collaborative neuroscience network, llc. clinical pharmacology unit 2600 redondo avenue, suite 500...

Collaborative Neuroscience Network, LLC.

CLINICAL PHARMACOLOGY UNIT

2600 Redondo Avenue, Suite 500Long Beach, CA 90806

Presented October 2013Bobbie TheodoreAlliance Director

[email protected]

www.clinicaltrialcenters.com

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

Facility – Click here for a video of the phase I unit25,000 sq ft facility dedicated and designed specifically for early phase clinical research50+ beds in the phase I unit for healthy normal subjects, and for CNS, medical and ethno-bridging patient population trialsAdditional 20 beds in separate PHF unit (Psychiatric Health Facility) licensed by the state of California for psychiatric patient population trialsPrivate and semi-private rooms for double occupancy to accommodate caregiver or significant other as neededLocated within a medical HMO building with a 7 day/week urgent care; acute hospital within 5 milesNumber of offices to accommodate monitors/CRA’s with internet access and copy/fax servicesBuilding has video surveillance that can be monitored in all nurses stationsSecure offsite automatic data back upEasy access to regional Long Beach airport for monitors and visitorsReverse airflow room for smoking breaks, or if protocol allows, patients are accompanied outside of facility for smoking breakContracted with trained pharmacist in compounding procedures; capabilities include encapsulating powder

http://www.cnstrial.com/for-sponsors-and-cros/phase-clinical-research-unit/


Staff

Full Time Experienced StaffPrincipal and Sub-Investigators Board Certified in Psychiatry, Neurology, Internal Medicine and Family Practice, and Licensed Clinical PsychologistsMultiple certified doctorate-level raters with vast cognitive rating scales experience24 hour staffing including licensed ACLS certified nurse’s (RNs, LVNs) on all shiftsDirector of nursing, charge nurse and director of social servicesMultiple dedicated experienced CCRCs and research assistantsLab technicians IATA certifiedDedicated medication dispensary with a Pharm.D. supervisorDedicated outreach and recruitment specialistsRecreational therapistOperations manager provides continuous staff training on GCP, SOPsDedicated internal QA staffDaily meals provided by caterer, and dietician for special meals or protocol mandated dietary requests


Therapeutic Areas

Therapeutic AreasPsychiatric 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 IBSBioequivalence and biosimilar studiesAsian bridging


Experience and CapabilitiesHealthy 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 experienceFIM experience in patient populations – Alzheimer’s, and schizophreniaSingle, and multiple dose escalation Serial PK, 24 to 36 hour draws, on the hour and or ½ hourDrug-drug interaction, food effect, fed and fastedProof-of-conceptCohort or competitive enrollments Up to 8 week inpatient staysfMRI , 1.5 and 3T, Arterial Spin Labeling (ASL), and PET imagingEEG/qEEG, evoked potentialsTQT, Qtc, single and continuous ECG, telemetry, holter and ambulatory cardiac monitoringAs 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 cathetersIV infusion, intravenous, injection, oral, device, and transdermal patch delivery system methods

Experience and Capabilities


Emergency Capabilities, Lab and Data Collection

Emergency Capabilities and TrainingEach unit has an emergency cart which includes an AED and emergency medications checked at every shiftStaff ACLS Certified and qualified in use of emergency crash cart, CPR, AED, oxygen tank Automatic defibrillators on site tested and calibrated annually8AM-8PM Urgent Care on site (1st floor)ER ½ mile awayAdmitting privileges at Pacific Hospital (2 miles)

Clinical/Analytical Specimens and LaboratoryRelationship with local laboratory for services24/7 Pick-upSTAT capabilities analyze within 1-2 hoursElectronic transmission capabilitiesRefrigerated and ambient centrifugesAlarmed refrigerators/freezers (-20, -70 and -80 degrees)CLIA waivered labDiesel generator provides 24-hour battery back up

Data CollectionAll data collected by experienced licensed staff, with strict adherence to the protocol, timely and accuratelyData entry between 24-48 hours


Clinical Trial Experience

Psychiatry: 150+ studies, inpatient and outpatient200+ 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 indications25+ Alzheimer’s - MCI, mild-to-moderate, severe25+ Pain studies - migraine, diabetic neuropathy, OA, chronic back/knee pain, fibromyalgia10+ 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+ Bioequivalence15+ Japanese bridging

General Medical10+ Type 2 diabetes, NOH, hypercholesterolemia, OIC, IBS, asthma, crohn’s


Early Phase Trial Experience

Phase I: (includes Dr. Mark Leibowitz’ trial experience)70+ healthy normal subjects, 40+ FIM, 200+ bioequivalence and ethno-bridging50+ 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 endpointsCognition dysfunction in schizophrenia, depression, MCI and Alzheimer’sCANTAB administered over 300+ times in 3 yrs (additional rating scale experience on slide 15)


Phase I Sample Metrics

Study Title# of Patients

Screened# of Patients Randomized

Length of Enrollment Year Status

A Phase I, Open-label, Multiple Dose, Safety and Tolerability Study of XXX Administered in the Deltoid Muscle in Adult Subjects with Schizophrenia

40 28 1 month 2013 Active

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

54 27 2 months 2013 Active

A Phase I, Evaluation of the Effects of Sequential Multiple-dose Regimens of XXX on Cardiac Repolarization in Patients with Schizophrenia

58 30 6 months 2012 Closed

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

22 15 3 weeks 2012 Closed

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


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


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



Phase I Sample Metrics (cont'd)




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

54 20 (SFs due to pts not having a migraine in req’d window)

8 months 2012 TOP 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

34 25 1 month 2012 Closed

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

10 1-2 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)

11 7 4 months 2011 RESCUE SITE

A Phase I Randomized, Double-Blind, Placebo-Controlled Study of Safety and Pharmacodynamic Effects of XXX in Major Depressive Disorder Subjects


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



Phase IIa Sample Metrics




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

11 10 1 month 2010 RESCUE 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


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)



Recruitment

LA/Orange County catchment area 16MPartnered 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 researchMultiple fulltime, experienced dedicated field-based and recruitment specialistsRecruitment 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 placementsRecruitment plans tailored to each studyInternal Call CenterAds 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 phoneAbility to pre-qualify patients via IRB-approved pre-screen consent form


Retention

Units designed specifically for research, with patient comfort and safety in mindPrivate rooms for caregiver accommodations as needed32” flat screen TVs with cable in each room and in common areasWireless internet and community computers allows patients to keep in touchGames and reading material providedRecreation Therapist provides ongoing activities for longer inpatient staysLounge, break room, dining room with full kitchenFulltime caterer and dietician provide meals and protocol mandated special dietary requestsSite owns vans and contracts with town car service to provide patient transportation to and from visits, including to and from the imaging facility, as neededDedicated staff for regular contact with patient and familySome investigators treat the research patients in their practice which promotes retention, and allows for ease in transition and follow up


Site Advantages

Swift start up – Central IRBCNS and healthy subject expertise – PIs provide clinical feedback, vendor vetting, and CRO recommendations during development process if neededAbility to recruit quality patients for low drop out/high retentionProven study metricsProven placebo separation resultsParticipation in many pharmaceutical and CRO preferred site programs13+ years experienced staff, low turnover

Rating Scale Experience:

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

ACDSACRADAS-COGADCS-ADLADCS-CGIADFACSADRADMACQAIMSAISRS/ADHD RS-IVASEXBACSBAIBARSBASBDIBPI-SFBPRSBSSBVMTCAADID CAARS CAI

CANTABCADSSCBQCCTCDISCDR/CDR-SOBCDRS-RCDSSCFCGDSCGI-BP/I/S/SCA-SCIBICCIBIS-plusCOG STATECOWSCPRSCPTCRTTCSDDC-SSRSDADDCSQDESS

DSDSISDSM-IV DiagnosisDSSTEQ-5D 5L and 3L proxyESRSESSFAQFASTFCSRT-IRFIQFMSFOSQFTNDGAFGASGBIGDSGo/ No Go TaskHAM-AHAM-DHISHoehn & Yahr

HRUQHUIHVLTIADCQISIKBITK-SADSLSEQMADRSMATRICSMCCB (Matrics)MGH ATRQMINImMIDIMMSEMNSI Part bMoCAMOSMOS-SSMSLT NABNC070NDS

NDTNINCDSNPINPSNRSNSANTBNTSS-6NYPRSPAC-QoLPANSSPDQPGAPINRSPOMSPPSQAPQASP-R CSAPSPPSQIPUTSPWIPWC

QIDS-16QL21, QL 98Q-LES-QQOLQOL-ADRAVLTRSQ – D/WRUD-LiteRUSPRUQSANSSASSASSSBQ-RSCIDSCL-90SCOPASCoRSSDSSIBSIGH-DSLOFSOWS

SQLMSRTTSTSSWNTMTP 1, 2TrailsTSQMTSSRUPDRSVASWCSTWMSWOMACWPAIWRAADSWTARUPSAYBOCSYGTSSYMRS


Curriculum Vitae

Click on names to view CVs:David P. Walling, Ph.D. – CEO and PIMark Leibowitz, M.D. - PIArmen 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. – PISeanglong Te, M.D. – Sub-I Kim Lorine, Ph.D. – RaterMelissa Huy, Ph.D. – RaterThanh Ho, Ph.D. – RaterDenise Stephens, L.M.F.T. – RaterDalia R. Botros, M.B.B.S. – Director of OperationsAnne Cabral, M.A. – Senior Study CoordinatorGeraldine Lucas, RN, CCRC – Study CoordinatorMinie Del Rosario Mercado, L.V.N. – Study Coordinator

Additional investigators, raters, and coordinators CVs upon request

http://www.box.net/shared/4aplmydtul

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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 TheodoreAlliance Director

[email protected](866) 669-0234

Annie SpenoOperations Manager

mailto:[email protected]


CNS Network Clinical Pharmacology Unit Floor Plan

collaborative neuroscience network, llc. clinical pharmacology unit 2600 redondo avenue, suite 500...

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