The pharmaceutical industry has entered a critical period of transition. Business models that have proven remarkably successful over the past 20 years are now encountering major challenges. As companies grapple with the leading symptoms of these challenges — pricing pressures, pipeline productivity concerns, a growing public distrust, and greater political…
Investigator Initiated Trials (IITs) can be a valuable part of a pharmaceutical or medical device manufacturer’s marketing claims arsenal. IITs are relatively low cost, because much of the upfront work is performed by the investigator, and the investigator normally “donates” facilities and staff to the conduct of the trial. In…
Much of the common advice related to outsourcing of clinical research focuses on the obvious issues — the relative cost of performing research internally versus turning all or part of it over to a CRO, the impact of internal time and resource constraints on time-to-market, the relative experience of the…
To be successful in today’s dynamic and increasingly cost conscious healthcare environment requires companies to fundamentally change the way they think about their products. Companies need to develop an understanding of how their products contribute to improved clinical outcomes against existing therapies and what data they will need to prove…
One of the most critical processes for any R&D organization is project prioritization — deciding which projects will be funded over the next period and which will not. Pharmaceutical companies, in particular, have to make big investment decisions about their drug pipelines. These decisions involve complex assessments of technical, clinical,…
Time-to-market is one of the most crucial determinants of success in the pharmaceutical industry. The shorter the time between your competitors’ first hearing about your potential new drug and that drug’s introduction into the marketplace, the longer you will reap the rewards of sole ownership of the niche. Pharmaceutical companies…
