Maximizing the Value of a Product: A Perspective from China

Drug Development Market Access Covance Shanghai at night, ChinaDrug development in China is progressing quickly, due in part to shifting regulations, increased innovation and growing opportunities for global partnerships. However, making the most of market opportunities requires not only a focus on the intended end results but also careful, early phase planning. At a recent clinical seminar in China, a panel of Covance market access experts shared their thoughts on how to increase a product’s commercial potential.

Incorporating a business case

“In China, we discussed the theme of ‘beginning with the end in mind,’” said Eric Lang, MD, Vice President and Global Head of Clinical Development Leaders, Early Phase Development Solutions. “We find that a lot of biopharmaceuticals are focused more on the science of their treatment and don’t realize that they also need a strong business case to develop a product,” he said. Continue reading

Clinical Outcomes in NASH: Choosing the Right Endpoints

Non-alcoholic steatohepatitis (NASH) can lead to serious conditions such as cirrhosis and its complications, liver cancer and hepatic transplantation. Many patients eventually die from liver-related problems or cardiovascular disease. The challenge in developing drugs for NASH is to demonstrate an improvement in clinical outcomes. Cirrhosis takes several years to develop, and it is impractical to perform such long studies to identify treatment benefits. Therefore, to expedite the process and deliver new drugs to patients, biopharmaceutical companies have to consider surrogate endpoints that are reliable, can be obtained within a reasonable amount of time and are associated with progression of the disease.

A range of liver-related outcomes

NASH patients face many potential disorders and complications. In addition to overall death and liver-related mortality, the following endpoints should be evaluated in a clinical Clinical Outcomes in NASHoutcomes study:

  • Portal hypertension. Chronic injury to the liver results in a wounding response that leads to fibrosis, scarring and ultimately replacement of normal liver architecture with regenerative nodules. As a result of these changes, portal hypertension develops.
  • The accumulation of fluid in the abdomen results from portal hypertension. Using diuretics and reducing sodium intake often helps, but some cases are difficult to treat.

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The Tale of a Real-life SEND Test Submission

What to Expect When Submitting Your First SEND Dataset to the FDA

SEND test submission with Covance. Photo of binary codeWith the December 17, 2016* requirement for the FDA Standard for the Exchange of Nonclinical Data (SEND*) fast-approaching, our Covance SEND action team prepared a dataset for test submission to the FDA. This helped us to better understand the FDA’s SEND submission requirements, build experience and confirm our readiness to help clients submit their SEND datasets.

During this process, we uncovered a couple of significant learnings:

  • Allow for adequate time to prepare and submit to the FDA
    • The process to deliver our first test submission took more than two months from kickoff to FDA notification
    • It’s important to start early to understand the preparation time needed for submissions
  • For test submissions only, the dataset must be submitted on a physical CD and sent to the FDA via postal mail
    • This came as a surprise to us, since SEND is a streamlined electronic format of the data
    • (Note: In a real submission, the SEND datasets will appear in a specific location labeled “tabulations” in the submission folder structure as described in section 7 of the FDA CDER/CBER Study Data Technical Conformance Guide).

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Clinical Trials and the Growing Importance of Informatics

Demonstrating the efficacy, safety and differential benefit of a new drug relies on collectingClinical Trial Data Xcellerate Informatics Covance Blog and analyzing enormous amounts of data generated in a clinical trial. Yet this process of extracting knowledge from data is often the source of many inefficiencies.

We recently spoke with Dimitris Agrafiotis, PhD, Vice President and Chief Data Officer at Covance to hear his thoughts on how informatics has affected drug development and will continue to transform the pharmaceutical industry.

Q: Why is informatics important in a global context?

More and more major businesses and industries are being run on software and delivered as online services―from movies to agriculture to national defense. Many of the winners of this new economy are Silicon Valley-style technology companies that are invading and overturning established industry structures. Continue reading

What Are the Emerging Noninvasive Biomarkers in NASH?

Novel biomarkers represent a promising means to improve diagnosis of nonalcoholic steatohepatitis (NASH). Currently, a definitive diagnosis requires a liver biopsy, a surgical Covance NASH Liver Disease Blogprocedure with many limitations. There are a variety of biomarkers that can assess liver status, but they do not always distinguish between patients with NASH and those with other disorders. Advanced imaging techniques, while useful for evaluating some liver features, can be impractical and costly.

The ultimate goal is to find noninvasive biomarkers that clearly show if the patient has steatohepatitis or liver fibrosis associated with nonalcoholic fatty liver disease (NAFLD). Recent studies suggest that nuclear magnetic resonance (NMR) spectroscopy, microRNA tests and genotyping may prove to be useful tools. Incorporating additional biomarkers into clinical trials can give biopharmaceutical companies an early indication of whether a compound is efficacious — and provide the confidence to move forward to the next phase of clinical testing. Continue reading

The Shift Toward More-Personalized Medicine in China

image of a world map with pills placed on top. Topic: Personalized Medicine in China

Chinese biopharmaceuticals are expanding development beyond generics to focus on producing more personalized medicine, novel therapies, biomarkers and companion diagnostics. Steven Anderson, PhD, chief scientific officer at Covance, recently discussed his thoughts on biomarkers and precision medicine in China’s drug development and translational medicine landscape.

An emerging focus on biomarkers

“Efficacy of a drug therapy can vary widely and adverse effects can be common, but these parameters are not easily predicted,” explained Anderson. “That’s why biomarker-based, targeted treatments can guide therapy decision-making and better identify those individuals most likely to benefit.”

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Advancing Rare Disease Drug Development: Four Key Considerations for Market Access

Our industry is witnessing increasing growth in the rare disease market, thanks to financial and regulatory incentives to develop orphan drugs. This has been good news for Covance Rare Disease Drug Development Market Access Blog. Photo of a man holding a pill. both sponsors and patients, but the fact remains that rare disease trials are inherently challenging to run. In addition, completing a complex study and reaching regulatory approval does not necessarily translate to market success.

John D. McDermott, Jr., Vice President of Covance Market Access Services, recently shared his insights on the market access challenges in rare disease drug development and discussed key considerations for sponsors and stakeholders.

  1. Provide early education about the disease

Even though rare diseases as a whole are getting more attention, sponsors cannot assume that their potential payers know much about the particular condition they are targeting and its importance to patients. Continue reading

How to Navigate Pre-Clinical Issues in NASH Development

The pre-clinical phase of development for non-alcoholic steatohepatitis (NASH) drugs faces many challenges. Biopharmaceutical companies have several options for rodent Pre-Clinical Issues in NASH Development - Covance Blog. Image of molecules.models, but they must weigh factors such as customization versus speed before deciding on the best approach.

Some of the challenges include:

  • Diet: There is no prevailing wisdom in the field suggesting that one induction diet is superior to another.
  • Duration of disease induction: Depending on the type of diet, it will take 6 to 9 months for models to exhibit NASH-like features.
  • Translation: Novel biomarkers used in human clinical trials need further validation in rodent models.

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Accelerating Rare Disease and Orphan Drug Development: Opportunities for Biomarkers, Diagnostics & Patient Engagement

Rare diseases affect more than 350 million people worldwide but patients often face limited Covance Labs Rare and Orphan Drug Development. Photo of DNA Strandoptions for approved therapies. As a result, many patients have joined advocacy groups first and foremost to connect with others struggling with their rare disease, but also to promote research, unite multiple stakeholders and stimulate new possibilities in the therapeutic pipeline. Research and orphan drug development efforts are starting to follow suit by increasingly incorporating patients’ needs and examining potential outcomes.

Addressing clinical challenges in rare disease and orphan drug development

With government-driven financial incentives, advances in genomic technology to identify promising targets for drug development, increasingly organized patient communities, and above average regulatory approval rates, drug developers are motivated to address rare diseases. While these trends are promising for patients with urgent unmet medical needs, orphan drug development still faces many challenges. The very nature of rare disease places pressure on identifying and accessing a sufficient number of patients for clinical trials.

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Capitalizing on Global Drug Development Opportunities from China

The Chinese pharmaceutical market continues to grow steadily, but drug developers in Covance China Drug DevelopmentChina face similar challenges as their global counterparts: Development times are increasing and success rates are declining. Xiaoning Guo, PhD, PMP, clinical development program director of Covance Asia Pacific, recently discussed potential strategies to improve investment returns and accelerate global development.

An evolving landscape

“Regulations in China have changed a lot with new policies and guidelines as the China Food and Drug Administration (CFDA) is strongly promoting innovation,” said Guo. “Domestic pharma companies in China can benefit from revised IND review timelines and approval processes to get their clinical trials in Phases I through III approved simultaneously.”

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