v. 7 Guidance to Breakout Session Chairs & Participants

Speaker Sessions 1 - 2 Set the Context for Breakout Discussions

• The goals and outputs of the NIST USMS process are provided pre-Session 1
  
  
• Session 1: Standards Needs from Public Private Partnerships
  Focus: Imaging as a Biomarker - Sources of Image Variability in the Measurement of Change Over Time
  
  • ADNI -- Alzheimer's Disease Neuroimaging Initiative
  • OAI -- Osteroarthritis Initiative
  • RIDER + Oncology Biomarkers -- Reference Image Database to Evaluate Response and Related Oncology Biomarker Initiatives
  • FDA -- Necessity for Standardization of Imaging in Multicenter Clinical Trials for Investigational Drugs and Biologics
    
    
• Session 2: Private Sector Stakeholder Perspectives concerning imaging change measurements in therapy
  • PhRMA -- Pharmaceutical Research & Manufacturers of America
  • RSNA -- Radiological Society of North America
  • ACR -- American College of Radiology
  • AAPM - American Association of Physicists in Medicine
  • SNM -- Society for Nuclear Medicine
  • IT and Architectures for Imaging Biomarkers
  • CRO -- Contract Research Organizations

Overall Goal of Breakout Sessions

The Breakout Sessions will allow the participants to take what is learned from the perspectives presented and apply it to real world situations - calibrating the challenges to the timeframes needed in the clinic/industry. This will provide a rough roadmap of the challenges to be overcome along a general timeline: Near-term 1-3 years, Mid-term 3-5 years, and Long-term 5+ years?

The output from the first day's breakout discussions will be this rough roadmap, from near to long-term. This will also include discussions of emerging imaging modalities that are on the horizon.

The output from the second day's breakout discussion will be a more detailed roadmap focused on the near and mid-term, with specific Measurement Need one-page recommendations from each technical breakout session. (see template and examples attached)

First Day Breakout Session Approach: "BIG PICTURE ROADMAPPING - THE WHAT by WHEN?"

1. Session Leader defines the technical topic area for the group (15 min) and may have some "thought leaders" address the following questions to set the stage for open discussion. A NIST person will help with taking notes and clarifying the outputs needed for USMS, but it is expected that the outputs will be of use beyond NIST. The matrix below will the group organize ideas to report out a 10 minute summary from the discussion at the end of the session. The shaded columns are to be reported out on the powerpoint template.

2. Identify the imaging approaches and the associated technical challenges for measuring change in therapy for the technical area assigned to your breakout session.

• What is the technological innovation at stake?
• What is the technical barrier to the innovation?
  

3. Describe the benefit of resolving the challenge and getting the innovation to the marketplace in the preferred timeframe.

• What is the economic significance of the innovation to the nation?
• What is the timing priority for resolving the challenge?
  

4. Describe which innovations and challenges have technical barriers that will require advancement in measurement science and standards. What is the measurement problem aspect of the technical barrier?

5. Who are the potential providers of solutions? Who are the critical players and stakeholders? Industry, government, academia, clinicians - name key players.

Second Day Breakout Session Approach: "THE DETAILED MEASUREMENT SCIENCE and STANDARDS WHAT by WHEN"

The presentations and discussions from Session 6: "Medical Imaging-Integrated Solutions" sets the stage for focusing on actions in the near and mid-term. Using what your session has identified and prioritized for the Near and Mid-Term timeframes, what are the challenges that require measurement science and standards to reach solutions? Design a potential program strategy to apply standards and appropriate metrology to approach the challenges - starting with the Near and Mid-term opportunities. What should a next 5-year plan look like, 2007 - 2011?

Using the Near and Mid-term results from the first day, expand the discussion into these areas:

• the measurement science or standards barriers of the innovations or challenges
• the potential solutions to the measurement problem (what is missing today that could be developed to facilitate a solution?)
• the role for Government, if any, and why industry can't provide the solution alone
• the definition of success, what it would look like and how it could be measured

This additional focus will help round out the development of the information for one or more "Measurement Need Datums" (MNs) one-pagers. Some information for these one-pagers was developed on the first day. These one-pagers will be fine tuned following the workshop with the breakout participants before submission to the NIST USMS process.

Think of each one-pager as a critical element within a measurement science and standards effort supporting "Imaging as a Biomarker: Standards for Change Measurement in Therapy." The goal of Day 2 is for each Breakout Area to develop a minimum of ONE of these one-pagers, but ideas for more than one are likely - save those ideas, as we may be able to finish more as part of the workshop followup activities.

The information headers for each one-pager concept are shown below to help organize discussion to report out a 15 minute summary at the end:
(http://usms.nist.gov/MN-template.doc) These are also the sections in the powerpoint template for reporting out after the breakout discussion.

Technology at Issue:
Submitter(s):
Technological Innovation at Stake:
Economic Significance of Innovation:
Technical Barrier to the Innovation:
Stage of Innovation Where Barrier Appears [Choose one]: (R&D, Production, Marketplace, End Use)
Measurement-Problem Part of Technical Barrier:
Potential Solutions to Measurement Problem:
Potential Providers of Solutions:
What is the role for Government, if Any?:
If There is a Government Role, Why Industry Says It Can't/Won't Pay for That Part of Solution:

Technical Scope and Staffing for each Breakout Session

Modality Areas #1-3: Overall Scope Guidance:
Modality focused areas should include discussion of phantom design, physical performance measurements of imaging system, and image modeling and image processing methods for measurement of change over time for the modalities in the session, focused on the predominant measurement challenges for that area.

Area #1: X-Ray & X-Ray CT: What can be measured over time?
(Disease models: Lung Cancer, Bone Imaging and Osteoarthritis)
Chair: Charles Peterfy, MD - Synarc charles.peterfy@synarc.com
Co-Chairs:
1. Robert Ford, MD -- RadPharm ford@radpharm.com
2. Xiang (Sean) Zhou -- Siemens -- xiang.zhou@siemens.com
3. Geoff McLennan, MD, PhD - Univ of Iowa: geoffrey-mclennan@uiowa.edu
4. Tom Fuerst, PhD -- Synarc thomas.fuerst@synarc.com

NIST Technical Assistants to the Chairs:
1. Lisa Karam, PhD - Physics Lab lisa.karam@nist.gov
2. Herbert Bennett, PhD -- Electronics & Electrical Engineering Lab herbert.bennett@nist.gov

Area #2: PET & PET CT: What can be measured over time?
(Disease models: Alzheimer's Disease and Lung Cancer)
Chair: Paul Kinahan, PhD -- University of Washington kinahan@u.washington.edu
Co-Chairs:
1. David Mozley, PhD -- Merck mozley@merck.com
2. David Rollo, MD, PhD -- Philips Medical Systems david.rollo@philips.com
3. Saara Totterman, PhD - Virtualscopics saara_totterman@virtualscopics.com

NIST Technical Assistants to the Chairs:
1. Brian Zimmerman, PhD - Physics Lab brian.zimmerman@nist.gov
2. Jeffrey Cessna - Physics Lab jeffrey.cessna@nist.gov

Area #3: MRI, MRS, DCE and Diffusion MRI: What can be measured over time?
(Disease models: Cardiology, Oncology, Osteoarthritis)
Chair: Jeffrey L. Evelhoch, PhD - Amgen evelhoch@amgen.com
Co-Chairs:
1. Derek Hill, PhD -- IXICO, derek.hill@ixico.net
2. Jonathan Allis, PhD -- GE Healthcare, jonathan.allis@ge.com
3. Chun Yuan, PhD -- University of Washington, cyuan@u.washington.edu

NIST Technical Assistants to the Chairs:
1. Ron Goldfarb, PhD -- Electronics & Electrical Engineering Lab ron.goldfarb@nist.gov
2. Steve Russek, PhD -- Electronics & Electrical Engineering Lab stephen.russek@nist.gov

IT Methods Areas #4-6: Overall Scope and Guidance:
Some modality specific IT issues may come out the above discussions. However, the predominant discussion of cross-cutting information technology issues will be focused in these three areas.

Area #4: Open architecture and software tools: Image and meta-data collection and analysis, data integration and display
Chair: Larry Tarbox, PhD -- Washington University tarboxl@mir.wustl.edu
Co-Chairs:
1. Howard Foster, MS -- Perceptive -- howard.foster@perceptive.com
2. John Pearson, PhD -- Siemens Corp. Research -- pearson.john@siemens.com
3. Gary Mallow, PhD -- Merck -- gary_k_mallow@merck.com
4. Stephen R. Aylward -- Kitware -- stephen.aylward@kitware.com

NIST Technical Assistants to the Chairs:
1. Afzal Godil, MS - Information Technology Lab godil@nist.gov
2. Alan Bond, PhD - Manufacturing Engineering Lab alan.bond@nist.gov

Area #5: Resources for qualification of imaging systems, benchmarking of image processing and data integration tools, and related statistical methods.
Chair: Nick Petrick PhD, CDRH, FDA -- nicholas.petrick@fda.hhs.gov
Co-Chairs:
1. Colin Miller, PhD -- Bio-Imaging Technologies, Inc, cmiller@bioimaging.com
2. Ruzena Bajcsy, PhD -- University of California, Berkeley bajcsy@eecs.berkeley.edu
3. Dorin Comaniciu, PhD -- Siemens (dorin.comaniciu@siemens.com)
4. Paul Maguire, PhD -- Pfizer paul.maguire@pfizer.com

NIST Technical Assistants to the Chairs:
1. Charles Fenimore, PhD - Information Technology Laboratory charles.fenimore@nist.gov
2. Mala Ramaiah, PhD -- Manufacturing Engineering Lab mala.ramaiah@nist.gov

Area #6: Data archival and access methods: Image, related meta-data and clinical outcome data, related data interoperability standards, and innovative methodologies for data interpretation.
Chair: Mike Vannier, MD - University of Chicago mvannier@uchicago.edu
Co-Chairs:
1. David Clunie, MD - RadPharm clunie@radpharm.com
2. Mike Hehenberger, PhD -- IBM Healthcare & Life Sciences hehenbem@us.ibm.com
3. Richard Close, PhD - Pfizer richard.close@pfizer.com

NIST Technical Assistants to the Chairs:
1. Wo Chang, PhD - Information Technology Lab wo.chang@nist.gov
2. Eswaran Subrahmanian, PhD - Manufacturing Engineering Lab eswaran.subrahmanian@nist.gov