Life Sciences Luminaries PanelHarnessing the BioIndia CRO Opportunities!
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
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.
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
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