……a Global CRO……a Global CRO

1

OUR JOURNEY• Acquired one of the oldest CRO in Canada for Early Phase TrialsAcquired 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

L bd li i l i l b di EDC l b ll• Lambda clinical operations go paperless by extending EDC globally

2011‐2016

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

• Acquired CRO in London, UK for  PV services2000 20052006‐2010

q ,• Acquired CRO in Warsaw, Poland for Late Phase Trials• 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

2000‐2005

• Incorporated in Ahmedabad Gujarat

beds and a dedicated 16 bedded for Phase‐1• Awarded Best “Indian CRO “ in 2010 by Frost & Sullivan, 

US1999

Incorporated in   Ahmedabad, Gujarat, India

• Initiated BA/BE & Bio‐analytical services

2

GEOGRAPHICAL PRESENCE

Warsaw, Poland2007

London UK

Ahmedabad, India1999

Mumbai IndiaLondon, UK2008

Toronto, Canada2010

Mumbai, India2003

New Delhi, India20092010

Istanbul, Turkey2011

2009

Hyderabad, India2009

Bangkok, Thailand2011

Operational Capabilities:Operational Capabilities:Asia Pacific Europe Other Geographies

IndiaSri LankaThailand

UK, Germany  FranceSpain Turkey PolandEstonia Belarus Czech Republic

North AmericaLatin AmericaCIS CountriesThailand

BangladeshEstonia  Belarus  Czech RepublicUkraine  Romani  Latvia LithuaniaBulgaria 

CIS CountriesSouth East Asia

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EXECUTIVE SUMMARY: LAMBDA

I di CRO ith tIndian CRO with a true global presence

End to end service offerings covering entire

Best CRO of rating ‘AA‐’ in long term and highest possible in short term ‘A1+’ in CARE

Strong and stable Leadership team  with  >20 years of  industry experience

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

Impeccable regulatory 

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

Global Revenues of $ USD 50 million during last FY

Multi continental presence:

• North America

track record

Front runner: in Medical Imaging  & Panomics

50 million during last FY and growing.... • Europe

• Asia

700+ employees globallyRobust  Digital platforms across  service verticals Customizable & scalable 

business models

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LAMBDA LOCATIONS

Ahmedabad, India Warsaw, Poland

Toronto, Canada London, UK

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LAMBDA HOUSE ‐ AHMEDABAD

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REGULATORY INSPECTIONS

US‐FDA [36]NGCMA [01] HEALTH CANADA [02]

IGZ [02]WHO [02]POLISH [04]ANSM [02]

FAMHP [02] TURKEY MOH [01]

AGES [01]

EMA [01] BFARM [01]

SCC [03]

CDSCO [14]

FAMHP [02] [ ]

Thai MOH [04] CAP [07]

EMA [01] BFARM [01]

NABL [03]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

BioanalyticalCentral 

Laboratory

P iMedical Writing PanomicsMedical Writing

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Late Phase Clinical Trials(Phase II‐IV)

Data Services (BSP, CDM)

PHASE‐1: AT GLANCE

l d hi i h i i h dli di lik

• 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 Man

Multiple Ascending Dose (MAD)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

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

f

Canada

• Parallel submission for MAD study in India

• Study start with healthy subjects followed by patientcohorts

di

• Cost effective option for subsequent Phase ‐1 studies

• Easier Access for Renal and Liver impaired subjects study

India

• Naive patient pool, qualified medical doctors and hospitalinfrastructure

Value Proposition• Cost Effective business model (Hybrid)

• Faster turn around time

• Global scientific overview

Value Proposition

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Global scientific overview

• Flexible Operational approach

PHASE‐I CAPABILITIES: INDIA & CANADA

Dedicated state‐of‐the‐art ICU’s

Central Cardiac Monitoring System

Cardiac Telemetry/ Holters / IV Infusion PumpsCardiac Telemetry/ Holters / IV Infusion Pumps

X‐ray, Ultrasound facilities

TET studies TET studies  

GE MUSE system for ECG processing and management

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) Pulmonary Function Testing (PFT) 

Cognitive testing (CDR) 

Gastroesophageal monitoring 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 Beds

1 IndiaAhmedabad 360 16 8

Mumbai 66 ‐ 2

2 C d T t 128 122 Canada Toronto 128 12 ‐

Total number of beds 554 28 10

Lambda’s current total bed capacity is 592 beds globally

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GLOBAL VOLUNTEER DATABASE

Population Ahmedabad Mumbai Toronto

Healthy Male 50,700 8,500 60,000

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

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

Elderly 1,255 50 3,500

Patient Populations:

• Hypertensive • Fast/Slow metabolizers

• Schizophrenic • Obese

• Diabetic • Migraine 

• Cancer • Hepatic impaired Patients

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• Renal

BIOAVAILABILITY / BIOEQUIVALENCE STUDIES

Formulations Experience: Oral Dosage Forms: 

Tablets and CapsulesTablets and Capsules

Suspensions

Buccal

Sublingualg

Lozenges

Injectables:  IV, IM, SC

Inhalers

Nasal sprays

Suppositories

Transdermal patches 

Ointments & Creams

Intravaginal tabs

Lambda has conducted over 5000 BE studies till date globally

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C bilitiBIOANALYTICAL : INDIA & CANADA

Capabilities Scientists with 10 + years of experience

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 andk l l lMonkey using low sample volume

Robust system for failure investigation

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

InfrastructureCountry LC‐MS/MS  FTIR *

India 34 3

Canada 08

* Fourier Transform Infrared Spectroscopy

Canada 08 ‐

Total 42 3

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BIOANALYTICAL LAB

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PANOMICS  SERVICES FOR CLINICAL RESEARCH

DNA, RNA Extractions, Target DNA & miRNA Analysis, MolecularDi i f B t i d Vi

GENOMICS

Diagnosis of Bacteria and Viruses

SDS PAGE Analysis, Western Blotting, Peptide Mapping, ProteinCharacterization, Biosimilars, Targeted Proteomics, etc

PROTEOMICS

l b l b l f l d d d b lMETABOLOMICS

Global Metabolite Profiling, Targeted and Untargeted MetaboliteDetection, Pathway Centric Analysis

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PANOMICS SERVICES 0.525.51 7.98

4.72 5.926.12 7.39

3 75

0.

3.754.16

3.11 9.82

2.182.591.749.12Protein Characterization Studies & Biosimilars Analysis

Global Proteomics Profiling: Protein identifications & Validation 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

Serum & In vitro Based Studies

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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p ,

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 SitesTherapeutic 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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2 887 51

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

Gastroenterology 1016 74 EMEA, USFDA India, EU, Sri Lanka

Cardiology 3653 62 EMEA Europe

Urology 24 1 EMEA Europe

Endocrinology 235 40 EMEA Europe

Pulmonology 791 57 EMEA Europe & India

Diabetology 316 55 EMEA EuropeDiabetology 316 55 EMEA Europe

Dermatology 852 30 EMEA, USFDA India & Poland

Musculoskeletal 1944 48 EMEA USFDA IndiaMusculoskeletal 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

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

Atopic dermatitis 2 147 29 2 EMEA

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GLOBAL NETWORK OF SITES

Europe: • PolandE i

Investigator Sites

India:• Andhra Pradesh

ih

New geographies*• CIS  countriesS h E A i

North America• CanadaUSA

Asia:• Sri LankaB l d h • Estonia

• Latvia• Lithuania• BelarusUk i

• Bihar• Delhi • Gujarat• Haryana

Hi h l P d h

• South East Asia• Latin America

• USA• Bangladesh

• Ukraine• Romania• Bulgaria• Czech RepublicG

• Himachal Pradesh• Karnataka• Kerala• Madhya Pradesh

M h h • Germany• France• Spain

• Maharashtra• Punjab• Rajasthan • Tamil Nadu

T l• Telangana• Uttar Pradesh • West Bengal

23*covered through partner CRO

DATA MANAGEMENT: OVERVIEW

Technology /Platforms:

• BIZNET for CTM and BA/BE

• DMP and DVP • eCRF/CRF Designing

b /f d l

Services:

BA/BE• MedDRA : 18.1• WHO‐DD:2007

Value Proposition:

• 21CFR Part 11 compliant EDC platform

Data Management

• CCG & Lab Data T/f Guidelines• Database Designing • Database Testing and UAT• Medical Coding & Drug Coding• SAE Reconciliation 

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

• Paperless System to support BA/BE Studies

• LPLV to DBL: 10 WDl d l f• Data Migration

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

/ j

• Regulatory Inspected  Platform

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

IIS, NIS,  Observational etc.

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BIO‐STATS & PROGRAMMING

Expertise:

• In Vitro Data Analysis

• PK/PD Analysis

• Statistical Inputs to the ProtocolStatistical 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• 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

Phoenix® (WinNonlin®) 6.4 PK/PD Analysis Software

SAS® Server 9 3 Statistical Analysis SoftwareSAS Server  9.3 Statistical Analysis Software

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MedSci: OVERVIEW

• Abstracts

• Posters

• ePosters

• IB

• Protocols

• CSRs

• RMPs

• REMS

• DSURs

• Review Articles

• Newsletters

• Visual Aids

• Oral Presentations

• Manuscripts

• Narratives

• Literature Reviews

• PSURs

• PBRERs

PADER

• LBLs

• Sales Force Training

• Review Articles

• Drug Compendiums

• Summary Documents

• eCTD Modules

• PADERs• Training 

Modules

• White Papers

• ADBOARDs

• ACOs

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REPORT WRITING: EXPERTISE

RegionalAdmin

Therapeutic experience: Complying with allli bl l

Module 1Information

2 5

• Oncology

• Dermatology

• Musculoskeletal

applicable regulatoryrequirements

2.4 NonclinicalOverview

2.5 ClinicalOverview

• Cardiology

• Gastrointestinal

• DiabetologyQualityOverallSummary

2.6 NonclinicalSummary

2.7 ClinicalSummary2.7 ClinicalSummary

• Diabetology

• Respiratory  

Module 3

Quality NonclinicalStudy Reports

ClinicalStudy Reports

ClinicalStudy Reports

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Module 4 Module 5Module 5

CENTRAL REFERENCE LABORATORY

BIOMARKERS &BIOSIMILARS

IMMUNOGENICITYIMMUNOGENICITY

CAP accredited

ASSAYDEVELOPMENT

SAFETY TESTING

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CENTRAL REFERENCE LABORATORY

• CAP & NABL accredited

• Validated LIMS

• 1st Indian Lab to offer 

• Clinical Pathologist

• Microbiologist

• Biotechnologist 

• Biosimilars

• Biomarkers

• ImmunogenicityImmunogenicity testing

• PK of Biosimilars testing

• 25+ validated 

g

• Medical Technologists

• Well defined SoPs and Work Instructions

g y

• Assay Development

• Safety Testing

Biomarkers

• Microbiological Testing for hygiene products

d b l f

Work Instructions

• Pan‐India capabilities for sample logistics

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MEDICAL IMAGING SERVICES

Study start‐up & Consultation:

Protocol & Study design, assessment criteria consultation etcy g ,

Project Management:

Site Support & Management

Image Management:

Image collection : MRI, CT Scan and X‐ray

Project Management & Archival

Independent Review:

Training, Testing & Quality monitoring

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PACS: 21CFR part‐II 

Compliant

BoardBoard Certified 

RadiologistCustomizable Evaluation Guidelines 

Fully Automated 

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with built in QC system

MEDICAL IMAGING EXPERIENCE

Sr. 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

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

Cancer 1 129 RECIST 1.1

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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)

Cost effective customizable user friendly regulatory compliant safety database Cost effective, customizable, user friendly, regulatory compliant safety database

Successfully 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)• Signal Generation

Operational Services

• EU Qualified Responsible PersonPV System

• Signal Generation• Literature Screening

• Safety Database• Pharmacovigilance System Master File(PSMF)• Safety Data Exchange Agreement

PV System

• Risk Management Plan (RMP)• Risk Benefit Analysis• Signal Detection• Responding to Regulatory Enquiries

Specialist Services

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

Support Services

p g g y q

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• Trainings/Consultancy• CAPAs execution

PROPRIETARY SAFETY DATABASE

LITERATURE AUTOMATION MODULE

ICSR PROCESSING: EFFECTIVE & EFFICIENT 

PRODUCT INQUIRY TRAIL & 

RESPONSE

GLOBAL SUBMISSION & SUPPORT

xEVMPDMODULE

SIGNAL CLINICAL TRIAL /

36

DETECTION MODULE

TRIAL / VACCINE  MODULE

WHY LAMBDA ?

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

SPONSOR• Financial Stability (Credit Rating AA+)

• CAGR ~20%• Futuristic approach:

• Global Footprint:• NA / EU / APAC• World‐class  Infrastructure pp

• Medical Imaging• Proteomics

Infrastructure• Flexible Business Model

• Impeccable  regulatory track records

• > 5000 Pk studies

37

CONTACT• Global:                                                                   .

Dr. Mrinal KammiliExecutive DirectorGlobal Head‐Business Development

• North America:                                                          .

Ms. Cathy Lopez Director ‐Business Developmentcathy.Lopez@lambdacanada‐cro.com

mrinal@lambda‐cro.com

Mr. Akshaya Nath Chief Operating Officer

Richard TullyDirector‐ Business Developmentrichard.tully@lambdacanada‐cro.com

akshayanath@lambda‐cro.com

Dr. Nermeen VarawallaExecutive Vice PresidentGlobal Clinical Trials

• Europe:                                                                        .

Dr. Peter‐Jan van DoornDirector, Business Development

nermeenvarawalla@lambda‐cro.com peter@lambda‐cro.com

Mr. Chris CarterDirector, Business Development (Pharmacovigilance)h i @l bd

Mr. Naresh SinghAssociate Vice PresidentBusiness Development

chriscarter@lambda‐cro.com

• Turkey:                                                                         .

Ms. Devrim  SabuncuogluManager Business Development

• Panomics:                                                               .

Dr.  Ravi KrovidiA i t t G l M

nareshsingh@lambda‐cro.com

Manager ‐ Business Developmentdevrim@lambda‐cro.com

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Assistant General Managerravikrovidi@lambda‐cro.com

Follow us on:

www.lambda‐cro.com

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