drug discovery and development-药物发现与发展.pptVIP

Drug DiscoveryDevelopment Introduction In the past most drugs have been discovered either by identifying the active ingredient from traditional remedies or by serendipitous discovery. But now we know diseases are controlled at molecular and physiological level. Also shape of an molecule at atomic level is well understood. Information of Human Genome History of Drug Discovery : Registration: The Ministry of health Family Welfare and the Ministry of Chemicals Fertilizers have major role in regulation of IPM. NDA must be submitted to DCGI Phase III study reported to CDL, Kolkata Package inserted approved by DCI Marketing approval from FDA ~$800 M spent to bring a new drug to market. $127 Billion spent on Pharma RD in 2010 Share of CROs in research operations is 27% World CRO market is 16.3 B (Indian share $500 M) Market Scenerio: Top CROs (By Revenue) Contract Research Organizations Revenue Quintiles $2.5 Billion Pharmaceutical Product Development $1.8 Billion Covance $1.4 Billion Charles River Laboratories $1.2 Billion Parexel $930 Million Icon $887 Million Kendle $590 Million Pharmanet $470 Million PRA International $410 Million 4G Pharmacovigilance $391 Million Top CROs (India) Contract Research Organizations Location Actimus Biosciences Hyderabad Advinus Therapeutics Bangalore Aurigene Discovery technologies Bangalore Chembiotek Kolkata GVK Biosciences Hyderabad Jubilant Organosys Bangalore Ranbaxy Life Sciences Mumbai Reliance Life Sciences Mumbai Suven Life Sciences Hyderabad Syngene Bangalore Most valuable RD Projects Rank Product Company Phase Pharmacological class Todays NPV($mn) 1 Degludec Novo Nordisk Phase III Insulin 5,807 2 Tofacitinib Pfizer Phase III JAK-3 inhibitor 4,953 3 BG-12 Biogen Idec Phase III Fumarate 4,666 4 Incivek J J Phase IV Hep C protease inhibitor 4,332 5 Relovair Theravance Phase III Corticosteroid 4,241 6 DR Cysteamine Undisclosed Phase III Lysosomal transport modulator 4,155 7 AMR 101 Undisclosed Phase III Omega-3 fatty acid 4,