Expanded Access as a Key Component in the Development and Launch Process
Expanded access to medicines (pre-approval access, early access, compassionate use, named patient supply) is becoming more and more a part of the standard development and launch process of bringing a pharmaceutical product to market. The focus of pipelines on rare diseases and oncology, combined with a heightened awareness of access delays, is driving this change from Top 10 Pharma down to small biotechs. Done well, expanded access can help patients access your medicine sooner, can contribute to a positive corporate reputation, allow data to be captured from the first patients outside of a trial setting and gain early market share. Done badly, expanded access can damage goodwill amongst patients and physicians, cause supply chain and regulatory issues and can negatively impact your commercial roll-out and reputation.
This webinar will provide a current overview of the Expanded Access sector, including the major policy developments and shifts in approach, alongside a view into the future. It will review the evolution, from the initial rationale behind Expanded Access to how industry now views these activities as core aspects of bringing a product to market. It will cover how best to develop custom programs, tailored to the specifics of your product and your commercial/corporate plans. A detailed analysis of how to use Expanded Access globally to pave the way for successful commercial launch will be provided.
Opportunities, obstacles, politics and competitive interests relevant to Expanded Access will be highlighted. An overview of how and when to consider Expanded Access to a particular asset, based on criteria demonstrated to be central to successful programs will be presented.
This webinar will examine the state-of-the-art in Expanded Access, as showcased at the recent Expanded Access 3.0 Summit in Washington DC. The speakers, including global authority on Expanded Access, Paul Aliu (Novartis) will assess and contextualise the claims and developments in this space, providing insight and guidance for anyone with an interest in early patient access to medicines.
Presented by
Stuart Bell,
VP Consulting
Stuart Bell has more than 20 years of healthcare consulting experience, with a particular focus in unlicensed medicines and pre-approval access. Stuart is responsible for Inceptua’s consulting covering strategy and policy, real-world evidence, communications and market access. Prior to Inceptua, Stuart pioneered the development of global corporate strategies on pre-approval access and developed the first pre-approval-specific EDC for real-world data collection at Idis/Clinigen.
Paul Aliu,
Global Head Medical Governance, Novartis
Paul Aliu is in the cross-divisional Chief Medical Office at Novartis, with responsibility for the oversight, processes, training and systems for compassionate use/expanded access, and post-registration medical programs (e.g. Investigator initiated trials , research collaborations, non-interventional studies, registries and local Phase IV studies). He has almost 20 years’ experience in the Pharma industry across multiple therapeutic areas and functions. Prior to joining the pharma industry, he trained and practised as a clinical pharmacist. He also served as an industry representative on the WHO/Roll-Back Malaria (RBM) case management working group over many years, and has managed various partnerships (Public-Private & Private-Private).
Paul is a regular speaker at various forums and conferences on global health and pre-approval access, and has been engaged with various stakeholders (including regulators, academia and bioethicists) in advancing this space to better address patients’ needs.
