Market access of Advanced therapy medicinal products (ATMPs) is key to make innovative and potential curing therapies available for patients. Pricing and reimbursement are organized at the national level, though international initiatives are fundamental, essentially in the context of complex treatments covering ATMPs. The webinar will explains the main market access principles for medicinal products and innovative payment models for ATMP market access.
dir Pharmaceutical Policy
Francis Arickx is the head of the directorate Reimbursement of Medicines and Pharmaceutical Policy within the Health Care Department at the National Institute for Health and Disability Insurance (NIHDI RIZIV/INAMI) in Belgium where he manages the departments responsible for administrative and scientific assessment and appraisal of reimbursement claims for medicines, orphan drugs, medical nutrition,…
Francis Arickx is the former secretary general for the Commission for Reimbursement of Medicines and acts as representative/expert for the Institute and Belgium on a number of national and European platforms (NM CAPR, MEDEV, EUnetHTA,..). He is one of the country coordinators for the BeNeLuxA Initiative (www.beneluxa.org), and today the overall coordinator of the Initiative.
Prof. dr. Isabelle Huys
Prof. dr. Isabelle Huys is professor Regulatory Sciences at the University of Leuven (Belgium). She is pharmacist by training and with PhD in pharmaceutical sciences (toxicology) and further specialisation in regulations on medicinal product development at KU Leuven, including intellectual property rights (IPRs).
Her research focusses on access to medicines and therapies. The research program studies diverse legal and regulatory aspects along the continuum of a medicinal product life cycle, from medicinal product discovery, development, approval, reimbursement and market adoption. The research program focuses on all types of medicinal products (small molecules, biologicals, advanced therapy medicinal products (ATMPs)) and diagnostics. Topics include biobanking and access to (human) biological samples and data, the use of real-world data/evidence (RWE) in medicinal product development and market access, repurposing of medicines for other (e.g. cancer) indications, patient preferences in medicinal product development and evaluation, precision medicine and companion diagnostics, off-patent strategies of biological products and market access of biosimilar and drug shortages.
Isabelle Huys actively participated in several collaborative projects, bilateral university-industry, university-non-profit organisations, public-private partnerships of large scale (e.g. IMI, H2020, ERASMUS+, Marie-Curie ITN). Currently she is co-leading the IMI PREFER project, with 33 partners, focussing on patient preferences in medicinal product development and evaluation. She is also involved in other IMI projects: IMI CARE on corona therapeutics (Role I Huys: ELSI task), IMI ConcePTION on use of medicines during pregnancy and lactation (Role I Huys: stakeholder engagement and regulatory interaction)..
Isabelle Huys supervises PhD projects in this research program and publishes the research in diverse journals.
This webinar is brought to you by the ADVANCE Project, co-funded by the Erasmus + Programme of the European Union.
ADVANCE IN A NUTSHELL
ADVANCE is a 30-month EU training project, supported by Erasmus Plus with the objective to develop a 3-stage blended learning programme to support early-career biomedical scientists in developing currently missing scientific knowledge, transversal skills and competences to meet the key challenge areas existing in the ATMP development cycle.
The “next generation of ATMP developers” – i.e. early-career biomedical academics (PhDs, Postdocs), including doctors in training, clinician-scientists and SME-based professionals, who are considered to be an important component of the labour market and the critical intermediaries of the ATMP development pipeline – are the core target group for the three-stage blended learning programme foreseen by ADVANCE.