Committee for Building Credible Multiscale Models for Healthcare

1. Committee for Building Credible Multiscale Models for Healthcare

2. Charge of the Committee The committee will be dedicated to: • Defining and advocating for methods/processes the MSM community can use to demonstrate and enhance the credibility of their multiscalemodels and simulations (M&S) to inform clinical research with the prospect of eventually transitioning the M&S to augment the work of healthcare practitioners for developing and administering treatments • Establish clear definitions of M&Sterms and practices (e.g. validation and types of models) for consist communication within the MSM community • Provide repository of examples to demonstrate how to implement credibility assessment methods/processes to demonstrate and enhance M&S credibility • Bridge the relationship between the MSM community, clinical practitioners and regulatory agencies to ensure the M&S are developed and vetted appropriately to enable accelerated transition to clinical practice (e.g. the effort of meeting FDA V&V standards/requirements may be minimized). Consequently, the work carried out by the committee should complement the biomedical modeling V&V standard/guidelines that are currently being developed by the FDA and ASME. • Host webinars, lectures and discussions on relevant topics (Frequency: Quarterly or as needed)

3. Levels of Participation • Co-Chairs • Two Committee Members who are appointed to provide leadership and guidance to the committee to execute the committee’s charge/objectives. • Committee Member • The participant are expected to actively participate in the development of the end product, and to serve as a voice or representative for a particular discipline(s) or area of practice (e.g. computational sciences, biological sciences, clinical practitioners). The membership will also be to small group not exceeding 10 people including the two co-chairs. This small number is recommended for efficiency purposes. • Advisory Council to the Committee • The Advisory Council participants are individuals who possess substantial experience and expertise in areas of interest and are cannot commit to the level of effort that committee members are expected to provide. The role of the Council is to provide consultation/guidance/feedback to the committee on the contents of the end product.

4. How to Participate Membership to the Committee and Advisory Council • Participation as a member of the Committee or Advisory Council are by invitation only, which are issued by the Chairs with (6/10) majority consensus from the committee. • Invitations will be issued to individuals who have been recommended to the Chairs by members of the Committee or Advisory Council based on the qualifications, Committee’s needs and potential contributions of the candidate (e.g. We should not bring on a committee member who will play a redundant role, or cannot dedicate the required amount of time to meet expectations. In such cases, we would invite the individual to serve on the Advisory Council. We should also look to the Advisory Council if we need a new Committee Member before we look outside) Chairs of the Committee • Future Chairs of the Committee will be appointed via nomination and election by the members of the Committee and Advisory Council. The first Chairs were appointed via IMAG consensus. • Service terms of the Chairs will be two years with a possibility of reappointment via re-nomination and re-election • Elections should take place six months prior to the completion of the current two year term to allow sufficient time for chairman handovers • Two co-chairs are recommended at all times for redundancy in case one chairman is unavailable or step-down before the two year term is up. • The co-chairs will share equal guidance authority of the committee unless explicitly agreed to otherwise by the co-chairs and committee members

5. Ground Rules of the Committee • All committee members are expected to adhere to the schedules and deliverable obligations assigned to them, as well as attending bi-weekly or monthly meetings. If a committee member foresees a challenge in meeting any of their obligations, advanced notice (at least one week) should be given to the Chairs of the committee (and appropriate team leads when applicable) in conjunction with a proposed new date to meet their obligation. • If a member is consistently not able to meet their obligations resulting in a detrimental impact on the committee’s progress, the Chairs (and team leads when applicable) should work with the member on a transition plan. This will typically mean replacement of the member with a new candidate. In addition, the past member will be given the option to transition to an Advisory Council member status, if appropriate. • Committee members should plan to invest 5 hours per month on this effort. • The Chairs should anticipate investing 7 hours each on a monthly basis. • Committee members are strongly encouraged to attend the annual Multiscale Modeling Consortium meeting for a face to face working sessions with the rest of the committee. The Chairs will make appropriate arrangements to facilitate these meetings.

6. Ground Rules of the Advisory Council • Advisory Council members should plan to invest an average of 1 hour per month on this effort (12 hours per year). • Advisory Council members are strongly encouraged to adhere to provide feedback to the Committee within the requested time frame to ensure the Committee can produce the best product possible that is intended to benefit the stakeholders in the bio-computation/MSM research and healthcare community. • Advisory Council members are encouraged to freely engage the Committee with their ideas and perspectives regarding M&S credibility assessmement

7. Committee Membership • Members of the committee should represent the following groups. It is possible for a single member to represent more than one group: • IMAG representatives • MSM representatives willing to represent the following working groups • Multiscale Systems Biology Working Group • Biomechanics Working Group • Theoretical and Computational Methods • Clinical and Translational Issues Working Group • Computational Neuroscience Working Group • Population Modeling Working Group • Cell-to-Macroscale Working Group • External representatives (m • Clinical practice • Computational methods (e.g. Uncertainty quantification) • Commercial biomedical sector • Regulatory body

8. Committee Membership • Overall, the committee should represent the following professions/disciplines. It is possible for a single member to represent more than one dicipline. • Clinical practitioners (e.g. MDs) • Theoretical and Applied Mathematicians • Biologists • Engineers • Statisticians • Computer science • Commercial biomedical product developers

9. Current Interested Parties Committee members • Lealem Mulugeta – Co-chair (NASA/IMAG Rep) • Ahmet Erdemir – Co-chair (Cleveland Clinic and Biomechanics WG Rep) • Tina Morrison – FDA/IMAG Rep (provide regulatory perspective) • Jerry Myers - NASA • Jacob Barhak – Computer Scientist Participation TBD • Thomas Russel - NSF • VasilisMarmarelis – USC • Marc Garbey – Clinical and translational WG • Tony Hunt - UCSF • Wing Kam Lui – Device modeling, uncertainty quantification (North Western University) • PrasPathmanathan – FDA Advisory Council • Martin Steele – NASA (M&S and V&V standards development expert) • Donna Lochner – FDA/IMAG Representative (provide regulatory perspective)

10. Preliminary Timeline • April 2013 through April 2014 • By April 30, 2013: • Invite and appoint all 10 committee members • Invite and appoint the first members of the advisory council • By May 31, 2013 • Hold the first meeting with all 10 committee members to discuss objectives and required tasks • Assign specific tasks to all members for follow on meeting • By June 30, 2013 • Flesh out the contents of the first draft document • Assign specific writing tasks to all committee members with delivery dates • MSM 2013 meeting • Face to face working meeting to begin integrating content • Present to MSM community on progress and forward plans • By November 30, 2013 • Develop first integrated document and circulate within the committee • Request feedback from the Advisory council • By February 28, 2014 • Receive all feedback from committee and advisory council • By April 30, 2014 • Establish first draft release for the guidance document for detailed review by the Committee and Advisory council, and possibly external reviewers • By June 30, 2014: Begin edits for first official release of the guidance document • October 2014: Release final guidance document by MSM 14 Meeting • November 30, 2014: • Publish journal article/white paper based on the guidance document • Chair nomination and election • December 2014 – April 2015: Transition of Chairs and planning for guidance document updates