PharmExec Blog

The Baltic States: A Location for Your Next Clinical Trial

The Baltic States with its appropriate population size, sufficient infrastructure, and experienced and motivated investigators, make it an attractive choice for a clinical trial.

In this article, Doatas Grina, Indre Tutlyte and Auudius Sveikata, PhD, that ran in the February 2013 issue of Applied Clinical Trials, presents a persuasive case for the area’s present desirability as well as a history of steady growth in the past that indicates the Baltic clinical research market is poised to grow. Already it has proven rich in clinical research potential. Consider:

  • The Baltic States approve around 80 new clinical trial applications per country each year.
  • The biggest part of clinical trials performed are within the therapeutic areas of oncology, neurology/psychiatry, and endocrinology.
  • Nearly 70% of the studies performed are Phase III trials.
  • States legislation is harmonized and the regulatory process is similar to other EU countries.
  • The timelines are attractive—the approval process takes approximately 60 days.
  • The region has an appropriate population size to populate large trials.
  • Its infrastructure is sufficient and their investigators are experienced and motivated.
  • A considerably large pool of treatment-naïve subjects is available, similar to most of the Central and Eastern European counties. Read More »
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New CDER “Super Office” to Promote Drug Quality

After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research, has administration approval for organizational changes to bolster programs and policies to ensure drug quality. The Department of Health and Human Services and the White House have finally signed off on her plan to establish a new CDER “super” Office of Pharmaceutical Quality (OPQ), a change originally proposed in the fall of 2012. The change aims to establish the “once voice for quality” that Woodcock has championed by providing “better alignment among all drug quality functions at CDER, including review, inspection and research,” Woodcock explained in an internal staff memo. Read More »

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Pulling Back the Curtains on Obamacare Rx Usage

It’s fall and the 2015 Obamacare Exchange Rx insurance offerings will be presented to patients on November 15th. But at this point, what insights do American Rx brand managers and marketers actually have on the results of the Obamacare Rx experience in 2014?

Up until now, very little publicly available information on what Obamacare Rx utilization has been available. We’ve known next to nothing about the demographics of patients who used the program, and most importantly, the costs associated with various Rx therapeutic groups were unclear. All of this changed this past week.

On October 7, 2014 the New York Times published a story detailing the first six months of Rx experience with the Obamacare exchanges as reported by two of Obamacare’s major public exchange pharmacy benefit managers: Express Scripts and Prime Therapeutics. Read More »

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Cancer Medicines: Setbacks and Stepping Stones

A report released on this week by the Pharmaceutical Research and Manufacturers of America (PhRMA), “Researching Cancer Medicines: Setbacks and Stepping Stones,” highlights the number of investigational cancer medicines that did not succeed in clinical trials and how these so-called “failures” are a crucial part of the drug development process. Read More »

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Unlocking the True Value of Big Data: A Pharm Exec Global Digest Special

In this special issue of Pharm Exec Global Digest: Unlocking the true value of Big Data; Data privacy
and the health sciences; In-silico modeling and real-word outcomes; and more…PEGD0914_thumb

Click here to access the issue.

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