GVK Biosciences Private Limited-Corporate-Presentation-9-11-13
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GVK Bio Is Among top 25 Business Groups of India, GVK Group has diverse business interests with committed investments of over $20B.
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GVK Biosciences Private Limited-Corporate-Presentation-9-11-13
- 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 11/13/2013 Hospitality Airports Energy GVK BIO Confidential Resources Transportation 2
- 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 11/13/2013 GVK BIO Confidential 3
- 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 11/13/2013 Multiple Standalone Services GVK BIO Confidential 4
- 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 11/13/2013 GVK BIO Confidential 5
- 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 7
- 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 11/13/2013 Case Study GVK BIO Confidential 10
- 8. Discovery Services • Computational Chemistry • Medicinal & Synthetic Chemistry • Biology Back
- 9. Discovery Services Computational Chemistry 11/13/2013 GVK BIO Confidential 13
- 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 11/13/2013 GVK BIO Confidential 14
- 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 11/13/2013 GVK BIO Confidential 15
- 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 11/13/2013 GVK BIO Confidential 16
- 13. Discovery services Chemistry Services Discovery Services Medicinal & Synthetic Chemistry 11/13/2013 GVK BIO Confidential 18
- 14. Medicinal & Synthetic Chemistry Medicinal Chemistry • Hit Identification • Lead Generation • Lead Optimization Design & Synthesis of Libraries • Design • Target-based • De Novo libraries • Fragment-based • Parallel Medicinal Chemistry Synthesis Synthetic Chemistry Specialty Chemistry • Medchem Support • Agrochemicals • Intermediates & Building Blocks • Carbohydrates • Reference Standards • Analogue Compounds • Impurity Synthesis • Metabolite Synthesis • Chiral Chemistry • Isotope labeling • Nucleosides & Nucleotides • Peptides • Electronic grade chemicals (OLED precursors) • Organo Boron Chemistry Differentiator 11/13/2013 GVK BIO Confidential 19
- 15. Integrated Services across R&D Value Chain Discovery Services Biology Discovery services 11/13/2013 GVK BIO Confidential Biology Services 22
- 16. Biology at a Glance In Vitro Pharmacology Reagent Generation • • Molecular biology Protein production & Purification • Insect cells, bacteria • • Genotoxicity • • Mini Ames/ Complete Ames • Biochemical and cellular screens expression Stable cell line generation Assay development & screening • Customized assay development & Screening • AKTA based purification • Toxicology • Chromosomal Aberration • Mouse Lymphoma Assay • Micronucleus Test Specialized cellular assays • Transient/stable transfection • E-Phys (Build area) • Lenti-viral based cell line generation • • Phenotypic (Build area) Exploratory Toxicity • Acute Toxicity/Maximum Tolerated Dose • 7-90 Days Toxicity • CHO/HEK or custom cells • Toxicokinetics Animal Models • HTS & MTS screening • Histopathology • Disease Biology • Functional Observational Battery Assays • Inflammation • Diabetes • Inflammation & cytokines • CNS • Oncology • Pain • Diabetes • Oncology (Build area) • Neurobiology • Pain • Biomarker (Build area) 11/13/2013 GVK BIO Confidential Safety Pharmacology • Spontaneous locomotor activity Tail suspension test • BP & Blood Flow 23
- 17. Biology at a Glance Drug Metabolism and Pharmacokinetics Physicochemical Characterization • Solubility: Equilibrium/kinetic • Type of Studies • Stability (Microsomes, S9 & • Stability • Metabolism Lipophilicity: Log P, Log D, CHI, pKa Hepatocytes Permeability/Transporters of different Single/Multiple Dose( s) Discrete/Cassette PK • Tissue Distribution • Phase-I & Phase-II metabolism • BBB & CSF species) • PAMPA: GIT/ BBB, • Reactive metabolites • Excretion (bile, urine and feces) • Caco-2 /MDCKpermeability, Pgp efflux • CYP Inhibition /induction • PK/PD correlation • MDCK and LLCPK1-Transfected ABC • TDI/MDI • CYP Inhibition/DDI • Met ID • Tailor-made Surgery Routes of Administration transporters (stable cell lines) • SLC transporters: OATP1B1, OATPB3, OAT1, OAT3 & OCT2 • Skin and buccal permeability by Franz Diffusion Method • Jugular vein • Portal vein • Bile duct Intraduodenal /Intracolonic matrices: Ki/Kinact • Femoral vein /Intracranial Blood Cell Partitioning • Double cannulation Distribution • • Protein Binding across species and • Oral/IV/IP/SC/IM • Intratracheal /Sublingual /Buccal Value Proposition 11/13/2013 GVK BIO Confidential 24
- 18. Process R&D and Custom Chemical Synthesis Back 11/13/2013 GVK BIO Confidential 26
- 19. Process R&D and Custom Chemical Synthesis (CCS) Process R&D • Process Development • Route Selection • Route Optimization CCS • Impurities Profiling : identification, characterization , synthesis • Synthetic Demonstration • Scale Up/Piloting • Salt Screening • GMP Commercial Manufacturing • Enzyme Screening • Validations • Data supporting CMC Filings • Contract Manufacturing Case Study Differentiator 11/13/2013 GVK BIO Confidential 27
- 20. Analytical Services 11/13/2013 GVK BIO Confidential 30
- 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 11/13/2013 IND GVK BIO Confidential 31
- 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 11/13/2013 GVK BIO Confidential 32
- 23. Clinical Development Services Clinical Pharmacology Back 11/13/2013 GVK BIO Confidential 34
- 24. Clinical Pharmacology Clinical Services Therapeutic Areas: Healthy and Special Population PK based Bio Analysis NCE’S Generics and NCE Small Molecules • C.V.S 290 methods • Capsules • C.N.S • • Tablets • Endocrinology • Matrix: Blood • Sublingual • Anti infective • Urine, Plasma • Suspensions • Pain Management • Injectables • Oncology • Gender-based Studies Large Molecules • Ophthalmology • Platform: LCMS/MS Analysis up to 5 KD • Respiratory Obesity • • • • Ophthalmology PD based • Bioavailability Studies Dermatology Global Accreditations Differentiator 11/13/2013 GVK BIO Confidential 35
- 25. Clinical Development Services Clinical Research Preferred partner of Back 11/13/2013 GVK BIO Confidential 37
- 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 11/13/2013 GVK BIO Confidential 38
- 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 11/13/2013 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 GVK BIO Confidential 39
- 28. Informatics & Analytics Back 11/13/2013 GVK BIO Confidential 40
- 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……. 11/13/2013 GVK BIO Confidential 41
- 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 11/13/2013 GVK BIO Confidential 42
- 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 11/13/2013 GVK BIO Confidential 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 11/13/2013 GVK BIO Confidential 44
- 33. Discovery Research Back 11/13/2013 GVK BIO Confidential 47
- 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 11/13/2013 GVK BIO Confidential 48
- 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) 11/13/2013 GVK BIO Confidential 51
- 36. GVK BIO making News 11/13/2013 GVK BIO Confidential 52
- 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 11/13/2013 GVK BIO Confidential 53
- 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. 11/13/2013 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. 54
- 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 11/13/2013 GVK BIO Confidential 55
- 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 11/13/2013 GVK BIO Confidential 56
Notas do Editor
- GVK Group is placed among the top 25 business houses in India and has diverse business interests with committed investments of over $20B.