DALLAS and NEW YORK – February 2021 – The Heart Valve Collaboratory (HVC) announced today that the U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) will participate in this “collaborative community”. A medical “collaboratory” is a forum in which multidisciplinary private and public sector members work together on medical device challenges to achieve aligned outcomes, solve shared problems, and leverage collective opportunities, in the interest of improving patient care.
Achalasia is a serious motility disorder of the esophagus that impacts more than 5,000 people in the US each year. Patients with achalasia experience damage to muscle and nerve cells in the esophagus, resulting in a loss of the peristaltic activity that normally pushes food through the esophagus into the stomach, and failure of the lower esophageal sphincter (LES) to relax with swallowing, which further blocks the transit of food. Thus, achalasia patients experience severe swallowing difficulty that adversely impacts their quality of life. Because the etiology of achalasia is not known, current therapies do not cure the disease and only address its symptoms. Exciting new research from Baylor Scott & White Research Institute (BSWRI) shows that LES muscle in achalasia exhibits profound mast cell degranulation, a hallmark of allergy-induced inflammation. This work adds support to the novel hypothesis developed by BSWRI researchers that achalasia might be an allergic disorder.
Tumorigenesis is a complex process regulated by multiple factors in the cancer cells and the surrounding tumor microenvironment. Because the microenvironment can accelerate tumor growth and contribute to therapeutic resistance, there is great interest in developing cancer therapeutics that directly target the microenvironment. Pancreatic adenocarcinoma is an important example of an aggressive and deadly cancer supported by an abundant microenvironment of non-malignant cells. Chemotherapies and targeted therapies only have modest efficacy against pancreatic adenocarcinoma, leading to an overall 5-year survival rate of 9%, and the microenvironment is thought to contribute to this drug resistance. Thus, the pancreatic tumor microenvironment is under active investigation as a source of new possibilities for therapeutic development.
Since the beginning of the COVID-19 pandemic, researchers have been racing to identify therapeutics that prevent the progression of SARS-CoV-2 infection to serious disease. Although vaccine rollout is ongoing, SARS-CoV-2 infection rates are increasing nationwide and there is an urgent need for life-saving interventions. Results of the BLAZE clinical trials involving LY-CoV555, an antibody against the SARS-CoV-2 spike protein, provide context on these therapeutic possibilities. This research is being conducted through multiple Baylor Scott & White Research Institute (BSWRI) sites across Texas.