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Collaborative Neuroscience Network, LLC. CLINICAL PHARMACOLOGY UNIT 2600 Redondo Avenue, Suite 500 Long Beach, CA 90806 Presented October 2013 Bobbie Theodore.

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Presentation on theme: "Collaborative Neuroscience Network, LLC. CLINICAL PHARMACOLOGY UNIT 2600 Redondo Avenue, Suite 500 Long Beach, CA 90806 Presented October 2013 Bobbie Theodore."— Presentation transcript:

1 Collaborative Neuroscience Network, LLC. CLINICAL PHARMACOLOGY UNIT 2600 Redondo Avenue, Suite 500 Long Beach, CA Presented October 2013 Bobbie Theodore Alliance Director

2 CNS Network State-of-the-Art Clinical Pharmacology Unit Facility – Click here for a video of the phase I unithere 25,000 sq ft facility dedicated and designed specifically for early phase clinical research 50+ beds in the phase I unit for healthy normal subjects, and for CNS, medical and ethno-bridging patient population trials Additional 20 beds in separate PHF unit (Psychiatric Health Facility) licensed by the state of California for psychiatric patient population trials Private and semi-private rooms for double occupancy to accommodate caregiver or significant other as needed Located within a medical HMO building with a 7 day/week urgent care; acute hospital within 5 miles Number of offices to accommodate monitors/CRA’s with internet access and copy/fax services Building has video surveillance that can be monitored in all nurses stations Secure offsite automatic data back up Easy access to regional Long Beach airport for monitors and visitors Reverse airflow room for smoking breaks, or if protocol allows, patients are accompanied outside of facility for smoking break Contracted with trained pharmacist in compounding procedures; capabilities include encapsulating powder

3 Staff Full Time Experienced Staff Principal and Sub-Investigators Board Certified in Psychiatry, Neurology, Internal Medicine and Family Practice, and Licensed Clinical Psychologists Multiple certified doctorate-level raters with vast cognitive rating scales experience 24 hour staffing including licensed ACLS certified nurse’s (RNs, LVNs) on all shifts Director of nursing, charge nurse and director of social services Multiple dedicated experienced CCRCs and research assistants Lab technicians IATA certified Dedicated medication dispensary with a Pharm.D. supervisor Dedicated outreach and recruitment specialists Recreational therapist Operations manager provides continuous staff training on GCP, SOPs Dedicated internal QA staff Daily meals provided by caterer, and dietician for special meals or protocol mandated dietary requests

4 Therapeutic Areas Psychiatric special patient populations include addictions (smoking cessation, alcohol dependence, eating disorders, opioid dependence), bipolar disorders, cognitive dysfunction, MCI, depression, schizophrenia Non-psychiatric CNS and medical special patient populations include Alzheimer's, pain disorders (headache, migraine, diabetic neuropathy, chronic, PHN, fibromyalgia, osteoarthritis), Parkinson's, type 2 diabetes, hypertension, high cholesterol, women’s health, asthma, multiple sclerosis, OIC, asthma, and IBS Bioequivalence and biosimilar studies Asian bridging

5 Experience and Capabilities Healthy normal subjects (HNS), adult and elderly – Dr. Mark Leibowitz, PI/Medical Director: 70+ HNS, 40+ FIM (first in man), and 200+ bioequivalence and multiple Japanese ethno-bridging trial experience FIM experience in patient populations – Alzheimer’s, and schizophrenia Single, and multiple dose escalation Serial PK, 24 to 36 hour draws, on the hour and or ½ hour Drug-drug interaction, food effect, fed and fasted Proof-of-concept Cohort or competitive enrollments Up to 8 week inpatient stays fMRI, 1.5 and 3T, Arterial Spin Labeling (ASL), and PET imaging EEG/qEEG, evoked potentials TQT, Qtc, single and continuous ECG, telemetry, holter and ambulatory cardiac monitoring As of May 2012, CNSN has conducted 26 Alzheimer’s studies, 16 of which included CSF sampling sub-studies CSF sampling conducted by Neurologist and Internists on site. Additional access to anesthesiologists from the surgical center within the unit that perform and monitor the setting of the spinal catheters IV infusion, intravenous, injection, oral, device, and transdermal patch delivery system methods Experience and Capabilities

6 Emergency Capabilities, Lab and Data Collection Emergency Capabilities and Training Each unit has an emergency cart which includes an AED and emergency medications checked at every shift Staff ACLS Certified and qualified in use of emergency crash cart, CPR, AED, oxygen tank Automatic defibrillators on site tested and calibrated annually 8AM-8PM Urgent Care on site (1 st floor) ER ½ mile away Admitting privileges at 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 Diesel generator provides 24-hour battery back up Data Collection All data collected by experienced licensed staff, with strict adherence to the protocol, timely and accurately Data entry between hours

7 Clinical Trial Experience Psychiatry: 150+ studies, inpatient and outpatient 200+ Schizophrenia and schizoaffective disorders - acute, negative symptoms, stable, cognition 50+ Depression – MDD, refractory/treatment resistant, depression with sexual dysfunction 20+ Bipolar mania and mixed 5+ Other indications - anxiety, PTSD, chemical dependency Neurology: 50+ studies, inpatient and outpatient, broad range of indications 25+ Alzheimer’s - MCI, mild-to-moderate, severe 25+ Pain studies - migraine, diabetic neuropathy, OA, chronic back/knee pain, fibromyalgia 10+ Parkinson’s trials - early stage and advanced 8+ Epilepsy - adjunctive therapy and monotherapy 8+ MS – relapsing remitting 5+ Sleep disorders studies – insomnia, restless legs syndrome Healthy Normal: (Dr. Mark Leibowitz) 70+ Healthy Normal (adult and elderly subjects) 40+ FIM (first in man) 200+ Bioequivalence 15+ Japanese bridging General Medical 10+ Type 2 diabetes, NOH, hypercholesterolemia, OIC, IBS, asthma, crohn’s

8 Early Phase Trial Experience Phase I: (includes Dr. Mark Leibowitz’ trial experience) 70+ healthy normal subjects, 40+ FIM, 200+ bioequivalence and ethno-bridging 50+ patient populations including schizophrenia, Alzheimer’s, Parkinson’s, depression, obesity, migraine, insomnia, gastrointestinal disorders, diabetes, hypertension, multiple sclerosis and epilepsy Cognition: 20+ trials targeting cognitive primary endpoints Cognition dysfunction in schizophrenia, depression, MCI and Alzheimer’s CANTAB administered over 300+ times in 3 yrs (additional rating scale experience on slide 15)

9 Phase I Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase I, Open-label, Multiple Dose, Safety and Tolerability Study of XXX Administered in the Deltoid Muscle in Adult Subjects with Schizophrenia month2013Active A Phase I, Prospective, Randomized, Double-blind, Placebo-controlled, Sequential-cohort, Escalating, Single-dose Study designed to determine the maximum tolerated oral dose of XXX in Healthy, Male volunteers months2013Active A Phase I, Evaluation of the Effects of Sequential Multiple-dose Regimens of XXX on Cardiac Repolarization in Patients with Schizophrenia months2012Closed A Phase I, Placebo-and Positive-controlled Study of the Electrophysiological Effects on the QT Interval after a Supratherapeutic Dose of XXX in Subjects with Schizophrenia weeks2012Closed A Phase Ib, Randomized, Double-Blind, Placebo-Controlled, Sponsor- Open, Study to Examine the Safety, Tolerability and Pharmacokinetics of XXX in Psychiatrically Stable Subjects with Schizophrenia months2012Closed A Phase I, Open-Label, Single Group, Multiple-Dose, Study to Evaluate the Pharmacokinetics of XXX Drug Delivery System following 24-hr Application in Patients Diagnosed with Parkinson’s Disease months2012Closed A Phase I, 2-part, open label, inpatient study to assess the safety and tolerability of multiple ascending doses of XXX in subjects with Schizophrenia months2012Closed

10 Phase I Sample Metrics ( cont'd ) Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus Phase I, Open-Label, Randomized, Parallel Group, Crossover Study to Compare the Pharmacokinetcs of XXX in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period 5420 (SFs due to pts not having a migraine in req’d window) 8 months2012TOP ENROLLING SITE A Phase I Parallel-group, Double-blind, Placebo and Positive Controlled Multiple Oral Dose Administration Trial to Evaluate the Effects of XXX on QT/QTc in Subjects with Schizophrenia or Schizoaffective Disorder month2012Closed 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 months depending on cohort 2011 TOP ENROLLING SITE 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 (included Lumbar Puncture and PET) 1174 months2011RESCUE SITE A Phase I Randomized, Double-Blind, Placebo-Controlled Study of Safety and Pharmacodynamic Effects of XXX in Major Depressive Disorder Subjects 1371 month2011Closed A Phase I 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 month2010Closed

11 Phase IIa Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase IIa Randomized, Double-blind, Crossover Study Comparing the Tolerability of Two Dose Regimens of XXX in Adult Patients with Parkinson's Disease who are receiving XXX month2010RESCUE SITE A Phase IIa, Multicenter, 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 months2010Closed 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) months2008Closed

12 Recruitment LA/Orange County catchment area 16M Partnered with PIs that are part of large psychiatric mental health facility, group neurology practice, and group family practice with access to thousands of patients Extensive site and practice databases of over 18,000 subjects across a variety of therapeutic areas, established over 13+ years of clinical research Multiple fulltime, experienced dedicated field-based and recruitment specialists Recruitment staff have established relationships in the community; visit referring physicians, residential facilities and senior communities, providing free seminars, lunch and learns, distributing flyers and attending community events Established relationship with media buyers, with discounted ad pricing and preferred placements Recruitment plans tailored to each study Internal Call Center Ads contain number that directs callers straight to our recruitment department call center staff who are trained specialists that field incoming calls and conduct prescreening over the phone Ability to pre-qualify patients via IRB-approved pre- screen consent form

13 Retention Units designed specifically for research, with patient comfort and safety in mind Private rooms for caregiver accommodations as needed 32” flat screen TVs with cable in each room and in common areas Wireless internet and community computers allows patients to keep in touch Games and reading material provided Recreation Therapist provides ongoing activities for longer inpatient stays Lounge, break room, dining room with full kitchen Fulltime caterer and dietician provide meals and protocol mandated special dietary requests Site owns vans and contracts with town car service to provide patient transportation to and from visits, including to and from the imaging facility, as needed Dedicated staff for regular contact with patient and family Some investigators treat the research patients in their practice which promotes retention, and allows for ease in transition and follow up

14 Site Advantages Swift start up – Central IRB CNS and healthy subject expertise – PIs provide clinical feedback, vendor vetting, and CRO recommendations during development process if needed Ability to recruit quality patients for low drop out/high retention Proven study metrics Proven placebo separation results Participation in many pharmaceutical and CRO preferred site programs 13+ years experienced staff, low turnover

15 Rating Scale Experience: Certified, experienced raters, including M.D., Ph.D. and M.A.-level ACDS ACR ADAS-COG ADCS-ADL ADCS-CGI ADFACS ADR ADMACQ AIMS AISRS/ADHD RS-IV ASEX BACS BAI BARS BAS BDI BPI-SF BPRS BSS BVMT CAADID CAARS CAI CANTAB CADSS CBQ CCT CDIS CDR/CDR-SOB CDRS-R CDSS CF CGDS CGI-BP/I/S/SCA-S CIBIC CIBIS-plus COG STATE COWS CPRS CPT CRTT CSDD C-SSRS DAD DCSQ DESS DS DSIS DSM-IV Diagnosis DSST EQ-5D 5L and 3L proxy ESRS ESS FAQ FAST FCSRT-IR FIQ FMS FOSQ FTND GAF GAS GBI GDS Go/ No Go Task HAM-A HAM-D HIS Hoehn & Yahr HRUQ HUI HVLT IADCQ ISI KBIT K-SADS LSEQ MADRS MATRICS MCCB (Matrics) MGH ATRQ MINI mMIDI MMSE MNSI Part b MoCA MOS MOS-SS MSLT NAB NC070 NDS NDT NINCDS NPI NPS NRS NSA NTB NTSS-6 NYPRS PAC-QoL PANSS PDQ PGA PINRS POMS PPSQA PQAS P-R CSA PSP PSQI PUTS PWI PWC QIDS-16 QL21, QL 98 Q-LES-Q QOL QOL-AD RAVLT RSQ – D/W RUD-Lite RUSP RUQ SANS SAS SASS SBQ-R SCID SCL-90 SCOPA SCoRS SDS SIB SIGH-D SLOF SOWS SQLM SRTT STS SWN TMTP 1, 2 Trails TSQM TSSR UPDRS VAS WCST WMS WOMAC WPAI WRAADS WTAR UPSA YBOCS YGTSS YMRS

16 Curriculum Vitae Click on names to view CVs: David P. Walling, Ph.D. David P. Walling, Ph.D. – CEO and PI Mark Leibowitz, M.D.Mark Leibowitz, M.D. - PI Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. – PI Omid Omidvar, M.D. Omid Omidvar, M.D. – PI Nirav S. Patel, M.D. Nirav S. Patel, M.D. – PI Steven H. Reynolds, D.O. Steven H. Reynolds, D.O. – PI Seanglong Te, M.D. Seanglong Te, M.D. – Sub-I Kim Lorine, Ph.DKim Lorine, Ph.D. – Rater Melissa Huy, Ph.DMelissa Huy, Ph.D. – Rater Thanh Ho, Ph.D.Thanh Ho, Ph.D. – Rater Denise Stephens, L.M.F.T. Denise Stephens, L.M.F.T. – Rater Dalia R. Botros, M.B.B.S. Dalia R. Botros, M.B.B.S. – Director of Operations Anne Cabral, M.A. Anne Cabral, M.A. – Senior Study Coordinator Geraldine Lucas, RN, CCRC Geraldine Lucas, RN, CCRC – Study Coordinator Minie Del Rosario Mercado, L.V.N.Minie Del Rosario Mercado, L.V.N. – Study Coordinator Additional investigators, raters, and coordinators CVs upon request

17 Sponsor Relations Team Expedited feasibility and budget/contract negotiation handled by single point of contact with Sponsor 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), budgets and contracts, 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 Finance Manager Bobbie Theodore Alliance Director (866) Annie Speno Operations Manager

18 CNS Network Clinical Pharmacology Unit Floor Plan


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