2012 - Venice - Italy

PAGE 2012: Other Modelling Applications
Georgios Vlasakakis

Landscape on technical and conceptual requirements in Drug/Disease Modelling & Simulation

G. Vlasakakis (1), E. Comets (2), A. Drescher (6), I. Gueorguieva (3), P. Magni (4), N. Terranova (4), O. della Pasqua (1), E.C. de Lange (5), C. Kloft (6)

(1) GSK, Clinical Pharmacology Modelling & Simulation, Tech. & Dev, Stockley Park, UK; (2) INSERM, UMR 738 Univ Paris Diderot, Sorbonne Paris Cité, Paris, France; (3) Lilly UK, Global PK/PD Department, Erl Wood Manor, Windlesham, Surrey, UK; (4) Dipartimento di Ingegneria Industriale e dell’Informazione, Università degli Studi di Pavia, Pavia, Italy; (5) Leiden University, Leiden, The Netherlands; (6) Freie Universitaet Berlin, Dept. of Clinical Pharmacy and Biochemistry, Berlin, Germany

Objectives: A survey was performed between Nov 2011 and Jan 2012 among the Drug/Disease Modelling and Simulation (DD M&S) community to better understand the technical and theoretical requirements for DD M&S.

Methods: The target audience of the survey was: members of the IMI DDMoRe (Drug Disease Model Resources) project consortium, members of their institutions and companies, colleagues in the DD M&S community, regulators. A mailing list was created based on the input from all WP9 members. The survey was designed as an online questionnaire using the SurveyMonkey system and defined four target groups, namely those who (i) develop models/perform DD M&S activities (‘modellers'), (ii) apply/interpret results from DD M&S or produce data without hands-on involvement (‘appliers'), (iii) review DD M&S results (‘reviewers'), (iv) are involved with all the above (‘all'). Questions in all four groups (n=22-29) included free text, multiple choice questions, and scaling questions with weights assigned to the answers.  Descriptive statistics and graphs were used to tabulate the answers.

Results: After database cleaning, 137 responses were available from academia (54%), pharmaceutical industry (43%) and SME (3%). When asked to define their primary DD M&S activity, almost 2/3 identified themselves as ‘modellers', 1/4 as ‘all' and the remaining as ‘reviewers' or ‘appliers'. Regarding the level of experience 64% of the responders work at senior positions and 36 % at training positions (PhD, post-docs).

The survey included 4 sections: perceived impact and communication of DD M&S within organisations, current DD M&S concepts, methodologies and tools used, perceived gaps in the environment and personal challenges. The impact of DD M&S is perceived as large throughout the drug development pipeline, being used from basic understanding of drug features to decision making both for drug approval and therapeutic use. Lack of training, time and resources was often cited as a difficulty for applying DD M&S approaches, and a large majority (70%) of responders, although often already trained in several aspects of the DD M&S, would participate in further training courses if given the chance.

Conclusions: The survey provided a landscape of impact, weaknesses and requirements in DD M&S. It will be used to develop a competence framework for future training and education curricula, which will go beyond technical and statistical competences; understanding of the clinical implications of modelling assumptions as well as communication skills are urgently needed.




Reference: PAGE 21 (2012) Abstr 2449 [www.page-meeting.org/?abstract=2449]
Poster: Other Modelling Applications
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