title: Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT).
abstract: Substantial changes in Pharmaceutical R&D strategy are required to address existing issues of low productivity, imminent patent expirations and pressures on pricing. Moves towards personalized healthcare and increasing diversity in the nature of portfolios including the rise of biopharmaceuticals however have the potential to provide considerable challenges to the establishment of cost effective and robust supply chains. To guarantee product quality and surety of supply for essential medicines it is necessary that manufacturing science keeps pace with advances in pharmaceutical R&D. In this position paper, the EUFEPS QbD and PAT Sciences network make recommendations that European industry, academia and health agencies focus attention on delivering step changes in science and technology in a number of key themes. These subject areas, all underpinned by the sciences allied to QbD and PAT, include product design and development for personalized healthcare, continuous-processing in pharmaceutical product manufacture, quantitative quality risk assessment for pharmaceutical development including life cycle management and the downstream processing of biopharmaceutical products. Plans are being established to gain commitment for inclusion of these themes into future funding priorities for the Innovative Medicines Initiative (IMI).
authors: Santa Farma Pharmaceuticals, Sisli, Istanbul, Turkey.
authors: Buket
authors: B
authors: Aksu
authors: Thomas
authors: T
authors: De Beer
authors: Staffan
authors: S
authors: Folestad
authors: Jarkko
authors: J
authors: Ketolainen
authors: Hans
authors: H
authors: Lindén
authors: Joao Almeida
authors: JA
authors: Lopes
authors: Marcel
authors: M
authors: de Matas
authors: Wim
authors: W
authors: Oostra
authors: Jukka
authors: J
authors: Rantanen
authors: Marco
authors: M
authors: Weimer
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000592:standards; D001702:Biopharmaceutics / Q000191:economics / Q000592:standards; D015195:Drug Design; D004345:Drug Industry / Q000191:economics / Q000592:standards; D005062:European Union; D057285:Precision Medicine; D011786:Quality Control; D018570:Risk Assessment; D013678:Technology, Pharmaceutical / Q000191:economics / Q000592:standards