R&D/Clinical Trials

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...

If R&D doesn't rebound, the growth prospects of R&D services providers will suffer, and even commercial CMOs will see fewer opportunities coming their way, writes Jim Miller.

Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R&D, clinical research, and market growth.

Mollie Roth discusses how complementary diagnostics can improve disease management and optimize therapy.

Real-world pharmacoeconomic data can provide critical insight for maximizing US market access and oncology product differentiation, and should be central to the overall brand strategy of any oncology product

Industry experts talk to Pharmaceutical Technology's Adeline Siew about the requirements and challenges involved in getting a biosimilar product to market.

Companies are leveraging combinations of drugs and other products to gain competitive advantage and market share.

With their knowledge of molecular genetics, Pathologists are transforming the way healthcare is provided.

The lifeblood of the life sciences industry is continuous innovation-it is not a business that can survive by standing still.

Project Data Sphere aims to liberate clinical trial data sets from industry and academic vaults, in an attempt to catalyze cancer research and discovery.

While not as bleak as believed, the outlook of European biotech sector is struggling compared with its US counterpart.

New research from the Tufts Center for the Study of Drug Development identifies a significant contributor to the rising cost of clinical trials-the first step in meeting a growing strategic imperative to help senior management and the regulatory community craft new approaches to make trials more efficient in delivering results to clinicians and patients.

Improving the quality of clinical trials is a major strategic activity for Big Pharma, one where efficient management of a demanding set of regulatory requirements can have a positive impact on the bottom line.

Ken Getz of the Tufts University Center for the Study of Drug Development (CSDD) explains how building a stakeholder outreach agenda around the community pharmacist can lead to a better outcome in managing the complex ins and outs of a trial protocol.

Today's most important public health story is the advance in our understanding of the biology of cancer, writes Pharm Exec Editor-in-Chief William Looney.

Pharm Exec recently convened a cross-section of industry experts to review current and pending efforts to turn great science into good oncology practice.

By Jacky Law.

With the shadow cast by Mediator across Europe now receding to a focus on the French law courts, the European Union (EU) said in late November that its pharmacovigilance arrangements offer “one of the most advanced and comprehensive systems in the world”.

The Patient-Centered Outcomes Research Institute, or PCORI, announced last week that it will be granting a total of $12 million for up to 14 contracts for studies aimed at improving upon existing research methodologies to demonstrate clinical effectiveness.

While the nation was embroiled in the presidential elections, a number of important legal and regulatory issues absorbed pharmaceutical executives, writes Jill Wechsler.

Ideology, politics, and a stilted political debate may be causing pharma to overlook the potential of emerging stem cell therapies in fostering a new generation of cures.

There is much talk today about "open innovation" in business and research forums-but what exactly does it mean? How does open innovation as a concept apply to the pharmaceutical sector? Does it signal a change in the way pharmaceutical companies approach research and innovation?