2600 Redondo Avenue, Suite 500Long Beach, CA 90806

Collaborative Neuroscience Network, Inc.

CLINICAL PHARMACOLOGY UNIT

Presented By

Bobbie TheodoreAlliance Director

clinicaltrials@btheodore.comwww.clinicaltrialcenters.com

CNS Network State-of-the-Art Clinical Pharmacology Unit

Facility 25,000 Square Feet, 2 units Unit with 50 private and semi-private beds to conduct Phase I

clinical trials (35 beds for healthy, neurology, pain, medical, and ethno-bridging populations; and 15 beds for psychiatry special patient populations)

• Dedicated medication dispensary with a PharmD supervisor PHF Unit (Psychiatric Hospital Facility) with 14 private patient

rooms licensed by the state of CA Double occupancy to accommodate caregiver or significant other as needed Building has video surveillance that can be monitored in all nurses stations Secure offsite automatic data back up Diesel generator provides 24-hour battery back up Easy access to regional Long Beach airport

Full Time Experienced Staff Board Certified Psychiatrists, Neurologists, Internists and Licensed

Psychologists PIs & Sub-Is Operations Manager provides continuous staff training on GCP, SOPs and QA RNs, Director of Nursing, Charge Nurse and Director of Social Services Pharmacist, Caterer, Dietician and Recreational Therapist PhD, MD and Masters Level Clinical Raters Multiple Coordinators Field based Recruitment Specialists

Indications Psych special patient populations – Schizophrenia, Bipolar Disorders,

Cognition Disorders, Depression, Addictions (Smoking Cessation, Alcohol Dependence, Opioid Dependence)

Non-psych special patient populations - Alzheimer’s, Parkinson’s, MS, Pain Disorders (Migraine, Diabetic Neuropathy, Acute and Chronic pain, PHN, Fibromyalgia, Osteoarthritis), Epilepsy, Type 2 Diabetes, Hepatitis C, COPD, OIC/IBS, Bioequivalence and Biosimilar Studies

Japanese and Chinese Bridging Healthy Normal

CNS Network State-of-the-Art Clinical Pharmacology Unit (cont’d)

Experience and CapabilitiesPsychometric Ratings (scales page 12)Extensive PKsImaging:

3T MRI Scanner capable of FMRI Procedures64-Slice PET/CT SystemSPECT ScannerSite transports patients to and from the imaging facility

EEG/qEEG, Evoked PotentialsTQTc, Cardiac/Telemetry Monitoring/Continuous ECGDelivery methods include transdermal patch delivery systems, IV infusion, oral

and deviceLumbar Puncture/Continuous 24-hour CSF Collection

Neurologist PIs and Contracted Anesthesiologists from Surgical Center inside unit perform Lumbar Punctures

DDIFood EffectSAD/MADBioavailibilty, Bioequivelance

CNS Network State-of-the-Art Clinical Pharmacology Unit (cont’d)

Emergency Capabilities and Training Staff ACLS Certified Staff trained and qualified in use of emergency crash cart, CPR, AED,

oxygen tank Stocked emergency cart checked every shift. Automatic defibrillators on site tested and calibrated annually 8AM-8PM Urgent Care on site (1st Floor) In a medical HMO building with 7-days/week urgent care ER ½ mile away Arrangement with Pacific Hospital (2 miles)

Clinical/Analytical Specimens and Laboratory Relationship with local laboratory for services 24/7 Pick-up STAT capabilities analyze within 1-2 hours Electronic transmission capabilities Refrigerated and ambient centrifuges Alarmed refrigerators/freezers (-20, -70 and -80 degrees) CLIA waivered lab Back-up Generator

Data Collection Collection and integration of laboratory data, images and scans Bar-coded labeling to track samples from draw to dispatch Call center with detailed metrics and recruitment plans tailored to

each study Central IRB

CNS Network State-of-the-Art Clinical Pharmacology Unit (cont’d)

Recreation 32” LCD TVs in every room with cable Community computers, wireless internet access for personal

laptops Recreation Therapist Transportation Services Lounge, break room, dining room with kitchen

CNS Network State-of-the-Art Clinical Pharmacology Unit (cont’d)

CNS Network Clinical Pharmacology Unit Floor Plan

Phase I Trial ExperiencePsychiatry 150+ studies, inpatient and outpatient 100+ Schizophrenia and schizoaffective disorders - acute, negative symptoms,

stable, cognition 25+ Bipolar mania and mixed 30+ Depression – MDD, refractory/treatment resistant, depression with sexual

dysfunction 10+ Other indications - anxiety, PTSD, chemical dependency, etc.

Neurology 50+ studies, broad range of indications 20+ Alzheimer’s studies - mild-to-moderate, severe - CSF, MRI, PET, PK 15+ Pain studies - migraine, diabetic neuropathy, OA, chronic back/knee pain,

fibromyalgia 5+ Parkinson’s trials - early stage and advanced 5+ Epilepsy studies - adjunctive therapy and monotherapy 10+ Sleep Disorders studies – insomnia, Restless Legs Syndrome

General Medical 5+ Type 2 Diabetes, Diabetic Neuropathy, OIC

Phase I Trial Experience (cont’d)

Phase I/Ib and IIa 30+ studies in Special Patient PopulationsSchizophrenia and schizoaffective disordersMajor depressionParkinson’sAlzheimer’s diseaseEpilepsy

Cognition 20+ studies targeting cognitive primary endpointsCognition Dysfunction in Schizophrenia, and Depression; MCICANTAB Administered over 300+ times in 3 yrs

Phase I Sample Metrics

Study Title

# of Patients

Screened

# of Patients

Randomized/ # of

Patients Completed

Length of Enrollme

nt YearMet

Target?

A Phase I, Double-Blind, Randomized, Placebo-Controlled, Multiple, Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of XXX in Elderly Volunteers and in Subjects With Mild Alzheimer's Disease (includes Lumbar Puncture and PET)

11 7/6 4 months 2011 Yes

A Phase I, Randomized, Double-blind, Placebo-controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, Immunogenicity, Pharmacodynamic Response, and Pharmacokinetics of Intravenous Infusions of XXX in Subjects With Mild to Moderate Alzheimer’s Disease

Study design 5 cohorts;

1 pt/cohort from ea

site

Goal 5/ 4 to date

1-2 months

depending on

cohort

2011 Ongoing

A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study of Safety and Tolerability of XXX in Adult Patients With Parkinson’s Disease Who Are Receiving XXX

26 15/4 (to date)

1 month 2010 Ongoing

A Phase I, Multi-center, Randomized, Double-Blind, Comparator-Controlled Study to Assess the Tolerability, Safety, Efficacy, and Pharmacokinetics of Ascending Multiple Oral Doses of XXX in Adult Subjects with a Diagnosis of Schizophrenia or Schizoaffective Disorder

36 20/20 4 months 2009 Yes

A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Multiple Oral Doses of XXX as Adjunctive Therapy in the Treatment of Patients with Major Depressive Disorder

36 10/10 2 months 2009 Competitive

Phase IIa Sample Metrics

Study Title

# of Patients

Screened

# of Patients

Randomized/ # of Patients

Completed

Length of Enrollmen

t YearMet

Target?

A Two-Period, Two-Treatment, Open-Label, Two-Way Steady-State Crossover Bioequivalence Study of XXX Extended Release 400-mg Tablets under Fasting Conditions in Patients

4 3/3 1 month 2008

Competitive

A Phase IIa Randomized, Double-blind, Cross over Study Comparing the Tolerability of Two Dose Regimens of XXX in Adult Patients with Parkinson's Disease who are receiving XXX

11 10/6 1 month 2010

Yes

A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Oral Multiple Ascending Doses for XXX in Patients with Schizophrenia(included 24 hours of telemetry and holter monitoring)

134 98/80 7 months 2010

Yes

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating QT/Qtc Intervals Following Administration of Extended-Release XXX And XXX in Subjects with Schizophrenia or Schizoaffective Disorder

31 21/20 1 month (across

two sites)

2007

Yes

A 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)

8 8/8 1 month 2007

Yes

Recruitment and Retention

Recruitment: Second largest market in the US with between 12-14 million population Full time Recruitment Specialists 3 full time Field Based Specialists (prior pharmaceutical reps) Recruiters visit established relationships with a network of physicians

(Neurologists, Psychiatrists and Internists) with access to patient databases and referrals

Community Outreach includes visiting residential facilities, senior communities and community events, providing free seminars, lunch and learns, and distributing flyers

Site Database of 12,000+ subjects across all indications accumulated over 10 years of research

2,000+ schizophrenia patients, 1,500+ depression, 1,000+ AD, 1,000+ pain and 700+ Parkinson’s patients in practice and database

Ability to pre-qualify patients via IRB-approved pre-screen consent form for queries allowing non-evasive procedures

High Retention / Low Drop Out: Spacious 25,000 square feet of living space Units designed for disease specific research with patient comfort and safety in

mind Private rooms for caregiver accommodations if requested 32” flat screen TVs in each room and in community areas Wireless Internet and community computers allows patients to keep in touch Recreation Therapist provides ongoing activities for longer inpatient stays Dietician provide palatable meals and protocol mandated special dietary requests Site contracted with van service to provide patient transportation when needed Dedicated staff for regular contact with patient and family to promote retention PIs and Sub-Is treat these patients in practice for ease in transition and follow up

Site Advantages Swift start up – Central IRB IRB-approved pre-screen consents to pre-qualify subjects PIs provide clinical feedback and protocol consult during

development process if needed Ability to recruit quality patients Low drop out / high retention Placebo separation results Repeat business Participating in many pharmaceutical and CRO preferred

site programs Experienced, dedicated staff and PI expertise Expedited feasibility and budget/contract negotiation

handled by single point of contact with Site Relations Team: Bobbie Theodore, Annie Speno, Jeanette Caruso

ADAS-COGADCSACDSAIMSAISRS/ADHD RS-IVASEXBACSBAIBARSBASBDIBPI-SFBPRSBSSCAICANTABCAARSCADSSCDRCDSS

CGI-BP/I/S/SCA-SCIBICCOG STATECPRSCPTCRTTC-SSRSDADDCSQDESSDSM-IV DiagnosisDSSTESRSESSFASTFIQFMSFOSQGAFGASGBI

HAM-AHAM-DHISISIKBITK-SADSLSEQMADRSMATRICSMCCB (Matrics)MGH ATRQMINIMMSEMOSMOS-SSMSLT NABNPINSANTBNYPRS

PANSSPGAPOMSPQASPSPPSQIPUTSPWIQIDS-16Q-LES-QRAVLTRSQ – D/WRUSPRUQSANSSASSASSSBQ-RSCIDSCL-90SCoRS

SDSSQLMSRTTSTSSWNTMTP 1, 2TSSRUPDRSVASWCSTWMSWOMACWPAIWTARUPSAYBOCSYGTSSYMRS

Rating Expertise Includes:

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

Curriculum VitaeClick on names or icons to view CVs:

David P. Walling, Ph.D. CEO and PI Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. PI Omid Omidvar, M.D. PI Nirav S. Patel, M.D. PI Steven H. Reynolds, D.O. - PI Kim Lorine, Ph.D. Rater Melissa Huy, Ph.D. Rater Thanh Ho, Ph.D. Rater Dalia R. Botros, M.B.B.S. – Director of Operations Erica O’Brien, MSW – Senior Study Coordinator

Chang (Peter) H. Kim, BS – Study Coordinator

Contact InfoWebsite: www.clinicaltrialcenters.com

For more information or to arrange a site visit, please contact Alliance Team:

Bobbie Theodore – Alliance Directorclinicaltrials@btheodore.com email(866) 669-0234 or (916) 939-6696

Annie Speno – Operations Managerannie@btheodore.com email916-934-0569 phone / 866-745-8708 fax

Jeanette Caruso – Site Liaison & Budgets/Contracts Manager

jeanette@btheodore.com email916-933-3023 phone / 916-933-3097 fax