SOURCE: Xtalks


November 20, 2017 07:00 ET

Improving Regulatory and Operational Performance in Orphan Drug Development, a New Webinar Presented by Premier Research and Hosted by Xtalks

TORONTO, ON--(Marketwired - November 20, 2017) - Today more than ever, regulatory bodies are providing a progressive platform for rare disease drug development. Extensions to existing regulations and incentives and attempts to reduce orphan drug designation applications provide a collaborative environment for companies developing orphan drugs.

Understanding the regulatory landscape in orphan drug development -- specifically the various pathways, incentives, and engagement opportunities -- with regulators can help optimize the process and bring therapies to market faster. The U.S. Food and Drug Administration is introducing new review cycles and initiatives to aid researchers, and regulators in other countries will likely follow with similar measures to promote orphan drug development.

Sponsors stand to gain by seeking FDA engagement early and often, performing relevant studies in rare populations and using federal grants and other available programs. All of these measures can increase the value of their companies and contribute to a growing database within the rare disease space.

People attending this webinar will better understand:

  • Changes in the regulatory landscape that provide a favorable environment for development of orphan drugs
  • The need for early regulatory engagement when developing and operationalizing plans for drug development
  • Operationalizing clinical trials within rare disease to support orphan drug designation, including:
    • Patient identification, engagement, and retention
    • Investigative site selection and site team engagement
  • Involving patient groups, obtaining increased funding, and taking advantage of significant government reforms that are focusing much-needed attention on treating rare diseases

Join the live session on Tuesday, December 5, 2017 with Premier Research's experts Kimberly Glen, Executive Director of Rare Diseases, and Nach Davé, Vice President of Global Regulatory Affairs.

To learn more about this complimentary event visit: Improving Regulatory and Operational Performance in Orphan Drug Development.

About Premier Research

Premier Research is a leading clinical development service provider that helps highly innovative biotech, specialty pharma, and medical device companies transform breakthrough ideas into reality. 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, dermatology, medical device, neuroscience, oncology, pediatrics, and rare disease. Premier Research operates in 84 countries and employs 1,100 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. They are focused on smart study design for advanced medicines that allow life-changing treatments.

To learn more about Premier Research visit:


Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device 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.

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