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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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.

Establishing Control Over the Manufacturing Process and the Quality of your Biologic

101679_Large-Molecule_1575263331When a patient reads the label on their medicine bottle, he or she naturally relies on the medicine to contain the correct drug, be safe, work as intended and list the correct dosage. The pharmaceutical companies that produce these medicines similarly must rely on their internal manufacturing processes and quality control testing to generate the medicine responsible for this patient trust.

For the development of biologic medicines, the process of generating a quality product is less straightforward than that of a small-molecule medicine, like pain relievers such as aspirin. Selecting the right partner, such as Covance and its ‘Central GMP Testing Laboratory’ model, can smooth the path to validation and consistent manufacturing quality for your biologic.    Continue reading

Experiencing the Impact of a Life-Changing Treatment Sven’s Story

Sven, Senior Study Director, Toxicology at Covance, discovered his team’s work had Covance Careers unpredictably reached his home – and impacted his family’s life.

In January 2016, Sven’s 3-year-old daughter was complaining about pain in her legs. At first, it seemed like natural growing pains, but it then became difficult for her to walk in the mornings. An ultrasound with an orthopedic doctor revealed a high level of swelling in her knees and she received a diagnosis of juvenile rheumatoid arthritis – a disorder where the body’s immune system attacks its own cells and tissues. Continue reading

5 Tips for Proactively Managing Risks in Your Clinical Studies

Facing ever-increasing costs of running a clinical trial, sponsors must ensure they are properly directing their budget and resolving the areas of highest risk while maintaining patient safety and data integrity.

How can sponsors implement a robust process to allow earlier identification of emerging risks during the course of a trial? This article covers five tips for defining risk levels, categorizing risk and maintaining oversight to ensure that risks and responses are appropriately identified, documented, tracked and managed throughout the life cycle of a study. Continue reading

A Creative Solution to Address the Biosimilar Boom

Identifying viable study sites presents a challenge in many clinical trials. Biosimilar Biosimilars Covancedevelopment is especially challenging as the number of sponsors preparing to broaden access to today’s blockbuster biologics, by providing lower-cost biosimilar alternative, continues to grow. While this flood of research activity will make a significant improvement for patient access to breakthrough treatments, it has also created an increasingly competitive environment for finding suitable, experienced sites.

Compounding the issue, physicians are often less interested in supporting biosimilar studies, preferring to engage in clinical trials involving novel targets and compounds or those being conducted by larger academic institutions. Additionally, the level of education and training regarding the established development process for biosimilars is generally low. To overcome these hurdles, Covance has expanded its strategy to help sponsors find qualified sites and investigators willing to provide reliable clinical evidence.    Continue reading

Untangling the Mechanisms of the Diabetic Heart

Diabetes frequently accompanies heart failure (HF) and HF is observed in up to 15% of diabetic cardiomyopathypatients with type 2 diabetes (T2D). The relationship between diabetes and the heart is, however, complex. It has long been known that diabetes is an important risk factor for coronary artery disease, resultant myocardial ischemia and infarctions leading to HF. But the direct effect of diabetes on the heart muscle is less clear.

The existence of a non-ischemic diabetic cardiomyopathy, disease of the cardiac muscle that is directly related to diabetes and not due to coronary atherosclerosis, has been a longstanding topic for debate. The recent EMPAREG-OUTCOME study in which patient assignment to the sodium-glucose co-transporter-2 (SGLT-2) inhibitor, empagliflozin, was associated with a reduction in HF hospitalizations by 35%1 (for unclear reasons) has reignited this discussion.
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