The introduction of vaccines against Measles, Mumps, Rubella (MMR), and Varicella (the “V” in MMRV vaccines) led to a drop in the incidence of these diseases by 89% (Varicella) and 99% (MMR). These effective vaccines are a core component in most pediatric immunization programs across the world. Hence, every time a new pediatric vaccine is added to the existing immunization schedule, clinical evidence must be provided that the newcomer does not adversely influence the immunogenic response to the MMRV-licensed vaccines. These required non-inferiority studies when vaccines are co-administered (known as concomitant vaccine testing) come with their own challenges.
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We’re excited to be on the cutting edge of drug development solutions. Take a look at past and future webinar topics and leverage our experience.
Kidney Biomarkers in Drug Development
Experts discuss emerging translational biomarkers and insights into evaluation of nonclinical urine biomarker data. We’ll also discuss translational biomarkers in clinical trials for recent renal-related diseases/mechanisms. Continue reading
Covance is 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.
The Xcellerate Medical Review informatics product provides a critical function to study sponsors to safeguard subject safety, increase the robustness and quality of clinical trial execution, improve the reliability of investigational data and ensure adherence to ethical standards. Xcellerate Medical Review is a part of the larger award-winning Xcellerate Clinical Trial Optimization® suite, a comprehensive informatics solution that can meaningfully reduce the cost, time, complexity and risk of drug development. Continue reading
Using a cGMP pharmacy at your CRU for Phase I drug manufacturing yields benefits in quality and safety, timeline reduction and cost efficiency.
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:
- Quality and safety
- Timeline reduction
- Cost efficiency
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? Continue reading
The NIH defines precision medicine as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person1.” In cancer patients, we can rephrase the definition to “through detailed understanding of a cancer’s biology, providing the right drug, for the right patient, at the right time.”
In order to identify the correct drug, biomarkers are used to identify patients that can be treated with the appropriate therapy for their cancer. The FDA defines biomarkers as “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions2.” Great strides have been made in the discovery and validation of biomarkers in drug development. Continue reading
Skin sensitization testing is a major gap for many companies addressing the 2018 REACH substance registration deadline. Join us for a Q&A session with our Covance experts as we review REACH requirements and focus on a better solution for skin sensitization studies: in vitro assays as new alternatives to animal testing.
Q: What do REACH regulations hope to achieve?
A: The European Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) places responsibility on companies to assess and manage risks posed by chemicals. They also have to provide appropriate safety information to users. The first purpose is to ensure protection of human health and the environment. Next, the regulation promotes using alternatives to animal test methods. Third, it seeks free circulation of substances to the market, with enhanced competitiveness and innovation. Continue reading
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.
In our previous blog post, we focused on the value of early drug abuse potential testing. In this blog, we’ll delve into important regulatory and market access considerations for abuse liability testing that can help drug developers maximize the potential of their molecule.
Clinical trials are becoming increasingly complex and competitive, so attracting the best investigator sites to participate in a trial is a crucial step in meeting patient enrollment targets.
Delaying approval by even one day can cost hundreds of thousands of dollars or more, depending on the drug. This means that timely trial implementation, including patient enrollment, may add significant value.
Meeting patient enrollment milestones in cooperation with investigators has traditionally been viewed as the responsibility of the contract research organization (CRO). Now, important new data show that a sponsor’s choice of a central lab impacts the willingness of investigators to work with a sponsor on clinical trials. Continue reading
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.
Given this increased spotlight and focus on preventing opioid abuse and deaths in the US and abroad, it has become more critical than ever to better understand the abuse liability potential of a drug as early as possible in the development process. As part of the overall assessment of drug safety for a New Drug Application (NDA) in the United States or a Market Authorization Application (MAA) outside the United States, drug abuse potential testing is required – regardless of indication – on any drug that is active in the brain. This encompasses all properties of the drug (e.g., chemical, pharmacological, pharmacokinetic, clinical safety, etc.).
In the first of a two-part blog, we share important early considerations for abuse liability testing to help drug developers test the abuse potential of their molecule and better understand their path to viability in this changing landscape.