2017

Electronic informed consent: The star bench-warmer?

Monday, February 27, 2017

The Pulse on Technology by Elisa Cascade

“If you build it, they will come.” While this was clearly the case in the baseball film “Field of Dreams,” the same does not hold true for all site-facing clinical trial technology. As the last Pulse on Technology column highlighted, several technologies are still sitting on the bench when it comes to use across all trials. This column takes a closer look at the technology with the lowest awareness and adoption: electronic informed consent (eConsent). To continue the baseball analogy, picture eConsent as a little boy sitting on the bench waiting to get into the game.

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Icon steps up for patient-reported outcome measure endpoint validation

Monday, February 27, 2017

The FDA has chosen Icon to create industry-standard patient-reported outcome (PRO) measures and to validate those endpoints for antibacterial drug trials. Partnering on the initiative with Icon is the Biomarkers Consortium and the Foundation of the National Institutes of Health (FNIH). Also involved is the Infectious Diseases Society of America and the National Institute of Allergy and Infectious Diseases.

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PureTech Health appoints Atul Pande chief medical officer

Friday, February 24, 2017

PureTech Health, a cross-disciplinary biopharmaceutical company, has announced the appointment of Atul Pande, M.D., as the company’s chief medical officer. In this new role, Dr. Pande will oversee all clinical operations across PureTech Health’s pipeline and work closely with the team to de-risk and advance opportunities that hold the most potential for patients.

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Tocagen receives FDA Breakthrough designation for glioma

Friday, February 24, 2017

Tocagen, a clinical-stage, cancer-selective gene therapy company, has announced the FDA granted Toca 511 & Toca FC Breakthrough Therapy designation for the treatment of patients with recurrent high grade glioma (HGG). Toca 511 & Toca FC is currently under evaluation in an international, randomized phase II/III clinical trial, which is designed to serve as a potential registrational study. The trial involves patients with first or second recurrence of glioblastoma or anaplastic astrocytoma who are undergoing resection. Enrollment in the phase II portion of the trial has completed and top-line results are anticipated in the first half of 2018.

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NIH launches MarkVCID dementia biomarkers consortium

Friday, February 24, 2017

To better predict, study, and diagnose small vessel disease in the brain and its role in vascular contributions to cognitive impairment and dementia (VCID), the NIH has launched MarkVCID, a consortium designed to accelerate the development of new and existing biomarkers for small vessel VCID.

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NIH respiratory syncytial virus vaccine enters clinical testing

Friday, February 24, 2017

A phase I clinical trial to test the safety and tolerability of an investigational vaccine against respiratory syncytial virus (RSV) has begun at the NIH Clinical Center in Bethesda, Maryland. The trial will also assess the vaccine’s ability to prompt an immune response in healthy adult participants. The investigational vaccine was developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH.

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Northwell Health, GE Ventures partner on bioelectronic medicine

Thursday, February 23, 2017

Northwell Health‘s Feinstein Institute for Medical Research has announced a strategic alliance with GE Ventures to support the Feinstein’s Center for Bioelectronic Medicine (CBEM). With this investment, the Feinstein Institute will continue its work in discovering, developing and commercializing new diagnostic and therapeutic solutions in bioelectronic medicine for a wide range of acute and chronic diseases and injuries, including neurodegenerative diseases, cancer, diabetes and hypertension.      

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