Early Access Programs – The Definitive Test for Guiding Pharma’s Commercialization Strategy

Commercializing a new medicine is a complex undertaking, with various elements that need to be planned for and understood prior to launch. The success of a launch can vary greatly between assets depending on how a company manages this. The majority of launches have their longer-term fate determined in the first six months of their commercial life.

After that period of time, it is very difficult to make up the ground lost before. Early access programs not only help to create early engagement with the medical community enabling more successful launches but also provide an opportunity for the pharmaceutical company to build pre-launch experience in various markets to help them to make informed decisions about their organizational structure (commercial strategy (including price)).

This enables companies to identify which markets to prioritize or maybe decide not to launch in at all. Essentially early access programs allow pharma to ‘test the waters’ to understand real-world demand and facilitate decision making based on factual information, with the added benefits of being able to understand patient pathways, engage with payers, develop prescriber relationships, collect outcomes data, generate revenue and demonstrate demand / willingness to pay for their product.

From a patient perspective, early access programs provide access to promising medicines before launch (if they are not participating in the clinical trial), which would have otherwise not been available to them for as long as three to four years, following the first global approval of the medicine (e.g. US Food and Drug Administration (FDA) or European Medicines Agency (EMA)). Providing patients with access to these medicines can have a dramatic positive effect on a patient’s quality of life, and in some cases, can extend or even save a patient’s life.

During the webinar, participants will get expert perspectives on how early access programs are a critical element to any commercial planning process. They will discuss best practices on how considering early access programs during clinical phases II and III can help achieve success and help define strategy and objectives, maximize benefit for patients/company and strengthen launch trajectory/commercial proposition.

Register for this webinar today to discover how early access programs can shape successful pharmaceutical commercialization.

Speakers

Paul Stanton, Senior Director, Global Strategy, Early Access, Inceptua Group

Paul Stanton has spent 18 years working in pharma, both on the manufacturer and provider side in strategic and commercial roles, with the last five years exclusively focussed on early and managed access. Past companies include Roche, Eli Lilly, IQVIA and Phoenix Group.

In the early access space, Paul has worked on programs of all kinds, ranging from free-of-charge, donations and for-charge, in regions all over the world, for products in rare and genetic diseases, oncology and infectious diseases. He is based in London, UK.

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Sebastian Stachowiak, CEO, ICE BIOPHARMA

Sebastian Stachowiak has over 20 years’ experience working in large pharma and biotechs and is currently the CEO of ICE BIOPHARMA who in-licenses and commercializes innovative medicines in Europe.

Previously, Sebastian was Head of Europe & Middle East for Global Blood Therapeutics (GBT) and VP Commercial Operations International for TESARO. Sebastian splits his time between the UK and Switzerland and is passionate about supporting children with debilitating conditions.

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