Transcript Title of Presentation - Clinical Trial Centers
CNS, LLC CLINICAL PHARMACOLOGY UNIT 2600 Redondo Avenue, Suite 500 Long Beach, CA 90806
Bobbie Theodore
Alliance Director
[email protected]
Annie Speno
Operations Manager
[email protected]
www.clinicaltrialcenters.com
State-of-the-Art Clinical Pharmacology Unit
Facility
60+ bed flexible capacity CPU dedicated and designed specifically for early phase clinical research for stable psychiatric, CNS, targeted healthy normal volunteers, medical and ethno-bridging special patient population trials Additional 20 beds in separate PHF unit (Psychiatric Health Facility) licensed by the state of California for acute psychiatric patient population trials Private and semi-private rooms for double occupancy to accommodate caregiver or significant other 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
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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 comprehensive cognitive rating scales experience 24 hour staffing includes licensed ACLS certified nurse’s (RNs, LVNs) on all shifts Director of nursing, charge nurse and director of social services Multiple dedicated early phase 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 conducts internal audits Caterer provides daily meals, and dietician for special meals or protocol mandated dietary requests
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Experience
Healthy normal volunteers (HNV), adult and elderly Psychiatric, neurological, pain and medical patient populations including FIM Alzheimer's, schizophrenia and MS SAD/MAD, single, and multiple dose escalation TQT, Qtc, single and continuous ECG Telemetry, holter and ambulatory cardiac monitoring EEG/qEEG, evoked potentials Drug-drug interaction (DDI), food effect, fed and fasted Serial PK, 24 to 36 hour draws, on the hour and or ½ hour Imaging, fMRI , 1.5 and 3T, Arterial Spin Labeling (ASL), and PET imaging CSF 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 designs Large cohorts, and competitive enrollments with high retention rates Up to 8 week inpatient stays with high retention rates Delivery system methods – oral, IV infusion, intravenous, injectable, device, patch Bioequivalence
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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 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 IBS
Bioequivalence and biosimilar Ethno-bridging
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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 24-48 hours
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Phase I Trials
Phase I:
(includes Dr. Mark Leibowitz’ trial experience)
70+ healthy normal subject trials, 40+ FIM, 200+ bioequivalence and ethno-bridging 50+ patient populations – Alzheimer’s, depression, diabetes, epilepsy, gastrointestinal disorders, hypertension, insomnia, migraine, multiple sclerosis, obesity, Parkinson’s, and schizophrenia
Cognition:
20+ targeting cognitive primary endpoints
Cognitive dysfunction in schizophrenia, depression, MCI and Alzheimer’s CANTAB administered over 300+ times in 3 yrs (additional rating scale experience on slide 18)
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Phase II – III Trials
Psychiatry: 300+ 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 – ADHD, anxiety, PTSD, chemical dependency Neurology: 80+ studies, inpatient and outpatient, broad range of indications 30+ Alzheimer’s - MCI, mild-to-moderate, severe 25+ Pain studies - migraine, diabetic neuropathy, OA, chronic back/knee pain, fibromyalgia 15+ 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+ Bioequivalence 15+ Japanese bridging
General Medical:
10+ across broad range of indications – type 2 diabetes, NOH, hypercholesterolemia, OIC, IBS, asthma, crohn’s, women’s health
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Phase I Sample Metrics
Study Title
A 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
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
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
# of Cohorts Contracted
6 cohorts of 15 (90 patients between the MAD + SAD studies, below) Same as above (both SAD and MAD ran simultaneously)
# of Cohorts Enrolled
128 screened 90 enrolled (6 cohorts of 15) Same as above 5 max per cohort, 20 patients 1
Length of Enrollment
Less than 3 months Same as above 2 months
Year
2014 2014 2014
Status
RESCUE SITE (1 site) RESCUE Same as above Active – multi-site
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Phase I Sample Metrics (
cont'd
)
Study Title
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
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
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 # of Cohorts Contracted
5 cohorts of 12 (60) 5 cohorts of 8 1 (5 patients)
# of Cohorts Enrolled
Screened 90, enrolled 60 (5 cohorts of 12)
Length of Enrollment
5 months 60 patients screened, 40 enrolled (5 cohorts of 8) 20 patients enrolled (2 cohorts of 10 each) 3 months 12 months
Year
2013 2014 2013 2014
Status
Active – 1 site Completed – 1 site 2012 2013 TOP ENROLLING SITE
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Phase I Sample Metrics (cont'd)
Study Title
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 A Phase I, Open-label, Multiple Dose, Safety and Tolerability Study of XXX Administered in the Deltoid Muscle in Adult Subjects with
Schizophrenia
A Phase I, Evaluation of the Effects of Sequential Multiple-dose Regimens of XXX on Cardiac Repolarization in Patients with
Schizophrenia
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
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 # of Patients Screened
57 40 58 22 46 18
# of Patients Randomized
41
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28 30 15 30 12
Length of Enrollment
5 months
Year
2014
Status
Active 1 month 6 months 3 weeks 3 months 4 months 2013 Active 2012 Closed 2012 Closed 2012 Closed 2012 Closed
Phase I Sample Metrics (
cont'd
)
Study Title
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, 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
# of Patients Screened
62 54 34
# of Patients Randomized
40 20 (SFs due to pts not having a migraine in req’d window) 25 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
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 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) 18 11 12 7 7
Length of Enrollment
8 months 8 months 1 month 4 months 4 months 1 month 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 13 26
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15 1 month
Year
2012 2012 2012 2012 2011 2011 2010
Status
Closed TOP ENROLLING SITE Closed Closed RESCUE SITE Closed Closed
Phase IIa Sample Metrics
Study Title
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 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 telemetry and holter monitoring)
# of Patients Screened
11
# of Patients Randomized
10
Length of Enrollment
1 month
Year
2010
Status
RESCUE SITE 57 134 41 98 5 months 7 months 2010 Closed 2008 Closed
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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 recruitment Partnered 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 research Dedicated, 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 events Established relationships with media buyers; discounted print and radio ad pricing and preferred placements Recruitment 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 phone Ability to pre-qualify patients via IRB-approved pre-screen consent form
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Retention
Investigators treat research patients in their practices which promotes retention, and allows for ease in transition and follow up Units designed specifically for research, with patient comfort and safety in mind Private rooms for caregiver accommodations as needed 32” LCD flat screen TVs with cable in every room, and in lounge areas Wireless internet for personal lab tops and community computers allows patients to keep in touch Board games, and video systems for video games and movies (DVDs) 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 owned vans and town car service provides patient transportation to and from visits, including to and from the imaging facility, as needed Dedicated staff for regular contact with patient and family
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Advantages Swift start up – Central IRB CNS and healthy subject expertise – thought leaders 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
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Testimonials
Phase I Schizophrenia Study Sponsor
We have been extremely pleased with Dr. [David] Walling’s [CNS] sites performance as a “rescue” site for our phase I schizophrenia study. We will use you again for any new early phase opportunities we have.
Phase I Schizophrenia Study Sponsor
Both [ Dr. David Walling ] [CNS] site and the CRO have done topnotch work and we’re very pleased.
Phase I Schizophrenia Study CRO
From your [ Dr. David Walling ][CNS] presentation at the bid defense meeting I could tell you are a cohesive, well organized and efficient team but I did not realize to this extent!! Your turnaround time on the ICF and IRB submission is amazing!
Phase I Alzheimer’s Study CRO
We could not have achieved this important milestone without your [ when we say we could not have done this without you!
Dr. Omidvar and CNS Phase I Unit and dedication to have completed all of this while enrolling patients, entering new data and working with your monitor at monitoring visits and through remote source verification. We state the obvious ] tireless efforts to reconcile data, resolve queries and approve eCRF pages. It is a testament to your skills
Phase I Multiple Sclerosis Study Sponsor
Dr. [Nirav] Patel’s [CNS] site has been nothing short of great and we’re really happy with them. They’ve been one of our “go to” sites thus far so I’m very pleased. Dr. Patel was one of our best enrollers and a great site to work with.
Phase I Migraine Study Sponsor
Dear Dr. [Omid] Omidvar [CNS], We were happy with your site and your recruitment was the best among all the sites for this study. It was a pleasure working with your group on this study. We will definitely consider you for our future studies.
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Rating Scale Experience:
ACDS ACR ADAS-COG ADCS-ADL ADCS-CGI ADFACS ADMACQ ADR AIMS AISRS/ADHD RS-IV ASEX BACS BAI BARS BAS BDI BES BIS11 BPI-SF BPRS BSS BVMT CAADID CAARS CADSS CAI CANTAB CBQ CCT CDIS CDR CDR-SOB CDRS-R CDS CDSS CF CGDS CGI-BP/I/S/SCA-S CIBIC CIBIS-plus COG STATE COWS CPRS CPT CRTT CSDD CSFQ C-SSRS CVLT DAD DCSQ DEQ DESS DS DSIS DSM-IV Diagnosis DSST EDE-Q EDSS EQ-5D 5L and 3L proxy ESRS ESS FAQ FAST FCSRT-IR FIQ FMS FOSQ FrSBe GAF GAS GBI GDS Go/ No Go Task HADS HAM-A HAM-D HIS Hoehn & Yahr HRUQ HUI HVLT IADCQ ISI KBIT Kellgren-Lawrence KSQ K-SADS LHIB-Q20 LSEQ MADRS MCCB (Matrics) MCQ MGH ATRQ MGH CPFQ MINI mMIDI MMSE MNSI Part b MoCA Modified Hachinski MOS/ MOS-SS MSLT NAB NC070 NDS NDT NINCDS NPI NPS NPSI NSA NTB NTSS-6 NYPRS PAC-QoL PANSS PDQ PDSS-2 PGA PGIC PI NRS POMS PPSQA PQAS P-R CSA PSP PSQI PUTS PWC PWI QIDS-16 QL21, QL 98 Q-LES-Q QOL/ QOL-AD RAVLT RBANS Rey Cpx Figure Roland-Morris RSQ – D/W RUD-Lite RUSP RUQ SANS SAS SASS SBQ-R SCID SCL-90 SCOPA SCoRS SDS SF-12 SFI SGI-Cog SIB SIGH-D SIS SLOF SOWS SQLM SRTT STS SWN TMTP 1, 2 TNSn Scoring TooL TOVA TSQM TSSR UPDRS UPSA VAS WAIS/R/S WCST WMS WOMAC WoRQ WPAI WRAADS WTAR YBOCS YGTSS YMRS Trails
Certified, experienced raters, including M.D., Ph.D. and M.A.-level
Curriculum Vitae
Click on names to view CVs:
David P. Walling, Ph.D. – CEO and PI Mark Leibowitz, M.D.
- 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 Seanglong Te, M.D.
– Sub-I Kim Lorine, Ph.D
. – Rater Sara Deering, Ph.D.
– Rater Thanh Ho, Ph.D.
– Rater Christopher Webb, MA – Rater Denise Stephens, L.M.F.T. – Rater and Clinical Director Dalia R. Botros, M.B.B.S. – Director of Operations Anne Cabral, M.A. – Study Coordinator Supervisor Geraldine Lucas, RN, CCRC – Study Coordinator Hanna Voltattorni, B.S. – Study Coordinator Marilou Dichoso – Study Coordinator
Additional investigators, raters, and coordinators CVs upon request
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Sponsor Relations Team
Jeanette Caruso Finance Manager Bobbie Theodore Alliance Director Annie Speno Operations Manager 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.
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Contact Information
For Inquiries contact: Bobbie Theodore Alliance Director (916) 939-6696 [email protected]
Annie Speno Operations Manager (916) 934-0569 [email protected]