The complexity of clinical trials continues to rise. New biomarkers for safety and efficacy continue to emerge, and new types of information – such as genomic profiles – have become critical to submissions for drug approval. Against this dynamic backdrop the central challenge facing trial sponsors remains the same: the …
Measuring Extracellular pH Within Tumors Using CEST MRI
pH is one of the key microenvironmental factors in the development of tumors. Tumor cells are often viewed as high lactate and H+ producers.1 Extracellular acidosis represents a threat to cell survival by modifying the intracellular pH (pHi), wherein a 0.1 pHi variation can disrupt multiple biological functions.2 Measurements of tumor extracellular pH …
TQT Waivers: One Year Later
Overcoming Design Challenges ICH E14 REGULATORY GUIDANCE 2005 AND 2015 It has been one year since the International Conference on Harmonisation (ICH) updated its 2005 cardiac safety guidelines. The 2015 update allows for specific QT interval analysis based upon concentration effect modeling up to supratherapeutic during Phase I as a …
Longitudinal Evaluation of Orthotopic Lung Tumors With Imaging
Lung cancer is the most common cause of cancer related deaths for men and second for women (after breast cancer). Worldwide, 1.8 million diagnoses and 1.6 million deaths occur annually.1 While incidences have been decreasing over recent decades and advances in diagnosis and treatments are being made in cancer as a …
Leveraging the Clinical Power of MRI in Preclinical Liver Tumor Imaging
The liver is an ideal organ for magnetic resonance imaging (MRI) due to its size, plus the inherent contrast it enables compared to other tissues and lesions; this results from the high iron content which acts as a natural MRI contrast agent. For such reasons, liver tumor MRI is a …
In-Depth Myeloid Cell Characterization in the Murine Syngeneic CT.26 Colon Carcinoma Model by 10-Color Flow Cytometry
The efficacy of immune-modulating anti-cancer therapeutic antibodies that have been FDA-approved in recent years, such as anti-CTLA-4 and anti-PD-1, has driven growing interest in methods that provide a mechanistic understanding of drug function. Development of new mono- and combination therapies with immune-modulatory effects requires more powerful immunophenotyping techniques capable of …
Clinical Outcomes in NASH: Choosing the Right Endpoints
Non-alcoholic steatohepatitis (NASH) can lead to serious conditions such as cirrhosis and its complications, liver cancer and hepatic transplantation. Many patients eventually die from liver-related problems or cardiovascular disease. The challenge in developing drugs for NASH is to demonstrate an improvement in clinical outcomes. Cirrhosis takes several years to develop, …
What Are the Emerging Noninvasive Biomarkers in NASH?
Novel biomarkers represent a promising means to improve diagnosis of nonalcoholic steatohepatitis (NASH). Currently, a definitive diagnosis requires a liver biopsy, a surgical procedure with many limitations. There are a variety of biomarkers that can assess liver status, but they do not always distinguish between patients with NASH and those …
Accelerating Rare Disease and Orphan Drug Development: Opportunities for Biomarkers, Diagnostics & Patient Engagement
Rare diseases affect more than 350 million people worldwide but patients often face limited options for approved therapies. As a result, many patients have joined advocacy groups first and foremost to connect with others struggling with their rare disease, but also to promote research, unite multiple stakeholders and stimulate new possibilities …
Capitalizing on Global Drug Development Opportunities from China
The Chinese pharmaceutical market continues to grow steadily, but drug developers in China face similar challenges as their global counterparts: Development times are increasing and success rates are declining. Xiaoning Guo, PhD, PMP, clinical development program director of our Asia Pacific services, recently discussed potential strategies to improve investment returns …