FHI Clinical Partners With IDRI to Provide Full-Service CRO Capabilities for COVID-19 Trials
FHI Clinical Inc. has announced it has partnered with Infectious Disease Research Institute (IDRI), a Seattle-based not-for-profit organization, to provide full-service contract research organization (CRO) capabilities for an immunotherapy clinical trial to combat moderate to severe cases of COVID-19.
IDRI recently announced it has received funding from New Jersey-based Celularity, a clinical-stage cell therapeutics company, to launch a clinical trial to investigate the use of Celularity’s NK cell therapy, currently under study for the treatment of various hematologic cancers and solid tumors, as a potential treatment option against the novel coronavirus.
In a recent interview, Dr. Corey Casper, CEO of IDRI, explained that the targeted therapy will “essentially be a way of giving patients the immune cells that are critical in fighting this infection.” Casper is hopeful this immunotherapy can be introduced to the market within a year, pending clinical trial success.
“When an outbreak like coronavirus occurs, new therapies and vaccines are vital and require rapid start-up of clinical trials,” commented Ted FitzGerald, FHI Clinical president and CEO. “Our extensive experience in past outbreaks and global epidemics positions us to lead a diligent, coordinated response while providing high-quality services in this rapidly evolving public health crisis.”
For more information on the importance of building research capacity in an outbreak setting, leveraging existing research capacity, and strengthening and localizing health systems, please refer to the FHI Clinical Outbreak Response Guide.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.
