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Michael Cohen-Wolkowiez

Kiser-Arena Distinguished Professor
Pediatrics, Infectious Diseases
300 West Morgan Street, Box 3850, Durham, NC 27701
300 West Morgan Street, Box 3850, Durham, NC 27701

Research Interests


Clinical trials, clinical research innovation, clinical pharmacology and coordinating center work.

Selected Grants


iPediHeart: Interdisciplinary Research Training Program for Pediatric Heart Disease

Inst. Training Prgm or CMEMentor · Awarded by National Institutes of Health · 2025 - 2030

2/3 CTSA K12 Program at Duke University

ResearchMentor · Awarded by National Institutes of Health · 2025 - 2030

Unified Program for Therapeutics in Children

Inst. Training Prgm or CMEPreceptor · Awarded by National Institutes of Health · 2025 - 2030

Short-course ampicillin in preterm neonates to promote antimicrobial stewardship

ResearchCo-Mentor · Awarded by National Institutes of Health · 2025 - 2029

Direct-to-family pharmacokinetics intervention for hydroxychloroquine non-adherence in adolescents with systemic lupus erythematosus

ResearchAdvisor · Awarded by National Institute of Arthritis and Musculoskeletal and Skin Diseases · 2024 - 2029

Stimulating Access to Research in Residency (StARR) - NIAID

Inst. Training Prgm or CMEPreceptor · Awarded by National Institute of Allergy and Infectious Diseases · 2018 - 2029

Stimulating Access to Research in Residency (StARR) - NHLBI

Inst. Training Prgm or CMEPreceptor · Awarded by National Heart, Lung, and Blood Institute · 2018 - 2028

NIH HEAL Initiative Research-Dissemination and Engagement Center (R-DEC). CORE 3: Project Management

ResearchCo Investigator · Awarded by National Institutes of Health · 2022 - 2027

Application of Physiologically-Based Pharmacokinetic Modeling to Characterize Drug-Drug Interactions in Infants

ResearchCo Investigator · Awarded by National Institutes of Health · 2023 - 2027

Duke Center for Advancement of Child Health (CAtCH).

Inst. Training Prgm or CMEMentor · Awarded by Eunice Kennedy Shriver National Institute of Child Health and Human Development · 2021 - 2027

Real World Data to Support Pediatric Drug Labeling

ResearchCo Investigator · Awarded by Burroughs Wellcome Fund · 2019 - 2026

UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program

Inst. Training Prgm or CMEPrincipal Investigator · Awarded by University of North Carolina - Chapel Hill · 2016 - 2026

Pediatric Trials Network_ Task Order 1_ Core Function Activities

ResearchCore Leader · Awarded by National Institute for Child Health & Human Develo · 2018 - 2026

Application of Physiologically-Based Pharmacokinetic Modeling to Characterize Drug-Drug Interactions in Infants

ResearchPrincipal Investigator · Awarded by University of North Carolina - Chapel Hill · 2021 - 2026

DCRI D-COHRe Partnership for Innovation, Improved Access, and Operational Capability for Decentralized Clinical Trials of Medical Countermeasures in Public Health Emergencies

ResearchCo-Principal Investigator · Awarded by Biomedical Advanced Research and Development Authority · 2024 - 2025

Optimal Dosing for Biologic Agents in Obese Patients with Rheumatoid and Juvenile Arthritis

ResearchMentor · Awarded by National Institutes of Health · 2020 - 2025

18-0006 Mod 6 (EA)

Clinical TrialPrincipal Investigator · Awarded by National Institute of Allergy and Infectious Diseases · 2019 - 2025

Physiologically-Based Pharmacokinetic Modeling to Guide Drug Dosing in Children with Obesity

ResearchCo Investigator · Awarded by University of North Carolina - Chapel Hill · 2018 - 2025

RADx-UP CDCC

ResearchPrincipal Investigator · Awarded by National Institutes of Health · 2020 - 2025

Mentoring in Clinical Pharmacology and Early Phase Trials

ResearchPrincipal Investigator · Awarded by National Institutes of Health · 2019 - 2024

Duke CTSA (TL1) Year 5

Inst. Training Prgm or CMEMentor · Awarded by National Institutes of Health · 2018 - 2024

Duke Summer Training in Academic Research (Duke's STAR)

ResearchMentor · Awarded by National Institutes of Health · 2018 - 2024

Duration of post-discontinuation antibiotic exposures in premature infants and associated outcomes

ResearchCo-Mentor · Awarded by Thrasher Research Fund · 2021 - 2024

ACTIV-1

Clinical TrialCo Investigator · Awarded by Technical Resources International · 2020 - 2023

Global Pediatric Clinical Trials Network

ResearchCo-Principal Investigator · Awarded by Food and Drug Administration · 2017 - 2023

TASK ORDER FY.2022.A1.01348 - Task Area A

ResearchPrincipal Investigator · Awarded by National Institute of Allergy and Infectious Diseases · 2021 - 2022

Project 2: Impact of immune-based intervention on viral rebound in orally SHIV infected infant monkeys

ResearchCollaborator · Awarded by Weill Cornell Medicine · 2020 - 2022

RTOP 18-0006 Option 1 Mod 5

Clinical TrialPrincipal Investigator · Awarded by National Institute of Allergy and Infectious Diseases · 2019 - 2022

RTOP 18-0006 Option 1 / Protocol Implementation

Clinical TrialPrincipal Investigator · Awarded by National Institute of Allergy and Infectious Diseases · 2019 - 2022

TASK ORDER FY.2021.A1.0128 - Task Area A

ResearchPrincipal Investigator · Awarded by National Institute of Allergy and Infectious Diseases · 2020 - 2021

VTEU Task D Option 6 - FY.2017.B2C2D2.0053

ResearchInvestigator · Awarded by National Institutes of Health · 2017 - 2021

VTEU Task B - FY.2017.B2C2D2.0053

ResearchInvestigator · Awarded by National Institutes of Health · 2016 - 2021

VTEU Task D Option 5 - FY.2017.B2C2D2.0053

ResearchInvestigator · Awarded by National Institutes of Health · 2016 - 2021

Project 2: The origin, predictors, and immune correlates of viral rebound in orally SHIV infected infant monkeys

ResearchCollaborator · Awarded by Weill Cornell Medicine · 2020 - 2021

UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program

Inst. Training Prgm or CMEPrincipal Investigator · Awarded by University of North Carolina - Chapel Hill · 2020 - 2021

PTN 2.0 TO 1 Core Function Activities_Option 2

Clinical TrialCore Leader · Awarded by Eunice Kennedy Shriver National Institute of Child Health and Human Development · 2020 - 2021

RTOP 18-0006 Option 1 / Protocol Implementation

Clinical TrialPrincipal Investigator · Awarded by National Institute of Allergy and Infectious Diseases · 2019 - 2021

TASK AREA A, TASK ORDER FY.2020.A1.0127 - Task Area A

ResearchPrincipal Investigator · Awarded by National Institute of Allergy and Infectious Diseases · 2019 - 2020

Zika virus pathophysiology during pregnancy

ResearchCollaborator · Awarded by University of Wisconsin - Madison · 2018 - 2020

Pharmacokinetics, Pharmacodynamics, and Safety of Methylprednisolone in Neonates on Cardiopulmonary Bypass

ResearchMentor · Awarded by National Institutes of Health · 2017 - 2020

Relationship between cerebrospinal fluid penetration of antimicrobials in infants and juvenile animals

ResearchCo Investigator · Awarded by Food and Drug Administration · 2016 - 2020

PTN2- TO#4 Data Closeout and Dissemination Option Period I

ResearchPrincipal Investigator · Awarded by National Institute for Child Health & Human Develo · 2019 - 2020

P1CTU_Task Order 16_Protocol Implementation (Mod 3)

Clinical TrialPrincipal Investigator · Awarded by National Institutes of Health · 2018 - 2020

Admin Supplement: Parmacokinetic and pharmacogenomic approach to indomethacin therapy in pregnancy

ResearchPrincipal Investigator · Awarded by University of Texas Medical Branch · 2018 - 2020

P1CTU_Task Order 16_Protocol Implementation

Clinical TrialPrincipal Investigator · Awarded by National Institute of Allergy and Infectious Diseases · 2017 - 2020

HCQ Pharmacokinetics in Pediatric Lupus

ResearchMentor · Awarded by Childhood Arthritis & Rheumatology Research Alliance, Inc. · 2019 - 2020

Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in Children

Clinical TrialPrincipal Investigator · Awarded by National Institutes of Health · 2014 - 2020

Pediatric Trials Network_ Task Order 1_ Core Function Activities Option Period 1

ResearchCore Leader · Awarded by National Institute for Child Health & Human Develo · 2019 - 2020

VTEU Task Area D Option 9 Protocol FY.2016.D1.0026

ResearchCo-Principal Investigator · Awarded by National Institutes of Health · 2017 - 2020

RTOP 18-0006 Base / Protocol Development

ResearchPrincipal Investigator · Awarded by National Institute of Allergy and Infectious Diseases · 2019 - 2020

PTN TO #30 POPS Lab Mod. 2

Clinical TrialPrincipal Investigator · Awarded by National Institute for Child Health & Human Develo · 2017 - 2020

POPS Lab

Clinical TrialPrincipal Investigator · Awarded by National Institutes of Health · 2014 - 2020

PTN2- TO# Data Closeout and Dissemination

ResearchPrincipal Investigator · Awarded by National Institute for Child Health & Human Develo · 2018 - 2019

PTN Task Order 25 SCAMP Modification

ResearchPrincipal Investigator · Awarded by National Institutes of Health · 2014 - 2019

PTN TO #25 SCAMP

ResearchPrincipal Investigator · Awarded by National Institutes of Health · 2013 - 2019

P1CTU Protocol Development for 17-0033 (Base)

Clinical TrialPrincipal Investigator · Awarded by National Institutes of Health · 2017 - 2019

UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program

Inst. Training Prgm or CMEMentor · Awarded by University of North Carolina - Chapel Hill · 2017 - 2019

VTEU Task Area D Option 8B Protocol FY.2016.D1.0026

ResearchInvestigator · Awarded by National Institutes of Health · 2016 - 2019

Echocardiogram to Diagnose Pulmonary Hypertension in Premature Infants

ResearchCo Investigator · Awarded by University of North Carolina - Chapel Hill · 2015 - 2019

PTN Task Order: CAFFEINE

Clinical TrialCo Investigator · Awarded by National Institutes of Health · 2014 - 2019

TASK AREA A, TASK ORDER FY.2018.A1.0095 Task Area A

ResearchPrincipal Investigator · Awarded by National Institutes of Health · 2017 - 2018

VTEU Task Area D Option 8 Protocol FY.2016.D1.0026

ResearchCo-Principal Investigator · Awarded by National Institutes of Health · 2016 - 2018

SOLI - Solithromycin Pediatric Development Program (Phase 2/3)- Labor & Sub Cost

Clinical TrialPrincipal Investigator · Awarded by Cempra Pharmaceuticals, Inc. · 2016 - 2018

Hyperimmune globulin treatment of Zika virus during pregnancy to reduce Congenital Zika Syndrome

ResearchCollaborator · Awarded by University of Wisconsin - Madison · 2017 - 2018

Duke CTSA (UL1)

ResearchProgram Director · Awarded by National Institutes of Health · 2013 - 2018

Pass-Through cost- CLIN04

Clinical TrialPrincipal Investigator · Awarded by Cempra Pharmaceuticals, Inc. · 2016 - 2018

Role of pharmacokinetics and genomics in tocolytic therapy with indomethacin (subcontract)

ResearchPrincipal Investigator · Awarded by University of Texas Medical Branch · 2015 - 2018

PTN POPS III

Clinical TrialPrincipal Investigator · Awarded by National Institutes of Health · 2014 - 2018

P1CTU_Task Order 16_Protocol Development

ResearchPrincipal Investigator · Awarded by National Institute of Allergy and Infectious Diseases · 2017 - 2017

Phase I CTU Task Area A: Administrative and Overal Clinical Operations Support and Concept Development, Year 3

ResearchPrincipal Investigator · Awarded by National Institutes of Health · 2016 - 2017

PTN Task Order #17: Bioanalytical Analysis: POPS1, Fluconazole, and Meropenem

ResearchPrincipal Investigator · Awarded by National Institutes of Health · 2012 - 2017

SOLI - Solithromycin Pediatric Development Program (Phase 2/3 start up)- MOD 2

Clinical TrialPrincipal Investigator · Awarded by Cempra Pharmaceuticals, Inc. · 2016 - 2017

TASK AREA A TASK ORDER FY.2016.A1.0041

ResearchPrincipal Investigator · Awarded by National Institute of Allergy and Infectious Diseases · 2015 - 2016

SOLI - Solithromycin Pediatric Development Program (Phase IB)- MOD 2

Clinical TrialPrincipal Investigator · Awarded by Cempra Pharmaceuticals, Inc. · 2014 - 2016

Clinical Practice Data to Aid Narrow Therapeutic Index Drug Classification

ResearchPrincipal Investigator · Awarded by Food and Drug Administration · 2013 - 2016

PTN Task Order #19: Lorazepam

Clinical TrialCo Investigator · Awarded by National Institutes of Health · 2012 - 2016

PTN Task Order 29: Clindamycin Bactrim

Clinical TrialPrincipal Investigator · Awarded by National Institutes of Health · 2014 - 2016

CISA TO2 Prophylactic Antipyretics Revision 3-A

ResearchInvestigator · Awarded by Centers for Disease Control and Prevention · 2014 - 2016

CISA TO2 Prophylactic Antipyretics Revision 1-A

ResearchInvestigator · Awarded by Centers for Disease Control and Prevention · 2014 - 2016

CISA TO2 Prophylactic Antipyretics

ResearchCo Investigator · Awarded by Centers for Disease Control and Prevention · 2013 - 2016

PTN Task Order #20: POPS II

Clinical TrialPrincipal Investigator · Awarded by National Institutes of Health · 2012 - 2016

DAP Phase I PK/PD Analysis Budget

ResearchCo-Principal Investigator · Awarded by Jacobus Pharmaceutical Company, Inc. · 2016 - 2016

Role of pharmacokinetics and genomics in tocolytic therapy with indomethacin (subcontract)

ResearchPrincipal Investigator · Awarded by University of Texas Medical Branch · 2015 - 2016

Phase I CTU Task Area A: Administrative and Overal Clinical Operations Support and Concept Development

Clinical TrialPrincipal Investigator · Awarded by National Institutes of Health · 2014 - 2015

Pharmacokinetics and Pharmacodynamics of Antibiotics in Premature Infants

Clinical TrialPrincipal Investigator · Awarded by National Institutes of Health · 2010 - 2015

PTN Task Order #3 - Safety and Pharmacokinetics of Multiple Dose Metronidazole in Premature Infants

Clinical TrialPrincipal Investigator · Awarded by National Institutes of Health · 2010 - 2013

CTSA UL

ResearchJunior Faculty · Awarded by National Institutes of Health · 2006 - 2012

Best Pharmaceutical for Children Act (BPCA): Use of Meropenem in Infants

Clinical TrialFellow · Awarded by National Institutes of Health · 2007 - 2010

External Relationships


  • ExecRx
  • GlaxoSmithKline
  • Leo Pharmaceuticals
  • Lightship

This faculty member (or a member of their immediate family) has reported outside activities with the companies, institutions, or organizations listed above. This information is available to institutional leadership and, when appropriate, management plans are in place to address potential conflicts of interest.