Drug development
[1][2] The entire process—from concept through preclinical testing in the laboratory to clinical trial development, including Phase I–III trials—to approved vaccine or drug typically takes more than a decade.
[citation needed] In addition, drug development must establish the physicochemical properties of the NCE: its chemical makeup, stability, and solubility.
These generally constitute a number of tests designed to determine the major toxicities of a novel compound prior to first use in humans.
[10][11] A study covering clinical research in the 1980–1990s found that only 21.5% of drug candidates that started Phase I trials were eventually approved for marketing.
[21] The average cost of conducting a 2015–16 pivotal Phase III trial on an infectious disease drug candidate was $22 million.
[21] The full cost of bringing a new drug (i.e., new chemical entity) to market—from discovery through clinical trials to approval—is complex and controversial.
[24] Alternatives to conventional drug development have the objective for universities, governments, and the pharmaceutical industry to collaborate and optimize resources.
[26][27] The nature of a drug development project is characterised by high attrition rates, large capital expenditures, and long timelines.
The most commonly used valuation methods are risk-adjusted net present value (rNPV), decision trees, real options, or comparables.
Well-designed, dose-finding studies and comparisons against both a placebo and a gold-standard treatment arm play a major role in achieving reliable data.
[37] In March 2020, the United States Department of Energy, National Science Foundation, NASA, industry, and nine universities pooled resources to access supercomputers from IBM, combined with cloud computing resources from Hewlett Packard Enterprise, Amazon, Microsoft, and Google, for drug discovery.
The partnership is a distributed computing project that "will automatically run a simulated experiment in the background [of connected home PCs] which will help predict the effectiveness of a particular chemical compound as a possible treatment for COVID-19".
