Transcript Title of Presentation - Clinical Trial Centers Alliance

Collaborative Neuroscience
Network, LLC.
CLINICAL PHARMACOLOGY UNIT
2600 Redondo Avenue, Suite 500
Long Beach, CA 90806
Presented October 2013
Bobbie Theodore
Alliance 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 unit
25,000 sq ft facility dedicated and designed specifically for early phase clinical research
50+ beds in the phase I unit for healthy normal subjects, and for 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
www.clinicaltrialcenters.com
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 including licensed ACLS
certified nurse’s (RNs, LVNs) on all shifts
Director of nursing, charge nurse and director
of social services
Multiple dedicated 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
Daily meals provided by caterer, and dietician for special meals or protocol mandated
dietary requests
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Therapeutic Areas
Therapeutic Areas
Psychiatric 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 IBS
Bioequivalence and biosimilar studies
Asian bridging
www.clinicaltrialcenters.com
Experience and Capabilities
Experience and Capabilities
Healthy 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 experience
FIM experience in patient populations – Alzheimer’s, and schizophrenia
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
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
As 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 catheters
IV infusion, intravenous, injection, oral, device, and transdermal patch delivery system methods
www.clinicaltrialcenters.com
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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Clinical Trial Experience
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 - anxiety, PTSD, chemical dependency
Neurology: 50+ studies, inpatient and outpatient, broad range of indications
25+
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
Healthy Normal: (Dr. Mark Leibowitz)
70+ Healthy Normal (adult and elderly subjects)
40+ FIM (first in man)
200+ Bioequivalence
15+ Japanese bridging
General Medical
10+ Type 2 diabetes, NOH, hypercholesterolemia, OIC, IBS, asthma, crohn’s
www.clinicaltrialcenters.com
Early Phase Trial Experience
Phase I: (includes Dr. Mark Leibowitz’ trial experience)
70+ healthy normal subjects, 40+ FIM, 200+ bioequivalence and ethno-bridging
50+ 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 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)
www.clinicaltrialcenters.com
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
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, 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
www.clinicaltrialcenters.com
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
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 of telemetry and holter monitoring)
134
98
7 months
2008
Closed
Study Title
www.clinicaltrialcenters.com
Recruitment
LA/Orange County catchment area 16M
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
Recruitment 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 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 that field incoming calls and conduct
prescreening over the phone
Ability to pre-qualify patients via IRB-approved prescreen consent form
www.clinicaltrialcenters.com
Retention
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 owns vans and contracts with town car service to
provide patient transportation to and from visits, including
to and from the imaging facility, as needed
Dedicated staff for regular contact with patient and family
Some investigators treat the research patients in their
practice which promotes retention, and allows for ease in
transition and follow up
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Site 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
ADR
ADMACQ
AIMS
AISRS/ADHD RS-IV
ASEX
BACS
BAI
BARS
BAS
BDI
BPI-SF
BPRS
BSS
BVMT
CAADID
CAARS
CAI
CANTAB
CADSS
CBQ
CCT
CDIS
CDR/CDR-SOB
CDRS-R
CDSS
CF
CGDS
CGI-BP/I/S/SCA-S
CIBIC
CIBIS-plus
COG STATE
COWS
CPRS
CPT
CRTT
CSDD
C-SSRS
DAD
DCSQ
DESS
DS
DSIS
DSM-IV Diagnosis
DSST
EQ-5D 5L and 3L proxy
ESRS
ESS
FAQ
FAST
FCSRT-IR
FIQ
FMS
FOSQ
FTND
GAF
GAS
GBI
GDS
Go/ No Go Task
HAM-A
HAM-D
HIS
Hoehn & Yahr
HRUQ
HUI
HVLT
IADCQ
ISI
KBIT
K-SADS
LSEQ
MADRS
MATRICS
MCCB (Matrics)
MGH ATRQ
MINI
mMIDI
MMSE
MNSI Part b
MoCA
MOS
MOS-SS
MSLT
NAB
NC070
NDS
Certified, experienced raters, including M.D., Ph.D. and M.A.-level
NDT
NINCDS
NPI
NPS
NRS
NSA
NTB
NTSS-6
NYPRS
PAC-QoL
PANSS
PDQ
PGA
PINRS
POMS
PPSQA
PQAS
P-R CSA
PSP
PSQI
PUTS
PWI
PWC
QIDS-16
QL21, QL 98
Q-LES-Q
QOL
QOL-AD
RAVLT
RSQ – D/W
RUD-Lite
RUSP
RUQ
SANS
SAS
SASS
SBQ-R
SCID
SCL-90
SCOPA
SCoRS
SDS
SIB
SIGH-D
SLOF
SOWS
SQLM
SRTT
STS
SWN
TMTP 1, 2
Trails
TSQM
TSSR
UPDRS
VAS
WCST
WMS
WOMAC
WPAI
WRAADS
WTAR
UPSA
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
Melissa Huy, Ph.D. – Rater
Thanh Ho, Ph.D. – Rater
Denise Stephens, L.M.F.T. – Rater
Dalia R. Botros, M.B.B.S. – Director of Operations
Anne Cabral, M.A. – Senior Study Coordinator
Geraldine Lucas, RN, CCRC – Study Coordinator
Minie Del Rosario Mercado, L.V.N. – Study Coordinator
Additional investigators, raters, and coordinators CVs upon request
www.clinicaltrialcenters.com
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 .
www.clinicaltrialcenters.com
CNS Network Clinical Pharmacology Unit Floor Plan
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