Global healthcare systems are currently undergoing major transformations spurred by increasing regulation, record public debt and shrinking budgets. The U.S. has the dubious distinction of leading the way in this regard. The mandates of the Affordable Care Act, along with shrinking reimbursement to providers are fundamentally changing the operation of…
The approval last year in the EU of generic Remicade represents a milestone of sorts. Biosimilars aim to replace, or at least compete with, products that generated over $100 billion in worldwide sales in 2013. While Europe has led the way in the development of a regulatory pathway for the…
Expanding government and payer requirements for additional data on products, whether for safety monitoring, efficacy confirmation or economic and clinical value evaluation, underscore the importance of an integrated strategy for investigator initiated trials (IIT) and real world evidence (RWE) research. In developing an IIT/RWE strategy, companies need to be clear…
The Affordable Care Act (ACA) has elicited intense national debate and sent biopharmaceutical companies scrambling to understand how their business model, including its ability to innovate, will change as healthcare reform moves forward. Within this uncertain market, what is obvious is that the industry is in the midst of significant…
The FDA’s Breakthrough Therapy Designation — created when the FDA Safety and Innovation Act was signed on 9 July 2012 — is in its second year after a successful start. Enacted to provide another mechanism to accelerate the path of critical therapeutics to market, the statute has exceeded expectations. The…
The life sciences industry faces an unprecedented number of challenges led by concerns about escalating healthcare costs. With a consolidating payer base increasingly driving healthcare decision-making, more evidence of both safety and effectiveness is required than randomized clinical trials (RCTs) — the familiar “gold standard” — can offer. Against this…
