January 2021 | Industry Watch

 Published: January 13, 2021

By: Debbie Bunch



COPD Foundation Joins Effort to Find Core Set of Outcomes

A new core set of outcomes for use in latephase clinical trials of therapies for patients with stable COPD is in the works. The Green Park Collaborative is partnering with the COPD Foundation on the initiative, which will draw input from patients, clinicians, researchers, regulators, payers, health technology assessors, product developers, and more. A consensus process will be used to come up with the core set of outcomes. “With the advancement of therapies for COPD, it is imperative to incorporate the patient voice in research and policy decisions to ensure a patient-centered model of care,” says Jean Rommes, COPD Foundation patient advocate. “By identifying outcomes that matter to patients who live with COPD, we will create a foundation for better treatment decision-making ahead.” The Green Park Collaborative is an initiative of the Center for Medical Technology Policy. Read More  

Molecular Entity Therapy Targets HAP, VAP

Hoth Therapeutics, Inc. is working with the U.S. Army Medical Research and Development Command on a new molecular entity (NME) with a novel antibacterial mechanism of action that targets multiple bacterial pathogens. Developed by the Walter Reed Army Institute of Research, the NME will initially be geared to treating serious bacterial infections of the lung, such as hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP).  Hoth intends to pursue streamlined development opportunities under an FDA program for antibacterial therapies for patients with unmet needs that allows for the use of nonclinical animal studies to reduce clinical studies required for approval. Read More 

Lung Imaging Technology Moves Forward

The University of Miami Health System and the University of Miami Leonard M. Miller School of Medicine have joined forces with 4DMedical to create the Functional Lung Imaging Research Program at the Miller School to study four-dimensional lung imaging technology. The technology will be used to define the physiological impact of emphysema, cystic fibrosis, pulmonary hypertension, pulmonary embolism, lung cancer, and other lung conditions. “Effective treatment protocols require an accurate understanding of the disease’s presentation,” says Henri Ford, MD, MHA, dean and chief academic officer of the Miller School of Medicine. We plan to add 4DMedical’s XV Technology to help us gather and apply foundational medical information required to deliver customized and effective therapies for those suffering from chronic lung diseases.” Read More 

New Monoclonal Antibodies Added to Ongoing Trial

The AIDS Clinical Trials Group has added a new agent to the ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies Trial. This phase 2 study will evaluate the combination of two monoclonal antibodies, BRII-196 and BRII-198, to treat early COVID-19. Developed by Brii Biosciences, BRII-196 and BRII-198 were derived from antibodies made by people who had recovered from COVID-19. Since they target two different parts of SARS-CoV-2, the investigators hope the combination therapy will improve treatment efficacy and reduce the likelihood that the virus will develop resistance to the treatment. Read More 

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Debbie Bunch

Debbie Bunch is an AARC contributor who writes feature articles, news stories, and other content for Newsroom, the AARC website, and associated emailed newsletters. In her spare time, she enjoys reading, traveling, photography, and spending time with her children and grandchildren. Connect with Debbie by email or on AARConnect or LinkedIn.

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