R&D/Clinical Trials

For years, many companies have competed to demonstrate that their products could achieve the holy grail in type 2 diabetes (T2D): cardiovascular (CV) risk reduction. According to the American Diabetes Association, pharma companies to date have spent over $2 billion and tested 138,000 patients in company-sponsored CV-risk reduction T2D trials, including the recent large-scale TECOS, SAVOR, EXAMINE, and ELIXA studies. 

The Alliance for Clinical Research Excellence and Safety (ACRES) is advocating a “systems thinking” approach in efforts to meet increasing demands to standardize and integrate support for trial sites.

Casey McDonald previews pharma’s Oscars, the Prix Galien USA Awards, which this fall will bring some red carpet glamor and, hopefully, cheer to the industry.

September 28, 2015.

The need for biopharma executives to combine a "culture of quality" with value-added processes and improvements in the area drug manufacturing is critical. Here are steps and strategies than can help.

Mike Straw argues that many pharmaceutical companies are mistaking simple cooperation for collaboration.

Finding the R&D sweet spot.

A review of an online, cross-sectional survey in Belgium that was conducted to systematically assess the opinions of clinical research professionals from different stakeholders about using social media as a targeting recruitment tool.

Patient centricity requires clinical trials to be based on life outside the lab, writes Mads Holme.

William Looney reviews EvaluatePharma's World Preview 2015 - Outlook to 2020, launched at last week's BIO International Convention.

Drug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority

Masters of the deal converge in New York to discuss the status of their trade and the forces propelling M&A, licensing, and partnerships in the life sciences for 2015.

Susan Crowley reviews the hotly debated agenda items from last month's World Health Assembly (WHA) in Geneva, Switzerland.

 This article originally appeared on Applied Clinical Trials.

Emerging technology partnerships in the biopharma space may be provide hope in accelerating patient enrollment, writes Michael Christel.

The concept of increasing the speed and efficiency of clinical trials is a well understood and agreed upon priority of most clinical operations professionals.

Current clinical trials are regarded as “too slow, too expensive, not reliable, and not designed to answer the important questions,” according to FDA’s new deputy commissioner for medical products &tobacco, Robert Califf.

Why executives should make the US R&D tax credit part of their planning discussions, by Chai Hoang and Chris Bard.

Meike Wenzel and Clifford Hall examine a new concept for early commercialization planning to facilitate good cross-functional working practice.

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.

Moe Alsumidaie looks at data collection methods and concepts that can result in predicting patients at risk of dropping out from a clinical trial.

The US drug regulatory system fails to address the country’s most urgent medical needs with the resources appropriate for the task. But change is possible.

According to experts on Pharm Exec's Editorial Advisory Board, 2015 is set to be another interesting year from a consolidation perspective.

Juan Pablo Bagó, general director of pharma in Argentina for the Bagó group, discusses the state of R&D in Argentina, and explains why his group is planning for a 75 percent of turnover from international markets in the coming years.