India as an Outsourcing Frontier in Biotechnology

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Ashlyn Curtis
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1 1 India as an Outsourcing Frontier in Biotechnology K.V. Subramaniam President & CEO 3 rd Annual Biotech Supply Chain Academy Conference San Francisco Oct 26, 2010

2 Biotechnology Industry Issues Long gestation period High costs of development High costs of manufacturing Regulatory hurdles Diverse competency needs Competition Funding constraints The biotechnology industry today faces several issues in its growth and development. 2

Biotechnology Outsourcing Advantages (1) Long gestation period Shorter time to market High costs of development Favorable fixed to variable cost ratio High costs of manufacturing Access to:

3 Biotechnology Outsourcing Advantages (1) Long gestation period Shorter time to market High costs of development Favorable fixed to variable cost ratio High costs of manufacturing Access to: high-productive process technologies larger scale Regulatory hurdles Access to: genetically diverse patients therapeutically naïve patients inaccessible domains ( stem cell research, large animal studies) Outsourcing can address several of the issues faced by the biotechnology industry. 3

4 Biotechnology Outsourcing Advantages (2) Diverse competency needs Access to competencies Competition challenge Lower costs (biosimilars) Funding constraints Lower burn rates Outsourcing can address several of the issues faced by the biotechnology industry. 4

5 Biotechnology Outsourcing Opportunities BUSINESS DOMAINS Biotherapeutics Diagnostics Plant Biotechnology Industrial Biotechnology Biosimilars Molecular Diagnostics Plant Tissue Culture Biofuels Novel Proteins Molecular Genetics Plant Metabolic Engineering Biomaterials Vaccines Predictive Diagnostics Stem cell therapies Companion Diagnostics Tissue Engineered Products There are several outsourcing opportunities across many business domains in biotechnology. 5

6 Biotechnology Outsourcing Opportunities FUNCTIONAL DOMAINS Molecular Biology Process Development Quality Management Clinical Research Regulatory Affairs Manufacture Marketing Cloning Expression Cell line development Product characterisation Bioprocess development Process scaleup Quality control Quality assurance Validation Pre-clinical Animal model development Toxicity studies Efficacy studies Animal models Bioassays Clinical Phase 1 to 4 PK-PD studies QTc studies Mass balance studies Biometrics Dossiers preparation Regulatory Interface Intellectual property Clinical lots Commercial batches Cell line characterisation There are several outsourcing opportunities in functional domains across the value chain in biotechnology. Product mgmt. Sales Medical affairs Pharmaco- Vigilance Market research 6

Outsourcing - India Advantages Large home market Enables scale Less obscure regulatory pathway Faster time to market Large and diverse patient pool Faster accrual and time to market Lower development

7 Outsourcing - India Advantages Large home market Enables scale Less obscure regulatory pathway Faster time to market Large and diverse patient pool Faster accrual and time to market Lower development costs Genetic diversity for stratified studies Therapeutically naïve patients Growing biotechnology industry Access to competencies Innovation Manufacturing Frontier areas Regenerative Medicine Biofuels India has several advantages as an outsourcing frontier in biotechnology. 7

8 India Home Market Advantage $ 66 billion market growing 16% p.a. to $ 146 billion by 2013 Public spending 0.9% of GDP, expected to increase to 2% of GDP by 2010 Life-threatening + Lifestyle diseases Cardiac disease capital of the world Diabetic capital of the world Diverse oncology patient pool Growing medical tourism $ 2 billion by 2012 Strong in healthcare IT Healthcare Spend India ($ bn) India has a reasonably large and growing healthcare market, which can offer scale advantages E 2010E 2011E 2012E 2013E % of GDP Healthcare Statistics India US Population 1.1bn 0.31bn Hospitals 15,097 7,569 Medical Colleges Statistics per 1,000 population Hospital beds Nurses Physicians Source: McKinsey, E&Y 8

9 India Regulatory Advantage Gene Synthesis Gene Validation Electrophoresis Stable Clone Clone Expression Process Dev. Analytical Dev. Stability Studies Process Scale-up Toxicity Studies Approval by IBSC and RCGM Toxicity Studies Clinical Studies Approval by IBSC and RCGM Clinical Studies Commercial Manufacturing Approval DCGI 6 to 12 6 to to to to 57 months India has a well-defined regulatory pathway for biotechnology products, which can enable speed to market. 9

10 India Clinical Development Advantage Faster patient accrual Therapeutically naïve patients Genetically diverse patient pool Lower costs (~30% less than USA) Sites India UK USA Germany ICH / GCP Sites 500 3,500 25, Investigators ICH / GCP trained investigators 450 1,500 3,500 6,000 # of Personnel required ,000 50,000 Trials E 2010E Global Trials 16,700 17,700 18,900 20,000 Trials in India ,350 2,000 India Mkt. Share 2% 4% 7% 10% India has several advantages in clinical development, which can enable better patient quality and faster time to market. 10

11 India Innovation Advantage Novel product research Reliance Life Sciences, Biocon, Dr. Reddy s, Nicholas Funding DBT-SIBRI / DBT-BIPP schemes Global Biotech in India > $ 250 million invested to date > 100 Trans-national company funded R&D centers Amgen, Genzyme, BMS State-of-the-art Facilities Talent Reliance Life Sciences, Biocon, Piramal Indian R&D institutions Returning overseas Indians Indian companies have been investing in innovation, which can enable access to competencies. 11

12 India Manufacturing Advantage Sr Company Microbial Capacity (Litres) Mammalian Capacity (Litres) Planned Capacity (Litres) 1 Avesthagen - 2 Biocon 3 Cadilla Pharma - 4 Dr. Reddy s (Mammalian) 5 Intas 6 Ranbaxy/ Zenotech 7 Reliance Life Sciences 8 Serum Institute (Vaccines) 9 Shantha (Vaccine) 10 Wockhardt (Insulin), (Hep B/ Other proteins) India is gaining ground in biopharmaceutical manufacturing, which can enable competitive contract manufacturing. 12

13 India Competency Advantage Value Chain Molecular Biology Process Development Quality Management Clinical Research Regulatory Affairs Manufacture Marketing Target identification Gene synthesis Gene validation Electroporation Stable clone Clone expression Biorocess dev. Bioanalytical dev. Stability studies Process scaleup Quality control Quality assurance Validation Pre-clinical Toxicity studies Efficacy studies Animal models Bioassays dev. Clinical Clinical opns. Project mgmt. Biometrics Medical writing Dossiers preparation Regulatory Interface Intellectual property Upstream Downstream Purification Fill-finish Packaging Bioprocess control Product mgmt. Sales Medical affairs Pharmaco- Vigilance Market research GXP Compliance India has an endowment in competencies, many of them a legacy from its pharmaceutical industry. 13

India Talent Advantage 15,000 Biotech scientists 75 universities with biotechrelated programs India produces each year 25,000 pharmacy graduates 10,000 chemistry postgraduates 4,500 Ph.

14 India Talent Advantage 15,000 Biotech scientists 75 universities with biotechrelated programs India produces each year 25,000 pharmacy graduates 10,000 chemistry postgraduates 4,500 Ph.Ds 1,000 Engineering Ph.Ds 1,000 Biochemistry and Chemistry Ph.Ds 2,500 chemical engineers 1,000 biotech postgraduates Medical Institutions India has a strong talent base in biotechnology and allied areas, which can enable access to competencies. Source: E&Y, IBEF 14

15 India Diaspora Advantage Indian Diaspora 25 million strong Primarily in education, information technology, communications, semiconductors, pharmaceuticals, biotechnology and health care Africa, 11% USA, 11% UK, 6% 35,000 physicians of Indian origin in USA with 15% in academic medicine Asia, 72% India has a 25 million strong diaspora, many of them in the pharmaceutical, biotechnology and health care sectors. 15

16 India Cost Advantage India has a cost advantage, which can enable lower development and operational costs. Source: KPMG CII Report 16

India Limitations Research Extensive biological product characterisation Clinical Research Manufacture Regulatory Large animal studies Large-scale

17 India Limitations Research Extensive biological product characterisation Clinical Research Manufacture Regulatory Large animal studies Large-scale manufacture (especially MAb production) Developed market biotherapeutic dossiers India does have some limitations in certain functional domains of the value chain. 17

18 India Outsourcing Market Indian CRO Industry USD Billion Source: India Life Sciences Vision - Yes Bank CII Study The Indian CRO industry is estimated to grow at a CAGR of 31% to reach USD 3 billion by the year

19 Reliance Life Sciences Initiatives Biopharmaceuticals Pharmaceuticals Clinical Research Services Biofuels Regenerative Medicine Molecular Medicine Plant Biotechnology Industrial Biotechnology Plasma Proteins Biosimilars Monoclonal Antibodies Novel Therapeutics Fusion Proteins sirna Molecules API Formulations Pre-clinical Studies BA/BE Studies Phase 1 Studies Phase 2/3/4 Studies Data Mgmt. & Biostatistics Agronomy Farm Advocacy Plant Metabolic Engineering Plant Tissue Culture Trans- Esterification Embryonic Stem Cells Hematopoietic Stem Cells Ocular Stem Cells Skin and Tissue Engg. Cord Blood Repository Molecular Diagnostics Genetics Predictive Diagnostics Plant Tissue Culture Plant Metabolic Engineering Plant Products QTc Studies Largest pipeline of biosimilars under development globally Conducting the largest clinical research study in India (prophylactic for DVT, MNC client, 4050 patients) Biopolymers Biochemicals Largest biopharmaceutical manufacturing capacity in India. Also received European regulatory approval for drug substance Only plasma proteins manufacturer in South Asia Only company with commercial stem cell therapies in India Reliance Life Sciences represents one of the most diversified and integrated life sciences initiatives in the world. 19

Summary Advantages Limitations Growing domestic market to enable scale Defined regulatory pathway for speed to market Large patient pool for faster clinical development Emerging biotech innovation

20 Summary Advantages Limitations Growing domestic market to enable scale Defined regulatory pathway for speed to market Large patient pool for faster clinical development Emerging biotech innovation hub Strong talent pool and Diaspora for value chain competencies Cost competitive in clinical development and manufacturing Extensive product characterisation Large animal studies Large-scale manufacture Developed market biotherapeutic dossiers India is emerging as an important outsourcing frontier in biotechnology. 20

21 Thank You 21

Investor Presentation. September 2018

Investor Presentation. September 2018 Investor Presentation September 2018 Safe Harbour Certain statements in this release concerning our future growth prospects are forward-looking statements, which are subject to a number of risks, uncertainties