According to an article in Bit-IT World, the US FDA is taking disease and drug simulation seriously: and a post on Simblog argues that quiet revolutions in simulation techniques will culminate in an in silico human system.
Firstly, FDA is working on a disease modelling programme, using Pharsight software to make a data warehouse. This will “support Clinical Data Interchange Standards Consortium (CDISC) data formats, and interact with other FDA databases.”
Secondly, FDA is building a database of models that would eventually be made broadly available to sponsors, including â€œdisease models in Parkinsonâ€™s disease, Alzheimerâ€™s disease, non-small-cell lung cancer, diabetes, and osteoarthritis.â€? using FDA data.
Thirdly, it is using simulation to streamline the complex drug approval process: at the so-called EOP2a stage, “FDA will build a model based on sponsor data and relevant historic FDA data from other trials and perform simulations to guide next steps (dosing, trial size, attrition) and even suggest go-no-go decisions”.
So far, disease modelling has tended to be either macro or micro – that is, you may model the spread of a disease through a community using impersonal actors who have an arbitrary x per cent chance of catching it, or you may model the spread, or the effects of a drug, inside one complex actor, simulating in detail the interactions in one body. Given modern computing power, it may now be possible to do both at the same time. I wonder if that would make any difference to the results?
The Simblog posting, by Niell McMahon, instances the foundation of specialist medical simulation companies such as Entelos, as well as Blue Gene and the Human Genome project. He might also have added IBMs attempts to model the brain, which offer the possibility of psychiatric as well as physical modelling.
Lets hope the FDA and others can achieve a degree of compatibility between models, and also that these models eventually turn into an open source project like PHP or MySQL, not a closed, expensive cash cow like M***o***t software. A naive hope? yes. But Im just a blogger and theres no harm in dreaming.