Computer Aided Drug Design and Pharma Industry

This post is intended to justify use of Computer Aided Drug Design methodologies for accelarating the drug discovery processes of the pharma industry.
Phases in Drug Discovery

• Pre-Clinical Research

This includes synthesis, purification and animal testing.

• Phase I Clinical Trials

Phase I studies may be conducted in patients, but typically involve healthy volunteer subjects. These studies are designed to determine the pharmacokinetic (how the drug is absorbed, distributed, metabolized, and excreted by the body) and pharmacologic (the effect of the drug on the body) actions of the drug in humans, the side effects associated with increasing doses, and, if possible, early evidence on effectiveness.

• Phase II Clinical Trials

Phase II studies are designed to obtain data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition. They also help determine the common short-term side effects and risks associated with the drug. Phase II studies are closely monitored and conducted in a relatively small number of patients.

• Phase III Clinical Trials

Phase III studies are expanded controlled and uncontrolled trials. They are done to gain additional data about effectiveness and safety needed to evaluate the benefits and risks of the drug. Results from Phase III studies also yield data that will provide the information that eventually will go on physician labeling.

Facts

• Cost of developing a new drug in 1979 was $54mn, in 1991 it was $231mn and in 2001 it was $802mn.

• It takes between 10 and 15 years to develop a new prescription medicine and win approval to market it in the United States.

• Had costs increased at the pace of inflation, the average cost of new drug development would have risen from $231 million in 1987 dollars to $318 million in 2000 dollars.

• The full capitalized resource cost of new drug development was estimated to be $802 million (2000 dollars). This estimate accounts for the cost of failures, including research on compounds abandoned during development, as well as opportunity costs of incurring R&D expenditures before earning any returns.

• When compared to the results for previous similar studies, the R&D cost per approved new drug increased 2.5 times in inflation-adjusted terms.

• While costs have increased in inflation-adjusted terms for all R&D phases, the increases were particularly acute for the clinical period. The inflation-adjusted annual growth rate for capitalized clinical costs (11.8%) was more than five times greater than that for pre-clinical R&D.

Links

• CIO Speed - How IT and Pharma are merging
• Tufts Group