SOURCE: Xtalks

Xtalks Webinars

May 19, 2016 06:30 ET

No Opportunity Unturned: Optimizing Orphan Drug Development, New Webinar Presented by Premier Research and Hosted by Xtalks

TORONTO, ON--(Marketwired - May 19, 2016) - During a webinar on Wednesday, June 1, 2016 at 11am EDT (4pm BST/UK), an expert panel from Premier Research will discuss current regulation and how sponsors optimize their orphan drug development process.

Regulations supporting orphan drug research have been evolving for more than 20 years, providing incentives and guidance for development of potentially promising drugs to treat rare indications. More recently, with global attention and advocacy focused on improving treatments in these areas of unmet need, regulators and legislators have sought meaningful changes in the design and execution of rare disease drug development programs.

Understanding existing resources, financial aid, and incentives -- and how to access them -- is important for any orphan product developer. This webinar will describe support offerings available through global regulatory agencies and examine pending initiatives affecting orphan drug clinical development. These include:

  • Relevant guidance documents such as natural history studies and biomarkers.
  • Expedited review pathways such as FDA breakthrough therapy and EMA accelerated assessment designations.
  • Engaging regulators to advance development of priority medicines.
  • What lawmakers are discussing.

The session includes a live Q&A with the audience. For more information about this event or to register, visit:

About Premier Research

Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs, with a special focus on addressing unmet needs in areas such as analgesia, CNS, rare diseases, medical device and diagnostics, oncology, and pediatric research. Premier Research operates in 84 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.

To learn more about Premier Research visit:

About Xtalks

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit
For information about hosting a webinar visit

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