Mra Main Presentation 08 25 11 Ppshow Final Tw

“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

Mission Statement

To share our clinical research expertise in partnership with the pharmaceutical industry, in

order to discover and develop innovative medicines and other healthcare solutions that

enrich people’s lives.

Overview

Miami Research Associates (MRA) was established in 1996.

MRA is the largest physician-ownedMulti-specialty clinical research center in the United States.

Over 1,000 Phase I-IV clinical trials successfully conducted.

MRA Research Centers

MRA Operations

MRA Primary Campus Phase I Center Broward Research Group (Sister Site) Sleep Centers (Broward & Miami-Dade) International Operations (Dominican Republic) Patient Recruitment Advertising Agency

Overview > Multi-specialty Therapeutic Divisions:

Dermatology- Dr. Robert Goddard

Gastroenterology- Dr. Harris Goldberg - Dr. Howard Schwartz

Phase I Unit Director- Dr. Patricia Pardo

Nutrition/Endocrinology- Dr. Diane Krieger

Pulmonology- Dr. Jeremy Tabak

Rheumatology- Dr. Jaime Pachón

- Dr. Eric Sheldon

Neuroscience> Psychiatry

- Dr. Americo F. Padilla

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

> Neurology- Dr. Bruce Kohrman

Ophthalmology- Dr. Ann Elizabeth Ballen

Pediatrics - Dr. Adriana Castro

Urology - Dr. John Mekras

MORE >

Sleep Disorders- Dr. Howard Schwartz - Dr. Timothy Grant

Vaccines- Dr. Eric Sheldon

Cardiology- Dr. Harry Aldrich- Dr. Abbe Rosenbaum

Women’s Health- Dr. Robert Feldman

Anesthesiology- Dr. Michael Meister- Dr. Guillermo Pol

Overview > Multi-specialty Therapeutic Divisions:

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

Human Subject Protection

Accredited Since 2010

Our History

1992- Hurricane Andrew

- Dr. Howard Schwartz began conducting H. Pylori studies

1996- Dr. Schwartz

partnered with Dr. Eric Sheldon and Dr. Robert Salzman’s Rheumatology research division to form Miami Research Associates

Our History > Growth/New Divisions

1998 Psychiatry Division established

o Pediatric & Adult Psychiatry

1999 Established the Women’s Health Division

2000 Sleep Medicine Division Nutrition/Endocrinology Division

Broward Research Group (BRG) opened its doors under the care of Medical Director Dr. David Seiden,Board Certified in Neurology & Sleep Medicine

Our History > Growth/New Divisions

2001

2005 Opened the In-patient

& Sedation Divisionat South Miami Hospital

Increased our patientrecruitment resourcesto include in-house Multi-Media Radio & TV capabilities

Our History > Growth/New Divisions

Our History > Growth/New Divisions

Miami Research Associates built an 18,000 square feet research facility.2006

Key Advantages: All Investigators are on-site, which makes

them easily accessible South Miami Hospital is located on the

same city block Improved flexible staff resourcing between

divisions

On-site Equipment Includes: Endoscopy Suite Clinical RSVP (Digital Subject Validation) DEXA Scan Echocardiogram ECGs Digital X-Ray Driving Simulator

2007

Opened an 11,000 square foot, 50 bed state of the art Phase 1 Unit

Began Latin American Research, in Santo Domingo, D.R.

Expanded our Sleep Center capabilities to 12 bedroom suites

Added Text Marketing capabilities to our in-house patient recruitment multi-media center

Our History > Growth/New Divisions

Sponsor PartnersSome of our sponsor partners include:

Research Staff Overview

MRA is proud of its 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

30 years or more Linda Camp, MA*

20 years or more Vivian Rosales*

15-20 years Margarita Mederos

10-15 years Mirnaya Alabaci* Isabel Pino, ARNP-BC* Marlene Piloto Linda Nannini, LPN* Teresa L. Wright, CCRP Meredith Arguelles, LPN* Martha I. Quinones

5-10 years Douglas Kalman, PhD* Terry Piedra* Thelma Beltran, LPN* Gisela Cortina Surisaday Mederos, RN* Sharon Oxford, CDT Jack Mesa, MCP Elaine Moncayo Samantha Feldman, RD* Karol Keller, DVM Ricardo Aleman, BA* Jose Garcia, MBA

Our Dedicated Staff

* = denotes CCRC Certification

5-10 years Edith Bethencourt* Olga Gisbert Anita Puras* Melissa Gonzalez* Karin Suarez* Delia Fernandez Marysol Cassola Krizia Vidiella Ann Kramer Karina Arencibia* Beatriz Rivera Alexandra Galvis

Adriana Acosta, ARNP-BC Elsa V. Esquen Karla Pentzke Pilar Hurtado, RMA* Asly Uzcategui Isett Caro* Noris Peraita, RN* Janeen Rosales, BS* Kenia Capdevilla* Frances Beltran Myriam Rosado

Our Dedicated Staff > (continued):

* = denotes CCRC Certification

Many of our staff members continue their education while working at MRA.

Here are some recent graduates …

Our Dedicated Staff > Education

Ivette Hernandez, RN Naime Reyno-Ramos, RN Yelenia Reyno, RN Noris Peraita, RN Surisaday Mederos, RN Ricardo Aleman, BA Jose Garcia, MBA Poliana Ayala, completing RN degree Chelsea Cabrera, completing RN degree George Sanchez, MD

Dedicated Phase I Center

We do studies other sites can’t.We do studies other sites can’t.

Phase I > Overview

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 I > Trial Experience

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 January 2011, our Phase I Center completed over 80 trials, including:

Phase I > Facility Description

11,000 Square Feet 50 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 I > Clinical Capabilities

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 I > Special Populations

Elderly Hepatic Renal Psoriasis Type II Diabetes Post-Menopausal Hypertension

Obesity Parkinson’s Depression Pediatric ADHD Arthritis

o Rheumatoido Osteoarthritis

Lupus

MRA Business DevelopmentSite Feasibility

Initial Communication with Sponsor/CRO

Confidentiality Agreements

Synopsis Review

Feasibility Questionnaires

Pre-Study Site Visits

Teresa L. Wright, CCRP

Karol Keller, DVM

Protocol Development

Under Direction of: Diane R. Krieger, MD Samantha Feldman, MS, RD, CDE, CCRC Doug Kalman, PhD, RD, CCRC, FACN

Protocol Design Protocol Monitoring Report Writing Statistical Analysis Meeting Presentations

Contracts & Regulatory

Rapid turnaround time

Regulatory Document Completion

Central IRB Submissions

Interfaced with Marketing & Advertising Division for in-house ad creations, expediting the approval process for rapid advertising campaign executions

Marketing/Advertising

In-house advertising agency Multi-media capabilities

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

SMS (Text Messaging) News Releases Conferences/Special Events

Media Buying Power Public Relations Campaign Response Analytics

Recruitment/Retention

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

Quality Assurance

SOP Creation, Revision, and Implementation Sponsor/FDA Audit Preparation Inform Study Coordinators through the “QA Tip of the Week” Standardization Upfront/Backend QA

Linda Camp (Center), along with Ana Soler and Victoria Czenstochouski,are responsible for:

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

GCP training Training Sessions for ACRP

Certification Exam Research Assistant Training

for new employees HIPAA Training Investigator’s Lunch and

Learn Series

Pharmacy/Drug Storage

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 Backup-Generator in case of power failure

Laboratory

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

Safety & Protocol Adherence

Prior to screening the first subject:

Protocol-specific training is held with PI, Sub-Is, study coordinator and research staff

Research staff must complete study review sheet

Technology 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

Electronic Data CaptureOur 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 ControlSubject’s source

document is reviewed prior to and during data entry

Data Clarifications are answered within 24 hours of receipt

MRA excels at conducting complex clinical trials due to:

Highly-trained clinical staff 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

Key Contacts 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

Business Development:• Teresa L. Wright, CCRP

• Phone: (305) 279-0015 ext. 4223 / Email: twright@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