ARGOS Global Conference: Parallel Session 1 – VPH May 11 th, 2011 Budapest

US Developments New Interagency Multi-Scale Modeling Call Predictive Multiscale Models for Biomedical, Biological, Behavioral, Environmental and Clinical Research (Interagency U01) html New NIH Center for Advancing Translational Sciences Continued growth of interest and activity at the FDA Expressions of interest from medical device and pharmaceutical industry

US Input to Policy Brief  Give more emphasis to industry/commercial application of VPH models for pharmaceutical and medical device development Drafted a new subsection between 9.2 (Biomedical Research) and 9.3 (Clinical Practice) on “Drug and Device Development” (With input on PK/PD from Dan Beard)  In this respect, the key US government agency is the Food and Drug Administration, which could play a useful role possibly with NIST  Interest in Minimal Information Standards and Quality Assurance/Validation Protocols Add a paragraph under section 8.0 Lessons Learned and cross-reference Semantic Interoperability report

VPH Breakout Summary  There was support for the current draft; we discussed topics to add rather than subtract  We recognized the importance of the research and clinical communities as stakeholders, and recommended increasing the prominence of the importance of the proposed infrastructure to the biomedical device and pharmaceutical industries  Strengthen the ability of the proposed infrastructure to serve as an incubator for innovation without prescribing a specific business model (while citing possible examples)  Some continued discussion of terminology  Expanded discussion of role of regulatory agencies, such as FDA, EMA and non-medical agencies such as EPA, EEA, NIST

Industry/Regulatory Agency Perspectives  Industry is interested in taking advantage of models to give them a competitive advantage, but are more reluctant to share them especially if a consequence is that it makes their numerical investigations reproducible  Regulatory agencies are very interested in taking advantage of standardized models to improve regulatory filings especially if a consequence is that it makes results in applications reproducible, but agencies are concerned about compromising industry competitiveness with additional regulatory mandates

Industry/Regulatory Agency Perspectives  This community identifies well with “Models” of human disease E.g. Gene-targeted mice  Tends to be emphasis on the model as a distinct entity: The policy brief should help to clarify the distinction between modeling research information resources and the set of digital artefacts and processes that define a specific validated model instance (i.e. workflow).  Major concern is “validation” or more broadly “quality assurance”

Terminology Europe:  Virtual Physiological Human (VPH)  Infostructure US:  Multi-Scale Modeling (MSM); Systems Biology and Bioengineering  Cyberinfrastructure (NSF) Neutral Generic Suggestion: “Human Physiological Modeling Infrastructure”