R&D/Clinical Trials

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?

The time and cost of developing new drugs are rising, venture capitalists make no return on investments in biopharma R&D, and other countries are boosting support in this area while U.S. policy makers propose funding cuts for the National Institutes of Health (NIH).

Mastery of the clinical trial process has become essential to positioning new therapies for leadership in an increasingly crowded-and lengthy-race to registration.

As brands are required to produce more and more data to convince not only regulators, but payers, physicians, and patients, Jeffrey Jonas is pushing Shire's "search and develop" R&D model into new and sometimes uncomfortable territory.

Poland's government is aiming to make the Eastern European country a biotech powerhouse.

To gain market access in emerging markets, pharma companies face pressure to offer a convincing Corporate Value Proposition to governments.

The quest for 'radical' R&D innovation is often pursued at the expense of treatments with hidden blockbuster potential, writes Bert Spilker.

After his predecessor and countryman left the EMA in disgrace, Guido Rasi jumps in as executive director-with great challenges ahead.

Sponsor sourcing requirements are diverging from the operating needs and long-term strategies of the major CROs.

A new generation of products for inflammatory disease is coming forward, promising better promise and possibly a cure.

Henry Waxman, Congressional Representative from Los Angeles, California

The rise of advocacy groups has helped patients find their voice, but the power to change health profiles remains an elusive goal.

Henry Grabowski, PhD, Professor of Economics, Duke University

Observational studies present a compelling real-world corollary to the classic randomized clinical trial.