2024 Research Advancement Meeting

Page 1

MEETING Highlights and Key Takeaways

MAY 2024

ANNUAL RESEARCH ADVANCEMENT
2024

• A Note of Thanks ………………………………………………………………………4

SESSION I: ACCOMPLISHMENTS AND OPPORTUNITIES

• Research and Innovation Accomplishments and Opportunities…8

• Evolution of Research Enterprise at Meharry

• Transformation of Meharry:2026 Sesquicentennial Plan

• Capacity-Building Initiatives to Expand Meharry’s Reach

• Competitiveness Conversation to Forge the Future

Session II: Assurances and Liabilities – Administrative Processes

• Research Administration Processes and Services………………………55

• Research Administration Services Staff

• Research Enterprise Functional Organizational Chart

• Assurances and Certifications Meharry Provides for Funding

• Liabilities In Research and Sponsored Awards

• Consequences of Non-Compliance and Liabilities

• Research and Sponsored Programs Compliance Areas

• The Grant Lifecycle

• Grants Submission and Management Processes……………………….64

• Grants Management Staff

• Applications submitted

• Pre-Award Grant Process (NIH model)

• Select the Meharry budget template based on the annual costs of the project

• Preparing Your Application Using ASSIST

• Research Performance Progress Reports (RPPR)

• Carryover of Unobligated Balances

• Liabilities of Grant Non-compliance

• Regulatory Affairs Processes…………………………………………………………….77

• Regulatory Affairs Staff

• Processes in Regulatory Affairs How to Submit a Research Protocol

• FDA and USDA unannounced inspections

• Some examples of Noncompliance

• Liabilities and Consequences of Noncompliance

• Regulatory Tips

• Financial Monitoring Processes…………………………………………………….....91

• Finance and Business Staff

• Post Award Activities Overview

• Processes and Tasks for Award Management

• Award Set-Up Tips & Reminders for PIs

• Charging and Reviewing Expenses Tips & Reminders for PIs

• Cost Transfers, Re-budgeting PI Tips & Reminders

• Prepare and Submit Financial Reports Tips & Reminders

• Prepare and Send Invoices PI Tips & Reminders

• Subaward Agreements and Modifications Tips & Reminders

• Review Subaward Invoices Tips & Reminders

• The Finance Division Performs These Tasks

• Closeout Tips and Reminders

• Key PI Responsibilities

• Grants and Contracts Office Updates……………………………………………..107

• Grants Workday Video Training and Job Aids Link

• Procurement Workday Job Aids Link

Table of Contents
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SESSION III: RESEARCH ADVANCEMENT NETWORKING ACTIVITY

• Networking Question A……………………......................................110

• Meharry’s research and innovation has excelled in multiple disciplines over the last few years, where would you like to see the Meharry research enterprise in the next five years?

• Networking Question A – Summary of Responses

• Networking Question A - Common Themes

• Networking Question B………………………………………….................112

• What new transdisciplinary research groups can be forged to advance Meharry’s research and innovation - how can the Office for Research and Innovation help in facilitating these collaborations and what new funding streams can be targeted and/or developed to realize this effort?

• Networking Question B – Summary of Responses

• Networking Question B - Common Themes

• Networking Question C………………………………………………….........114

• How can Meharry’s Research Enterprise contribute to a healthy Nashville community?

• Networking Question C – Summary of Responses

• Networking Question C - Common Themes

Session IV: Lessons Learned from Mount Sinai Transformative Model

• The House of Noble Deeds………………………………………………….118

• Strategies for Facilitating Biomedical Breakthroughs

• Clinical and Translational Institutes

• Genomics Institute – A Core Technology Institute

• Keys to Our Continued Success

• CARTS Financial Structure

• CARTS Financial Distribution Model

• Leadership Matters

• Leadership of Discipline

• Growth Needs New Space

Session V: Advancing Research Panel Discussion

• Key Takeaways from Panel Discussion…………………………………141

• The Roadmap to R1 Status………………………………………………….142

• Acknowledgements…………………………………………………………….143

Table of Contents
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Dear Colleagues,

A Note of Thanks

On behalf of the Office for Research and Innovation, I want to extend my deepest gratitude for your presence and participation in the 2024 Annual Research Advancement Meeting. Your involvement made this event an outstanding success. Over the course of our gathering, we discussed a remarkable range of innovative research currently taking place at the Institution and opportunities to further our research enterprise. The insightful discussion, diverse viewpoints, and shared expertise among attendees truly made this event exceptional. Your contributions, whether through sharing the cuttingedge projects you’re working on, participating in the “flip the panel” discussion, or simply engaging in thoughtful conversation, enriched the experience for everyone involved.

The collective energy and enthusiasm you brought to this event affirmed the crucial importance of transdisciplinary collaboration in advancing healthcare research, equity, outreach, and workforce development. Attached are copies of the presentations, highlights, and takeaways from the event sessions. As we take the knowledge and connections forged here back to our respective departments, I am confident that the partnerships and insights gained will continue to bear fruit long after the inaugural research advancement meeting. It is indeed an exciting time in Meharry’s history to be at the forefront of pioneering efforts to address the global healthcare challenges affecting our communities. Thank you for your unwavering dedication to advancing research and innovation. Together, we can turn today’s ideas into tomorrow’s healthcare breakthroughs.

Warm regards,

May 6, 2024

Senior
for Research and Innovation 4
5

Session I ACCOMPLISHMENTS AND OPPORTUNITIES

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About the Presenter

SESSION I: ACCOMPLISHMENTS AND OPPORTUNITIES

Dr. Anil Shanker is Senior Vice President for Research and Innovation and a tenured Professor of Biochemistry, Cancer Biology, Neuroscience and Pharmacology at Meharry Medical College, the oldest historically Black medical school in the South – comprised of the schools of medicine, dentistry, graduate studies, applied computational sciences and global health. As a renowned scientist in cancer immunology, Dr. Shanker’s pioneering studies established the thymic development of tumor-reactive CD8 T cells against cancer-germline self-antigens . He discovered the phenomenon of T- cell help for innate NK cell effector function against tumors . His laboratory studies the mechanics of lymphocyte and neuroimmune networks, mitochondrial dysfunction and inflammaging with a focus on preventing the escape of solid tumors and neurovascular pathologies.

Dr. Shanker has a history of providing vibrant mentoring to the next generation of biomedical scientists from underrepresented backgrounds . For his passion to nurture young talents, he played an active role in organizing city science fairs and young investigators colloquium. He contributed to upgrading the graduate school curriculum at Meharry Medical College and developed a new graduate course in cancer immunotherapy. Working with the education committee of the American Association of Immunologists, he developed a curriculum to assist universities and colleges in undergraduate tumor immunology instruction. One of his PhD students, Samuel Troy Pellom Jr., was recognized as the “most published” Ph.D. graduate at Meharry . All his trainees progressed to tenure-track faculty/scientist positions in academia, government, or industry.

Dr. Shanker has fostered a collaborative research ecosystem and entrepreneurship at Meharry. He has forged strategic publicprivate capacity-building partnerships . Under his leadership, Meharry’s research and innovation enterprise has attained a high research-active category per NIH with 5-fold growth in three years to $112 million. He leads the Southeast Leadership/Administrative Hub for the NIH-funded ($100 million) Artificial Intelligence and Machine Learning consortium to advance health equity and researcher diversity (AIM-AHEAD) in 11 Southeastern states of the US. In collaboration with the Tennessee State University and Fisk University, he also leads the Department of Energy’s Tennessee HBCU partnership for environmental health management. He established the NHGRI-funded Diversity Center for Genome Research at Meharry – one of the first to study the genomics of chronic diseases prevalent in African Americans . He is the founding member of the Board of Directors of the Diaspora Human Genomics Institute. Working with the biopharmaceutical consortium of Regeneron, AstraZeneca, Novo Nordisk and Roche, he co-developed a transformative 300 million dollar “Together for CHANGE” (T4C) initiative to close the gap of historical underrepresentation of global Black communities in reference genomic database. The T4C is designed to empower science and education in HBCUs in the US and HDIs in Africa. Launched on October 18, 2023, T4C was positively received by the community and media worldwide; over 250 news outlets, including Associated Press, Science, ABC, NBC, African Dream, Bloomberg Radio, BBC etc reported the launch, with 35.5 million unique digital views of the press release.

Among many honors, Dr . Shanker is recognized as a member of the National Academies of Sciences, Engineering and Medicine Board on Health Sciences Policy, an Overseas Fellow of the Royal Society of Medicine, UK, a Fellow of the International Union Against Cancer, and a Champion of the Society for Immunotherapy of Cancer. He received the NIH Director’s Award of Merit, the NCI Mentoring Award, and several Minority-Serving Faculty Scholar awards. He participates on the executive steering committee of the AAMC Leadership Group on Research Advancement and Development, including serving as a scientific and policy advisor to multiple national and international bodies. He is committed to advancing equity and inclusion in education and healthcare innovation.

7

Research and Innovation Accomplishments and Opportunities

Shanker, MS, PhD

Senior Vice President for Research and Innovation

May 6, 2024

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• Evolution of Research Enterprise at Meharry

• Transformationof Meharry: 2026 Sesquicentennial Plan

• Capacity-Building InitiativestoExpand Meharry’s Reach

• CompetitivenessConversation toForge the Future

Agenda
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VISION

Establish Meharry a global leader in research and innovation with a thriving and inclusive ecosystem to discover healthcare breakthroughs for eliminating health disparities

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Align pedagogical, biomedical, clinical and community health research, and policy initiatives toward a transdisciplinary “systems medicine” health equity approach

COMMUNITY

Microbiome
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Financial Sustainability + Global Outreach + Impact

Academics Clinic

Academic Health Sciences Center of Excellence

(Singular focus on data-driven health equity)

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September 2019

Minu Chaudhuri, PhD

Chandravanu Dash, PhD (Chair, 2020 – 2022)

Pius Nde, PhD

Amos Sakwe, PhD (Chair, 2022 – 2023)

Anil Shanker, PhD

President’s Research Advisory Council

Mekeila Cook, PhD

Pandu Gangula, PhD

Stephania Miller-Hughes, PhD

Heather O’Hara, MD

Rajbir Singh, MBBS

Robert L Cooper, PhD

Bindong Liu, PhD (Chair, 2023 – Present)

Amosy M’Koma, MD, PhD

Aramandla Ramesh, PhD

Qingguo Wang, PhD

Karen Winkfield, MD, PhD

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Developed Safety Protocols for:

• Meharry Research Labs

• Metro Nashville Public Schools

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8 HBCUs: MMC, Florida A&M, MSM, Hampton, Howard, Texas Southern, Tuskegee & Xavier

Million $12 Million

Atanu Khatua, PhD

JeffreyLeegon, MS

Dana Marshall, PhD

Franklin Nouvet, BS

Anil Shanker, PhD

WBSB 1,024 sq. ft. lab space COVID-19
Diagnostics Lab – CLIA Certified
Renovated
Molecular
$15
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(S)HEROES

Gamaliel Ballard

Christopher Crowell

Jaqueline Harding

Lisa Johnson

Nasrin Karim

Mohammad Niaz

Nihad Sakic SanjoySircar

Karen Smith

Zudi-Mwak Takizala

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for Research, 1978 17 FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION
CharlesW
Johnson Sr, MD First VP

1952 – 66:

Research Evolution and Transformation

Foundation Phase – Harold D. West, PhD – First Black President

– Radioactive tracers todetect tumors

– Cancer Health Disparity Research (American Cancer Society)

– Sponsored research grew from $80K to $1M

– Endowment doubled to $7 Million

RenaissancePhase – Lloyd C. Elam, MD

1968 – 81:

– $89 Million campaign

– Elam Mental HealthCenter (1971)

– InternationalCenter for Family Planning Trainingand Research (1971,11African countries)

– Sickle Cell Center (one of first 10 in thenation) – Thomas Shockley, PhD

– Division of Genetics andMolecular Medicine

– SOGS accreditedto grant PhD (1972)

– First R01 award (Das)

Transformation(Metamorphosis) Phase – James E.K. Hildreth, PhD, MD

Meharry 2026 SesquicentennialStrategic Plan

Meet thechallenges of the 21st century

2015
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“Working for Underserved low income and >71%”

Meharry 2026 and Beyond

Pioneering Approaches to Health Equity

Global Presence with Global Reach”

DVANCEMENT MEETING
19

• Reviewed all regulatory policies

• Instituted r egular campus-wide research laboratoryinspections to assess the safety and riskoflaboratory environments

• Implemented mandatory labsafety training

• Restructured Institutional Regulatory Affairs committees with termed memberships – IRB,IBC, IACUC and Radiation Safety committees

• Hired Human Subject Protection and Bioethics Officer

• Organized Regulatory symposiums

• Reduced re turn time for signing MTAs, CDAs etc to less than 12 hours following thecompletion of legal review

• Successfully completed site visits/inspections from the FDA,

International, USDA and NIH

AAALAC
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Transformation of Meharry’s Research Enterprise

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PubMed

Meharry Publications

LaTayia Aaron-Brooks

Vladimir Berthaud

ZhenbangChen

Jamaine Davis

Taneisha Gillyard

James Hildreth

ThanigaivelanKanagasabai

Wenfu Lu

Stephania Miller-Hughes

KeAndreya Morrison

Maureen Sanderson

Duane Smoot Lancet

Nature Nature Genetics
NEJM
Nature Communications Cell
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Meharry Investigator Networks

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MMC– U Memphis Program to Enhance Collaborative & Interdisciplinary Research

Meharry PI U Memphis PI Project

Cunningham- Seok Won Jin Erves/Sanderson

Brown Pichon

Data Acquisition Poster/ Manuscript Grants

Assessing Vaccine Hesitancy for Flu, Yes HPV, and COVID-19 Vaccines in Tennessee

Informing Future Delivery of Trauma Yes

Informed Care in Community-Based HIV Service Organizations, Faith-Based Organizations, the Local Health Department, and Federally Qualified Health Care Centers

Mukherjee Young A Focus Group Study of the Communication and Educational Needs of Parents and Patients with Sickle Cell Disease or Sickle Cell Trait Yes

Misra Puppa Elucidating Mechanisms for the Sexually Dimorphic Response to Diet Induced Obesity and Metabolic Syndrome

Chen Z Wang Discovery of Exosome-Based Molecular Biomarkers for Predicting Prostate Cancer Impending Metastasis

Abstract

Yes

Ukoli Antipova Eliminating Socially-Driven Infant Obesity Disparities in Minority Communities of Memphis and Nashville: A Community-Based Intervention

NIH R15 Area Grant “Improving HPV Vaccination using VR in College Students” Resubmitted for 2/25/24 deadline. Amount: $488,521 over 3 years

Yes In Progress Awarded funding for P30 AI110527 NIAID Tennessee CFAR ARC/EHE Supplement (PI Brown Co I Pichon). Amount: $376,115.

2 grants awarded with Pichon as Lead PI: 1) NIH R61/R33 entitled “A

Multimethod Assessment of the Clinical, Economic & Social Impact of the Rejection of Federal HIV Prevention Funds in Tennessee.” Amount $683,496. 2) CDC subaward to state of Tennessee. “National HIV Behavioral Surveillance (NHBS) 2022.” Amount: $35,732

None (Dr. Mukherjee retired from Meharry)

Yes Yes

None

Yes Yes

In Progress

Award from DoD with Chen as lead PI, with a total of $1,048,111 with a project period from 08/01/2022-07/31/2025. Title: “Novel Mechanism and Targeting of Neuroendocrine Prostate Cancer”.

R15 grant submitted on 10/25/2023 deadline with Wang as PI. Amount: $419,861. “Artificial Intelligence assisted discovery on integrins based molecular biomarkers for cancer metastasis detection

Grant submitted to Robert Wood Johnson Foundation. “Bridging the Gap in Socially-Driven Infant Obesity Disparities via Healthy Eating Intervention in Disadvantaged Communities of Memphis and Nashville.” Amount: $50,000.

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Investigator-Initiated R-Research Awards

• Dorin Borza, PhD

R21 HL168484

• Minu Chaudhuri, PhD

R01 AI125662

• Clivel Charleton, PhD

R21 ES027663

• Chandravanu Dash, PhD

R01 AI136740

R01 AI170228

• Xinhong Dong, PhD

R01 AI157764

• Pandu Gangula, PhD

R16 GM149440

$109,126 /annum 02/2023 – 01/2025

$449,588 /annum 06/2016 – 05/2023

$181,875 /annum 09/2018 – 08/2021

$370,000 /annum 07/2019 – 06/2024

$658,830 /annum 05/2022 – 04/2027

$363,750 /annum 04/2021 – 03/2025

$145,500 /annum 09/2023 – 06/2027

• Jui Pandhare, PhD (Resignedin Aug 2022; CurrentPI: Dash)

R01 DA057204

• Waldemar Popik, PhD

R21 DA052832

• Hua Xie, PhD

R16 GM149359

$754,666 /annum 09/2022 – 08/2027

$218,250 /annum 04/2021 – 03/2023

$145,500 /annum 04/2023 – 03/2027

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Scientific Review Framework for NIH Research Grants

Significance Innovation Approach

Investigator Environment

Criterion scores from individual reviewers for NIH grant applications submitted by MMC investigators (Red = Not Funded;Blue = Funded).

A poor score for environment was almost alwaysassociated with poor scores in every otherreview criterion.

• Factor 1: Importance of the Research Significance & Innovation: scored 1-9

• Factor 2: Rigor and Feasibility Approach: scored 1-9

• Factor 3: Expertiseand Resources

Investigator & Environment: Evaluated as binary

• Appropriate

• Gaps identified

Executive SteeringCommittee Member, AAMC Group onResearch Advancement and Development

– Submitted recommendations for a blind review

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Research Sabbatical Opportunities

• IcahnSchool of Medicine at Mount Sinai Visiting Scientist Program ,8-weeks, for earlystage investigators – Dr.Rachakonda; and faculty exchange speaker visits – Drs. Chirwa, Slesinger& Benson

• Novartis Early Career Investigator Award Program : An all-paid 10-wk sabbaticalat Novartis Institutes of BiomedicalResearch– Dr. Jamaine Davis (SOM) and Dr. Thanigaivelan Kanagasabai (SOGS)

• Novartis “Beacon of Hope” Summer GraduateScholars Fellowship at Novartis Institutes of Biomedical Research, Boston

• First cohortof 4 students completed: KeAndreya Morrison (SOGS), Azizat Adediran (SOD), Mikaela Gay (SOM) and WajehahSanders (SACS)

• Second cohort:Biomedical Translational Research and Analytics Graduate Summer 2024 Fellowships(7): Kaitlyn Williams (SOGS), Ernest Taku (SACS), Javeia JohnsonMcCoy (SACS), Mikaela Nixon (SACS), Julian Broughton (SACS), LaureBien Aime (SACS), Uma Sander (SACS)

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Student Research Innovation

• UNC Eshelman Institute ofInnovation

Chinomunso Ahanotu, MD candidate – Rankin Innovator Award ( $25,000 )

• Vanderbilt W’ondry:Innovation Corps Award – NSF ( $50,000 )

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The Departmentof Defense Nunn-Perry Award to Meharry in the Mentor-Protégé Program

• MMC worked with TecMasters, Inc . (Mentor) and GeneCapture Inc . (Protégé)

• Meharry facultylead Dr. Pius Nde helped developremote diagnostic panel of parasites and infectiouspathogens for use in the warfield

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Capacity-Building Initiatives To Expand Meharry’s Reach

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John Lewis Endowment for CardiometabolicHealth Disparities Research

1 S21 MD018959-01, 07/2023 – 05/2028

NIMHD: $10,000,000

MPIs: Drs. Hildreth andShanker (Contact)

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NIHArtificial Intelligence/Machine Learning (AI/ML) Consortium to Advance Health Equityand Researcher Diversity(AIM-AHEAD)

1OT2OD032581, 09/2021,$100 million – National Consortium

Leadership Core Southeast Hub MPI: Shanker, Co-I: Wang, Singh (Director, Regulatory Compliance Office)

Southeast Hub includes 11 states:

Tennessee (TN), Arkansas (AR), Missouri (MO), Kentucky (KY),Illinois(IL), Indiana (IN), Michigan (MI), Ohio (OH), West Virginia(WV),Virginia (VA), and North Carolina (NC)

93 MSI (HBCU, HSI, PBI, AANAPISI, ANNH & NASNTI); 141 Community organizations

38 Industry partners; 1438 healthcarepartners (IHRSA, HPSA)

Meharry Hub supports 21research and fellow projects, including $648,827 Project, PI: Vibhuti Gupta (SACS)

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Cancer Health Disparity in Rural Appalachia

● Testing AI/ML Model with expanded EHR datasets from the rural Southeast region of the US (65% ofpop.) in partnership withthe Association of Community Cancer Centers

○ Test on health conditions demonstrating disparity (diabetes, CVD, CKD)

○ Testin the racially diverse dataset to measure SDOH effects (rural US is 25% minority)

● Build diverse EHR datasets to support AI/ML health disparities research

○ Black,Hispanicand others

● Develop AI/ML-basedinterventions&policies to reduce disparities

Southeast Hub

AI/MLto Identify
Stratify Non-Clinical
and
Factors Contributing to
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• Section 5.2: Emphasized theResponsible AI development and use through the NIHAIM-AHEAD program and highlighted AIM-AHEAD activitiesin underserved communities.

• Directs other agencies, NSF, Dept of Energy, NASA etc. to work with the AIM-AHEAD program.

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https://www.aim-ahead.net/webinars/ smohanty@mmc.edu

AIM-AHEADYear 3 New Call For Proposals https://www.aim-ahead.net/call-for-proposals-year-3/
Mohanty, MS, MBA FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION 36
Smruti

TN-HBCU Department of Energy Alliance

Environmental Health and Toxicology Research and Training Hub

TSU-MMC-Fisk Consortium

MPIs: TSU Quick/MMC Shanker/FISK

Hussain – $5,000,000 (2022 – 2025)

PD: Aramandla Ramesh, PhD

Microbial Transformation of PFASContaminated Groundwater & Soil from Hazardous Waste Sites (PI: Ramesh), $346,971

Efforts appreciated by Secretary of Energy Jennifer Granholm and U.S.

Representative Chuck Fleischman (R-Chattanooga) at the Waste Management

Symposia Conference 2023 in Arizona

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OTHER SELECT LONG-TERM NIH FUNDED CAPACITY-BUILDING PROGRAMS

The RCMIProgram in Health Disparities Research at Meharry Medical College: U54MD007586, 1997 – 2027, $4,008,042/annum —PIs: Adunyah & Hildreth (MMC)

MMC,VICC&TSU: Partners in Eliminating Cancer Disparities: U54CA163069, 2011 – 2026, $1,485,821/annum (MMC) —PIs: Adunyah & Stewart (MMC), Pal & Winkfield (VICC), Whalen & Quick (TSU)

Tennessee Center for AIDSResearch (TN-CFAR): P30AI110527, $2,095,757/annum, 2015 – 2025 —PI: Koethe (VUMC), Sub-PI: Hildreth (MMC)

Vanderbilt Institute for Clinical and Translational Research (VICTR): UL1TR002243, $9,858,660/annum, 2017 –2027 —PIs: Self, Bernard, Wilkins (VUMC), Sub-PI: Miller-Hughes (MMC)

Southeast Collaborative for Innovative and Equitable Solutions to Chronic Disease Disparities: P50MD017347, $2,482,970/annum, 2021 – 2026 —PIs: Wilkins, Cox (VUMC), Miller-Hughes (MMC), Weiss (U Miami)

Multidisciplinary Practice-Based Research Training in Meharry Medical College School of Dentistry: U01DE033241, 2023 – 2028 —PI: Gangula, $589,905/annum

Engaging Cooperate Sites for Trial Acceleration, Trust, Innovation, and Capability (ECSTATIC): 1U24TR004437, 2023 – 2030, $249,786/annum (MMC) — PIs: Bernard, Casey, Lindsell (VUMC), Sub-PI: Rajbir Singh (MMC)

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CONSORTIUM

Improving HIV Care in Lusaka, Southern,and Copperbelt Districts, Zambia and Malawi

HRSA Cooperative Agreement for Global Healthcare Program

To develop, expand,and improve the delivery of quality HIV/AIDS healthcare services in Zambia, Malawi, andother PEPFAR-supported Africa countries

1 UV9OA47276-01-00, $46,234,000 (2022 – 2026)

PD: Matthews-Juarez,PI: Hildreth & Meharry key personnel: Drs. Vladimir Berthaud, Sanika Chirwa, Paul Juarez

Patricia Matthews-Juarez, PhD Senior Vice President Office of Strategic Initiatives and Innovation

MMC-HBCU GLOBAL HEALTH
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Diversity in Genetic Information is Lacking

Dominantpower dynamics and structural inequities

Member, Board on Health Sciences Policy

National Academies of Sciences, Engineering and Medicine

Member, ClinGen JEDI Advisory Board

Cell, 2019
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Chan Zuckerberg Initiative: Accelerate Precision Health Partnership

April 20,2021: MMC – Regeneron – CZI leadership meeting

Drs. James Hildreth, Anil Shanker, Aris Baras, Lyndon Mitnaul

Cori Bargmann, Marc Malandro & Hannah Valentine

$46 Million –4 HBMSs ($11.5M/School)

Transform Genomics Research and Training at Meharry Medical College

● Year 1: Anchor Basic Scientist

● Year 2: Anchor Basic Scientist +ESI 1+ESI 2

● Year 3: Anchor Physician Scientist +ESI 3+ESI 4

Establish adepartment of genetics in SOGS

Genomics Scientists Hiring

• Korn Ferryreached out to >650 candidates.

• Short-listed 14 candidates for interviews

• Invitedselectedonesto Meharry for campus visits, presentations, and interviews.

• Candidate interviews are ongoing

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Diversity Center for Genome Research at Meharry

NHGRI: $7 Million, 09/2023 – 08/2030, PI: Shanker

Project 1: Genotype-disease associations for AA LoF variants (Borza)

Biospecimens from ~2500 AA DNA, serum Risk of TB, sarcoidosis

Cytokine profiles NGS data

analysis

Genomic Workforce Development Core (Ramesh, Chirwa)

Genomic Data Analytics (Wang)

`

Project 3: Patient recruitment, biospecimen & data repository (Singh)

Project 2: Immunophenotype & mitochondrial profiling (Ivanova, Shanker)

Administrative Core (Shanker, Stewart)

Return of results to patients

Community Engagement Core (Miller-Hughes et al.)

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CZI Metagenomics Workshop

Received funding from Chan Zuckerberg Biohub to organize a two-week in-person metagenomics workshop MMC,May 13 - 24.

Week 1 (WET LAB):MetagenomicNextGeneration Sequencing (mNGS) Laboratory Skills

Week 2 (DRY LAB): Analysis and Interpretation of Data

TotalRegistered= 38

= 32

=2 Morehouse = 1 U

=1 Virginia Polytech =1 Connecticut DoH =1

Qingguo Wang, PhD Director, GenomicData Core Professor of Computer Science

AfricanAmerican/ black Asian White Native American Other
TSU
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MMC
Hawaii

Meharry Research Facilities for Advanced Genomics (MeRFAG)

1C06 OD037828-01, PI: Shanker

$6,007,395 (Construction grant pending review)

George Kelly, PE

Awadh Binhazim, DVM, PhD

Rajbir Singh, MBBS

Sanford Barsky, MD

Zaid Khoury, DDS, PhD

Minu Chaudhuri, PhD

Alla Ivanova, PhD

Pandu Gangula, PhD

Hua Xie, PhD

Pius Nde, PhD

Smita Misra, PhD

Amos Sakwe, PhD

Zhengbang Chen, PhD

Qingguo Wang, PhD

Anil Shanker, PhD

Bindong Liu, PhD

Aramandla Ramesh, PhD

Sakina Eltom, PhD

MeRFAG Biorepository Digital Pathology Genotyping & Microarray Mitochondrial Genomics Single Cell Sequencing NGS Immuno Genomics Microbial Genomics Pharmaco & Toxico Genomics
FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION 44

BIOPHARMA PARTNERSHIPS

Beacon of Hope Program ($11.9 Million)

Clinical andTranslational Research Center of Excellence

• Novartis: $5. 8 Million (PI:Shanker), 10 years (2022 to 2031) –5 staff positions

• Sanofi: $6. 1 Million(PI: Rajbir Singh), 10 years (2024 to 2034) –5 clinical research staff positions + Equipment (freezers and centrifuges)

- Community Outreach and Engagement

- New clinical trials (5 new trials sponsored by ATS, Vertex, Roche, NIH, & NHGRI)

- Clinical research training (11 MD students and residents)

FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION 45
39 TOGETHER for C HA N GI NG H EA LTH CAREF OR P EOP LE OF A FR I C A N - AN CES TR Y TH R OU G H AN INT E R N AT I O N A L G EN OM I C S A N D E QU I T Y I N T I AT I V E FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION 46

The Diaspora Human Genomics Institute (DHGI) wasestablished withthe mission to improve the quality of the human condition and its environment with a particular focus on persons of African ancestry. The DHGI was chartered by MeharryMedical College as a Tennessee NonprofitCorporation and is the overall governing organization for the Together for CHANGE initiative.

Together for CHANGE

Close the gap on historical inequitiesin health care, education, andtraining that have left global Black communities underrepresented.

Our Goals

Buildsustainablepartnerships to support impactful programs in globalBlack communities

DHGI’s Differentiation

A proactive focuson promoting health andpreventing disease.

DHGI is the governing organization, with ethics at the forefront, for Together for CHANGE and future initiatives.

A unique, 10-year model of a publicprivatepartnerships with focus on HBCUs and African Institutions.

A comprehensive solution

Why This is Important Now

Without a diverse workforce and database, the research and treatments being developed will never fully meet the needs of global Black communities.

We areat a revolutionary stage of science and technology so we must ensure there isdiverse decisionmaking representation, consideration and respect.

02 Deepen Community STEM Education 01 Empower Communities on Health and Medical Research Studies 04 Increase African Genomics Researchers 03 Expand the Genetic Counseling Workforce 05 Diversify Genomics Research and Participation thedhgi.org 47 FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION

Historically Black Colleges & Universities

Unique Collaborative Ecosystem

Community Engagement

Collaborative Projects

Multi-Institutional Funding

Mentorship & Training

Knowledge Sharing

Professional Development

Career Opportunities

HBCU
FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION 48
• 35.5 million unique views of the press release • Reported by 400+ news outlets: Science, Associated Press, African Dream, ABC, NBC, Bloomberg Radio, BBC etc 49 FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION
FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION 50

SPONSORED RESEARCH FUNDING GROWTH

Total Applications submitted FY 2024: 134 14% growthfrom last year

GrantsAwarded (Direct + IDC) $29,353,626 $111,964,424

FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION 51
40,000,000 20,000,000 0 60,000,000 80,000,000 120,000,000 100,000,000 Jan18 Apr18 Jul18 Oct18 Jan19 Apr19 Jul19 Oct19 Jan20 Apr20 Jul20 Oct20 Jan21 Apr21 Jul21 Oct21 Jan22 Apr22 Jul22 Oct22 Jan23 Apr23 Jul23 Oct23 Jan24 Apr24

THANK YOU!

PresidentJames Hildreth

Chairman Nelson Adams

Dr. Eric Floyd

ELC Colleagues

OfRI Colleagues

Faculty Students Staff

FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION 52

Session II

ASSURANCES AND LIABILITIES: ASSOCIATED ADMINISTRATIVE, GRANTS MANAGEMENT REGULATORY AND INANCIAL PROCESSES

FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION 53

RESEARCH ADMINISTRATION PROCESSES

FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION 54

About the Presenter

SESSION II: ASSURANCES AND LIABILITIES –ADMINISTRATIVE PROCESSES

Tiffany Taylor serves as the Director for Research Administration at Meharry Medical College. She isresponsible for directing operational activities and managingadministrative servicesacross theunits within OfRI. She also assists in the developmentof strategies to grow the capacity of programs, centers, and institutes reporting to the Senior Vice President for Research andInnovation. Ms.Taylor most recentlyserved as Manager of the Office of Business Diversity Development for the Metropolitan Nashville Airport Authority. At the airport she managed administrativeactivities related to supplier diversity business development, disparity reduction, reporting, and capacity building for small,minority, and womenowned business enterprises (SMWBE) in the airport’s federal and local economic inclusion programs. Throughthis role she assisted SMWBEs in successfully competing for andearning over$300 millionin contractswith the airport.

Prior to herappointment at the airport, Tiffany served as the Senior Compliance Officer and Director of Compliance for Tennessee State University’s Research andInstitutionalAdvancement Division. In this role she oversaw theuniversity’s regulatory research compliance program, developed transdisciplinary and workforce pipeline funding initiatives,led research and sponsored programs business processimprovement efforts, and prepared and negotiated university awards, agreements, and contracts. With nearly twenty yearsof regulatory compliance, policy development, grantsmanagement, and administrative operationsexperience, Ms. Taylor’s career hasincluded several leadership appointments in governmentandhigher education. Shehas served as the State ofTennessee’s Director of Title VI Compliance at the Human Rights Commissionwhere she led monitoring reviews and initiatives for compliancewith federal and state JEDIA (Justice, Equity, Diversity, Inclusion,and Accessibility) regulations for forty-two state executive branch entities awarded over$15 billionin federal financial assistance. Duringher appointmentas Deputy Director at Tennessee’sDepartmentof Safety and HomelandSecurity, she directed statewide policy development, programaccreditation efforts, budget development, and administrative operationsof the agency’s2nd largest division and significantly increased the division’s federal funding portfolio.Her work at theUniversity ofTennessee’s Institute for Public Serviceprovidedelected and appointed officials across Tennessee’s ninety-five counties organizational development pathways and advisoryservices for countygovernment administration.

Tiffanyhas developed and been tapped to present seminars to government officials, law enforcement, community groups, andnon-profit organizations focusedon effectively managing federal funding, implementinglegislative mandates, and complyingwith privacy andnon-discrimination laws. She has also authoredandcontributed to funding proposals resulting in over$10+ millionin awards from federal agencies and private foundations. Throughher workwith various task forces, commissions, corporations, and professional associations, shehas successfully establishedpublic-private partnerships and strategic alliances.A native of Memphis, Tennessee,Tiffany earnedaBachelorof Science degree as well as a Master of PublicAdministration degree from Tennessee State University. She isalso a graduate of theTennesseeGovernment Executive Institute at theUniversity of Tennessee.

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RESEARCH ADMINISTRATION SERVICES

tltaylor@mmc.edu

TBD

ORU Manager

• Develops policies in consultation with Research Advisory Council and Policy Committee

• Implements research policies, procedures, and processes

• Provides research professional development, training, and capacity building opportunities for researchers, faculty, and staff

• Monitors research enterprise metrics

• Develops and prepares Research Enterprise reports and strategic initiatives

• Develops and manages OfRI strategic plan and SOPs

• Administers and manages intramural awards programs under direction of SVP for Research and Innovation

• Provides administrative support to Research Advisory Council

• Processes applications and monitors Organized Research Units (ORUs) progress under direction of SVP for Research and Innovation

• Tracks legislation and regulations affecting Research Enterprise

• Coordinates Research Enterprise Week, symposiums, and sponsor days on campus

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ASSURANCES AND CERTIFICATIONS

MEHARRY PROVIDES FOR FUNDING

 Scientific Misconduct Management

 Compliance with Federal Laws, Regulations, Policies

 Financial Management System

Administrative Capability  Internal Controls

No Debarment or Suspension

Lobbying Restrictions

Drug-Free Workplace

Cost Sharing or Matching

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LIABILITIES IN RESEARCH AND SPONSORED AWARDS

 Multiple Cost Transfers

 Multiple Budget Revisions

 Large Carryforward Balances

 Unallowed Expenditures

 Unrecovered IDC, Underfunded IDC

 Falsifying Data and Results

 Not following Approved IRB/IACUC/Biosafety/Radiation Protocol

 Not adhering to Award Research Terms and Conditions (RTC) and/or Agency

Specific Requirements (ASR)

 Not adhering to Institutional Research and Sponsored Programs Policies, Procedures, and Processes

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 Repayment of funds

 Suspension or withholding of current funding

 Fines and penalties assessed against the PI and/or Institution

 Debarred, suspended, or excluded from receiving state, local and federal funding

 Loss of Indirect Costs (IDC)

 Administrative Sanctions

 Monitoring and Audits

 Loss of future funding from foundations and industry

 Damage to the institution’s reputation

 Institutional value depreciation

 Loss of community and/or consumer trust

 Disqualification from certain publications

 Legal Action/Lawsuit

 Prosecution/Imprisonment

 Closing of the institutional research projects, labs, centers, etc..

 Decertification of Institution’s research program(s)

CONSEQUENCES OF NON-COMPLIANCE AND LIABILITIES
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The Grant Lifecycle

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GRANTS SUBMISSION AND MANAGEMENT PROCESSES

FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION 63

ASSURANCES AND LIABILITIES –

GRANTS MANAGEMENT PROCESSES

About the Presenter

Gamaliel L. Ballard, B.S. is Director of the Grants Management Office at Meharry Medical College. Mr. Ballard holds a Bachelor of Science from the University of Pittsburgh. In addition to this degree, he has completed more than four years of continuing education courses with a concentration in science and computer technology at Tennessee State University, Nashville, Tennessee and Nashville State Technical Institute with course work and labs in biology, chemistry, physics, mathematics, statistics, personal computing skills, word processing, database files, and Excel software. As Director of the Grants Management Office, Gamaliel oversees all pre -award functions pertaining to investigator initiated research grants and contracts at Meharry including budget development, presentations, compliance with regulatory affairs, and pre award activities in coordination with Meharry’s PI negotiation team when contracting or receiving federal and state contracts, biopharmaceutical technology companies, as well as national and international pharmaceutical companies.

Mr. Ballard has been an active participant from 1988 in the National Council of University Research Administrators (NCURA) and NCURA Region III activities. NCURA is the nations’ preeminent research administration organization. Mr. Ballard’s activities in NCURA includes presenting workshops on preparing SF 424 R&R budgets, co-chair Region III NCURA nominating committee, program evaluator, and new member mentorship advisor. He currently serves as the NCURA liaison at Meharry.

SESSION II:
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Gamaliel L. Ballard

Director Grants Management gballard@mmc.edu

Office: 615-327-6738

Christopher Crowell, EdD

Associate Director ccrowell@mmc.edu

Office: 615-327-6739

Nasrin Karim, MS

Senior Grants Review Manager nkarim@mmc.edu

Office: 615-327-6730

Tonya Micah

Grants Management Specialist tmicah@mmc.edu

Office: 615-327-6715

The OfRI’s GMO administers $75.6 million of Meharry's grant portfolio.

Grants Management Staff
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Grant Applications Submitted 66
Applications submitted

Finding Grant opportunities

Weekly announcements to the campus

Pre-Award Grant Process (NIH model)

PI notifies GMO of application submission

Notice of Award

PI writes the grant

GMO assist in budget prep

GMO submits grant application

GMO submits grant application

ASSIST

GMO reviews for compliance

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Grant Submission Form

GRANT SUBMISSION FORM

Grants Management Office (GMO); WBSC Room 2230; Phone 615 327 6703.

Ext. GL Ballard, 6738, C Crowell 6739, N Karim 6730, T Micah 6715

INSTRUCTIONS

Complete items 1-33, sign the form (34) and have the chairperson(s) of all participating departments sign it Signatures on this form can be Adobe digital signatures or ink signatures. All corrections from submitted applications must be completed by the due date for an application to be considered on-time by the sponsor. To ensure the College’s grant applications are received by the sponsor’s deadline, the Grants Management Office must receive collaborative applications with subcontracts at least ten business days prior to the sponsor’s deadlines. If a PI is submitting an application with no subcontracts, the GMO must receive the application at least five business days before the sponsor’s deadline.

• For proposals submitted electronically to grants.gov, after completing this form, save it in your folder on the Carpenter drive. When your complete application is n the Carpenter drive and GMO has approved it, GMO will submit your proposal to grants.gov or to the sponsor’s portal.

• For all other proposals, submit one copy of your application, including the original face page. GMO will submit the application to the sponsor electronically after it has been approved. If it is a paper application, GMO will return the signed application to you for mailing to the sponsor.

*IMPORTANT NOTICE – Some funding agencies, including NIH, require investigators to disclose their significant financial interests to their institution before an application can be submitted. Therefore, for proposals subject to the PHS financial disclosure regulations, all investigators must submit the Summary Disclosure of Financial Interests form along with the Investigator's Detailed Disclosure Form (when applicable) to GMO before the application can be submitted to the funding ☒

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Select the Meharry budget template based on the annual costs of the project

NIH form 398 budget page < $250,000

NIH form R & R budget > $250,000

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Preparing Your Application Using ASSIST

1. Find a Funding Opportunity Announcement (FOA)

2. Make a submission plan

3. Login to ASSIST & Initiate Your Application

4. Provide application access to your team

5. Enter Application Data

6. Finalize your application and prepare for submission 7. Submit your application

8. Track your application status and view your assembled application image

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Research Performance Progress Reports (RPPR)

GMO recommends PIs meet with business and finance departments at least 10 days before submitting RPPRs and final progress reports. Due dates are below.

 45 days before the next budget period start date for Streamlined NonCompeting Award Process (SNAP) RPPRs

 60 days before the next budget period start date for Non-SNAP RPPRs

 120 days from period of performance end date for the competitive segment - final RPPR due date

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Carryover of Unobligated Balances

 If unobligated balance is greater than 25% of the NIH approved budget

 Requires an explanation

 Plan of spending

 In some cases NIH approval

 Funds are automatically carried over in SNAP grants

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PROCESS NIH Grant Cycle

Just in time Regulatory Approvals

74

Thank you for your attention!

75 FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION

REGULATORY AFFAIRS PROCESSES

FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION 76

About the Presenter

SESSION II: ASSURANCES AND LIABILITIES –

REGULATORY PROCESSES

Kimberly Thomas started her career at Meharry in 2014 and progressed to current position as the Directory of Regulatory Affairs in February 2021. In this role she oversees regulatory committees, polices, and procedures related to research regulatory compliance. Ms. Thomas is a certified clinical research professional for oncology clinical trials who specializes in oncology and hematology. Prior to joining Regulatory Affairs, she worked as an oncology clinical research coordinator at Meharry. In her free time, she loves to write and is currently working on a fictional novel. Ms. Thomas is also a legacy employee at Meharry.

Her family’s employment history at Meharry stretches back to her grandmother Helen Weeden who retired as a nurse from the then Hubbard Hospital in 1975. Her aunt Bonita Dailey was an HR administrator for over a decade until she retired in 2009. Her cousin Karen Rhodes is a nurse who worked at Meharry from 1970 to 1975. She then returned in 1982 to assume a role in research at the Participant & Clinical Interactions Research (PCIR) till 2001. Another cousin Barbara Dailey, also a nurse, assumed roles in research at Meharry and bedside nursing at Nashville General Hospital from 1989 to 1993. Her grandson Carter Todd is Dr. D. B. Todd’s great-grandson.

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Regulatory Affairs Staff

Kimberly A Thomas, RN, CCRP, LNC

Director of Regulatory Affairs

kthomas@mmc.edu

Office: 615-327-6735

Lisa M. Jones MS, RRA

Regulatory Review Administrator - IACUC and IBC

Lmjones@mmc.edu

Office: 615.327.6599

Abdul H Sawas, BPharm, PhD, EHS

HSP Administrator and Bioethics Officer

asawas@mmc.edu

Office: 615-327-5654

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Processes in Regulatory Affairs

 Maintain compliance, certifications, and registrations with all governing bodies for the

 Institutional Review Board (IRB)

 Institutional Animal Care and Use Committee (IACUC)

 Institutional Biosafety Committee (IBC)

 Provide service and support to researchers

 Responsibilities include

 Guide researchers on protocol submissions

 Keep electronic submission system updated

 Monitor and maintain compliance for the OfRI

 Conduct internal audits and work with external auditors

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Processes

Maintain Compliance

Regulatory Affairs

Review and monitor research protocols Maintain Renewals

Maintain Certifications

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How to Submit a Research Protocol

Complete CITI/eProtocol/OFH training and IBC registration

Reviewer makes the recommendations

Approval

Decline Approval

Log into eProtocol

Enter information

Submit

Reviewer communicates with PI Comments/questions to be addressed

Protocol is reviewed for missing items Assigned to a reviewer

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Assurances

 Committee Oversight

 Regulatory Affairs Staff Meeting

 Monthly meeting of IRB, IACUC and IBC

 Professional Memberships

 OHRP, AAALAC, PRIME & R, ONS, SCAW, TN Notary Public

 Maintain PI compliance, develop and ensure compliance with SOPs

 Meet with internal and external auditors, conduct internal audits to ensure compliance.

 Prepare and submit the annual Meharry Research Integrity Report and submit it to the DHHS ORI

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Assurances

• 46 / 21 CFR 50 & 56), FDA regulations (21 CFR 312 & 812 when applicable), HIPAA regulations (45 CFR 164), state and local laws, and Meharry policies for the protection of human subjects.

• As required by the HIPAA Privacy Rule for human subjects’ research, the PI will ensure that only the minimum individually identifiable private information needed will be requested to achieve the goals of the research described in the study protocol application.

• The PI will ensure that all study personnel have completed all trainings, including biosafety, animal safety, radiation safety or HIPAA educational training in case of human subjects’ research, and that all applicable CITI certifications are current.

• All required research records and personnel training certifications will be maintained both in the PI’s labs, respective administrative offices, and made available when requested for IRB, IBC, radiation safety committee or IACUC inspections.

• If unable to direct this research personally, when on leave (annual and medical) or vacation or on travel to conduct official business, the PI will arrange for a designee to accept responsibility for the conduct of the study protocol in his/her absence and the pertinent documentation must be submitted ahead of time to the Institutional Official and Senior Vice President for Research and Innovation During the PI’s absence the designee is expected to discharge those duties (which are routinely done by the PI) in a timely manner.

• In case of departure from MMC, the PI is responsible for the proper transfer or closure of the research study prior to his or her departure. All required documentation (including but not limited to material transfer agreements, partnerships, raw data, audit reports, anonymized clinical records, unused vouchers etc.) must be submitted ahead of time to Meharry first and also to other regulatory bodies as required.

Print Name of Principal Investigator: Date: Signature of PI:

Failure to comply with any of the applicable regulations, laws, policies, and the provisions of the approved protocol may result in suspension or termination of this research project and notification by the IRB/IBC/IACUC/Radiation Safety committee to the Institutional Official, study sponsor and respective governmental agencies that have administrative oversight. In addition to the actions warranted by the applicable regulatory body, the Institutional Official may impose additional conditions or restrictions or sanctions on the conduct of the study, including but not limited to appropriate administrative actions and financial penalties levied on the PI.

In case of an ongoing active study protocol (where the PI change is being requested):

________________________________________
Print Name of Current Principal Investigator: ______________________________________ Date: ____________Signature of Current PI: ______________________________________
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FDA and USDA unannounced inspections

 FDA is responsible for clinical research regulatory oversight. Enforces the Food, Drug and Cosmetic Act

 USDA is responsible for animal welfare in lab animal research. Enforces the Animal Welfare Act

 OHRP - Office for Human Research Protections regulates any research that is federally funded

 Internal inspections and audits

 Meharry has to be inspection ready at all times!

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Some examples of Noncompliance

 Protocol deviations and violations

 All protocol deviations must obtain PRIOR approval

 Inadequate records

 Post Approval Monitoring (PAM) inspections

 Poor drug accountability

 Lack of licensure for DEA controlled substances/TN Board of Pharmacy

 Protection of rights, safety and welfare of participants in research studies

 Protection of animal welfare

 Responsible conduct of research and research integrity

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Liabilities and Consequences of Noncompliance

 Institutional/individual financial liabilities and penalties

 Loss of funding from federal agencies

 Damage to the institution’s reputation

 Institutional value depreciation

 Loss of community/consumer trust

 Disqualification from certain publications

 Legal notices/lawsuits

 Prosecution/imprisonment

 Closing of the Institution

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Regulatory Tips

 Trust the process

 Good record keeping

 Whenever in doubt ask

 Complete compliance is the goal

 Stay ready for inspection!

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Thank you!

89

FINANCIAL MONITORING PROCESSES

FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION 90

About the Presenter

SESSION II: ASSURANCES AND LIABILITIES –FINANCIAL PROCESSES

Alexis Dean is a highly analytical decision-maker and business savvy professional with over 20 years of experience in nonprofit financial and operational management experience. His multidivisional experience at Meharry include Finance, School of Medicine, School of Dentistry and Office for Research and Innovation. As a team leader, he has contributed to increased revenue, expense reduction and improved processes, through proactive problem solving, partnerships, interpersonal communication and SMART Goals. Alexis has been successful in managing all aspects of budgeting, forecasting, strategic planning, P&L activities and operations.

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Alexis Dean, MBA

Director of Finance and Business

alexis.dean@mmc.edu

Recruitment in progress

Finance and Business Administrator

Primary Responsibilities

• OfRI budget development and planning

• Assist in the institutional financial management oversight of sponsored programs

• Resource for PI’s and sponsored programs administrative personnel

• Management of the financial compliance of sponsored programs

and Business Staff
Finance
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Processes

Pre award

Normal Grant Lifecycle

• Post award activities overview • Award start-up • Spending award funds • Award monitoring

• Award closeout

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Processes and Tasks for Award Management

• Award Set-up and Modifications

• Charging & review of expenses

• Initiate, review, or approve cost transfers

• Prepare and submit financial Reports

• Prepare and send invoices

• Issue subaward agreements and modifications

• Review Subaward Invoices

• Reconcile Accounts and Draw Down Cash

• Apply Payments and Monitor Accounts Receivable

• Follow Up on Uncollected Payments

• Prepare or submit prior Approval Requests

• Effort Reporting or Payroll Certification

• Answer Questions from PIs, Administrators, and Sponsors

• Closeout

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Award Set-Up Tips & Reminders for PIs

• Request Workday grant ID from Grants and Contracts Office (GCO)

• Identify the grants manager and grants analyst

• Submit completed line item budget (LIB) based on notice of award (NOA) including subaward agreements

• Enter completed costing allocations

• Hold award-kickoff meeting with grant team

…now
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what?

Charging and Reviewing Expenses Tips & Reminders for PIs

• Desired vendors are in Workday

• Expenses are allowable, allocable, and permissible

• Do the purchases require a bidding process?

• Expend the award funds as approved

• Reconcile expenditures monthly

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Cost Transfers, Re-budgeting

PI Tips & Reminders

• Complete cost transfer within 90 days of expense

• Not to be used to cover costs, or fund depletion on another award

• Justification may be required by GCO and Grants Management (GM) if over 90 days of expense or close to grant closeout date

Transfers

Cost
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Prepare and Submit Financial Reports Tips & Reminders

• All expenses are correct in Workday.

• Notify GCO if there are any errors.

• GCO will prepare and submit sponsor required Financial Reports.

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Prepare

and Send Invoices

PI Tips & Reminders

• All subawards are current and uploaded in Workday.

• GM is notified of changes to award amount.

• GCO will prepare and send invoices.

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Subaward Agreements and Modifications Tips & Reminders

• PI completes subrecipient paperwork for each subaward.

• PI monitors subrecipient progress on scope of work

• PI notify GM and GCO of any sub agreement changes and pending amendments.

• PI uploads any sub-agreement amendments to Workday.

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Review Subaward Invoices Tips & Reminders

• PI, Program Manager (if applicable), and Department Administrator should review incoming invoices for reasonableness in relation to the contract.

• Note on invoice, who approved it, proper award worktag, and cost center.

• Upload approved invoice in Workday.

• Keep a copy of the invoice in the grant file.

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The Finance Division Performs These Tasks

• Reconcile accounts and draw down cash

• Apply payments and monitor accounts receivable

• Follow up on uncollected payments

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Closeout Tips and Reminders

• At minimum 90 days prior to award end date notify GM and GCO if seeking NCE

• Within 60 days of end of grant notify GM, HR, and GCO if employees paid by grant will be terminated, transferring, or new funding source is identified.

• Within 60 days of end of grant review and obligated funds, outstanding expenditures, and subaward SOW progress.

• No unreasonable purchases within final 30 days of award ending.

• Ensure all travel has been reimbursed.

• Notify IACUC and IRB the project is closing out and/or completed.

• Complete final programmatic/technical report, invention disclosures and any other deliverables. Send GM copies of final reports.

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Key PI Responsibilities

• PI adheres to Meharry and funding agency guidelines

• PI submits progress reports in a timely manner

• PI shares external advisory committee recommendations (program grants) with funding agencies

• GCO submits invoices

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Reasonable Costs:

The cost must be able to withstand public scrutiny, i.e., objective individuals not affiliated with the institution would agree that a cost is appropriate on a sponsored research award or as a component in its Facilities and Administration Cost proposal.

Allowable Costs:

• Must be reasonable and conform to the award’s terms and conditions

• The costs must be given consistent treatment through application of those generally accepted accounting principles appropriate to the circumstances.

• The costs must adhere to any limitations or exclusions set forth in the sponsored agreement or in the Federal Cost Principles (OMB Uniform Guidance §200.403).

Allocable Costs:

• A cost is allocable to a particular award if the goods or services involved can be directly charged to the award based on the benefit provided.

• To determine if a cost is allocable, ask the following questions:

• Does it benefit the award and/or other funding sources?

• Can it be distributed to all benefited funding sources using reasonable methods?

• Does the basis for allocating the cost represent a reasonable estimation of the benefit provided to the award objectives?

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GRANTS AND CONTRACTS

OFFICE UPDATES

Staff members of the Grants and Contracts Office attended the Research Advancement Meeting and were on hand to answer questions that participants had about post award grant activities.

• Ms. Zulfat Suara, AVP for Grants Accounting Management provided invaluable information to meeting participants about requesting award worktags and grants roles in Workday. She also noted there would be additional training forthcoming for PIs and the research community on managing awards in Workday .

• The following Workday training videos and job aids links were suggested to assist meeting participants in learning more about navigating the grants module and creating a purchase requisition.

• Grants Workday Link

https://mmc0.sharepoint.com/sites/ProjectWhetstone/Sit ePages/Grants-Module.aspx

• Procurement Workday Link

https://mmc0.sharepoint.com/sites/ProjectWhetstone/Sit ePages/Procurement-Module.aspx

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Session III NETWORKING UNCHEON

FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION 107

Networking Questions

• A. Meharry’s research and innovation has excelled in multiple disciplines over the last few years, where would you like to see the Meharry research enterprise in the next five years?

• B. What new transdisciplinary research groups can be forged to advance Meharry’s research and innovation -how can the Office for Research and Innovation help in facilitating these collaborations and what new funding streams can be targeted and/or developed to realize this effort?

• C. How can Meharry’s Research Enterprise contribute to a healthy Nashville community?

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NETWORKING QUESTION A

Meharry’s research and innovation has excelled in multiple disciplines over the last few years, where would you like to see the Meharry research enterprise in the next five years?

Summary of Responses

The responses detail various aspirations and strategic goals for genomic and biomedical research at Meharry. They emphasize advancements in genomic testing, significant improvements in infrastructure, and an increase in highquality research publications. Key goals include acquiring more substantial research grants, expanding international presence, and fostering collaborations both within and outside the institution.

Specific areas of focus are highlighted, such as public health, tele-pharmacy, geriatrics, neuroscience, cardiovascular, neurological, and metabolic diseases. There's a strong push towards community-centered research, increased utilization of data science, and enhanced transdisciplinary training and collaborations.

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Networking Question A - Common Themes

These themes reflect a comprehensive strategy to enhance Meharry's research capabilities and impact, focusing on innovation, collaboration, and community engagement.

1. Infrastructure Development: Significant emphasis on building new facilities, such as the proposed Research and Innovation Center with a skywalk to the West Basic Science Building. This infrastructure aims to support the expanded research capacity and foster more significant partnerships.

4. Diversity and Inclusion: Several responses emphasize the importance of inclusivity in research, particularly encouraging participation from African Americans, other minorities, and women in securing grants and leading research projects.

2. Grant Acquisition: A recurring theme is the goal to secure more 'R' series grants and other research funding to support ongoing and new research initiatives. This includes a focus on increasing funding for specific disease areas like cardiovascular, neurological, and metabolic diseases.

5. Community Engagement: Many responses stress the importance of community-centered research and effective communication of research findings to the community. The Meharry Community Engagement Core (MCEC) is mentioned as a key player in translating research into community-relevant outcomes.

3. Collaborative Research: Responses highlight the need for increased collaboration within Meharry and with external partners, focusing on areas like public health informatics, bioinformatics, molecular biology, and clinical collaborations. There's also a call for more community-led research and transdisciplinary efforts.

6. Focus on Emerging Technologies and Fields: There is a keen interest in integrating more advanced technologies such as AI and informatics into research. Additionally, there is a focus on developing research capacities in emerging and critical fields like geriatrics and public health policies.

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NETWORKING QUESTION B

What new transdisciplinary research groups can be forged to advance Meharry’s research and innovationhow can the Office for Research and Innovation help in facilitating these collaborations and what new funding streams can be targeted and/or developed to realize this effort?

Summary of Responses

The responses collectively outline strategies for advancing research and innovation at Meharry, focusing on enhancing infrastructure, forming collaborative teams, and integrating advanced technologies.

There's a strong emphasis on identifying and tapping into new funding streams, developing comprehensive training programs, and promoting public interest technology.

Key initiatives proposed include forming research groups combining senior and junior faculty, incorporating AI in education and healthcare research, and focusing on community-centric research projects.

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Networking Question B - Common Themes

These themes indicate a comprehensive strategy aimed at not only enhancing the research capabilities at Meharry but also ensuring that the research conducted is relevant, responsibly integrated with advanced technologies, and beneficial to both the community and broader public interests.

1. Collaboration and Teamwork: Many responses emphasize forming collaborative research groups that include both senior and junior faculty, focusing on multidisciplinary approaches. This is aimed at enhancing research output and fostering mentorship.

4. Community and Public Health Focus: Responses suggest moving more research into community settings and combining public health efforts with clinical trials. There's a strong call for research that addresses the health issues of vulnerable populations and integrates social and political determinants of health.

2. Funding and Resources: Identifying new funding streams and providing internal support for grant writing are highlighted. The establishment of pilot grants and internal partnership development funding are suggested to bolster research initiatives.

5. Institutional Support and Development: Enhancing institutional infrastructure such as better websites for researcher information, standard operating procedures across the institution, and focused training and education for the workforce are key themes.

3. Integration of Technology and AI: Several responses focus on incorporating AI and technology in different aspects of Meharry’s operations, from research on AI’s impacts in medical fields to embedding it in education and curriculum development.

6. Public Interest and Ethical Technology: Emphasis is placed on public interest technology, ensuring that technological developments promote public good and are created responsibly to limit negative consequences.

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NETWORKING QUESTION C

How can Meharry’s Research Enterprise contribute to a healthy Nashville community?

Summary of Responses

The responses focus on strategies for enhancing research at Meharry, particularly through community engagement, interdisciplinary approaches, and expanding funding sources.

Key points include prioritizing community-focused research, integrating various research disciplines to tackle health disparities, and establishing strong partnerships with local leaders and organizations.

Additionally, there's an emphasis on improving institutional support structures like clinical trials registries and research coordinating teams to better connect with at-risk populations and address specific community health challenges.

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Networking Question C - Common Themes

These themes illustrate a concerted effort to make Meharry's research more inclusive, community-oriented, and interdisciplinary, with a strong focus on addressing local health disparities and improving overall community health outcomes.

1. Community-Centered Research: A strongemphasis is placed on involving the community directly in research processes, establishing genuinepartnerships,and prioritizinglocal healthneeds.Thisincludes working with communityleaders, fosteringdialogueswith county officials,and ensuringresearch isculturally sensitiveand inclusive.

4. Inclusive and Participatory Approaches: Responses suggest expanding research opportunities specifically designed toinclude underserved and underdeveloped communities. Thisincludes moreinclusive enrollment requirementsforresearchand participatoryresearch approachesthat actively involve communitymembers.

2. Interdisciplinary and Translational Research: Many responses highlight the need for a multidisciplinary approachthat combines physiological, clinical,and transdisciplinaryresearchto address healthdisparities moreeffectively.There'salso a call forenhancing translational research capabilities to bridge thegap betweentheoreticalresearchand practicalapplication.

5. Education and Awareness: Enhancing community education and awareness about health issues is seen as essential. This involvesmoreintentional communications and disseminationstrategies to educate and engage the communityaboutongoing research and health advancements.

3. Funding and Resource Development: Identifyingnew funding sources such as private foundations, ARPA, the U.S. Department of the Interior,andSAMHSA is considered crucialforexpanding research opportunities and supporting broader efforts.

6. Institutional Integration and Support: Expanding institutional support structures such as the ELAM center,synchronizingclinical trialsregistries,and developingresearchcoordinating teamsto better manage and launch studiestargeting at-risk populations.

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Session IV

ESSONS EARNED ROM MOUNT INAI RANSFORMATIVE MODEL

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SESSION IV: LESSONS LEARNED FROM MOUNT SINAI TRANSFORMATIVE MODEL

About the Presenter

Reginald Wayne Miller, DVM, DACLAM, brings over three decades of extensive experience and leadership in veterinary medicine and research administration. He has held pivotal roles at esteemed institutions such as Mount Sinai School of Medicine and Fordham University, where he has contributed significantly to the advancement of biomedical research and animal welfare.

Dr. Miller's illustrious career began with appointments as an Attending Veterinarian at Eastman Dental Center and St. Mary’s Hospital in Rochester, NY, followed by a distinguished tenure as Chief of the Section of Veterinary Medicine at Columbia University's Institute of Comparative Medicine. Throughout his career, he has served as a Consulting Veterinarian for prestigious organizations such as Fordham University and the New York City Department of Health, showcasing his expertise in ensuring the ethical treatment and care of animals in research settings.

As Director and Attending Veterinarian at Mount Sinai School of Medicine's Center for Comparative Medicine and Surgery (CCMS), Dr. Miller played a pivotal role in transforming the institution's animal care program into one of the best in the country. Under his leadership, the program achieved 100% cost recovery and received high praise for its operational excellence and commitment to animal welfare. His impact extended beyond animal care, as he assumed roles such as Associate Dean for Research Resources and Research Integrity Officer, overseeing critical aspects of research infrastructure and integrity.

He holds a Bachelor of Science degree in Biology and Doctorate of Veterinary Medicine from Tuskegee University in Tuskegee, Alabama. Dr. miller completed a residency in Laboratory Animal and Zoological Medicine at the University of Rochester, Schools of Medicine and Dentistry and the Seneca Zoo in Rochester, New York. He has been licensed to practice veterinary medicine by the State of Georgia and the State of New York. In 2018 he has named an Innovator in Science & Medicine. In 2019 he received the Icahn School of Medicine at Mount Sinai Jacobi Medallion Award and was named Member of Year by the 100 Black Men, Inc. of New York.

Beyond his administrative roles, Dr. Miller is a dedicated mentor and advocate for diversity in biomedical research. His initiatives, such as the Historically Black Colleges and University (HBCU) Engagement Initiative and the Friends of Odysseus Mentoring Program, underscore his commitment to fostering the next generation of underrepresented scientists. His leadership in diversity councils and initiatives reflects his personal dedication to promoting inclusivity and equity in academic and research environments.

Dr. Miller's influence extends beyond institutional boundaries, as evidenced by his leadership roles in national organizations such as the Association of American Medical Colleges (AAMC) and the National Association for Biomedical Research (NABR). He continues to be a prominent voice in research administration, advocating for best practices and policies that uphold the highest standards of scientific integrity and animal welfare.

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LESSONS LEARNED FROM MOUNT SINAI TRANSFORMATIVE MODEL

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The House of Noble Deeds

Reginald W. Miller,

Mount Sinai Health System

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The History of The Mount Sinai Hospital

On January 15, 1852, nine men representing a variety of Jewish charities agreed on a vision for free medical care for indigent Jews in New York City. In 1855, that vision came to fruition with the establishment of the 45 - bed Jews' Hospital in New York in what was then a rural neighborhood on West 28th Street between Seventh and Eighth Avenues.

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120 FOR RESEARCH MEETING DISCUSSION PURPOSES ONLY. NOT FOR PUBLIC DISTRIBUTION

1968 - Teaching Tomorrow’s Medicine Today

Boldly Expandlng the Frontier of Science and Medicine

From a renovated bus garage on 102nd Street in 1968 to a brand new building in 1974

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Strategies for Facilitating Biomedical Breakthroughs

Academic Medical Centers

Mount Sinai

1. Create mu ltidisciplinary interdepartmental research institutes and centers which are high in scientific diversity,depth, and integration.

2. Encourage ahighly focused research effort and intense and frequent interaction of faculty fromdiverse backgrounds

3. Create a D epartmental -Institute matrix that results in scientific breakthroughs relevant to human disease

4. Recruit great scientists

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Mount Sinai Institutes of Clinical & Translational Sciences

CTSA: PI

H Sampson, MD

Dean for Translational Biomedical Sciences

Award: $35m over 5 years

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Genomics Institute

NEW NIHDIRECTOR’S TOP TWO OBJECTIVES

“ Apply High-Throughput Technologies to Understand Fundamental Biology and Uncover the Causes of Disease.”

“Support Translational Research to Take Advantage of New Discoveries that Can Lead to New Diagnosticsand Treatments.”

August 17, 2009

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MISSION:

To provide the latest Genetic/Genomic Technologies and Computational and Analytical

Capabilities for MSSM Investigators

Sinai Genomics Institute - A Core Technology Institute
Mount
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Mount

• Provide L atest Technologies & Analytical Capabilities:

– Expand Cu rrent Genome Capabilities:

• Recruit Expert Facultyand Staff

• High Throughput Sequencers

• Chip - Bas ed Technologies

– Expand P roteomics/Metabolomics Technologies:

• Recruit Expert Facultyand Staff

• Mass S pectrometers

• Provide Bioinformatic/Computational Capabilities:

– Recruit ExpertFacultyand Staff

– SuperComputer Power

– Develop & Provide New Analytical Tools

Core Technology Institute
Sinai Genomics Institute - A
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1. Recruit World-Class Director

• Providethe Latest Technologiesfor Genomic, Proteomics,& Metabolomics:

RecruitExpertFaculty & Staff

• Next Generation Sequencers

• WholeGenome Sequencers

• MassSpectrometers, etc.

• Markedly Expand BioInformatics &Computational Capabilities:

RecruitExpertFaculty & Staff

– Hardware and Software, etc.

– Tool Development

Total Costs

$15M

$15M

Sinai Genomics Institute - A Core Technology Institute
Mount
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$30M

Keys to Our Continued Success

• Great l eadership at all levels

• Financial d iscipline

• Transparent d ecision - making based on performance

• Recruitment a nd retention at all levels

• Alignment of E ducation, Research & Clinical missions

A CULTURE OF EXCELLENCE

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Strategic Plan - Proposal

New Life Science Center at 102-103 St and Madison Ave Proposed Site

Boldly Expandlng the Frontier of Science and Medicine

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CARTS Financial Structure

• C = Clinical (Not for Basic Sciences)

• A= Administrative (For Chairs)

• R= Research dollars

• T= Teaching (Teaching in the Medical School)

• S= Strategic (Seed money for new recruits )

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CARTS – Financial Distribution Model

“R” = Research – Based on research dollar expenditures from prior year – not grants awarded. Incentivize grant spending.

R Dollars returned to the Dept/Institute/Center based on formula below:

For grants that bring the full federally negotiated overhead of 69.5%,

• “R” component of the CARTS budget will be 20% of direct cost spending. For grants that provide at least 25% overhead, but less than the full NIH rate,

• “R” payment will be 5%.

For grants with 20-24% overhead rates,

• “R” allocations will be 0 - 4%.

Below 20% overhead, with the exception of training grants and fellowships, the differential overhead will be charged against the R distribution.

R will be provided only on that portion subject to Mount Sinai overhead for grant funds used for subcontracts to other institutions.

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Leadership matters……….

Disciplined innovation is NOT a contradiction DISCIPLINE

Launching
New Era of Discovery SINA I nnovations
a
51
Adapted from: Jim Collins & Morten T. Hansen “Great By Choice”
VIGILANCE
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AMBITION CREATIVITY

Leadership of Discipline

Acknowledge unpredictability of external environment BUT Will not allow results to be determined by them INSTEAD:

– Define values

Discipline

– Set Goals

– Develop performance standards

– Make informed decisions

– Maintain consistency

– Change course quickly if needed

Launching a New Era of Discovery

SINA I
nnovations
52
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Leadership of DisciplinedCreativity

Encouragecreativityand innovation

BUT

Will not commit resourceswithout validation INSTEAD:

Creativity

– Identifyareasof opportunity

– Develop multiple parallelsmall initiativesin those areas

– Definemetricsand a clear timeline for progress

– Evaluate success ofeach initiative objectively

– Commit resources to themostpromising initiatives

– Makestrategicinvestments in most successful ones

Launching a New Era of Discovery

SINA
Innovations
53
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Leadership of Disciplined Creativity with Vigilance

Recognize unexpected adverse events occur regularly BUT

Will not allow them to dilute the institution’s strengths

VIGILANCE

INSTEAD:

– Prepare for worst case scenarios

– Recognize threats early

– Avoid asymmetric risks

– Create shock absorbers to deal with the unexpected

– Adjust pace of decisions to speed of events

– Focus on superb execution

Launching a New Era of Discovery SINAInnovations
54
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Growth Needs New Space

MountSinaiDiscovery andInnovationCenter

• WestCampus—78711thAvenue

- Occupyingsixth, seventh,andeighthfloors

- HousingmajorresearchprogramsandMSWclinicalprograms

- Occupancy:January2023

CenterforArtificialIntelligence

• Renovationof3East101Street

• HousingnewDepartmentofAI/HumanHealthandInstitute forGenomicHealthandDivisionofGenomicMedicine

Icahn School of Medicine at Mount Sinai | State of the School | January 2022
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Session V

ANEL DISCUSSION: ADVANCE RESEARCH, NEXT TEPS, MEHARRY TRATEGIC DIRECTION BEYOND 2026

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SESSION V: ADVANCING RESEARCH PANEL DISCUSSION

About the Panelist

James E.K. Hildreth Sr., Ph.D., M.D., has transformed institutions and lives through a unique combination of skills, expertise and passionate drive. He seeks to achieve organizational success by nurturing passion and developing confidence in others. Hildreth’s enthusiasm and love for the work he does inspires others and draws them into bold visions and new directions.

Because of his standing as a world-class infectious disease expert, excellent ability to explain complex science to laypersons and engaging communication style, Hildreth has emerged as a respected national figure in the response to the COVID-19 pandemic. In September 2020, he was appointed to the FDA Vaccines and Related Biological Products Advisory Committee that is reviewing COVID-19 vaccine candidates for approval, and in February 2021, Dr. Hildreth was named to President Joseph Biden’s Health Equity Task Force

Currently, as president and CEO of Meharry Medical College, Hildreth is leading the technological, academic and clinical transformation of the nation’s largest private historically Black academic health sciences center. Focusing on the future of an organization with challenges represented by constant changes in higher education and health care, he has positioned the organization for success through innovative programs, strategic partnerships and entrepreneurial culture.

Previously, Hildreth served as dean of the College of Biological Sciences at University of California, Davis. In this role he oversaw the education of thousands of undergraduates—the majority of whom had aspirations for health care careers. He totally revamped the college’s student advising system and created novel student learning communities. These visionary changes were adapted by the entire UC Davis campus comprising six undergraduate colleges. He also created a unique research program called “Kingdom Crossing” involving collaborations between scientists who focused on organisms from distinct kingdoms of life (plants, animals). This program resulted in novel discoveries including a plant hormone with significant potential as an antimalarial drug. Hildreth spent 23 years at Johns Hopkins School of Medicine as student, postdoc, professor and associate dean. His research on HIV resulted in international recognition for several key discoveries including identifying a critical role of cholesterol in HIV infection. His research resulted in 11 patents and a technology licensed by Genentech which resulted in an FDA-approved drug, Raptiva.

Hildreth holds an M.D. from Johns Hopkins School of Medicine, a Ph.D. from Oxford University and a B.A. from Harvard University. He is a Rhodes Scholar who has been elected to the National Academy of Medicine. He has received numerous awards and recognition, including honorary degrees, for his scientific accomplishments, leadership, service to disadvantaged communities and mentorship of students and junior colleagues. In 2021 Dr. Hildreth was inducted into the Tennessee Health Care Hall of Fame. Modern Healthcare named him one of the “50 Most Influential Clinical Executives” for 2021. In recognition of his leadership in the fight against COVID-19, Nashville Scene magazine named him “Nashvillian of the Year. ” He has served on numerous national scientific councils including current membership on the Advisory Council to the NIH director. Hildreth currently serves as Chair of the Board of Trustees of the St Jude’s Research Hospital Graduate School of Biomedical Sciences. He also serves on other boards including the Nashville Healthcare Council, Nashville Health, Boy Scouts of America and the General Board of Higher Education of the United Methodist Church.

139

V:

ADVANCING RESEARCH PANEL DISCUSSION

About the Panelist

Juan is the Senior Vice Presidentfor InstitutionalAdvancement at Meharry Medical College. Serving as a key member of the President’s Cabinet, he is responsible for designingand executing theoverall strategy for advancement. He leads Meharry’s Institutional Advancement teamof 18, which includes Alumni Relations,Corporate andFoundation Relations, Development,DonorRelations&ProspectResearch, Gift Management Services, andMarketing & Communications.

Mostrecently, he served as Vice President for Advancement at Oglethorpe University—leading theinstitution’s development efforts. Prior to joining Oglethorpe University, he was the Senior Vice President & Chief Development Officer at JuniorAchievement of Georgia (JA), where he managed JA’s statewide comprehensive resourcedevelopment activities throughout Atlanta, Augusta,Columbus,Dalton, Gainesville, andSavannah. Prior to joining JA, he was Director ofDevelopment for Ivan Allen College of Liberal Arts at Georgia Institute of Technology—while the Institute launched and successfully completed itshistoric $1.5 billion capitalcampaign, the largest university campaign in theState of Georgia, surpassing the goalby over$300 million. Under Juan’s leadership, the College also successfully surpassed its campaigngoal of$35M, while assisting colleagues across all colleges and schools to raise over $958M in the campaign. Duringhis thirteen-year tenure at Georgia Tech,he also served in progressiveroles as Associate Director of Developmentfor the College of Computingand later as the first Director of Developmentfor the School of Computer Science.

Higher education administrative experience also comprises tenure as the former Assistant Vice President for Institutional Advancement at MorehouseSchoolof Medicine andserving on the Administrative Cabinetas Special Assistant to President Thomas W.Cole, Jr., and later as Director of Alumni Relations at Clark Atlanta University. Prior, he served on a national level as Assistant Director of theConsortium for theAdvancement of Private HigherEducation at theCouncil of Independent Colleges (CIC) in Washington, DC managing andprovidingtechnical assistance on multimillion-dollar grantprograms for small liberal arts colleges throughoutthecountry.

Earlierin his career, heheld positions in Student Affairs at RadcliffeCollege, Simmons College, Western Kentucky University,University of Louisville, and Morehouse College. He also served as an instructor in General Education at Clark Atlanta Universityand as a Teaching Assistant in Organizational and Human Development atVanderbilt University Peabody College. Juan was also a facultymember atLaGrange College’s Philanthropyand Development Master’s Programfor five years—teaching courses in CapitalCampaignsManagement and Strategy.

Juan completedadoctorate(Ph.D.) in Higher Education Administration and Human Development atVanderbilt University in 1999, where his research included HBCUs andinstitutionaladvancement—a dissertationentitled: The Impactof Intuitional Collaboration on Mission, Character and FinancialStability: The Caseof the Atlanta UniversityCenter. McGruder earneda master’s (Ed.M.) atHarvard University’s Schoolof Education in Administration, Planning,and Social Policy (APS). He holds a master’s (M.A.) in Counselingand Human Development from Clark Atlanta University, an Education Specialist (Ed.S.) in Student Affairsfrom Western KentuckyUniversity,and a Certificate in Romanesque and Gothic Architecture inBritain andEurope from theUniversity of Cambridge, England. His baccalaureate (B.A.) is in Political Science/pre-law from Clark College. He also earned the Certified Fund-Raising Executive(CFRE)international professional designation (2008).

Juan is the past Presidentof the Association of Fundraising Professionals (AFP) – Greater Atlanta Chapter (500+ members), served as a member of the Certified Fund Raising Executive(CFRE)International Job Analysis Task Force and the Committee on Directorship, as aBoard member of the African American Development Officers Network (AADO), and is on the Practitioner Advisory Board of The Science of Philanthropy Initiative (SPI) at theUniversity of Chicago. He was also Presidentof MidtownAtlanta Rotary Cluband a is member ofLeadership Atlanta Class of 2018.

SESSION
140

Key Takeaways from Panel Discussion

Dr. James Hildreth

President

• Meharry is climbing the ranks to be an R1 Institution (Carnegie Classification)

• As an Institution we don’t need to catchup but leapfrog toward our destination

• We can lead in Artificial Intelligence

• Much excitement generated about forthcoming MD-PhD Data Science for AI degree

• MMC must increase the number of faculty with R01 NIH grants

Dr. Juan McGruder

Senior Vice President for

Advancement

• It is a clear necessity for Research and Institutional Advancement to work together

• The regulations may not be the same for private philanthropy but the responsibility is the same

• Infrastructure and collaboration are important to advance MMC

• Institutional Advancement is working on a toolkit for faculty to use

Dr. Anil Shanker

Senior Vice President for Research & Innovation

• We have been working on building OfRI infrastructure

• West Basic Sciences building built around 1975, a $6M infrastructure grant is pending to renovate laboratories and research facilities on the 3rd floor

• Next step is to move MMC to R1 status

• All five schools need to generate new PhD programs and bring in more research dollars

• MMC needs to spend at minimum $50M in research dollars annually

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The Roadmap to R1 Status

The Carnegie Classification is a national framework for categorizing universities in the United States. Under the Carnegie Classification system, doctoral-degree-granting research universities fall into one of three categories:

● Very high research activity (R1)

● High research activity (R2)

● Doctoral/professional universities (R3)

Currentlyonly146universities in the U.S. out of the 3939 included in the classification system have an R1 designation andnone of the 107 HBCUs have the designation.R1 status willenhanceMeharry’scompetitiveness for externalfunding and attract top-tierfaculty, staff and students. Often R1 institutions are invited to apply for more generous grants allowing for additional investments in state-of-the -art facilities,dollars to secure highlysought after faculty,and expandedresources for students. Bypursuing R1 classification, MMC also has the potential to significantly impactour local economy andbusinessesby attracting and developing top tiertalent to live, work, and discover healthcarebreakthroughsinMiddleTennessee.

We will need to…

• Increase and diversify our research and sponsored programs funding portfolio

• Meet and/or exceed annual research expenditure threshold of $50M

• Award an average of 70 doctorate degrees each year

• Recruit and/or develop high caliber research faculty

• Promote interdisciplinary and collaborative research

• Increase the number of research publications

• Optimize the research efforts, revenue, and services provided by ORUs

• Prioritize technology transfer and commercialization activities

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~Acknowledgements ~

Successful events require the talents, time, and service of dedicated staff. The Office for Research and Innovation gratefully acknowledges the efforts of the inaugural 2024 Research Advancement Core Planning Committee: Dr. Awadh Binhazim (Chairperson), Dr. Michael Caldwell, Dr. Aramandla Ramesh, Dr. Anil Shanker, Dr. Rajbir Singh, Ms. Karen Smith and Ms. Tiffany Taylor. The Office for Research and Innovation sincerely appreciates and acknowledges the contributions of the following MMC staff members for making this year’s inaugural Research Advancement Meeting a success!

Ms. Karen Smith, Event Logistics & Volunteers

Ms. Victoria Leuang, Photography & Marketing

Dr. Virginia Brennan, Event Setup

Ms. Joan Kite, Registration

Mr. Stephon Briscoe, Event Set-up

Ms. Tamela Ensrud, Luncheon

Ms. Smruti Mohanty, Giveaways

Ms. Lisa Jones, Event Runner

Ms. Jannie Frierson, Event Runner

Ms. Robin Griffin, Luncheon

Mr. Harshana Rajakaruna, A/V Assistant

Dr. Awadh Binhazim, Presenter Prep

Mr. Nihad Sakic, Registration

Dr. Adul Sawas, Event Runner

Dr. Juan McGruder, Emcee & Panelist

Dr. Michael Caldwell, Session & Panel Moderator

Ms. Tiffany Taylor, Event Coordination, Presenter, & Highlights and Takeaways Document

Dr. Sandra Williams, Special Invitations

Dr. Aramandla Ramesh, Keynote Speaker Introduction

Dr. Rajbir Singh, Networking Luncheon Activity

Mr. Alexis Dean, Presenter

Mr. Kimberly Thomas, Presenter

Mr. Gamaliel Ballard, Presenter

Mr. Donnie Frierson, A/V Coordination

Mr. Lucius Patenaude, Photography & Videography

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