1. Life Sciences Luminaries Panel
Harnessing the BioIndia CRO Opportunities!

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. 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. 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. 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