Life Sciences Luminaries Panel

Harnessing 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