Transcript Title of Presentation - Clinical Trial Centers Alliance

CNS, LLC
CLINICAL PHARMACOLOGY UNIT
2600 Redondo Avenue, Suite 500
Long Beach, CA 90806
Bobbie Theodore
Alliance Director
[email protected]
www.clinicaltrialcenters.com
State-of-the-Art
Clinical Pharmacology Unit
Facility
80 bed facility dedicated and designed specifically for early phase clinical research
60+ beds in the phase I unit for healthy normal subjects, 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
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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 vast 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 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 subjects (HNS)
FIM in patient populations – Alzheimer’s, and schizophrenia
SAD/MAD, 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
Imaging, 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
CSF collection, as of May 2013, CNSN has conducted 15+ trials with CSF sampling
CSF sampling conducted by Neurologists 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
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Therapeutic Areas
Psychiatric special patient populations - Addictions (smoking cessation, alcohol
dependence, eating disorders, opioid dependence), bipolar disorders, cognitive
dysfunction, MCI, depression, schizophrenia
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 IBS
Bioequivalence and biosimilar
Asian 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 (1st 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 subjects, 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
Cognition dysfunction in schizophrenia, depression, MCI and Alzheimer’s
CANTAB administered over 300+ times in 3 yrs (additional rating scale experience
on slide 15)
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Phase II – III Trials
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 – ADHD, anxiety, PTSD, chemical dependency
Neurology: 50+ studies, inpatient and outpatient, broad range of indications
30+
25+
10+
8+
8+
5+
Alzheimer’s - MCI, mild-to-moderate, severe
Pain studies - migraine, diabetic neuropathy, OA, chronic back/knee pain, fibromyalgia
Parkinson’s trials - early stage and advanced
Epilepsy - adjunctive therapy and monotherapy
MS – relapsing remitting
Sleep disorders studies – 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
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Phase I Sample Metrics
# 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 – 3 days/2 overnights
1:5
36 pts
(3 cohorts),
approved add’l 2
cohorts of 12
3 cohorts
randomized &
completed
thus far
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, SponsorOpen, 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
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
Study Title
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Phase I Sample Metrics (cont'd)
# of Patients
Screened
# of Patients
Randomized
Length of
Enrollment
Year
Status
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
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
Study Title
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Phase IIa Sample Metrics
# of Patients
Screened
# of Patients
Randomized
Length of
Enrollment
Cohorts
Ongoing
1st cohort
fully
enrolled
2nd cohort
enrolling
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
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)
Study Title
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
Year
Status
Sponsor
approved
add’l cohorts
2013
Active
10
1 month
2010
RESCUE
SITE
57
41
5 months
2010
Closed
134
98
7 months
2008
Closed
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Recruitment
16M LA/Orange County catchment area
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
Established relationships in the community; 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
Internal Call Center
Ads contain number that directs callers straight to our
recruitment department call center staff who are
trained specialists who conduct prescreening over the
phone
Ability to pre-qualify patients via IRB-approved prescreen 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” 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 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 – 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
www.clinicaltrialcenters.com
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
Certified, experienced raters, including M.D., Ph.D. and M.A.-level
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 Trails
TNSn Scoring
TooL
TOVA
TSQM
TSSR
UPDRS
UPSA
VAS
WAIS/R/S
WCST
WMS
WOMAC
WoRQ
WPAI
WRAADS
WTAR
YBOCS
YGTSS
YMRS
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
Annie Speno
Bobbie Theodore
Operations
Manager
Alliance Director
[email protected]
(866) 669-0234
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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Clinical Pharmacology Unit Floor Plan
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