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Archive for the ‘ clinical trials ’ Category

Survey: Lack of funds, regulatory climate threaten biomedical industry

Friday, January 13th, 2012

Future growth for the biomedical industry faces growing and unprecedented threats, according to a newly released survey of CEOs from life sciences companies in California, the largest biomedical cluster in the world. The three biggest threats reported were access to capital, a burdensome and uncertain regulatory environment, and lack of ...

Pediatric trial education in focus

Monday, November 14th, 2011

With new legislation and regulatory polices calling for more pediatric research as part of a drug-development program, the need for increased education around pediatric clinical trials is paramount, experts in this space stress. Unlike the case under earlier regulations, companies developing a drug intended for an adult market can no ...

African-American patient recruitment: Trust matters

Monday, November 7th, 2011

Inherent in effective patient recruitment for clinical trials is gaining sufficient trust from prospective subjects. Although this can be considered a universal predicate to study participation, there is a considerably greater need for this foundation when it comes to African-American patient populations, according to Carmen Gonzalez, manager of strategy and ...

Smart pill quickens drug assessment process

Friday, October 28th, 2011

In case you missed the news, there was a pretty neat technology unveiling at this week's annual meeting of the American Association of Pharmaceutical Scientists, which wrapped up yesterday. New partners Bio-Images Research Ltd. and Medimetrics Personalized Drug Delivery B.V. introduced a smart pill technology called the IntelliCap, declaring it a ...

Molecular targeted therapy progress with lung cancer

Tuesday, July 5th, 2011

(This is a guest post from Sally Church, Ph.D, who writes the Pharma Strategy Blog. If you are on Twitter, follow her here.) In this second part of the ASCO report, we look at another area where significant strides are being made with molecular targeted therapy, lung cancer. For years, this ...

Pfizer pacts are further proof of CRO shift

Wednesday, June 8th, 2011

It’s no secret Pfizer, perhaps more than any other big pharma, is looking to “gain efficiencies” in R&D at every turn. Gaining efficiencies, of course, is just a fancy way of describing the need to cut costs, which it appears Pfizer, as it looks to divest many of its businesses, ...

INC exec: Global scale-up key driver of Kendle deal

Friday, May 13th, 2011

We caught up with INC Research’s chief operating officer John Potthoff, Ph.D., by email for more on INC’s big deal to acquire CRO rival Kendle, a move that could elevate the privately held company into a top five industry player. R&D Directions: How will the acquisition of Kendle position INC ...

Quintiles backs innovative breast cancer trial

Thursday, April 14th, 2011

Today, Quintiles got into the "spy" game - the I-SPY 2 clinical trial, to be exact. The contract research organization has committed a total of $2.6 million over four years to support the trial, formally known as the "Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular ...

Show us the data! Economists tackle clinical trial cost triggers

Wednesday, April 13th, 2011

After hearing the recent news that the National Bureau of Economic Research is investigating the rising costs of drug development, you might be wondering why the non-profit group is even taking a stab at what has long been a difficult area to pin down statistically. While it is well documented ...

Benlysta nod should benefit remaining lupus prospects

Thursday, March 10th, 2011

FDA's approval of Benlysta is indeed an historic moment for lupus patients, a community that has waited 50 years for a new treatment. The milestone, however, may have even bigger ramifications going forward. The door for additional – and perhaps more effective – new drugs for the autoimmune disorder has suddenly ...

   
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