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Harnessing BioIndia CRO Opportunities


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Harnessing BioIndia CRO Opportunities

  1. 1. Life Sciences Luminaries PanelHarnessing the BioIndia CRO Opportunities!
  2. 2. Market Place and India offer Market Place Need  Total # of Active drug in development 7406 up only by 1.1% Source: Pharmaprojects  Growth in pipeline is virtually static and may decline Source: Pharmaprojects  To get approval for a marketable drug requires $1.1 Billion in R&D (including all failures) Source: MPM capital  Scarcity of Resources – Financial, Scientific and Ecosystem (Like Government Regulatory Policies & Processes, patient population) India Offers:  Largest pool of Scientists in Biology and Chemistry • 600,000+ Doctors, 200+ Medical colleges, 120+ Pharmacy colleges, 3 Million Biosciences graduates, 1.5 Million+ Hospital Beds,  4th Largest Pharma Industry (by volume)  Fast evolving CRO and Biotech Industry  Huge patient population; mostly untreated  US-FDA equivalent regulations and Evolving government policies
  3. 3. Aagami and Dinesh Jain Aagami, Inc. – Chicago Suburb based  Full Cycle Drug Development Services Provider (CRO)  Uses Global Delivery Model using Indian companies and resources  Operates in • Clinical Research – Trials, PK/PD and BA/BE studies • Pre-Clinical Toxicity studies • Analytical Services and stability studies • Formulation and Manufacturing Services • Custom Synthesis and Contract research • Proteins, Viral vectors and Biologics synthesis  Have done 27 projects with 14 customers in US and Europe Dinesh Jain:  Entrepreneur applying Global Delivery business model in Drug Research  18 Years in IT Offshoring, 3 Years in CRO industry  Managed complex projects comprising several countries teams  Developed markets like Japan, Korea, Israel, Australia for IT companies  Developed customers like NEC, Mitsubishi, IBM, AMP, Mitsui, Nomura  Founder of IJSF Tokyo, LIPIC Chicago etc.
  4. 4. India CRO scene & Aagami experience CRO scene in India  Started in Mid 1990s; around 70 companies and growing  $120 M in ’05 expected to be $1.5 Billion by ’10 (50-75% CAGR)  Enlightened Government – Even FM highlighted in his ADB speech  Struggling with Processes and Quality of resources  Lack of experienced professionals  MNC CROs have set up shops already Aagami Experience  Used Partnership model - Apothecaries, Shasun and Others  Took 3 years to make sensible revenues  Experienced Bio-Pharma Industry professionals critical  US LifeSciences industry is filled with Indian professionals
  5. 5. Key ‘Take Away’s Opportunities: • Humongous opportunity - 10 times growth in 5 years • CRO industry in India is, where IT was around 10 years ago • “Next BIG thing is Biology”- John Doerr at TiECON2006 • “Engineers are critical to Medicine” – Tom Fogarty at TiECON2006 Challenges: • Finding Skilled & experienced resources is major challenge • Universities not graduating immediately usable resources • GCP & GLP processes are still being learnt Ecosystem • Supportive Governments on both sides – India and US • CRO Industry has a ‘Can Do’ attitude ‘Thanks to IT guys’ • US BioPharma industry is filled with Indian professionals Analogy and differences with IT: • All risks and challenges learned from IT Offshoring are quite useful • Building a team of Experienced LS professional is critical • BioPharma has Regulatory environment • Hence One needs to be of top quality from the start • Must enter with long term view at least 5 years