Case Study: Developing a Complex Dosing Drug Schedule for a DART Pompe Disease Study

Amics Therapeutics, based in Cranbury, NJ (USA), focuses on finding treatments for a DART Pompe disease studyrange of devastating and rare and orphan diseases. Its lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease enzyme replacement therapy that will be administered in combination with a pharmacological chaperone and tested in multiple human genetic diseases.

A Short-Half Life Investigational Drug Suggests an Every-Other-Day Complex Dosing Regime

The Amicus and Covance dialogue began at the 2017 Society of Toxicology conference and resulted in a large series of DART studies being awarded to Covance at its center for biotech excellence in Greenfield, IN. Early in the engagement, Covance’s most experienced US-based DART team member provided consultation on study design to make it more consistent with FDA guidelines and expectations. Continue reading

Empowering CRAs with Mobile Technology to Improve Site Quality through Monitoring Efficiency

Clinical research associates (CRAs) need immediate access to relevant and accurate site performance metrics, but information is often isolated within multiple databases and spread across different tracking systems. To deliver key site performance data to CRAs via mobile and web applications – quickly and conveniently – Covance has created a specialized clinical analytics suite of products, Covance Xcellerate® Informatics. This powerful solution integrates data from all sources and allows a CRA to gain a clear and concise view of all clinical trial data, in one place, for all the sites that a CRA is monitoring.

Xcellerate Informatics CRA Blog Continue reading

Creating Connections with Covance Employees at the Madison Movie Night

Covance employees often say that working with exceptional people makes all the Covance Employee Culturedifference in their careers. To help expand connections and create opportunities for employees to get to know their co-workers outside of work, the Covance Recognition Events Committee at the Madison, WI facility sets up events that strengthen their supportive, people-focused culture.

Manuel “Manny”, a Covance billing and revenue coordinator, recently shared his experience as a volunteer on the committee to help set up the Madison Movie Night. Continue reading

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When to Assess a Drug’s Potential for Abuse: Series Introduction

Drug abuse and potential drug abuse are critical issues for today’s pharmaceutical White Pills Drug Abuse industry and the health of patients. Understanding the latest FDA regulatory requirements, different study types, relevant timelines and logistics can be challenging. Conducted at a critical stage of drug development, the assessment for drug abuse potential is complex and must be acceptable to regulators.

If a drug or its major metabolite penetrates the brain, then an abuse potential assessment is required, regardless of the therapeutic indication. 

Developing a strategy around relevant timelines

The doses for drug abuse testing are selected based on the exposure/plasma levels produced in humans by the highest therapeutic dose. Therefore, drug abuse studies are not recommended until the human therapeutic dose range has been determined; however, your testing strategy should begin much earlier. Continue reading

Non-Compartmental Analysis of Pharmacokinetic Data: Considerations to Gain Efficiencies and Meet SEND Requirements

Pharmacokinetic (PK) data gathered in the early phases of drug discovery program can provide insights on a compound’s mechanism of action, identify specific attributes of interest and guide decision points to optimize downstream development. Selecting the most appropriate analysis technique is essential to computing PK parameters.

This article discusses how non-compartmental analysis (NCA) of pharmacokinetic data can help support regulatory filings, create predictive simulations and help researchers select lead molecules or formulations. We also explore the topic of data handling as differing approaches and anomalous results can cause delays through investigations and inconsistencies across a program. Finally, we’ll cover unique considerations when working with biologics and the challenges involved with submitting regulatory filings formatted to the Standard for Exchange of Nonclinical Data (SEND) specifications. Continue reading

The Promise of Vaccines for Fighting C. difficile

Over the last decade, Clostridium difficile (C. difficile) infection has rapidly become more prevalent. C. difficile, often abbreviated as C. diff, usually spreads through hospitals and other healthcare facilities, and the elderly are particularly vulnerable. Our society’s overuse of antibiotics has been eliminating normal microbes, allowing C. difficile to take over. Infected patients then release bacterial spores and spread the pathogen to others.

Vaccines are a promising strategy to address this critical public health issue. They are a well-established form of medicine that could be utilized to prevent illness rather than treating an existing infection. While fecal transplants also are being explored, these treatments are very new, and clinicians do not yet know the long-term effects of such procedures. Continue reading

Exploring New Opportunities for Biomarkers in Immuno-Oncology

Pharmaceutical companies are increasingly relying on biomarkers to deliver precisionOpportunities for Biomarkers in Immuno-Oncology medicine in immuno-oncology. Biomarkers can accelerate drug development and reduce the overall cost; they also allow sponsors to identify failed treatments sooner so that resources are not wasted on expensive, late-stage trials with unsafe or inactive compounds. Finally, these tests lead to better outcomes for patients, which help companies make a stronger case for reimbursement.

However, biomarker discovery requires substantial time and resources. While expenses will likely be outweighed by increased development efficiency, companies must ensure that drug and diagnostic timelines are closely aligned so that the treatment and test can launch simultaneously. Technical, workflow and commercial factors are critical to the successful use of immuno-oncology biomarkers. Continue reading

Dr. Barbara Gillespie to participate in a scientific workshop collaboration with the National Kidney Foundation, EMA and FDA

Kidney disease is often called a “silent killer” as it often develops unrecognized and DrGillespie_Headshot
gradually progresses into chronic kidney disease. Earlier detection to identify kidney disease and slow its progression has relied on measuring changes in two key biomarkers – glomerular filtration rate (GFR) and albuminuria.

Dr. Barbara Gillespie, vice president and therapeutic head of nephrology at Covance, was recently asked to attend an invite-only workshop on March 15-16, 2018 sponsored by the National Kidney Foundation (NFK), U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

As the only representative from a CRO invited to this unique meeting, Dr. Gillespie will offer valuable insights from the perspective of clinical research. She also serves on the NFK regional medical advisory board and is the only CRO member of the NFK scientific advisory board for chronic kidney disease (CKD) registry.

Continue reading

Meet Me in 5: Developing a Global Perspective

Our ongoing “Meet Me in 5” series covers 5 people, topics or questions to illustrate how Covance nurtures exceptional people, provides an energizing purpose and enables extraordinary potential in its employees’ careers.

In this article, Brian Maron, executive director, global operations, immunology & immunotoxicology, discusses culture and his global career journey with Covance.

Covance Careers

1. A global journey

Brian Maron has a deep history with Covance, a journey that has taken him to many places around the world. Starting out in cardiac safety for clinical trials as a software developer in the mid-90s, he worked his way up to supervise a team of software developers and was then asked if he’d like to relocate from Wisconsin to Nevada to lead the IT department. “For someone who had never lived outside of Wisconsin, this was a big move, but my wife and I decided it was a great opportunity for us,” says Brian.

It turned out Nevada was just the beginning of Brian’s global career journey with Covance. Brian was then given the chance to expand cardiac safety in the United Kingdom and was later presented the opportunity to move to Shanghai, China to set up a new facility to expand the Covance global footprint. Coming full circle, Brian now resides back in Wisconsin and enjoys nurturing talent and encouraging his team to take on assignments that allow them to see the world and grow our business.

2. A proud accomplishment

In Shanghai, Brian was tasked to develop solutions for toxicology, lead optimization toxicology, metabolism and in vivo PK screening services. The team had a goal to achieve good laboratory practices (GLP) certification of the new facility – something no other foreign company had achieved in China at the time.

“It was a learning experience,” says Brian, “but also very satisfying. From a technical perspective, we had to learn the local regulations, which are different from the US. and Europe, and build local relationships. I learned a lot about international business culture and how to leverage the phenomenal leadership and experience of our colleagues in China.”

3. Responding to rapid growth

Now responsible for expanding immunology and immunotoxicology solutions, Brian notes the exciting culture. “Even though Covance has been in this area for a while, this fast-growth environment feels like a start-up. Our team is extremely energized, so more than ever, I believe it’s important to help mentor our new leaders and those driven to succeed at Covance. I am highly focused on the short- and long-term needs of our clients and our employees.”

 4. Exploring unique career tracks

For Brian, his career advances at Covance were about seeking out new opportunities. “If you are willing to explore unique career tracks, Covance will be there as your partner,” explains Brian. “You can play a major role in some really interesting global initiatives and have confidence you will succeed with the support of exception people. That’s why I really enjoy working for a larger company like Covance. There are many opportunities to advance drug development – and your career.”

5. Making a positive impact

In his day-to-day work, Brian interacts with people from around the world. He says, “It’s inspiring to be a piece of something large and impactful, and even more exciting to see what our team can achieve together.”

When thinking about his next career move, Brian jokes, “I’ve definitely given up on predicting the future.” But one constant remains in his daily work. “I continue to believe in the underlying mission of Covance to help produce medicines which improve global health. The things I do with my team have an impact on my own life and the lives of my family and friends – work that makes us all proud.”

To learn more about life at Covance and explore careers, visit www.Careers.Covance.com.