Vaccine and Novel Immunotherapeutic Development: A Personal Quest

Like my colleagues at Covance, my work ultimately contributes to improving Vaccine and Novel Immunotherapeutic Development Covance Bloghealthcare and patients’ lives. Our efforts to accelerate fresh approaches towards effective treatments became deeply personal in 2007 when my oldest sister, Vicki, was diagnosed with advanced Triple Negative Breast Cancer (TNBC).

From her initial diagnosis, my sister was full of vitality and enjoyed a high quality of life due in part to several of the novel treatments that Covance had helped develop. She even participated in a long-term clinical trial involving an angiogenesis-inhibitor, in addition to traditional chemotherapy, during her early treatment.

Vicki became a student of her diagnosis, reading countless journal articles on the rapid advances in scientific understanding. When her health took a sharp decline, she asked for my support in helping her gain access to a new trial focused on the immune system. She wanted to do whatever she could to help others find a better treatment, or even a cure, for TNBC. Ultimately, she was too weak to make the journey to participate in a cutting-edge clinical trial. Vicki died on October 1st, 2013.

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Five Key Advances in Infectious Disease Drug Development

Infectious diseases contribute to approximately 25%Advances in Infectious Disease Drug and Vaccine Development Covance Blog of global mortality and present critical healthcare challenges, especially in under-resourced countries. Recent research and development breakthroughs may help transform this situation. The industry is now leveraging novel analytical and bioinformatics technologies to better understand the biology and response to viral and bacteriological infections, and thereby develop more rapid and effective strategies for evaluating new therapeutic agents in clinical trials.

1. Applying lessons learned

Hepatitis C virus (HCV) therapeutics, frequently described as a breakthrough area in drug development, because it highlights the result of combining the biological understanding of disease and prioritizing appropriate resources to speed drug development. The first curative therapeutic regimens containing direct-acting agents for this important cause of liver disease were approved in 2011. Since then, seven additional regimens have received FDA approval with several more promising treatments currently in late stage clinical trials. Continue reading

More Attention to Patients Can Increase Inflammation Study Effectiveness

(This is part 3 of a 3-part series on Inflammatory Disorders Studies. View part 1 here.

Patient-reported outcomes, compliance and retention are key components of success.

Recent research contends some underlying immune system response mechanismsCovance Inflammation Studies -BLOG are common to inflammation-related diseases, such as asthma, COPD, psoriasis, rheumatoid arthritis, lupus and inflammatory bowel disease. These diseases are referred to as Immune-Mediated Inflammatory Disorders (IMIDs). There is a significant shift in the approach to managing traditional inflammatory diseases from organ-based symptom relief to tackling common underlying pathways of immune dysregulation which offers the hope of disease modification. Continue reading

Effectively Managing Investigators and Sites in Inflammation Clinical Trials

(This is part 2 of a 3-part series on Inflammatory Disorders Studies. Each Tuesday we will publish a new article in the series.View part 1 here.

Ensure your ROI and keep studies on track.

The good news: The surge in the number and size of industry-sponsored trials in Covance Inflammation Bloginflammation presents opportunity. The not-so-good news: The surge also presents challenge. Clinical trials for Immune-Mediated Inflammatory Disorders (IMIDs) present certain pressures for even the most committed investigators and sites: IMID trials frequently have longer than usual duration and enrollment can be highly competitive. Additionally, patients whose disease is well-managed by the new treatments available may not be motivated to try something different. Continue reading

Non-Alcoholic Steatohepatitis: Limited Available Treatment Options but Promising Drugs in Development and Recent Progress Towards a Regulatory Approval Pathway


The prevalence of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) is increasing world-wide in parallel to the increase of the obesity epidemic. Insulin resistance (IR) and the accumulation of triglyceride-derived 103072_liver bw1toxic lipid metabolites play a key role in its pathogenesis. Multiple biomarkers are being evaluated for the non-invasive diagnosis of NASH. However, a percutaneous liver biopsy is still the gold standard method; the minimal diagnostic criteria include the presence of >5 % macrovesicular steatosis, inflammation, and liver cell ballooning. Several pharmaceutical agents have been evaluated for the treatment of NASH; however, no single therapy has been approved so far. Due to the increasing prevalence and the health burden, there is a high need to develop therapeutic strategies for patients with NASH targeting both those with early-stage disease as well as those with advanced liver fibrosis.
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How to Deal with Eligibility Creep in Immune-Mediated Inflammatory Disorders Studies

(This is part 1 of a 3-part series on Inflammatory Disorders Studies. Each Tuesday we will publish a new article in the series. View part 2 here.) 

Placebo response rates can obscure treatment effects, putting effective drugs at risk

One of the confounding factors in clinical studies that can contribute to difficulty in Inflamation Blog Covance Patientdiscriminating an active treatment effect versus placebo is subject eligibility creep when subjects (e.g. with milder forms of disease severity at baseline) may get enrolled inappropriately by sites when struggling to meet recruitment targets and timelines. Baselines are skewed and misrepresented since subjects initially may be assessed as suffering from the more severe disease grades required to meet inclusion criteria. Continue reading

Solving Culinary Challenges with Custom Study Solutions

I am a scientist, and sometimes my workspace is more like a kitchen. For over 30 years, I’ve led custom research studies for companies needing scientific evidence that their food products are safe. Often that means meticulously recreating food Covance Food Safety Testing Heat Kill Studymanufacturing processes in the lab.

The importance of this work is obvious—ensuring food safety is critical for companies to protect consumers and their brand reputations. Although some situations require in-plant studies, with which Covance can also assist, there are reasons for conducting these studies in the lab rather than on-site.  Laboratory studies minimizeisruptions to manufacturing operations.  More importantly, they also avoid potentially introducing pathogens, spoilage organisms or surrogates into the plant during testing. Critically, they definitively yield scientifically valid results. Continue reading

A New Level of Brand Protection: Five Things You Need to Know About PDE5 Inhibitor Adulterants

The adulteration of dietary supplements with synCovance Supplement Testingthetic phosphodiesterase type 5 (PDE5) inhibitors can cause serious adverse health risks. Covance has introduced a new non-targeted analysis method using liquid chromatography-high resolution mass spectrometry (LC-HRMS) for screening and identification of known and novel PDE5 inhibitors in dietary ingredients and supplements, leading the industry and our clients to a new level of brand protection.

Below are five things you need to know about PDE5 inhibitors in sexual enhancement supplements and how to screen for these dangerous adulterants. Continue reading

Assessing New Medicines for Potential Abuse, Right from the Start

The abuse of prescription medications is reaching epidemic proportions worldwide.  Some judge prescription drug abuse to be as prevalent and as deadly as an epidemic caused by an infectious agent. Consider recent news reports about an HIV outbreak in a rural Indiana town that resulted from widespread addiction to a prescription painkillerCovance Labs Safety Pills.

The tragedy of Austin, Indiana is the tip of the iceberg. Prescription drug abuse is responsible for 16,000 deaths annually in the United States, a number that’s rising steadily. Meanwhile, 52 million people over age 12 in the US — nearly 1 in 6 — have misused prescription drugs, 6 million of them in the past month alone. Continue reading

New Potentials in the Journey Ahead for Companion Diagnostics

Companion diagnostics are evolving quickly as novel technologies emerge and new drug Covance Companion Diagnostics Drug Development Journeytargets appear. Dr. Mark Roberts, Director of Diagnostics Development, recently shared his thoughts on the industry trends ahead of the World CDx Boston 2015.

How much progress has been made in the area of companion diagnostics? Continue reading