R&D/Clinical Trials

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.

How will companies market similarity in a way that differentiates from the innovator? Customer experience may be the key.

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.

AstraZeneca (AZ) and The University of Texas MD Anderson Cancer Center (Houston, TX) have announced a multi-year, strategic research collaboration.

AstraZeneca (AZ) and The University of Texas MD Anderson Cancer Center (Houston, TX) have announced a multi-year, strategic research collaboration.

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

The science of drug discovery is back on script-and the stars are cued up for a new generation of breakthrough therapies. But is pharma ready to raise its game and cut a deal with all those "prove it to me" payers?

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.

Amid a resurgence in drug development for hard-to-treat conditions, the bigger question is whether the times are as good for the industry tasked with rendering basic science into therapeutically effective medicines.

New research on the role of microbes in fighting disease is transforming the way medicine views bacteria, writes Lee Jones.

Pharma backs federal standards for compassionate use, drug importing, data transparency, and track-and-trace. Jill Wechsler reports.

Its only recently that vaccine producers experienced the commercial returns commensurate with vaccines: long record of positive public health performance.

The potential of comparative effective research in transforming healthcare remains untapped, but the opportunities are there, writes Michael Christel.

As interest grows in this productivity-enhancing tool for seamless drug development, there is a need for a better working consensus on standardized metrics that monitor progress and certify success.

The Cancer Research Institute is clearing a path to the future of immunotherapeutics. Ben Comer speaks to its CEO and director of scientific affairs, Jill O'Donnell-Tormey

Elderly patients are underrepresented in clinical trials, but there are few obstacles to including this patient group in trials that cannot be overcome, writes Sydney Rubin.

In light of the risks and challenges inherent in the development of oncologics, some pharmacos are questioning whether it remains an attractive therapeutic area in which to invest its resources.

Four commercial line executives serve as our jury of peers on what's in store for the future of pharma, and discuss the changing criteria for market success, from drugs to consumer products to vaccines.

Ben Comer reports on how new pipeline therapies, public research investments, and a renewed sociopolitical focus are working toward a happier outcome for sickle cell disease patients.

Politicians and health campaigners are celebrating the final agreement of the EU's new clinical trials rules. But the European drug industry is not so euphoric, writes Reflector.

The Healthcare Businesswomen's Association honored three female leaders this year. We take an in-depth look at each winner's background and career-and what factors helped push them to the top of their game.

With 2014 shaping up to be a pivotal year for the American pharma industry, Tom Norton wonders how much longer American dominance in R&D spending can continue.

Millennium Takeda's new president, Anna Protopapas, explains the life choices that brought her from Cyprus to Cambridge-and a lead position in the hotly contested search to make cancer a treatable disease.

Today, there is promise in new approaches that rely on the "other language of biology," using the human body's own circuitry of cells and nerves to induce precisely targeted therapeutic effects against a range of debilitating diseases.

Successful innovation now has to align with key metrics of value-can an old baseball metaphor help guide the way?

Where are the biosimilars to help cut costs as the first wave of biologics, or complex, small molecule respiratory drugs, for example, go off patent? They've arrived in Europe, but the U.S. lags...