……a Global CRO……a Global CRO

1

OUR JOURNEY• 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

2011‐2016

• Initiated Late phase studies• Started Clinical Lab (CAP)Started Clinical Lab (CAP) • Launch of Mumbai Operations

• Acquired CRO in London, UK for  PV services• Acquired CRO in Warsaw, Poland for Late Phase Trials• Cleared US‐FDA ANVISA DCGI etc inspections for BA/BE

2000‐20052006‐2010

Cleared US FDA, ANVISA, DCGI etc inspections for BA/BE & CT studies

• Expansion of  Ahmedabad facility ‐with a capacity of 360 beds and a dedicated 16 bedded for Phase‐1

• Awarded Best “Indian CRO “ in 2010 by Frost & Sullivan

• Incorporated in   Ahmedabad, Gujarat, I di

Awarded Best  Indian CRO   in 2010 by Frost & Sullivan, US

1999

India• Initiated BA/BE & Bio‐analytical services

2

GEOGRAPHICAL PRESENCE

Warsaw, Poland2007

Ahmedabad, India1999

London, UK2008

Mumbai, India2003

Toronto, Canada2010

Istanbul Turkey

New Delhi, India2009

Hyderabad IndiaIstanbul, Turkey2011

Bangkok, Thailand

Hyderabad, India2009

2011

Operational Capabilities:Asia Pacific Europe Other GeographiesAsia Pacific Europe Other Geographies

IndiaSri LankaThailand

l d h

UK, Germany  FranceSpain Turkey PolandEstonia  Belarus  Czech Republick h

North AmericaLatin AmericaCIS Countries

hBangladesh Ukraine  Romani  Latvia LithuaniaBulgaria 

South East Asia

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EXECUTIVE SUMMARY: LAMBDA

Indian CRO with a true global presence Best CRO of rating ‘AA‐’ in 

long term and highest possible in short term ‘A1+’

Strong and stable Leadership team  with  >20 years of industry

End to end service offerings covering entire spectrum of  clinical research from Phase‐I to IV

possible in short term A1+  in CARE

Company growing with a CAGR of  ~20% p.a YoY.

years of  industry experience

Multi continental presence:

Impeccable regulatory track record

Global Revenues of $ USD 50 million during last FY and growing....

• North America

• Europe

Front runner: in Medical Imaging  & Panomics

Robust  Digital platforms 

• Asia

700+ employees globally

C stomi able & scalableg p

across  service verticals Customizable & scalable business models

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LAMBDA LOCATIONS

W P l dAhmedabad, India Warsaw, Poland

Toronto, Canada London, UK

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LAMBDA HOUSE ‐ AHMEDABAD

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REGULATORY INSPECTIONS

US‐FDA [37]NGCMA [01] HEALTH CANADA [02]

IGZ [02]WHO [02]POLISH [04]ANSM [02]

AGES [01]SCC [03]

[ ]

FAMHP [02] TURKEY MOH [01]EMA [01] BFARM [01]

CDSCO [15]

Thai MOH [04] CAP [07]

NABL [04]OGYI [01]ANVISA [08]AIFA [01]

UK‐MHRA [10]

MHSD [01]

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SERVICE PORTFOLIO

Phase‐1(First in Man)Pharmacovigilance

Bioavailability &BioequivalenceMedical Imaging Bioequivalenceg g

BioanalyticalCentral 

Laboratory

PanomicsMedical Writing

Late Phase Clinical TrialsData Services

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Late Phase Clinical Trials(Phase II‐IV)

Data Services (BSP, CDM)

PHASE‐1: AT GLANCE

• Dedicated phase‐1 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 phase‐I 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

VALUE PROPOSITION: PHASE‐1

• 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

Value Proposition• Cost Effective business model (Hybrid)

• Faster turn around time

• Global scientific overview

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• Flexible Operational approach

PHASE‐I CAPABILITIES: INDIA & CANADA

Dedicated state‐of‐the‐art ICU’s

Central Cardiac Monitoring System

Cardiac Telemetry/ Holters / IV Infusion Pumps

X‐ray, Ultrasound facilities

TET studies  

GE MUSE system for ECG processing and managementy p g g

GE Apex Pro Telemetry System / DASH 4000 Cardiac Monitors

Multilevel ECG reading by Cardiologists 

Internet access to ECG data through ECG web portal

Pulmonary Function Testing (PFT) 

Cognitive testing (CDR) 

Gastroesophageal monitoring

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GLOBAL CLINICAL BED CAPACITY

Sr. No Country City No. of Beds No. of Phase‐1 Beds No. of ICU BedsNo

1 IndiaAhmedabad 360 16 8

Mumbai 66 ‐ 2Mumbai 66 2

2 Canada Toronto 128 12 ‐

Total number of beds 554 28 10

Lambda’s current total bed capacity is 592 beds globally

Total number of beds 554 28 10

p y g y

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GLOBAL VOLUNTEER DATABASE

Population Ahmedabad Mumbai Torontop

Healthy Male 50,700 8,500 60,000

Healthy Female with childbearing potential 4 380 300 30 000Healthy Female with childbearing potential 4,380 300 30,000

PM & Surgically Sterile Women 2,295 300 2,200

Eld l 1 255 50 3 500

Patient Populations:

Elderly 1,255 50 3,500

Patient Populations:

• Hypertensive • Fast/Slow metabolizers

• Schizophrenic • Obese

• Diabetic • Migraine 

• Cancer • Hepatic impaired Patients

R l

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• Renal

BIOAVAILABILITY / BIOEQUIVALENCE STUDIES

Formulations Experience: Oral Dosage Forms: 

Tablets and Capsules

Suspensions

BuccalBuccal

Sublingual

Lozenges

Injectables:  IV, IM, SC

Inhalers

Nasal sprays

Suppositories

Transdermal patches 

Ointments & CreamsOintments & Creams

Intravaginal tabs

L bd h d t d 5000 BE t di till d t l b llLambda has conducted over 5000 BE studies till date globally

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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 8‐10 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.

Sample Storage Controlled and monitored low temperature storage (‐22±5°C,‐65±10°C)

Capacity to store 3 million samples

InfrastructureInfrastructureCountry LC‐MS/MS  FTIR *

India 34 3

Canada 08 ‐

* Fourier Transform Infrared Spectroscopy

Total 42 3

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BIOANALYTICAL LAB

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PANOMICS  SERVICES FOR CLINICAL RESEARCH

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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PANOMICS SERVICES 0.525.51 7.98

4.72 5.926.12 7.39

3.754.16

3.11 9.82

2.182.591.749.12Protein Characterization Studies & Biosimilars Analysis

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 & In‐vitro Based Studies

Molecular Biology and Genomics Profiling

Genomics Based Studies: DNA , RNA extractions, miRNA analysis

Pharmacogenomics Studies: Profiling for Potential Responders

RT‐PCR Validation Studies: Serum and Tissue Samples, Biomarkers

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CLINICAL TRIAL EXPERIENCE

Carried out more than 50 multi‐centric trials across different geographies

Enrolled 8000+ patients in last 7 years in various therapeutic categories

Team with expertise in managing Multi‐Country Trials

Therapeutic Area  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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1 120 29

THERAPEUTIC / EFFICACY STUDIES IN ONCOLOGY

Sr. No. Indication # Studies # Sites Regulatory # Patients

1 CNS Tumor 4 46 USFDA, EMEA  184

2 ALL 1 6 Health CANADA 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 Solid Tumor 1 4 DCGI 32

8 NSCLC 1 24 DCGI 129

Note: * Includes MBC patients.# Includes Ovarian cancer patients.

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OTHER THERAPEUTIC / EFFICACY STUDIES

Therapeutic Category 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, Sri Lanka

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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PATIENT BASED PHARMACOKINETIC STUDIES

Indication / Therapy Studies Patients Sites Submissions

Schizophrenia  9 610 58 5 FDA, 2 EMEA, 2 DCGI

Malignant Glioma 4 156 45 1 FDA, 2 EMEA, 1 ANVISA

MBC, MCC 7 560 76 1 CANADA, 3 FDA, 2 EMEA, 1 ANVISA

Advanced solid tumor 2 72 18 1 DCGI, 1 EMEA

MBC 3 210 27 3 DCGI

ALL 1 16 4 Canada

Ovarian /Pancreatic 1 66 8 USFDA

Atopic dermatitis 2 147 29 2 EMEA

Total  33 Regulatory inspections at various sites: USFDA (28), MoH‐Malaysia (4) & MHRA (1).

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GLOBAL NETWORK OF SITES

Europe: P l d

Investigator Sites

India:dh d h

New geographies*CIS i

North AmericaC d

Asia:S i L k • Poland

• Estonia• Latvia• Lithuania

• Andhra Pradesh• Bihar• Delhi • Gujarat

• CIS  countries• South East Asia• Latin America

• Canada• USA

• Sri Lanka• Bangladesh

• Belarus• Ukraine• RomaniaB l i

Gujarat• Haryana• Himachal Pradesh• Karnataka

K l • Bulgaria• Czech Republic• Germany• France

• Kerala• Madhya Pradesh• Maharashtra• Punjab

• Spainu jab

• Rajasthan • Tamil Nadu• Telangana

Utt P d h• Uttar Pradesh • West Bengal

23*covered through partner CRO

DATA MANAGEMENT: OVERVIEW

Technology /Platforms:

BIZNET f CTM d

• DMP and DVP

Services:

• BIZNET for CTM and BA/BE

• MedDRA : 18.1• WHO‐DD:2007

Value Proposition:

• DMP and DVP • eCRF/CRF Designing• CCG & Lab Data T/f Guidelines• Database Designing • Database Testing and UAT

• 21CFR‐Part‐11 compliant EDC platform to support MedAff/LReg studies

• Paperless System to support BA/BE Data 

Management

Database Testing and UAT• Medical Coding & Drug Coding• SAE Reconciliation • Data Migration• Data Upload: LIMS to Database

p y pp /Studies

• LPLV to DBL: 10 WD• Regulatory Inspected  Platform

Data Upload: LIMS to Database• Data Review and Query  Mgt. • Help Desk Support for sites etc Expertise:

• BA/BE Projects• Phase I• Phase‐I• Phase‐II to IV• Online Registry, Epi, 

IIS, NIS,  Observational etcObservational etc.

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BIO‐STATS & PROGRAMMING

Expertise:

• In Vitro Data Analysis

• PK/PD Analysis/ y

• Statistical Inputs to the Protocol

• Two Stage Study Design(Adaptive study/Group Sequential approach)

• Sample Size Calculation

• SAP Development

• CDISC Compliant Datasets Creation

• ADaM & SDTM compliant dataset preparation

• Define.xml file preparation 

• Data analysis

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SOFTWARE IN BIOMETRICS

Software Version Description

BIZNET® (CTM & BABE) 5.0 EDC / eCRF CDMS platform

MedDRA® 18.1 Medical Coding Dictionary

WHO‐DD 2007 Drug Coding Dictionary

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 Analysis Software

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MedSci: OVERVIEW

• Abstracts

• Posters

• IB

• Protocols

• RMPs

• REMS

• Review Articles

• Newsletters

• ePosters

• Oral Presentations

• CSRs

• Narratives

• DSURs

• PSURs

• Visual Aids

• LBLsPresentations

• Manuscripts

• Review Articles

• Literature Reviews

• Summary 

• PBRERs

• PADERs

• Sales Force Training

• Training 

• Drug Compendiums

• White Papers

Documents

• eCTD Modules

• ACOs

Modules

White Papers

• ADBOARDs

ACOs

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REPORT WRITING: EXPERTISE

Regional Therapeutic experience:C l i i h ll

Module 1

gAdmin

Information • Oncology

• Dermatology

Therapeutic experience: Complying with allapplicable regulatoryrequirements

2.4 NonclinicalOverview

2.5 Clinical

• Musculoskeletal

• Cardiology

QualityOverall

O e e

2.6 Nonclinical

Overview

2.7 Clinical2.7 Clinical

• Gastrointestinal

• Diabetology

• RespiratoryOverallSummary Summary SummarySummary

Cli i lCli i l

• Respiratory  

Module 3

Quality

Module 4

NonclinicalStudy Reports

Module 5Module 5

ClinicalStudy Reports

ClinicalStudy Reports

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Module 4 Module 5Module 5

CENTRAL REFERENCE LABORATORY

• Biomarkers & Biosimilars

CAP• Immunogenicity

CAP

• Assay Development

• Safety Testing

NABL

Safety Testing

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CENTRAL REFERENCE LABORATORY

• CAP & NABL accredited

• Validated LIMS

• Clinical Pathologist

• Microbiologist

• Biosimilars

• Biomarkers

• 1st Indian Lab to offer Immunogenicity testing

• PK of Biosimilars testing

g

• Biotechnologist 

• Medical Technologists

• Immunogenicity

• Assay Development• PK of Biosimilars testing

• 25+ validated Biomarkers

• Well defined SoPs and Work Instructions

• Safety Testing

• Microbiological Testing for hygiene products

• Pan‐India capabilities for sample logisticssample logistics

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MEDICAL IMAGING SERVICES

Study start‐up & Consultation:

Protocol & Study design, assessment criteria consultation etc

Project Management:

Site Support & Management

Image Management:

Image collection : MRI, CT Scan and X‐rayg , y

Project Management & Archival

Independent Review:

Training, Testing & Quality monitoring

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PACS: 21CFR part‐II 

Compliantp

Board Certified 

RadiologistCustomizable Evaluation RadiologistEvaluation Guidelines 

Fully Automated with built in

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with built in QC system

MEDICAL IMAGING EXPERIENCE

Sr No Indication No of studies No of patients Imaging CriteriaSr. No. Indication No.  of studies No. of patients Imaging Criteria

1 Metastatic Breast Cancer 5 552 RECIST 1.1 

2 Non‐Hodgkin's Lymphoma 1 144 IWG

3 Fracture of distal radius (Colles’) 1 120Fracture Healing Assessment Criteria

4Unresectable or Metastatic Non‐squamous Non‐small cell Lung Cancer

1 129 RECIST 1.1Cancer 

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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 client’s 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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SPECTRUM OF SERVICES: BRIEF OVERVIEW

• Case Processing (ICSRs)• Aggregate Reports (PSUR/PADER)

Operational Services• Aggregate Reports (PSUR/PADER)• Signal Generation• Literature Screening

• EU Qualified Responsible Person• Safety Database• Pharmacovigilance System Master File(PSMF)

PV System

• Safety Data Exchange Agreement

• Risk Management Plan (RMP)Ri k B fit A l iSpecialist Services • Risk Benefit Analysis

• Signal Detection• Responding to Regulatory Enquiries

p

• SOPs, WIs, Guidance• Audits/Inspection support• Trainings/Consultancy

Support Services

35

g y• CAPAs execution

PROPRIETARY SAFETY DATABASE

LITERATURE AUTOMATION MODULE

ICSR PROCESSING: EFFECTIVE &

PRODUCT INQUIRY TRAIL & EFFECTIVE & 

EFFICIENT TRAIL & 

RESPONSE

GLOBALEVMPD GLOBAL SUBMISSION & SUPPORT

xEVMPDMODULE

SIGNAL DETECTION

CLINICAL TRIAL / 

36

DETECTION MODULEVACCINE  

MODULE

WHY LAMBDA ?

• Strong Leadership• One‐stop solution• Phase‐I to IV

• Financial Stability (Credit Rating AA+)

• Global Footprint:• NA / EU / APAC

SPONSOR(Credit Rating AA+)

• CAGR ~20%• Futuristic approach:

• Medical Imaging• Proteomics

• NA / EU / APAC• World‐class  Infrastructure

• Flexible Business Model • ProteomicsModel

• Impeccable  regulatory track records

• > 5000 Pk studies

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CONTACT• Global:                                                                   .

Dr. Mrinal KammiliExecutive Director

• North America:                                                          .

Ms. Cathy Lopez Director ‐Business Development

Global Head‐Business Developmentmrinal@lambda‐cro.com

pcathy.Lopez@lambdacanada‐cro.com

Richard TullyDirector‐ Business Development

M N h Si hp

richard.tully@lambdacanada‐cro.com

• Europe:                                                                        .

Mr. Naresh SinghAssociate Vice PresidentBusiness Developmentnareshsingh@lambda‐cro.com

Dr. Peter‐Jan van DoornDirector, Business Developmentpeter@lambda‐cro.com

• Panomics:                                                               .

Dr.  Ravi Krovidil

Mr. Chris CarterDirector, Business Development (Pharmacovigilance)chriscarter@lambda‐cro.com

Assistant General Managerravikrovidi@lambda‐cro.com

• Turkey:                                                                         .

Ms. Devrim  SabuncuogluManager ‐ Business Developmentdevrim@lambda‐cro.com

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Follow us on:

www.lambda‐cro.com

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