aGlobalCROaGlobalCRO

1

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

2

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

3

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

4

LAMBDALOCATIONS

W P l dAhmedabad,India Warsaw,Poland

Toronto,Canada London,UK

5

LAMBDAHOUSE AHMEDABAD

6

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]

7

SERVICEPORTFOLIO

Phase1(FirstinMan)Pharmacovigilance

Bioavailability&BioequivalenceMedicalImaging Bioequivalenceg g

BioanalyticalCentral

Laboratory

PanomicsMedicalWriting

Late Phase Clinical TrialsData Services

8

LatePhaseClinicalTrials(PhaseIIIV)

DataServices(BSP,CDM)

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

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

10

Flexible Operational approach

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

11

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

12

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

13

Renal

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

14

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

15

BIOANALYTICALLAB

16

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

17

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

18

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

19

1 120 29

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.

20

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

21

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).

22

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

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.

24

BIOSTATS&PROGRAMMING

Expertise:

InVitroDataAnalysis

PK/PDAnalysis/ y

StatisticalInputstotheProtocol

TwoStageStudyDesign(Adaptivestudy/GroupSequentialapproach)

SampleSizeCalculation

SAPDevelopment

CDISCCompliantDatasetsCreation

ADaM&SDTMcompliantdatasetpreparation

Define.xmlfilepreparation

Dataanalysis

25

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

26

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

27

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

28

Module4 Module5Module5

CENTRALREFERENCELABORATORY

Biomarkers&Biosimilars

CAP Immunogenicity

CAP

AssayDevelopment

Safety Testing

NABL

SafetyTesting

29

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

30

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

31

PACS:21CFRpartII

Compliantp

BoardCertified

RadiologistCustomizableEvaluation RadiologistEvaluationGuidelines

FullyAutomatedwith built in

32

withbuiltinQCsystem

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

33

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

34

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

35

g y CAPAsexecution

PROPRIETARYSAFETYDATABASE

LITERATUREAUTOMATIONMODULE

ICSRPROCESSING:EFFECTIVE &

PRODUCTINQUIRYTRAIL & EFFECTIVE&

EFFICIENTTRAIL&

RESPONSE

GLOBALEVMPD GLOBALSUBMISSION&SUPPORT

xEVMPDMODULE

SIGNALDETECTION

CLINICALTRIAL/

36

DETECTIONMODULEVACCINEMODULE

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

37

CONTACT Global:.

Dr.MrinalKammiliExecutiveDirector

NorthAmerica:.

Ms.CathyLopezDirectorBusinessDevelopment

GlobalHeadBusinessDevelopmentmrinal@lambdacro.com

pcathy.Lopez@lambdacanadacro.com

RichardTullyDirector BusinessDevelopment

M N h Si hp

richard.tully@lambdacanadacro.com

Europe:.

Mr.NareshSinghAssociateVicePresidentBusinessDevelopmentnareshsingh@lambdacro.com

Dr.PeterJanvanDoornDirector,BusinessDevelopmentpeter@lambdacro.com

Panomics:.

Dr.RaviKrovidil

Mr.ChrisCarterDirector,BusinessDevelopment(Pharmacovigilance)chriscarter@lambdacro.com

AssistantGeneralManagerravikrovidi@lambdacro.com

Turkey:.

Ms.DevrimSabuncuogluManager BusinessDevelopmentdevrim@lambdacro.com

38

Followuson:

www.lambdacro.com

39