Technology Advisory Board

About the Technology Advisory Board

Board Chair:
Andrew Jacobson, Ph.D.
Member, LSIT Board of Directors

TAB Members:
Jason Cooper
Director - Analytics & Outcomes, Accordant Health Services

William J. Branan
Project Lead for GIP, Creator of the GIP Architecture
Principal, w j branan | consulting

Paul Laskin
CEO, Etechnico

Jay Kunin, Ph.D.
Member, LSIT Board of Directors

Barbara Nollau
Lead Representative to LSIT, GAMP Americas
Director, Quality Systems Abbott Vascular

Klaus Krause
Representative to LSIT, GAMP Americas
Manager Corporate Quality, Corporate Validation, Amgen

John McNeil
President, John McNeil & Company, Inc.

Leslie Cirillo-Plante
Director of IT Compliance, Novartis Pharmaceuticals

John Kim
Project Manager, Pfizer

David C. Spellmeyer, Ph.D.
CTO & CIO, Nodality, Inc

U.S. FDA Advisors:
John F. Murray
Software Compliance Expert, U.S. Food and Drug Administration

Robert D. Tollefsen
Consumer Safety Officer, National Computer Expert, U.S. Food and Drug Administration

About the Technology Advisory Board (TAB)
Continuing development of Good Informatics Practices (GIP) requires an impartial and involved group of technical advisors to guide and promote the activities of working groups and to facilitate LSIT's technical goals and objectives. LSIT has created a Technical Advisory Board (TAB) to serve this function.

TAB members (Advisors) are prominently known, well-connected, and highly qualified individuals who lend their credibility to LSIT's Good Informatics Practices (GIP) development efforts and provide deep technical and practice expertise. They represent LSIT member organizations, regulatory bodies, and standards organizations and come from key disciplines in IT and life sciences that have a direct impact on the content and effectiveness of GIP.

The TAB conducts quarterly meetings, either face to face or by conference call. TAB advisors receive quarterly status reports on GIP activities, and respond with advice and counsel.

TAB decisions also consider leading trends in IT processes, infrastructures, software, middleware and hardware, and in the standards that impact technology implementation in a life science organization. The TAB advisors coordinate efforts to collaborate with regulatory and standards organizations. The challenge that the TAB faces is to be contemporary, to be balanced in its decision-making approach, to use critical thinking in planning for new technology scenarios, and to expect a high level of quality in the LSIT work products.

Purpose:
The board is charged with directing and managing the conception, development, review, and publication of GIP. In this capacity, it will:

• Define and manage the formal architecture and components of GIP, and determine what practices will be addressed and included within the body of GIP knowledge.
• Identify and authorize specific areas of inquiry that may fall outside of the GIP architecture.
• Formally charter and constitute working groups, call for volunteers and assign resources, and monitor progress toward defined goals of the working groups.
• Redirect or alter the scope, goals, personnel, and timelines of any working group, as necessary.
• Conduct the final review of GIP deliverables, and be solely responsible for the decision to publish any deliverable of the working groups.
• Set timelines and expectations for updates and revisions to GIP and to LSIT publications.

Qualifications:

• Board or committee seat from a standards organization

• Employed with a regulatory agency

• Subject Matter Expertise (15+ years) and demonstrated leadership in key disciplines/functions

Activities:

• Conduct or commission strategic and long-range planning with regard to best practice direction within the life sciences industries.
• Identify, research, review and recommend best practices, standards, and technologies that should be included in the GIP body of work.
• Maintain the formal architectural structure of GIP; determine those practices that should and should not be included within the GIP body of work.
• Prioritize areas of inquiry and execution order for developing content of GIP. Manage and maintain the overall GIP development plan.
• Manage working groups
  • Define (scope) working group areas of inquiry.
  • Identify and install working group leadership.
  • Each TAB advisor will be a liaison to a specific workroup. The advisor is responsible for monitoring the progress of the workgroup, determining what issues surfaced in the group should be brought to the full TAB for resolution, and communicating from the workgroup to the TAB and from the TAB to the workgroup.
  • Monitor progress of working groups.
  • Address performance deficiencies of working groups.
• Make final decisions on conflicting practices or areas of confusion.
• Set timelines and expectations for updates and revisions to GIP and to LSIT publications. Maintain the master publication schedule.
• Conduct final review of GIP work products.
• Act as the publisher of "official" GIP documents.
• Maintain QA & QC at all levels.