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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.
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.
REACH a Better Solution: in vitro Skin Sensitization Assays as Animal Testing Alternatives
Skin sensitisation testing is a major gap for many companies addressing the 2018 REACH substance registration deadline and other global regulations. Join us for a Q 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.
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."
Hot Topics Discussed in Covance Spring Webinars
Unlock opportunities for your clinical research programs and deliver results that matter. 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.
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.
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...
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 being recognized for its modern approach to improving the clinical trial process. The CARE Awards recognize excellence across the global clinical research enterprise.
Covance and Arcinova Providing Integrated Services
Covance and Arcinova recently expanded a strategic relationship following the signing of a sales services agreement at the end of 2016. Under the terms of the agreement, Covance is offering Arcinova services alongside its own extensive range of drug development capabilities.
An Agile, Career-Focused Business Develops From Within
Jonathan Zung, Group President, Clinical Development & Commercialization Services, has only been at Covance for a short time, but he already has big plans for the future of our clinical and commercialization businesses, as well as fresh ideas on talent development.
Rheumatoid Arthritis Biosimilars: Regulatory and Clinical Considerations
Three biosimilars for rheumatoid arthritis (RA) were approved by the FDA last year, but the regulatory pathway in the US is still considered a new frontier, especially when compared to regulatory guidance in the EU. With our global industry's growing interest in developing biosimilars, it's critical that sponsors have a clear understanding of key clinical issues and develop a strategy for navigating today's regulatory environment.
A Holistic View of the Biosimilars Landscape: Key Factors for Clinical and Commercial Success
Biosimilars have dominated the headlines in the U.S. with several FDA approvals, legal battles and questions around reimbursement, placing an increased focus on how to successfully navigate this relatively new pathway from end to end.
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.
Patient Centricity and the Role of the CRO
Biopharmaceutical companies both big and small have witnessed the shift toward patient-centric practices in the current healthcare landscape. As a result, many are now including or planning to incorporate the voice of the patient in their drug development strategy.
ELISPOT Assay: A Powerful Tool in Vaccine Development and Immune Monitoring
Over the past several years, the scientific community has made tremendous progress in advancing our understanding of the immune system, from the basic functions of its various components to molecular pathways that operate within those components. With new, state-of-the-art tools and technologies, immunologists now have the ability to better understand the mechanisms of immune response to various antigens, thereby aiding them in the development of novel approaches to treat...
Going with the Flow: Key Flow Cytometry Challenges and Solutions at CYTO 2017
When it comes to novel drug discovery and development, flow cytometry is known for being both a powerful and versatile technology. It can deliver valuable information to advance early biomarker development, tolerability, clinical studies and even companion diagnostics. But leveraging flow cytometry technologies to answer analytical questions and empower decision making from the research lab to the clinic requires a deep knowledge of cutting-edge approaches.