Tag Archives: clinical research

Adaptive Licensing: The Start of a Slow Revolution in Europe

By Peter O’ Donnell. So at last it’s happened. Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation. Is this the beginning of the end of binary decision-making on the merits of a new medicine? Has a half-century of the “yes/no” authorization process peaked, to be replaced […]
Posted in Europe, Global, Guest Blog, Op-Ed, R&D, Regulatory, Safety | Also tagged , , , , | Leave a comment

The Broken Clinical Research System

Dr. Greg Koski of the Alliance for Clinical Research Excellence and Safety (ACRES) talks to Moe Alsumidaie of Applied Clinical Trials about the urgent need for change in the clinical research industry.
Posted in Guest Blog, R&D | Also tagged , | 1 Comment

Assessing the Value of Retrospective Studies: Real-World Data, Real-World Applications

by Sarah Ray The value of retrospective studies cannot be overstated. Retrospective studies affect many healthcare sectors, including the pharmaceutical industry and general public health. Applying these studies provides clear advantages at different points of the product life-cycle. During drug development, these studies may help clinical teams propose adaptations or even a companion diagnostic tests […]
Posted in Gene therapy, Global, Guest Blog, healthcare, R&D, Strategy | Also tagged , , , , , , , , , , | Leave a comment

Bringing Genetic Data into the Clinic

While Big Pharma frets over the costs and risks associated with exploratory endpoints in the clinic and the vagaries of companion diagnostic reimbursement, non-profit organizations like the Multiple Myeloma Research Foundation (MMRF) are stepping in to provide pharmacogenomic research for the next generation of cancer drugs.
Posted in Gene therapy, leadership, R&D, Regulatory, Strategy, Technology | Also tagged , | Leave a comment

Europe Wrestles with Outdated Clinical Research Rules

By Reflector, Brussels correspondent. Man can live as a free being only when he is free to develop his innate abilities, maintained Baruch Spinoza, that quintessential European, back in the 17th century. He might have been talking about the aspirations in the European pharmaceutical sector, which is currently struggling to articulate a clear plan for […]
Posted in Europe, Global, Guest Blog, R&D, Regulatory | Also tagged , , | 1 Comment
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