PharmaTimes -
November 2016

When working on last month's feature on the future of clinical trials, one thing that came up again and again from the interviewees was how real-world data would soon be a keystone of the drug development process - so this month we've decided to take a deeper look at how real-world evidence could change the landscape for regulation in the near future (Getting real, p25). Needlessly to say, looking at how a drug's economics, safety and effectiveness function outside of the heavily-controlled setting of a clinical trial can give both pharma companies and regulators a completely different view of a product.

Meanwhile in the world of healthcare, the UK's two biggest political parties have laid out their plans for the future of the NHS (Drawing the NHS roadmap, p34) and a new report has reiterated the health services's woes (Underfunded, overstretched, p31). With all this pessimism in the air, it's good to be reminded that the pharma industry can make a difference, so we have two articles about how companies can help improve the health service (The integration generation, p17) and overcome trust issues the NHS might have with the industry.

Elsewhere we look at orphan drug pricing (Worth the weight? p20) and get some expert advice on what not to do when applying for an orphan designation (Securing an orphan drug designation, p38), plus there's a focus on the software that can simulate how drugs affect cancer pathways (Simulate to medicate, p40), and this month's Patient Files focuses on the badly-understood form of cancer mesothelioma.

I hope you enjoy the issue.

October 2016 - magazine highlights

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The integration generation

The NHS needs to deliver a more holistic, joined-up experience for patients – and pharma can seize the opportunity to help shape new patient pathways

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Worth the weight?

Even though they may only treat a few patients per year, orphan drugs are raising big questions about their impact on the wider industry

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Relationship advice

A new survey reveals what NHS workers think pharma can do to improve joint-working relationships

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Getting real

Pharma is starting to use real-world evidence to get a more accurate picture of how drugs fare outside a clinical setting – but it needs to stop being a new concept and start being an integral part of operations

Thumbnail image for Securing an orphan drug designation

Securing an orphan drug designation

Getting an orphan designation isn't as simple as just targeting a rare disease. Tim Coté, former director of the FDA's Office of Orphan Products, tackles the most common mistakes companies make

Thumbnail image for Simulate  to medicate

Simulate to medicate

Jonathan Dry, principal scientist, bioinformatics, oncology, innovative medicines & early development at AstraZeneca, explains how his company is using new technologies to simulate how drugs affect cancer pathways without the need for a trial

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