Upload
robert-sturm
View
3.776
Download
3
Embed Size (px)
DESCRIPTION
Presentation explains the Drug Development Process in terms of time/costs from initial research to final manufacturing. It presents strategies for increasing profits/decreasing costs, shows the impact of generics and details how Information Technology fits into this equation. It uses research from DiMasi and Grabowski to identify drug costs and product revenue.
Citation preview
DRUG DEVELOPMENT PROCESS
Bob Sturm Director, IT Validation
Goals for Today
• To understand the Drug Development Process
• How long does it take?
• How much does it cost?
• Where does I.T. fit in?
Purpose of I.T. at any company
• What is the purpose of I.T. at any company?
• Why does I.T. exist?
Purpose of I.T. at any company
• As told to me by a manufacturing company CFO
– I.T. exists to increase profits or decrease costs
– After profits and costs, everything else is fluff
Purpose of I.T. at any company
• Told to me by a manufacturing company CFO
– I.T. exists to increase profits or decrease costs
– After profits and costs, everything else is fluff
• I added that following the law comes first – FDA, CIA and SOX
• Then we have the profits and costs axiom
Service Level Agreement I.T. Vision Statement
• The goal of the I.T. organization is to support its customers to bring new patient treatments to market by providing information technology services that optimize business processes to reduce time and cost associated with product development.
Drug Development Process – 28,800 hits
Process vs. Creativity over Time
Time
Drug Development Cycle Time to Market - 2003
Infotechgraphics.com/projects/drug-development-cycle/
Critical Path for Medical Product Development and Approval per the
FDA
FDA, Challenge and Opportunity on the Critical Path to New Medical Products 2004, p. 4
Three Dimensions on the Critical Path - FDA
FDA, Challenge and Opportunity on the Critical Path to New Medical Products 2004, p. 10
Drug Development Cycle – FDA Interactions
FDA, Challenge and Opportunity on the Critical Path to New Medical Products 2004, p. 12
CDER New Drug Development and Review Process
See notes for additional explanation of this chart.
Clinical Trial Process Ph 3 Costs Exceed $26,000 / patient-2006 (1)
1) prnewswire.com, Phase 3 Clinical Trial Costs; Ph 1: $15.7k/ patient, Ph2: $19.3k/patient, Ph3 $26k/patient See Definitions for an explanation of the Approval Process
Drug Development by the Numbers (DiMasi et al, 2003, except where noted)
• Drug synthesis to FDA approval is about 12 years
• Drug Synthesis to IND is ~4.3 years
• IND submittal to NDA submittal is ~6 – 7 years
• NDA submittal to FDA approval is ~0.5 – 1.5 years
• Clinical phases 1, 2 and 3 are ~5.7 years (phases overlap each other)
• Only 1 in 3 drugs cover their R&D costs (1)
• Roche stopped a Ph 3 study of 15,000 patients for a cholesterol drug (2)
1) Grabowski et al, “Returns on R&D”, 2002, p. 27: 2) Pharmalot.com, August 2012
Total Drug Development Costs (1)
2011: New drug development costs are about $1.3 billion (2)
1) DiMasi et al 2003, p.167. Columnar years are 1979, 1991 and 2003 2) http://csdd.tufts.edu/news/complete_story/pr_outlook_2011/, Drug developers are aggressively changing the way they do R&D
Clinical Trials (Trail Duration and Capitalized Expected Costs (1) / Approved Drug)
• Phase 1 (22 months / $30.5 million) – Evaluate Safety
• Phase 2 (26 months / $29.5 million) – Identify the correct dosing level – Monitor safety
• Phase 3 (31 months / $37.4 million) – Evaluate safety in a large population over time – Evaluate effectiveness (Meets it’s end points?)
• Long Term Animal Studies (37 mo / $3.0 million) • Phase 4
– Marketing studies DiMasi et al, 2003, p. 165, Table 3
1) Includes out-of-pocket costs, inflation rates, cost of capital, attrition rates, see DiMasi pp 158 – 161;
Total Costs/Approved Drug – the Math: C x P = E
• (Actual Capitalized Costs) X (Probability of success) = Capitalized Expected Costs
• (Actual Capitalized Costs) X 21.5% (1) = $100.4 Mil
• Actual Capitalized Costs = $467 Million • Preclinical Costs = Discovery + Preclinical • Preclinical Costs = $335 Million • Total Costs / Approved Drug = $802 Million
1) 21.5% - Source: DiMasi et al, 2003, p 165;
IND Filing to NDA Filing Time (All NMEs Approved 1981 to 1989)
Differences due to process efficiencies and drug types
New Product Revenue – 2002 Approved drugs
Avg. of 118 NMEs introduced into the US market from 1990 - 1994
Generics Quickly Impact Sales Volume
• For 2010 within six months of a patent loss, generics took more than 80% of sales volume from the branded version (on average). (1)
• Plavix (BMS) went off patent in May 2012. Within 2 months it’s sales dropped by 60%. (2)
• Avapro (BMS) went off patent in March 2012. By July 2012 it’s U.S. sales dropped by 85%. (2)
• Singulair (Merck) went off patent in August 2012. Merck expect sales to drop by 90%. (3)
Fierce Pharma: 1) April 20, 2011; 2) July 25, 2012; 3) August 6, 2012
Impact of Generics
Increased Product Revenue
Strategies for Profits / Costs • Fail fast, Win quick • Focus on niche population instead of a block buster
– Genentech’s Heparin • Adaptive trial design
– Modify the trial at specific points • Reformulate and extend patent exclusivity
– Oxycontin – Perdue Pharma (1)
• Get an expert opinion to shorten the clinical trial time – KaroBio for their cholesterol drug (2)
1) Wall Street Journal - June 28, 2012 2) Business Week May 31, 2010
Gov’t Pricing System/Medicaid
Commercial FDA Clinical Pre-clinical
Drug Dev. Cycle - Application Systems
Discovery Research
Documentum / Ascent Capture
eCTD Xpress/ ISI Toolbox
SLIM STAT
MediData
WinNonlin
SAS
Refrigeration Manager
Chemstation /Chemlaunch/Chemstore
Calibration Manager
CRM
Infomatica
Business Intelligence
SAP
Argus Drug Safety IDBS Activity Base
CCP4
Rigaku
Pipeline Pilot
Symyx Compound Reg
Symyx Isentris
Lasergene
GCK
MOE
Cellomics cHCS Viewer
GeneGo
Where Does I.T. Fit In?
• Decrease Costs – Cloud strategy
– SharePoint 2010
– FAST search
• Increase Profits – Reduce time to product launch
Questions??
Definitions
BLA: Biologics License Application NDA: New Drug Application
CNS: Central Nervous System NME: New Molecular Entity
IND: Investigational New Drug R&D: Research & Development
FDA: Food and Drug Administration
NCE: New Chemical Entity
Approval process: Final review of process before patients are recruited. It includes drug supply, randomization, FDA forms, signed patient consent forms , CRFs and Life Sciences company and vendor project team readiness, etc.
References
• DiMasi, et al, 2003. The price of innovation: new estimates of drug development costs. Journal of Health Economics 22, 151-185.
• Grabowski, H.G., et al, 2002. Returns on research and development for 1990s new drug introductions. Pharmacoeconomics 20 (Supplement 3), 11-29.
• Food and Drug Administration, March 2004, Challenge and Opportunity on the Critical Path to New Medical Products