Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT)

TY - JOUR

T1 - Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT)

AU - Aksu, Buket

AU - De Beer, Thomas

AU - Folestad, Staffan

AU - Ketolainen, Jarkko

AU - Lindén, Hans

AU - Lopes, Joao Almeida

AU - de Matas, Marcel

AU - Oostra, Wim

AU - Rantanen, Jukka

AU - Weimer, Marco

N1 - Copyright © 2012 Elsevier B.V. All rights reserved.

PY - 2012/9/29

Y1 - 2012/9/29

N2 - 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).

AB - 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).

KW - Biomedical Research

KW - Biopharmaceutics

KW - Drug Design

KW - Drug Industry

KW - European Union

KW - Individualized Medicine

KW - Quality Control

KW - Risk Assessment

KW - Technology, Pharmaceutical

KW - Former Faculty of Pharmaceutical Sciences

U2 - 10.1016/j.ejps.2012.06.009

DO - 10.1016/j.ejps.2012.06.009

M3 - Journal article

C2 - 22749874

SN - 0928-0987

VL - 47

SP - 402

EP - 405

JO - Norvegica Pharmaceutica Acta

JF - Norvegica Pharmaceutica Acta

IS - 2

ER -