Rahn Kennedy Bailey, M.D., D.F.A.P.A.
Executive Director Behavioral Medicine
Chair of Psychiatry and Behavioral Medicine
Wake Forest Baptist Medical Center
July 28, 2015
InterAC Forum
Medical School Board Room
Winston Salem, NC
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Mandatory annual
research project for all
residents
Full-time research
assistant/ coordinator,
starting August 10th
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Mood disorder
endowed
professorship
Geriatric endowed
professorship
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Mental Health Intervention with the Homeless
(KBR Charitable Trust)
Evaluation of Reclaiming Futures (KBR Charitable
Trust & Duke Endowment; PI: Doug Easterling,
PHS)
Borderline Personality Disorder (NIMH, PI: Will
Fleeson, Reynolda Campus)
The Homeless Opportunities and Treatment
(HOT) Project: Education and Training
Enhancement (AHEC)
Pending: Spirituality and the Homeless
(subcontract with Case Western from Templeton
Foundation)
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Cognitive aging
◦ PI, Women’s Health Initiative Memory Study (NIA)
◦ PI, Validation of a Simulation-Based Assessment of
Cognitive Function (Alzheimer‘s Association)
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Improving cognitive functioning in vulnerable
populations
◦ Co-I, Systolic Blood Pressure Intervention Trial (NHLBI)
◦ Co-I, Look AHEAD Continuation: Action for Health in
Diabetes (NIDDK)
◦ Co-I, Multi Ethnic Study of Atherosclerosis II (NHLBI)
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Modifying neurocognitive effects of cancer and
treatment
◦ PI, Phase 3 RCT Donepezil in the Irradiated Brain (NINR)
◦ Co-I, Preventing Anthracycline Cardiovascular Toxicity with
Statins (NHLBI)
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An RCT of CBT-Telephone for Late-Life GAD,
National Institute of Mental Health, Brenes (PI)
Sequential Care Approach in the Management
of Musculoskeletal Pain, National Institute of
Arthritis, Muscuoloskeletal, and Skin
Diseases, Ang (PI)
Reducing Lung Cancer Survivor Anxiety with
Brief Device-Guided Breathing (RELAX),
National Cancer Institute, Danhauer (PI)
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TMS is a non-invasive method of brain
stimulation that relies on electromagnetic
induction. When focused on an area of the
brain it is thought to play a role in mood
regulation.
Neuroscience tool
◦ Test brain-behavior relationships
Treatment tool
◦ TMS is FDA approved to treat depression
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Continue to be involved in this work by
linking with:
◦ Maya Angelou Center for Health Equity (MACHE)
 Associate Member
◦ HERO Workshop
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Geriatrics; Dementia Research
◦ Snyder Grant
◦ Collaboration with Internal Medicine and GO
Program
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Addiction Psychiatry
Mood Disorders
Health Disparities
Wake Forest
School of Medicine
Looking Back, Looking Forward
Edward Abraham, MD
Professor and Dean
Key Drivers for Change (2011)
• Must reposition WFSM for new internal/external
financial realities
• Reduced internal income streams
• $45 million annual VAC income gone 3 years
earlier than expected
• Anticipated NIH funding reductions:
• “If you’re not preeminent, you won’t get funded.”
Wake Forest School of Medicine
Our Response (2011)
• Coalesce our research strengths in highly
defined, visible areas of clear opportunity
where WFSM has substantial existent strengths
and that offer true opportunity for preeminence
• Focus our research investments for high
impact/high funding opportunity
Wake Forest School of Medicine
Next Steps (2011)
• Working groups to refine research foci
• Determine desired profiles for high impact
recruitment
• Review centers and institutes to optimize their
alignment with strategic plan and institutional
needs
• Identify infrastructure needs
• Develop business plan
• Enhance and optimize clinical trials operations
• Identify outstanding recruits
Wake Forest School of Medicine
WFSM Research Strategic Plan
Accomplishments: WFSM Strategic Plan
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Leadership recruitments
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Develop New Organizational Structures to Enhance Translational Research and Team Science
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BRSA (Biomedical Research Science Administration) established
CTSA application received highly competitive score
Scientific neighborhoods formed
Development of new review and funding mechanisms for institutionally supported research centers and
cores
New compensation model for early stage investigative faculty
Enhanced Clinical Trials Activities
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Alzheimer’s Disease Center – Suzanne Craft Ph.D.
Cancer Center – Boris Pasche MD, PhD
Center on Diabetes, Obesity, and Metabolism – Donald McLain MD
Optimization of Clinical Trials organizational structure
Numbers of patients enrolled into clinical trials increased by approximately 25% in FY15 compared to FY14
Strengthen Educational Programs
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New Associate Deans for Academic Affairs and Student Services
Refinement of medical school curriculum
Step 1 Board Scores have increased over the past 4 years from 219 to 235 (national mean 227)
New Medical Education Building in Innovation Quarter
Re-establishment of Post-Baccalaureate program
Optimization of financial model for Graduate School
Establishment of tuition generating MS programs in Biomedical Sciences, Informatics, Neurosciences
Expansion of PA program to Boone, with Appalachian State University
Planning for combined undergraduate programs with Reynolda Campus (in technology, human biology, preengineering, public health)
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Active portfolio of awards as of 4/30/2014 and 4/30/2015
Active awards includes awards received July 1-April 30 of each respective fiscal
year as well as awards from prior years that remain active
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Key codes: Endocrine System (B06); Urinary System/Kidney (B16); Diabetes (C18); Fitness/Physical (C24);
Metabolism (C39); Nutrition (C44); Obesity (C68)
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Key codes: Regenerative Medicine (B18); all WFIRM awards
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Key codes: Cardiovascular System (B04); Atherosclerosis/Thrombosis (C06); Cardiac Function (C10);
Hypertension (C30); Vascular Diseases (C61); Fitness/Physical (C24)
All data restated effective FY 2015 Q2 due to addition of C24 key code not previously included
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Key codes: Aging (C01); Arthritis (C05); Cognition/Learning (C12); Osteoporosis (C46); Alzheimer’s Disease
(C72); Physical/Muscular Function (C73)
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Key Codes: Hematologic System (B08); Cancer/Oncogenesis (C09)
Revisiting the WFSM Research
Strategic Plan
Strategic Research Cycle
Pop & Behavioral
Analytics, Risk
Stratification,
Clinical Trials
Commercialization
Research
Translational
Research
Talent,
Engagement
Clinical Care
Translation
Research in a Limited
Number of Strategically
Important Areas
T1  T4
Philanthropy,
Population
research
Infrastructure
Diverse & Reliable
Extramural Funding
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“…achieving a learning health care system—one in which science and informatics,
patient-clinician partnerships, incentives, and culture are aligned to promote and enable
continuous and real-time improvement in both the effectiveness and efficiency of care—
is both necessary and possible for the nation.” (IOM, 2012)
WFSM Strategies:
Strategy 1: Align the incentives of the clinical, research and education enterprises in
building a continuously learning system for generation and application of knowledge for
care improvement for individuals and populations.
Strategy 2: Develop pre-eminent, highly innovative, impactful, and internationally
renowned research programs, linked to major health issues and health system priorities
and including overlapping teams of basic, translational and clinical faculty, in well-defined
areas
Strategy 3: Improve translational efficiency by creating and integrating assets and
programs to accelerate the pace of research translation by fostering team-based multidisciplinary approaches, leveraging WF strengths, and catalyzing a local and regional
environment of accelerated discovery and implementation.
Strategy 4: Develop a robust informatics and scientific infrastructure to reliably capture,
curate, and deliver the best available evidence to guide, support, tailor, and improve
clinical decision making and patient care, safety, and quality.
Strategy 5: Develop system competencies by ongoing team training and skill building,
system analysis and information development, and creation of feedback loops for
continuous learning and system improvement.
Strategy 6: Engage and empower the community by inclusion of patients, families, other
caregivers and community members as vital members of the continuously learning health
care team.
Planning Process for Updated Strategic Plan
(2017-2020)
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Questionnaire and portal on BRSA website for faculty to provide suggestions for new
research directions in which we have the intellectual capital to become an international
leader (linked to RFA for emerging Centers)
Teams of faculty to define priorities in six areas (and specifically areas where we can
develop highly innovative programs that have a major impact on our understanding of
the pathogenesis and treatment of disease)
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Education
Core/Center/Infrastructure and CTSA related activities
Research in diabetes/obesity/metabolism and related cardiovascular diseases
Research in aging/Alzheimer's Disease
Research in regenerative medicine
Research in cancer
Retreat in mid-August to further define our vision for excellence in research and
education, and ensure that the identified priorities interface and synergize with health
system goals to take full advantage of our structure as an integrated academic medical
center
Meeting with external advisory board of highly accomplished investigators on September
25 to critique the strategic plan, provide insights into what we may be missing in terms
of scientific opportunities and emerging technologies, and help define how we can best
use resources to ensure that our scientific enterprise is truly pre-eminent.
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Clinical Trials Initiatives
July 28, 2015
Bio: New Clinical Trials Office Director
Selvin Ohene, MS
 Boston Medical Center: Director, Clinical Trial Office
• Created and developed new Clinical Trial Office focused on financial, legal and
administrative components of clinical research.
• Developed Medicare Coverage Analysis program
• Helped implement Velos eResearch (CTMS) and ClinCard (participant
compensation program)
 Tufts Medical Center: Cancer Center
• Administrative Director, Cancer Center (oversight of Cancer Product Line)
• Manager, Cancer Clinical Trials and Operations (oversight of Cancer CTO)
 Dana-Farber Cancer Institute: Office of Human Research Studies
• Coordinator and member of IRB and SRC
• Member of Standard Operating Procedures Committee
 Tufts Medical Center: Department of Surgery
• Clinical Research Coordinator
• Lab Research Assistant
Wake Forest Baptist Medical Center
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Why are Clinical Trials Important?
 Strong Brand
• Physicians choose Wake Forest Baptist Health (WFBH) to participate in and
shape innovative care
• Patients choose WFBH to receive innovative care and the anticipated better
outcomes
 Better Care, Better Outcomes
• Patients participating in clinical trials receive better care resulting in better
outcomes
 Revenue
• Access to highly specialized care and novel therapies leads to revenue from
ancillary/residual visits
• Patients that come for clinical trials increase our patient base
Wake Forest Baptist Medical Center
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Clinical Trial Initiatives
Ultimate Goal: To increase the number of patients participating
in, and benefiting from, clinical trials.
 Improve central infrastructure to allow for:
• Rapid initiation of clinical trials
• Efficient operations throughout the life of a clinical research study
• Timely and accurate patient billing and invoicing/accounts receivable
• Improved ability to determine feasibility of clinical trials and identification of
potential research participants
• More accurate tracking of clinical research productivity
• Increased access to new and different clinical trial opportunities
 Provide a central resource for clinical research support through our Study
Coordinator Pool
 Focus on compliance and patient safety through every phase of research
 Create regional Clinical Research Support Teams
Wake Forest Baptist Medical Center
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Observations: 60 days
 Provide more financial start-up support for Faculty/Study Teams
• Assist in the development of clinical research budgets that reflect the institution’s
acceptable margin, based on Medicare Coverage Analysis results
• Expand on our ability to budget and bill industry-sponsored clinical research for
professional fees and hospital service costs
• Hire 2 additional FTEs within our Study Administration Pool to support these initiatives
 Facilitate improvements in study recruitment; streamline enrollment
tracking
 Assist in the identification of patients for research studies utilizing our existing systems
(Translational Data Warehouse, WakeOne, etc.)
 Enhance the clinical research billing process
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Document the current process – assess our SWOT
Educate the clinical research community on the regulations
Clarify and communicate clearly defined Roles and Responsibilities
Implement policies, procedures and systems that create efficiencies
Wake Forest Baptist Medical Center
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Observations: 60 days (Cont.)
 Re-engineer Sponsor Invoicing and A/R practices
 Create and develop “Desk-Level Procedures” (DLPs) for study–related
responsibilities (e.g., CRMS and WakeOne)
 Find ways to communicate more efficiently
• Constant and Consistent
• Build upon SCaRF and other existing forums for faculty and staff involved in clinical
research
• Online Education tools are currently in development
Wake Forest Baptist Medical Center
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Future State CTO
Staffing Structure
Edward Abraham, MD
Dean, School of Medicine
King Li, MD, MBA: Sr. Assoc. Dean, Clinical & Translational Science
Terry Hales, MBA: VP: Academic Administration & Operations
Lynne Wagenknecht, DrPH: Assoc. Dean, Interdisciplinary Research
Stephen Kritchevsky, PhD: Assoc. Dean, Research Development
Study Administration Responsibilities
 MCA completion
 CRMS entry
 Budget confirmation
 Invoicing
 A/R
 Billing issue resolution
VACANT
Project Manager II, Study Administration
Study Coordination Responsibilities
 Regulatory Submissions
 Budget development
 Participant Recruitment
 Patient Visits
 Data Entry
 Specimen Collection
Christopher O’Byrne, MS
Asst. Dean, Research Services
Selvin Ohene, MS
Director, Clinical Trials Office
Nancy Lawlor, LPN
Project Manager II, Study coordination
Sandra Byers
Research Admin. Coordinator II
Penny Spernoga, MS
Asst. Project Manager,
Study Coordination
Emily Ansusinha, MA
Asst. Project Manager,
Study Coordination
Daniel Lipford
Clinical Studies
Coordinator
Sandra Norona
Clinical Studies
Coordinator
Holli Davis
Research Admin. Coordinator I
VACANT
Research Admin. Coordinator I/II
Kelsey Shore
Clinical Studies
Coordinator
Alexandra Bolick
Clinical Studies
Coordinator
Seema Dixit
Data Coordinator I
Study Administration
Wake Forest Baptist Medical Center
Study Coordination
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Reorganize Clinical Trials Infrastructure
Regional Clinical Trials Teams
Wake Forest Baptist Medical Center
Clinical Research Support Teams
 Create 5-6 regional clinical research support teams, in addition to the
central Clinical Trials Office to support:
• All aspects of clinical research (e.g. administration, regulatory, conduct)
• Clinical research funded by all sources (e.g. industry, NIH)
• All IPUs, Departments, Centers, and Institutes
 Teams will create a reporting structure focused on the support of
clinical research with:
• Standardized training
• Job descriptions and career ladders
• Flexibility to support the types of research within each team (e.g. coordinators, nurses,
PAs)
• Improved economies of scale to weather funding gaps by individual investigators
• Ability to shift staff among teams if needed
• Ability to efficiently disseminate institutional priorities/policies/etc.
 There will be a base level of institutional support for each team with
the ultimate size of the team dependent on activity/support.
 Leaders of each team will co-report to faculty leadership and the
Clinical Trials Office Director
Wake Forest Baptist Medical Center
Regional Clinical Trials Offices (Cont.)
 Departments/IPUs will be grouped to receive support from 5-6
regional teams and the central Clinical Trials Office.
• As much as possible, teams will be organized to have similar research activity
• After initial organization, there will be flexibility among teams to allow Departments/IPUs to
choose the team they feel is most appropriate
 Team creation will be rolled out over the next several months.
• Team 1 includes the Comprehensive Cancer Center, Surgical Oncology, Hematology &
Oncology, Medical Oncology, Radiation Oncology and Pediatric Oncology
• The composition of the remaining teams will be determined and announced as soon as
possible.
Wake Forest Baptist Medical Center