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.

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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.

Moving the Needle for Rare Diseases

Each year, we designate the last day in February as Rare Disease Day to raise awareness about the potential impact we can make for this important segment of the world’s population. From policy makers to researchers to health authorities, we all play a part in making a difference for more than an estimated 300 million people in the world suffering from a rare disease.

To mark the event, I would like to reflect on my role to move the needle and make a difference to patients that are awaiting life-changing treatment. My journey started as a clinician where I had the privilege in caring for patients with a variety of rare diseases. At a personal level, I am also the aunt of a very special boy who suffered for 8 years with a rare cardiopulmonary disease. To me, rare diseases are not so rare.  Continue reading

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

Achieving Compliance with E6: Exploring the Workflow Challenges

Most sponsors are well aware of the recent revision (R2) of ICH GCP E6, which outlines recommendations to unify standards across the EU, Japan and the U.S. with defined requirements for sponsors regarding the role of monitoring and risk management, there are many factors to consider for a successful implementation.

This article discusses a variety of challenges sponsors may face when preparing to address these recommendations and also examines opportunities to drive greater efficiencies in today’s complex trial ecosystem.

Addressing varying levels of adoption

According to the latest revision, sponsors are tasked with a requirement to employ an adaptable quality management system and are expected to maintain oversight of CROs. But with various tracking systems, vendor logs, CTMS and monitoring platforms, seeing the complete picture can be an overwhelming, error-prone effort. 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

Target-Mediated Drug Disposition

“Affinity” is defined as, “a spontaneous or natural liking or sympathy for someone or or datasomething.” This concept applies also to the biologics (large molecules) we help to develop. Drugs like monoclonal antibodies (mAb) or bispecific antibodies are ideal drug candidates since they have very high affinity to bind to their target substance or site. Given the variability of the targets, safety profiles, and therapeutic windows, it is important to understand the characteristics of the affinity of the target and how to translate phenomena such as target mediated drug disposition (TMDD). Continue reading

Challenges in the Diagnosis of NAFLD, NASH and Comorbidities in the Pediatric Population

Nonalcoholic fatty liver disease (NAFLD) is the accumulation of fat or lipids in the liver in NASH NAFLD Blogthe absence of significant alcohol uptake or viral infection. Within NAFLD there is a spectrum of disease ranging from excess storage of fat in the liver (NAFL) to fat plus inflammation (called nonalcoholic steatohepatitis or NASH), to liver fibrosis and cirrhosis, or end stage liver disease with loss of liver function. NASH is the most common cause of liver disease in developed countries, largely due to the increased prevalence of obesity and type 2 diabetes. A percentage of patients with NASH and liver fibrosis will progress to liver failure or hepatocellular carcinoma or liver cancer. In fact, NASH is expected to be the number one cause for liver transplantation in a few years, making it critical to identify high-risk patients early. 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