2. Among top 25 Business Group in INDIA
Among top 25 Business Groups of India, GVK Group has diverse business interests with
committed investments of over $20B.
Life Sciences
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Hospitality
Airports
Energy
GVK BIO Confidential
Resources
Transportation
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3. GVK BIO : Preferred Partner across R&D value chain
IND
DISCOVERY SERVICES
CLINICAL DEVELOPMENT (CLINOGENT)
• Computational Chemistry • PK/ADME profiling
and Molecular Modeling
• In Vivo/In Vitro
Pharmacology
• Synthetic Chemistry
• Library Design and
Synthesis
• Analytical Chemistry
• Medicinal Chemistry
ANDA
NDA
PoC
• Bio analytical Services
DISCOVERY
• Clinical Pharmacology (BA/BE)
• Bio-Analysis of samples (Biologics and Small Molecules)
• Phase ll – IV Clinical Studies
RESEARCH
• Non GLP Toxicology
•
Clinical Operations
• Data Management, Bio Statistics, Medical Writing
• GLP Toxicology**
• 3 IND candidates delivered to
clients (IP assigned to client)
** To be setup in the FORMULATION R&D and MANUFACTURING*
future
• Focused Therapeutic Areas:
• Pre-Formulation R&D
• Analytical R&D, Stability testing
• High Throughput Screening
Oncology, Pain, Inflammation, M
• Formulation R&D
• cGMP Clinical Supply
etabolic-Disorders
• Assay Development
• Intellectual Property and Regulatory • cGMP Formulation Manufacturing
• Strong scientific Program
• Radio-Isotope labeling
management capabilities
• Metabolite Identification
API R&D and MANUFACTURING (INOGENT)
• Team with hands-on experience
• Reagent Generation
in Research Programs of big
• ProcessDiscovery and
Pharma
Development
• Flexibility in resourcing as
• Analytical Services
required by programs
• Custom Chemical Synthesis
* FY14
• cGMP Contract Manufacturing
• API and Intermediate Manufacturing
INFORMATICS and ANALYTICS
• GOSTAR Database
• GOBIOM Database
• Clinical Trial Outcome Databases
• Drug Repositioning
• Patent Services
• PK/PD Modeling (with partner)
• Bio IT
• Curation Services
** To be setup in the future
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4. GVK BIO : Client Engagement Models
3. Strategic Co-inventor
Discovery Research to
generate IP for client
2. Research Partner
Discovery Services
around a Target
1. Execute
Quality Standalone
Services
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Multiple Standalone
Services
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5. : Quality Stand-alone Services
Hit Generation
Hit Identification
Lead Optimization
IND
Medicinal & Synthetic Chemistry
Computational Chemistry
• QSAR & Pharmacophore
Models
• Design & Synthesis
• Specialty Chemistry
• Homology Modeling
• SBDD & Fragment based
Design
Process R&D and CCS
•
Lead Optimization
Biology
• Route Selection & Optimization
• In Vitro
• GMP Manufacturing & Validation
• ADME/PK
• Contract Manufacturing
• Animal Models
• Safety Pharmacology
Back
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6. : Discovery Services around a Target
Project Management Team
Hit Generation
Hit Identification
Computational Chemistry
Lead Optimization
Centralized Project
Management
IND
Medicinal & Synthetic Chemistry
• QSAR & Pharmacophore
Models
• Design & Synthesis
• Homology Modeling
• Lead Optimization
• Specialty Chemistry
• SBDD & Fragment based
Design
Process R&D and CCS
Discovery Services Around
a Target
Biology
• Route Selection &
Optimization
• In Vitro
• GMP Manufacturing &
Validation
• Animal Models
• ADME/PK
• Safety Pharmacology
• Contract Manufacturing
Back
11/13/2013
Case Study
GVK BIO Confidential
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7. : Discovery Research to Generate IP for the Client
• Hit Generation
Virtual Screening, HTS,
Fragment-based Screening
• Lead Identification
Identification of potent
selective compounds with
desired PK properties
• Lead Optimization
PK efficacy and safety
profile to deliver clinical
candidate
Program
Hit
Setup
Validation
• Project feasibility
• Reference
compound
synthesis
• Assay
development
• Potency/ADME
• Profiling of
reference
compounds
Drug
Lead
Candidate
Optimization
Regulatory Studies
• Medicinal
Chemistry
• Medicinal
Chemistry
• Informatics
• In Vitro potency
• In Vitro potency
• Selectivity
• Selectivity
profiling
• In-depth ADME,
PK, In vivo
efficacy
• ADME, PK, In vivo
IND
• GLP/GMP
manufacturing:
PMDA
• Metabolism
• Met ID
Characterization
• Exploratory Tox
• Patent filing
• Virtual library
design
Back
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Case Study
GVK BIO Confidential
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10. Computational Chemistry
In silico Drug Discovery
Ligand
based design
e-ADME
Virtual
Screening – Hit
Identification
Hit Optimization
Lead Identification
Lead Optimization
Receptor
based design
Toxicity
Models
Differentiator
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11. Virtual Screening & e-ADMET
Ligand
based design
e-ADME
Virtual Screening
– Hit
Identification
Hit Optimization
Lead Identification
Lead Optimization
Receptor
based design
Ligand - based design
•
Feature, and shape field-
Toxicity
Models
Receptor - based design
e-ADME
Toxicity Models
based pharmacophore
In silico Target
•
Aqueous solubility
•
Hepatotoxicity
identification and validation
•
•
Microsomal stability
•
hERG Model
•
Caco-2 and MDCK
•
Carcinogenicity Model
permeability
•
Mutagenicity Model
models
•
Homology modeling
•
Similarity & diversity analysis
•
De novo compound design
•
Scaffold hopping Studies
•
Binding pose & interaction
•
Blood–brain barrier (BBB),
•
LD50 & LC50 Models
•
Bio-isostere replacement
fingerprinting analysis
•
Human intestinal
•
Skin Sensitization
studies
•
Virtual Library Screening
•
QSAR Models
•
Structure-based
absorption (HIA)
pharmacophore modeling
•
Focused library design &
enumeration
•
•
Plasma protein binding
(PPB)
•
Oral bioavailability
Receptor Based Screening
Differentiator
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12. Hit & Lead Identification & Optimization
Ligand
based design
e-ADME
Hit Optimization
Virtual Screening
– Hit
Identification
Lead Identification
Lead Optimization
Receptor
based design
Toxicity
Models
Lead Identification &
Optimization
Hit Identification &
Optimization
•
Docking & Pharmacophore analysis
•
Bio-isostere replacement
•
Drug/lead like filters
•
Library Enumeration
•
Synthetic feasibility
•
SAR Analysis
•
Patent busting approach
•
Potency and Selectivity
•
Novelty Analysis
•
ADMET Analysis
•
SAR Analysis
•
Multi Parameter Optimisation
•
ADMET Analysis
•
IP Analysis
•
FEB, QM-MM, Semiempirical, DFT, ab initio studies
Differentiator
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21. Analytical Services
• Isolation, purification and characterization
of New Chemical Entities
• Expertise in SFC, mass-based high
throughput library purification services
• cGMP compliant analytical services from
pre-clinical to commercial phase lll supplies
in compliance with current regulatory
requirements
• cGMP compliant stability studies as per
ICH prescribed conditions
Complete spectrum of Analytical Services
Discovery
Medchem
Preclinical
Drug Candidate
Phase 1 to III
Differentiator
Detail
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IND
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22. Analytical Services
Regulatory focussed analytical services (for Generics)
• Method Development and Validation
• Complete Impurity Profiling (identification, isolation and structural
elucidation of organic impurities and isomers)
• Complete Analytical Services for Residual solvents, Residual metal
content and Genotoxic Impurities
• Polymorph / Powder characterization
• Accelerated and Real time Stability Studies
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26. Clinical Research
Clinical Operations Services
Regulatory
Clinical
Monitoring
Medical
Affairs
Allied Services
Project
Management
Data
Management
Biostatistics
Medical
Writing
Quality
Assurance
Study experience more than
14 therapeutic areas
Differentiator
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27. Clinical Research
Differentiators
Multiple Regulatory Agencies
Across Therapeutic Areas
Infectious Disease
MHRA
12%
18%
Vaccines
14%
Oncology
USFDA
39%
10%
GI
10%
Gynaecology
8%
8%
CNS
DCGI
41%
8%
Dermatology
7%
CVS
7%
Pain Management
6%
Ophthalmology
3%
Nutrition
3%
Bone Disease
3%
Others
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1%
MOH
Bangladesh
• Hands-on experience of working in more than 14
TA’s covering approx. 80+ clinical research
projects so far
• More than 9 trials in oncology (distinct expertise)
• 17 trials in vaccines (CRO with most extensive
experience in India)
• Preferred partner of BMGF
• Established infrastructure in South Asia
• Capable of doing global projects in partnership
with Research Point Global
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29. Informatics & Analytics Services
“Scientific Custom Curator of Choice”
Clinical
• GOSTAR - Small Molecules
• Drug Repurposing
SAR Database
• Clinical Pharmacology
Analytics
• Predictive Biology
• GOBIOM - Biomarker Database
• CTOD
• Environmental Modeling
Outcome Database
Knowledge
Management
• Scientific Journals & Patents
• Public Domain Information
• Client’s Proprietary data
Scientific Application Development,
Scientific Data indexing
and Curation
Chemical
- Clinical Trial
Data Integration & Management
Biological
Providing Scientific Data Curation and
Knowledge Management Services for the last 12 years…….
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30. Rich Curation Experience…
6.3 Million Chemical
Structures
Targets
8,200+
6,500 Marketed
Drugs
1.2 Million Chemical
Reactions
1.1 Million Scaffolds
Literature Screened
3.5 Million
26,100
Toxic Compounds
0.5 Million Articles
Iandexed
Frameworks or Cores
150,000
70K Patents
(3.2 M Screened)
27,000 Biomarkers
2.3 Million
Experimental
Procedures
SAR Activities
~ 12 Million
Exp Records
~325K
>10,000 Clinical
Trials
18 Therapeutic Areas
Pharmacokinetics/
Metabolism
1.4 Million
24,500 Clinical
Compounds
1000 Indications
>10,000 Efficacy and
Safety outcomes
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31. Informatics & Analytics Services – Products (Databases)
Enables……
Drug Discovery
Translational Science
Clinical Development
Comprehensive
StructureActivity
Relationship
Database
One of Kind
Manually
Curated
Biomarker
Database
Custom
Developed
Clinical Trial
Outcome
Database
27,000 Biomarker,
18 therapeutic Areas
& ~1000 Indications
100,000 Clinical Trials,
14therapeutic Areas
& 80+ Indications
7 Million Compounds
& 20 Million Structure
Activity Points
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Knowledgebase(s)
Supporting
Bench to Bedside
43
32. Informatics & Analytics Services: Products & Services
Drug Discovery & Development Paradigm
Identify
Disease
Identify &
Validate
Pharma
Target
Identify
Lead
Molecules
Optimize
Lead
Molecules
Preclinical
Trials
Clinical
Trials
Approvals
&
Circulation
Predictive Analytics
Services
GOSTAR
GOBIOM
Drug Repurposing
CTOD
Clinical Pharma Analytics
Chemical/Biological/Clinical Curation
Predictive Biology
Scientific Data Integration & Application Development
Environmental Modeling
Differentiator
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34. Discovery Research
• Hit Generation
Virtual Screening, High
Throughput Screening,
Fragment-based Screening
Program
Setup
Validation
• Hit Validation
• Lead Generation
Identification of potent and
selective compounds with
desired PK properties
• Lead Optimization
PK efficacy and safety
profile to deliver clinical
candidate
Hit
• Project feasibility
• Reference
compound
synthesis
• Assay
development
• Potency/ADME
• Profiling of
reference
compounds
Drug
Lead
Candidate
Optimization
Regulatory Studies
• Medicinal
Chemistry
• Medicinal
Chemistry
• Informatics
• In Vitro potency
• In Vitro potency
• Selectivity
• Selectivity
profiling
• In-depth ADME,
PK, In vivo
efficacy
• ADME, PK, In vivo
IND
• GLP/GMP
manufacturing:
PMDA
• Metabolism
• Met ID
Characterization
• Exploratory Tox
• Patent filing
• Virtual library
design
Case Study Differentiator
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35. Human Capital & Infrastructure
Facilities (Sq ft)
Service Line
Human Capital
Area
(Sq ft)
Discovery Services
183519
Clinical Development
2086
Scientific Domain
1828
98,966
Pharmaceutical Mfg &
Development
Total Employees
157,000
Informatics & Analytics
Total
Functional Domain
258
Instruments
37,500
• LCMS , LCMS-MS
476,985
• NMR Spectrophotometer
• Super fluid Chromatography (SFC)
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37. Global Foot Print
Head Quarters
U.S.A, India, Singapore &
Netherlands
Ground Presence
Maryland, Boston, Albany, San Francisco, New York, New Jersey, United kingdom, Netherlands, Tokyo
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38. GVK Beyond Business
HEALTHCARE
GVK EMRI
ENVIRONMENT &
SUSTAINABILITY
Largest emergency
response services which
attends to emergencies
like medical crises, law
& order situations and
fire disasters.
Covers over 500 million
people across
India, saving precious
lives.
Environment and
sustainability initiatives
including energy
conservation, water
management and efforts
to minimize ecological
impact are the conscious
steps taken for each of
GVK’s projects.
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COMMUNITY
DEVELOPMENT
Provides
• Education
• Health and hygiene
• Community-based
projects
• Empowerment
• Entrepreneurship
development for the
underprivileged
GVK BIO Confidential
ART, CULTURE AND
SPORTS
1.25 km scenography/Art
Wall, at the new T2
terminal at
CSIA, Mumbai, which is
the world’s longest art
wall in a public utility
building. Supports and
endorses excellence in
sports.
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39. GVK BIO in Japan
•
GVK BIO has 28 collaborations and working engagements with Japanese companies in Japan
A] Big / Mid-Pharma
•
B] Cosmetics & Perfumery
C] Fine Chemicals
GVK BIO engaged in services across the R&D value with Japanese Companies
I – Informatics – a) Databases (GOSTAR, GOBIOM, CTOD)
b) Services (Drug Repurposing, Custom Curation)
II - Chemistry Services – synthesis of building blocks, advanced intermediates and NCEs
III - Medicinal Chemistry Services – Target Identification
III - Biology – HTS, ADME PK services.
IV - Custom Chemical Synthesis & Manufacturing – Intermediates and APIs
GVK BIO’s Japan focused delivery team:
a) Educated in prestigious Japanese universities / experience of working in Japanese
company in Japan
b) Proficient in Japanese language
c) Insight into Japanese working style / culture / market requirements
d) Teams can work on real time of Japan (No time lag)
e) Flexibility of commercial models & believes in long-term relationship with client
companies
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40. Reach Us
Corporate Office - INDIA
Plot No. 28 A, IDA Nacharam
Hyderabad – 500076, India
Tel : +91 40 6692 9999
Fax : +91 40 6692 9900
U.S.A
5457 Twin Knolls Road, Suite 101, Columbia, MD 21045
Tel : 001 443 542 5805, Fax : 001 703 940 4088
SINGAPORE
333, North Bridge Road, #08-00, KH KEA Building, Singapore 188721
Tel : (65) 6837 2133
NETHERLANDS
GVK Biosciences B.V. Burgemeester de Manlaan 2, 4837BN Breda
Tel : 0765609900
www.gvkbio.com
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Notas del editor
GVK Group is placed among the top 25 business houses in India and has diverse business interests with committed investments of over $20B.