Webinar
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WEBINAR
As a drug developer you may wonder if you have a portfolio product or development candidate that qualifies as an orphan drug and thus provides options unique to orphan drug development.

There are approximately 7000 known rare diseases and more expected to be identified in the future and your drug may be effective against a rare disease. A number of these orphan diseases are well known, and the epidemiology well characterized, however, there are still numerous rare diseases still in need of an effective treatment.

This webinar will provide an overview of Orphan Drug Designation and the benefits from both a development and commercial viewpoint. It will explore the benefits of early planning and early engagement with the FDA.

A panel of CATO SMS experts will review the key issues encountered during the development of a product receiving Orphan Designation and explore what challenges and options for sponsors may be seen in the coming months.
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CATO SMS is a full-service clinical and regulatory contract research organization (CRO), specializing in complex areas such as (immuno-) oncology, advanced therapeutics and orphan diseases. We offer regulatory consulting and drug development affairs in addition to clinical trial management services, leveraging the experience and expertise in all disciplines to the full benefit of your company. We are committed to supporting small and mid-sized biotech, top-tier pharmaceutical companies and investigator groups from strategy to approval, from phase I to IV. CATO SMS employs over 320 dedicated professionals with offices and operations in over 25 countries around the globe including the United States (US), Canada, Europe, Israel and South Africa. Offices are strategically located close to the European Medicines Agency (EMA) in Amsterdam, the Netherlands, and the Food and Drug Administration (FDA) in Washington, US.
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