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……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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