a global cro - lambda cro, contract research...
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aGlobalCROaGlobalCRO
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OURJOURNEY Acquired one of the oldest CRO in Canada for Early Phase Trials Established collaboration with Government Pharmaceutical
Organization (GPO), in Thailand Established Medical Writing / Medical Imaging services Started Panomics for Large molecule assay capabilities Lambda clinical operations go paperless by extending EDC globally
20112016
InitiatedLatephasestudies Started Clinical Lab (CAP)StartedClinicalLab(CAP) LaunchofMumbaiOperations
AcquiredCROinLondon,UKforPVservices AcquiredCROinWarsaw,PolandforLatePhaseTrials Cleared USFDA ANVISA DCGI etc inspections for BA/BE
2000200520062010
ClearedUS FDA,ANVISA,DCGIetcinspectionsforBA/BE&CTstudies
ExpansionofAhmedabadfacilitywithacapacityof360bedsandadedicated16beddedforPhase1
Awarded Best Indian CRO in 2010 by Frost & Sullivan
IncorporatedinAhmedabad,Gujarat,I di
AwardedBest IndianCRO in2010byFrost&Sullivan,US
1999
India InitiatedBA/BE&Bioanalyticalservices
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GEOGRAPHICALPRESENCE
Warsaw,Poland2007
Ahmedabad,India1999
London,UK2008
Mumbai,India2003
Toronto,Canada2010
Istanbul Turkey
NewDelhi,India2009
Hyderabad IndiaIstanbul,Turkey2011
Bangkok,Thailand
Hyderabad,India2009
2011
OperationalCapabilities:Asia Pacific Europe Other GeographiesAsia Pacific Europe OtherGeographies
IndiaSriLankaThailand
l d h
UK, Germany FranceSpain Turkey PolandEstonia Belarus CzechRepublick h
North AmericaLatin AmericaCIS Countries
hBangladesh Ukraine Romani LatviaLithuaniaBulgaria
South East Asia
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EXECUTIVESUMMARY:LAMBDA
IndianCROwithatrueglobalpresence BestCROofratingAAin
longtermandhighestpossible in short term A1+
StrongandstableLeadershipteamwith>20years of industry
EndtoendserviceofferingscoveringentirespectrumofclinicalresearchfromPhaseItoIV
possibleinshorttermA1+ inCARE
CompanygrowingwithaCAGRof~20%p.aYoY.
yearsofindustryexperience
Multicontinentalpresence:
Impeccableregulatorytrackrecord
GlobalRevenuesof$USD50million duringlastFYandgrowing....
NorthAmerica
Europe
Frontrunner:inMedicalImaging&Panomics
RobustDigitalplatforms
Asia
700+employeesglobally
C stomi able & scalableg p
acrossserviceverticals Customizable&scalablebusinessmodels
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LAMBDALOCATIONS
W P l dAhmedabad,India Warsaw,Poland
Toronto,Canada London,UK
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LAMBDAHOUSE AHMEDABAD
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REGULATORYINSPECTIONS
USFDA[37]NGCMA[01]HEALTHCANADA[02]
IGZ[02]WHO[02]POLISH[04]ANSM[02]
AGES[01]SCC[03]
[ ]
FAMHP[02] TURKEYMOH[01]EMA[01] BFARM[01]
CDSCO[15]
ThaiMOH[04] CAP[07]
NABL[04]OGYI[01]ANVISA[08]AIFA[01]
UKMHRA[10]
MHSD[01]
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SERVICEPORTFOLIO
Phase1(FirstinMan)Pharmacovigilance
Bioavailability&BioequivalenceMedicalImaging Bioequivalenceg g
BioanalyticalCentral
Laboratory
PanomicsMedicalWriting
Late Phase Clinical TrialsData Services
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LatePhaseClinicalTrials(PhaseIIIV)
DataServices(BSP,CDM)
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PHASE1:ATGLANCE
Dedicated phase1 unit in India (16 bedded) and Canada (12bedded)
Strong leadership with expertise in handling studies like:
Single Ascending Dose (SAD) First in Mang g
Multiple Ascending Dose (MAD)
PK Studies
Drug Drug Interaction
Food Effect Studies
PK /PD studies
Executed over 25 phaseI studies in the last 5 years for various formulations includingOral, Parenteral, Inhalers etc
D l d Ski V i d bili i f i l id
9To be continued...
Developed Skin Vasoconstrictor study capabilities for topical steroids
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VALUEPROPOSITION:PHASE1
FiH Or SAD study in Canada
Faster regulatory approval: ~35 days
Canada
Faster regulatory approval: ~35 days
Parallel submission for MAD study in India
Study start with healthy subjects followed by patientcohortscohorts
India
Cost effective option for subsequent Phase 1 studies Easier Access for Renal and Liver impaired subjects study Naive patient pool, qualified medical doctors and hospitali f t tinfrastructure
ValueProposition Cost Effective business model (Hybrid) Faster turn around time Global scientific overview
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Flexible Operational approach
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PHASEICAPABILITIES:INDIA&CANADA
DedicatedstateoftheartICUs
CentralCardiacMonitoringSystem
CardiacTelemetry/Holters /IVInfusionPumps
Xray,Ultrasoundfacilities
TETstudies
GEMUSEsystemforECGprocessingandmanagementy p g g
GEApexProTelemetrySystem/DASH4000CardiacMonitors
MultilevelECGreadingbyCardiologists
InternetaccesstoECGdatathrough ECGwebportal
PulmonaryFunctionTesting(PFT)
Cognitivetesting(CDR)
Gastroesophageal monitoring
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GLOBALCLINICALBEDCAPACITY
Sr.No Country City No.ofBeds No.ofPhase1Beds No.ofICUBedsNo
1 IndiaAhmedabad 360 16 8
Mumbai 66 2Mumbai 66 2
2 Canada Toronto 128 12
Total number of beds 554 28 10
Lambdascurrenttotalbedcapacityis592 bedsglobally
Totalnumberofbeds 554 28 10
p y g y
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GLOBALVOLUNTEERDATABASE
Population Ahmedabad Mumbai Torontop
HealthyMale 50,700 8,500 60,000
Healthy Female with childbearing potential 4 380 300 30 000HealthyFemalewithchildbearing potential 4,380 300 30,000
PM&SurgicallySterileWomen 2,295 300 2,200
Eld l 1 255 50 3 500
Patient Populations:
Elderly 1,255 50 3,500
PatientPopulations:
Hypertensive Fast/Slowmetabolizers
Schizophrenic Obese Diabetic Migraine Cancer HepaticimpairedPatientsR l
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Renal
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BIOAVAILABILITY/BIOEQUIVALENCESTUDIES
FormulationsExperience: OralDosageForms:
TabletsandCapsules
Suspensions
BuccalBuccal
Sublingual
Lozenges
Injectables:IV,IM,SC
Inhalers
Nasalsprays
Suppositories
Transdermal patches
Ointments & CreamsOintments&Creams
Intravaginal tabs
L bd h d t d 5000 BE t di till d t l b llLambdahasconductedover5000BEstudiestilldateglobally
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BIOANALYTICAL:INDIA&CANADACapabilities Scientists with 10 + years of experience
Capacity to analyse 75 000 + samples / month Capacity to analyse 75,000 + samples / month
800+ validated methods ( incl. methods as low as 0.5 pg/mL)
Approx 810 new methods in development every month.
Expertise to develop sensitive methods for NCEs in different species like Rat, Mice, Dog andMonkey using low sample volume
Robust system for failure investigationy g
GLP certified Bioanalytical lab in India and Canada.
SampleStorage Controlled and monitored low temperature storage (225C,6510C)
Capacity to store 3 million samples
InfrastructureInfrastructureCountry LCMS/MS FTIR*
India 34 3
Canada 08
*FourierTransformInfraredSpectroscopy
Total 42 3
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BIOANALYTICALLAB
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PANOMICSSERVICESFORCLINICALRESEARCH
DNA RNA E t ti T t DNA & iRNA A l i M l lGENOMICS
DNA, RNA Extractions, Target DNA & miRNA Analysis, MolecularDiagnosis of Bacteria and Viruses
SDS PAGE Analysis, Western Blotting, Peptide Mapping, ProteinPROTEOMICS
y , g, p pp g,Characterization, Biosimilars, Targeted Proteomics, etc
Global Metabolite Profiling, Targeted and Untargeted Metabolitei h C i A l i
METABOLOMICS
Detection, Pathway Centric Analysis
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PANOMICSSERVICES 0.52 5.51 7.984.72 5.92
6.12 7.393.75
4.16
3.11 9.82
2.182.591.749.12ProteinCharacterizationStudies&BiosimilarsAnalysis
0.
Global Proteomics Profiling: Protein identifications, & Validation
Intact Protein and Peptide Mapping Analysis Innovator and CompetitorTherapeutic Monoclonal Antibody Drug Candidates
Pharmacokinetics Based Studies: FSH and PTH Studies Ongoing
Global and Targeted Metabolite Profiles: Biological Fluids including; Urine,Serum & Invitro Based Studies
Molecular Biology and Genomics Profiling
Genomics Based Studies: DNA , RNA extractions, miRNA analysis
Pharmacogenomics Studies: Profiling for Potential Responders
RTPCR Validation Studies: Serum and Tissue Samples, Biomarkers
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CLINICALTRIALEXPERIENCE
Carriedoutmorethan50multicentrictrialsacrossdifferentgeographies
Enrolled8000+patientsinlast7yearsinvarioustherapeuticcategories
TeamwithexpertiseinmanagingMultiCountryTrials
TherapeuticArea Studies Patients Sites
33 3028 353
1 1944 48
2 720 59
9 610 58
3 766 49
1 120 8
2 887 51
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THERAPEUTIC/EFFICACYSTUDIESINONCOLOGY
Sr.No. Indication #Studies #Sites Regulatory #Patients
1 CNSTumor 4 46 USFDA,EMEA 184
2 ALL 1 6 HealthCANADA 10
3 CML 2 22 USFDA,EMEA 152
4 MBC 10 94 DCGI,USFDA,EMEA,ANVISA,EMEA 708
5 MCC* 6 62 USFDA,EMEA,ANVISA,EMEA 482
6 Pancreatic# 4 32 USFDA,EMEA 221
7 SolidTumor 1 4 DCGI 32
8 NSCLC 1 24 DCGI 129
Note:*IncludesMBCpatients.#IncludesOvariancancerpatients.
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OTHERTHERAPEUTIC/EFFICACYSTUDIES
TherapeuticCategory Patients Sites Regulatory Countries
G t t l 1016 74 EMEA USFDA I di EU S i L kGastroenterology 1016 74 EMEA,USFDA India,EU,SriLanka
Cardiology 3653 62 EMEA Europe
U l 24 1 EMEA EUrology 24 1 EMEA Europe
Endocrinology 235 40 EMEA Europe
l l & dPulmonology 791 57 EMEA Europe&India
Diabetology 316 55 EMEA Europe
Dermatology 852 30 EMEA,USFDA India&Poland
Musculoskeletal 1944 48 EMEA,USFDA India
Others 1923 10 EMEA Europe
Total 10,754 377
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PATIENTBASEDPHARMACOKINETICSTUDIES
Indication/Therapy Studies Patients Sites Submissions
Schizophrenia 9 610 58 5FDA,2EMEA,2DCGI
MalignantGlioma 4 156 45 1FDA,2EMEA,1 ANVISA
MBC,MCC 7 560 76 1CANADA, 3 FDA,2EMEA,1 ANVISA
Advancedsolidtumor 2 72 18 1DCGI,1EMEA
MBC 3 210 27 3DCGI
ALL 1 16 4 Canada
Ovarian/Pancreatic 1 66 8 USFDA
Atopicdermatitis 2 147 29 2EMEA
Total33Regulatoryinspectionsatvarioussites:USFDA(28),MoHMalaysia(4)&MHRA(1).
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GLOBALNETWORKOFSITES
Europe:P l d
InvestigatorSites
India:dh d h
Newgeographies*CIS i
NorthAmericaC d
Asia:S i L k Poland
Estonia Latvia Lithuania
AndhraPradesh Bihar Delhi Gujarat
CIScountries SouthEastAsia LatinAmerica
Canada USA
SriLanka Bangladesh
Belarus Ukraine RomaniaB l i
Gujarat Haryana HimachalPradesh Karnataka
K l Bulgaria CzechRepublic Germany France
Kerala MadhyaPradesh Maharashtra Punjab
Spainu jab
Rajasthan TamilNadu Telangana
Utt P d h UttarPradesh WestBengal
23*coveredthroughpartnerCRO
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DATAMANAGEMENT:OVERVIEW
Technology/Platforms:
BIZNET f CTM d
DMP and DVP
Services:
BIZNETforCTMandBA/BE
MedDRA :18.1 WHODD:2007
ValueProposition:
DMPandDVP eCRF/CRFDesigning CCG&LabDataT/fGuidelines DatabaseDesigning Database Testing and UAT
21CFRPart11compliantEDCplatformtosupportMedAff/LReg studies
PaperlessSystemtosupportBA/BEData
Management
DatabaseTestingandUAT MedicalCoding&DrugCoding SAEReconciliation DataMigration DataUpload:LIMStoDatabase
p y pp /Studies
LPLVtoDBL:10WD RegulatoryInspectedPlatform
DataUpload:LIMStoDatabase DataReviewandQueryMgt. HelpDeskSupportforsitesetc Expertise:
BA/BEProjects Phase I PhaseI PhaseIItoIV OnlineRegistry,Epi,
IIS,NIS,Observational etcObservationaletc.
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BIOSTATS&PROGRAMMING
Expertise:
InVitroDataAnalysis
PK/PDAnalysis/ y
StatisticalInputstotheProtocol
TwoStageStudyDesign(Adaptivestudy/GroupSequentialapproach)
SampleSizeCalculation
SAPDevelopment
CDISCCompliantDatasetsCreation
ADaM&SDTMcompliantdatasetpreparation
Define.xmlfilepreparation
Dataanalysis
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SOFTWAREINBIOMETRICS
Software Version Description
BIZNET(CTM&BABE) 5.0 EDC /eCRF CDMSplatform
MedDRA 18.1 MedicalCodingDictionary
WHODD 2007 Drug CodingDictionary
Ph i (Wi N li ) 6 4 PK/PD A l i S fPhoenix(WinNonlin) 6.4 PK/PD Analysis Software
SAS Server 9.3 Statistical AnalysisSoftware
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MedSci:OVERVIEW
Abstracts
Posters
IB
Protocols
RMPs
REMS
ReviewArticles
Newsletters
ePosters
OralPresentations
CSRs
Narratives
DSURs
PSURs
VisualAids
LBLsPresentations
Manuscripts
ReviewArticles
LiteratureReviews
Summary
PBRERs
PADERs
SalesForceTraining
Training
DrugCompendiums
White Papers
Documents
eCTD Modules
ACOs
Modules
WhitePapers
ADBOARDs
ACOs
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REPORTWRITING:EXPERTISE
Regional Therapeutic experience:C l i i h ll
Module1
gAdmin
Information Oncology
Dermatology
Therapeuticexperience:Complying with allapplicable regulatoryrequirements
2.4NonclinicalOverview
2.5Clinical
Musculoskeletal
Cardiology
QualityOverall
O e e
2.6Nonclinical
Overview
2.7Clinical2.7Clinical
Gastrointestinal
Diabetology
RespiratoryOverallSummary Summary SummarySummary
Cli i lCli i l
Respiratory
Module3
Quality
Module 4
NonclinicalStudyReports
Module 5Module 5
ClinicalStudyReports
ClinicalStudyReports
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Module4 Module5Module5
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CENTRALREFERENCELABORATORY
Biomarkers&Biosimilars
CAP Immunogenicity
CAP
AssayDevelopment
Safety Testing
NABL
SafetyTesting
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CENTRALREFERENCELABORATORY
CAP&NABLaccredited
ValidatedLIMS
ClinicalPathologist
Microbiologist
Biosimilars
Biomarkers
1st IndianLabtoofferImmunogenicitytesting
PK of Biosimilars testing
g
Biotechnologist
MedicalTechnologists
Immunogenicity
AssayDevelopment PKofBiosimilars testing
25+validatedBiomarkers
WelldefinedSoPs andWorkInstructions
SafetyTesting
MicrobiologicalTestingforhygieneproducts
PanIndiacapabilitiesforsample logisticssamplelogistics
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MEDICALIMAGINGSERVICES
Studystartup&Consultation:
Protocol & Study design, assessment criteria consultation etc
ProjectManagement:
SiteSupport&Management
ImageManagement:
Imagecollection:MRI,CTScanandXrayg , y
ProjectManagement&Archival
IndependentReview:
Training, Testing & Quality monitoring
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PACS:21CFRpartII
Compliantp
BoardCertified
RadiologistCustomizableEvaluation RadiologistEvaluationGuidelines
FullyAutomatedwith built in
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withbuiltinQCsystem
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MEDICALIMAGINGEXPERIENCE
Sr No Indication No of studies No of patients Imaging CriteriaSr.No. Indication No.ofstudies No.ofpatients ImagingCriteria
1 MetastaticBreastCancer 5 552 RECIST1.1
2 NonHodgkin'sLymphoma 1 144 IWG
3 Fractureofdistalradius(Colles) 1 120FractureHealingAssessmentCriteria
4Unresectable orMetastaticNonsquamous NonsmallcellLungCancer
1 129 RECIST1.1Cancer
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PHARMACOVIGILANCE
Offices in UK (London), India (Ahmedabad) and Canada (Toronto)
Global safety team comprises of Physicians, Pharmacists and PV specialists with wealth of
therapeutic expertise, to provide proficient services for clients products (300 plus active
moieties)moieties)
Cost effective, customizable, user friendly, regulatory compliant safety database
Successfully underwent 15+ Regulatory audits for PV functionality in last 2 yearsSuccessfully underwent 15 Regulatory audits for PV functionality in last 2 years
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SPECTRUMOFSERVICES:BRIEFOVERVIEW
CaseProcessing(ICSRs) Aggregate Reports (PSUR/PADER)
OperationalServices AggregateReports(PSUR/PADER) SignalGeneration LiteratureScreening
EUQualifiedResponsiblePerson SafetyDatabase Pharmacovigilance SystemMasterFile(PSMF)
PVSystem
SafetyDataExchangeAgreement
RiskManagementPlan(RMP)Ri k B fit A l iSpecialistServices RiskBenefitAnalysis
SignalDetection RespondingtoRegulatoryEnquiries
p
SOPs,WIs,Guidance Audits/Inspectionsupport Trainings/Consultancy
SupportServices
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g y CAPAsexecution
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PROPRIETARYSAFETYDATABASE
LITERATUREAUTOMATIONMODULE
ICSRPROCESSING:EFFECTIVE &
PRODUCTINQUIRYTRAIL & EFFECTIVE&
EFFICIENTTRAIL&
RESPONSE
GLOBALEVMPD GLOBALSUBMISSION&SUPPORT
xEVMPDMODULE
SIGNALDETECTION
CLINICALTRIAL/
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DETECTIONMODULEVACCINEMODULE
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WHYLAMBDA?
StrongLeadership Onestopsolution PhaseItoIV
FinancialStability(Credit Rating AA+)
GlobalFootprint: NA / EU / APAC
SPONSOR(CreditRatingAA+)
CAGR~20% Futuristicapproach:
MedicalImaging Proteomics
NA/EU/APAC WorldclassInfrastructure
FlexibleBusinessModel ProteomicsModel
Impeccableregulatorytrackrecords
>5000Pk studies
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CONTACT Global:.
Dr.MrinalKammiliExecutiveDirector
NorthAmerica:.
Ms.CathyLopezDirectorBusinessDevelopment
RichardTullyDirector BusinessDevelopment
M N h Si hp
Europe:.
Mr.NareshSinghAssociateVicePresidentBusinessDevelopmentnareshsingh@lambdacro.com
Dr.PeterJanvanDoornDirector,[email protected]
Panomics:.
Dr.RaviKrovidil
Mr.ChrisCarterDirector,BusinessDevelopment(Pharmacovigilance)[email protected]
Turkey:.
Ms.DevrimSabuncuogluManager [email protected]
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Followuson:
www.lambdacro.com
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