Early Access Programs in Europe: ‘A Friend or a Foe’

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.

Speakers

Akshay Kumar, Partner, Partner4Access

Akshay Kumar is a Partner at Partners4Access. He has 13+ years of experience helping pharmaceutical and biotech companies develop market access & pricing solutions – which are aligned to their broader commercial, organizational and environmental context. These solutions could be at the product, process and/or capability level. Besides market access, Kumar also has supported pharmaceutical companies in allied commercial areas such as – epidemiology, opportunity assessments, product positioning, product performance tracking, customer insights, and organizational design.

Prior to joining Partners4Access, Kumar worked at Huron Consulting and ZS Associates, including secondments at 3 large Pharmaceutical companies. During this period, he was involved in supporting over 15+ orphan and specialty drugs with their EAP strategy and implementation across Europe.

Kumar has a D.Phil in materials science and master’s degrees in business engineering and business management.

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Luke Robinson, Head of EU Marketing and UK & Nordics GM, BioCryst Pharmaceuticals

Luke Robinson is a successful and highly effective commercial business leader with over 20 years of experience gained across the pharmaceutical, biotech and healthcare sectors in Specialty, Oncology and Rare Diseases. He is accomplished at delivering commercial goals for brands at Country, European and Global level.

Luke Robinson is currently the Head of EU marketing at BioCryst Pharmaceuticals Inc. He has previously worked at Akcea Therapeutics, Novartis Oncology, GSK, Pfizer and UCB in a career spanning 27 years. Over this period, Luke has been involved with setting-up Early Access Programs for a number of specialty and orphan drugs across a range of European major markets.

Robinson also has significant experience in sales & marketing, organizational redesign, strategy development, operational leadership and implementation, customer strategy, product launch, lifecycle management, commercial development of products, management of revenue and expenses/P&L, sales and marketing leadership, leading and developing diverse, cross-cultural and functional teams to deliver business goals.

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