State of

University Hospitals
Research Address 2024

Daniel I. Simon, MD
President Academic & External Affairs and CSO, UHHS
Professor and Senior Associate Dean for Academic Affairs, CWRU
April 16, 2024
 UH Academics
Mission: To Heal. To Teach. To Discover.
Vision: Advancing the Science of Health & the Art of Compassion

“A next-generation academic health system dedicated to

accelerating discovery, innovation, and translation of scientific
breakthroughs which address unmet clinical needs and enhance
the lives of our patients, our community, and the world.”

Cleveland, Ohio | 2
 Why is Research Important?
RESEARCH = HOPE Enhances Health System
Differentiation

Attracts Patients
Offers HOPE for patients with
“no options”

Improves Healthcare
Outcomes
Patient triumphs over sickle cell DCCT/EDIC study to manage T1D Clinical trial uses novel drug for
disease with gene therapy (Rose Gubitosi-Klug, MD, PhD) pancreatic cancer
(Jignesh Dalal, MD) (Jordan Winter, MD
David Bajor, MD) Attracts Top Talents

Produces Intellectual
Property

Drives Philanthropy
Limb Salvage Advisory Council to Diaphragm Pacing System to help Wearable technology allows clinicians
avoid amputation patients breath without ventilator to access how oxygen returns to the
(Mehdi Shishehbor, DO, PhD) (Raymond Onders, MD) muscle after ACL surgery Creates Biomedical
(James Voos, MD)
Ecosystem Impact
$1 NIH Funded Research
Cleveland,= Ohio
$2.46| 3
Economic Activity
Value of Research at Medical School and Teaching Hospitals
Disease is Costly Research Provides Hope

Cleveland, Ohio | 4
https://www.aamc.org/advocacy-policy/research-policy-and-priorities
 2023 Key Academic Metrics

$197M $105M ( 11%) $9.4M ( 27%)

Total Research Funding Total Sponsored Research Total Research Indirect through UH
(JobsOhio 2030 Target $204M Expenditures through UH

100 3,450+ 1,189

UH plus CWRU-UH Joint Active Clinical Faculty Members
Invention Disclosures Research Studies

1,185 104 2,023 ( 12%) 1,550+

Residents & Fellows Residency & Fellowship Medical Students Clerkships & Peer-reviewed Articles
Programs Elective Rotations

2023 data

Cleveland, Ohio | 5
 UH Research
UH Grant Expenditures UH Grant Indirect
(2019-2023, Millions) (2019-2023, Millions)

$120
$10 $9.4 UH Grant Indirect Allocation
$105.3
Support Clinical Research
$100
$88.4
$8 $7.4 1 Center infrastructure
$6.7 $6.7
$80
$71.3 $70.7 $5.8
$6
2 Return to Department
$62.2
$60
Support Health Services
$40
$4
3 Research

$20 $2 Support UH Academic

4 Mission (e.g. grant
$0
writers, biostatisticians)
2019 2020 2021 2022 2023 $0
2019 2020 2021 2022 2023
Junior Faculty Support
5 (K-R transition)
Top 4 Department Indirect
• Seidman Cancer Center
• Medicine
• Ophthalmology
• Pediatrics
Cleveland, Ohio | 6
 UH Commitment to Academic Mission
2018 2019 2020 2021 2022 2023
Education 18.7 18.8 18.6 18.7 18.3 17.4
(Teaching, GME office)

Faculty Support
(MSA, PSA, SSA, Stipend, Research)
66.8 68.9 68.8 68.4 71.9 76.3
Academic
Recruitment/Retention*
(Packages, Chair Discretionary) 13.9 20.1 22.9 26.9 30.9 26.8
UH Research & Education
(CRC, UH R&E Office) 2.7 3.1 4.7 4.0 5.9 5.6
Distinctive Programs
(CCCC, CICB, CBHI, HDI, COEs, CFAR, CRM)
10.3 10.3 10.3 11.2 12.3 9.8
Academic Affiliation**
(CRI, WRB, Affiliation agreement, NEOMED)
12.7 13.2 15.4 12.8 17.4 11.8
Faculty Practice Plan
(UHMG investment before corp. allocations)
15.6 21.1 42.1 57.1 106.9 122.7
Total $140.7 $155.5 $182.8 $199.1 $263.8 $270.3
($ in Millions)
*Denotes commitments budgeted; actual expenditures not at committed level
** Reduction in affiliation expense is due to the termination of CRI in August 2021 Cleveland, Ohio | 7
 Academic Strategic Partnerships
CWRU + UH + Other Affiliates Statewide Global

Oxford-Harrington Rare
Diseases Centre

Morgan Stanley
GIFT Cures

UH-Technion (Israel
Cleveland Digestive
Center for Imaging Disease Research Institute of Technology)
Research Core Center

Visual Sciences
Research Center
UH-NTU College of
Medicine

Cleveland, Ohio | 8
 CWRU-UH Joint Strategic Leadership Committee

Summary (2021 – present)

39 Applications
Joint efforts to attract, retain the right talent
33 JSLC Approved and develop programs in key research areas

12 New Recruits (Accepted Offer) Total Commitment - $15,237,604

1 New Recruit (In Process) (2021-2028)

11 New Recruits (Declined Offer) UH: $7,268,642

CWRU: $7,968,963
7 Retentions (Accepted)
2 Programs (Accepted)

Cleveland, Ohio | 9
CWRU-UH Joint Strategic Leadership Committee
Faculty Recruit Faculty Retention New Programs
2023 Collaborative Science Pilot Award

CWRU-UH Blood, Heart, Lung and

Immunology Research Center

Kenneth Remy, MD
Center Director

Cleveland, Ohio | 10
JSLC activities (March 2021 - present)
 JobsOhio Cleveland Innovation District

January 2021 – December 2023

$10.3M $67.2M
New Capital Investment in Research Expenditure Growth
Research/Clinical Infrastructure (Target Y1–Y3: $24M; 2.5% CAGR)
(Target: $10M)

423 $30M
Board Directed Research and
New Research Positions
Drug Development Investment
(Target: 235)

UH Focus:
Research & Product Innovation

Cleveland, Ohio | 11
 CICB Health Informatics Collaboration With UH

OMOP Common Data Model for Patient Data Electronic MEdical Record Search Engine

Structured/coded EHR data Clinical, pathology, radiology, nurses' notes, etc.

>1.9 million UH patients >1.84 million UH patients, >55 million notes
• Population-level clinical characterizations • Rapid searching across all patients
• Longitudinal/temporal analyses • >2 million synonyms and phrases
• Population-level estimation • Rapid cohort selection and chart review
Machine • Import/export/compare patient lists
• Patient-level prediction learning & AI
• Filtering by EHR source, dates, demographics

Present state: CICB-facilitated utilization Present state: Self-service after training

CICB facilitated
Self-service tools in fall 2024 data exchange + guided CICB consultations
Upgrade in fall 2024

Cleveland, Ohio | 12
 Success Story of UH-CICB Collaborations
Center to Improve Clinical Diagnosis
Project number: R18HS029358
Total award: ~ $4M
Co-Investigators: Marlene Miller, Mary Dolansky, Sarah-Koopman Gonzalez, Peter Pronovost, Jessica Goldstein
CICB involvement: preliminary data, grant application, and health analytics portion of awarded grant
Goutham Rao, MD
(Family Medicine)

Empowering Women and Providers for Improved Care of Urinary Incontinence:

EMPOWER Study
Project number: U18HS028742-02S1
Supplement award: $156,000 (Parent award: ~ $3 million, PI: Adonis Hijaz)
Co-Investigators: Elizabeth Harris, Goutham Rao
Elizabeth Harris, MD CICB involvement: data extraction for awarded grant and training investigator to use informatics tools
(Psychiatry)

Developing Real-world Understanding of Medical Music Therapy using the

Electronic Health Record (DRUMMER)
Project number: F31AT012592
Total award: $95,400
CICB involvement: preliminary data, grant application, and data extraction for the awarded grant
Samuel N. Rodgers-Melnick,
MPH, MT-BC
(Connor Whole Health)

Cleveland, Ohio | 13
 UH Hearing Research Center at NEOMED
UH Team (Peripheral Hearing Loss) NEOMED Team (Central Hearing Loss)

Collaborations between
basic and clinical
scientists to increase
high impact and
meaningful research

Diverse clinical expertise and $26M NIH funding

research excellence ($7.3M (over 5 years)

extramural funding over 5 years )

Cleveland, Ohio | 14
UH–NEOMED Faculty Scholar
Class of 2024

Cleveland, Ohio | 15
Full Spectrum of Research – Bench to Bedside and Beyond

UH Medical Centers

Departments/ Centers of
Institutes/Centers Excellence

Strategic Partners
(select)

Departments/
Institutes/Centers

Pharma/Biotech

UH Health Services
Departments/ Research Center
Institutes/Centers
Cleveland, Ohio | 16
 Building Research Excellence
Dept. Total Research Expenditures
Pediatrics 2023 Research Highlights $40
(Millions) $37

Renewal NIH Clinical and Translational Science $32

$28
Collaborative (CTSC) Grant
$25 $24
$56.3M (2023-2030) $24 $23
$21

Millions
$20
Grace McComsey, MD $15 $15
$16 $13 $14
$13
- HRSA Pediatric Pandemic Network $50M (2021-2026) $11 $11
- HRSA EMSC Innovation and Improvement Center $1.04M $6
$8
(2023 – 2024)
- ASPR Region V Kids Pediatric Disaster Center of
$0
Excellence $8.9M (2019 – 2024) CWRU, Dept. of UH CRC, Rainbow Total
Pediatrics
Charles Macias, MD, PhD
210
Dept. Number of New Grants
176
NICHD Neonatal Research Network Clinical Center 180
$2,479,400 (2023 – 2030)
150 140
UG1HD021364-38 136

# of New Grants
129
120 113
102 102
Anna Maria Hibbs, MD 95
90 83 82

PCORI HSII Implementation Science Capacity 60

39
Building Grant 27 27
30 19
$500,000 (2023-2026) 13

0
Peter Pronovost, Marlene Miller, MD CWRU, Dept. Of UH CRC, Rainbow Total
MD, PhD Pediatrics
2019 2020 Cleveland,
2021 2022 Ohio | 17
2023
 Building Research Excellence
Urology 2023 Research and Innovation Highlights
Somatic Mutation Rates in Healthy Aging The Neovaginal Microbiome of Transgender
Women after Gender-Affirming surgery
R01 - $4.2M
(R01AG081622) CTSC Pilot Award - $50,000

Jonathan Shoag, MD Rachel Pope, MD, MPH

Empowering Women and Providers for Improved
Care of Urinary Incontinence (UI): EMPOWER
Study Supplement focused on AA women. Evaluation of Genetic and Metabolic Markers in the
AHRQ – U18 Diversity Supplement - $156,000 Development of Urinary Urgency Incontinence
(U18HS028742-02S1) R03 - $187,000 (R03AG077132)

Adonis Hijaz, MD Convening a Community Health Advisory Board

to Guide Research Priorities in Urologic
Multi-Epitope MAGEA6 Based Peptide David Sheyn, MD
Vaccine for Muscle Invasive Bladder Cancer PCORI - $100,000

CTSC Pilot Award - $50,000

Sanjay Gupta, PhD

155+ Active Research 140+ Journal 90+ Meeting Abstracts 31+ Projects $4.5M Newly Funded
Studies Publications Submitted Funded (inOhio
Cleveland, 2023)
| 18
 Building Research Excellence
Radiology Clinical Faculty Radiology Academic Faculty

Development of Magnetic Resonance Fingerprinting (MRF) to Assess

R01 Response to Neoadjuvant Chemotherapy in Breast Cancer
MPIs: Yong Chen, Dan Ma, Holly Marshall; $3,050,512
MR Fingerprinting based Quantitative Imaging and Analysis Platform (MRF-
R01 QIA) for brain tumors.
MPIs: Chaitra Badve, Dan Ma, Christos Davatzikos; $3,034,497
SCH: Artificial Intelligence for Contrast-Enhanced Imaging
NSF Co-PIs: Leonardo Kayat Bittencourt, Sree Tirumani, Shuo Li (contact PI),
Vipin Chaudhary; $1,125,000

Exploring SGLTs as Theranostic Targets for Cancer Metastasis

R01 PI: Ray Muzic; $434,366

Jobs Blocking salivary uptake for targeted radioligand therapy (RLT) of prostate cancer

$49.4M 2023 Calendar Year Ohio PI: Zhenghong Lee; $86,500

Development of a safe and effective islet-targeted nanoplasmid based CXCL12

(New grant awards since New Grants: $7.8M JDRF
gene delivery system using cationic nanobubble-mediated sonotransfection to
restore and immune protect the residual beta cell mass in T1D.
January 2021) PI: Agata Exner; $61,835
Publications: 98 Cleveland, Ohio | 19
 Building Research Excellence
Radiology Oncology Academic Success
Peer Reviewed Publications National/International Presentations

8x increase
Lauren Henke, MD
NCT05975619
Clinical Trial Accruals
Varian Receives FDA 510(k) Clearance for
TrueBeam and Edge Ratiotherapy Systems
Featuring HyperSight Imaging Solution

Grant Funding Navigator-assisted hypofractionation

(NAVAH) to address RT access
disparities facing African-Americans

Woody McClelland, MD

Cleveland, Ohio | 20
Impact factor >30
 Building Research Excellence
The B(E) Team Pathways of Injury and Repair in Barrett's Carcinogenesis

Amitabh Chak, MD Kishore Guda, PhD Katherine Garman, MD Andrew Blum, MD, PhD Tom LaFramboise, PhD Simon Gregory, PhD Joe Willis, MD Shannon McCall, MD
Co-Director Co-Director (Duke) (Duke) (Duke)

P01CA269019
$11.2M
(9/20/2023 – 8/31/2028) Project 1: A. Chak
Project 2: K. Garman
Project 3: A. Blum and K. Guda

Core 1: A. Chak and K. Guda

Core 2: J. Willis and S. McCall
Core 3: T. LaFramboise and S.
Gregory

Cleveland, Ohio | 21
 Basic and Translational Research

UH Medical Centers

Departments/ Centers of
Institutes/Centers Excellence

Cleveland, Ohio | 22
 First Independent Grant R grants

Ian Neeland, MD Yong Chen, PhD Jonathan Shoag, MD Rui Wang, PhD Leonardo Kayat Bittencourt, MD, PhD
(Medicine) (Radiology) (Urology) (Surgery) (Radiology)

The ADIPOSA Study MRF for Renal and Somatic Mutation Colorectal Cancer Prostate MRF to Optimize
Breast Cancer Imaging Rates in Healthy Aging Tumorigenesis Biopsy Avoidance
R01 $3.4M R01 $2.6M R01 $4.2M R37 $1.84M R01 proposal: $3.8M
(7/20/23-6/30/28) (9/1/22 – 8/31/27) (9/1/23-5/31/28) (2/1/24-1/31/29) (7/20/23-6/30/24)
R01 $3.1M + 2-year non-
competitive extension scored at the 6th percentile
(9/1/23 – 8/31/28)

Long-term grant to support outstanding

Early Stage Investigator Cleveland, Ohio | 23
 Scientific Discovery
Potential Target for New Class of Diabetes Drugs
• SCAN catalyzes S-nitrosylation of insulin receptor (INSR)
• Hypernitrosylation of INSR by SCAN causes diabetes
Hualin Zhou, PhD Jonathan Stamler, MD
**** ****
(Medicine) (Medicine) 300 Wild type
300
SCAN KO

(mg/dL Blood)

(mg/dL Blood)
200 *
*

Glucose
200 * **

Glucose
* **
** *
100 * **
100 **

0
e
typ KO type KO 0
li d CAN ild CAN 0 15 30 60 90120
W S W S
Chow HFD (min) post insulin

• SCAN expression correlates with human BMI and INSR S-nitrosylation

r2=0.314

adipose (vs average)

r2=0.272

SCAN in adipose
4 p=0.002 2.5 p=0.006

(vs average)

SNO-INSR in
3 2.0
2 1.5
1.0
1 0.5
0 0
20 40 50 0 1 2 3 4
30 SCAN expression
BMI
Cleveland, Ohio | 28
 Scientific Discovery
Repurposing Fenofibrate for HPV+ Cancers
• Fenofibrate: FDA approved drug to manage high cholesterol and triglyceride levels
• Fenofibrate exhibits high efficacy in HPV+ cancers
Quintin Pan, PhD
(Otolaryngology)
• Fenofibrate reactivates p53 tumor suppressor program in HPV+ cancers
• IND for Fenofibrate in HPV+ cancer patients: FDA approved, Q3 2023

Wendi O’Neill, DDS, MS

(Otolaryngology)

Lindsay Ferguson, MD Phase I trial for HPV+ cancers

(OB/GYN)
Cervical Cancer (Q1 2024) Diagnosis
Clinical PI: Ferguson Winder Of Opportunity:
Fenofibrate
Standard Of Care
Lab PI: O’Neill Biopsy
(Pre-treatment tumor) Clinical trial accrual Surgical resection
H&N Cancer (Q4 2024) Schedule Toxicity and (Post-treatment tumor)
Clinical PI: TBD for surgery response Cleveland, Ohio | 29
Lab PI: O’Neill
 Scientific Discovery
Ultra-fast (UF)<1 day CAR-T Manufacturing: The Next Generation
CAR-T Platform
• UF-CAR manufacturing process designed to overcome enormous costs, delays to
treatment, accessibility and efficacy of CAR-T therapy
David Wald, MD, PhD
(Medicine)

Traditional
(7-14 days)

UF-CAR
(<1 day)

• Phase 1 trial (PI Changchun Deng) for UF-Kure19 product for

lymphoma nearing completion
• 100% manufacturing success (9 patients)
• 5 of 6 patients with outcome data achieved remission with favorable
safety profile
• IND approval for pending Phase 1 trial for UF-Kure-BCMA for Multiple
Myeloma (PI James Ignatz-Hoover)
Cleveland, Ohio | 30
 Scientific Discovery
BAFF CAR Therapy For B-Cell Cancers and Autoimmune Diseases
$1.35M (Dr. Ralph and Marian Falk Medical Research Trust Award)
Developed a BAFF CAR-T autologous therapy and BAFF CAR-NK allogeneic therapy to treat B-
cell cancers and autoimmune disorders with B cell involvement.
Technology description
Reshmi Parameswaran, PhD
(Medicine) • BAFF ligand-based CAR-T and CAR-NK cells capable of binding three receptors: BAFF-R,
TACI, and BCMA.
Current development status
• BAFF CAR-T is currently in clinical trials for Multiple Myeloma and Non-Hodgkin Lymphoma.
• BAFF CAR-T received IND approval for treating lupus patients.
• Developing BAFF CAR NK cells as an allogeneic “off the shelf”.
In vivo BAFF CAR T cell efficacy BAFF CAR NK cell in vitro cytotoxicity with no CRS
BAFF CAR-T/MCL xenograft

Case-Coulter Translational Research Partnership

U.S. Utility Patent Application No. 16/888,989 Cleveland, Ohio | 31

U.S. Provisional Application No. 63/482,049
Translational and Drug Development

Cleveland, Ohio | 32
 Radiology A.I. & Diagnostic Innovation Collaborative
Strategic Collaborations

Projects

• Sensitivity 94-97% for fracture detection, w ith 30% of reduction in time to read x-ray.
• FDA clearance from clinical study performed at UH.

• Clinical study and data enablement in Prostate MRI

• UH to be one of 5 main academic US sites for co-development
• Opportunities for screening of underserved communities through other initiatives such as CAAPP

• 86% sensitivity/specificity, 70% faster total turnaround time for x-rays w ith pneumothorax.
• UH now main site for x-ray AI co-development w ith GE. Endotracheal tube algorithm and others.
• Morningstar Investments report mentioning this UH collaboration as an upside for GE stock.

• Long term collaboration in Breast/mammogram A.I. Applications

• Cardiovascular risk assessment algorithm leveraging on unique calcium score CT database at UH
• Ohio-w ide collaboration, leading to co-development and co-marketing opportunities

• Prestigious group of contributors of data to RSNA AI challenge

• Project delivered in record time (4 w eeks), joint effort w ith research and informatics teams.
• Publication to follow in Radiology AI

Project Funnel and more…

Lt Gov. Jon Husted

at Ohio AI Forum

Cleveland, Ohio | 33
 Accelerating Therapeutics

Areas of Focus
Jonathan Stamler, MD

Cleveland, Ohio | 34
 Accelerating Therapeutics

Impact
Funded Institutions

Medicines in
178 the Making

Institutions
65 Supported

Companies
39 Launched

Medicines in
21 the Clinic

Licenses to
15 Pharma

Cleveland, Ohio | 35
 Accelerating Therapeutics
2023 Highlights Therapeutics Accelerator Launch
October 2, 2023 | The University of Oxford
• 11th class of Scholar-Innovators selected
 108 physician-scientists to date
• Drugs licensed to industry, including:
 AcuraStem (Takeda)
• Programs (progressing) in clinical trials, including:
 Phase 3 – Rare cancer (Sol-Gel)
 Phase 2 – Alzheimer’s & Parkinson’s (Allyx)
 Phase 2 – Osteoarthritis pain (Levicept)
 Phase 1/2 – Cancer (Aleta)
• First Harrington MSTP Scholar published findings (Oncology
target)
• Announced Oxford-Harrington Rare Disease Centre
Therapeutics Accelerator
• Goal: 40 new therapies into clinical trials in 10 years
• David Cameron - Former UK PM Founding Chair, Advisory
Council Cleveland, Ohio | 36
 Accelerating Diagnostics and Devices
Investing in Promising Companies
Source
UH Ventures Investment Portfolio
5

Inside-Out Outside-In

Stage
1
2
6

Seed Series A Series B Series C

Domain
2

HIT Med Device Supply Chain

Cleveland, Ohio | 37
 Accelerating Diagnostics and Devices
Accelerating Commercialization of UH IP
UH Ventures and Shared IP
Spinouts

185+ Public offering - June 2020 Acquired by Amgen - March 2021

Patent Filings

100 Public offering - October 2021

Invention Disclosures
(UH and CWRU/UH Joint ID)

35+
Deals (Licenses/Options)
Ureteral Stent Company

1/1/2023 – 12/31/2023 Cleveland, Ohio | 38

 UH Haslam Sports Innovation Center

$20 Million Gift to Launch

James Voos, MD
Haslam Sports Innovation Center (Orthopedics)

The UH Haslam Sports Innovation Center provides a

pipeline for new sports medicine technologies.
Dee and Jimmy Haslam
Our goal is to identify, showcase and accelerate the
Transform Sports through Innovation for world’s best innovations and establish University Hospitals
Professional and Recreational Athletes as the nation’s #1 destination for sports medicine.

Cleveland, Ohio | 39
Clinical Research

Pharma/Biotech

UH Departments/
Institutes/Centers

Cleveland, Ohio | 40
 Clinical Research
Randomized Controlled Trial to Optimize Patient's
Selection for Endovascular Treatment in Acute
Ischemic Stroke
• Prospective, randomized, multicenter, open-label, phase III
clinical trial with assessing Thrombectomy in large core
strokes
Amrou Sarraj, MD
(Neurology)

Global Principle NEJM 2023

Investigator

• 352 patients enrolled across 31 sites worldwide (USA,

Canada, Europe, Australia and New Zealand)
Conclusion Lancet 2024
• Comparing to standard medical management,
thrombectomy procedure result in better outcome*
• Sustained benefit across different imaging
modalities
• Sustained benefit at 1-year follow-up

*: 1.5 times more lik ely to result in better functional outcome; 3 times more lik ely to result in functional independence; 2 times
more lik ely to achieve independent ambulation
JAMA 2024
 Clinical Research

Mehdi Shishehbor,
DO, MPH, PhD
(Medicine)

STAT All Star Top 4

Competition

Top 10
(United States)

Cleveland, Ohio | 42
 Clinical Research
CMS Approval Guideline Endorsement

Daniel Spratt, MD
(Radiation Oncology)

5 Phase III Randomized Trials

65% can
16 Terabytes of Digital Pathology avoid
hormone
therapy

Cleveland, Ohio | 43
 Clinical Research
Adipose Dysfunction, Imaging, Physiology, and Outcomes with
SGLT2is for Sleep Apnea The ADIPOSA Study
• Obstructive sleep apnea (OSA) is a major cardiovascular risk factor
• Current therapy is poorly tolerated and does not address the underlying pathophysiology
• We observed a 50% reduction in new onset OSA in two large cardiovascular outcomes trials of
SGLT2 inhibitors in post-hoc analyses
Ian Neeland, MD • The goal is to perform a mechanistic clinical trial of SGLT2 inhibition in participants with moderate to
(Medicine)
severe OSA and overweight/obesity to better understand how and why SGLT2 inhibitors may improve
Co-PI: OSA
Henry Klar Yaggi, MD, PhD
(Yale Medical School)

R01HL163627

Cleveland, Ohio | 44
 Clinical Research
Paradigm Shift in ACL Surgery: Rotator Cuff and ACL
Collagen Scaffolds Enhances Repair

James Voos, MD Jacob Calcei, MD

(Orthopedics) (Orthopedics)

Robert Gillespie, MD Jason Ina, MD

(Orthopedics) (Orthopedics)

• Electrochemical compaction (ELAC) - Converts solubilized collagen into dense collagen threads
• Completed rabbit and sheep RTC repair studies (Improvement in RTC repair strength and quality)
• Repair ACL and support with scaffold instead of reconstruction. Avoids morbidity of harvesting
autologous tissue.
Andrew Moyal, MD
• 6 pigs implanted with novel implant ACL collagen scaffold repair, 9 additional surgeries schedule
(Orthopedics)

FDA 501k Submission Complete Plan for 1 st Human Implantation in the Summer

Cleveland, Ohio | 45
 Clinical Research
Retinoblastoma protein is Functional in a Subset of Small Cell Lung
Cancer and Responds to CDK4/6 Inhibitors
• Small cell lung cancer (SCLC) exhibits no currently targetable genetic mutations.
• SCLC cells and xenograft tumors with retinoblastoma 1 (RB1) protein expression were
sensitive to growth inhibition by the CDK4/6 inhibitor.
Afshin Dowlati, MD • Patient with biopsy-validated wild-type RB1 SCLC who received the CDK4/6 inhibitor
(Medicine)
(Abemaciclib) demonstrated a major response and tumor shrinkage.
Growth inhibition by Palbociclib Response to Abemaciclib treatment
(RB1 CRISPR knockout cells) (wt RB1 SCLC patient )

Clinical research funded by Eli Lily (CASE1519 – trial has enrolled 9 patients as of now) DowlatiCleveland, OhioTher
Lab – Mol Cancer | 46
2023
 Clinical Research
CORVETS - Cleveland Ohio Respiratory Viruses Vaccines Effectiveness
across Traditional Risk Factors and Social Determinants of Health
$14.2M (2022-2027) awarded by the CDC, with options for additional funding and term extension
Elie Saade, MD
(Medicine)

Integral to the U.S. Flu Vaccine Effectiveness Network:

• Generates effectiveness estimates for licensed flu vaccines
• Analyzes by age, influenza type, and subtype

Core Objectives:
• Public Health Initiatives: Evaluate seasonal flu vaccine effectiveness and
contribute to future vaccine composition decisions
• Clinical Research: Conduct trials assessing immune responses to flu
vaccines
• Immunology Testing Center: Lead advanced immune testing for network
sites and CDC collaborative projects 7 reporting sites + 1 coordinating site
• Collaborative Team: Experts from University Hospitals (UH), Veterans (UH is the only site in Ohio)
Affairs (VA), and Case Western Reserve University
• UH Clinical Sites: 5 Emergency Departments, Urgent Care Centers, select
outpatient clinics
Cleveland, Ohio | 47
 Health Outcome/Health Services Research

UH Health Services
Departments/Centers Research Center
/Institutes

Cleveland, Ohio | 48
Neurological and Behavioral Outcomes Center
2023 Highlights
14
$10.8M
Newly funded research grants

New manuscripts, books/book

58 chapter published or in press

Alzheimer’s Regional, national, and

Disease/
Dementia 68 international presentations
Medical
Epilepsy
Education
& Training
79 Mentees supported
NBOC 79
Multiple
Stroke
$10.8M in new research grant
Sclerosis
funding as Principal Investigators
Mental
Health

Cleveland, Ohio | 49
 Impact Community and World
World’s Largest No Charge Precision Medicine Screening: Impact of CLARIFY

20+ Papers
Sanjay Rajagopalan, MD
40+ Scientific Abstracts
(Medicine)
40+ Presentations
$20M+ Extramural Funding
>100,000 Patients Across Ohio and the United States
IMPACT ON PATIENT GROUPS
• Impact in Severe Hypercholesterolemia
• Women
• African Americans
• Elevated Lp(a)
• Diabetics and Prognosis
• Diagnosis of Thoracic Aortic Aneurysm
• IBD, Crohn’s Disease

UH initiative offering community members with high

risk-factors for heart disease a free CT scan calcium
score assessment Cleveland, Ohio | 50
 Impact Community and World
Employ Cutting-Edge AI Techniques to Recognize Complex Patterns in
Medical Images to Produce Precise Insights and Predictions

Sanjay Rajagopalan, MD
(Medicine)

Multi-PI:David Wilson, PhD

$2.82M
R01HL167199
(2023-2027)

$2.8M Whole heart

R01HL165218 •Agatston score
•Volume,
(2023-2027) •Mass,
• …
Artery
• LAD mass,
• LCX num of
lesions,
• RCA Agatston
score.
• … Agatston score Calcium-omics

Survival probability
2D Calcification
• Surface Area,
• meanHU,
• num of 2D Lesions Group # Group #
(Agatston score) (Calcium-omics score)
•… Risk 0, (0) Risk 0, (<0.99)
3D Calcification Risk 1, (1-99) Risk 1, (0.99 to 1.56)
•Mass, Risk 2, (100-299) Risk 2, (1.56 to 1.76)
•distance to next, Risk 3, (300-999) Risk 3, (1.76 to 2.09)
•HU_histogram Risk 4, (>1000)
•... Cleveland, Ohio | 51
Risk 4, (>2.09)
 Impact Community and World
UH Connor Whole Health

Francoise Adan, MD Samuel N. Rodgers-Melnick, MPH, MT-BC Christine Kaiser, DACM, LAc, LCH, FABORM
Chief Whole Health and Well-Being Officer Music Therapy Researcher (PhD Candidate) Connor Endowed Director of Reproductive Well-being

Received $3.15M from The Elisabeth Received F31 Pre-doctoral Fellowship (NCCIH) $200,000 from The Vitamix Foundation
Severance Prentiss Foundation • Exam music therapy’s impacts on pain, stress, for research within UH Fertility Center
medication use, and length of stay • Shared medical appointments +
• Conduct practice-based research health coaching to promote
• Multi-site feasibility study to address chronic
• Investigate impacts on health-related pain in sickle cell disease wellbeing
quality of life, utilization, and costs • Examine impact on health
• Feasibility study in COPD and heart failure
funded by Kulas Foundation behaviors, sleep, stress, and self-
efficacy

Cleveland, Ohio | 52
 Impact Community and World
HIV/HCV/Syphilis Screening and Substance Use Disorder
Linkage to Care Screening and Treatment
$1.3M Dedicated HIV Funding 2023-2024 $1M Dedicated SUD 2023-2024
Samuel Stitzel,
• HIV Frontlines of Communities in the • Project DAWN (Deaths Avoided PharmD, BCPS
Kiran Faryar, MD, MPH United States (FOCUS)
(Emergency Medicine) With Naloxone)
• Ending the HIV Epidemic • Survey on Microinduction Protocol
• Creation of a Novel Geospatial • Health Systems Comprehensive
Information System (GIS)-based Care Tier 1 HZ24 Ryan Marino, MD
Reportable Diseases Mapping Tool (Emergency Medicine)
Project DAWN Naloxone Kits
(REDMAP) Distributed
Justin Yax, DO, DTMH
(Emergency Medicine)

Lauren Porter, DO
(Emergency Medicine)

Project DAWN Heat Map:

Naloxone recipients (by zip code)
and distribution sites (blue squares)

Heat map of HIV testing facilitated by FOCUS Bryan Ross, MD

Cleveland, Ohio | 53Medicine)
(Emergency
 University Hospitals Health Services Research Center

Vision
Catalyze excellence and national leadership in the development, evaluation, and translation
of evidence and policies to enhance the efficacy, efficiency, and equity of healthcare
delivery to improve health and well-being outcomes at the individual and population levels.
Samudragupta Bora, PhD
(Pediatrics)
Founding Director

Boost Research Capacity in Health Services Research

Improve Population Health and Community Impact Cleveland, Ohio | 54
 University Hospitals Health Services Research Center
Key Progress Updates
(Since launch in January 2024)

Foundation of Health Services Research

Certificate Program
Samudragupta Bora, PhD • 3-week intensive, fast-paced, in-person program
(Pediatrics)
Founding Director • Fundamentals of health services research
methodology as well as broad skills to pursue Deputy Director of Community-
innovative, transdisciplinary, and team science in a Engaged Research
mentored research environment. (recruitment in progress)

• 2024 cohort enrollment opens from April – May 2024

2023 Cohort Coming Soon (June 2024)
• Distinguished Speaker Series
• Health Services Research
Grand Rounds
• Health Services Research Pilot
Grants
• Health Services Research
Career Development Grant
Workshop Series
Cleveland, Ohio | 55
 Faculty Recognition Celebration
• Acknowledgment of the esteemed 63 UH faculty
promoted at CWRU (July 1, 2023)
• Commemoration of this significant achievement
on August 24, 2023
• Inspiring remarks from the distinguished faculty
members who have been promoted
“It has been here that I have been able to serve as an educator, a
neurosurgeon, organizer, mentor, team player, leader and a human
being who walks one foot in front of the other everyday when I enter
the hospital doors” – Tiffany Hodges, MD

“Teaching people from all over the world, teaching our

fellows, while still providing excellent care” - Guilherme
Attizzani, MD Cleveland, Ohio | 56
Academic Promotion

63 New Senior
CWRU Promotions
(July 1, 2023)

Cleveland, Ohio | 57
 Special Recognition

Jonathan Stamler, MD Mehdi Shishehbor, MD Amrou Sarraj, MD Jeanne Lackamp, MD

Fellow of the 2023 National Chair, Department of

Academy of Inventors Psychiatry and Director,
Behavioral Health Institute

Cleveland, Ohio | 58
Congratulations
The Most Reputable Academic Medical Centers

#28 World

#14 U.S.

by UK Brand Finance

Cleveland, Ohio | 59
 UH Research & Education (UH R&E) Institute

Grace McComsey, MD Deborah Slogar, CPA Yi Fritz, MS, MBA, PMP Debra Leizman, MD Elizabeth Harcher
Director, Clinical Research Director, Academic Finance Director, Research Strategy and Director, Medical Student Interim DIO, GME
Center Administration Education

Daniel Simon, MD
President Academic & External Affairs and CSO
University Hospitals Health System
Professor and Senior Associate Dean for Academic Affairs Samudragupta Bora, PhD Jori Mintz Luke Cleland, J.D. Elizabeth Hammack, J.D. Kumar Mukesh
CWRU School of Medicine Director, Health Services Vice President, Development Deputy General Counsel Deputy General Counsel Director, Grants Accounting
Research Center Institutional Giving and Strategic Initiatives

Est. 2017

Nicole Bollinger, MBA Lisa Hackle Shelly Parkhurst Abigail Zona Marjorie Greenfield, MD COO, Clinical
Sr. Academic Marketing Sr. Academic Digital Physician Marketing Academic Affairs Career Development and Research Center
Strategist Strategist Coordinator Advancement Officer

Cleveland, Ohio | 60
 Research Support Highlights
Seidman Cancer Center Research & Clinical Trials Unit William T. Dahms Clinical Research Unit (DCRU)

Research Compliance Institutional Review Grants & Contract FDA Regulatory Investigational
Board Drug Services

250+ 6,500 1,190 FE Agreements 56 Submissions 4,495 IDS Procedures

Audits completed Submissions processed 20 Master Agreements 1,582 IP Shipments

Clinical Research UH Mobile Clinical Research Unit OPENED the new

Education & Training Bionutrition Metabolic Kitchen

2,085 Online class (UH GPS) 1,249 Procedures

147 Participants
14 High Schools & 7 Colleges
417 Unique patient encounters Only resource of this kind in NE Ohio
Cleveland, Ohio | 61
Research Support Highlights

Support Diversity in
Clinical Research

William T. Dahms Clinical Research Unit (DCRU)

Seidman Cancer Center Research & Clinical Trials Unit

Cleveland, Ohio | 62
 Research Support Highlights
2023 Attainment: $38.2M
Select 2023 Successes Your Partners in Funding Pursuit
1. Health Resources & Services Administrations
• PI: Michelle Hereford, MSHA, RN, FACHE
• Project: Nurse Education, Practice, Quality and Retention (UH as sub-grantee to
KSU)
• $2,413,506 (over 4 years)
2. The Leona M. and Harry B. Helmsley Charitable Trust
• PI: Julia Blanchette, RN, PhD Jori Mintz Madison Wheeler Keyara Garner
• Project: Type 1 Diabetes Financial Toolkit
• $2,251,238 Corporate & Foundation
3. American Cancer Society
Research Development
• PI: Jordan Winter, MD
Relations
• Project: Mission Boost- Immune Response to Pancreatic Cancer
• $600,000
4. Patient Centered Outcomes Research Institute
• PI: Marlene Miller, MD/Peter Pronovost, MD, PhD, FCCM
• Project: Health Services Implementation Initiative Capacity Building Grant
• $500,000 Margaret Roudebush
5. Susan G. Komen Foundation Abby Bruell
• PI: Shearwood McClelland, MD
• Project: Navigator-Assisted Short-Course Radiation Therapy in Black Breast
Cancer Patients Frank Ballish
• $450,000
6. Merck & Co.
• PI: Sakti Chakrabarti, MD
• Project: EQUITY GI: A prospective study to Enhance QUality, Inclusivity, and Sally Garrett-Karyo Eleanor Leahy Thea DeRosa Cerra
Trial participation in Black patients with GastroIntestinal cancer
• $280,000
Cleveland, Ohio | 63
 Research Support Highlights
Communication – Stay Connected
2024 Focus: Advancing National Research Reputation
Yi Fritz Lisa Hackle Nicole Bollinger Abigail Zona Shelly Parkhurst

2023 Success National Reputation Campaign

Social campaign targeting academic
• Website traffic increased 19% over 2022 medicine, medical research,
• Grew social media by 217% across all R&E physicians, and medical students
channels based on interests and web behavior.

• Science@UH podcast currently has 2,150

downloads in 36 countries ResearchGate Campaign
• Innovation email campaign continues to 4-month ad placement targeting
perform above industry benchmarks national audience. Ads placed next to
contextually relevant publications.
• Research & Innovation Day event had 310
registrants (+7%) including registrants from
higher education, industry, and community.
National Research Email Campaign
Quarterly email highlighting high impact
scientific advances to a national AMA
physician list.
Cleveland, Ohio | 64
 Look Ahead……..

• Recruitment of diverse faculty to promote team science through

collaborative, interdisciplinary efforts

• Augment and diversify revenue streams for academic activities

(AHRQ/PCORI/HRSA/CDC, foundation and industry grant support
and indirect, IP & commercialization, philanthropy)

• Strengthen our academic partnerships

Cleveland, Ohio | 65
It Takes a Team to Make
Research Happen.

THANK YOU!
https://tw itter.com/UH_RE_Institute

https://w ww.linkedin.com/company/uh-research-education-institute/

[email protected]

Cleveland, Ohio | 66