase I Unit DirectorsDr. Patricia PardoDr. Martha Hernandez-Illas

AnesthesiologyDr. Michael MeisterDr. Guillermo Pol

CardiologyDr. Harry AldrichDr. Abbe Rosenbaum

DermatologyDr. Georgette Rodriguez

GastroenterologyDr. Harris Goldberg Dr. Howard Schwartz

Neuroscience Psychiatry

Dr. Americo F. Padilla

Neuropsychology

Rafael Rivas-Vazquez, Psy.D. Gustavo J. Rey, PhD

Neurology Dr. Bruce Kohrman Nutrition/Endocrinology

Dr. Diane KriegerDr. Douglas S. Kalman

OphthalmologyDr. Ann BallenDr. Juan Aguilar

PediatricsDr. Adriana Castro

PulmonaryDr. Jeremy Tabak

RheumatologyDr. Jaime PachónDr. Eric Sheldon

Specialty Specialty InvestigatorsInvestigators

Sleep Disorders Dr. David Seiden

Dr. Howard Schwartz Dr. Timothy Grant

Urology Dr. John Mekras

VaccinesDr. Eric Sheldon

Women’s HealthDr. Robert Feldman

Research Staff Overview

MRA has 150 employees, 40 of whom are ACRP-certified CCRC’s, and has a very low employee turnover rate

Our Senior Research Coordinators have an average of 8 years of experience

Our dedicated staff has been an integral part to the company’s success

Association for the Accreditation of Human Research Protection Programs (AAHRPP)

MRA is one of only two non-academic clinical research centers to receive this prestigious recognition

Accredited Since 2010

Human SubjectProtection

THERAPEUTICAREAS

MRATherapeutic Areas

Investigators: Timothy Grant, MD. & David Seiden, MD.Location:Miami Research Associates & Broward Research Group

Study Indications: Chronic Insomnia Delayed Sleep Phase

Syndrome Driving Simulation Elderly Insomnia Jet Lag Narcolepsy in Children Non-restorative Sleep Pediatric ADHD Insomnia Primary Insomnia Restless Leg Syndrome Shift Work Sleep Apnea Transient Insomnia

Equipment MRA

10 beds Polysomnography equipment by GRASS Technology Operation is a joint venture between MRA and Baptist Health Systems

BRG 9 beds Polysomnography equipment by GRASS Technology Operation is a joint venture between MRA and Baptist Health Systems

1999: Dr. David Seiden, Board-Certified Neurologist and Sleep Specialist, Dr. Timothy Grant, Board-Certified Neurologist and Sleep Specialist, began conducting Insomnia studies with Dr. Howard Schwartz and Miami Research Associates

2001: Drs. Seiden founded the Broward Research Group (BRG) and the Broward Sleep Division; today BRG is a privately owned multi-specialty clinical research center in Fort Lauderdale

SleepDepartment

Investigator:  Howard Schwartz, MD

Study Indications:  GERD IBS Hep C Crohns UC Hepatic Safety Endoscopy Safety H Pylori

Dr. Howard Schwartz belongs to GI practice with 14 doctors.

GastroenterologyDepartment

Equipment Endoscopy Liver Biopsy Colonoscopy

Study Indications:  Osteoarthritis – Knee, Hip, Spine Rheumatoid Arthritis Narcotic Pain Trials

Equipment Analog Hybrid Digital X-Ray Machine Muscle Skeletal Ultrasound machine for diagnostic

and procedure guidance

Investigators: Eric Sheldon, MD & Jaime Pachon, MD

Participated in trials for  the following marketed drugs:

Participated in Phase 1 Trials  thru IV using IV infusions / SQ Injections/Oral

Screening/Enrollment 2012 a total of 7 Rheumatoid Arthritis trials were

performed including a phase 1 and an automatic injector device trial

Enrollment total screened 121 Randomized 91

Rheumatology Department

Anthrax

Ebola

Meningococcal Grp B

Staph aureus

Clostridium difficile

Pandemic (Avian) Flu

Seasonal Flu

RSV

Pneumococcal

Herpes Zoster (intradermal)

Influenza H1/H5 (electroporation)

Tetanus/Diphtheria/Pertussis

H1N1 (Swine) Flu

Botulism

HIV

Pseudomonas Monoclonal

Antibody

VaccineDepartmentInvestigator: Eric Sheldon, MD

> 15 years of experience with over 100 clinical trials > 4 Investigators

2 Psychiatrists 2 Psychologists

> 3 Coordinators 2 Certified Coordinators with more than 7

years of experience 1 Coordinators with more than 4 years of

experience 1 Assistant Coordinator with more than 2 years

Investigator:  Americo F. Padilla, MD

Study Indications: Phase 1 to IV Trials Adults

• Depression (Phase I, II, & III)• Schizophrenia (Phase II & III)• Eating Disorder, Binge (Phase III)

Children and Adolescents ADHD (Phase I, II, & III) PK Studies (Phase I) Classroom Studies

Narcotic Pain Trials

Screening/Enrollment Standard enrollment target of 10-20 patients per trial History of being a high enrollment site Access to the Hispanic population

PsychiatryDepartment

Expertise in Scale Administration• MINI• K-SADS-PL• ADHD-RS-IV• CSSR-S• HAM-A• HAM-D

• MADRS• CGI-I/S• SCID • ATRQ • SDS • BARS/AIMS/SAS

Psychiatry Team

Investigator: Bruce Kohrman, MDNeurologyDepartment

Investigator: Robert Feldman, MD.

Screening/Enrollment In complex, multiprocedural studies with frequent

visits, we have an compliance/retention rate approaching 100%

Enrolled 1500 subjects in Pap/HPV testing trail and followed 300 subjects in a 3 year colposcopy study

Women’s HealthDepartment

Investigator: Diane R. Krieger, MDDouglas S. Kalman, PhD, RD, FACN -DirectorSamantha Feldman, MS, RD, CCRC- Special Projects

Nutrition/Endocrinology Division  Pharmaceutical Studies OTC Medical Nutrition Therapy Products Nutritional Product Studies Dietary Supplement Functional Food Raw Material

NutritionDepartment

Pulmonary Allergy Asthma WPD Smoking Cessation

Cardiology High blood pressure A fib PVD Hyperlipidimia

Urology BPH Sexual Dysfunction

Ophthalmology Safety Studies

OtherDepartments

Study Indications: Clinical Lab  Chemistry: CMP, Magnesium, CK, LDH, Amylase,

Phosphorus, Lipid Panel, A1c, Uric Acid, GGT, & NEFA

Hematology: CBC with Diff, & ESR Special Chemistry: Serum Pregnancy, Insulin, C-

Peptides, Thyroids (T3, T4, TSH), Cystatin C, FSH, IgE, & Testosterone

Urinalysis with Microscope exam

Investigator: Diane Krieger, MDLab Managers: Sonia Torres & Maria Alarcon

The MRA Lab is… CLIA and COLA certified Participants of American Proficiency

Institute proficiency testing service.

MRA Laboratory Management: Evaluates protocol to establish laboratory needs Attends SIV Coordinates with resource manager to generate

calendar of events Prepares pertinent logs & requisition forms Prepares laboratory kits needed throughout the

study Packs & ships specimens Oversees sample retention

LaboratoryDepartment

Full Time Pharmacist: Vilma Vales, Pharm D

Equipment: Compounding Scale Level 2 Certified Hood -20/-70 Degree Freezers Alarm Guard

All Study Drug is kept in secure Pharmacy Temperature (24/7, Min and Max Recording) Refrigerators, -20 & -70°C Freezers Alarm Guard Strictly enforced limited access Biosafety Cabinet Level 2 Certified Hood Back-up Generator in case of power failure

PharmacyDepartment

We do studies other sites can’t.

DedicatedPhase I Center

Conducts numerous complex studies that other sites can’t

Uniquely offers high-level medical oversight of special populations and healthy volunteers

Consistent in being highest enrollers

Excellent subject retention (over 90%)

Sponsor requests for additional cohorts

Multiple therapeutic areas

Phase IOverview

First-in Man PK/PD ECG/Cardiac Safety Special Populations Pediatrics Vaccines Food Interaction Pharmacokinetics Dose Ranging Jet Lag Polysomnography QTc Monitoring Endoscopic Safety Bioavailability/Bioequivalency

As of October 2013 our Phase I Center completed over 120 trials, including:

Phase ITrial Experience

20,000 Square Feet 72 Active Beds

Central Nursing Station Multiple dorms configured for

privacy, cohort mgmt. Internet access via desktops &

Wi-Fi Three activity areas 24-hour lab turnaround Customized meals by

registered dietitians Across from South Miami

Hospital

Security Cameras throughout the facility Key Card Restricted Access Closed-Circuit TV

Entertainment DVDs Video Games Board Games Flat panel TVs Educational/Art Activities

Phase IFacility Description

Equipment:

Mortara Wireless Telemetry EEG ECG Refrigerated Centrifuges Echocardiogram Endoscopy PSG Recording DEXA Scanner Digital X-Ray -70°C Freezers Spirometry Compounding Scale Biosafety Cabinet Level 2 Certified Hood Slit Lamp

Emergency Equipment:

Emergency Room located less than 100 yards from unit

Crash Cart Emergency Medications 2 Defibrillators Oxygen Tank Pull Cord Emergency Service

installed in bathrooms

Phase IClinical Capabilities

Elderly Hepatic Renal Psoriasis Type II Diabetes Post-Menopausal Hypertension

Obesity Parkinson’s Depression Pediatric ADHD Arthritis

o Rheumatoido Osteoarthritis

Lupus

Phase ISpecial Populations

In-house Advertising Agency Multi-media Production Capabilities

Print Radio Television Internet (Web Portals/Email Marketing) Social Media (i.e. Facebook, Twitter, YouTube)

SMS (Text Messaging) News Releases & On-air Endorsements Conferences/Special Events

Marketing &Advertising

Media Buying Power Public Relations Campaign Response Analytics Integrated Marketing Database and Targeted

campaigns based on Psychographics AIO (Activities, Interests and Opinions)

Recruitment

Advertising in local media, internet and conventional mediums

Dedicated Call Center with state of the art technology and experienced staff

Guerrilla Marketing HIPAA Compliant Database of

over 30,000 Willing Subjects

Retention

Early patient education Establish good rapport with

subjects Frequent follow-up and

reminder contacts via phone, emails and SMS texting

Clinical RSVP screening

Recruitment &Retention

SOP Creation, Revision, and Implementation Sponsor/FDA Audit Preparation GCP , Research Asst., HIPAA & ACRP Exam Prep Training Inform Study Coordinators through the “QA Tip of the Week” Standardization Upfront/Backend QA Investigator Lunch & Learn Series

Quality Assurance & SiteTraining

Our QA Team; Edith Bethencourt, Ana Soler, Linda Camp and Jose Garcia is responsible for:

GCP training Training Sessions for ACRP

Certification Exam Research Assistant Training for new

employees HIPAA Training Investigator’s Lunch and Learn Series

SiteTraining

MRA conducts various trainings throughout the year in order to provide our staff with the most current knowledge available:

High level of network security Virtualization- On-site and off-site 2 System-tier for Internet (T1 and Cable) Internet availability within and outside our

network Wi-Fi for Monitor Access

Optimized Data Management Telecommunications, including web

conferencing Enhanced Back Up System Higher Security including key card access,

DVR camera system throughout building and suites

Technology

Our research staff EDC systems

training includes:

I*NET Trialink Phoenix Data Systems Inform / Phase Forward Flex DMS Oracle RDC Medidata/Rave StudyWorks QDS DEAS

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

ElectronicData Capture

MRA excels at conducting complex clinical trials due to:

Highly-trained clinical staff All the benefits of an academic medical center without

usual impediments at start up. Multi-specialty physicians on-site and on-call High Investigator Involvement Ability to conduct trials from Phase I to IV Access to a diverse patient population Outstanding recruitment/retention capabilities

Conclusion

Medical Director: Howard I. Schwartz, MD• Phone: (305) 598-3125 / Email: hschwartz@miamiresearch.com

Medical Director: Eric A. Sheldon, MD• Phone: (305) 598-3125 / Email: esheldon@miamiresearch.com

Key Contacts

Business Development:

Teresa L. Wright, CCRP• Phone: (305) 279-0015 ext. 4223 / Email: twright@miamiresearch.com]

Douglas Kalman PhD, RD • Phone 305 666-2368 / Email: dkalman@miamiresearch.com

Karol Keller, DVM• Phone: (954) 351-8868 / Email: kkeller@miamiresearch.com

Director of Operations: Marysol Cassola• Phone: (305) 279-0015 ext. 4250 / Email: mcassola@miamiresearch.com