With 93 Crohn’s Disease
(CD) and 168 Ulcerative Colitis (UC) Phase I-III industry-sponsored studies planned
and open to enrollment, there is a significant focus on research into new
therapies for inflammatory bowel disease (IBD)1.
Remission is the main aim of IBD therapy, but IBD studies often face challenges with minimizing the placebo effect2,3,4. Placebo effect can be categorized into placebo response/benefit (patients demonstrating an improvement) or placebo remission (patients achieving remission). Factors believed to impact the level of placebo effect can be contradictory depending upon whether a study’s focus is upon placebo response/benefit or placebo remission5.
The Brexit1 deadline has been extended once again – now to January
31, 2020 – and a withdrawal deal seems likely given the result of the December
12 general election. However, drug manufacturers and contract test laboratories
should be proactive in understanding the
potential regulatory considerations relating to commercial drug product release
testing and Brexit.
This article provides a brief overview of the EU-U.S. Mutual Recognition Agreement (MRA) and discusses considerations for implementing viable alternatives for testing to support EU, U.K. and U.S. drug product releases if and when Brexit moves ahead.
Residues of plant protection products (PPPs) are inevitably present in or on food, even when they are applied in line with good agricultural practice. The upper limit of residue permitted on food or feed is the ‘maximum residue level’ (MRL), which, in Europe, is legislated by the European Commission based on scientific advice from the (EFSA).
MRLs are measured via crop residue field trials, which replicate the real-life agricultural conditions under which a PPP would be used. It sounds a simple enough procedure, but what studies are commonly used and what are the secrets to success?
Successfully demonstrating product safety and efficacy in a randomized clinical trial is a monumental event, but it doesn’t always translate to market access and uptake one it’s launched. Since clinical trials are limited to a controlled sub-set of patients, observations recorded in the clinical trial setting can vary from what actually occurs in clinical practice. That’s where real-world evidence (RWE) can help pharmaceutical companies to inform development planning and also to demonstrate a product’s comparative effectiveness, safety and value from the viewpoints of various stakeholders, including regulators, payers, prescribers and patients.
This article discusses the role of RWE, the different information needs among stakeholders and potential solutions for meeting their evolving requirements.
In our previous post, we outlined the dangers of Cytokine Release Syndrome (CRS) and the importance of preclinical Cytokine Release Assays (CRAs) when developing monoclonal antibodies (mAbs) that interact with the patient’s immune system. In this second post, we describe the different kinds of assays in use and how these may fit into your drug development program. An alternative type of CRA, peripheral blood mononuclear cell (PBMC) blood outgrowth endothelial cell (BOEC) co-culture, will be discussed in more detail in our next blog post.
Release Syndrome (CRS), otherwise known as cytokine storm, is a systemic
inflammatory response caused by complications due to disease, infection or an
adverse effect of biologic therapy. The clinical symptoms of a cytokine storm
are massive release of a potent cocktail of pro-inflammatory cytokines into the
general circulatory system, leading to severe multi-organ damage, failure or
potentially death. This is an extremely unwanted immunotoxicological side
effect in drug development.
Although a range of regulatory definitions exist, a biosimilar drug is generally defined as a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy and safety outcomes similar to the originator biologic.1
Covance Shanghai is pleased to announce an
expansion of its general toxicology capabilities to include
safety pharmacology studies, allowing our Asia-Pacific clients to more easily
complete their IND requirements for CFDA regulations.
are the new safety pharmacology offerings?
The general tox team in Shanghai is now
capable of running cardiovascular safety studies with dogs, using DSI PhysioTel
telemeters to monitor drug elicited effects on
electrocardiograms and hemodynamic parameters, heart rate and blood
pressure. They are also able to run neurological and
respiratory studies in rat models.
Team members from Shanghai were trained in
these experimental procedures by experienced safety pharm specialists from the
Covance Madison site. After several months of personnel training, beginning in
June 2018, validation studies at the Shanghai site were completed in early 2019.
Patient recruitment represents the biggest challenge in clinical trials. From general patient identification and participation to reducing screen failure rate or limiting patient drop out after enrollment, drug developers face many massive pain points to initiate their clinical trials.
Patient recruitment and retention continue to be the biggest challenge in clinical studies. Designing protocols with patient needs in mind will lead to higher levels of better clinical research recruitment, drive up participation rates and save both time and money.
Real-world evidence (RWE) can be used to meet different objectives, and RWE studies can be designed using different study types and methodologies, as well as multiple sources of real-world data (RWD). Teams often work separately and could benefit from a shared learning experience in the planning and execution process. A publicly-available RWE framework tool was recently released to help enhance collaborative efforts in RWE studies.
Earlier blogs in this series discussed closing the knowledge gap with RWE studies and how Covance and industry professionals worked to develop an RWE framework tool. This third and final blog further explores how the tool was applied in actual case studies to better support RWE efforts in treatments for diabetes and pain management.