CASSS AT Europe 2020 -- Forced degradation studies involve subjecting a putative drug substance or drug product to elevated chemical and environmental stress. This allows product degradation pathways and potential impact on efficacy or safety to be understood. It is also used to challenge the sensitivity and specificity of analytical methods.

CASSS AT Europe 2020 -- Antibody-drug conjugates (ADCs) represent a powerful weapon in the treatment of cancer. These combination biopharmaceuticals work by specifically targeting a tumour antigen allowing the delivery of a toxic payload to inhibit cell growth and induce tumour cell death.

CASSS AT Europe 2020 -- In monoclonal antibody (mAb) formulation development, colloidal stability and the propensity for these molecules to aggregate is a critical quality attribute, with implications for efficacy and patient safety.

EBF Open Symposium 2020 -- Residual drug tolerance issues in cell-based NAbs [Neutralizing Antibody (NAb) assays] is a common problem (particularly for IgG molecules), which can lead to false negative NAb detection.

EBF Open Symposium 2020 -- The use of acid treatment is a common approach to dissociate immune complexes to achieve highly drug tolerant and sensitive anti-drug antibody (ADA) assays. In June 2020, an alternative approach named HISDA (High Ionic Strength Dissociation Assay) was published (Jordan et al.

Covance was approached by a sponsor to conduct an entire COVID-19 antiviral program with their compound. The sponsor had already been in contact with regulatory authorities and was close to submitting the regulatory packages. Covance was able to implement extreme acceleration of the study startup timelines.

AACC 2020 -- Guideline for inflammatory bowel disease (IBD) suggests using fecal calprotectin (FC) for patient during diagnostic and monitoring phases, as well as in distinguishing between IBD and IBS (irritable bowel syndrome). Crohn's disease and ulcerative colitis are the principle types of Inflammatory bowel disease.

Prader-Willi Syndrome (PWS) is the most common genetic cause of life-threatening obesity. Occurring in close to one out of every 15,000 births, PWS currently has no cure and consists of chronic overeating, mild to moderate intellectual impairment and compulsive behavioral problems.

Advancements in Technology and Patient Access Deliver Better Clinical Trial Access, Quality, and Experiences BURLINGTON, N.C.--(BUSINESS WIRE)--Oct.

While the vast majority of the largest pharmaceutical and medical device sponsor companies around the world already rely on functional service providers (FSPs) in some capacity, the usage of FSPs is evolving. Not only is FSP being implemented across additional functions, but many strategic arrangements are pushing more accountability onto the FSP partner.