Lambda Therapeutic Research- Corporate Presentation

Lambda Therapeutic Research- Corporate Presentation

1. ……a Global CRO ……a Global CRO
1

2. OUR GLOBAL PRESENCE
Warsaw, Poland
2007
Ahmedabad, India
1999
London, UK
2008
TorontoCanada
Mumbai, India
2003
NewDelhiIndia
Toronto
, 
Canada
2010
Istanbul, Turkey
2011
New
 Delhi
, 
India 2009
Hyderabad, India
2009
2011 Bangkok, Thailand
2011
2009
2

3. LAMBDA HOUSE ‐AHMEDABAD
3

4. LAMBDA HOUSE ‐AHMEDABAD
4

5. LAMBDA HOUSE ‐AHMEDABAD
5

6. LAMBDA HOUSE ‐AHMEDABAD
6

7. LAMBDA ‐POLAND
7

8. LAMBDA ‐UK
8

9. LAMBDA ‐CANADA
9

10. 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
]
10
HEALTH CANADA [02]
GLP [01]
SCC [02]

11. SERVICE PORTFOLIO
LAMBDA LAMBDA
11

12. PHASE‐I CAPABILITIES: INDIA & CANADA
ƒDedicated state‐of‐the‐art ICU’s
Central Cardiac Monitoring System Cardiac Telemetry/ Holters / IV Infusion Pumps
ƒX‐ray, Ultrasound facilities
ƒTET studies  
GE MUSE s
y
stem for ECG 
p
rocessin
g
 and mana
g
ement
ypgg
GE Apex Pro Telemetry System / DASH 4000 Cardiac Monitors Multilevel ECG reading by Cardiologists  Internet access to ECG data through ECG web portal
ƒPulmonary Function Testing (PFT) 
ƒCognitive testing (CDR) 
ƒGastroesophageal monitoring
12

13. PHASE‐I EXPERIENCE
ThevariousPhase01studiescarriedoutareasunder The
 various
 Phase
 01
 studies
 carried
 out
 are
 as
 under
ƒSingle Ascending Dose (SAD) ‐First in Man ƒMultiple Ascending Dose (MAD)
ƒ
PKStudies PK
 Studies
ƒDrug ‐Drug Interaction ƒFood Effect Studies
/d
ƒPK 
/
PD stu
d
ies 
13

14. GLOBAL CLINICAL BED CAPACITY
SN
C
Cit
NfBd
NfPh
1Bd
NfICUBd
S
r. 
N
o
C
ountry
Cit
y
N
o. o
f
 B
e
d
s
N
o. o
f
 Ph
ase‐
1
 B
e
d
s
N
o. o
f
 ICU
 B
e
d
s
1
India
Ahmedabad 360 16 8
1
India
Mumbai 63‐2
2 Canada Toronto 128 12‐
Total number of beds 551 28 10
589
Lambda’s current total bed capacity is 
589
beds globally
14

15. GLOBAL VOLUNTEER DATABASE
li
Ah dbd
Mbi
Tt
Popu
lat
ion
Ah
me
d
a
b
a
d
M
um
b
a
i
T
oron
t
o
Healthy Male 47,500 8,500 60,000
Healthy Female with  childbearing potential3,890 300 30,000
PM & Surgically Sterile Women 2,260 300 2,200
Elderly 1,183 50 3,500 Patient Populations
Hypertensive, Schizophrenic, Diabetic, Cancer, Renal, Fast/Slow metabolizers, Obese, Migraine
and Hepatic impaired Patients
15

16. BIOAVAILABILITY / BIOEQUIVALENCE STUDIES
Formulations Experience:
ƒOral Dosa
g
e Forms: 
g
Tablets and Capsules Suspensions Buccal Buccal Sublingual Lozenges
ƒInjectables:  IV, IM, SC
ƒInhalers
ƒNasal sprays
ƒSuppositories
ƒTransdermal patches 
ƒ
Ointments&Creams
ƒ
Ointments
 &
 Creams
ƒIntravaginal tabs
Lbdhdtd5000BEtditilldtlbll L
am
bd
a 
h
as con
d
uc
t
e
d
 over 
5000
 BE
 s
t
u
di
es 
till
 d
a
t
e g
lo
b
a
ll
y
16

17. BIOANALYTICAL : INDIA & CANADA
Capabilities
ƒ
Scientists
with
10
+
years
of
experience
Sample Storage
ƒ
Controlled
and
monitored
low
temperature
ƒ
Scientists
with
10
+
years
of
experience
ƒCapacity to analyse 75,000 + samples /
month
ƒ
Controlled
and
monitored
low
temperature
storage (‐22±5°C,‐65±10°C)
ƒCapacity to store 3 million samples
ƒ750+ validated methods ( incl. methods as
low as 0.5 pg/mL)
ƒ
Approx
8
‐
10
new
methods
in
development
Infrastructure
Approx
8
10
new
methods
in
development
every month.
ƒExpertise to develop sensitive methods for
NCEs
in
different
species
like
Rat
Mice
Dog
Country LC‐MS/MS FTIR *
India 34 3
NCEs
in
different
species
like
Rat
,
Mice
,
Dog
and Monkey using low sample volume
ƒRobust system for failure investigation
Canada 08‐
Total 42 3
ƒGLP certified BA lab in India and Canada.
* Fourier Transform Infrared Spectroscopy
17

18. BIOANALYTICAL LAB
18

19. PAN‐OMICS  SERVICES FOR CLINICAL RESEARCH
DNA
RNA
Et ti
Tt
DNA
&
iRNA
Ali
Ml l
GENOMICS
DNA
,
RNA
E
x
t
rac
ti
ons,
T
arge
t
DNA
&
m
iRNA
A
na
lys
is,
M
o
lecu
lar
Diagnosis of Bacteria and Viruses
SDS PAGE Anal
y
sis
,
Western Blottin
g,
Pe
p
tide Ma
pp
in
g,
Protein
PROTEOMICS
y,
g,
p
pp g,
Characterization, Biosimilars, Targeted Proteomics, etc Global Metabolite Profiling, Targeted and Untargeted Metabolite
i
h
Ci
Ali
METABOLOMICS
D
etect
ion,
P
at
h
way
C
entr
ic
A
na
lys
is
19

20. PANOMICS SERVICES
0.52
5.51
7.98
4.72
5.92
6.127.39
3.75
4.16
3.119.82
2.18
2.59
1.74
9.12
Protein Characterization Studies & Biosimilars Analysis
0.
ƒGlobal Proteomics Profiling: Protein identifications, & Validation
ƒIntact Protein and Peptide Mapping Analysis ‐Innovator and Competitor
Therapeutic
Monoclonal
Antibody
Drug
Candidates
Therapeutic
Monoclonal
Antibody
Drug
Candidates
ƒPharmacokinetics Based Studies: FSH and PTH Studies Ongoing.
ƒGlobal and Targeted Metabolite Profiles: Biological Fluids including;
Molecular
Biology
and
Genomics
Profiling
Urine, Serum & In‐vitro Based Studies.
Molecular
Biology
and
Genomics
Profiling
ƒGenomics Based Studies: DNA , RNA extractions, miRNA analysis ƒPharmacogenomics Studies: Profiling for Potential Responders
ƒRT‐PCR Validation Studies: Serum and Tissue Samples, Biomarkers
20

21. CLINICAL TRIAL EXPERIENCE
ƒCarried out more than 30 multi‐centric trials across different geographies ƒEnrolled 5800+ patients in last 7 years in various therapeutic categories
ƒTeam with expertise in managing Multi‐Country Trials
Therapeutic Area Studies Patients Sites 
17 1044 164
3%6%
Oncology 
1 1944 48
2 720 59
8
491
50
50%
23%
Musculoskeletal   Gastrointestinal  Phit
8
491
50
3 766 49 1
120
8
9%
3%
6%
P
syc
hi
a
t
ry 
Respiratory  Gyneacology
1
120
8
2 887 51
Gyneacology
 
Dermatology 
21

22. THERAPEUTIC / EFFICACY STUDIES IN ONCOLOGY
Therapeutic Category Patients Sites Regulatory Countries
S lidt
23
30
EMEA
Idi(Gl b l
)
S
o
lid
 t
umor 
23
30
EMEA
I
n
di
a 
(Gl
o
b
a
l)
Solid tumor and hematologic tumor 17 28 EMEA India (Global) NHLCLLMM
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

23. 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
E
Oth
ers
1923
10
EMEA
E
urope
Total 10,754 377
23

24. 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, 1ANVISA
MBC, MCC 7 560 76 1 CANADA, 3 FDA, 2 EMEA, 1ANVISA
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

25. GLOBAL NETWORK OF SITES
Investi
g
ator 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
•
CzechRepublic
•Karnataka
•Kerala
•Madhya Pradesh
•Maharashtra
•Taiwan
New geographies
•CIS  countries
SthEtAi
Czech
 Republic
•Germany
•France
•Spain
•Punjab
•Rajasthan
•Tamil Nadu
•
UttarPradesh
•
S
ou
th
 E
as
t
 A
s
ia
•Latin America
Uttar
 Pradesh
•West Bengal
(* Many countries are covered by our own CRAs, in some countries freelance CRAs or partner CRAs)
25

26. CLINICAL DATA MANAGEMENT SERVICES
ƒeCRF / pCRF & database designing
ƒCRF annotation as per CDISC
ƒData Management & Data Validation Plan
ƒUAT, Data validation & Query resolution
ƒMedical Coding, External data upload
ƒOnsite / remote trainings for the study team and site staff
BIOSTATISTICS SERVICES
ƒProtocol inputs, Sample size estimation and Study Design
ƒSAP Preparation & Mock shells creation
ƒProduction of customized Tables, Listings and Graphs
ƒStatistical analysis & Reporting for BABE, CT (Phase I to IV) & Registry projects
ƒ
CDISC
SDTM
ADaM
dataset
submission
ƒ
CDISC
SDTM
ADaM
dataset
submission
26

27. SOFTWARE IN BIOMETRICS
Software Version Description
BIZNET®(CTM&BABE)
40
EDC
/
CRF
CDMSltf
BIZNET®
 (CTM
 &
 BABE)
4
.
0
EDC
/
 e
CRF
CDMS
 p
la
tf
orm
MedDRA® 18.0 Medical Coding Dictionary
WHO‐DD 2007 Dru
g
Codin
g
 Dictionar
y
g
gy
WinNonlin®/ Phoenix® 5.3 / 6.3 PK Analysis Software
SAS® Server 9.3 Statistical Analysis Software
B B
IZ IZ
NET NET
27

28. MEDICAL IMAGING SERVICES
Study start‐up & Consultation:
ƒProtocol & Study design, assessment criteria consultation etc
Site Support & Management:
ƒIdentification, Qualification, Training & Support
Studydocuments: Study
 documents:
 
ƒAcquisition Manual, Charter & Reviewer Manual
Image Management:
ƒImage collection, QC, Project Management & Archival
Independent Review:
ƒTraining, Testing & Quality monitoring
28

29. Paperless, Automated, Sturdy & Smart
ƒLambda Ima
g
in
g
Central Review PACS s
y
stem
gg
y
ƒDeveloped under direct guidance of an experienced Radiologist ƒ
Complete
Audit
trail
from
Image
Upload
till
Data
Export
ƒ
Complete
Audit
trail
from
Image
Upload
till
Data
Export
ƒ“Validated” & 21 CFR Part 11 compliant ƒNo “manual errors” due to automated calculations
ƒBuilt‐in error checks to prevent reviewer mistakes
ƒiCRF for specific assessment criteria for Oncology, MSK, CNS, CVS etc.
ƒCustomizable RECIST 1.0
&
RECIST 1.1 Icrf
29

30. CENTRAL REFERENCE LABORATORY
BIOMARKERS &
BIOSIMILARS BIOSIMILARS
IMMUNOGENICITY
CAP accredited
ASSAY
DEVELOPMENT DEVELOPMENT SAFETY TESTING
30

31. CENTRAL REFERENCE LABORATORY
Accreditations & Certifications:
ƒCAP (College of American Pathologists) ƒNABL (ISO 15189:2012]
Resources:
ƒ
Team
of
Experienced
Clinical
Pathologists,
Biotechnologists,
Medical
Technologists
and
Team
of
Experienced
Clinical
Pathologists,
Biotechnologists,
Medical
Technologists
and
Project Managers
ƒFully automated state of art analyzers
ƒValidated LIMS
31

32. CENTRAL REFERENCE LABORATORY
SERVICES: ƒ
p
Kofbiosimilars
p
ƒBiomarkeranalysis for early and late phase trials
ƒImmunogenicitytesting for biological therapeutic proteins, including MAbs
ƒCentral Laboratory services during Late Phase Trials – Customized Project Management
ƒMicrobiological Testing for Hygiene Products as per ASTM guidelines
EXPERIENCE: ƒ25+ validated Biomarkers
ƒFirst Indian Laboratory to offer Immunogenicity Testing services: Completed rHu ‐EPO ,
Darbepoetin
Ranibizumab
and
Rituximab
Darbepoetin
,
Ranibizumab
and
Rituximab
.
ƒCompleted pK for EPO, Peg‐GCSF , INFα2b, Etanercept, Rituximab, Iron Sucrose and FSH.
32

33. PHARMACOVIGILANCE
ƒOffices in UK (London), India (Ahmedabad) and Canada (Toronto) ƒGlobal 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)
.
ƒCost effective, customizable, user friendly , regulatory compliant safety database.
ƒ
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

34. OPERATIONS  ‐‘HUB & SPOKE’ MODEL
UKUK
[HQ] INDIA
European
i
North
[Global 
back‐end 
Operations]
Un
ion
•LRPVs
North
 
America
•Canada 
•
US
•
US
  
34

35. SPECTRUM OF SERVICES: BRIEF OVERVIEW
Operational
•Case Processing (ICSRs)
•Aggregate Reports (PSUR/PADER)
•Si
g
nal Generation
Operational
 
Services
g
• Literature Screening •EU Qualified Responsible Person
•Safety Database
PV System
• Pharmacovigilance System Master File(PSMF)
•Safety Data Exchange Agreement
35

36. SPECTRUM OF SERVICES: BRIEF OVERVIEW
Specialist
•Risk Management Plan (RMP)
•Risk Benefit Analysis
•Si
g
nal Detection
Specialist
 
Services
g
• Responding to Regulatory Enquiries •SOPs, WIs, Guidance
• Audits/Inspection support
Support 
Services
• Trainings/Consultancy
• CAPAs execution
36

37. PROPRIETARY SAFETY DATABASE
ICSR PROCESSING: 
EFFECTIVE, 
GLOBAL 
SUBMISSION & 
EFFICIENT 
SUPPORT
CLINICAL 
/CC
O
TRIAL/VACCINE
  
MODULE
xEVMPD M
O
DULE
LITERATURE 
AUTOMATION 
SIGNALDETECTION
MODULE
SIGNAL
 DETECTION
 
MODULE
37

38. ADVANTAGE LAMBDA
ƒGlobal footprint and world class infrastructure: India, UK, Europe, North America ƒCustomized full spectrum services per clients drug development program:
9EndtoEnd:Phase1/BA/BE/LatePhase/Bioanalytical / CDM / Central Laboratory /
Pharmacovigilance
/
Medical
Imaging
Pharmacovigilance
/
Medical
Imaging
9Bespoke services
ƒImpeccable Regulatory track record
ƒCapability to handle large multi ‐centric trials
ƒNiche expertise & experience of carrying out studies in
9Biosimilars / Vaccines / Nutraceuticals / Cosmetics
ƒLive database of healthy and patient populations
ƒEDC platform for BE and Phase I ‐IV studies
38

39. •
Global:
•
NorthAmerica
:
CONTACT
•
Global: Dr. Mrinal Kammili
Executive Director
Global Head‐Business Develo
p
ment
•
North
 America
:
Ms. Cathy Lopez 
Director ‐Business Development
cath
y
.Lo
p
ez@lambdacanada‐cro.com
p
mrinal@lambda‐cro.com Mr. Akshaya Nath  SeniorVicePresident
yp
Mr. Roger Stein
Director ‐Business Development
ro
g
er.stein@lambdacanada‐cro.com
Senior
 Vice
 President
Global Operations and Business Development
akshayanath@lambda‐cro.com
Dr.
Nermeen
Varawalla
g
•Europe
:
DP
J
D
Dr.
 Nermeen
Varawalla
Executive Vice President
Global Clinical Trials
nermeenvarawalla@lambda‐cro.com
D
r. 
P
eter‐
J
an van 
D
oorn
Director, Business Development
peter@lambda‐cro.com
Ms.BeataGralak
‐
Dabrowska
Ms.
 Beata
 Gralak
 
Dabrowska
Head‐Late Phase Clinical Trials‐Poland
bgralakdabrowska@lambda‐cro.com
Tk
•Biometrics
Dr. Kamlesh Patel
Associate Vice President
•
T
ur
k
ey:
Ms. Devrim  Sabuncuoglu
Manager ‐Business Development
devrim@lambda
‐
cro.com
kamleshpatel@lambda‐cro.com
•Panomics
DrRaviKrovidi
devrim@lambda
cro.com
39
Dr
.  
Ravi
 Krovidi
Assistant General Manager
ravikrovidi@lambda‐cro.com

40. www.lambda‐cro.com
40