Showing results 1233 - 1248 of 91813 for .
Showing results 1233 - 1248 of 91813 for .
Biosimilars: The Commercial Challenge
Gain insight on payer coverage and management of biosimilars.
Choosing the Best Pathway for CDx Development and Commercialization
Drug developers are increasingly incorporating a companion diagnostic (CDx) strategy into their programs to deliver safer, more effective and appropriate therapies to the right patients. While the end result can be rewarding, the path from analytical and clinical validation to demonstrate clinical utility and obtain regulatory approval is often arduous. It requires a comprehensive understanding of clinical trial design, regulatory submission strategies both for therapy and diagnostic assay,...
Clinical Quality Control Visits
A Predictive, Proactive and Preventative Approach to Site Quality. Clinical trials are conducted to collect the data necessary to make decisions about the safety and efficacy of new drugs. To help ensure patient rights and well-being, data integrity, investigational product and device safety, scientific operational excellence and regulatory compliance, quality control processes are embedded in clinical trials, no matter how large or how small.
Achieve Cost-Efficiencies and Speed Data Delivery: The Benefits of Combining Bioanalytical and Central Laboratory Services for Clinical Trials
Several challenges within the pharmaceutical industry are driving change. Sponsors are requiring higher throughput; forcing managers to do more with the same or fewer resources and causing a strain in scientific depth. In addition, the pressure on internal resources also increases as the complexities of therapeutic targets and technologies increase, forcing companies to look at different opportunities to fill pipeline gaps. Sponsors are often not aware of the benefits that can be achieved...
Immuno-Oncology and the Role of Biomarkers, Companion and Complementary Diagnostics
The recent evolution of immunotherapies and their potential applications have greatly impacted patients' options for effective oncology treatments. These advances have been powered in part by the use of a variety of biomarkers, companion diagnostics (CDx) and complementary diagnostics.This white paper shares some of the highlights in personalized medicine Covance has been involved with during the last few years as new immuno-oncology therapies have emerged.
Changing the Trajectory of Chronic Kidney Disease in Patients with Diabetes
Diabetic kidney disease affects approximately 40% of type 1 and type 2 diabetic patients and is the leading cause of end-stage kidney disease (ESKD). A key component of this disease is an increase in urinary albumin excretion (albuminuria/proteinuria) in the absence of any other kidney disease. Individuals may be genetically predisposed to diabetic kidney disease, but an increase in blood pressure and the defining characteristic of diabetes - hyperglycemia - are also major risk factors.
Addressing Immunotherapy Drug Development Challenges: An Evidence-Based Approach
Oncology trials are undeniably complex. Discover how you can successfully mitigate risks and maximize trial success by creating a comprehensive strategy that plans for the differences in immunotherapy development and proactively monitors execution.
The Food Packaging and Safety Modernization Act
President Barack Obama signed the Food Safety Modernization Act (FSMA) into law on January 4, 2011. Many suppliers and end users of food packaging materials are trying to determine how FSMA affects their businesses. While the initial implementation of FSMA does not address food packaging materials, the FDA states it is considering adding this to future guidelines. Risk analysis, material testing, documentation and recall plans are key components of FSMA and will likely be incorporated for...
APPLICATIONS FOR GENOMIC TECHNOLOGIES IN IMMUNO-ONCOLOGY
One of the most promising advancements in oncology in recent years is the alignment of new immuno-oncology therapeutic approaches with the tools of precision medicine. Using cell-, tissue- or genomic-based biomarkers, the interaction between an individual's immune system and tumor can be better understood, ultimately enabling a personalized approach to therapy. Genomic-based biomarkers are powerful tools used to assess mutational burden, production of novel or neo-antigens and hallmarks of...
High Pressure Processing: Insights On Technology and Regulatory Requirements
High Pressure Processing (HPP) is a pasteurization method that uses pressure rather than the traditional method of heat to kill microorganisms in foods. This process, like thermal processing, helps extend the shelf life of foods by killing spoilage organisms including yeasts and lactic acid bacteria. It also helps improve the safety of foods by killing vegetative pathogenic microorganisms including Escherichia coli O157:H7, Salmonella and Listeria monocytogenes. However, compared to thermal...
Immune Monitoring Insights to Advance Drug Development: A Key Component of Clinical Trials
While the immune system protects organisms from infections, it can react adversely to certain therapeutic interventions such as biologics that target various components of the immune system. Monitoring the responsiveness of the immune system to therapeutic interventions is crucial. This process, called immune monitoring, helps determine the safety and efficacy of therapeutic agents like vaccines or biologics.
Leverage Agitating Retort Processing to Optimize Product Quality
Beyond ensuring product safety, retort process optimization can help minimize retort cycle time and improve finished product quality. There are many processing variables involved-including time, temperature, agitation and heating medium. What is the best combination? Process engineers and food scientists regularly ask this question when developing low-acid packaged foods. A well-designed process development and sensory testing plan can help you evaluate processing options.
Leveraging Technological Advances to Accelerate HIV Vaccine Development
Over the last three decades, advances in antiretroviral (ARV) drug treatment have transformed HIV-1 infection from a progressive fatal disease into a stable and manageable chronic viral infection. However, more than 1 million people died from AIDS-related illnesses in 2015, in large part due to limited access to ARV drugs. In this white paper, you'll learn about current methods for assessing neutralizing antibody (nAb) responses, defining genetic determinants of neutralization escape and...
LICENSED VACCINES AND IMMUNOLOGICAL MECHANISMS: VACCINE-ELICITED PROTECTION
Recent discoveries and technological breakthroughs have advanced our industry's understanding of the mechanisms of vaccine-induced immunity and revealed new approaches to improve currently licensed vaccines. There are, however, ongoing challenges in the field, spanning process development to effectiveness monitoring. Making a difference in this dynamic area requires an integrated review of the mechanisms that mediate protection following vaccination against pathogens like Bordetella...
Microbiological Safety Validation of Food Processes
The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011 by President Obama. It represents the largest expansion of food safety requirements and FDA food safety authorities since the enactment of the original Food Drug & Cosmetic Act in 1938. It adds Section 418 to the US FD Act, requiring facilities to perform a hazard analysis and implement a preventive controls plan. The intent of the law is to protect foods from exposure to known or reasonably foreseeable...
The Mobile Health Application Revolution: Realizing the Potential of a Rapidly Growing Field
While mobile health apps hold promise for reducing the cost of clinical trials, concerns about issues such as validation, logistics and data security must be addressed. Interoperability of health care systems and seamless information flow will be a key focus. To succeed, companies will need to keep pace with changing guidelines, make informed design decisions and develop quality systems that ensure patient safety.