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Biopharmaceutical Innovation: the Complexity of the R&D Process
| April 19, 2012
Created in 1992, bioskin® is a leading dermatology CRO which plans and conducts clinical trials for drugs, medical devices, food supplements and advanced cosmetics.
Article | April 11, 2020
Rene Roach fired off a quick email in late March for an update on a colorectal cancer clinical trial for which she hoped to qualify. Worried about the coronavirus, she asked, almost as an afterthought, whether the study had been put on hold because of the pandemic.The answer crushed her: It had been. "That's when COVID-19 shut down everything," says Roach, 50, of Germantown, Md. Roach assumed that there would be workarounds for patients like her, who have stage IV cancer. These patients often depend on clinical trials as their best chance to knock cancer out when other therapies have failed. For now, she's being treated with traditional chemotherapy, but she was counting on the drug cocktail from the clinical trial. She figures if chemo was going to rid her body of cancer for good, it would have done so already.
Everyone in pharma knows that product success depends on the results of clinical trials — but we don’t usually hear from the people who are involved in running them. Recently, four Clinical Research Managers (CRM) from Merck (known as MSD outside the United States and Canada) discussed how Merck is overcoming the barriers to clinical trial recruitment by adopting a patient-centric process — a model that affects their trials top to bottom, from design through implementation. Each of the panel members manages clinical trials, serving as the main point of interaction with the Clinical Research Associates (CRAs) on research requirements, goals, and resources, including recruiting and retention.
Swiss pharma giant Roche is joining the race to develop a test for COVID-19 antibodies in people who have been exposed to the disease. This morning, Roche announced the development and upcoming launch of its Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the SARS-CoV-2, the virus that causes COVID-19. Roche is eying May for the launch of the test in Europe and is in talks with the U.S Food and Drug Administration for emergency approval of the system.
Antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms, the company said. Roche noted that as more information becomes available about immunity levels to COVID-19, society can return to a sense of normal much more quickly. Roche’s test will join a number of other antibody tests that have recently come on the market. Earlier this month the U.S. Food and Drug Administration approved the first blood test for COVID-19 antibodies.
Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).
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