Translational Research

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Wake Forest University Translational Science
Institute(WFU TSI)February 20, 2008
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What is the CTSA? - Clinical Translational
Science Award an NIH-funded infrastructure
grant designed to assist medical centers to

• Create a transformative, novel and integrated
  academic home for translational science, and
• Train a cohort of inter- and multi-disciplinary
  investigators and teams to apply new tools,
  technologies and knowledge to patient care.
• Funds available for new awards 25 million /5
  years for each funded site
• Total Anticipated No. of Awards Nationally 50-60

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National CTSA Consortium Sites
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National CTSA Consortium Sites

• 2007 Awardees
• Case Western Reserve University
• Emory University
• Johns Hopkins
• University of Chicago
• University of Iowa
• University of Michigan
• University of Texas Southwester Medical Center
• University of Washington
• University of Wisconsin
• Vanderbilt University
• Washington University
• Weill Cornell Medical College

• 2006 Awardees
• Columbia University Health Sciences
• Duke University
• Mayo Clinic College of Medicine
• Oregon Health Science University
• Rockefeller University
• University of California, Davis
• University of California, San Francisco
• University of Pennsylvania
• University of Pittsburgh
• University of Rochester
• University of Texas Health Sciences Center at
  Houston
• Yale University

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WFU Translational Science Institute (TSI)

• Mission to accelerate the discovery and
  application of new knowledge to improve human
  health
• Established March 14th, 2007
• Team Leadership
• TSI Directors Burke, Herrington, McCall,
  Shumaker
• Program Leaders

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WFU TSI Structure
PROGRAMS/LEADERS Translational Technologies
Resources Loeser, Lyles, Bleeker Novel
Methodologies Tool Development Christ,
Hiltbold, Clarkson Pilot/Collaborative Projects
Herrington, Burke Bioinformatics
Communications Langefeld, Boehme, Wang
(Virg.Tech) Bioethics King, Hall,
Coughlin Non-Human Primate Models Kaplan,
Comuzzie, Adams Community Engagement
Easterling, Foy Regulatory, Knowledge Support
Friedman, Furberg
Education and Career Development Goff,
McPhail, Diz, OShea Biostatistics and Study
Design Ambrosius, Rejeski Transdisciplinary
Team Science Altman, Shumaker UNITS/EXECUTIVE
DIRECTORS Administrative Unit T.
Thornburg Clinical Research Network Unit M.
Poletti Education Coordination Unit A.
Pulley Evaluation Strategic Planning Unit S.
Ellis Translational Resource Unit W. Somerville
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WFU TSI Principles

• Multi-disciplinary team research and education
• Regional emphasis
• Coordinated, scientific focus

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What is the Status of the WFU CTSA Application?

• Submitted Nov. 7th, 2007 (850 pages)
• Reviewed Feb. 12th, 2008
• Pink sheets April 1st, 2008
• Next submission deadline June 17th ,2008

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Part 2 Team Science

• Aims of Team Science
• Why and What of Team Science
• Funding to Facilitate Team Formation
• Partnering with the Center for Creative
  Leadership to Facilitate the Success of Teams

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Aims of Team Science in TSI

• Facilitate the establishment of new,
  multidisciplinary teams of scientists.
• Enhance team skills of faculty and students.
• Advance the knowledge of team science.

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Why is the Team Concept Incorporated into Most
Aspects of the TSI?

• Speed of Discovery Achieve more rapid progress
  than when individuals work in isolation
• Complexity More effectively address the
  complexity of new biomedical technologies,
  clinical care, and social/cultural issues that
  require teams of individuals with different and
  complementary skills
• Innovation Produce innovative and unique ways
  to conceptualize, communicate, and solve critical
  research questions
• Dissemination Develop and implement creative
  ways to disseminate knowledge and influence more
  rapid uptake within the broader community.

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Defining Teams

• Uni-disciplinary Scholars working together from
  a single field of study
• Cross-disciplinary teams

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Cross-Disciplinary Teams

• Multidisciplinary -- scholars from diverse fields
  study work more independently or sequentially,
  and come together to share individual purposes
  for addressing a broader common research theme or
  goal
• Interdisciplinary -- scholars from diverse fields
  come together in an integrated approach to the
  issue, while maintaining their identification
  within their field of study
• Transdisciplinary -- scholars from diverse fields
  work to develop a shared conceptual and
  methodological framework that transcends their
  respective disciplinary perspectives

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Funding to Facilitate Team Science

• TSI K12 Scholar - 838,000
• 3 awards variable/award
• TSI Team Science 500,000
• 4 awards - 125,000/award
• TSI Team Development awards - 400,000
• 8 awards - 50,000/award

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Partnering with CCL to Facilitate Success of Team
Science

• Incorporate a problem-based learning module on
  team science in the summer practicum for all TSI
  graduate students.
• Conduct fall and spring workshops on team science
  and leadership for all TSI members.
• Provide online team science and leadership
  modules for TSI members, and the national
  consortium of CTSA members.
• Maintain a cadre of faculty consultants trained
  in communication skills, group facilitation,
  negotiations, and conflict management to
  addresson an ongoing basisemerging and urgent
  team issues.

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The Science of Team Science

• Organize, host, and disseminate scientific
  information from biennial national conferences
  with experts in team science and leadership.
• Conduct research on team science.

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Part 3 Brief Overview of
The Clinical Research Network (formerly the
GCRC) and The Translational Resources Unit
(TRU)
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Goal of the TSI
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Dont mess with things that are going well
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TSI Clinical Research Network (CRN)(Currently
known as the GCRC)

• Aim 1 Form a Local Clinical Research Network
• Reconfigure, expand and optimize the
  academic-based resources of the GCRC
• Develop an Acute Care Clinical Research Unit, a
  Mobile System for Translational Research and
  Community Unit
• Provide a Participant Recruitment Coordinating
  Center
• Use the TSI Translational Resources Unit as both
  a web and personal interface that facilitates
  resources access and regulation adherence, while
  streamlining the review process.
• Mentor young investigators in translational
  science approaches, methods, and ethics

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WFU GCRC pre-TSI
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TSI Clinical Research Network (CRN)(Currently
known as the GCRC)

• Aim 2 Form a Local Clinical Research Network
• Work with Virginia Tech, East Tennessee State
  University and Mission Hospitals of Asheville to
  facilitate a regional research network for the
  conduct of clinical and population research
  studies

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Regional TSI Partners
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Translational Resources Unit (TRU)
Primary Goal To proactively offer new and
experienced translational investigators
comprehensive ongoing support and guidance
through all phases of their research projects.
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Translational Resources Unit (TRU)

• Aim 1 To facilitate and speed the preparation,
  conduct, and dissemination of translational
  research
• to consolidate and expand current institutional
  resources via expert facilitators and a
  comprehensive, interactive, web-supported
  interface that will facilitate access to
  resources and track project progress.
• Streamline the protocol review process, both by
  using the TRU to help investigators produce
  better protocols at the outset, and by
  eliminating potential bottlenecks and unnecessary
  redundancies in the review process.
• Create a single point of contact for new and
  experienced investigators to take advantage of
  the transformational efficiencies being
  implemented in this and the other WFU TSI
  Programs.

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Translational Resources Unit (TRU)

• Aim 2 To assure that translational research at
  WFUHS is carried out in compliance with
  institutional and governmental regulations and
  guidelines, and with the highest integrity and
  regard for research participant respect and
  safety.
• Establish within the WFU TSI an institutional
  Human Subject Protection and Advocacy group
  devoted to assuring the safety of, and improving
  communications with, research participants. This
  will be accomplished by facilitators to track and
  monitor the progress and safety of TSI studies.
• Establish within the WFU TSI an institutional
  Data and Safety Monitoring Board (DSMB), which,
  working through the existing institutional IRB,
  will help to assure human subject safety by
  closely monitoring reported adverse events and
  taking any necessary action.
• Establish a TSI Drug Safety Committee to alert
  institutional colleagues to potential issues of
  experimental and already approved drugs, both in
  research studies and in clinical care settings.

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Translational Resources Unit Assistance
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Translational Resources Unit Assistance
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Translational Resources Unit Assistance
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"Someone's sitting in the shade today because
someone planted a tree a long time ago."
Warren Buffett
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TSI Education Coordination Unit

• Executive Director Anita Pulley
• Program Directors Debra Diz, David Goff, Linda
  McPhail, Mike OShea
• Program members representative faculty
• Responsible Director Cash McCall

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Principles TSI Education Coordination Unit

• Indentify, coordinate, integrate, and track
  translational education opportunities
• Foster competencies in translational science

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The Challenge Filling missing pieces
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Pieces of the PuzzleFive Competencies

• Understanding the nature and scope of clinical
  and translational science
• Conducting research responsibly
• Developing relevant scientific competencies in
  one or more discipline
• Working effectively in teams
• Understanding translational tools and technologies

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Graduate Degree Pathways

• Clinical and Population Translational Science
• Transformation of PHS program in Health Sciences
  Research
• MS only at present
• Molecular Medicine and Translational Sciences
• Transformation of Molecular Medicine program
• MS and PhD
• MD/PhD or MD/MS
• Others

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Non degree Pathways

• TSI Seminar Series
• Most Wednesdays at noon _at_ Commons
• Synergy symposia
• Obesity prevention and control April 30
  Inflammation - May 23
• Health Analytics Conference Oct. 1-3, 2008
• Completing the competency 5 category matrix

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Finding your way to competency
http//www1.wfubmc.edu/tsi
The Translational Resources Unit ( TRU)
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Translational ScholarsA Star-studded Cast