1 / 12

A Brief Review of Drug Development Metrics

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

uri
Download Presentation

A Brief Review of Drug Development Metrics

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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

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

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

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

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

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

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

  8. 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

  9. 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, ClinPharmacolTher, 2010;87:356-361http://www.nature.com/clpt/journal/v87/n3/full/clpt2009293a.html

  10. 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

More Related