The use of computer-driven approaches from the very first steps in drug discovery through to marketing and the supply chain places the onus on the FDA to understand the technology and how it can help it meet its goals. This is reflected in the list of research areas in which the FDA wants to invest in 2014, which is littered with references to in silico modeling, omics and mobile applications.
The FDA broke the list up into 9 broad categories, the specifics of many of which include new and improved uses of computers. To meet its first goal of modernizing toxicology, the FDA wants to assess in silico modeling, which could allow researchers to more accurately predict how a drug will behave in humans and cut the need to use animals. Development of computer models of cells, organs and systems that better predict safety and efficacy is one of the FDA's specific goals.
The computer-enabled objectives also cover clinical trials--which the FDA wants to improve through use of simulations--and on to postmarketing. If the FDA achieves its ambition to integrate pharmacokinetic, pharmacodynamic and other safety data into a computer model, it thinks it can better predict clinical risk-benefit and confirm postmarketing safety in different patient populations. The FDA also wants to explore the use of wireless technologies and mobile apps as therapies and diagnostics.
While many of the tools have the potential to improve how the FDA works, the scope of the document shows how hard it could be to understand, master and incorporate rapidly advancing technologies. The FDA has a patchy track record with IT initiatives--as attested to by slapdowns by the Government Accountability Office--but the roadmap, opening of a computer-focused regulatory science center and appointment of chief health informatics officer show it is trying to use tech to its advantage.
- read Regulatory Focus' take
- here's the FDA filing