PharmExec Blog

Clinical Trials in the Digital Age

In 1995, there were 16 million internet users — or 0.4% of the world’s population. In just 17 years, this figure has grown to 2.4 billion and 34.3% adoption. At the current rate, each year, the penetration percentage sees a 2–4% growth. Many services, such as banking, have moved towards online service models, shutting down branch offices. This has led to some countries, like Finland, for example, making access to broadband internet a basic civil right.

What does this mean for clinical trials? In this Applied Clinical Trials article, Kai Langal considers how the internet and other digital technologies have transformed — and continue to transform — patient-centric engagement. Read More »

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Six Steps to Better Cancer Care in Europe

A  report published yesterday provides recommendations for combating the “significant inequalities” affecting access to quality cancer care in Europe. Read More »

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"Work to Be Done" on EU Clinical Trials Regulation, Says Industry

The European Parliament yesterday voted towards the adoption of the new Clinical Trials Regulation, which removes the legal framework for pharma to not publish its data by stating that information from  trial study reports should not be considered commercially confidential. Read More »

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FDA Wants YOU!

A number of top management positions at the Center for Drug Evaluation and Research (CDER) need to be filled, and Center leaders are looking for experienced industry managers to help rebuild its staff. Many experienced FDAers are ending their careers or taking on new challenges, creating a need for “renewal and replenishment” of the agency, explains Richard Moscicki, deputy director for science operations at CDER, who is leading its executive recruitment campaign. Moscicki formerly headed clinical development at Genzyme before coming to FDA in February 2013 and hopes to attract more people with similar backgrounds to public service. While some positions may be filled by internal candidates, Moscicki is looking to bring in people with leadership and management experience that may not exist at the agency.

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The Sovaldi Case: Is American Biotech History About to Repeat Itself?

Recent Congressional investigations over the pricing scheme of Gilead’s much-heralded hepatitis C drug Sovaldi – and a decline in stocks across the biotech sector – rings a familiar bell, writes Tom Norton.

Twenty years ago in May, US Senator Joe Lieberman carefully questioned biotech CEO Harry Penner of then Neurogen Corporation about why his company’s stock had taken a dive [transcript p. 94]:

Sen. Lieberman: Do you have any doubt that the actions that were at least included in the original Administration (Clinton Health Care) proposal, such as the price controls and the breakthrough drug committee, Medicaid black-listing, would have a very serious negative effect on the availability of capital for a company like yours?

Mr. Penner: There is no question about it.  As I indicated in my testimony, the present effect on our stock has been something in the neighborhood of a 50- to 60-percent decline.

Sen. Lieberman: There is no other reason for that drop to have occurred, is that correct?

Mr. Penner: No; none at all.

Senator Lieberman: There is no other variable out there?

Mr. Penner: Not at all, and I think the (biotech) industry figures are more in the nature of two-thirds.
[Note: Neurogen was acquired by Ligand Pharmaceuticals in 2009.]

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