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The Affordable Care Act’s Impact on Innovation in Biopharma

BioPharm International

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 Breakthrough Designation Program: Four Factors for Long Term Success


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…

Tighten Up Your Product Lifecycle Management


In today’s global market environment, payers are looking hard to reduce reimbursement and resist paying for incremental product enhancements.  On top of that, manufacturers’ revenue streams continue to be threatened by looming patent expiration dates and the simultaneous influx of generic competition.  What actions should companies consider taking to protect…

Market Access — Global Challenges for Oncology Drugs


Oncology drug and biologics makers face increasing demands for data that demonstrates the benefit and cost-effectiveness of their products. Not only are treatment cost increases considered unsustainable, questions about new product effectiveness are being openly raised by physicians and payers alike. Pharmaceutical companies are increasingly being expected to demonstrate the…

In Search of the Silver Bullet: The Illusion of Big Data


While big data by definition captures a large amount of detail for a large number of patients, what it can’t do is provide a company with the big picture, “the wide angle view.”  While big data sets such as SharedClarity, formed by UnitedHealthcare and several large provider systems, can be…