Stepping Up the Game: Measles, Mumps, Rubella and Varicella (MMRV) Concomitant Testing Support for Vaccine Evaluation

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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Hot Topics Discussed in Covance Spring & Summer Webinars

Unlock opportunities for your clinical research programs and deliver results that Covance Spring Webinars Video Nash Diabetic Heart Biomarkersmatter.
We’re excited to be on the cutting edge of drug development solutions. Take a look at our recent webinar topics and leverage our experience.

Assessing Abuse Potential of CNS-Active Compounds:  Regulatory Environment & Challenges

Learn about the regulatory environment for the assessment of abuse potential of CNS-active drugs, explore the importance of early vetting of abuse potential and identify critical steps in your regulatory strategy.

June 29, 11 a.m. EDT | Register Now

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Clinical & Research Excellence Awards Shortlist Xcellerate Medical Review

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 Clinical & Research Excellence Awards Shortlist Xcellerate Medical Reviewbeing 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

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

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 cGMP pharmacy Covance Blogat 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:

  1. Quality and safety
  2. Timeline reduction
  3. Cost efficiency

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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 Covance Contract Research Org Biosimilars Webinar 2a 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

Precision Medicine in Immuno-Oncology

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.” Covance CRO Labs Blog

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

REACH a Better Solution: in vitro Skin Sensitization Assays as Animal Testing Alternatives

REACH a Better Solution: in vitro Skin Sensitization Assays as Animal Testing Alternatives

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

Keeping Skills Sharp For CRAs

The drug industry is evolving and clinical trials are becoming more complex. How do CRAs in a large global company keep their skills up to date? Recognizing that large group meetings are costly and virtual training feels impersonal, Covance decided to address this challenge with an innovative model called CLIK: Country Leadership Imparting Knowledge.Covance CRA Careers

With selected leaders identified from each of the 70+ countries that Covance serves, the CLIK program brings CRAs face-to-face to share their experiences, gain new knowledge and then serve as training representatives for peers in their own regional teams. Continue reading

Understanding Regulatory and Market Access Considerations With Drug Abuse Potential

Each assessment for abuse liability is as unique as the molecule in question, reiterating Regulatory And Market Access Considerations With Drug Abuse Potentialthe 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.

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Getting Investigators Onboard: Lab Preferences Make a Difference in Trial Participation

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, Covance Labs Clinical Trial Participationdepending 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