2016 - Lisboa - Portugal

PAGE 2016: Methodology - Other topics
C.J. Musante

The International Society of Pharmacometrics’ Special Interest Group on Quantitative Systems Pharmacology: Developing a community and advancing a field

CJ Musante (1), S Ramanujan (2), M Zager (3), V Damian (4), M Weis (5), J Woodhead (6)

(1) Pfizer Inc, Cambridge MA USA, (2) Genentech Inc, South San Francisco CA USA (3), Janssen Pharmaceutical Companies of Johnson & Johnson, San Diego CA USA, (4) GlaxoSmithKline, King of Prussia PA USA (5) Rosa & Co, San Carlos CA USA, (6) DILIsym Services, Inc, Research Triangle Park NC USA

Objectives: Quantitative Systems Pharmacology (QSP) has been described as the “quantitative analysis of the dynamic interactions between drug(s) and a biological system that aims to understand the behavior of the system as a whole…” [1]. The field, which has emerged at the interface of engineering, pharmaceutical sciences and systems biology, is realizing increased adoption in pharmaceutical research and development with the hope of improving the efficiency of getting new medicines to patients in need.  With the emergence of this field, there is greater need for sharing and dissemination of learnings and coordination of efforts. To this end, the International Society of Pharmacometrics (ISoP) initiated a Special Interest Group on QSP (QSP SIG) with aims to: advance the science of QSP by fostering a community for the exchange of ideas and knowledge; promote the application of QSP in drug development and regulatory decision-making; develop and maintain information resources for its members, including establishment of “best practices”, and; facilitate communication and advance knowledge through sponsored sessions at professional meetings, white papers, discussion groups, and publications.  

Methods:  The SIG has initiated numerous efforts to support its mission. Multiple programming sessions were contributed and held at professional conferences. Member-driven working groups have been formed that focus on specific topics of interest, including: GPS for QSP; QSP Workflows and Methodologies; Software and Tools; The Interface of QSP and Pharmacometrics; and Advancing the Role of QSP in Regulatory Interactions. The SIG is actively working with QSP-related communities in ASCPT, AAPS, and FIP to ensure consistent and cooperative efforts.

Results: In its first year, the SIG has grown to over 100 members, with a leadership team and steering committee that includes industry, regulatory, nonprofit, and academic representatives from the United States, Europe, and Asia. Tutorials and white papers from these working groups are already being developed and shared on our website.

Conclusions: The ISoP QSP SIG is actively promoting the sharing and dissemination of QSP-related content to advance this field and its continued application in pharmaceutical research & development. We welcome participation, collaboration, and contributions from all interested parties and organizations.

[1] van der Graaf PH, Benson N. Systems pharmacology: bridging systems biology and pharmacokinetics-pharmacodynamics (PKPD) in drug discovery and development. Pharm Res. 2011 Jul;28(7):1460-4. doi: 10.1007/s11095-011-0467-9. Epub 2011 May 11.

Reference: PAGE 25 (2016) Abstr 5801 [www.page-meeting.org/?abstract=5801]
Poster: Methodology - Other topics
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