TQT Waivers: One Year Later

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 reasonable substitute for a Thorough-QT (TQT) dedicated trial.

Important Early Considerations For Assessing Drug Abuse Liability

Assessment of abuse potential of compounds in development is one of the most complex regulatory requirements and constitutes a critical exercise for sponsors and regulators. The strategy for the assessment of abuse potential cannot be customized and requires individual evaluation of the compound, its target indication and the entirety of the nonclinical and clinical safety database. In July 2016, the United States Congress passed the Comprehensive Addiction and Recovery Act (CARA) bill to address prescription opioid abuse and overdoses that have killed more than 165,000 people between 1999 and 20141.

The Need for Anatomical MRI Staging in Orthotopic Brain Models Monitored by Bioluminescence

The use of MRI to monitor the progression of brain tumors has been an accepted method both in the clinic and preclinically as well. Glioblastoma multiforme (glioblastoma; GBM) is a fast-growing glioma that develops from star-shaped glial cells (astrocytes and oligodendrocytes) that support the health of the nerve cells within the brain. These tumors are usually highly malignant because the cells reproduce quickly and they are supported by a large network of blood vessels. GBM is the most common and most aggressive form of malignant primary brain tumors, affecting nearly 23,000 people in the United States annually. Most preclinical studies in glioma utilize survival as the primary endpoint, which provides limited information about disease progression or primary tumor response to treatment.

Understanding Regulatory and Market Access Considerations With Drug Abuse Potential

Each assessment for abuse liability is as unique as the molecule in question, reiterating the importance of early awareness, understanding the current regulatory landscape, and being able to plan your development and post-marketing accordingly.

Use of Luminex® Technology to Quantify Biomarkers and Provide Agent Efficacy

In recent years many researchers have focused on the analysis of circulating soluble cancer biomarkers as an indicator of the host immune response to oncogenesis.1,2,3 Multiple biomarkers can be quantified in order to fully characterize changes in homeostasis brought on by tumor growth and metastasis. The ability to multiplex tumor-type specific antigens and general immune response biomarkers in a small plasma or serum sample can provide the researcher a broad picture of test agent efficacy.

Clinical & Research Excellence Awards Shortlist Xcellerate Medical Review

We are excited to announce that Xcellerate® Medical Review has been named a finalist in the Clinical & Research Excellence (CARE) Awards. As a finalist in the Best Sponsor-Focused Technological Development category, Xcellerate Medical Review is being recognized for its modern approach to improving the clinical trial process. The CARE Awards recognize excellence across the global clinical research enterprise.

Phase I cGMP Drug Manufacture at the CRU: 3 BIG Benefits

The regulatory environment continues to move toward requiring drug manufacturing at current good manufacturing practice (cGMP)-compliant pharmacies. This trend and other factors make it increasingly attractive to use cGMP compounding on-site at your CRU for early development. Let’s look at Three Big Benefits for Phase I drug manufacturing:

Preclinical Success to Clinical Failure: Do We Have a Model Problem or an Endpoint Problem?

As the AACR (American Association for Cancer Research) Annual Meeting is fast approaching, many industry and academic scientists are busy preparing talks and posters for what they hope will be the next new wave in cancer therapy or the next “new and improved” preclinical model. However, while these may be long shots, it’s the scientific drive for improvement that keeps us moving forward. As, patients and clinicians, we are desperately looking for new therapies, even if the odds are against us. The desire to fulfill that unmet medical need is exactly how the one new drug is discovered. New oncology drugs only have a 5% success rate once making it from Phase I clinical trials to FDA approval. This is the lowest success rate among the 21 major disease indications.1

The Biosimilars Landscape: What All Developers Need to Know

As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, stressing the need to understand this rapidly changing landscape. What is the real potential for clinical and health-economic benefits offered by these agents?

Finding the Other 90%: Attracting Naïve Patients to RA Studies

A recent study by Tufts Center for the Study of Drug Development, based on a survey of 2,000 physicians and nurses primarily in the United States and Europe, found that 91% of physicians feel ‘somewhat’ or ‘very’ comfortable discussing the opportunity to participate in a clinical trial with patients, but actually refer less than 0.2% of their patients into clinical trials.1 In conjunction, more than 80% of patients say they are willing to participate in clinical research studies, but only around 10% actually do so.2 It is further reported that while 85% of patients are generally comfortable presenting any clinical research information they find to their doctor, only 17% have actually done so.3 And what of those patients that are interested in participating in a clinical study only to find they are ineligible? When queried on next steps after finding out he/she did not qualify, 36% stopped looking for a clinical research study to participate in.3 This latter fact is a staggering waste of potential when you consider that there are currently >130 planned or ongoing industry-sponsored Phase II-III rheumatoid arthritis (RA) studies to choose from (>210 when you consider any type of study sponsor).4