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.
September 17, 2020
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’ve 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.
Join Sophie Schmitz, Managing Partner, Partners4Access, Akshay Kumar, Partner, Partner4Access and Luke Robinson, Head of EU Marketing and UK & Nordics GM, BioCryst Pharmaceuticals in a live webinar on Wednesday, September 30, 2020 at 11am EDT (4pm BST/UK).
For more information or to register for this event, visit Early Access Programs in Europe: ‘A Friend or a Foe’.
Partners4Access are experts in orphan drug, cell and gene therapy access, partnering with the biotechnology industry to support launches worldwide. Our services focus on five key areas: orphan drugs pricing and market access strategy; bespoke access roadmap; rare disease foresights; evidence mitigation solutions; access team excellence.
As one of the only consultancies with comprehensive experience in cell and gene therapies, P4A are excellently placed to help clients successfully achieve access. Through various media initiatives, P4A are able to inform and shape the conversation around orphan drugs.
The team at P4A believe in striking an equilibrium in the rare disease world. That means helping drive access to the most appropriate treatments for patients and physicians, a fair return on investment for manufacturers at an affordable proposition for payers.
For more information, please visit P4A’s website: http://www.partners4access.com or email at firstname.lastname@example.org.
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