a brief review of drug development metrics
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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 - PowerPoint PPT PresentationTRANSCRIPT
A Brief Review of Drug Development Metrics
What Does it Really Cost to Develop a New Treatment?
Kenneth I Kaitin, Ph.D. Director, Tufts Center for the Study of Drug Development
Prof. of Medicine, Prof. of Pharmacology & Exp. Therapeutics
ASENT Annual MeetingDinner Session
Bethesda, MD, March 4, 2010
The Drug Development Pathway
BasicResearch
Prototype Design or Discovery
PreclinicalDevelopment
FDA Review/ Approval & Launch
Clinical Development
Phase I
Phase II
Phase III
Phase IV, PMS, Life Cycle Management
IND Filing
NDA/BLA Submission
5.2 0.6
5.2 1.7
6.0 1.7
6.5 1.9
7.0 1.4
7.1 1.7
7.9 0.8
0 10Years
AIDS Antiviral
Cardiovascular
Antiinfective*
Anesthetic/Analgesic
Endocrine
Neuropharmacologic
Antineoplastic
Clinical Phase Approval Phase
Clinical and Approval Times Vary Across Therapeutic
Classes, 2003-07
* excludes AIDS antivirals
8.7
8.8
8.4
8.4
7.7
6.9
5.8
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%
8.2%
8.7%
9.4%
19.4%
20.4%
23.9%
0 27Clinical Approval Success Rate
Neuropharmacologic
Cardiovascular
GI/Metabolism
Oncology/Immunology
Musculoskeletal
Sys. Antiinfective
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
615
439
626
879
1,2411,318
0
1500
Mill
ions
of 2
005
Dol
lars
Non-Clinical Clinical Total Costs
Biotech Pharma (Time Adjusted)
Source: DiMasi & Grabowski, Managerial Decision Econ, 2007;28:469-479
Time Adjusted Capitalized Clinical Costs by Therapeutic
Area
$604
$741 $750$792
$849
0
1000
Mill
ions
of 2
005
Dol
lars
Anesth/Analg Cardiovascular All Antiinfective CNS
Source: DiMasi et al, Drug Info J, 2004;38:211-223
Global Pharma Sales in 2008 by Therapeutic
Category
$12.0 bil
$17.1 bil
$18.9 bil
$19.1 bil
$21.7 bil
$23.9 bil
$34.6 bil
$43.8 bil
$59.9 bil
$78.0 bil
$84.7 bil
Hematology
Gastrointestinal
Hormone Control
Vaccines
Inflammation
Diabetes
Respiratory
Antiinfectives
Cancer
CNS
Cardiovascular
Source: Lehman Brothers, Sept 2008; in Parexel Statistical Sourcebook 2008-2009
10.3% of Global Market
Drivers of Rising R&D Costs
Chronic and complex indications Clinical trial size Protocol design complexity Patient recruitment/retention High cost discovery/research tools Regulatory demands Market oriented studies Late-stage attrition
New Drug Approvals Are Not Keeping Pace with Rising
R&D Spending
0
15
30
45
60
1963 1968 1973 1978 1983 1988 1993 1998 2003 2008
New
Dru
g A
ppro
vals
0
13
26
39
52
R&
D Expenditures
(Billions of 2008$)
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 Tufts Center for the Study of Drug Study of Drug DevelopmentDevelopmentTufts University, Boston, Tufts University, Boston, Massachusetts, USAMassachusetts, USAKenneth I Kaitin, Ph.D.Kenneth I Kaitin, Ph.D.DirectorDirectorProfessor of MedicineProfessor of MedicineProfessor of Pharmacology & Exp. TherapeuticsProfessor of Pharmacology & Exp. Therapeutics
Websitehttp://csdd.tufts.eduhttp://csdd.tufts.edu
[email protected]@tufts.edu