cns, llc clinical pharmacology unit 2600 redondo avenue, suite 500 long beach, ca 90806
Post on 31-Dec-2015
27 Views
Preview:
DESCRIPTION
TRANSCRIPT
CNS, LLCCLINICAL PHARMACOLOGY
UNIT2600 Redondo Avenue, Suite 500
Long Beach, CA 90806
Bobbie TheodoreAlliance Director
clinicaltrials@btheodore.com
Annie SpenoOperations Manager
annie@btheodore.com
www.clinicaltrialcenters.com
www.clinicaltrialcenters.com
State-of-the-Art Clinical Pharmacology Unit
Facility60+ bed CPU dedicated and designed specifically for early phase clinical researchTargeted healthy normal volunteers, stable psychiatric, CNS, medical and ethno-bridging special patient population trialsAdditional 20 beds in separate PHF unit (Psychiatric Health Facility) licensed by the state of California for acute psychiatric patient population trialsPrivate and semi-private rooms for double occupancy to accommodate caregiver or significant otherLocated 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
www.clinicaltrialcenters.com
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 comprehensive cognitive rating scales experience24 hour staffing includes licensed ACLS certified nurse’s (RNs, LVNs) on all shiftsDirector of nursing, charge nurse and director of social servicesMultiple dedicated early phase 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 staff conducts internal auditsCaterer provides daily meals, and dietician for special meals or protocol mandated dietary requests
www.clinicaltrialcenters.com
Experience
Healthy normal volunteers (HNV)First in human (FIM) patient populations – Alzheimer’s, schizophreniaSAD/MAD, single, and multiple dose escalation TQT, Qtc, single and continuous ECGTelemetry, holter and ambulatory cardiac monitoringEEG/qEEG, evoked potentialsDrug-drug interaction (DDI), food effect, fed and fastedSerial PK, 24 to 36 hour draws, on the hour and or ½ hourImaging, fMRI , 1.5 and 3T, Arterial Spin Labeling (ASL), and PET imagingCSF collection (conducted by Neurologists and Internists on site. Additional access to anesthesiologists that perform and monitor the setting of spinal catheters)
Proof-of-concept (POC), pilot, pivotal and crossover designsLarge cohorts, and competitive enrollments Up to 8 week inpatient staysDelivery system methods – oral, IV infusion, intravenous, injectable, device, patchBioequivalence
www.clinicaltrialcenters.com
Therapeutic Areas
Psychiatric special patient populations - Addictions (smoking cessation, alcohol dependence, eating disorders, opioid dependence), ADHD, bipolar disorders, cognitive dysfunction, MCI, depression, schizophrenia, stable and acute Non-psychiatric CNS and medical special patient populations - 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 Ethno-bridging
www.clinicaltrialcenters.com
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
www.clinicaltrialcenters.com
Phase I Trials
Phase I: (includes Dr. Mark Leibowitz’ trial experience)70+ healthy normal subject trials, 40+ FIM, 200+ bioequivalence and ethno-bridging50+ patient populations – Alzheimer’s, depression, diabetes, epilepsy, gastrointestinal disorders, hypertension, insomnia, migraine, multiple sclerosis, obesity, Parkinson’s, and schizophrenia
Cognition: 20+ targeting cognitive primary endpointsCognitive dysfunction in schizophrenia, depression, MCI and Alzheimer’sCANTAB administered over 300+ times in 3 yrs (additional rating scale experience on slide 18)
www.clinicaltrialcenters.com
Phase II – III Trials
Psychiatry: 300+ 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 – ADHD, anxiety, PTSD, chemical dependency
Neurology: 80+ studies, inpatient and outpatient, broad range of indications30+ Alzheimer’s - MCI, mild-to-moderate, severe25+ Pain studies - migraine, diabetic neuropathy, OA, chronic back/knee pain, fibromyalgia15+ Parkinson’s trials - early stage and advanced 8+ Epilepsy - adjunctive therapy and monotherapy 8+ MS – relapsing remitting 5+ Sleep disorders – insomnia, restless legs syndrome
Dr. Mark Leibowitz:20+ patient populations
200+ Bioequivalence15+ Japanese bridging
General Medical:10+ across broad range of indications –
type 2 diabetes, NOH, hypercholesterolemia, OIC, IBS, asthma, crohn’s, women’s health
www.clinicaltrialcenters.com
Phase I Sample Metrics
Study Title# of
Cohorts Contracted# of Cohorts
EnrolledLength of
Enrollment Year StatusA Phase I, Randomized, Single Blind, Placebo Controlled, Ascending Multiple Oral Dose Study Assessing the Safety, Tolerability, and Pharmacokinetics of XXX in Male and Female Subjects with Schizophrenia.
Up to 60 (5 cohorts of 12)
1(12) enrolled in
1 week
ongoing 2014 RESCUE SITE
Active – 1 site
A Phase I, Randomized, Single-Blind, Placebo-Controlled, Ascending Single Oral Dose Study Assessing the Safety, Tolerability, and Pharmacokinetics of XXX in Male and Female Subjects with Schizophrenia
Up to 60 (5 cohorts of 12)
1(12) enrolled in
1 week
ongoing 2014 RESCUE SITE
Active – 1 site
A Phase I, Randomized, Double-blinded, Multiple Ascending Dose Study in Patients with Early-stage Parkinson’s Disease to Evaluate the Pharmacokinetics and Safety of XXX following Intramuscular Injections
Up to 20 (5 max per cohort)
Cohort 1 currently enrolling
2 months 2014 Active
www.clinicaltrialcenters.com
Phase I Sample Metrics (cont'd)
Study Title# of
Cohorts Contracted# of Cohorts
EnrolledLength of
Enrollment Year Status
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 – 3 days/2 overnights
45 (3 cohorts of 12) 4th and 5th cohorts
added
3 (36)Cohort 4 enrolling
6 months 20132014
Active – 1 site
Phase I/II Randomized, Double-blind, Placebo-controlled, Sequential Dose Escalation Cohort Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of XXX in Psychiatrically Stable Schizophrenia Subjects – 2 weeks inpatient
Up to 32 (4 cohorts of 8)
5th cohort added
4 (32)Cohort 5 currently enrolling
5 months 20132014
Active – 1 site
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
1 (5 patients) 2 (10 patients)
12 months 2012 2013
TOP ENROLLING
SITE
www.clinicaltrialcenters.com
Phase I Sample Metrics (cont'd)
Study Title# of Patients
Screened# of Patients Randomized
Length of Enrollment Year Status
A Phase I, Randomized, Double-blind, Placebo-controlled, Sequential Dose Escalation Cohort Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of XXX in Psychiatrically Stable Schizophrenia Subjects
57 41 5 months 2014 Active
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, 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
46 30 3 months 2012 Closed
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
18 12 4 months 2012 Closed
www.clinicaltrialcenters.com
Phase I Sample Metrics (cont'd)
Study Title# of Patients
Screened# of Patients Randomized
Length of Enrollment Year Status
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
62 40 8 months 2012 Closed
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, Open-Label, Single Group, Multiple-Dose, Study to Evaluate the Pharmacokinetics of XXX Patch (XXX Transdermal Drug Delivery System) following 24-hr Application in Patients Diagnosed with Parkinson’s Disease
18 12 4 months 2012 Closed
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 CSF 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
13 7 1 month 2011 Closed
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
26 15 1 month 2010 Closed
www.clinicaltrialcenters.com
Phase IIa Sample Metrics
Study Title
# of Patients Screened
# of Patients Randomized
Length of Enrollment Year Status
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
57 41 5 months 2010 Closed
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 telemetry and holter monitoring)
134 98 7 months 2008 Closed
www.clinicaltrialcenters.com
Recruitment
Located within three large metropolitan areas, strategically situated to recruit from a very diverse ethnic population of over 15 million people (Los Angeles County – 9MM, Orange County – 3M, and Riverside/San Bernardino Counties – 3M). There are also several major universities and community colleges nearby for healthy normal volunteer recruitmentPartnered with PIs that are part of large psychiatric mental health facilities (serving 5,000 schizophrenia patients), group neurology practice of over 4,000 patients, and a 15 physician family practice with access to thousands of patients Extensive site and practice databases of over 40,000 subjects across a variety of therapeutic areas, established over 13+ years of clinical researchDedicated, 15+ recruitment specialists including field-based outreach staff with established community relationships that visit referring physicians, residential facilities and senior communities, provide free seminars, lunch and learns, distribute flyers and attend community eventsEstablished relationships with media buyers; discounted print and radio ad pricing and preferred placementsRecruitment plans tailored to each study, consistently meet or exceeds enrollment goals in a timely and efficient manner Ads contain number that directs callers straight to our internal call center staff of trained specialists who conduct prescreening over the phoneAbility to pre-qualify patients via IRB-approved pre-screen consent form
www.clinicaltrialcenters.com
Retention
Investigators treat research patients in their practices which promotes retention, and allows for ease in transition and follow upUnits designed specifically for research, with patient comfort and safety in mindPrivate rooms for caregiver accommodations as needed32” LCD flat screen TVs with cable in every room, and in lounge areasWireless internet for personal lab tops and community computers allows patients to keep in touchBoard games, and video systems for video games and movies (DVDs)Recreation 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 owned vans and town car service provides patient transportation to and from visits, including to and from the imaging facility, as neededDedicated staff for regular contact with patient and family
www.clinicaltrialcenters.com
Advantages
Swift start up – Central IRBCNS and healthy subject expertise – thought leaders 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:ACDSACRADAS-COGADCS-ADLADCS-CGIADFACSADMACQADRAIMSAISRS/ADHD RS-IVASEXBACSBAIBARSBASBDIBESBIS11BPI-SFBPRSBSSBVMTCAADID CAARS CADSS CAI
CANTABCBQCCTCDISCDRCDR-SOBCDRS-RCDSCDSSCFCGDSCGI-BP/I/S/SCA-SCIBICCIBIS-plusCOG STATECOWSCPRSCPTCRTTCSDDCSFQC-SSRSCVLTDADDCSQDEQDESS
DSDSISDSM-IV DiagnosisDSSTEDE-QEDSSEQ-5D 5L and 3L proxyESRSESSFAQFASTFCSRT-IRFIQFMSFOSQFrSBeGAFGASGBIGDSGo/ No Go TaskHADSHAM-AHAM-DHISHoehn & Yahr
HRUQHUIHVLTIADCQISIKBITKellgren-LawrenceKSQK-SADSLHIB-Q20LSEQMADRSMCCB (Matrics)MCQMGH ATRQMGH CPFQMINImMIDIMMSEMNSI Part bMoCAModified HachinskiMOS/ MOS-SSMSLT NABNC070
NDSNDTNINCDSNPINPSNPSINSANTBNTSS-6NYPRSPAC-QoLPANSSPDQPDSS-2PGAPGICPI NRSPOMSPPSQAPQASP-R CSAPSPPSQIPUTSPWCPWI
QIDS-16QL21, QL 98Q-LES-QQOL/ QOL-ADRAVLTRBANSRey Cpx FigureRoland-MorrisRSQ – D/WRUD-LiteRUSPRUQSANSSASSASSSBQ-RSCIDSCL-90SCOPASCoRSSDSSF-12SFISGI-CogSIBSIGH-DSIS
SLOFSOWSSQLMSRTTSTSSWNTMTP 1, 2 TrailsTNSn ScoringTooLTOVATSQMTSSRUPDRSUPSAVASWAIS/R/SWCSTWMSWOMACWoRQWPAIWRAADSWTARYBOCSYGTSSYMRS
Certified, experienced raters, including M.D., Ph.D. and M.A.-level
www.clinicaltrialcenters.com
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. – RaterSara Deering, Ph.D. – RaterThanh Ho, Ph.D. – RaterChristopher Webb, MA – RaterDenise Stephens, L.M.F.T. – Rater and Clinical DirectorDalia R. Botros, M.B.B.S. – Director of OperationsAnne Cabral, M.A. – Study Coordinator SupervisorGeraldine Lucas, RN, CCRC – Study CoordinatorHanna Voltattorni, B.S. – Study CoordinatorMarilou Dichoso – Study Coordinator
Additional investigators, raters, and coordinators CVs upon request
www.clinicaltrialcenters.com
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
Annie SpenoOperations Manager
www.clinicaltrialcenters.com
Contact Information
Bobbie TheodoreAlliance Director(916) 939-6696
clinicaltrials@btheodore.com
Annie SpenoOperations Manager
(916) 934-0569annie@btheodore.com
For Inquiries contact:
top related