……a Global CRO……a Global CRO

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OUR GLOBAL PRESENCE

Warsaw, Poland2007

Ahmedabad, India1999

London, UK2008

Toronto Canada

Mumbai, India2003

New Delhi IndiaToronto, Canada2010

Istanbul, Turkey2011

New Delhi, India2009

Hyderabad, India20092011

Bangkok, Thailand2011

2009

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LAMBDA HOUSE ‐ AHMEDABAD

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LAMBDA HOUSE ‐ AHMEDABAD

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LAMBDA HOUSE ‐ AHMEDABAD

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LAMBDA HOUSE ‐ AHMEDABAD

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LAMBDA ‐ POLAND

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LAMBDA ‐ UK

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LAMBDA ‐ CANADA

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REGULATORY INSPECTIONS

NABL [03] OGYI [01]POLISH [04] NABL [03]

US FDA [34]

OGYI [01]

ANVISA [07]

POLISH [04]

FAMHP [02]

US‐FDA [34]

UK‐MHRA [09]Thai MOH [04]AGES [01] AIFA [01]

CDSCO [13]EMA [01]

CDSCO [13]CAP [06]WHO [02]IGZ [02]

BFARM [01]ANSM [02]TURKEY MOH [01]

BFARM [01]

10HEALTH CANADA [02]GLP [01]SCC [02]

SERVICE PORTFOLIO

LAMBDALAMBDA

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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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PHASE‐I EXPERIENCE

The various Phase 01 studies carried out are as underThe various Phase 01 studies carried out are as under

Single Ascending Dose (SAD) ‐ First in Man

Multiple Ascending Dose (MAD)

PK StudiesPK Studies

Drug ‐ Drug Interaction

Food Effect Studies

/ dPK /PD studies 

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GLOBAL CLINICAL BED CAPACITY

S N C Cit N f B d N f Ph 1 B d N f ICU B dSr. No Country City No. of Beds No. of Phase‐1 Beds No. of ICU Beds

1 IndiaAhmedabad 360 16 8

1 IndiaMumbai 63 ‐ 2

2 Canada Toronto 128 12 ‐

Total number of beds 551 28 10

589Lambda’s current total bed capacity is 589 beds globally

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GLOBAL VOLUNTEER DATABASE

l i Ah d b d M b i T tPopulation Ahmedabad Mumbai Toronto

Healthy Male 47,500 8,500 60,000

Healthy Female with  childbearing potential 3,890 300 30,000

PM & Surgically Sterile Women 2,260 300 2,200

Elderly 1,183 50 3,500

Patient PopulationsHypertensive, Schizophrenic, Diabetic, Cancer, Renal, Fast/Slow metabolizers, Obese, Migraineand Hepatic impaired Patients

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BIOAVAILABILITY / BIOEQUIVALENCE STUDIES

Formulations Experience:Oral Dosage Forms: g

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 & CANADA

Capabilities

Scientists with 10 + years of experience

Sample Storage

Controlled and monitored low temperatureScientists with 10 + years of experience

Capacity to analyse 75,000 + samples /month

Controlled and monitored low temperaturestorage (‐22±5°C,‐65±10°C)

Capacity to store 3 million samples

750+ validated methods ( incl. methods aslow as 0.5 pg/mL)

Approx 8‐10 new methods in developmentInfrastructure

Approx 8 10 new methods in developmentevery month.

Expertise to develop sensitive methods forNCEs in different species like Rat Mice Dog

Country LC‐MS/MS  FTIR *

India 34 3NCEs in different species like Rat, Mice, Dogand Monkey using low sample volume

Robust system for failure investigation

Canada 08 ‐

Total 42 3

GLP certified BA lab in India and Canada.

* Fourier Transform Infrared Spectroscopy

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BIOANALYTICAL LAB

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PAN‐OMICS  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 CandidatesTherapeutic Monoclonal Antibody Drug Candidates

Pharmacokinetics Based Studies: FSH and PTH Studies Ongoing.

Global and Targeted Metabolite Profiles: Biological Fluids including;

Molecular Biology and Genomics Profiling

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 30 multi‐centric trials across different geographies

Enrolled 5800+ patients in last 7 years in various therapeutic categories

Team with expertise in managing Multi‐Country Trials

Therapeutic Area Studies Patients Sites 

17 1044 1643% 6%

Oncology 

1 1944 48

2 720 59

8 491 50

50% 23%Musculoskeletal  

Gastrointestinal 

P hi t 8 491 50

3 766 49

1 120 8

9%3%6%

Psychiatry 

Respiratory 

Gyneacology 1 120 8

2 887 51

Gyneacology 

Dermatology 

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THERAPEUTIC / EFFICACY STUDIES IN ONCOLOGY

Therapeutic Category Patients Sites Regulatory Countries

S lid t 23 30 EMEA I di (Gl b l)Solid tumor  23 30 EMEA India (Global)

Solid tumor and hematologic tumor 17 28 EMEA India (Global)

NHL CLL MM 31 41 EMEA India (Global)NHL, CLL, MM 31 41 EMEA India (Global)

Hematolo‐oncology 162 43 EMEA Europe

Onco‐urology 259 33 EMEA Europe

Ovarian cancer 44 6 USFDA India

Locally advance or MBC 72 6 DCGI India

MBC 120 10 DCGI India

MBC (newly diagnosed ER/PR positive) 18 4 DCGI India

Chemotherapy induced neutropenia 100 5 DCGI India

Total 846 206

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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 Europe

Dermatology 852 30 EMEA, USFDA India & Poland

Musculoskeletal 1944 48 EMEA, USFDA India

Oth 1923 10 EMEA EOthers 1923 10 EMEA Europe

Total 10,754 377

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PATIENT BASED PHARMACOKINETIC STUDIES

Indication / Therapy Studies Patients Sites Submissions

Schizophrenia  8 491 50 5 FDA, 2 EMEA, 1 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 DCGI, EMEA

MBC 3 210 27 3 DCGI

ALL 1 16 4 Canada

Ovarian /Pancreatic 1 66 8 USFDA

Atopic dermatitis 1 72 19 EMEA

Total 29 Regulatory inspections at various sites: USFDA (25) & MoH‐Malaysia (4).

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GLOBAL NETWORK OF SITES

Investigator Sites

Europe: • Poland• Estonia

India:• Andhra Pradesh • Bihar

g

North America• Canada• USA• Estonia

• Latvia• Lithuania• Belarus

• Delhi • Gujarat• Haryana• Himachal Pradesh

Asia:• Sri Lanka• Bangladesh

• Ukraine• Romania• Bulgaria• Czech Republic

• Karnataka• Kerala• Madhya Pradesh• Maharashtra

• Taiwan

New geographies• CIS  countriesS th E t A iCzech Republic

• Germany• France• Spain

• Punjab• Rajasthan• Tamil Nadu• Uttar Pradesh

• South East Asia• Latin America

Uttar Pradesh• West Bengal

(* Many countries are covered by our own CRAs, in some countries freelance CRAs or partner CRAs)25

CLINICAL DATA MANAGEMENT SERVICES

eCRF / pCRF & database designing

CRF annotation as per CDISC

Data Management & Data Validation Plan

UAT, Data validation & Query resolution

Medical Coding, External data upload

Onsite / remote trainings for the study team and site staff

BIOSTATISTICS SERVICES

Protocol inputs, Sample size estimation and Study Design

SAP Preparation & Mock shells creation

Production of customized Tables, Listings and Graphs

Statistical analysis & Reporting for BABE, CT (Phase I to IV) & Registry projects

CDISC SDTM ADaM dataset submissionCDISC SDTM ADaM dataset submission

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SOFTWARE IN BIOMETRICS

Software Version Description

BIZNET® (CTM & BABE) 4 0 EDC / CRF CDMS l tfBIZNET® (CTM & BABE) 4.0 EDC / eCRF CDMS platform

MedDRA® 18.0 Medical Coding Dictionary

WHO‐DD 2007 Drug Coding Dictionaryg g y

WinNonlin® / Phoenix® 5.3 / 6.3 PK Analysis Software

SAS® Server  9.3 Statistical Analysis Software

BBIZIZNETNET

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MEDICAL IMAGING SERVICES

Study start‐up & Consultation:

Protocol & Study design, assessment criteria consultation etc

Site Support & Management:

Identification, Qualification, Training & Support

Study documents:Study documents: 

Acquisition Manual, Charter & Reviewer Manual

Image Management:

Image collection, QC, Project Management & Archival

Independent Review:

Training, Testing & Quality monitoring

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Paperless, Automated, Sturdy & Smart

Lambda Imaging Central Review PACS systemg g y

Developed under direct guidance of an experienced Radiologist

Complete Audit trail from Image Upload till Data ExportComplete Audit trail from Image Upload till Data Export

“Validated” & 21 CFR Part 11 compliant

No “manual errors” due to automated calculations

Built‐in error checks to prevent reviewer mistakes

iCRF for specific assessment criteria for Oncology, MSK, CNS, CVS etc.

Customizable RECIST 1.0 & RECIST 1.1 Icrf

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CENTRAL REFERENCE LABORATORY

BIOMARKERS &BIOSIMILARSBIOSIMILARS

IMMUNOGENICITY

CAP accredited

ASSAYDEVELOPMENTDEVELOPMENT

SAFETY TESTING

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CENTRAL REFERENCE LABORATORY

Accreditations & Certifications:

CAP (College of American Pathologists)

NABL (ISO 15189:2012]

Resources:

Team of Experienced Clinical Pathologists, Biotechnologists, Medical Technologists andTeam of Experienced Clinical Pathologists, Biotechnologists, Medical Technologists andProject Managers

Fully automated state of art analyzers

Validated LIMS

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CENTRAL REFERENCE LABORATORY

SERVICES:

pK of biosimilarsp

Biomarker analysis for early and late phase trials

Immunogenicity testing for biological therapeutic proteins, including MAbs

Central Laboratory services during Late Phase Trials – Customized Project Management

Microbiological Testing for Hygiene Products as per ASTM guidelines

EXPERIENCE:

25+ validated Biomarkers

First Indian Laboratory to offer Immunogenicity Testing services: Completed rHu‐EPO ,Darbepoetin Ranibizumab and RituximabDarbepoetin, Ranibizumab and Rituximab.

Completed pK for EPO, Peg‐GCSF , INF α 2b, Etanercept, Rituximab, Iron Sucrose and FSH.

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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 years.Successfully underwent 15 Regulatory audits for PV functionality in last 2 years.

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OPERATIONS  ‐ ‘HUB & SPOKE’ MODEL

UKUK[HQ]

INDIA

Europeani North

[Global back‐end Operations]

Union• LRPVs

North America• Canada • US• US  

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SPECTRUM OF SERVICES: BRIEF OVERVIEW

Operational

• Case Processing (ICSRs)

• Aggregate Reports (PSUR/PADER)

• Signal GenerationOperational Services

g

• Literature Screening

• EU Qualified Responsible Person

• Safety Database

PV System• Pharmacovigilance System Master File(PSMF)

• Safety Data Exchange Agreement

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SPECTRUM OF SERVICES: BRIEF OVERVIEW

Specialist

• Risk Management Plan (RMP)

• Risk Benefit Analysis

• Signal DetectionSpecialist Services

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• Responding to Regulatory Enquiries

• SOPs, WIs, Guidance

• Audits/Inspection support

Support Services

• Trainings/Consultancy

• CAPAs execution

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PROPRIETARY SAFETY DATABASE

ICSR PROCESSING: EFFECTIVE, 

GLOBAL SUBMISSION & 

EFFICIENT  SUPPORT

CLINICAL / CC OTRIAL/VACCINE  

MODULExEVMPDMODULE

LITERATURE AUTOMATION SIGNAL DETECTION

MODULESIGNAL DETECTION 

MODULE

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ADVANTAGE LAMBDA

Global footprint and world class infrastructure: India, UK, Europe, North America

Customized full spectrum services per clients drug development program:

End to End: Phase 1 / BA/BE / Late Phase / Bioanalytical / CDM / Central Laboratory /Pharmacovigilance / Medical ImagingPharmacovigilance / Medical Imaging

Bespoke services

Impeccable Regulatory track record

Capability to handle large multi‐centric trials

Niche expertise & experience of carrying out studies in

Biosimilars / Vaccines / Nutraceuticals / Cosmetics

Live database of healthy and patient populations

EDC platform for BE and Phase I‐IV studies

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• Global: • North America:

CONTACT• Global:

Dr. Mrinal KammiliExecutive DirectorGlobal Head‐Business Development

• North America:

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

mrinal@lambda‐cro.com

Mr. Akshaya Nath Senior Vice President

y p

Mr. Roger SteinDirector ‐Business Developmentroger.stein@lambdacanada‐cro.comSenior Vice President

Global Operations and Business Developmentakshayanath@lambda‐cro.com

Dr. Nermeen Varawalla

g

• Europe:

D P J DDr. Nermeen VarawallaExecutive Vice PresidentGlobal Clinical Trialsnermeenvarawalla@lambda‐cro.com

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

Ms. Beata Gralak ‐ DabrowskaMs. Beata Gralak  DabrowskaHead‐Late Phase Clinical Trials‐Polandbgralakdabrowska@lambda‐cro.com

T k

• Biometrics

Dr. Kamlesh PatelAssociate Vice President

• Turkey:

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

kamleshpatel@lambda‐cro.com

• Panomics

Dr Ravi Krovidi devrim@lambda cro.com

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Dr.  Ravi KrovidiAssistant General Managerravikrovidi@lambda‐cro.com

www.lambda‐cro.com

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