Hot Topics Discussed in Covance Spring & Summer Webinars

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Going Virtual: Evolving Real World Evidence Study Design for
Speed, Flexibility and Lower Cost

Using a traditional clinical-site recruitment approach is no longer the only option in observational research. With the increased adoption of electronic informed consent methods by the FDA, it is now feasible to conduct real world evidence (RWE) studies using a virtual model that eliminates entirely the need for clinical sites.

Join us to learn how to lower cost and improve the efficacy of current, site-based RWE studies as well as:

  • The implications of electronic informed consent by the FDA
  • What is required to conduct a prospective virtual RWE study
  • How to use electronic data for a retrospective virtual RWE study

September 19, 2017 | 11 a.m. EDT | Register Now

 

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The Importance of Stakeholder Research in Rare Disease Drug Development

The approval of novel orphan drug designations continues to grow, while many existing rare disease therapies are receiving approval for expanded indications. With this increase Rare Disease Drug Developmentand broadening class of products, including some that target the same mutation or molecular defect, sponsors face new and significant market access challenges in securing reimbursement.

Leading manufacturers increasingly employ stakeholder research early in development to better identify the needs of patients and providers. This strategy can build in compelling asset value during development, help avoid pitfalls and better inform go/no-go decisions earlier to avoid costly development delays or even dead-ends. Continue reading

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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The Evolution of Open-Label Extensions and Rare Disease Studies

When running early development studies, sponsors must consider whether orCovance Employees in Lab Rare Disease Studies not to provide open-label, long-term treatment at the end of their randomized, placebo-controlled trial. In the past, sponsors have been hesitant to offer open-label extensions. But with our industry’s increasing focus on patient-centric care, sponsors are now weighing their options to incorporate more patient input into early development, especially when working with promising novel treatments in rare disease studies.

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