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……a Global CRO……a Global CRO
1
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
2
LAMBDA HOUSE ‐ AHMEDABAD
3
LAMBDA HOUSE ‐ AHMEDABAD
4
LAMBDA HOUSE ‐ AHMEDABAD
5
LAMBDA HOUSE ‐ AHMEDABAD
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LAMBDA ‐ POLAND
7
LAMBDA ‐ UK
8
LAMBDA ‐ CANADA
9
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
11
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
12
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
14
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
15
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
17
BIOANALYTICAL LAB
18
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
19
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
20
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
21
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
22
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
23
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).
24
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
26
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
27
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.
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)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.
33
OPERATIONS ‐ ‘HUB & SPOKE’ MODEL
UKUK[HQ]
INDIA
Europeani North
[Global back‐end Operations]
Union• LRPVs
North America• Canada • US• US
34
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
35
SPECTRUM OF SERVICES: BRIEF OVERVIEW
Specialist
• Risk Management Plan (RMP)
• Risk Benefit Analysis
• Signal DetectionSpecialist Services
g
• Responding to Regulatory Enquiries
• SOPs, WIs, Guidance
• Audits/Inspection support
Support Services
• Trainings/Consultancy
• CAPAs execution
36
PROPRIETARY SAFETY DATABASE
ICSR PROCESSING: EFFECTIVE,
GLOBAL SUBMISSION &
EFFICIENT SUPPORT
CLINICAL / CC OTRIAL/VACCINE
MODULExEVMPDMODULE
LITERATURE AUTOMATION SIGNAL DETECTION
MODULESIGNAL DETECTION
MODULE
37
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
38
• 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
39
Dr. Ravi KrovidiAssistant General Managerravikrovidi@lambda‐cro.com
www.lambda‐cro.com
40