Transcript Title of Presentation

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 (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 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+
25+
15+
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 – 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
# of
Cohorts Contracted
# of Cohorts
Enrolled
Length of
Enrollment
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
6 cohorts of 15
(90 patients
between the MAD
+ SAD studies,
below)
128
screened
90
enrolled (6
cohorts of
15)
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
Same as above
(both SAD and
MAD ran
simultaneously)
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
5 max per cohort,
20 patients
Year
Status
Less than
3 months
2014
RESCUE
SITE
(1 site)
Same as
above
Same as
above
2014
RESCUE
Same as
above
1
2 months
2014
Active –
multi-site
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Phase I Sample Metrics (cont'd)
# of
Cohorts Contracted
# of Cohorts
Enrolled
Length of
Enrollment
5 cohorts of 12 (60)
Screened 90,
enrolled 60
(5 cohorts of
12)
Phase I/II Randomized, Double-blind, Placebocontrolled, Sequential Dose Escalation Cohort
Study to Evaluate the Safety, Tolerability, and
Pharmacokinetics of XXX in Psychiatrically Stable
Schizophrenia Subjects – 2 weeks inpatient
5 cohorts of 8
A Phase I, Randomized, Double-blind, Placebocontrolled, 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)
Study Title
A Phase I, Prospective, Randomized, Doubleblind, 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
Year
Status
5 months
2013
2014
Active – 1
site
60 patients
screened, 40
enrolled (5
cohorts of 8)
3 months
2013
2014
Completed
– 1 site
20 patients
enrolled (2
cohorts of
10 each)
12 months
2012
2013
TOP
ENROLLING
SITE
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Phase I Sample Metrics (cont'd)
# 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
Study Title
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Phase I Sample Metrics (cont'd)
# 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
Study Title
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Phase IIa Sample Metrics
# 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, Placebocontrolled, 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
Study Title
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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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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
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]
www.clinicaltrialcenters.com