……a Global CRO……a Global CRO

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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• 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 2005

2006-2010q ,

• 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

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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

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 [37]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 [15]

FAMHP [02] [ ]

Thai MOH [04] CAP [07]

EMA [01] BFARM [01]

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 &Bioequivalence

Medical Imaging

C t lBioanalytical

Central Laboratory

Late Phase Clinical Trials(Phase II-IV)

Medical Writing

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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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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

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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 734 56 DCGI USFDA I di S i L kGastroenterology 734 56 DCGI, USFDA India, Sri Lanka

Cardiology 22 03 DCGI India

Nephrology 24 175 DCGI India

Pulmonology 678 27 DCGI India

Dermatology 888 71 EMEA, USFDA India & Poland

Orthopedic 2034 60 DCGI India

Others 1923 10 EMEA Europe

Total 6303 402

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PATIENT BASED PHARMACOKINETIC STUDIES

Indication / Therapy Studies Patients Sites Submissions

Schizophrenia /BPD 10 641 63 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 4 688 54 2 EMEA 2 USFDA

Rheumatoid Arthritis 2 287 26 2 DCGI

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

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GLOBAL NETWORK OF SITES

Europe: • Poland

E i

Investigator Sites

India:• Andhra Pradesh

ih

New geographies*• CIS countries

S h E A i

North America• Canada

USA

Asia:• Sri Lanka

B l d h • Estonia• Latvia• Lithuania• Belarus

Uk i

• Bihar• Delhi • Gujarat• Haryana

Hi h l P d h

• South East Asia• Latin America

• USA• Bangladesh

• Ukraine• Romania• Bulgaria• Czech Republic

G

• Himachal Pradesh• Karnataka• Kerala• Madhya Pradesh

M h h • Germany• France• Spain

• Maharashtra• Punjab• Rajasthan • Tamil Nadu

T l• Telangana• Uttar Pradesh • West Bengal

21*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) 5.1 EDC / eCRF CDMS platform

MedDRA® 19.1 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 1

Information

2 5

• Oncology

• Dermatology

• Musculoskeletal

applicable regulatoryrequirements

2.4 NonclinicalOverview

2.5 ClinicalOverview

• Cardiology

• Gastrointestinal

• DiabetologyQualityOverall

Summary

2.6 NonclinicalSummary

2.7 ClinicalSummary

2.7 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

CAP• Immunogenicity

• Assay Development

NABL

• 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 /

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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%

F t i ti h

• Global Footprint:• NA / EU / APAC• World-class

Infrastructure • Futuristic approach:• Medical Imaging

Infrastructure• Flexible Business

Model

• Impeccable regulatory track records

• > 5000 Pk studies

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CONTACT

• Global: . • North America: .

M C h LDr. Mrinal KammiliExecutive DirectorGlobal Head-Business Developmentmrinal@lambda-cro.com

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

Richard TullyRichard TullyDirector- Business Developmentrichard.tully@lambdacanada-cro.comMr. Naresh Singh

Associate Vice PresidentBusiness Developmentnareshsingh@lambda-cro.com

• Turkey: .

Ms. Devrim Sabuncuoglu

nareshsingh@lambda cro.com

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

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