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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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
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
Covance is proud to announce that Xcellerate® Trial Design has been selected as the winner of the Fierce Innovation Awards: Life Sciences Edition in the Data Analytics/Business Intelligence category. The Fierce Innovation Awards: Life Sciences Edition recognizes outstanding innovations that are driving improvements and transforming the life sciences industry. Xcellerate Trial Design was recognized for its innovative approach to improving site selection, forecasting resource demand and optimizing of clinical trial design. Continue reading
Agrafiotis’ Leadership in Bringing Xcellerate® Informatics to Market Demonstrates How Software Can Improve Health and Improve Lives
IDG’s Computerworld recently recognized Dimitris Agrafiotis, PhD, chief data officer and head of technology products for Covance Drug Development, as a 2017 Premier 100 Technology Leaders honoree. This year’s Premier 100 spotlights 100 leaders from both the technology and business sides of companies for their exceptional technology leadership and innovative approaches to business challenges. Covance is the drug development business of LabCorp.
“The Premier 100 awards program highlights the exceptional work of an elite group of IT executives who are leading their organizations through times of unprecedented change. They are using technology to drive high-stakes business projects and create dynamic growth in their organizations,” said Scot Finnie, editor in chief of Computerworld.
“These 100 men and women are not only strategic business thinkers, but also team leaders who recognize the importance of recruiting and retaining the brightest talent to enable digital transformation and harness the opportunities of cloud, big data, mobile and social. We’re pleased to recognize their leadership and honor their achievements.” Continue reading
Over the last 10 years, clinical trials have changed substantially in response to increasing globalization and study complexity, along with new technological capabilities and industry guidelines,7. With these noticeable transformations, sponsors are increasingly revisiting their monitoring methods to uncover new efficiencies and develop more robust risk management processes that can enhance ongoing patient safety and data quality.
At the forefront of this movement is risk-based monitoring (RBM) – a broad term for a variety of clinical monitoring methods that combine people, process and technology, enabling project teams and Clinical Research Associates (CRAs) to focus on the most important risks in clinical trials.
Since starting my drug development journey as quality assurance manager in a laboratory that would later become part of Covance to now serving as the CEO, I’ve witnessed our industry’s notable shift to support more nimble drug development. From improved trial design to companion diagnostics and more predictive insights fueled by advanced informatics, it’s exciting to see bold ideas enable smarter decisions and speed the introduction of groundbreaking therapies.
Progress is evident in many areas—starting at early phases through market access—but one factor remains constant throughout the years: our hard-working employees continue to advance innovation. They are the reason we can deliver unique perspectives that shape new solutions and carry out the vision of a healthier future. Continue reading
The Importance of Clinical Research Associate Training to Support Effective Trials
The clinical trial landscape is witnessing an increase in Phase III trials that average more than 3,500 patients. As more of these large trials continue to emerge, many contract research organizations (CROs) and sponsors are struggling to recruit qualified clinical research associates (CRAs) to support the influx of work.
Lack of experienced talent represents one of the main challenges facing the market, impacting sponsors and CROs alike with increased costs and extended timelines. Yet the urgent need for qualified CRAs will continue given that the demand in the field is projected to grow by 36.4% from 2012 to 2022 in the US, an issue also reflected worldwide.
Incorporating technologies such as biomarkers into the development of inflammation therapies can improve the development and delivery of the right therapy, at the right dose, to the right patient. Nonetheless, there are numerous risk factors inherent in inflammation studies and drug development overall. It’s crucial to identify these risks early on in your development plan and develop mitigation strategies that will help decrease your chances for failure. Continue reading
As the biopharmaceutical industry increasingly turns its focus to discovering and delivering targeted, personalized medications, the companion diagnostics field is rapidly advancing. By 2015, the worldwide companion diagnostics market will be worth $3.45 billion, according to London-based market research firm Visiongain. The involvement of central laboratories in the companion diagnostics space is also growing, as they increasingly play a role as partners with, and facilitators between, biopharma and diagnostic companies. Continue reading