R&D/Clinical Trials

Even on the contentious topic of orphan drug pricing, the last few months have brought hopeful signs that patients, pharmaceutical companies, health insurers, and the academic bodies that counsel them are trying to speak the same language.

Dogs and kids both spontaneously develop a number of cancers, making it a no-brainer for those on both sides of the disease to work together in finding new therapies.

With the patient voice growing louder in all aspects of the drug development and commercialization journey, Pharm Exec examines some of the current industry thinking on the evolving pharma-patient relationship.

Six years in, Pharm Exec looks at the progress of the International Rare Diseases Research Consortium-an ambitious global effort focused on accelerating orphan disease diagnosis, and ultimately enabling better treatment options for these underserved patient populations.

Despite Big Pharma's success in translating discovery research into products with proven clinical value, the industry continues to struggle in positioning medical research to the public as a distinctive force for good.

The industry is readying for a leap into a new age of complex therapies, as new heights are reached in fields such as regenerative cell-based therapies, CAR-T and immuno-oncology combinations. Elaborate manufacturing and soaring drug costs, however, loom as deep chasms to cross in bridging the potential with reality.

The FDA’s Dr. John Whyte offers his perspectives on patient centricity and the issues that FDA and industry are facing.

Highlights from Peter Young's conversation with Dr. Steven Miller, Chief Medical Officer and SVP of Express Scripts, on Miller's business philosophy and the current issues facing the sector.

The influx of treatment breakthroughs and expanding science has not silenced the debate over the productivity of biopharma's R&D model, and the looming challenges for R&D decision-makers.

Michael Gordon charts the evolution of regulatory operations and suggests how it can spearhead opportunities for innovation in pharma data.

When lobbying tips the scales: a path to drug approval.

Pharm Exec convenes an expert Roundtable to discuss one of the hottest topics in big data today-how to make that data relevant to payers, regulators and the patient through reliance on real-world evidence in driving better health outcomes.

Pharm Exec sits down with Anthony Marucci, co-founder and CEO of Celldex, a stealth player in the immunotherapy field.

Pharm Exec and inVentiv Health convened a roundtable discussion at the 2016 ASCO meeting to review the use of patient-reported outcomes (PRO) in the clinical trial and commercialization space.

A significant change is under way as the industry shifts from passive to active trial master file (TMF) management, writes Rik van Mol.

Dave Handelsman offers a smart approach to dealing with the EMA's new guidelines on the anonymization of clinical trial data.