Rahn Kennedy Bailey, M.D., D.F.A.P.A. Executive Director Behavioral Medicine

Chair of Psychiatry and Behavioral MedicineWake Forest Baptist Medical Center

July 28, 2015InterAC Forum

Medical School Board RoomWinston Salem, NC

Psychiatry & Behavioral Medicine Research Directions

Mandatory annual research project for all residents

Full-time research assistant/ coordinator, starting August 10th

Mood disorder endowed professorship

Geriatric endowed professorship

Vision towards “learning organization”

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)

Dr. Arnold’s Research & Grants

Cognitive aging◦ PI, Women’s Health Initiative Memory Study (NIA)◦ PI, Validation of a Simulation-Based Assessment of Cognitive

Function (Alzheimer‘s Association) 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)

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)

Dr. Rapp’s Research

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)

Dr. Brenes’s Research

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

Repetitive Transcranial Magnetic Stimulation (rTMS)

Continue to be involved in this work by linking with: ◦ Maya Angelou Center for Health Equity (MACHE) Associate Member

◦ HERO Workshop

Health Disparities

Geriatrics; Dementia Research◦ Snyder Grant◦ Collaboration with Internal Medicine and GO

Program Addiction Psychiatry Mood Disorders Health Disparities

Future Research Projects

Thank You!Q&A

Wake ForestSchool of Medicine

Looking Back, Looking Forward

Edward Abraham, MDProfessor and Dean

Wake Forest School of Medicine

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

WFSM Research Strategic Plan

Accomplishments: WFSM Strategic Plan• Leadership recruitments

– Alzheimer’s Disease Center – Suzanne Craft Ph.D.– Cancer Center – Boris Pasche MD, PhD– Center on Diabetes, Obesity, and Metabolism – Donald McLain MD

• Develop New Organizational Structures to Enhance Translational Research and Team Science– 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– 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– 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, pre-

engineering, public health)16

• 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

• Key codes: Endocrine System (B06); Urinary System/Kidney (B16); Diabetes (C18); Fitness/Physical (C24); Metabolism (C39); Nutrition (C44); Obesity (C68)

• Key codes: Regenerative Medicine (B18); all WFIRM awards

• 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

• Key codes: Aging (C01); Arthritis (C05); Cognition/Learning (C12); Osteoporosis (C46); Alzheimer’s Disease (C72); Physical/Muscular Function (C73)

• Key Codes: Hematologic System (B08); Cancer/Oncogenesis (C09)

Revisiting the WFSM Research Strategic Plan

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Strategic Research Cycle

Translational Research

Talent, Engagement

Pop & Behavioral Analytics, Risk Stratification, Clinical Trials

Diverse & Reliable Extramural Funding

Research in a Limited Number of Strategically

Important Areas

Clinical Care Translation

CommercializationT1 T4

Philanthropy, Population research

Research

Infrastructure

“…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 multi-disciplinary 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)

• 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)• 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 InitiativesJuly 28, 2015

Wake Forest Baptist Medical Center 30

Bio: New Clinical Trials Office DirectorSelvin 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 31

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 32

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 33

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 • 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 34

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 35

Edward Abraham, MDDean, School of Medicine

King Li, MD, MBA: Sr. Assoc. Dean, Clinical & Translational ScienceTerry Hales, MBA: VP: Academic Administration & Operations

Lynne Wagenknecht, DrPH: Assoc. Dean, Interdisciplinary ResearchStephen Kritchevsky, PhD: Assoc. Dean, Research Development

Christopher O’Byrne, MSAsst. Dean, Research Services

Selvin Ohene, MSDirector, Clinical Trials Office

VACANTProject Manager II, Study Administration

Nancy Lawlor, LPNProject Manager II, Study coordination

Seema DixitData Coordinator I

Sandra ByersResearch Admin. Coordinator II

Holli DavisResearch Admin. Coordinator I

VACANTResearch Admin. Coordinator I/II

Penny Spernoga, MSAsst. Project Manager,

Study Coordination

Emily Ansusinha, MAAsst. Project Manager,

Study Coordination

Daniel LipfordClinical Studies

Coordinator

Sandra NoronaClinical Studies

Coordinator

Kelsey ShoreClinical Studies

Coordinator

Alexandra BolickClinical Studies

Coordinator

Study Administration Study Coordination

Future State CTO Staffing Structure

Study Administration Responsibilities MCA completion CRMS entry Budget confirmation Invoicing A/R Billing issue resolution

Study Coordination Responsibilities Regulatory Submissions Budget development Participant Recruitment Patient Visits Data Entry Specimen Collection

Wake Forest Baptist Medical Center

Reorganize Clinical Trials InfrastructureRegional 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.