Presented By Bobbie Theodore Alliance Director clinicaltrials@btheodore

FutureSearch Clinical Trials, L.P.

EARLY PHASE CAPABILITIES5508 Parkcrest Drive, Suite 300

Austin, TX 78731

Presented ByBobbie TheodoreAlliance Director

[email protected]

www.clinicaltrialcenters.com

FutureSearch Clinical Trials, L.P.FACILITY

Brodie Ranch Rehabilitation and Healthcare Center – licensed healthcare facility built with attention to patient care, safety and convenience4 units, 120 beds with one unit (30 beds) designated for research, with overflow beds if neededSemi-private rooms, can house caregivers24-hr locked unit, CRU fire alarm system, synchronized timing/clock system throughoutCrash cart, MDs on call02SAT MeterCardiac monitoring capability24-hour medical staffLicensed kitchen with full-time chef for in-house meals


FutureSearch Clinical Trials, L.P.FULL TIME STAFF

Full-time inpatient staffPI with 10+ years research experience2 MD Sub-Is – 1 Psychiatrist & 1 NeurologistMultiple full-time doctorate-level ratersRNs and LVNs ACLS/ALS or BLS certifiedSite manager with 10+ years research experienceCCRCs with up to 10 years research experienceFulltime dedicated recruitment specialistsSpecial pharmacy services including IV dose preparation, randomization, blinding, radio-labeling


FutureSearch Clinical Trials, L.P.TRIAL EXPERIENCE

Phase II – IV Trial Experience Since 1998 Pediatric to adult ADHD, addictions; alcohol dependence, smoking cessation, eating disorders, anxiety, bipolar depression and disorder, depression, mild cognitive impairment, schizophrenia, schizoaffective disorder

Early Phase Trial ExperiencePhase I MDD and schizophreniaPhase I bio-equivalence bipolar, and acute agitation associated with bipolar disorderPhase IIa schizophrenia, and schizoaffective disorderFirst human dose/first in man with new chemical conducted within last 2 yearsADHD

Interest/Capacity in addition to abovePhase I healthy, pain, sleep, and general medical special patient populations


FutureSearch Clinical Trials, L.P.CAPABILITIES

Experience and CapabilitiesPsychometric ratingsExtensive PKs and ECGsEEG/qEEG, evoked potentialsCardiac/telemetry monitoringQtC and TQTAmbulatory BP monitoring / holter monitoring Delivery systems: IV infusion, intra-muscular, oral, transdermal patch, deviceOP exam capabilities within one mile

Emergency Capabilities and TrainingStaff trained and qualified in use of emergency crash cart, CPR, AED, oxygen tankStocked emergency cart checked every shiftAutomatic defibrillators on site tested and calibrated annually5 miles to nearest trauma or intensive care center – fully accredited St. David’s South Austin Medical Center


FutureSearch Clinical Trials, L.P.

Clinical/Analytical Specimens and LaboratoryCentral labRelationship with CPL local certified lab for high priority local laboratory processing1-2 day turn-around time for safety lab report results24/7 Pick-upElectronic transmission capabilitiesRefrigerated and ambient centrifugesAlarmed refrigerators/freezers (-20, -70 and -80 degrees) monitored daily by staffBack-up GeneratorLaboratory and data collection


Phase I and IIa Sample Metrics

Study Title# of

Patients Screened

# of Patients Randomized/ # of Patients Completed

Length of Enrollment Year Status

A Phase I Effect of XXX on Ambulatory Heart Rate and Blood Pressure in patients with Major Depressive Disorder who are being Treated with Selective Serotonin Reuptake Inhibitors

12 12/12 6 weeks 2011

Closed

A Phase IIa, Multi-center, Double-Blind, Randomized, Parallel Group, 4-Week Inpatient Treatment Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Two Fixed Doses of XXX Compared to Placebo, Using XXX as an Active Control, in the Treatment of Acute Exacerbation of Schizophrenia

9 8/7 4 months 2011

Closed

A Phase IIa Study Investigating the Potential Interaction Between XXX and Antipsychotic Treatments in Subjects with Schizophrenia or Schizoaffective Disorder

14 9/8 12 weeks 2010

Closed

A Phase IIa, Multi-center, Randomized, Double-blind, Placebo-controlled, Cross-Over Study to Assess the Efficacy, Safety and Pharmacokinetics of two Oral XXX a Dose Regimens and Placebo during 2 weeks of Treatment in Adult Users of Nicotine Containing Products and three Oral XXX Dose Regimes and Placebo during 2 weeks of Treatment in Adult Non-Users of Nicotine Containing Products in Patients with Attention-Deficit/Hyperactivity Disorder

49 24/14 5 months 2010

Closed – Top

Enrolling Site


Phase I and IIa Sample Metrics (cont'd)

Study Title# of

Patients Screened

# of Patients Randomized/ # Completed

Length of Enrollment Year Status

A Phase IIa Multi-center, Randomized Double-Blind, Double-dummy, and Placebo- and Active Controlled Study to Investigate the Safety and Efficacy of XXX Administered to Subjects with Major Depressive Disorder

18 18/18 2 months 2008 Closed

A Phase IIa, Multi-center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of XXX as Adjunctive Treatment in Combination with a Preexisting Antipsychotic in Patients with Cognitive Impairment Associated Schizophrenia in Non-Smoking Schizophrenia population

9 6/5 8 months 2008 Closed

A Phase IIa Placebo- and Positive-Controlled, Randomized Study, Evaluating QT and QTc Intervals following administration of Immediate-release of an Atypical Antipsychotic in Subjects with Schizophrenia or Schizoaffective Disorder (involved TQT measurements and a comparator drug)

10 7/5 1 month 2007 Closed


Recruitment

Austin, TX – Over 1 million populationSite database of 10,000+ subjects across all indications accumulated over 10 years of researchFull-time field-based recruiters with direct access to and contact with patients through board and care homes and community groups for referrals including from The Lakes, a local inpatient psychiatric unitOutreach efforts include attending community events, providing free seminars, lunch and learns, and distributing flyersFull-time Community Liaison builds and maintains relationships with a network of local physicians (Neurologists, Psychiatrists and Internists) with access to patient databases for additional patient referralsInternal Call Center with 4 full-time staff members field calls and emails from interested participants and schedule them accordingly with our clinicians to be further evaluated Full-time marketing managerAbility to pre-qualify patients via IRB-approved pre-screen consent form for queries allowing non-evasive proceduresRelationship with media buyer with history of successful advertising


Retention

High Retention/ Low Drop OutExperienced MD always available on site at all patient visitsHighly trained and experienced staff very knowledgeable and comfortable working with these patient populationsFlat screen TVs in some rooms and in all common areasWireless internet and community computers allows patients to keep in touchCaterer prepares meals and protocol mandated special diets if requiredRefreshment cart for visitors/ familiesTransportation provided by site when needed for compliance with scheduled visitsDedicated staff for regular contact with patient and familyLounge, break room, dining room with kitchen


Site Advantages

Swift start up – Central IRBIRB-approved pre-screen consents to pre-qualify subjectsPI provides clinical feedback and protocol consult during development process if neededAbility to recruit quality patientsLow drop out/ high retentionPlacebo separation resultsExperienced, dedicated staff and PI expertiseFavorable sponsor and CRO audit results


Testimonials

Dear Dr. Garcia and the [FutureSearch Trials] study team, I am quite impressed with how extremely well you have recruited, enrolled, and completed so many subjects, e.g., LESS THAN 2 months from your initiation visit. Outstanding effort and I thank and congratulate you all on a tremendous effort. YOU ALL are responsible for exceeding expectations. You are incredible. My sincere thanks,~Phase I Depression Study Sponsor

I wanted to let you know what a nice job Dr. Garcia’s site has done in our adult ADHD trial. He is our highest recruiter by far! Very knowledgeable and good work. He will be on our upcoming studies as you are aware.~ADHD Study Sponsor

Dr. Garcia, I was working on the data review for this month and I wanted to tell you that your data looks very clean and impressive. I can tell that you work hard to follow the eCRF Completion Guidelines and I wanted to tell you that I notice it and I appreciate it. Many of the other sites could learn about complete and accurate data entry from you. (don’t tell ‘em I said that!) Keep up the good work!~Schizophrenia Study CRO

Rating Experience Includes:ADAS-COGADCSACDSAIMSAISRS/ADHD RS-IVASEXBACSBAIBARSBASBDIBPI-SFBPRSBSSCAICANTABCAARSCADSSCDRCDR-SOBCDSS

CGI-BP/I/S/SCA-SCIBICCOG STATECPRSCPTCRTTC-SSRSDADDCSQDESSDSDSM-IV DiagnosisDSSTESRSESSFAQFASTFIQFMSFOSQGAFGAS

GBIHAM-AHAM-DHISHUIISIKBITK-SADSLSEQMADRSMATRICSMCCB (Matrics)MGH ATRQMINIMMSEMOSMOS-SSMSLT NABNPINSA

NTBNYPRSPANSSPDQPGAPOMSPQASPSPPSQIPUTSPWIQIDS-16Q-LES-QRAVLTRSQ – D/WRUD-LiteRUSPRUQSANSSASSASS

SBQ-RSCIDSCL-90SCoRSSDSSQLMSRTTSTSSWNTMTP 1, 2TSSRUPDRSVASWCSTWMSWOMACWPAIWTARUPSAYBOCSYGTSSYMRS

Certified, experienced raters, including M.D., Ph.D. and M.A.-level


Curriculum Vitae

Click on names to view CVs:

Donald J. Garcia, Jr., M.D. – President and PIJohn Douglas Hudson, M.D. – PIJuan Carlos Gonzalez, M.D. – Sub-IStacey Stewart – Primary RaterMichael Heubner – Psychometric RaterJesse Loudin, M.Ed., CCRC – Director of Clinical Research

Multiple dedicated study coordinators and RAs on staff

http://www.box.net/shared/xz6qhvvvlb

http://www.box.net/shared/12hx6bkcs4

http://www.box.net/shared/r1m9holref

http://www.box.net/shared/to5ldtimz1

http://www.box.net/shared/tnl6702hyk



http://www.box.net/shared/r6hqgdrjt6




Sponsor Relations Team

Expedited feasibility and budget/contract negotiation handled by single point of contact with Site Relations Team. Our team is responsible for handling the business development needs of the group, sponsor and CRO relations, facilitating the site selection process (CDAs, feasibility questionnaires, CVs, site capabilities information), keeping in regular contact for feedback and garnering new study opportunities so the site personnel can focus on their studies in process. There is no charge to sponsors or CROs for these services .

Jeanette Caruso Budgets/Contracts Manager

Bobbie TheodoreAlliance Director

[email protected](866) 669-0234

Annie SpenoOperations Manager

mailto:[email protected]

Documents

Presented By Bobbie Theodore Alliance Director clinicaltrials@btheodore