Pharmaceutical Executive-03-01-2016

Positioning for success in biopharma requires a self-critical analysis of the risk and rewards among four categories of value differentiation. The key question: How do you define yourself against the competition?

As new ICH GCP draft guidelines now require root cause analysis, novel methods for risk analysis and triage must be adopted in drug development.

With the emerging industry commitment to publicly disclose research and clinical trial results, two pivotal issues come to mind - and serve as a reminder to companies that true transparency depends on the truthfulness of the evidence that binds it.

A new wave of technologies supported by innovative business models is transforming the vaccine landscape - and raising the bar on performance. As the demand for cures for chronic diseases accelerates, and with more global outbreaks of viral diseases like Zika and Ebola a virtual certainty, solutions can’t come soon enough.

Can novel drug delivery technologies offering options beyond the traditional tablet or syringe transform the therapeutic experience for patients?

More generics and biosimilars may generate competition - but FDA opposes broad compounding.

Europe’s contrasting views on rare disease drugs - one bashing pricing abuses, the other extolling their public health virtues - could ultimately leave these products out in the cold.

The Dutch healthcare system, dubbed today as a “laboratory for change,” is in the midst of reinventing itself around collaborations with industry and government in such areas as market and patient access, transparency, cost-effectiveness, and process innovation.

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