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Early access for patients with unmet medical needs

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 webinar provides 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.


Speaker Biographies:


Paul Ledger

Paul Ledger has held a number of mainly commercial roles within the UK and Global Healthcare sectors over a period of seventeen years. He is currently the Head of Commercialisation for EMAP Rare Disease for GSK. He has held previous commercial and operational roles with Alexion Pharma in Europe, Europe Area Markets, Emerging Markets and recently, before moving to GSK was the General Manager for MEA. He worked within early market development for Medtronic Neuromodulation across EMEA. He previously worked within primary and secondary sales with Eli Lilly UK. Paul studied holds a Bachelor of Science in Sports Science & Exercise Physiology as well as a Diploma in Engineering.


Mark Corbett

Mark Corbett joined Clinigen in mid 2010, as senior vice president Clinigen Global Access Programs. He has overall responsibility for Clinigen’s Global Access Programs (GAP) Division which specialises in the consultancy, development, set up and implementation of access programs on behalf of the Biotech and Pharmaceutical industries.  Mark has gained extensive specialist knowledge and operational expertise in implementation of more than 120 Global Early Access / Named Patient Programs for a variety of clients ranging from niche biotech to global pharmaceutical companies.

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