Addressing the Drug Development Gap in China

Each year, new medicines are launched globally but few are available to Chinese patients,  in comparison to those in the US or EU. Drug developers are working to reduce this gap and expand the reach of new molecular entities (NMEs) so that they can improve healthcare to patients in need. Confronting this issue requires navigating the evolving regulatory environment in China and capitalizing on parallel development opportunities in the global market.

PET Quantification of Receptor Occupancy

The use of PET imaging to detect and quantify receptor occupancy (RO) has become a translational standard in CNS discovery and clinical trials. For example, 18F radiolabeling of targeted small molecules enables a PET tracer-based PD biomarker. The tracer can be used for dynamic, non-invasive quantification of percentage RO.

The Evolution of Open-Label Extensions and Rare Disease Studies

When running early development studies, sponsors must consider whether or not to provide open-label, long-term treatment at the end of their randomized, placebo-controlled trial. In the past, sponsors have been hesitant to offer open-label extensions. But with our industry’s increasing focus on patient-centric care, sponsors are now weighing their options to incorporate more patient input into early development, especially when working with promising novel treatments in rare disease studies.

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 in the therapeutic pipeline. Research and orphan drug development efforts are starting to follow suit by increasingly incorporating patients’ needs and examining potential outcomes.

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 and accelerate global development.

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 with other disorders. Advanced imaging techniques, while useful for evaluating some liver features, can be impractical and costly.

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 in depth cell characterization.

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 major area of clinical and preclinical oncology imaging. We have been performing liver tumor MRI for over a decade to evaluate mouse syngeneic intrasplenic liver metastasis models, orthotopic human tumor xenografts (PDXs), and GEM models. Liver tumor MRI facilitates use of models with more clinically relevant context, enabling:

Endotoxin inhibition and enhancement: Critical considerations for medical device testing

A known structural component of gram-negative bacteria, endotoxins can elicit strong inflammatory responses and fever if they enter the human bloodstream. Because endotoxins can leach into the body from contaminated medical devices, rigorous endotoxin testing is crucial for patient safety and an essential prerequisite for marketing new medical devices.