wcct general presentation short

8/3/2019 WCCT General Presentation Short

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West CoastWest CoastClinical Trials, LLCClinical Trials, LLC

West Coast Clinical Trials considers the material contained in this presentation to be confidential and

proprietary information to WCCT and provides it to a client for its sole use. Access to this presentationshould be restricted exclusively to authorized individuals.All documents are property of WCCT.

CapabilitiesCapabilitiesPresentationPresentation


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Early-Phase Industry TrendsInnovative Phase I Trial DesignsAccelerating Global DrugDevelopmentWCCT Background and CapabilitiesQ&A

AgendaAgenda


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Incorporation of biomarkers andPOC PD measurements into PhaseI trialsInclusion of Asian sub-populationsearly in clinical development

Requirement of PediatricInvestigational Plan (PIP) by EMEA

E arlyE arly- -Phase IndustryPhase Industry

TrendsTrends


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Ex ample #1:Ex ample #1:

3E

ndpoints in One Study!3E

ndpoints in One Study!

32 glaucomapatients

24Caucasian

Dose level 1 Dose level 2


8 Japanese



Crossover

Data on 3 endpoints:E thnic data (Japanese vs. Caucasian)PK data in all patients, at all dose levelsIOP data in all patients, at all dose levels

Plus the traditional Safety data


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Combining NHV and PatientCombining NHV and PatientPopulationsPopulationsNHV Dose

level 1NHV Dose

level 2NHV Dose

level 3NHV Dose

level 4

AsthmaDose level 3

AsthmaDose level 1

AsthmaDose level 2

Design:Dose escalation of Asthma group to occur only if Safety and PK data OK from:

NHV group at higher dose levelAsthma group at preceding dose level


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Combining NHV andE

thnicCombining NHV andE

thnicPopulationsPopulationsCaucasian

Dose level 1Caucasian



Dose level 4

JapaneseDose level 4




Design:E thnic arms dosed with Caucasians at subsequent

dose levelsCan incorporate Chinese and Korean ethnic arms

along with Japanese and Caucasian


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Accelerating GlobalAccelerating GlobalDrug DevelopmentDrug Development


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F irst in Human

SAD

MAD

U.S. Japan

Phase II

Phase III

NDA in Japan

Phase II

Phase III

NDA in theU.S.

IND in the U.S.

F irst in Human

SAD

MAD

IND in Japan

The Traditional ModelThe Traditional Model


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Ex ample of AcceleratingEx ample of AcceleratingJapanese Drug DevelopmentJapanese Drug Development

F irst in Human

SAD

MAD

Japanese Bridging

U.S. Japan

Phase IIa

Phase III

NDA in Japan

Phase IIa

Phase III

NDA in theU.S.

IND in the U.S.W e s t C o a s t C l i ni c al

T r i al s

( a s a on e s t o p sh o pf or P h a s eI

s t u d i e s )

F irst in Human

SAD

MAD

Skip Phase I Studies in Japan(1) Cost down(2) Shorten timeline to NDA


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F IH

SAD

MAD

Chinese/Japanese/KoreanBridging Study

U.S. Japan, Korea, Taiwan

Phase II in Japan, Korea, andTaiwan

Phase I inChina

NDA inJapan

Phase II

Global Phase III(1) include Chinese, Japanese, Korean, and Taiwanese patients in the strategy

NDA in the U.S. & Europe

IND in theU.S.W e s t

C o a s t C l i ni c al

T r i al s

Skip Phase I Studies in Japan, Korea, andTaiwan

(1) Cost down(2) Shorten timeline to NDA in Japan, Korea

and Taiwan

NDA in China

Include Chinese NDA inyour global strategywithout delay

( After negotiation with SFDA,it is possible toconcurrently conduct arequired Chinese Phase

I and Global Phase IIIstudy in China)

China

NDA inKorea

NDA inTaiwan

IND in Japan, Korea, and Taiwan

Japanese PMDA accepts a NDA as long as

approximately15% of entire patient population in theglobal study is Asian (Chinese, Japanese,

Korean, and Taiwanese).

Simultaneous GlobalSimultaneous GlobalDrug DevelopmentDrug Development


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WCCT Background &

WCCT Background & CapabilitiesCapabilities


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W CCT LocationsW CCT Locations

2 facilities:Cypress, CA

Costa Mesa, CA


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Cypress, CA 1 20 Beds


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Costa Mesa, CA 3 0+ Beds



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Phase I UnitsPhase I Units


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Phase I UnitsPhase I Units


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Full-service drug developmentsupport15 0+ beds located in two facilities

Worked with 15 out of the top 20 Pharma companies3, 000+ unique clinical research

trials performedExecutive management team > 6 0 yrs combined experience

W CCT BackgroundW CCT Background


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Study BreakdownStudy Breakdown

4 0 -6 0 Studies per Year5 0% in NHVs

o FIHo PK/PDo Etc..

2 5 % in Asian Bridging2 5 % in Special Populations


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Special CapabilitiesSpecial CapabilitiesTQTHolter Monitoring and TelemetryPulmonary Function TestsPlatelet Aggregometers

Methacholine ChallengesBronchoscopyNitric OxideOphthalmology capabilities

Imaging CenterCSF collection and samplingRenal dialysis on siteComplete glucose monitoring


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Special CapabilitySpecial Capability- - TQTTQT


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WCCT Combined Staff and MDExperience:6 2 TQT Studies>1 00 Serial ECG studies

Experience and Partnerships with thefollowing core labs/vendors:

BMSeRTCardiocoreMediFacts InternationalDuke UniversityiCardiacQTino


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ADVANTAGES OF EXPERIENCE:

Experienced Physicians, Coordinators& ECG Technicians

Dedicated data transfer lines

Specific TQT SOPs and WorkInstructions

Sufficient capacity for largegroups in QTc study


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4 -Full-time Physician Investigators5-Part-time Physician Investigators4 -Full-time Pharmacy staff led byPharmD4 -Project Managers

17-Full-time Study Coordinators

18 0 FTE Research Assistants,Technicians, Lab staff, RN/LVNs

Clinical TeamClinical Team


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R ecruitment TeamR ecruitment Team

1 2 -Full-time, bi-lingual recruitersDatabase of 44 , 000+ potentialsubjects


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Successfully Completed Studies

In The Following IndicationsAsthmaRenalOphthalmology

AdvantagesCentralized Dosing and PK at OnePhase I Unit (WCCT)Accelerated Enrollment Timelines

through the Use of MultipleInvestigators

E arly Clinical DevelopmentE arly Clinical DevelopmentHybrid ModelHybrid Model


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Thank YouThank You

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