1. confidential ISO TC 229 - JWG1/PG12, TR 17302 1L.Ladic2012-05-10 ISO TC 229 – Nanotechnologies JWG1/PG12 TR 17302 : Framework for Identifying Vocabulary Development for Nanotechnology Applications in Human Healthcare Proposal for a Path Forward May 10, 2012

2. confidential ISO TC 229 - JWG1/PG12, TR 17302 2L.Ladic2012-05-10 Outline  Objective  Proposed Segmentation  Team Structure  Phased Approach  Next Steps

3. confidential ISO TC 229 - JWG1/PG12, TR 17302 3L.Ladic2012-05-10 Objective  This project aims to produce a Technical Report (TR) that will provide a possible taxonomic framework for nanotechnology applications in human healthcare ("nanomedicine").  The framework will identify the basic related categories of nanotechnology applications, as well as the core concepts within these categories.  It will also identify the intended touch points of these technologies within clinical workflow (largely stemming from related preclinical/translational developments).  From the core concepts, a list of core terms to be defined will be identified.  Definitions for these terms is beyond the scope of this TR, but will serve as input to one or more follow up ISO projects.

4. confidential ISO TC 229 - JWG1/PG12, TR 17302 4L.Ladic2012-05-10 Proposed Segmentation for Exploring Nanomedicine 1.Pre-clinical / Translational  Early, fundamental nanotechnology developments in academia, life science, biopharma that could have an eventual impact on, or application within, one or more of the clinical value chain segments (e.g. technologies used in the understanding of basic life processes); technologies that support the development of products that will be used in a clinical setting (e.g. pre-clinical biopharma) 2.Prediction, Prevention & Monitoring (combined due to similarities)  Nanotechnologies that are used to predict, or prevent disease; monitoring of disease after a therapy (treatment efficacy/side effects, recurrence); disease screening / surveillance 3.Diagnosis  Nanotechnologies that are used for in vitro and in vivo diagnostics (i.e. detection, classification, grading, etc. of disease) 4.Treatment  Nanotechnologies that are associated with therapy for disease; includes drugs/medicines (e.g. biopharmaceuticals) and surgery (e.g. implantable materials/devices or surgical aids), or alternative therapies (e.g. stem cells) Pre-clinical / Translational Prediction / Prevention DiagnosisMonitoringTreatment 1 2a 3 4 2b Clinical Value Chain

5. confidential ISO TC 229 - JWG1/PG12, TR 17302 5L.Ladic2012-05-10 Proposed Segmentation for Exploring Nanomedicine Preclinical / Translational Prediction / Prevention DiagnosisMonitoringTreatment 1 2a 3 4 2b

6. confidential ISO TC 229 - JWG1/PG12, TR 17302 6L.Ladic2012-05-10 Team Structure  Form sub-teams:  One sub-team per segment = 4 sub-teams  Participants:  Sub-team lead  3-4 (?) active sub-team members (to be based on # of interested participants identified)  Each team to work semi-autonomously  Set up own meetings  Conduct own investigation into assigned segment  Overall team integration  All sub-teams to come together on a regular basis to discuss overall progress, synergies  Segments are not mutually exclusive and will overlap  Pre-clinical / Translational sub-team may identify a broad spectrum of technologies that are relevant to multiple segments  Some technologies will have applications in more than one segment, but at different clinical touch-points  Convergence areas: e.g. companion Dx, theranostics (combination/integration of Dx/Rx)

7. confidential ISO TC 229 - JWG1/PG12, TR 17302 7L.Ladic2012-05-10 Phased Approach  Common approach for all sub-teams (i.e. for each segment) – Phases 1 & 2 Phase 1:  Information gathering - identify and consolidate information from a variety of appropriate sources  Identify relevant nanotechnologies  Identification of application areas – high level taxonomy within each segment  Identify trends, drivers Phase 2:  Within each application area, develop use cases: identify the touch-point(s) for nanotechnology within the associated clinical workflow, explaining how it is being used (i.e. input, output and context of use) Phase 3 (Sub-Team Leads, Project Lead)  Consolidation of results from teams into a final report

8. confidential ISO TC 229 - JWG1/PG12, TR 17302 8L.Ladic2012-05-10 Next Steps  Assign resources to sub-teams  Send out an email to the overall team mailing list  Notify participants about proposed sub-team structure  Give participants the opportunity to list first, second choices for sub-teams – try to accommodate this if possible  Finalize selection of sub-team leads  Determine if critical mass based on responses  (Re-)Establish regular communication plan within overall team  Use a standardized reporting format for each sub-team  Project lead to work with sub-team leads to define overall project plan, including timeline for main phases with milestones  Sub-team leads to develop own project plans (including a communication plan within their sub-team) within the context of the overall project plan