What Does it Really Cost to Develop a New Treatment?

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Presentation transcript:

What Does it Really Cost to Develop a New Treatment? A Brief Review of Drug Development Metrics Kenneth I Kaitin, Ph.D. Director, Tufts Center for the Study of Drug Development Prof. of Medicine, Prof. of Pharmacology & Exp. Therapeutics ASENT Annual Meeting Dinner Session Bethesda, MD, March 4, 2010

The Drug Development Pathway Basic Research Prototype Design or Discovery Preclinical Development IND Filing Clinical Development Phase I Phase II Phase III NDA/BLA Submission FDA Review/ Approval & Launch Phase IV, PMS, Life Cycle Management

Clinical and Approval Times Vary Across Therapeutic Classes, 2003-07 8.7 8.8 8.4 7.7 6.9 5.8 * excludes AIDS antivirals Source: Kaitin, Clin Pharmacol Ther, 2010;87:356-361 http://www.nature.com/clpt/journal/v87/n3/full/clpt2009293a.html

Overall Clinical Approval Success Rate for NCEs has Dropped to 16% Source: DiMasi et al, Clin Pharmacol Ther, 2010;87:272-277 http://www.nature.com/clpt/journal/v87/n3/full/clpt2009295a.html

Capitalized Cost per Approved Biotech Product is Similar to that for Pharma Source: DiMasi & Grabowski, Managerial Decision Econ, 2007;28:469-479

Time Adjusted Capitalized Clinical Costs by Therapeutic Area Source: DiMasi et al, Drug Info J, 2004;38:211-223

Global Pharma Sales in 2008 by Therapeutic Category 10.3% of Global Market Source: Lehman Brothers, Sept 2008; in Parexel Statistical Sourcebook 2008-2009

Drivers of Rising R&D Costs Chronic and complex indications Clinical trial size Protocol design complexity Patient recruitment/retention High cost discovery/research tools Regulatory demands Market oriented studies Late-stage attrition

New Drug Approvals Are Not Keeping Pace with Rising R&D Spending R&D Expenditures New Drug Approvals * Trend line is 3-year moving average; R&D expenditure adjusted for inflation Source: Kaitin, Clin Pharmacol Ther, 2010;87:356-361 http://www.nature.com/clpt/journal/v87/n3/full/clpt2009293a.html

Tufts Center for the Study of Drug Development Tufts University, Boston, Massachusetts, USA Kenneth I Kaitin, Ph.D. Director Professor of Medicine Professor of Pharmacology & Exp. Therapeutics Website http://csdd.tufts.edu Email kenneth.kaitin@tufts.edu