Early access for patients with unmet medical needs

Presented by

David Fisher, Paul Ledger, Mark Corbett

About this talk

Many patients around the world struggle to gain access to new therapeutic options. There may be no clinical trials in close proximity or the eligibility requirements are too limiting. In some cases the wait for approval may simply be too long. In such cases a Global Access Program can be an effective way to ensure the medicine reaches the patient. These programs (also referred to as expanded access, compassionate use and named patient programs) follow ethical and regulatory-compliant mechanisms, enabling patients to gain access to medicines that are in clinical development, are unlicensed in a specific market but licensed elsewhere, or are still going through the marketing authorization application (MAA) process. These programs afford companies the opportunity to meet ethical obligations, offering physicians and patients potentially life-saving or life-extending treatment options, ahead of commercial availability. In addition, Global Access Programs can assist in helping foster positive relationships with key opinion leaders and treatment centres, as well as providing an opportunity to gather limited, yet valuable, information about the use of a drug in a wider population. This free webinar will provide an overview of Global Access Programs and the current regulatory environment, describe best practices for implementation and present a case study detailing use of such programs to help patients with unmet medical needs. Please join us on December 4, 3pm Europe, 2pm UK time. Confirmed speakers: - Paul Ledger, Head of Commercialisation for EMAP Rare Disease for GSK - Mark Corbett, Senior Vice President, Clinigen Global Access Programs (GAP)

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