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2600 Redondo Avenue, Suite 500 Long Beach, CA 90806 Collaborative Neuroscience Network, Inc. CLINICAL PHARMACOLOGY UNIT Presented By Bobbie Theodore Alliance.

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Presentation on theme: "2600 Redondo Avenue, Suite 500 Long Beach, CA 90806 Collaborative Neuroscience Network, Inc. CLINICAL PHARMACOLOGY UNIT Presented By Bobbie Theodore Alliance."— Presentation transcript:

1 2600 Redondo Avenue, Suite 500 Long Beach, CA Collaborative Neuroscience Network, Inc. CLINICAL PHARMACOLOGY UNIT Presented By Bobbie Theodore Alliance Director

2 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

3 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)

4 Experience and Capabilities Psychometric Ratings (scales page 12) Extensive PKs Imaging: 3T MRI Scanner capable of FMRI Procedures 64-Slice PET/CT System SPECT Scanner Site transports patients to and from the imaging facility EEG/qEEG, Evoked Potentials TQTc, Cardiac/Telemetry Monitoring/Continuous ECG Delivery methods include transdermal patch delivery systems, IV infusion, oral and device Lumbar Puncture/Continuous 24-hour CSF Collection Neurologist PIs and Contracted Anesthesiologists from Surgical Center inside unit perform Lumbar Punctures DDI Food Effect SAD/MAD Bioavailibilty, Bioequivelance CNS Network State-of-the-Art Clinical Pharmacology Unit (cont’d)

5 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 (1 st 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)

6 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)

7 CNS Network Clinical Pharmacology Unit Floor Plan

8 Phase I Trial Experience Psychiatry 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

9 Phase I Trial Experience (cont’d) Phase I/Ib and IIa 30+ studies in Special Patient Populations Schizophrenia and schizoaffective disorders Major depression Parkinson’s Alzheimer’s disease Epilepsy Cognition 20+ studies targeting cognitive primary endpoints Cognition Dysfunction in Schizophrenia, and Depression; MCI CANTAB Administered over 300+ times in 3 yrs

10 Phase I Sample Metrics Study Title # of Patients Screened # of Patients Randomized/ # of Patients Completed Length of EnrollmentYear Met 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) 117/64 months2011Yes 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 2615/4 (to date)1 month2010 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 3620/204 months2009 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 3610/102 months2009 Competitive

11 Phase IIa Sample Metrics Study Title # of Patients Screened # of Patients Randomized / # of Patients Completed Length of EnrollmentYear Met 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 43/31 month2008 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 1110/61 month2010Yes 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) 13498/807 months2010Yes 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 3121/201 month (across two sites) 2007Yes 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) 88/81 month2007Yes

12 Recruitment and Retention Recruitment: Second largest market in the US with between 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

13 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

14 ADAS-COG ADCS ACDS AIMS AISRS/ADHD RS-IV ASEX BACS BAI BARS BAS BDI BPI-SF BPRS BSS CAI CANTAB CAARS CADSS CDR CDSS CGI-BP/I/S/SCA-S CIBIC COG STATE CPRS CPT CRTT C-SSRS DAD DCSQ DESS DSM-IV Diagnosis DSST ESRS ESS FAST FIQ FMS FOSQGAF GAS GBI HAM-A HAM-D HIS ISI KBIT K-SADS LSEQ MADRS MATRICS MCCB (Matrics) MGH ATRQ MINI MMSE MOS MOS-SS MSLT NAB NPI NSA NTB NYPRS PANSS PGA POMS PQAS PSP PSQI PUTS PWI QIDS-16 Q-LES-Q RAVLT RSQ – D/W RUSP RUQ SANS SAS SASS SBQ-R SCID SCL-90 SCoRS SDS SQLM SRTT STS SWN TMTP 1, 2 TSSR UPDRS VAS WCST WMS WOMAC WPAI WTAR UPSA YBOCS YGTSS YMRS Rating Expertise Includes: Certified, experienced raters, including M.D., Ph.D. and M.A.-level

15 Curriculum Vitae Click on names or icons to view CVs: David P. Walling, Ph.D. CEO and PIDavid P. Walling, Ph.D. Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. PIArmen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. Omid Omidvar, M.D. PIOmid Omidvar, M.D. Nirav S. Patel, M.D. PINirav S. Patel, M.D. Steven H. Reynolds, D.O. - PISteven H. Reynolds, D.O. Kim Lorine, Ph.D. RaterKim Lorine, Ph.D. Melissa Huy, Ph.D. RaterMelissa Huy, Ph.D. Thanh Ho, Ph.D. RaterThanh Ho, Ph.D. Dalia R. Botros, M.B.B.S. – Director of OperationsDalia R. Botros, M.B.B.S. Erica O’Brien, MSW – Senior Study CoordinatorErica O’Brien, MSW Chang (Peter) H. Kim, BS – Study CoordinatorChang (Peter) H. Kim, BS

16 Contact Info Website: For more information or to arrange a site visit, please contact Alliance Team: Bobbie Theodore – Alliance Director (866) or (916) Annie Speno – Operations Manager phone / fax Jeanette Caruso – Site Liaison & Budgets/Contracts Manager phone / fax


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