With over half a billion people worldwide suffering from a chronic respiratory condition and cases of COVID-19 climbing above 25 million globally, pulmonary drug delivery via specialist inhalation devices is more relevant than ever. Pulmonary drugs offer the best potential for optimal delivery to the lungs while minimizing systemic side …
Optimizing in vivo respiratory model studies
In vivo respiratory disease models are valuable in the identification of potential medications targeted at treating human respiratory diseases. Common respiratory diseases include lung fibrosis or the emerging COVID-19, where highly efficacious treatments are limited and where in vivo disease models can help to screen for potential new treatments. In …
Using acute respiratory disease syndrome (ARDS) in vivo models to screen for coronavirus inflammation treatment
Solutions to the current COVID-19 pandemic involve preventing coronavirus infection through vaccination and treating the severe clinical symptoms of the disease, including acute respiratory distress syndrome (ARDS). Establishing in vitro screening for potential treatments, though, can be challenging, due to the limited number of appropriate research models available, and the …
IND-Enabling programs for adoptive cell therapies
Chimeric Antigen Receptor T Cells, In Vitro and In Vivo Preclinical Models, plus regulatory and safety considerations We presented on and discussed in a webinar the adoptive cell therapy preclinical program central to an IND/IMPD submission. The following is a brief summary, plus insightful Q&As from that event.
The COVID-19 road to recovery: coordinating clinical trial testing and central lab solutions
As COVID-19 was declared a pandemic, our Clinical Trials Testing Solutions (CTTS) witnessed a sudden influx of COVID-19 studies from both large pharmaceutical organizations and biotechs. Not only did CTTS need to accelerate the timelines for these drug development sponsors’ urgent studies, but they needed to provide patient-centric testing solutions, …
An introduction to dendritic cell biology and analysis using syngeneic immuno-oncology models
Productive immunotherapy driven anti-tumor responses rely on the activation of T cells that target tumor-associated antigens (TAA). The dendritic cell (DC) plays an essential role in the activation of T cell antigen-specific responses, which occur naturally in the context of infection. However, this same process supports tumor-immune surveillance as well …
Precision imaging of antibody biodistribution in vivo with Zirconium-89 PET
Zirconium-89 (89Zr) has revolutionized discovery and translation of Ab (and Ab fragment) therapeutics via PET biodistribution imaging. With standard, straightforward labeling chemistry, 89Zr provides unprecedented specificity and sensitivity of PET Ab detection (to pM levels). We use 89Zr PET as a platform assay for in vivo quantification of:
Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs
Introduction Although a range of regulatory definitions exist, a biosimilar drug is generally defined as \a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy …
Minimizing placebo effect in inflammatory bowel disease clinical studies
With 93 Crohn’s Disease (CD) and 168 Ulcerative Colitis (UC) Phase I-III industry-sponsored studies planned and open to enrollment, there is a significant focus on research into new therapies for inflammatory bowel disease (IBD)1. Remission is the main aim of IBD therapy, but IBD studies often face challenges with minimizing …
Inflammatory bowel disease clinical studies – where do we go from here?
Inflammatory bowel disease (IBD), incorporating Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic relapsing-remitting inflammatory disorder of the gastrointestinal tract.1 There is currently no cure for IBD and available treatments (e.g. aminosalicylates, immunosuppressant, biologics) have variable degrees of efficacy and tolerance. As a consequence, there is a large …