gvk bio corporate presentation
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Corporate PresentationJanuary 2009
GVK BIO: Asia’s Leading CRO
GVK BIOGVK BIOAsia’s leading Contract Research Organization
Promoted by US$1.5 billion GVK Group and
Mr D S Brar (ex CEO and MD Ranbaxy)Mr. D S Brar (ex CEO and MD Ranbaxy)
Vision:Be a global leader in life‐sciences services
Mission:Deliver value‐added scientific services with Speed and Q litQuality
Values: Customer Focus: Change “expected” to “exceptional”Customer Focus: Change expected to exceptionalIntegrity: Integrity is IntegralRespect: Give to get Commit to Excel: In every act and deedLeadership and Teamwork: Team first p
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History
InformaticsClinical Pharmacology
Established Inogent
Private Equity
2001 2002 2003 2004 2005 2006 2007 2008
Informatics Pharmacology Inogent
Medicinal Chemistry
• Clinical Research• Biology
DiscoveryResearch
GVK BIO becomes a JV between GVK Group and Mr. Brar
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Locations and Activities
Gurgaon: Clinical Research
2
2
H d b d1
ca esea c
14
Hyderabad: • Corporate Office• Medicinal Chemistry• Informatics• Clinical PharmacologyMumbai:
Cli i l R h
46 61
3
gy• Clinical Research• Biology• Discovery Research• Custom Chemical Synthesis
Clinical Research
5
6
Bangalore: 5
Vishakhapatnam:Land for expansion
6
Synthesis• Process Research• Custom Manufacturing
Chennai:InformaticsClinical Research
3g
Land for expansion
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Business Portfolio
Discovery Development
HitValidation
LeadOptimization
TargetId. & Pre
ClinicalPhase
II IIIPhase I
PoCPhase
IVValidation OptimizationValidation Clinical II-IIIPoC IV
Development
•Clinical Research•Clinical Pharmacology
Discovery
•Medicinal Chemistry•Biology Clinical Pharmacology
•Process R&D•CMC•Custom Chemical Synthesis• Contract Manufacturing
Biology•Discovery Research
Informatics and Scientific Applications Development
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Discovery: Medicinal Chemistry
CapabilitiesSynthesis of
• Intermediates & Building Blocks
• Reference Standards
• Analogue Compounds for Lead Optimization
Design & Parallel Synthesis of Focused & Large Librariesg
Hit Validation & Lead Optimization
Specialty Chemistry• Chiral Synthesis, Synthesis of Dendrimers, Nucleotides Peptides PEGylation LipidNucleotides, Peptides, PEGylation, Lipid Chemisty, Metabolite Synthesis
Resources600 fume‐hoods
State of the art analytical chemistry facilities
2,00,000 sq.ft. of lab space
810 employees across four locations
Technical and project management training
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Discovery: Biology
CapabilitiesIn vitro Pharmacology
• Panel of GPCR and Kinase – Binding and Functional
• Cellular assays in inflammation and cancer
Drug Metabolism and Pharmacokinetics• Physicochemical properties• Absorption, Metabolism• In vivo PK – Bioavailability and Blood Brain Barrier Studies
Animal Models • Pain• Inflammation• CNS
Toxicology (exploratory in rodents)ResourcesState‐of‐the‐art laboratory with animal house Approved Type III radioactive labClass‐II cell culture lab
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Hi h
Continuous Upgrading of Services
High
Value Co‐creatorsDiscovery Research
ality
ts
Strategic Advisors
Integrated* Service
ess Technica
ue fo
r Client
Problem Solvers
Integrated Service Offerings (2 to 3
disciplines)
Busine
Valu
Order Takers
Commodity
Standalone Chemistry, Biology
Client SpecificityLow High
Low
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Discovery Research
I ili Hit G tiIn silico Hit Generation
Hit Validation
Lead Generation (identification of potent and selective compounds with adequate ( p p qPK features)
Lead optimization (process of optimizing efficacy, PK and safety profile to deliver a clinical candidate)
Drug Candidate IND Phase 1/ PoCLeadProgramSetup
Hit
• Med. Chemistry• Informatics
Optimization Regulatory Studies Clinical Studies
• GLP/GMP Synth.• PK & Metabolism
• Safety• Clinical PK
Validation
• Project feasibility • Ref compound
• Med. Chemistry• Informatics
• In vitro potency• Selectivity• In vivo efficacy• PK‐ADME studies• Exploratory Tox.• Patent ‐ IP
• Met. Character.• Regulatory Tox.• Safety Pharmacol.• Pharma. Technol.• IND filing
• Dose prediction• First indication of efficacy in man
pSynthesis• Assay dev.
• Potency/ADMEprofiling of ref compounds• Virtual library
• In vitro potency• Selectivity• Limited in vivo• Limited PK
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Virtual library design
Informatics
CapabilitiesDatabases
• Reference Centric
Astra Zeneca paper on GVK BIO Database
• Medhcem Database
• Target Inhibitor Database
• Molecule Centric• Clinical Candidate Database
D D t b• Drug Database
• Toxicity Database
• Mechanism‐based Toxicity Database
• Biomarker Database
Curation ServicesCuration Services
Training
Scientific Applications Development
ResourcesResourcesFacilities in Hyderabad & Chennai
~ 32,000 sq.ft.
~300 employeesp y
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Development: Clinical Research
CapabilitiesPhase II to Phase IV clinical trials: Oncology, CNS, Infectious Diseases, Pain Management and Vaccines
Clinical Data Management (Phase I to Phase IV)
Medical AffairsMedical Affairs
Biostatistics
Quality Assurance
ResourcesGVK BIO Sites: 143 sitesResources
Pan India coverage
Oracle Clinical, Thesaurus Management System
SAS 9.1.3
~75 professionals; Past work experience in Pharma companies and CROs
20,000 sq. ft. facility20,000 sq. ft. facility
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Development: Clinical Pharmacology
CapabilitiesBioavailability/Bioequivalence studies
Stand alone services • Clinical
• Bioanalytical Services
• PK & Statistical Analysis
• Report writingp g
ResourcesF li i ith 144 b dFour clinics with 144 beds
72,000 sq ft.
222 employees
Dedicated Analytical FacilityDedicated Analytical Facility
State‐of‐the‐art HPLC and LCMS machines –13 LCMS/MS machines
Pathological Laboratory
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Process R&D and Contract Manufacturing
CapabilitiesCapabilitiesProcess Development & Custom Synthesis
• Route Identification
• Process Feasibility, Optimization & Validation Discovery Services
Process R&D
Mfg. of Adv.Inters for
Mfg. of NCEs &
Contract Mfg.
Generic APIs
• Laboratory Scale Up, Engg. Studies including Hazard Evaluation
• Polymorph and Salt Screening
Analytical Development
Services R&DNCEs & APIs
APIsg
From Discovery to Commercial Quantities
• Method Development & Validation
• Impurity Profiling
• Stability Studies (ICH)
• Documentation for Regulatory FilingsDocumentation for Regulatory Filings
Contract Manufacturing• Scale Up & Manufacturing
• Technology Transfer
• Commercial Supply contracts• Commercial Supply contracts
Resources267 employees
64 KL capacity (250L 3000L)64 KL capacity (250L‐3000L)
Kilo Lab, Pilot Plant, 2 Production Blocks
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Industry Leading People Systems
General Development
Others, 10%
Others – 10%
Induction
On‐the‐job training
Competency Based Development
Domain
10%
PhD – 15%
M t 73%training
Quality & Safety
Domain Training
Customer interface
Leadership Development
Leadership Training Personalized Advanced Training
Others – 12% Masters – 73%Techno-Scientific – 90%
Soft SkillsManagerial
Employee Benefits
ESOPTransportati
/F d fInsurance/P id t Performance
Employee Engagement
Business Town B From the Value Coffee ith
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ESOPs on/Food forweekends
Provident Fund BonusUpdates halls Buzzz President Awards with
President
Scientific & Management Strength
• The GVK BIO team is a mix of senior members with international experience Scientific Leadership and scientists who worked extensively in domestic pharma and CROs.
Scientific Leadership
• The top management has the expertise and experience to make the Company a d i t f i th t
Professional Managementdominant force in the sector.
• The GVK BIO board bring together business and scientific visionaries who provide direction to the GVK BIO Management in the fast growing Life‐sciences segment
World Class Board
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the fast growing Life sciences segment.
Growth Strategy & Investments
Growth Strategy• Establish a leadership position in core business areas (Discovery Services)• Offer new and integrated services to enable GVK BIO be a preferred supplier of
contract research services (Collaborative Research, Phase I, Formulations)• Grow through Acquisitions • Explore new opportunities in other Life-Sciences domainsExplore new opportunities in other Life-Sciences domains
Investments• Capital Expenditure of approximately US$ 50 Million over the next three yearsCapital Expenditure of approximately US$ 50 Million over the next three years
o Private Equity invested US$ 25 Million into GVK BIO (Sequoia Capital)• Invested in land bank for growth and scale
o Hyderabad – 25 AcresB l B d 10o Bangalore – Bomasandra – 10 acres
o Vizag – Ramky Pharma City – 10 acres
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Campus
25 acres of land500,000 sq. ft of built up space
M di i l Ch i t• Medicinal Chemistry• Biology & Animal House• Kilo Lab• Administrative Block• Training• Informatics • Ancillary & Auxiliary services
3 phasesp• Each phase: 250,000 sft• Phase I – 2009• Ultimate Phase - 2011
2 Blocks for Medicinal Chemistry2 Blocks for Medicinal Chemistry• Each block with 500 fume hoods
Preliminary civil works commenced
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Summary
Integrated Offerings across the R&D Value Chain
No Conflict Model with focus on Value-added Services
P T k R d ith Abilit t S l
Accele
Proven Track Record with Ability to Scale
Industry Leading People Systems
erating R
Strong Scientific and Professional Management
esearch
Passionate about Science
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THANK YOU