Accelerating Generic Approvals by Dr Anthony Crasto
Dimasi 2007s
1. Joseph A. DiMasi, Ph.D. Director of Economic Analysis Tufts Center for the Study of Drug Development Tufts University SLA Pharmaceutical & Health Technology Division Spring Meeting Boston, MA, March 19, 2007 Measuring Trends in the Development of New Drugs: Time, Costs, Risks and Returns
4. Mean U.S. Approval and Clinical Phases for U.S. New Drug Approvals, 1963-2004 Total Phase IND Phase Approval Phase Points are 3-year moving averages Source: Tufts CSDD, 2006
5. Clinical and Approval Times Vary Across Therapeutic Classes, 2002-04 12.1 7.6 8.5 7.5 8.0 6.3 9.8 Source: Tufts CSDD, 2006 6.9
9. New Drug Approvals Are Not Keeping Pace with Rising R&D Spending Source: Tufts CSDD Approved NCE Database, PhRMA, 2005 R&D expenditures are adjusted for inflation R&D Expenditures New Drug Approvals
21. Present Values of Net Sales and R&D Cost for New Drugs by Sales Decile (millions of 2000 $) Source: Grabowski et al., PharmacoEconomics 2002; 20(Suppl 3):11-29
23. Transition Probabilities for Clinical Phases Source: DiMasi and Grabowski, Managerial and Dec Econ 2007, in press
24. Clinical Development and Approval Times 97.7 90.3 Source: DiMasi and Grabowski, Managerial and Dec Econ 2007, in press
25. ** All R&D costs (basic research and preclinical development) prior to initiation of clinical testing Pre-Approval Out-of-Pocket (cash outlay) and Time Costs per Approved New Biopharmaceutical* * Based on a 30.2% clinical approval success rate Source: DiMasi and Grabowski, Managerial and Dec Econ 2007, in press
28. * All R&D costs (basic research and preclinical development) prior to initiation of clinical testing Pre-Approval Out-of-Pocket Cost per Approved New Molecule ** Based on a 5-year shift and prior growth rates for the preclinical and clinical periods Source: DiMasi and Grabowski, Managerial and Dec Econ 2007, in press
29. * All R&D costs (basic research and preclinical development) prior to initiation of clinical testing Pre-Approval Capitalized Cost per Approved New Molecule ** Based on a 5-year shift and prior growth rates for the preclinical and clinical periods Source: DiMasi and Grabowski, Managerial and Dec Econ 2007, in press
31. Market Exclusivity for First-in-Class has Declined: Mean Time to First Follow-on Approval Source: DiMasi and Paquette, PharmacoEconomics 2004;22(Suppl 2):1-14
32. Percent of Follow-on Drugs Reaching Clinical Milestone Prior to First-in-Class Drug Reaching Same Milestone Source: DiMasi, Paquette, PharmacoEconomics 2004;22(Suppl 2):1-14
33. Follow-on Approvals Create Competition Resulting in Price Discounts Source: DiMasi, 2000 [http://aspe.hhs.gov/health/reports/drug-papers/dimassi/dimasi-final.htm] * Analysis based on FYs 1995-1999.
38. Clinical Testing Pipelines for Large Pharmaceutical Firms* Have Grown in Recent Years (Phase I Starts per year) Source: Tufts CSDD Impact Report, 8(3): May/June 2006 * Ten largest pharmaceutical firms
39. Trends in New Drug Development Pipelines* by Therapeutic Class Source: Tufts CSDD Impact Report, 8(3): May/June 2006 * Ten largest pharmaceutical firms
40. Large Pharmaceutical Firms* are Increasingly Licensing-in New Drugs Source: Tufts CSDD Impact Report, 8(3): May/June 2006 * Ten largest pharmaceutical firms
41.
Editor's Notes
Distribution of Research Terminations by Therapeutic Category
Total Capitalized Cost Reductions from Increases in the Clinical Success Rate
Capitalized Clinical and Total Cost Reductions from Simultaneous Reductions in all Phase Times
![Agenda ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)