Partially due to the Affordable Care Act which I have discussed numerous times on this blog, especially as it pertains to the world of clinical research, drug companies have been scrambling to get their drugs approved by the FDA and added to insurance company formularies before the legislation officially goes into action. Basically, drugs that do not show any significant differences or improvements from previous drugs that target the same medical conditions will NOT gain formulary approval by insurance companies. The FDA is also looking at these “me too” drugs and will make drug approval much more difficult for drugs that do not show any improvements from their predecessors.

Under the situation described above, at first glance, the situation for clinical trials going forward may seem dire. Fortunately for those of us working in this sector, I believe we are entering into a new era for not only clinical research, but for the pharmaceutical industry in general. This new era will usher in a new business model for drugmakers, CRO’s and research clinics alike, and we have already started seeing the beginning of niche studies, otherwise known as studies for drugs that target smaller populations and attack the biological pathways for the disease or disorder rather than focus on the symptoms. According to Novartis CEO Joseph Jimenez who was recently quoted in a Fortune magazine article regarding his company’s strategy going forward in terms of drug development, “The company plans to do that by attacking disease pathways, the biological processes. That way, you get a drug that, while designed for kidney cancer, is also helpful to patients with certain lung or breast cancers.” Novartis has already done this with several of it’s cancer drugs, essentially creating “mini blockbusters” by attacking the biological pathway of a disease rather than merely looking to subdue symptoms.

What does all this mean for clinical trial sites and CRO’s? Perhaps a new study participant recruitment model is in order combined with strategic partnerships and alliances in the industry which we have already begun to see with certain CRO’s and SMO’s lately. perhaps new business development tactics for getting the contracts for these studies at your organization? No matter how you may look at the situation and attempt a business strategy going forward, the industry is undergoing a paradigm shift and, as in all industries that eventually go through changes such as these, some will fail while others will succeed enormously.