Finding the best research companies? - What to look for and where Nidhi Saxena Presenter – Pharmaceutical Outsourcing Congress July 30, 2009
What constitutes best-in-class? Track Record Infrastructure & Systems Quality & Delivery Processes Relevant Research Experience Financial Stability Customer References Qualifiers Value Drivers Scientific Ingenuity Innovation Capacity Domain Super Specialization Creative Financial Models Creative Engagement Models - R&D Capacity - GLP/GMP/GCP - 21 CFR Part 11 - SOPs/GCP - ISO/Six Sigma - QA - Research Activity - Therapeutic Area -Discovery Milestone based pricing -Co-Development -US-FDA IND -Medical Device Regulations -Phase II Pediatric Oncology -Cardiac Stent Development Deep Regulatory Know-how -IPs Held -Research Papers Published -Demonstrated Innovation -Caliber of Scientific Team -Complex Scientific Problems Solved -Overall Corporate Track Record -Research Projects Track Record -Size/Profits -No. of Clients -Funding -Client Pedigree -Positive Customer Reference
Research Vendor Evaluation Matrix Parameter QualifiersValue Drivers Track Record Size & Financia l Stability Custom er Referen ces Infrastru cture & Systems Quality & Delivery Process es Relevant Researc h Experien ce Scientifi c Ingenuit y Innovati on Capacity Domain Super Speciali zation Deep Regulat ory Know- How Creative Engage ment Models Creative Financia l Models Research Company 1 Weightage (1-10) Score (1-10) Total Score Research Company 2 Weightage (1-10) Score (1-10) Total Score Research Company 3 Weightage (1-10) Score (1-10) Total Score
R&D Geo-Clusters Biotech Immologicals Bio-Informatics Drug Discovery Hyderabad Bangalore Delhi Ahmedabad Mumbai Pune Pharma Generics Bio-Analytical Global Pharma Clinical Trials Clinical Data Mgmt Central Labs Biotech/Biopharma Data Mgmt Drug Discovery Vaccines /Immunotech Drug Discovery Pharma Discovery Chemistry Global 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 India R&D Clusters
Thank You