Finding the best research companies? - What to look for and where

1. July 30, 2009 Finding the best research companies? - What to look for and where Nidhi Saxena Presenter – Pharmaceutical Outsourcing Congress

2. What constitutes “best-in-class”? Relevant Research Experience Qualifiers Infrastructure & Systems Quality & Delivery Processes • SOPs/GCP • ISO/Six Sigma • QA • Research Activity • Therapeutic Area • R&D Capacity • GLP/GMP/GCP • 21 CFR Part 11 Scientific Ingenuity Track Record • Overall Corporate Track Record • Research Projects Track Record • Caliber of Scientific Team • Complex Scientific Problems Solved Innovation Capacity Financial Stability • Size/Profits • No. of Clients • Funding • IPs Held • Research Papers Published • Demonstrated Innovation Customer References Domain Super Specialization • Client Pedigree • Positive Customer Reference Deep Regulatory Know-how Creative Financial Models Creative Engagement Models • Phase II Pediatric Oncology • Cardiac Stent Development • US-FDA IND • Medical Device Regulations • Discovery Milestone based pricing • Co-Development Value Drivers

3. Research Vendor Evaluation Matrix

4. Delhi • Pharma • Discovery Chemistry Ahmedabad • Pharma Generics • Bio-Analytical Mumbai Hyderabad • Global Pharma • Clinical Trials • Clinical Data Mgmt • Central Labs • Biotech • Immologicals • Bio-Informatics • Drug Discovery Pune • Vaccines /Immunotech • Drug Discovery Bangalore • Biotech/Biopharma • Data Mgmt • Drug Discovery R&D Geo-Clusters Global R&D Clusters India R&D Clusters • India – Discovery Chemistry, Formulations, Clinical Trials • China – Preclinical • UK – Phase I • Eastern Europe – Phase II to Phase IV • Israel – Generics • Australia – Oncology & Diabetes R&D

5. Thank You