In the EU, Early Access Programs enable patients to access therapies pre-commercialisation for diseases with high unmet need. Known as Expanded Access Programs in the US, these initiatives allow for orphan drugs to be made available to patients with rare diseases before they have been formally approved by regulators. While these programs can offer numerous benefits to patients, physicians and manufacturers, decisions made during their set-up can have downstream implications for access and commercialisation potential after marketing authorisation.
For example, decisions made around the patient eligibility criteria to access an in-development drug via an Early Access Program sets stakeholder expectations around the unmet need within the disease. This in turn could influence payer decisions around the patient population that they are willing to reimburse when the product finally launches commercially. In this webinar, featured speakers will bring multi-disciplinary perspectives to the benefits and pitfalls of Early Access Programs in Europe.
Through a mix of case examples and direct experiences, they will highlight insights into decisions made during program design, set-up, and ongoing implementation. Importantly, they will recommend key considerations for manufacturers to aid the design of their Early Access Program Strategy and associated implementation plans for Europe to optimise success with future launches
This webinar will be of interest to those working to commercialize orphan drugs, cell and gene therapies developed by small, medium and large biotech/pharma companies, with relevant areas of interest including Market Access