Research firm Research and Markets examined the US pharmaceutical and biotech industry macroeconomic challenges and industry issues in the firm’s report, “The US Pharmaceutical Market Outlook to 2014: Market Trends, Leading Players and Forecasts.” Some of the problems identified in the report can be alleviated by the implementation of business intelligence software. Here’s our take on how business intelligence can help pharmaceuticals and biotech companies manage industry-specific business issues.
One key finding of the report is that pharmaceutical companies and biotech firms are faced with greater FDA stringency. “Growing political pressure and criticism over drug safety issues in the past have lead [sic] to the FDA becoming increasingly vigilant, resulting in fewer drugs being approved.
Examples of recent changes at the FDA include the FDA’s Sentinel Initiative and the FDA’s “Safety First” program.
The FDA’s Sentinel Initiative is a “national electronic system that will transform [the] FDA’s ability to track the safety of drugs, biologics, medical devices, and eventually, all FDA-regulated products. The program will develop and implement a proactive system to complement existing systems that are used to track reports of adverse events. Once the Sentinel System is in place, the FDA will be able to actively query diverse automated healthcare data holders – such as electronic health record systems, administrative and insurance claim databases and registries – to evaluate medical product safety issues more quickly. The new system will be implemented in phases, and by the end, data “owners” – such as pharmaceutical and biotech firms – will be responsible for submitting more detailed information to the FDA.
The FDA’s “Safety First” program plans to address the safety of drugs already available on the market. Under this plan, the FDA will create a new database listing possible side effects of drugs, and clear up processes for following up on questions related to the side effects. The FDA will also strengthen the Office of Surveillance and Epidemiology, which focuses on the safety of marketed drugs. The OSE will be the lead regulator for “areas related to observational epidemiologic studies and medication error prevention.” While the “Safety First” program is still short on specifics, the conclusion is that pharmaceutical firms need to strengthen and enhance the systems that support their drug safety efforts.
Business Intelligence Solution: Pharmacovigilance
At the highest level, business intelligence software creates an environment to facilitate pharmacovigilance, the evaluation of drug safety information. Visualization, a key component of business intelligence software, can show analysts associations between adverse events and particular patient demographics. Additional ways business intelligence can help companies comply with more stringent FDA programs include examining drug safety over time, in more detail and with information updated in real-time.
Perhaps the unstated challenge for pharmaceuticals and biotech companies is that the regulatory environment is constantly changing. Increasingly often, regulators are asking drug developers and manufacturers to look at novel methods of analyzing drug data to ensure products that reach the market are safe.
Using business intelligence software, companies can detect drug safety issues earlier, providing them the strategic information needed to make changes to their drugs, their business plans and even their overall market strategies.
Kelley Kassa
Spotfire Blogging Team
