The impact of COVID-19 on reimbursement call center operations has the potential to be significant. However, a proactive crisis management plan and a dispersed, redundant operating model can go a long way towards safeguarding your patient support programs. As governments and citizens address challenges posed by this global pandemic, many companies are limiting in-office operations, or closing them entirely. Now is a good time to evaluate your current and future reimbursement call center strategy and be as prepared as possible for the unexpected events that interrupt patient access to your therapies.Continue reading
They are not something most of us think about, that is, until something goes wrong. They filter 53 gallons of blood per day, remove toxins and excess volume from your blood, and help control other things like blood pressure and hemoglobin counts. They are our kidneys: two fist-sized bean-shaped organs that keep you healthy by making sure your blood remains in metabolic balance. Once a patient approaches kidney failure, we hope to get them a kidney transplant, but the reality is that the majority of patients undergo dialysis simply because there are not enough donated kidneys to go around. Either dialysis or a kidney transplant is needed to survive once kidney function is so poor that it needs replacement therapy.Continue reading
Combination Products: What are they?
Any product formed from the combination of a drug, a device and a biologic is referred to as a combination product. Under 21 CFR 3.2 (e) this includes two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity.Continue reading
Some have famous fundraising events attached to them, like the Ice Bucket Challenge for ALS or the many walks, runs, and telethons for diseases ranging from Cystic Fibrosis to Muscular Dystrophy. Other conditions, like Wilson’s Disease – a rare condition in which excess copper builds up in the body — are virtually unknown except to the friends and family of those living with the disease. Collectively, there are 7,000 distinct rare diseases, which, according to the advocacy group Global Genes, affect up to 400 million people globally. About half of those diagnosed with a rare disease are children.Continue reading
Covance celebrated the grand opening of its new flagship Genomics Lab in Indianapolis, Indiana on February 14th. Co-located with its established, industry-leading Central Laboratory and Bioanalysis Lab, the site provides greater testing efficiencies and comprehensive scientific solutions to help biopharmaceutical companies develop therapies faster and with a greater probability of success.
The new Genomics Lab adds 16K ft2 of new, dedicated laboratory space to deliver applied genomics solutions from single target to whole genome analysis. The laboratory also consolidates exploratory studies and biomarker development, patient management (CAP/CLIA) laboratory testing and Companion Diagnostic (CDx) development.Continue reading
The process of ensuring clinical trial records are accurate and fully reconciled between laboratory and clinical data sources can be a point of frustration for today’s pharmaceutical and biotechnology companies. Whether the data is coming from a contract research organization (CRO), a central laboratory or third-party laboratories, the need for timely availability of clean data based on unique sponsor format/industry requirements has become extremely complex.
“As the complexity of today’s studies grow, sponsors are often working with a greater number of laboratories in their studies,” explained Richard Cesarski, SVP, Patient Solutions, Safety and Data Sciences. “While these labs are specialists in sample management and generating results, their standard report formats may not be aligned to individual sponsor requirements.”
Recognizing this gap between sponsors, their clinical partners and the labs, Covance has launched Laboratory Data Management FSPx (Lab FSPx), a new solution within its Functional Service Provider (FSPx) offering.Continue reading
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.Continue reading
Most people in our industry are familiar with the “Leaky Funnel” analogy that describes the model where we approach a large number of patients for inclusion in a study, but they leak out of the pipe at every juncture. The loss of patients through planning, screening and execution of the study is not only costly, but it can also significantly delay or even prevent the successful execution of an otherwise valid study.Continue reading
Updated February 3, 2020 – Brexit1 has been completed and the UK will now enter into a transition agreement with the EU until December 31, 2020. Until then, the current GMP regulations will continue to apply. . However, drug manufacturers and contract test laboratories should be proactive in understanding the potential regulatory considerations relating to commercial drug product release testing.
This article provides a brief overview of the EU-US Mutual Recognition Agreement (MRA) and discusses considerations for implementing viable alternatives for testing to support EU, UK and US drug product releases after Brexit.Continue reading
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?Continue reading