gvk biosciences private limited-corporate-presentation-9-11-13

Corporate Profile

04/11/2023 2GVK BIO Confidential

Among top 25 Business Groups of India, GVK Group has diverse business interests with committed investments of over $20B.

Among top 25 Business Group in INDIA

TransportationLife Sciences Hospitality Airports Energy Resources


GVK BIO : Preferred Partner across R&D value chain

** To be setup in the future

• Computational Chemistryand Molecular Modeling

• Synthetic Chemistry

• Library Design and Synthesis

• Analytical Chemistry

• Medicinal Chemistry

• High Throughput Screening

• Assay Development

• Radio-Isotope labeling

• Metabolite Identification

• Reagent Generation

• PK/ADME profiling

• In Vivo/In Vitro Pharmacology

• Bio analytical Services

• Non GLP Toxicology

• GLP Toxicology**

DISCOVERY SERVICES

IND

CLINICAL DEVELOPMENT (CLINOGENT)

PoC

• Clinical Pharmacology (BA/BE)

• Bio-Analysis of samples (Biologics and Small Molecules)

• Phase ll – IV Clinical Studies

• Clinical Operations

• Data Management, Bio Statistics, Medical Writing

• Pre-Formulation R&D

• Formulation R&D

• Intellectual Property and Regulatory

• Analytical R&D, Stability testing

• cGMP Clinical Supply

• cGMP Formulation Manufacturing

FORMULATION R&D and MANUFACTURING*

• cGMP Contract Manufacturing

• API and Intermediate Manufacturing

• Process Research and Development

• Analytical Services

• Custom Chemical Synthesis

API R&D and MANUFACTURING (INOGENT)

* FY14

** To be setup in the future

ANDANDA

• GOBIOM Database

• Patent Services

• Curation Services

• GOSTAR Database

• Drug Repositioning

• Bio IT

• Clinical Trial Outcome Databases

• PK/PD Modeling (with partner)

INFORMATICS and ANALYTICS

DISCOVERY RESEARCH

• 3 IND candidates delivered to clients (IP assigned to client)

• Focused Therapeutic Areas: Oncology, Pain, Inflammation, Metabolic-Disorders

• Strong scientific Program management capabilities

• Team with hands-on experience in Discovery Programs of big Pharma

• Flexibility in resourcing as required by programs


GVK BIO : Client Engagement Models

Quality Standalone Services

Multiple Standalone Services

1. Execute

Discovery Services around a Target

2. Research Partner

Discovery Research to generate IP for client

3. Strategic Co-inventor


INDLead OptimizationHit IdentificationHit Generation

• Route Selection & Optimization

• GMP Manufacturing & Validation

• Contract Manufacturing

Process R&D and CCS

• Design & Synthesis

• Specialty Chemistry

• Lead Optimization

Medicinal & Synthetic Chemistry

Biology

• In Vitro

• ADME/PK

• Animal Models

• Safety Pharmacology

Computational Chemistry

• QSAR & Pharmacophore

Models

• Homology Modeling

• SBDD & Fragment based

Design

: Quality Stand-alone Services

Back


INDLead OptimizationHit IdentificationHit Generation

• Route Selection &

Optimization

• GMP Manufacturing &

Validation


Process R&D and CCS Biology

• In Vitro

• ADME/PK

• Animal Models

• Safety Pharmacology

• Design & Synthesis

• Specialty Chemistry


Medicinal & Synthetic ChemistryComputational Chemistry

• QSAR & Pharmacophore Models

• Homology Modeling

• SBDD & Fragment basedDesign

Centralized Project Management

Discovery Services Around a Target

: Discovery Services around a Target

Case StudyBack

Project Management Team


• Hit Generation

Virtual Screening, HTS, Fragment-based

Screening

• Lead IdentificationIdentification of potent selective compounds with desired PK

properties

• Lead OptimizationPK efficacy and safety

profile to deliver clinical candidate

Drug

CandidateINDLead

Program

SetupHit

Optimization Regulatory StudiesValidation

• Project feasibility

• Reference compound synthesis

• Assay development

• Potency/ADME

• Profiling of reference

compounds

• Virtual library design


• Informatics

• In Vitro potency

• Selectivity profiling

• ADME, PK, In vivo



• Selectivity

• In-depth ADME, PK, In vivo efficacy

• Exploratory Tox

• Patent filing

• GLP/GMP manufacturing: PMDA

• Metabolism

• Met ID Characterization

: Discovery Research to Generate IP for the Client

Back Case Study

• Computational Chemistry

• Medicinal & Synthetic Chemistry

• Biology

Discovery Services

Back


Discovery Services




In silico Drug Discovery

Receptor based design

Virtual Screening – Hit Identification

Hit Optimization

Lead Identification

Lead Optimization

e-ADMELigand

based design

ToxicityModels

Differentiator



Hit Optimization

Lead Identification

Lead Optimization

e-ADME

ToxicityModels

Ligand based design


Virtual Screening & e-ADMET

• Hepatotoxicity

• hERG Model

• Carcinogenicity Model

• Mutagenicity Model

• LD50 & LC50 Models

• Skin Sensitization

Ligand - based design Receptor - based design e-ADME Toxicity Models

• Feature, and shape field-

based pharmacophore

models

• Similarity & diversity analysis

• Scaffold hopping Studies

• Bio-isostere replacement

studies

• Virtual Library Screening

• QSAR Models

• In silico Target identification

and validation

• Homology modeling

• De novo compound design

• Binding pose & interaction

fingerprinting analysis

• Structure-based

pharmacophore modeling

• Focused library design &

enumeration

• Receptor Based Screening

• Aqueous solubility

• Microsomal stability

• Caco-2 and MDCK

permeability

• Blood–brain barrier (BBB),

• Human intestinal

absorption (HIA)

• Plasma protein binding

(PPB)

• Oral bioavailability

Differentiator


• Docking & Pharmacophore analysis

• Drug/lead like filters

• Synthetic feasibility

• Patent busting approach

• Novelty Analysis

• SAR Analysis

• ADMET Analysis

• Bio-isostere replacement

• Library Enumeration

• SAR Analysis

• Potency and Selectivity

• ADMET Analysis

• Multi Parameter Optimisation

• IP Analysis

• FEB, QM-MM, Semi-empirical, DFT,

ab initio studies

Hit & Lead Identification & Optimization

Hit Identification &Optimization

Lead Identification &Optimization


Hit Optimization

Lead Identification

Lead Optimization

e-ADME

ToxicityModels

Ligand based design


Differentiator


Chemistry Services Discovery services

Discovery Services



• Medchem Support

• Intermediates & Building Blocks

• Reference Standards

• Analogue Compounds

• Impurity Synthesis

• Metabolite Synthesis

Synthetic Chemistry

• Agrochemicals

• Carbohydrates

• Chiral Chemistry

• Isotope labeling

• Nucleosides & Nucleotides

• Peptides

• Electronic grade chemicals (OLED precursors)

• Organo Boron Chemistry

Specialty Chemistry

• Hit Identification

• Lead Generation


Medicinal Chemistry

• Design• Target-based • De Novo libraries • Fragment-based

• Parallel Medicinal Chemistry Synthesis

Design & Synthesis of Libraries


Differentiator

04/11/2023 22GVK BIO Confidential Biology Services

Discovery services

Integrated Services across R&D Value Chain

Discovery Services

Biology


Biology at a Glance

Animal Models

• Inflammation

• Diabetes

• CNS

• Pain

• Oncology (Build area)

• Biomarker (Build area)

• Molecular biology

• Protein production & Purification

• Insect cells, bacteria expression

• AKTA based purification

• Stable cell line generation

• Transient/stable transfection

• Lenti-viral based cell line generation

• CHO/HEK or custom cells

Reagent Generation

• HTS & MTS screening

• Disease Biology

• Inflammation & cytokines

• Oncology

• Diabetes

• Neurobiology

• Pain

In Vitro Pharmacology

• Assay development & screening

• Customized assay development & Screening

• Biochemical and cellular screens

• Specialized cellular assays

• E-Phys (Build area)

• Phenotypic (Build area)

Safety Pharmacology

• Spontaneous locomotor activity Tail suspension test

• BP & Blood Flow

Toxicology

• Genotoxicity

• Mini Ames/ Complete Ames

• Mouse Lymphoma Assay

• Chromosomal Aberration

• Micronucleus Test

• Exploratory Toxicity

• Acute Toxicity/Maximum Tolerated Dose

• 7-90 Days Toxicity

• Toxicokinetics

• Histopathology

• Functional Observational Battery Assays


Drug Metabolism and Pharmacokinetics

Biology at a Glance

Physicochemical Characterization

•Solubility: Equilibrium/kinetic

•Stability

•Lipophilicity: Log P, Log D, CHI, pKa

Permeability/Transporters

•PAMPA: GIT/ BBB,

•Caco-2 /MDCKpermeability, Pgp efflux

•MDCK and LLCPK1-Transfected ABC

transporters (stable cell lines)•SLC transporters:

OATP1B1, OATPB3, OAT1, OAT3 &

OCT2•Skin and buccal permeability by Franz

Diffusion Method

Distribution

•Protein Binding across species and

matrices: Ki/Kinact•Blood Cell Partitioning

Metabolism

•Stability (Microsomes, S9 &

Hepatocytes of different

species)

•Phase-I & Phase-II metabolism

•Reactive metabolites

•CYP Inhibition /induction

•TDI/MDI

•Met ID

Surgery

•Jugular vein

•Portal vein

•Bile duct

•Femoral vein

•Double cannulation

Type of Studies

• Single/Multiple Dose( s)

Discrete/Cassette PK • Tissue Distribution

• BBB & CSF

• Excretion (bile, urine and feces)

• PK/PD correlation

• CYP Inhibition/DDI

• Tailor-made

• Oral/IV/IP/SC/IM

• Intratracheal /Sublingual /Buccal

Intraduodenal /Intracolonic

/Intracranial

Routes of Administration

Value Proposition


Process R&D and

Custom Chemical Synthesis

Back

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Process R&D and Custom Chemical Synthesis (CCS)

• Process Development

• Route Selection

• Route Optimization

• Synthetic Demonstration

• Salt Screening

• Enzyme Screening

Process R&D

• Impurities Profiling : identification,

characterization , synthesis

• Scale Up/Piloting

• Validations

• GMP Commercial Manufacturing

• Data supporting CMC Filings


CCS

DifferentiatorCase Study


Analytical Services


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

Phase 1 to III Discovery IND Drug Candidate PreclinicalMedchem

Complete spectrum of Analytical Services

DifferentiatorDetail


• 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

Analytical Services

Regulatory focussed analytical services (for Generics)


Clinical Development Services

Clinical Pharmacology

Back


Clinical Pharmacology

Clinical Services Healthy and Special Population

PK based

• Capsules

• Tablets

• Sublingual

• Suspensions

• Injectables

PD based• Ophthalmology

• Obesity

• Dermatology

NCE’S

• Gender-based Studies

• Bioavailability Studies

Bio Analysis Generics and NCE

Small Molecules• 290 methods

• Matrix: Blood

• Urine, Plasma

Large Molecules• Platform: LCMS/MS

• Analysis up to 5 KD

Therapeutic Areas:

• C.V.S

• C.N.S

• Endocrinology

• Anti infective

• Pain Management

• Oncology

• Ophthalmology

• Respiratory

Global Accreditations

Differentiator


Preferred partner of

Clinical Development Services

Clinical Research

Back


Clinical Research

Clinical Operations Services

RegulatoryProject

ManagementClinical

Monitoring

Medical Affairs

Quality Assurance

Study experience more than 14 therapeutic areas

Allied Services

Data Management

Medical Writing

Biostatistics

Differentiator


Others

Bone Disease

Nutrition

Ophthalmology

Pain Management

CVS

Dermatology

CNS

Gynaecology

GI

Oncology

Vaccines

Infectious Disease

1%

3%

3%

3%

6%

7%

7%

8%

8%

10%

10%

14%

18%

Clinical Research

Across Therapeutic Areas Multiple Regulatory Agencies

USFDA39%

MHRA12%

DCGI41%

8%

MOH Bangladesh

Differentiators

•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


Informatics & Analytics

Back


Clinical

Chemical Biological

• GOSTAR - Small Molecules

SAR Database

• GOBIOM - Biomarker Database

• CTOD - Clinical Trial

Outcome Database

• Drug Repurposing

• Clinical Pharmacology

• Predictive Biology

• Environmental Modeling

• Scientific Journals & Patents

• Public Domain Information

• Client’s Proprietary data

Scientific Application

Development,

Data Integration & Management

Scientific Data indexing and Curation

Analytics

KnowledgeManagement

Informatics & Analytics Services

Providing Scientific Data Curation and Knowledge Management Services for the last 12 years…….

“Scientific Custom Curator of Choice”


Rich Curation Experience…

6.3 Million Chemical Structures

1.1 Million Scaffolds

Frameworks or Cores150,000

SAR Activities~ 12 Million

Pharmacokinetics/Metabolism1.4 Million

Targets8,200+

Literature Screened3.5 Million

70K Patents (3.2 M Screened)

Exp Records~325K

24,500 Clinical Compounds

6,500 Marketed Drugs

26,100Toxic Compounds

27,000 Biomarkers

>10,000 Clinical Trials

1000 Indications

1.2 Million Chemical Reactions

0.5 Million Articles Iandexed

2.3 Million Experimental Procedures

18 Therapeutic Areas

>10,000 Efficacy and Safety outcomes


Knowledgebase(s) Supporting

Bench to Bedside

Enables……

Comprehensive Structure-Activity

RelationshipDatabase

Drug Discovery

7 Million Compounds& 20 Million Structure

Activity Points

One of Kind Manually Curated

Biomarker Database

Translational Science

27,000 Biomarker, 18 therapeutic Areas & ~1000 Indications

Clinical Development

Custom Developed

Clinical Trial Outcome Database

100,000 Clinical Trials, 14therapeutic Areas

& 80+ Indications

Informatics & Analytics Services – Products (Databases)


Drug Discovery & Development Paradigm

Identify & Validate Pharma Target

Identify Disease

Identify Lead

Molecules

Optimize Lead

Molecules

Preclinical Trials

Clinical Trials

Approvals &

Circulation

Predictive Analytics Services

GOSTAR

GOBIOM

CTOD

Chemical/Biological/Clinical Curation

Scientific Data Integration & Application Development

Drug Repurposing

Clinical Pharma Analytics

Predictive Biology

Environmental Modeling

Informatics & Analytics Services: Products & Services

Differentiator


Discovery Research

Back


Drug

CandidateINDLead

Program

SetupHit

Optimization Regulatory StudiesValidation

• Project feasibility

• Reference compound synthesis

• Assay development

• Potency/ADME

• Profiling of reference

compounds

• Virtual library design


• Informatics


• Selectivity profiling

• ADME, PK, In vivo



• Selectivity

• In-depth ADME, PK, In vivo efficacy

• Exploratory Tox

• Patent filing

• GLP/GMP manufacturing: PMDA

• Metabolism

• Met ID Characterization

Discovery Research

• Hit Generation

Virtual Screening, High

Throughput Screening, Fragment-based

Screening

• Hit Validation

• Lead GenerationIdentification of potent and selective

compounds with desired PK

properties

• Lead OptimizationPK efficacy and safety

profile to deliver clinical candidate

DifferentiatorCase Study


Human Capital & Infrastructure

Facilities (Sq ft)

Service Line Area (Sq ft)

Discovery Services 183519

Clinical Development 98,966

Pharmaceutical Mfg & Development

157,000

Informatics & Analytics 37,500

Total 476,985

Human Capital

Total Employees 2086

Scientific Domain 1828

Functional Domain 258

Instruments

• LCMS , LCMS-MS

• NMR Spectrophotometer

• Super fluid Chromatography (SFC)


GVK BIO making News


Global Foot Print

U.S.A, India, Singapore &Netherlands

Head Quarters

Maryland, Boston, Albany, San Francisco, New York, New Jersey, United kingdom, Netherlands, TokyoGround Presence


GVK Beyond Business

HEALTHCARE GVK EMRI

ENVIRONMENT & SUSTAINABILITY

COMMUNITY DEVELOPMENT

Provides • Education• Health and hygiene• Community-based

projects• Empowerment• Entrepreneurship

development for the underprivileged

ART, CULTURE AND SPORTS

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.

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.


• 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

GVK BIO in Japan


SINGAPORE333, North Bridge Road, #08-00, KH KEA Building, Singapore 188721Tel : (65) 6837 2133

U.S.A5457 Twin Knolls Road, Suite 101, Columbia, MD 21045Tel : 001 443 542 5805, Fax : 001 703 940 4088

NETHERLANDSGVK Biosciences B.V. Burgemeester de Manlaan 2, 4837BN Breda Tel : 0765609900

www.gvkbio.com

Corporate Office - INDIAPlot No. 28 A, IDA NacharamHyderabad – 500076, IndiaTel : +91 40 6692 9999Fax : +91 40 6692 9900

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