2. 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 services
2000 2005
2006-2010
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,
US
1999
Incorporated in Ahmedabad, Gujarat,
India
• Initiated BA/BE & Bio-analytical services
2
3. GEOGRAPHICAL PRESENCE
Warsaw, Poland
2007
London UK
Ahmedabad, India
1999
Mumbai IndiaLondon, UK
2008
Toronto, Canada
2010
Mumbai, India
2003
New Delhi, India
20092010
Istanbul, Turkey
2011
2009
Hyderabad, India
2009
Bangkok, Thailand
2011
Operational Capabilities:Operational Capabilities:
Asia Pacific Europe Other Geographies
India
Sri Lanka
Thailand
UK, Germany France
Spain Turkey Poland
Estonia Belarus Czech Republic
North America
Latin America
CIS CountriesThailand
Bangladesh
Estonia Belarus Czech Republic
Ukraine Romani Latvia Lithuania
Bulgaria
CIS Countries
South East Asia
3
4. 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 globally
Robust Digital platforms
across service verticals
Customizable & scalable
business models
4
8. SERVICE PORTFOLIO
Phase-1
(First in Man)
Pharmacovigilance
Bioavailability &
Bioequivalence
Medical Imaging
C t l
Bioanalytical
Central
Laboratory
Late Phase Clinical Trials
(Phase II-IV)
Medical Writing
8
Data Services
(BSP, CDM)
9. 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 including
Oral, Parenteral, Inhalers etc
9To be continued...
• Developed Skin Vasoconstrictor study capabilities for topical steroids
10. 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 patient
cohorts
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 hospital
infrastructure
Value Proposition
• Cost Effective business model (Hybrid)
• Faster turn around time
• Global scientific overview
Value Proposition
10
Global scientific overview
• Flexible Operational approach
11. 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
11
12. GLOBAL CLINICAL BED CAPACITY
Sr.
No
Country City No. of Beds No. of Phase-1 Beds No. of ICU Beds
1 India
Ahmedabad 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 592beds globally
12
13. 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
13
• Renal
14. 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
14
15. C biliti
BIOANALYTICAL : 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 and
k 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
Infrastructure Country LC-MS/MS FTIR *
India 34 3
Canada 08
* Fourier Transform Infrared Spectroscopy
Canada 08 -
Total 42 3
15
17. 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
17
19. 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
19
21. 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
22. 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 WD
l 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.
22
23. 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
23
24. 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
24
26. REPORT WRITING: EXPERTISE
Regional
Admin
Therapeutic experience:Complying with all
li bl l
Module 1
Information
2 5
• Oncology
• Dermatology
• Musculoskeletal
applicable regulatory
requirements
2.4 Nonclinical
Overview
2.5
Clinical
Overview
• Cardiology
• Gastrointestinal
• Diabetology
Quality
Overall
Summary
2.6 Nonclinical
Summary
2.7 Clinical
Summary
2.7 Clinical
Summary
• Diabetology
• Respiratory
Module 3
Quality Nonclinical
Study Reports
Clinical
Study Reports
Clinical
Study Reports
26
Module 4 Module 5Module 5
27. CENTRAL REFERENCE LABORATORY
• Biomarkers & Biosimilars
CAP
• Immunogenicity
• Assay Development
NABL
• Safety Testing
27
28. CENTRAL REFERENCE LABORATORY
• CAP & NABL accredited
• Validated LIMS
• 1st Indian Lab to offer
• Clinical Pathologist
• Microbiologist
• Biotechnologist
• Biosimilars
• Biomarkers
• Immunogenicity
Immunogenicity 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
28
29. 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
29
31. 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’) 1 120
Fracture Healing
Assessment
Criteria
Unresectable or Metastatic Non-
4 squamous Non-small cell Lung
Cancer
1 129 RECIST 1.1
31
32. 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
32
33. SPECTRUM OF SERVICES: BRIEF OVERVIEW
• Case Processing (ICSRs)
• Aggregate Reports (PSUR/PADER)
• Signal Generation
Operational Services
• EU Qualified Responsible Person
PV 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
33
• Trainings/Consultancy
• CAPAs execution
34. PROPRIETARY SAFETY DATABASE
LITERATURE
AUTOMATIO
N MODULE
ICSR
PROCESSING:
EFFECTIVE &
EFFICIENT
PRODUCT
INQUIRY
TRAIL &
RESPONSE
GLOBAL
SUBMISSION
& SUPPORT
xEVMPD
MODULE
SIGNAL
CLINICAL
TRIAL /
34
DETECTION
MODULE
TRIAL /
VACCINE
MODULE
35. 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
35
36. CONTACT
• Global: . • North America: .
M C h LDr. Mrinal Kammili
Executive Director
Global Head-Business Development
mrinal@lambda-cro.com
Ms. Cathy Lopez
Director -Business Development
cathy.Lopez@lambdacanada-cro.com
Richard TullyRichard Tully
Director- Business Development
richard.tully@lambdacanada-cro.com
Mr. Naresh Singh
Associate Vice President
Business Development
nareshsingh@lambda-cro.com
• Turkey: .
Ms. Devrim Sabuncuoglu
nareshsingh@lambda cro.com
Ms. Devrim Sabuncuoglu
Manager - Business Development
devrim@lambda-cro.com
36
