Post on 26-Mar-2020
……a Global CRO……a Global CRO
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OUR JOURNEY• Acquired 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• Lambda clinical operations go paperless by extending EDC globally
2011‐2016
• Initiated Late phase studies• Started Clinical Lab (CAP)Started Clinical Lab (CAP) • Launch of Mumbai Operations
• Acquired CRO in London, UK for PV services• Acquired CRO in Warsaw, Poland for Late Phase Trials• Cleared US‐FDA ANVISA DCGI etc inspections for BA/BE
2000‐20052006‐2010
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
• Awarded Best “Indian CRO “ in 2010 by Frost & Sullivan
• Incorporated in Ahmedabad, Gujarat, I di
Awarded Best Indian CRO in 2010 by Frost & Sullivan, US
1999
India• Initiated BA/BE & Bio‐analytical services
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GEOGRAPHICAL PRESENCE
Warsaw, Poland2007
Ahmedabad, India1999
London, UK2008
Mumbai, India2003
Toronto, Canada2010
Istanbul Turkey
New Delhi, India2009
Hyderabad IndiaIstanbul, Turkey2011
Bangkok, Thailand
Hyderabad, India2009
2011
Operational Capabilities:Asia Pacific Europe Other GeographiesAsia Pacific Europe Other Geographies
IndiaSri LankaThailand
l d h
UK, Germany FranceSpain Turkey PolandEstonia Belarus Czech Republick h
North AmericaLatin AmericaCIS Countries
hBangladesh Ukraine Romani Latvia LithuaniaBulgaria
South East Asia
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EXECUTIVE SUMMARY: LAMBDA
Indian CRO with a true global presence Best CRO of rating ‘AA‐’ in
long term and highest possible in short term ‘A1+’
Strong and stable Leadership team with >20 years of industry
End to end service offerings covering entire spectrum of clinical research from Phase‐I to IV
possible in short term A1+ in CARE
Company growing with a CAGR of ~20% p.a YoY.
years of industry experience
Multi continental presence:
Impeccable regulatory track record
Global Revenues of $ USD 50 million during last FY and growing....
• North America
• Europe
Front runner: in Medical Imaging & Panomics
Robust Digital platforms
• Asia
700+ employees globally
C stomi able & scalableg p
across service verticals Customizable & scalable business models
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LAMBDA LOCATIONS
W P l dAhmedabad, 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]
AGES [01]SCC [03]
[ ]
FAMHP [02] TURKEY MOH [01]EMA [01] BFARM [01]
CDSCO [15]
Thai MOH [04] CAP [07]
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 &BioequivalenceMedical Imaging Bioequivalenceg g
BioanalyticalCentral
Laboratory
PanomicsMedical Writing
Late Phase Clinical TrialsData Services
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Late Phase Clinical Trials(Phase II‐IV)
Data Services (BSP, CDM)
PHASE‐1: AT GLANCE
• 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 Mang g
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
D l d Ski V i d bili i f i l id
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
Canada
• Faster regulatory approval: ~35 days
• Parallel submission for MAD study in India
• Study start with healthy subjects followed by patientcohortscohorts
India
• Cost effective option for subsequent Phase ‐1 studies
• Easier Access for Renal and Liver impaired subjects study
• Naive patient pool, qualified medical doctors and hospitali f t tinfrastructure
Value Proposition• Cost Effective business model (Hybrid)
• Faster turn around time
• Global scientific overview
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• Flexible Operational approach
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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GLOBAL CLINICAL BED CAPACITY
Sr. No Country City No. of Beds No. of Phase‐1 Beds No. of ICU BedsNo
1 IndiaAhmedabad 360 16 8
Mumbai 66 ‐ 2Mumbai 66 2
2 Canada Toronto 128 12 ‐
Total number of beds 554 28 10
Lambda’s current total bed capacity is 592 beds globally
Total number of beds 554 28 10
p y g y
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GLOBAL VOLUNTEER DATABASE
Population Ahmedabad Mumbai Torontop
Healthy Male 50,700 8,500 60,000
Healthy Female with childbearing potential 4 380 300 30 000Healthy Female with childbearing potential 4,380 300 30,000
PM & Surgically Sterile Women 2,295 300 2,200
Eld l 1 255 50 3 500
Patient Populations:
Elderly 1,255 50 3,500
Patient Populations:
• Hypertensive • Fast/Slow metabolizers
• Schizophrenic • Obese
• Diabetic • Migraine
• Cancer • Hepatic impaired Patients
R l
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• Renal
BIOAVAILABILITY / BIOEQUIVALENCE STUDIES
Formulations Experience: Oral Dosage Forms:
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 & CANADACapabilities Scientists with 10 + years of experience
Capacity to analyse 75 000 + samples / month 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 andMonkey using low sample volume
Robust system for failure investigationy g
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
InfrastructureInfrastructureCountry LC‐MS/MS FTIR *
India 34 3
Canada 08 ‐
* Fourier Transform Infrared Spectroscopy
Total 42 3
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BIOANALYTICAL LAB
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PANOMICS 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 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
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 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 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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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
G t t l 1016 74 EMEA USFDA I di EU S i L kGastroenterology 1016 74 EMEA, USFDA India, EU, Sri Lanka
Cardiology 3653 62 EMEA Europe
U l 24 1 EMEA EUrology 24 1 EMEA Europe
Endocrinology 235 40 EMEA Europe
l l & dPulmonology 791 57 EMEA Europe & India
Diabetology 316 55 EMEA Europe
Dermatology 852 30 EMEA, USFDA India & Poland
Musculoskeletal 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
Atopic dermatitis 2 147 29 2 EMEA
Total 33 Regulatory inspections at various sites: USFDA (28), MoH‐Malaysia (4) & MHRA (1).
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GLOBAL NETWORK OF SITES
Europe: P l d
Investigator Sites
India:dh d h
New geographies*CIS i
North AmericaC d
Asia:S i L k • Poland
• Estonia• Latvia• Lithuania
• Andhra Pradesh• Bihar• Delhi • Gujarat
• CIS countries• South East Asia• Latin America
• Canada• USA
• Sri Lanka• Bangladesh
• Belarus• Ukraine• RomaniaB l i
Gujarat• Haryana• Himachal Pradesh• Karnataka
K l • Bulgaria• Czech Republic• Germany• France
• Kerala• Madhya Pradesh• Maharashtra• Punjab
• Spainu jab
• Rajasthan • Tamil Nadu• Telangana
Utt P d h• Uttar Pradesh • West Bengal
23*covered through partner CRO
DATA MANAGEMENT: OVERVIEW
Technology /Platforms:
BIZNET f CTM d
• DMP and DVP
Services:
• BIZNET for CTM and BA/BE
• MedDRA : 18.1• WHO‐DD:2007
Value Proposition:
• DMP and DVP • eCRF/CRF Designing• CCG & Lab Data T/f Guidelines• Database Designing • Database Testing and UAT
• 21CFR‐Part‐11 compliant EDC platform to support MedAff/LReg studies
• Paperless System to support BA/BE Data
Management
Database Testing and UAT• Medical Coding & Drug Coding• SAE Reconciliation • Data Migration• Data Upload: LIMS to Database
p y pp /Studies
• LPLV to DBL: 10 WD• Regulatory Inspected Platform
Data Upload: LIMS to Database• Data Review and Query Mgt. • Help Desk Support for sites etc Expertise:
• BA/BE Projects• Phase I• Phase‐I• Phase‐II to IV• Online Registry, Epi,
IIS, NIS, Observational etcObservational etc.
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BIO‐STATS & PROGRAMMING
Expertise:
• In Vitro Data Analysis
• PK/PD Analysis/ y
• Statistical 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
• 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
Ph i ® (Wi N li ®) 6 4 PK/PD A l i S fPhoenix® (WinNonlin®) 6.4 PK/PD Analysis Software
SAS® Server 9.3 Statistical Analysis Software
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MedSci: OVERVIEW
• Abstracts
• Posters
• IB
• Protocols
• RMPs
• REMS
• Review Articles
• Newsletters
• ePosters
• Oral Presentations
• CSRs
• Narratives
• DSURs
• PSURs
• Visual Aids
• LBLsPresentations
• Manuscripts
• Review Articles
• Literature Reviews
• Summary
• PBRERs
• PADERs
• Sales Force Training
• Training
• Drug Compendiums
• White Papers
Documents
• eCTD Modules
• ACOs
Modules
White Papers
• ADBOARDs
ACOs
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REPORT WRITING: EXPERTISE
Regional Therapeutic experience:C l i i h ll
Module 1
gAdmin
Information • Oncology
• Dermatology
Therapeutic experience: Complying with allapplicable regulatoryrequirements
2.4 NonclinicalOverview
2.5 Clinical
• Musculoskeletal
• Cardiology
QualityOverall
O e e
2.6 Nonclinical
Overview
2.7 Clinical2.7 Clinical
• Gastrointestinal
• Diabetology
• RespiratoryOverallSummary Summary SummarySummary
Cli i lCli i l
• Respiratory
Module 3
Quality
Module 4
NonclinicalStudy Reports
Module 5Module 5
ClinicalStudy Reports
ClinicalStudy Reports
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Module 4 Module 5Module 5
CENTRAL REFERENCE LABORATORY
• Biomarkers & Biosimilars
CAP• Immunogenicity
CAP
• Assay Development
• Safety Testing
NABL
Safety Testing
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CENTRAL REFERENCE LABORATORY
• CAP & NABL accredited
• Validated LIMS
• Clinical Pathologist
• Microbiologist
• Biosimilars
• Biomarkers
• 1st Indian Lab to offer Immunogenicity testing
• PK of Biosimilars testing
g
• Biotechnologist
• Medical Technologists
• Immunogenicity
• Assay Development• PK of Biosimilars testing
• 25+ validated Biomarkers
• Well defined SoPs and Work Instructions
• Safety Testing
• Microbiological Testing for hygiene products
• Pan‐India capabilities for sample logisticssample logistics
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MEDICAL IMAGING SERVICES
Study start‐up & Consultation:
Protocol & Study design, assessment criteria consultation etc
Project Management:
Site Support & Management
Image Management:
Image collection : MRI, CT Scan and X‐rayg , y
Project Management & Archival
Independent Review:
Training, Testing & Quality monitoring
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PACS: 21CFR part‐II
Compliantp
Board Certified
RadiologistCustomizable Evaluation RadiologistEvaluation Guidelines
Fully Automated with built in
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with built in QC system
MEDICAL IMAGING EXPERIENCE
Sr No Indication No of studies No of patients Imaging CriteriaSr. 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
4Unresectable or Metastatic Non‐squamous Non‐small cell Lung Cancer
1 129 RECIST 1.1Cancer
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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 yearsSuccessfully 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)
Operational Services• Aggregate Reports (PSUR/PADER)• Signal Generation• Literature Screening
• EU Qualified Responsible Person• Safety Database• Pharmacovigilance System Master File(PSMF)
PV System
• Safety Data Exchange Agreement
• Risk Management Plan (RMP)Ri k B fit A l iSpecialist Services • Risk Benefit Analysis
• Signal Detection• Responding to Regulatory Enquiries
p
• SOPs, WIs, Guidance• Audits/Inspection support• Trainings/Consultancy
Support Services
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g y• CAPAs execution
PROPRIETARY SAFETY DATABASE
LITERATURE AUTOMATION MODULE
ICSR PROCESSING: EFFECTIVE &
PRODUCT INQUIRY TRAIL & EFFECTIVE &
EFFICIENT TRAIL &
RESPONSE
GLOBALEVMPD GLOBAL SUBMISSION & SUPPORT
xEVMPDMODULE
SIGNAL DETECTION
CLINICAL TRIAL /
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DETECTION MODULEVACCINE
MODULE
WHY LAMBDA ?
• Strong Leadership• One‐stop solution• Phase‐I to IV
• Financial Stability (Credit Rating AA+)
• Global Footprint:• NA / EU / APAC
SPONSOR(Credit Rating AA+)
• CAGR ~20%• Futuristic approach:
• Medical Imaging• Proteomics
• NA / EU / APAC• World‐class Infrastructure
• Flexible Business Model • ProteomicsModel
• Impeccable regulatory track records
• > 5000 Pk studies
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CONTACT• Global: .
Dr. Mrinal KammiliExecutive Director
• North America: .
Ms. Cathy Lopez Director ‐Business Development
Global Head‐Business Developmentmrinal@lambda‐cro.com
pcathy.Lopez@lambdacanada‐cro.com
Richard TullyDirector‐ Business Development
M N h Si hp
richard.tully@lambdacanada‐cro.com
• Europe: .
Mr. Naresh SinghAssociate Vice PresidentBusiness Developmentnareshsingh@lambda‐cro.com
Dr. Peter‐Jan van DoornDirector, Business Developmentpeter@lambda‐cro.com
• Panomics: .
Dr. Ravi Krovidil
Mr. Chris CarterDirector, Business Development (Pharmacovigilance)chriscarter@lambda‐cro.com
Assistant General Managerravikrovidi@lambda‐cro.com
• Turkey: .
Ms. Devrim SabuncuogluManager ‐ Business Developmentdevrim@lambda‐cro.com
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Follow us on:
www.lambda‐cro.com
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