Parallel session 10:00 - 12:00

Complex drug products: new insights in development, production & characterization

Recent developments in innovative technologies like Advanced Therapy Medicinal Products (ATMPs) and Nano-medicines provide new opportunities to address the increasing demands of an aging population, as well as for diseases with high unmet medical needs.

Despite recent innovations and considerable research and development efforts there is clear mismatch between these research and development efforts and the number of approved products in the European Union. The road from development to approval poses many challenges for scientists, developers and regulators and asks for collaborative opportunities to meet those challenges, which we will discuss in this session.

Speakers

How to adapt to new technologies and ATMP’s: a CMO’s view
Alexander Willemse

PhD - BioConnection

Assuring quality of non-biological complex drugs (NBCDs): EDQM and the European Pharmacopoeia
Gerrit Borchard
Prof - Chair of the NBC working party at the European Directorate for the Quality of Medicines & Health Care (EDQM)

Development of a personalised, cellular product in hemato-oncology; risks and opportunities
Jeroen Rovers
PhD, MD - CMO Kiadis Pharma

How to bring ATMPs to the patient: a funders perspective
Ineke Slaper-Cortenbach
Programme Manager ‘Translational Research and International Programs' at ZonMw

 

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