NIH

The evolution of mobile technology use in clinical trials

Wednesday, October 18, 2017

William Osler, a founder of Johns Hopkins University, was a clinician ahead of his time. He was one of the first doctors to bring medical students out of the lecture hall and to the patient’s bedside — a revolutionary format change in its day. His 1892 book, The Principles and Practice of Medicine, was labeled as an “imaginative new curriculum” that prevailed for 50 years.1 Osler once said, “The good physician treats the disease; the great physician treats the patient who has the disease.”

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ACRP advances CRC competency-based standards

Monday, October 16, 2017

The Association of Clinical Research Professionals (ACRP) has launched a new initiative to develop competency standards for clinical research coordinators (CRCs) as part of a larger effort to advance the professionalism of the clinical research workforce. The project will establish minimum standards regarding the knowledge and skill required for entry-level study coordinators and create a hierarchy of competencies focused on performance rather than longevity. Pathways needed for CRCs to advance their careers will be clearly defined and ACRP will develop tools to assess job proficiency, identify gaps and provide training.

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NIH partners with 11 biopharmaceutical companies on cancer immunotherapy strategies

Friday, October 13, 2017

The NIH and 11 biopharmaceutical companies launched the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot. PACT will initially focus on efforts to identify, develop and validate robust biomarkers—standardized biological markers of disease and treatment response—to advance new immunotherapy treatments that harness the immune system to attack cancer. The partnership will be managed by the Foundation for the National Institutes of Health (FNIH), with the Food and Drug Administration serving in an advisory role. 

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Children’s Hospital Los Angeles to study “Bubble Boy” syndrome

Tuesday, October 10, 2017

Michael Pulsipher, M.D., of the Children’s Center for Cancer and Blood Diseases at Children’s Hospital Los Angeles, along with co-principal investigator, Sung-Yun Pai, M.D., of Boston Children’s Hospital, has been awarded nearly $9 million from the National Institute of Allergy and Infectious Diseases of the NIH to study a new treatment approach for babies born with severe combined immunodeficiency (SCID), which prevents the immune system from functioning normally. In a multi-site study, investigators plan to determine the lowest dose of chemotherapy needed for babies with SCID undergoing bone marrow transplant—the standard treatment for SCID. The goal is to restore the immune system safely and effectively with less toxicity than the higher dose regimens currently in use.

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NIH Director’s high-risk research awards announced for 2017

Tuesday, October 10, 2017

The NIH’s High-Risk, High-Reward Research program, part of the NIH Common Fund, funded 86 awards to exceptionally creative scientists proposing to use highly innovative approaches to tackle major challenges in biomedical research. The program supports high-risk ideas with high-impact potential, such as recording the history of an individual cell in its DNA for future playback; understanding how bacteria in the microbiome can share anti-drug-resistance genes among themselves; resetting the immune system to allow universal organ transplants; and reimagining clinical trials to make them more personalized and more effective.

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NIH to fund seven research centers in minority institutions

Tuesday, October 10, 2017

The National Institute on Minority Health and Health Disparities (NIMHD), part of the NIH, will fund seven new awards to support the Research Centers in Minority Institutions (RCMI) Specialized Centers program. RCMI is designed to support institutional research capacity and foster the career development of new and early career investigators conducting minority health and health disparities research. The centers will share approximately $122 million over five years, pending available funds.

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NIH to fund Centers of Excellence on Minority Health and Health Disparities

Tuesday, October 10, 2017

Twelve specialized research centers designed to conduct multidisciplinary research, research training and community engagement activities focused on improving minority health and reducing health disparities will launch. The centers, to be funded by the National Institute on Minority Health and Health Disparities (NIMHD), part of the NIH, will share approximately $82 million over five years, pending the availability of funds.

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Profectus BioSciences to develop vaccine for Ebola, Marburg, Lassa Viruses

Tuesday, October 3, 2017

Profectus BioSciences has received a contract for up to $22.25 million from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health. The base period of the contract, with a value of $6.96 million, will support a proof-of-concept (POC) study in non-human primates (NHP) and preparations for manufacture under Good Manufacturing Processes (GMP) of a vaccine designed to protect against Zaire ebolavirus, Sudan ebolavirus, Marburgvirus and Lassa viruses. The contract also includes $15.29 million in options that may be exercised by the NIAID to support GMP manufacture and clinical evaluation of the multi-component vaccine. The vaccine is being developed in lyophilized form to allow distribution without a cold chain and enable routine mass immunization.

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