The immune system is the body’s main defense against foreign materials and biologic agents such as bacteria, viruses, chemicals, and foreign cells and tissues. The immune response includes specific action of lymphocytes (one type of white blood cell) and is facilitated by other white blood cells, including neutrophils, monocytes, macrophages, eosinophils and basophils. The immune system can be viewed as a system controlled by negative feedback, meaning that normally it must reduce the effects of disturbance or invaders through self-regulation. 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
When developing a biologic, great science does not always translate into a great product. Doing the rights studies, the right way, is paramount to realizing the product’s potential. Knowing which studies to conduct, when to conduct them and interpreting the data in the context of the product’s development, can make the difference between success and failure.
For Biologics, “The Product is the Process”
Biological medicines, including therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins are large, complex molecules that cannot be fully defined by physicochemical analytical methods. They are manufactured from genetically modified living cells using processes that are usually complex. Biological medicines are often 200 to 1,000 times the size of small molecule drugs, and because of the biological nature of the starting materials, the manufacturing processes have inherent variability and product heterogeneity. Continue reading
When you think of a pathologist, you may picture a scientist peering through a microscope, viewing slides and making notes about a disease state, then moving on to the next sample. Indeed, the classic role of many contract pathologists is to evaluate large numbers of tissue slides and author pathology reports. However at Covance, the Lead Optimization Pathology group plays a much greater role in drug development.
The Lead Optimization Pathology group offers Project Pathologists—a staff pathologist with therapeutic area expertise who is assigned to a project and intimately involved in supporting the early drug development in both efficacy and non-GLP toxicity studies. As ACVP board certified veterinary pathologists with Ph.D. degrees and past experience working in large pharmaceutical companies, the staff can offer in-depth pathology support for both small and big clients. Continue reading
Cardiovascular safety remains a leading cause of drug attrition during preclinical and clinical development, accounting for discontinuation of approximately one third of marketed drugs.
These liabilities, which pertain to both cardiovascular- and non-cardiovascular-targeted drugs, can be identified during early development by addressing cardiovascular safety endpoints prior to the selection of a drug candidate, a process known as ‘frontloading’. Although not mandated by the key regulatory guidance for safety pharmacology (ICH S7A; US FDA, 2001), an increasing number of companies choose to conduct early non-GLP cardiovascular safety studies in support of decisions on the progression of their compounds. Continue reading
Lead optimization (LO) is one of the most expensive and time-consuming stages of the drug development process due to the number of programs running simultaneously and the number of molecules within each of those programs. Covance’s Lead Optimization Pharmacology & Toxicology services are designed to help you select the best molecule for candidate selection and further development. Our ability to integrate service lines, such as pharmacology, biomarkers, imaging and safety, and thoughtfully add endpoints to studies, maximizes the number of questions being answered in each study leading to improved probability of technical success. The following video gives an overview of our Lead Optimization Pharmacology & Toxicology services and the benefits of choosing Covance as your LO partner.
Identifying clinically useful compounds and developing a novel drug treatment to improve human health has many rewards. But with increasing press about the growing abuse of prescription medications and potentials for physiological or physical dependence, regulatory agencies around the world have taken note.
Called abuse liability testing, this stage of drug development was first officially recognized in 1970 with the U.S. Controlled Substances Act. Since then, many iterations and guidelines have been developed to determine a compound’s potential for abuse.
Abuse liability studies are very important because they are required by the regulatory agencies in U.S., Europe, and even Asia for setting the scheduling of new chemical entities that come into the marketplace. Continue reading
First established as a standard practice in clinics, in vivo imaging also benefits translational or preclinical research. For the past 25 years, many studies have relied on in vivo imaging as a method to quantify treatment response and gain early insights on efficacy. Now, as the technology advances, researchers can expect to benefit from greater spatial resolution and software advancements that allow faster, cost-effective translation of study results.
“Imaging often gives you unique information that can’t be obtained any other way. The phenomena that you would observe preclinically may be the same disease state in the clinical trial,” says Michael Cockman, Senior Scientist and Manager of the Imaging Center at Covance. “It’s common to hear from a client who wants to test a type of imaging, called a modality, in a particular disease state to find out if it is appropriate for clinical development later.” Continue reading
Successful drug development is increasingly dependent on a robust “fail fast” strategy that includes incorporation of safety / toxicology endpoints into lead optimization pharmacology studies. This early marriage of pharmacology and toxicology will provide insight into the margin of safety that is critical for advancing the molecule, the design of the GLP studies and the clinical plan. Biopharmaceutical companies that employ a “fail fast” strategy can make safety decisions from the integration of toxicology into pharmacology studies, which markedly reduces lead optimization cycle times and overall spend during this phase. Continue reading
Biosimilars, which are new versions of innovator biopharmaceutical products that are marketed after expiration of patents, have emerged as one of the fastest growing development opportunities in the biopharmaceutical sector. In the U.S. alone, industry analysts estimate that biologics worth $80 billion are slated to go off patent by 2015.
Regulatory agencies evaluate biosimilars based on their level of similarity to, rather than the exact replication of, the innovator drug. In the U.S., recent guidance by the FDA says it will “consider the totality of the evidence” when assessing follow-on products. This approach requires sponsors to demonstrate robust chemical comparability to the innovator compound. Continue reading