……a Global CRO……a Global CRO

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OUR GLOBAL PRESENCE

Warsaw, Poland2007

London, UK2008

Ahmedabad, India1999

Mumbai, India20032008

Toronto, Canada2010

2003

New Delhi, India2009

Istanbul, Turkey2011

Bangkok, Thailand

Hyderabad, India2009

2011

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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

US‐FDA [34]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 [02]

CDSCO [14]

FAMHP [02] TURKEY MOH [01]

Thai MOH [04] CAP [06]

EMA [01] BFARM [01]

NABL [03]OGYI [01]ANVISA [08]AIFA [01]

UK‐MHRA [10]

MHSD [01]

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SERVICE PORTFOLIO

LAMBDA

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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 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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PHASE‐I EXPERIENCE

The various Phase 01 studies carried out are as under

Single Ascending Dose (SAD) ‐ First in Man

Multiple Ascending Dose (MAD)

PK Studies

Drug ‐ Drug Interaction

Food Effect Studies

PK /PD studies 

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GLOBAL CLINICAL BED CAPACITY

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

Ahmedabad 360 16 81 India

Ahmedabad 360 16 8

Mumbai 63 ‐ 2

2 Canada Toronto 128 12 ‐

Total number of beds 551 28 10

Lambda’s current total bed capacity is 589 beds globally

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GLOBAL VOLUNTEER DATABASE

Population Ahmedabad Mumbai Toronto

Healthy Male 48000 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, Migraine andHepatic impaired PatientsHepatic impaired Patients

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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

750+ 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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PAN‐OMICS  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

Urine, 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 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  

2%5%

18%7% 2%

4%

Oncology

Musculoskeletal

28 1822 275

1 1944 482%

Gastrointestinal

Psychiatry

R i t

2 720 59

8 491 50

3 766 49

62%

Respiratory

Gyneacology

Dermatology

3 766 49

1 120 8

2 887 51gy

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THERAPEUTIC / EFFICACY STUDIES IN ONCOLOGY

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

1 CNS Tumor 4 38 USFDA, EMEA  160

2 ALL 1 5 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 # 3 26 USFDA, EMEA 158

7 Solid Tumor 1 4 DCGI 32

8 NSCLC 1 24 DCGI 120

* Also includes MBC patients. # Also 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  9 511 50 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 29 Regulatory inspections at various sites: USFDA (25) & MoH‐Malaysia (4).

Atopic dermatitis 2 147 29 2 EMEA

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GLOBAL NETWORK OF SITES

Europe: • Poland

India:• Andhra Pradesh

Investigator Sites

Asia:• Sri Lanka

New geographies• CIS countries

North America• CanadaPoland

• Estonia• Latvia• Lithuania• Belarus

• Andhra Pradesh • Bihar• Delhi • Gujarat• Haryana

Sri Lanka• Bangladesh• Taiwan

CIS  countries• South East Asia• Latin America

Canada• USA

Belarus• Ukraine• Romania• Bulgaria• Czech Republic

• Haryana• Himachal Pradesh• Karnataka• Kerala• Madhya PradeshCzech Republic

• Germany• France• Spain

• Madhya Pradesh• Maharashtra• Punjab• Rajasthan• Tamil Nadu• Tamil Nadu• Uttar Pradesh• West Bengal

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

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CLINICAL DATA MANAGEMENT SERVICES

eCRF / pCRF & database designing

CRF annotation as per CDISC

Data Management & Data Validation Plan 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

BIOSTATISTICS SERVICES

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 submission

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SOFTWARE IN BIOMETRICS

Software Version Description

BIZNET® (CTM & BABE) 4 0 EDC / eCRF CDMS platformBIZNET  (CTM & BABE) 4.0 EDC / eCRF CDMS platform

MedDRA® 18.0 Medical Coding Dictionary

WHO‐DD 2007 Drug Coding Dictionary

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 etcy g ,

Site Support & Management:

Identification, Qualification, Training & Support, Q , g pp

Study documents: 

Acquisition Manual, Charter & Reviewer Manualq ,

Image Management:

Image collection, QC, Project Management & Archival

Independent Review:

Training, Testing & Quality monitoring

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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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P l A d S d & SPaperless, Automated, Sturdy & Smart

Lambda Imaging Central Review PACS system

De eloped nder direct g idance of an e perienced Radiologist Developed under direct guidance of an experienced Radiologist

Complete Audit trail from Image Upload till Data Export

“Validated” & 21 CFR Part 11 compliant “Validated” & 21 CFR Part 11 compliant

No “manual errors” due to automated calculations

Built in error checks to prevent reviewer mistakes 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 Customizable RECIST 1.0 & RECIST 1.1 Icrf

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CENTRAL REFERENCE LABORATORY

BIOMARKERS &BIOSIMILARS

IMMUNOGENICITYIMMUNOGENICITY

CAP accredited

ASSAYDEVELOPMENT

SAFETY TESTING

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CENTRAL REFERENCE LABORATORY

Accreditations & Certifications:

CAP (College of American Pathologists)

NABL (ISO 15189:2012]NABL (ISO 15189:2012]

Resources:

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

Fully automated state of art analyzers Fully automated state of art analyzers

Validated LIMS

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CENTRAL REFERENCE LABORATORY

SERVICES:

pK of biosimilars

Bi k l i f l d l h i l 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 First Indian Laboratory to offer Immunogenicity Testing services: Completed rHu‐EPO ,Darbepoetin, 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).

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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OPERATIONS  ‐ ‘HUB & SPOKE’ MODEL

UK[HQ][HQ]

INDIA[Global back‐end 

North America• Canada 

EuropeanUnion

• LRPVs

Operations]

• US  

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SPECTRUM OF SERVICES: BRIEF OVERVIEW

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

Operational Services

• EU Qualified Responsible Person

• Signal Generation• Literature Screening

PV System• 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

ICSR PROCESSING: EFFECTIVE, EFFICIENT 

GLOBAL SUBMISSION & 

SUPPORT

CLINICAL TRIAL/VACCINE  

MODULExEVMPDMODULE

LITERATURE AUTOMATION 

MODULE

SIGNAL DETECTION MODULE MODULE

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MODULE

ADVANTAGE LAMBDA

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

Customized full spectrum services per clients drug development program:p p g p p g

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

Bespoke services

Impeccable Regulatory track record

Capability to handle large multi‐centric trials

Niche expertise & experience of carrying out studies in

Bi i il / V i / N t ti l / C ti Biosimilars / Vaccines / Nutraceuticals / Cosmetics

Live database of healthy and patient populations

EDC platform for BE and Phase I IV studies EDC platform for BE and Phase I‐IV 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

EMr. Akshaya Nath Senior Vice PresidentGlobal Operations and Business Developmentk h th@l bd

• Europe:

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

akshayanath@lambda‐cro.comMs. Beata Gralak ‐ DabrowskaHead‐Late Phase Clinical Trials‐Polandbgralakdabrowska@lambda‐cro.com

k

• Panomics

Dr.  Ravi KrovidiAssistant General Manager • Turkey:

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

Assistant General Managerravikrovidi@lambda‐cro.com

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Follow us on:Follow us on:

www.lambda‐cro.com

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