For a small biotech company, making the transition from discovery to clinical is where the rubber meets the road. This is where all your endless hours of planning pay off and where you will be challenged to put your risk and mitigation plans to the test. During this time, no position will be more important than your director of clinical development.
Clinical laboratory services are the most outsourced services by pharmaceutical, biopharmaceutical, and medical device companies. Trending in the central or core laboratory services market is consolidation and integration of services through acquisitions and collaborations inorganically to expand beyond core services. Through horizontal integration suppliers increase their market share.
Two issues continue to be a headache for those working in the clinical space: patient recruitment and communication. New technologies, including social media, seem to offer a glimmer of hope to getting more patients involved in trials. Unfortunately, the problem of poor communication between sponsors, CROs, and sites is an issue still in need of novel solutions. In this Q&A, Mary Rose Keller, VP of clinical operations for Heron Therapeutics, shares her insights.
Clinical news roundup for the week of October 30, 2017 with information on new Alzheimer’s disease trials, clinical monitoring salaries and turnover, emphasizing patient-centric trials, and GDPR compliance concerns.
A 2017 compensation study has found that employee turnover in clinical monitoring jobs outside the U.S. increased significantly in 2016. Turnover in the clinical monitoring job function, which monitors participants’ health during a clinical trial, jumped from 16.4 percent in 2015 to 22.9 percent in 2016, an increase of 40 percent. The increase in turnover was matched, not surprisingly, by increases in salaries for those positions.
Consolidation continues in the CRO space, with the acquisition of Chiltern by LabCorp being just the latest example of top CROs expanding and increasing their breadth of offerings. As large CROs continue to acquire smaller competitors, can sponsor companies expect to benefit from this development?
Patient centricity is a growing trend in our industry. From the creation of Chief Patient Officer positions to culture-change initiatives, one of the strategies to improve the quality of clinical trials is to treat patients as “consumers” rather than “subjects” in a study.
Clinical news roundup for the week of July 18, 2016 featuring GSK's use of Apple ResearchKit, guidance on first-in-human clinical trials, clinical research transparency in India, nudging patients into clinical trials, and more.
As an applied economic theoretic, by driving out inefficiencies from the current model used by researchers to find and contract with CROs, the Science Exchange should improve the business model for drug discovery. But will all parties — Pharma/Bio, CROs and individual researchers — benefit equally?
As therapies become more targeted, so does the research to develop those therapies. That means more complex, subject-specific research and more advanced intersections between diagnostics, drugs, and delivery methods to make high-precision medicine possible. This is a future the clinical research community is aware it’s facing. Look no further than the advocacy of patient-centric (and/or patient-centered, contingent on where the interest emanates) research as patients are asked to play a more active role in monitoring their health and, in some cases, administering their medicine, especially as individualized medicines demand varied regimens.
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