Dr. Diane Mould PhD, FCP, FAAPS

President, Projections Research, Inc.

Fields and Areas of Specialization:

Pharmacokinetics, pharmacodynamics, pharmacometrics, clinical trial design

(703) 919-1715

admin@pri-home.net
Languages:

French (read),
Latin (read)

Programming:

Fortran, Basic, Pascal,
C++, R

References upon request

138

Invited Presentations

116

Peer Reviewed Abstracts

91

Peer Reviewed Publications

19

Peer Reviewed Book Chapters

9 Journal Review Work

6 Patents

6 Podium Presentaitons

1 Non-Peer Reviewed Publication

Honors

Recognition

Recognition

Roche Management Incentive Bonus Award

1992

First installation and use of Nonmem at Roche

1994

Use of Nonmem for Megalone filing, for Zenepax filing

SmithKline Beecham Bronze Impact Award

1997

Population PKPD evaluation of Avandia

1997

Population pharmacokinetic evaluation of Topotecan, Paxil

SmithKline Beecham Special Award

1997

Top 1% Productivity

SmithKline Beecham Silver Impact Award

1998

Population PKPD evaluations to assist dose selection for FTIM studies – 3 agents

Education

Education

December 1989

Ph.D. Degree in Pharmaceutics and Pharmaceutical Chemistry

GPA: 3.8/4.0

The Ohio State University – College of Pharmacy
Columbus, Ohio

Dissertation Topic: The Oral and IV Pharmacokinetics of Ethyl Alcohol in the Fed and Fasted States Using the Dog Model.

May 1983

B.S. Chemical Biology

GPA: 3.0/4.0

Stevens Institute of Technology,
Hoboken, N.J.

Research Topic: Synthesis of Novel Beta Lactam Antibiotics.

Previous Positions

Previous Positions

1/01-Present

Projections Research Inc.

Phoenixville PA

President

Consulting company for conducting PK and PK/PD analysis, Population based analysis and clinical trial simulation following GCP (Good Clinical Practices) and nonclinical GLP (where applicable) analysis

9/00-3/02

Georgetown University Center for Drug Development Science

Washington DC

Associate Professor – Dept of Pharmacology

Provide technical and educational assistance to industry on clinical trial analysis and simulation through CDDS programs. Design, analyze and report on clinical PK and PD analysis from clinical trials. Teaching assistance for College of Medicine.

7/99-11/01

Pharsight Corporation Scientific Advisory Group

Mountain View CA

Scientific Advisory Group – Clinical Trial Simulation

Work with the Scientific Advisory Board and the engineers to develop, test, and document software for the simulation of clinical trial designs. Develop and review functional specifications documents to support software qualification

7/96-9/00

SmithKline-Beecham

King of Prussia, PA

Assistant Director – Clinical Pharmacokinetics DMPK

Work with multidisciplinary teams to develop strategies for conducting rapid drug development programs. Design and write clinical pharmacokinetics and pharmacodynamics aspects of clinical trials. Analyze clinical pharmacokinetic, pharmacodynamic and safety data. Develop user-friendly tools to facilitate modeling analysis. Test and qualify software for the department. Train and manage scientific staff (MS and BS level). Generate study reports and manuscripts. Deliver presentations at professional meetings, investigator meetings, and regulatory authority meetings. Prepare and present regulatory documentation including IND, IDB, NDA, PLA, and Package Inserts.

10/95-7/96

Amgen, Inc.

Thousand Oaks, CA

Clinical Manager-Clinical Affairs

Work with multidisciplinary teams to develop strategies for conducting rapid drug development programs. Design and write clinical pharmacokinetics and pharmacodynamics aspects of clinical trials. Analyze clinical pharmacokinetic, pharmacodynamic and safety data. Develop user-friendly tools to facilitate modeling analysis. Test and qualify software for the department. Train and manage scientific staff (MS and BS level). Generate study reports and manuscripts. Deliver presentations at professional meetings, investigator meetings, and regulatory authority meetings. Prepare and present regulatory documentation including IND, IDB, NDA, PLA, and Package Inserts.

2/90-10/95

Hoffmann-La Roche

Nutley, NJ

Clinical Research Scientist – Department of Clinical Pharmacology

Work with multidisciplinary teams. Design, write, place and implement clinical trials. Supervise monitoring staff, review safety data, oversee clinical data handling. Manage grants and budgets. Analyze clinical pharmacokinetic, pharmacodynamic and safety data. Develop test and qualify software for the department. Train and manage scientific staff (Pharm. D., MS and BS level). Generate study reports and manuscripts. Deliver presentations at professional meetings, investigator meetings, and FDA meetings. Prepare and present regulatory documentation including IND, IDB, NDA, PLA, and Package Inserts.

6/86-12/90

The Ohio State University

Columbus, Ohio

Graduate Fellow, Department of Pharmaceutics

Carried out analysis of ethanol in biological fluids. Wrote routines for data analysis and reduction. Developed and tested a software system for Molecular Modeling based on artificial intelligence software and Chou-Fasman algorithms. Created a system for determining hydrophobicity parameters for protein modeling. Designed and built an integrator for use with GC or HPLC.

1/84-6/86

The Ohio State University

Columbus, Ohio

Graduate Research Assistant, Department of Biophysics

Wrote routines for data analysis and reduction. Developed a software system for Molecular Modeling based on advanced engineering software. Developed graphics packages for drafting courses given in the College of Engineering. Developed and implemented software for EXAFS data reduction.

6/83-12/83

Lederle Labs

Pearle River, N.Y.

Scientific Consultant in Department of Pharmacokinetics

RIA, Tissue Preparation, Autoradiography, HPLC, GC-MS, Assays and TLC for metabolite identification. Performed statistical analysis of data, general programming as required.

9/79-5/83

Stevens Institute of Technology

Hoboken, N.J.

Research Assistant

Synthesis of Beta-Lactam antibiotics. IR, GC-MS, NMR TLC and other chromatography techniques. Enzyme and Protein assay work, electrophoresis, isoelectric focusing.

Teaching Experience

Teaching Experience

Ohio State University

7/10-Present

Columbus, OH

College of Pharmacy

Adjunct Professor

7/08-12/2019

Columbus, OH

Introduction to Nonmem

Population Pharmacodynamics

7/11-16/2010

Columbus, OH

Introduction to Nonmem

Population Pharmacodynamics

7/11-16/2013

Columbus, OH

Graduate Teaching Assistant, Department of Pharmaceutics.

Private Tutor for all undergraduate Pharmaceutics courses.

9/85-6/86

Columbus, OH

Graduate Teaching Assistant, Department of Pharmaceutics.

Private Tutor for all undergraduate Pharmaceutics courses.

9/87-6/89

Columbus, OH

Graduate Teaching Assistant, Department of Pharmaceutics.

Private Tutor for all undergraduate Pharmaceutics courses.

University of Rhode Island

9/04-Present

Providence, RI

College of Pharmacy

Adjunct Professor

3/11/2014

Providence, RI

College of Pharmacy

Adjunct Professor

12/11/2009

Providence, RI

College of Pharmacy

Modeling the Pharmacokinetics and Pharmacodynamics of Biotech Agents

4/13/2009

Providence, RI

College of Pharmacy

Modeling the Pharmacokinetics and Pharmacodynamics of Biotech Agents

9/10/2004

Providence, RI

College of Pharmacy

Introduction to Population Pharmacokinetic Methods

University of Montreal

8/2008

Montreal, QC, Canada

Modeling and Simulation in Drug Development

SUNY Buffalo

6/2005

Buffalo, NY

College of Pharmacy

Topics in Population PK PD Analysis

12/2001

Buffalo, NY

College of Pharmacy

Modeling the Progression of Disease

National Institutes of Health

2/2001-2/2012

Bethesda, MD

Clinical Pharmacology Course

Modeling the Progression of Disease, Bethesda Medical Center

Georgetown University

9/00-3/2001

Washington, DC

Georgetown University College of Medicine

Teach postdoctoral fellows techniques and theory of population modeling. Teach basic PK/PD overview to Clinical Pharmacology Fellows. Teach 2nd and 4th year Medical Students basic Pharmacokinetics

Patents

Patents

Application Number xxx

“Method of Maintenance of Platelet Inhibition Using Lotrafiban” Assigned to SmithKline Beecham”

Application Number xxx

“Method of Dosing CP101-606” Assigned to Pfizer Inc.

Application Number 20130324492

“Maintenance of Platelet Inhibition During Antiplatelet Therapy” Assigned to The Medicines Company

Application Number 20130303478

“Maintenance of Platelet Inhibition During Antiplatelet Therapy” Assigned to The Medicines Company

Application Number 14/047,545

System and Method for Providing Patient-Specific Dosing As A Function of Mathematical Models Updated to Account for An Observed Patient Response Assigned to Baysient LLC

Application Number 62/145,138

Systems and Methods for Patient-Specific Dosing Assigned to Baysient LLC

Invited Presentations

Invited Presentations
  1. D.R. Mould “Deconvolution and Precursor Order Determination: Applications in Industry”.  Lecture, Rutgers University, New Brunswick, NJ 1992.
  2. D.R. Mould “Population Pharmacometric Analysis and Its Application in the Development Process of Biopharmaceutical Agents”.  Invited Speaker, FDA/CBER Bethesda, MD 1994
  3. D.R. Mould and K.A. Nieforth “Population Pharmacokinetic/Pharmacodynamic Analysis of ZenapaxTM: Some Practical Considerations in the Development of Protein Pharmaceuticals”. Mid-Atlantic NONMEM Users’ Group Philadelphia, PA 1995.
  4. D.R. Mould, E.A. Minthorn K. Kwok, and C.B. Davis “The Population Pharmacokinetics and Pharmacodynamics of IDEC-151 (SB-217969) in Patients with Mild and Moderate Rheumatoid Arthritis” East Coast NONMEM Users Group Podium Session, Washington DC June 1998
  5. DR Mould, CB Davis, J Urbansky, D Citerone “A Population PK/PD Model for Drug X, a Novel Hematopoeitic Cytokine”  Population PK Session, San Francisco AAPS Nov 1998
  6. DR Mould “Approaches In Population PK/PD Modeling”  PAWS Auckland NZ Jan 1998
  7. DR Mould, CB Davis, J Urbansky, D Citerone “A Population PK/PD Model for Drug X, a Novel Hematopoietic Cytokine”  PAGANZ Auckland NZ Jan1998
  8. DR Mould, JB Aluri, MC Chapelsky, JG Granett, R Samuels “A Population Pharmacokinetic Pharmacodynamic and Logistic Regression Analysis of Lotrafiban”  Population PK Podium Session, New Orleans AAPS Nov 1999
  9. DR Mould “A Population PK Analysis of Topotecan in Patients”, PAGANZ Brisbane Queensland Australia Jan 2000
  10. DR Mould “Modeling the Population Pharmacokinetics and Pharmacodynamics of Therapeutic Monoclonal Antibodies”  Center for Drug Development Sciences Georgetown University March 2000
  11. DR Mould, CB Davis, J Urbansky, D Citerone “A Population PK/PD Model for Drug X, a Novel Hematopoietic Cytokine”  Durban South Africa Oct 2000
  12. DR Mould and NHG Holford “A Retrospective Pooled Population PK/PD Analysis of Topotecan in Patients with Solid Tumors”, EORTC PAMM Verona Italy February 2001
  13. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Feb 2001
  14. DR Mould “Integrating Pharmacokinetics-Safety Analysis Into the Clinical Drug Development Process”  Joint FDA/DIA Meeting Washington DC April 2001
  15. DR Mould “A Population PK/PD Analysis of Topotecan in Patients”, Hycamtin World Wide Investigators Meeting June 2001
  16. DR Mould “Clinical Trial Simulation in Cancer Chemotherapy”  5th Annual Cancer PKPD Meeting, Sea Island Georgia Sept 2001
  17. DR Mould “The Population Pharmacokinetics and Pharmacodynamics of Lotrafiban in Patients”  PAGANZ Christchurch NZ 2001
  18. DR Mould “Using Pharmacokinetic/Pharmacodynamic Modeling to Evaluate Hematopoietic Factors”  AAPS Denver Colorado Oct 2001
  19. DR Mould “Approaches for the Implementation of Bayesian Analysis”  AAPS Denver Colorado Oct 2001
  20. DR Mould “Clinical Trial Simulation Course”  Course Assistant AAPS Denver Colorado Oct 2001
  21. DR Mould “Using Population Analysis for the Development of Disease Progression Models” State University of New York Dec 2001
  22. DR Mould “Using Clinical Trial Simulation to Improve Cancer Chemotherapy”  PAGANZ Queenstown Australia Feb 2002
  23. DR Mould “Introduction to Population Pharmacokinetic and Pharmacodynamic Analysis”  CMIC Tokyo Japan Feb 2002
  24. DR Mould “Using Pharmacokinetic/Pharmacodynamic Analysis to Facilitate Decision Making In Drug Development”  CMIC Tokyo Japan Feb 2002
  25. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2002
  26. DR Mould “Application of Bayesian Approaches Using NONMEM”  PAGE Bayesian workshop Course Assistant June 2002
  27. DR Mould  “Using Clinical Trial Simulation in the Development of New Oncology Agents”  IIR Clinical Trial Simulation Workshop Washington DC August 19-23 2002
  28. DR Mould “Covariate Distribution Models”  CDDS Clinical Trial Simulation Workshop Washington DC August 18 2002
  29. DR Mould “Using PKPD to Evaluate and Optimize Dose for Hematopoietic Factors”  PAGANZA Capetown South Africa November 2002
  30. DR Mould   “Development and Utilization of a Model Describing the Relationship Between Exposure and Adverse Events for Topotecan” Application of Pharmacokinetics and Safety Information in Drug Development and Regulatory Decisions  DIA Washington DC Nov 3-5 2002
  31. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2003
  32. DR Mould “Pharmacokinetics and Pharmacodynamics of Therapeutic Monoclonal Antibodies – Scientific Considerations”  AAPS Biotech Roundtable Salt Lake City Utah October 2003
  33. DR Mould “Modeling Discrete Data”  PAGANZJ Tokyo Japan September 2004DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2004
  34. DR Mould “The Pharmacokinetics and Pharmacodynamics of Biotechnologically Derived Products:  Function Follows Form” WilBio Conference: Charaterization and Comparability for Complex Biolological Products San Diego CA January 24-26 2005
  35. DR Mould and M Pfister “Optimizing Dose Selection for Oncology Trials with Exposure/Response Modeling & Simulation” Evaluating Testing and Advancing Oncology Therapies.  Philadelphia PA February 9-11 2005
  36. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2005
  37. DR Mould “PKPD models for white cell responses to hematopoietic stimulation with and without chemotherapy” ASCPT Orlando Fl March 2-5 2005
  38. DR Mould “Meet the Experts”  Population Pharmacokinetics Roundtable AAPS Nashville TN November 2005
  39. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2006
  40. DR Mould “Modeling Disease Progression”  Symposium Chair ASCPT Baltimore MD March 2006
  41. DR Mould “Modeling Disease Progression”  EAHP Congress meeting Geneva Switzerland March 2006
  42. DR Mould “Using Nonmem to Evaluate Dose Proportionality and Drug Interactions” Canadian Society of Pharmacological Sciences Ottawa Canada May 2006
  43. DR Mould “The Pharmacokinetics and Pharmacodynamics of Therapeutic Monoclonal Antibodies”  AAPS Biological Sciences Meeting Boston Mass June 2006
  44. DR Mould “Developing models of disease progression: tools for evaluation of treatment strategies and new therapeutic agents”  Pediatric Pharmacology Research Unit Meeting NIH Bethesda MD June 21 2006
  45. DR Mould “Limitations of Commonly Used Diagnostic Plots and Value of The Predictive Check for Model Development”  ECPAG Meeting Washington DC July 23-24 2006
  46. DR Mould “The Pharmacokinetics and Pharmacodynamics of Therapeutic Biological Agents”  Land O Lakes Conference Wisconsin September 2006
  47. DR Mould Kevin Sweeney, Stephen Duffull, Ellen Neylon, and Owen A. O’Connor “Population Pharmacokinetic (PK) And Pharmacodynamic (PD) Evaluation of Pralatrexate (PDX) To Improve Dosing Results of the MSKCC Phase I/II Experience”  PAGANZ Annual Meeting Singapore February 2007
  48. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC March 2007
  49. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC February 2008
  50. DR Mould “Modeling and Simulation in Drug Development”  University of Montreal Canada August 2008
  51. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC February 2009
  52. DR Mould “Pharmacokinetics and Pharmacodynamics of Biopharmaceuticals” University of Rhode Island course April 2009
  53. DR Mould “Population Pharmacokinetic-Pharmacodynamic Modeling of Biological Agents: When Modeling Meets Reality” ACoP Mystic CT October 2009
  54. DR Mould “Modeling and Simulation tools for Development of Biopharmaceutical Agents” PMx Meeting Beijing October 2009
  55. DR Mould “Population Pharmacokinetic Modeling” Principles of Pharmacology Course Beijing China November 2009
  56. DR Mould “Overview of Disease Progression Modeling” Principles of Pharmacology Course Beijing China November 2009
  57. DR Mould “Obesity – Impact on Drug Development and Dose Selection” AAPS National Meeting Los Angeles CA November 2009
  58. DR Mould “Application of Disease Progress Modeling in Drug Development” Joint ASCPT/KSCPT Meeting Seoul Korea December 2009
  59. DR Mould “Pharmacokinetics and Pharmacodynamics of Biopharmaceuticals” University of Rhode Island course December 2009
  60. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC January 2010
  61. DR Mould, B Frame and B Green “Introduction to Population Pharmacokinetics and Pharmacodynamics Course”. The Ohio State University Columbus OH July 2010
  62. DR Mould “Using Pharmacokinetics and Pharmacodynamics of Therapeutic Monoclonal Antibodies to Improve Dose Regimens”  IBD Meeting New York NY August 2010
  63. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC February 2011
  64. DR Mould “Missing covariates and covariates measured with error” PAGANZ Auckland NZ February 2011
  65. DR Mould “Population Pharmacokinetic-Pharmacodynamics: When Modeling Meets Reality” PAGANZ Auckland NZ February 2011
  66. DR Mould “Clinical Pharmacology Development Strategy for Monoclonal Antibodies” ACCP Annual Meeting Chicago IL September 2011
  67. DR Mould “Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies: Concepts for Drug Discovery and Development”  AAPS Annual Meeting Sunrise Session Washington DC October 2011
  68. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC February 2012
  69. DR Mould “Clinical Trial Simulation – What Are We Trying to Do?” PAGANZ Melbourne AUS February 2012
  70. DR Mould “Adaptive Dosing in Clinical Trial Simulation” PAGANZ Melbourne AUS February 2012
  71. DR Mould “Modeling Heterogeneity from International Trials” ASCPT National Meeting Washington National Harbor March 2012
  72. DR Mould “The key PK and PD principles in biologic drugs” IOIBD Annual Meeting Melbourne Australia March 2012
  73. DR Mould “Dose-Response Evaluation Based on Exposure-Response Principles” ACDRS Course Washington DC May 2012
  74. DR Mould “Clinical Perspectives: Part B-PK/PD” Biotech Canada Biosimilarity Summit Ottawa Canada May 2012
  75. DR Mould “Clearance Mechanisms for Biologics” Land O Lakes Conference Wisconsin September 2012
  76. DR Mould “Personalized Medicine, Pharmacometrics and Dashboard Systems”  AAPS Pharmacometrics Focus Group AAPS National Meeting Chicago IL October 2012
  77. DR Mould “Pharmacokinetics of Anti-TNF Therapy in IBD: What You Don’t Know, but Should” ACG Symposium Las Vegas NV October 2012
  78. DR Mould “Population Modeling and Dashboard Systems: Bridging the Gap Between Drug Development and Patient Care” Real World Data and Health Outcomes meeting Boston MA November 2012
  79. DR Mould “Understanding the pharmacokinetics of antibodies” Leading the Change in IBD Madrid Spain January 2013
  80. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2013
  81. DR Mould “Models for Disease Progression” Pennsylvania State College of Medicine May 2 2013
  82. DR Mould “Population Pharmacokinetic Modeling” Principles of Pharmacology Course Moscow Russia May 2013
  83. DR Mould “Overview of Disease Progression Modeling” Principles of Pharmacology Course Moscow Russia May 2013
  84. DR Mould “Immunogenicity and Pharmacokinetics of Biologics” DDW Annual Meeting Orlando FL May 2013
  85. DR Mould “Using Pharmacology, Modeling, and Simulation to Effectively Dose Pediatric and Elderly Patients”  AAPS National Biotech Meeting San Diego CA May 2013
  86. DR Mould “Principles for characterising a biologic: The interplay of pharmacokinetics and immunogenicity”  EULAR Annual Meeting Madrid Spain June 2013
  87. DR Mould “Biological Therapy Challenges in RA”  New Perspectives For RA Treatment Sao Paolo Brazil September 2013
  88. DR Mould “Principles for characterising a biologic: The interplay of pharmacokinetics and immunogenicity”  Vancouver Canada November 2013
  89. DR Mould “Effective utilization of pharmacometric information in the realm of patient care – development of effective decision making tools for clinical use”  AAPS National Meeting San Antonio November 2013
  90. DR Mould “Effective utilization of pharmacometric information in the realm of patient care – development of effective decision making tools for clinical use.” University of Florida December 2013
  91. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Jan 2014
  92. DR Mould “Understanding pharmacokinetics of therapeutic antibodies”  IBD Today and Tomorrow, an Innovative IBD Congress Amsterdam April, 2014
  93. DR Mould “Principles of Clinical Pharmacology of Anti-TNF Antibodies”  DDW Chicago IL May 2014
  94. DR Mould “The PK/PD of MAbs and considerations for clinical practice in inflammatory conditions” AAPS National Biotech Meeting San Diego CA May 2014
  95. DR Mould “Pharmacokinetics of Monoclonal Antibodies: A Primer” Canada – Future Directions in IBD Toronto Canada Nov 2014
  96. DR Mould “The influence of inflammatory burden on pharmacokinetics of biologicals” ECCO Barcelona Spain February 2015
  97. DR Mould “Dashboard Systems:  Implementing Pharmacometrics from Bench to Bedside” IATDMCT Rotterdam NE October 2015
  98. DR Mould “Disease Progression Models” Principles of Clinical Pharmacology NIH Course Washington DC February 2015
  99. Mould DR “Pharmacokinetics of biologics: A primer” Falk Symposium Frankfurt Germany March 2015
  100. DR Mould “Disease Progression Models” Principles of Clinical Pharmacology NIH Course Washington DC February 2016
  101. DR Mould “Using Pharmacokinetics to Improve Outcomes” Interdisciplinary Autoimmune Summit NY NY April 2016
  102. DR Mould “General Considerations for Developing Disease-Drug-Trial Models for Assessment of Extrapolation Assumptions”  FDA/UMD CERSI Workshop Washington DC May 2016
  103. DR Mould and A Strik “Pharmacokinetics and Dose Adjustments for Monoclonal Antibodies in IBD – Considerations and Applications in Clinical Practice” CPT-PSP ASCPT Webinar June 2016
  104. DR Mould “Modeling and Simulation in Clinical Trials and Drug Development: Clinical Application of Bayesian Adaptive Dosing” EMBC Orlando Florida August 2016
  105. DR Mould “Clinical Pharmacology Considerations of Biologics: Important Concepts” University of Florida 2016
  106. DR Mould “Clinical Pharmacology Considerations of Biologics: Important Concepts” ACCP Annual Meeting Bethesda MD September 2016
  107. DR Mould “Combining “Bedside” and Clinical Research Data to Inform Disease Progression and Outcomes/Biomarker Selection” ACCP Annual Meeting Bethesda MD September 2016
  108. DR Mould “Precision Medicine in the Clinic: Dashboard Guided Dosing to Improve Outcomes” AAPS National Meeting Denver CO November 2016
  109. DR Mould “Combining “Bedside” and Clinical Research Data to Inform Disease Progression and Outcomes/Biomarker Selection.” NICHD’s Principles of Pediatric Clinical Pharmacology Webinar Series. December 2016
  110. DR Mould “Dose-finding and PK/PD optimization with biologicals” Therapeutic Drug Monitoring of Biologics: Progress in Chronic Inflammatory Diseases Amsterdam NE December 2016
  111. DR Mould “Therapeutic Drug Monitoring Overcoming the hurdles” ASCPT annual meeting Washington DC March 2017
  112. DR Mould “Living with Variability – Understanding MAb Exposure and Response” Northwestern University Fineberg School of Medicine May 2017
  113. DR Mould “Clinical decision support tools for therapeutic drug monitoring for monoclonal antibodies” ACCP annual meeting San Diego CA September 2017
  114. DR Mould “Disease Progression Models” Principles of Clinical Pharmacology NIH Course Washington DC October 2017
  115. DR Mould “The Impact of Traditional Pharmacometrics During Drug Development of Biologics in Autoimmune Diseases” ACoP annual meeting San Diego October 2017
  116. DR Mould “Why Use TDM and Dashboards for Monoclonal Antibodies? The Promise of Individualized Therapy” IADCTC annual meeting Kyoto Japan October 2017
  117. DR Mould “Combining “Bedside” and Clinical Research Data to Inform Disease Progression and Outcomes/Biomarker Selection.” NICHD’s Principles of Pediatric Clinical Pharmacology Webinar Series. December 2017
  118. DR Mould “Bayesian Adaptive Dosing: tailoring patient exposure reduces therapeutic failures” Joint Statistical Meeting Vancouver August 2018
  119. DR Mould “Is that a shark or a dolphin?  How individualized dosing may impact drug development programs” ACoP pre-meeting workshop October 2018
  120. DR Mould “Combining “Bedside” and Clinical Research Data to Inform Disease Progression and Outcomes/Biomarker Selection.” NICHD’s Principles of Pediatric Clinical Pharmacology Webinar Series. December 2018 Washington DC
  121. DR Mould “Applying Pharmacokinetics/Pharmacodynamics to Personalize Patient Treatment” Interdisciplinary Autoimmune Summit April 2019 Chicago IL.
  122. DR Mould “The Dashboard Approach in the Management of Biologics” June 2019 TDM in IBD Mumbai India
  123. DR Mould “Ushering in The Age of Individualized Dosing: Where do We Go From Here?” ACCP September 2019 Chicago IL
  124. DR Mould “Approaches To Improve Oncology Clinical Trials: Adapt, Modify and Overcome” ACCP September 2019 Chicago IL
  125. DR Mould “Modeling & Simulation for Patient Care/ Individualized Medicine” ACCP September 2019 Chicago IL
  126. DR Mould “Classification of Beside Pharmacometric Tools: Perspectives from a Pharmacometrician” ACOP December 2019 Orlando FL
  127. DR Mould “Combining “Bedside” and Clinical Research Data to Inform Disease Progression and Outcomes/Biomarker Selection.” NICHD’s Principles of Pediatric Clinical Pharmacology Webinar Series. December 2019 Washington DC
  128. DR Mould “Applying Pharmacokinetics to Personalize Patient Treatment with Biologics” CDDW February 2020 Montreal Canada
  129. DR Mould “Research Topics: Everything you wanted to know about clinical trials, but were (rightfully) afraid to ask” CDDW February 2020 Montreal Canada
  130. DR Mould “21st Century TDM: How Pharmacokinetic and Immunogenicity Assays are Used to Personalize Treatment with Biologics” ACCP Annual Meeting (Virtual) October 12 2021
  131. DR Mould “Combining “Bedside” and Clinical Research Data to Inform Disease Progression and Outcomes/Biomarker Selection.” NICHD’s Principles of Pediatric Clinical Pharmacology Webinar Series. December 2021 Washington DC
  132. DR Mould “Pharmacokinetics.  Why we actually do need to pay attention!” Northwestern University Journal Club May 2022
  133. DR Mould “Assessing the Feasibility of Model-informed Precision Dosing: A Point-Counterpoint Debate – Industry Perspective” ACCP September 26 2022
  134. DR Mould “Combining “Bedside” and Clinical Research Data to Inform Disease Progression and Outcomes/Biomarker Selection.” NICHD’s Principles of Pediatric Clinical Pharmacology Webinar Series. December 2022 Washington DC
  135. DR Mould “Lewis Sheiner’s Dream: A Long and Winding Road” ACoP Annual Meeting October 2022 Denver CO
  136. DR Mould “Can We Improve Outcomes for Biologics in Inflammatory Bowel Disease? YES! (and we can reduce cost)” ACCP Annual Meeting October 2023 Bellevue WA
  137. DR Mould “Bayesian Guided Dosing – Injecting Science into the Art of Medicine”  PKUK Annual Meeting November 2023 Lancaster UK

Podium Presentations

  1. D.R. Mould, J.W. Duane and E.L. Gross “Solid Modeling Used in Protein Design and Analysis”.  Podium Session, ASEE Annual Conference, University of Cincinnati, Cincinnati, Ohio 1986.
  2. S.D. Black and D.R. Mould “Calculation and Evaluation of Side-Chain Hydrophobicity for Physiological Amino Acids and Modified Derivatives”, Biotechnology Podium Session AAPS Annual Conference 1989.
  3. D.R. Mould and A.C. Fuller “Neural Network Models – Applied Pattern Recognition as a Pharmaceutical Tool”,  Podium Session, Midwest Graduate Students Conference, Minneapolis, MN l989.
  4. D.R. Mould, K.A. Nieforth, and I.H. Patel “Population Pharmacokinetic Analysis of Fleroxacin (Quinodis): Identification of Patient Effects”.  Podium Session, NONMEM Users’ Group Workshop, San Francisco, CA 1995.
  5. D.R. Mould and B.R. Patel “Population Pharmacokinetic Analysis of Paxil”.  Podium Session, NONMEM Users’ Group Workshop, San Francisco, CA 1997.
  6. R.N. Upton and D.R. Mould “Investigations of the Representation of Covariate Changes in Nonmem” Podium Session PAGANZ Brisbane AUS 2013

Peer-Reviewed Book Chapter

Peer-Reviewed Book Chapter
  1. J. Hakimi, D. R. Mould, T. Waldman, C. Anasetti, and S. E. Light in Antibody Therapeutics, Chapter 12: “Development of ZenapaxTM: A Humanized Anti-TAC Antibody”, CRC Press pp 277-300 1996
  2. S.Z. Fields, R. Beckman, D.R. Mould, K. Gossett, R. Johnson Topotecan (Hycamtin™) Monograph in Therapeutic Drugs Edition 2 1998
  3. NHG Holford, DR Mould and C Peck “Disease Progression Models” in Principles of Clinical Pharmacology, Editor: A. Atkinson Academic Press New York NY 2001
  4. D.R. Mould “Defining Covariate Distribution Models for Clinical Trial Simulation” in Simulation for Defining Clinical Trials, Editors: H. Kimko and S Duffell Marcel Dekker, New York, NY 2002
  5. D.R. Mould “Population Pharmacokinetics, Applications in Industry” in Population Pharmacokinetic Analysis: Industrial Applications and Perspectives Editor: P. Bonate AAPS Press 2107 Wilson Blvd, Suite 700 Arlington, VA 22201 2004
  6. N.H.G. Holford, D.R. Mould and C. Peck “Disease Progression Models” in Principles of Clinical Pharmacology 2nd Edition, Editor: A. Atkinson Academic Press New York NY 2006
  7. D.R. Mould “Using Pharmacometrics in the Development of Biological Therapeutic Biological Agents” in Pharmacometrics: The Science of Quantitative Pharmacology Editors: E. Ette and P Williams, John Wiley and Sons Hoboken, NJ 2007
  8. D.R. Mould “Development of Models of Disease Progression” in Pharmacometrics: The Science of Quantitative Pharmacology Editors: E. Ette and P Williams, John Wiley and Sons Hoboken, NJ 2007
  9. D.R. Mould, B. Frame, T. Taylor “Modeling and Simulation for Development of Cardiovascular Agents” in Clinical Trial Simulations: Applications and Trends, Editor: H. Kimko and C Peck, Springer, New York, NY 2010
  10. D.R. Mould “Models of Disease Progression” in Pharmacokinetics in Drug Development (Vol 3), Editor: P Bonate and D Howard, Springer, New York, NY 2010
  11. N.H.G. Holford, D.R. Mould and C. Peck “Disease Progression Models” in Principles of Clinical Pharmacology 3rd Edition, Editor: A. Atkinson Academic Press New York NY 2012
  12. D.R. Mould and L. Lesko “Personalized Medicine – Integrating Individual Exposure and Response Information at the Bedside” in Applied Pharmacometrics Editors: S Schmidt and M Derendorf, Springer New York NY 2015
  13. D. R. Mould and P. Hutson “Introduction to Pharmacodynamic Models and Integrated Pharmacokinetic-Pharmacodynamic Models” in Pharmacokinetics and Pharmacodynamics: An Integrated Textbook and Computer Simulations, 2nd Edition Editor S. Rosenbaum, John Wiley and Sons Hoboken, NJ 2016
  14. D. R. Mould and P. Hutson “Semi-Mechanist Pharmacokinetic-Pharmacodynamic Models” in Pharmacokinetics and Pharmacodynamics: An Integrated Textbook and Computer Simulations, 2nd Edition Editor S. Rosenbaum, John Wiley and Sons Hoboken, NJ 2016
  15. D.R. Mould, R.N. Upton and J. Wojciechowski. “Bayesian Adaptive Dosing Strategies to Manage Patient Variability”. In Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases Editors H. Zhou and DR Mould Wiley 2018
  16. M. Rosario, N. L. Dirks, D. R. Mould, C. Scholz, T. Wyant, A. Parikh, I. Fox. “Vedolizumab: A case example of using quantitative clinical pharmacology in developing therapeutic biologics in IBD” In Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases Editors H. Zhou and DR Mould Wiley 2018
  17. D.R. Mould “Using Pharmacometrics in the Development of Biological Therapeutic Biological Agents” in Pharmacometrics: The Science of Quantitative Pharmacology 2nd Edition Editors: E. Ette and P Williams, John Wiley and Sons Hoboken, NJ 2020
  18. D.R. Mould “Development of Models of Disease Progression” in Pharmacometrics: The Science of Quantitative Pharmacology 2nd Edition Editors: E. Ette and P Williams, John Wiley and Sons Hoboken, NJ 2020
  19. D.R. Mould, N.H.G. Holford and C. Peck “Disease Progression Models” in Principles of Clinical Pharmacology 4th Edition, Editor: A. Atkinson Elsevier New York NY 2021

Peer Reviewed Publications

Peer Reviewed Publications
  1. D.R. Mould, J.W. Duane* and E.L. Gross “Solid Modeling Used in Protein Design and Analysis”, ASEE Proc. Ann. Conference 2(1):1049-1053 1986.
  2. S.D. Black* and D.R. Mould “Calculation and Evaluation of Side-Chain Hydrophobicity for Physiological Amino Acids and Modified Derivatives”, Analytical Biochem. 193:72-82 1991.
  3. C. Anasetti*, M.-H. Binger, T. Waldmann, D. Mould, H. Satoh, F.R. Appelbaum, H.J. Deeg, K. Doney, P.J. Martin, R. Nash, R. Storb, K.M. Sullivan, R.P. Witherspoon and J.A. Hansen “Treatment of Acute Graft-Versus-Host Disease with a Humanized Monoclonal Antibody Specific for the IL-2 Receptor”, Blood Supplement 80(10):373-374A 1992.
  4. C. Anasetti*, J. Hansen, T. Waldmann, F. Appelbaum, J. Davis, J. Deeg, K. Dooney, P. Martin, R. Nash, R. Storb, K. Sullivan, R. Witherspoon, M. Binger, R. Chizzonite, J. Hakimi, D. Mould, H. Satoh, S. Light “Treatment of Acute GVHD with Humanized Anti TAC: An Antibody That Binds to the Interleukin-2 Receptor” Blood 84(4):1320-1327 1994.
  5. D.R. Mould*, T.M. DeFeo, S. Reele G. Milla, R. Limjuco, T. Crews, N. Choma, and I.H. Patel “Simultaneous Modeling of the Pharmacokinetics and Pharmacodynamics of Midazolam and Diazepam” Clin. Pharmacol. Ther., 58(1):35-43 1995
  6. B.E. Fayer*, P.P. Soni, M.H. Binger, D.R. Mould and H. Satoh “Determination of Humanized Anti-TAC in Human Serum by a Sandwich Enzyme Linked Immunosorbent Assay” J. Immunological Methods 186:47-54 1995
  7. K.A. Nieforth*, R. Nadeau, I.H. Patel and D.R. Mould “Use of an Indirect Pharmacodynamic Stimulation Model to Compare In Vitro Activity of Interferon a-2a and a Poly(Ethylene Glycol) Modified Derivative in Healthy Subjects” Clin. Pharmacol. Ther., 59(6):636-646 1996
  8. F. Vincenti*, M. Lantz, J. Birnbaum, M. Garovoy, D. Mould, J. Hakimi K. Nieforth and S. Light “A Phase I Trial of Humanized Anti Interleukin-2 Receptor Antibody in Renal Transplantation”. Transplantation 63(1) 1-5:1997
  9. D.R. Mould*, C.B. Davis, E.A. Minthorn, D.C. Kwok, M.J. Eliott, M.E. Luggen, and M.C. Totoritis “Population Pharmacokinetic/Pharmacodynamic Analysis of the Effects of Clenoliximab, a PRIMATIZEDÔ anti-CD4 monoclonal antibody, on T lymphocytes, following single doses to patients with active rheumatoid arthritis.” Clin. Pharmacol. Ther., 1999 Sep;66(3):246-57
  10. S. Akhtar, R.A. Beckman*, D.R. Mould, E. Doyle, S.Z. Fields, J. Wright “A Phase I Open Label Two Period Cross Over Study to Compare the Bioavailability of a Single Dose of Oral Topotecan in the Presence or Absence or Ranitidine.” Cancer Chemother Pharmacol. 2000;46(3):204-10
  11. D.R. Mould*, J.B. Aluri, M.C. Chapelsky, J.G. Granett, R. Samuels “A Population Pharmacokinetic Pharmacodynamic and Logistic Regression Analysis of Lotrafiban” Clin Pharmacol Ther 2001 69(4):209-222
  12. D.R. Mould*, N.H. Holford, J.H. Schellens, J.H. Beijnen, P.R. Hutson, H. Rosing, W.W. ten Bokkel Huinink, E.K. Rowinsky, J.H. Schiller, M. Russo, and G. Ross “Pooled Pharmacokinetic and Adverse Event Analysis of Topotecan in Patients with Solid Tumors” Clin. Pharmacol. Ther. 2002 71(5):334-48
  13. D.R. Mould, X. Zhang, K. Nieforth, M. Salgo, N. Buss I. H. Patel* “Population Pharmacokinetics of Enfuvirtide in Patients with Human Immunodeficiency Virus” Clin. Pharmacol. Ther. 2005 Jun;77(6):515-28
  14. J Martin* and D.R. Mould “Clinical Pharmacology: Drug Action in Progressing Disease” Eur J Hospital Pharm. Practice 2006 12(3):38-39
  15. D.R Mould, G.F. Fleming, K.M. Darcy, and D. Spriggs* “Population Analysis of a 24-hour Paclitaxel Infusion in Advanced Endometrial Cancer: A Gynecologic Oncology Group Study” British J. Clin. Pharmacol. 2006 62(1):56-70
  16. S.J. Tannenbaum*, N.H. Holford, H. Lee, C.C. Peck, and D.R. Mould “A Method for Simulation of Correlated Continuous and Categorical Variables using a Single Multivariate Distribution” J. Pharmacokin. Pharmacodyn. 2006 33(6):773-94
  17. D.R. Mould* and K.R Sweeney “A Review of the Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies – Mechanistic Modeling Applied to Drug Development” Current Opinion in Drug Discov. and Devel. 2007 10(1): 84-96
  18. D.R. Mould*, N.G. Denman, S. Duffull “Using Disease Progression Models as a Tool to Detect Drug Effect” Clin. Pharmacol. Ther. 82(1):81-86 2007
  19. D.R. Mould, A. Baumann, J. Kuhlmann, M.J. Keating, S. Weitman, P. Hillmen, L.R. Brettman, S. Reif, and P.L. Bonate* “Population Pharmacokinetics-Pharmacodynamics of Alemtuzumab (Campath®) in Patients with Chronic Lymphocytic Leukemia” British J. Clin. Pharmacol. 64(3):278-291 2007
  20. O.A. O’Connor*, P.A. Hamlin, C. Portlock, C.H. Moskowitz, A. Noy, D.J. Straus, B. Macgregor-Cortelli, E. Neylon, D. Sarasohn, O. Dumetrescu, D.R. Mould, M. Fleischer, A.D. Zelenetz, F. Sirotnak, S. Horwitz “Pralatrexate, A Novel Class of Antifolate with High Affinity for the Reduced Folate Carrier-Type 1, Produces Marked Complete and Durable Remissions in a Diversity of Chemotherapy Refractory Cases of T-cell Lymphoma” British J. Haematol. 139(3):425-8 2007
  21. A. Roy*, D.R. Mould, X-F. Wang, L. Tay, R. Raymond, and M. Pfister “Modeling and Simulation of Abatacept Exposure and Interleukin-6 Response in Support of Recommended Doses for Rheumatoid Arthritis” J Clin Pharmacol 47: 1408-1420 2007
  22. C. Cronenberger, D.R. Mould, H-J. Roethig, and M. Sarkar* “Population Pharmacokinetic Analysis of Carboxyhemoglobin Levels in Adult Cigarette Smokers.” British J. Clin. Pharmacol. 65 (1):30-39 2008
  23. F. Feillet*, L. Clarke, C. Meli, M. Lipson, A.A. Morris, P. Harmatz, D.R. Mould, B. Green, A Dorenbaum, M Giovannini and E. Foehr for the Sapropterin Research Group “Pharmacokinetics of Sapropterin Dihydrochloride in Patients with Phenylketonuria” Clin Pharmacokinet. 47(12):817-825 2008
  24. E.Y. Shang*, M.A. Gibbs, J.W. Landen, M Krams, T. Russell, N.G. Denman, D.R. Mould “Evaluation of Structural Models to Describe the Effect of Placebo upon the Time Course of Major Depressive Disorder” J Pharmacokin Pharmacodyn. 36:63-80 2009
  25. D.R. Mould*, K. Sweeney, S. Duffull, E. Neylon, P. Hamlin, S. Horwitz, F. Sirotnak, M. Fleisher, M.E. Saunders, and O.A. O’Connor. “A Population Pharmacokinetic And Pharmacodynamic Evaluation of Pralatrexate” Clin Pharmacol Ther 86(2):190-6 2009
  26. O.A. O’Connor*, S. Horwitz, P. Hamlin, C. Portlock, CH Moskowitz, D. Sarasohn; E. Neylon, J. Mastrella, R. Hamelers, B. Macgregor-Cortelli, M. Patterson, VE Seshan, F. Sirotnak, M. Fleisher. D.R. Mould, M. Saunders, A. D. Zelenetz, “A Phase ‘2-1-2’ Study of Two Different Doses and Schedules of Pralatrexate, a High Affinity Substrate for the Reduced Folate Carrier (RFC-1), in Patients with Relapsed or Refractory Lymphoma Reveals Marked Activity in T-cell Malignancies” J Clin Oncol 27(26):4357-4364 2009
  27. D.R. Mould*, B. Green “Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies: Concepts and Lessons for Drug Development” BioDrugs 24(1):23-39 2010
  28. D. Karhu*, G. Groenewoud, MA Potgieter, D.R. Mould. “Dose Proportionality of Once-Daily Trazodone Extended Release Caplets Under Fasting Conditions” J Clin Pharmacol 50(12):1438-49 2010
  29. D.R. Mould* and B. Frame “Population Pharmacokinetic-Pharmacodynamic Modeling of Biological Agents: When Modeling Meets Reality” J Clin Pharmacol 50(9 Suppl):91S-100S 2010
  30. L. Jain, S. Woo, E. R. Gardner, W. L. Dahut, E. C. Kohn, S. Kummar, D.R. Mould, G. Giaccone, R. Yarchoan, J. Venitz, W.D. Figg*. “Population Pharmacokinetic Analysis of Sorafenib in Patients with Solid Tumours.” Br J Clin Pharm 72(2):294-305 2011
  31. A Parikh, T Leach, T Wyant, C Scholz, S Sankoh, DR. Mould, T Ponich, I Fox, BG. Feagan* “Vedolizumab for the Treatment of Active Ulcerative Colitis: A Randomized Controlled Phase 2 Dose-Ranging Study”. Inflam. Bowel Diseases. 18(8):1470-9 2012
  32. I Ordás, DR Mould, BG Feagan, WJ Sandborn*. “Anti-TNF Monoclonal Antibodies in Inflammatory Bowel Disease: Pharmacokinetic Based Dosing Paradigms.” Clin. Pharmacol. Ther. 91(4):635-46 2012
  33. J.J. Perez-Ruixo*, B. Green, S .Doshi, Y-M. Wang, D.R. Mould “Development of a Dosing Strategy for Romiplostim to treat patients with Immune (Idiopathic) Thrombocytopenic Purpura”. J. Clin. Pharmacol. 52:(10):1540-1551 2012
  34. WB Smith, TC Marbury, SF Komjathy, MS Sumeray, GC Williams*, M-Y Hu, DR Mould. “Pharmacokinetics, Pharmacodynamics and Safety of Clevidipine after Prolonged Continuous Infusion in Subjects with Mild to Moderate Essential Hypertension” Eur J Clin Pharm 68(10):1385-94 2012
  35. DR Mould* “Models for Disease Progression – New Approaches and Uses”. Clin. Pharmacol. Ther. 92(1):125-131 2012
  36. DR Mould*. “Model-Based Meta-Analysis: An Important Tool for Making Quantitative Decisions During Drug Development” Clin. Pharmacol. Ther. 92(3):283-286 2012
  37. DR Mould* and RN Upton “Basic Concepts in Population Modeling, Simulation and Model-Based Drug Development” Clin. Pharmacol. Ther. Pharmacomet. and Systems Pharmacol. 1, e6 2012
  38. J Kay,*, B.G. Feagan, M.S. Guirguis, E. C. Keystone, A. V. Klein, A. S. Lubiniecki, D. R. Mould, K. A. Nyarko, A. A Ridgway, M. E. Trudeau, J. Wang. “Health Canada/BIOTECanada Summit on regulatory and clinical topics related to subsequent entry biologics (biosimilars), Ottawa, Canada, 14 May 2012.” Biologicals 40:517-527 2012
  39. J Ji, DR Mould, KA Blum, AS Ruppert, M Poi, Y Zhao, AJ Johnson, JC Byrd, MR Grever, MA Phelps*. “Population Modeling for Flavopiridol and its Primary Glucuronide Metabolite in association with Tumor Lysis Syndrome in patients with Chronic Lymphocytic Leukemia.” Cancer Chemother. Res. 19(5):1269-80 2013
  40. DR Mould*, RN Upton “Basic Concepts in Population Modeling, Simulation and Model-Based Drug Development – Part 2: Introduction to Pharmacokinetic Modeling Methods” Clin. Pharmacol. Ther. Pharmacomet. and Systems Pharmacol. 2, e38 2013
  41. JJ Perez-Ruixo*, S .Doshi, YM. Wang, DR Mould “A Semi-Mechanistic Model of Romiplostim for Stimulating Platelet Counts in Patients with Myelodysplastic Syndrome.” Br. J. Clin. Pharm. 2013;75(6):1445-54
  42. I Mikaelian*, ME. Dunn, DR Mould, G Hirkaler, W Geng, D Coluccio, R Nicklaus, T Singer, M Reddy. “Time-dependent Serum Cardiac Troponin I Concentration Increases in Rats Subjected to Simulated Tail Venipuncture” Pharmacol. Res. and Perspect. 1(2):1-12 2013
  43. P-H Hsyu*, DR Mould, R Upton, M Amantea. “Pharmacokinetic-pharmacodynamic relationship of bosutinib in patients with chronic phase chronic myeloid leukemia”. .Cancer Chemother Pharmacol. 2013;71(1):209-18
  44. Mould DR*, Moyer B, Amur S, Mukherjee A. “The Impact of New Technologies on the Science of Clinical Care and Drug Development”. AAPS Magazine December 2013
  45. RN Upton*, Mould DR. “Basic Concepts in Population Modeling, Simulation and Model-Based Drug Development – Part 3: Introduction to Pharmacodynamic Modeling Methods” Clin. Pharmacol. Ther. Pharmacomet. and Systems Pharmacol. (2014) 3, e88; doi:10.1038/psp.2013.71
  46. Q Zhao*, TG Tensfeldt, R Chandra, DR Mould. “Population Pharmacokinetics of Azithromycin and Chloroquine in Healthy Adults and Pediatric Malaria Subjects Following Oral Administration of Fixed Dose Azithromycin and Chloroquine Combination Tablets” Malaria. 2014;13:36
  47. P Liu*, DR Mould. “Population Pharmacokinetic Analysis of Voriconazole and Anidulafungin in Adult Patients with Invasive Aspergillosis” Antimicrob. Agent Chemother. 2014;58(8):4718-4726
  48. P Liu*, DR Mould. “Population Pharmacokinetic-Pharmacodynamic Analysis of Voriconazole and Anidulafungin in Adult Patients with Invasive Aspergillosis” Antimicrob. Agent Chemother. 2014;58(8):4727-4736
  49. Ghosh S*, Pariente B, Mould DR, Schreibern S, Petersson J, Hommes D. “New tools and approaches for improved management of inflammatory bowel disease” J. Crohns and Colitis 2014;8(10):1246-53
  50. Mould DR*, Upton R, Wojciechowski J. “Dashboard Systems: Implementing Pharmacometrics from Bench to Bedside”. AAPS J 2014;16(5):925-3
  51. I Dotan*, Y Ron, H Yanai, S Becker, S Fishman, L Yahav, M Ben Yehoyada, DR Mould. “Patient factors that increase infliximab clearance and shorten half-life in inflammatory bowel disease. A population pharmacokinetic study” Inflamm Bowel Dis. 2014 Dec;20(12):2247-59
  52. Qi Y, Mould DR, Zhou H, Merilainen M, Musson DG*. “A Prospective Population Pharmacokinetic Analysis of Sapropterin Dihydrochloride in Infants and Young Children with Phenylketonuria” Clin. Pharmacokin. 2015 Feb;54(2):195-207
  53. Venkatakrishnan K*, Zhou X, Ecsedy J, Mould DR, Liu H, Danaee H, Fingert H, Kleinfield R, Milton A. “Clinical pharmacologic considerations for the phase 2/3 dose/regimen of the investigational Aurora A kinase (AAK) inhibitor MLN8237 (alisertib): pharmacokinetics, pharmacodynamics, and exposure-safety relationships” Brit J Clin Pharm Epub October 2014
  54. Venkatakrishnan K*, Friberg LE, Ouellet D, Mettetal J, Stein A, Trocóniz I, Bruno R, Mehrotra N, Gobburu J, Mould DR*. “Optimizing Oncology Therapeutics through Quantitative Clinical Pharmacology: Challenges and Opportunities” Clin Pharmacol Ther. 2015;97(1):37-54
  55. Mould DR*, Walz A, Lave T, Gibbs J, Frame B. “Developing Exposure/Response Models for Anti-Cancer Drug Treatment: Special Considerations” Clin Pharmacol Ther: Syst Pharmacol Epub Jan 2015.
  56. Hsyu PH*, Mould DR, Abbas R, Amantea M. “Population Pharmacokinetic and Pharmacodynamic Analysis of Bosutinib.” Drug Metab Pharmacokinet. 2014 25;29(6):441-8
  57. Mould DR*, Dubinsky MC. “Dashboard Systems: Pharmacokinetic / Pharmacodynamic Mediated Dose Optimization.” J Clin Pharmacol. 2015;55 Suppl 3:S51-9
  58. Kimko H*, Thyssen A, Mould DR, Mannaert E, Treem W. “Helicobacter pylori Treatment in Children: Defining a Dose and Dosing Regimen for Rabeprazole” Ped. Neonat. Care 2015;55(5):592-600
  59. Wu L, Mould DR, Perez Ruixo JJ, Doshi S*. “Assessment of Hemoglobin Responsiveness to Epoetin alfa in Patients on Hemodialysis Using a Population Pharmacokinetic Pharmacodynamic Model.” J. Clin. Pharmacol. 2015; 55(10):1157-66
  60. Mould DR*. “The pharmacokinetics of biologics a primer.” Digestive Diseases 2015;33(suppl 1):61–69
  61. Mould DR* Commentary: “Why Therapeutic Drug Monitoring is Needed for Monoclonal Antibodies and How Do We Implement This?” Clin Pharmacol Ther. 2016;99(4):351-4
  62. Mould DR*, D’Haens G, Upton RN. “Clinical Decision Support Tools: The Evolution of a Revolution.” Clin Pharmacol Ther. 2016;99(4):405-18
  63. Mould DR*, Meibohm B. :Drug Development of Therapeutic Monoclonal Antibodies.” BioDrugs 2016;30(4):275-93
  64. Melmed GY*, Irving PM, Jones J, Kaplan GG, Kozuch PL, Velayos FS, Baidoo L, Sparrow MP, Bressler B, Cheifetz AS, Devlin SM, Raffals LE, Vande Casteelle N, Mould DR, Colombel J-F, Dubinsky M, Sandborn WJ, Siegel CA. “Appropriateness of Testing and Interpretation of anti-TNF Drug and Antibody Concentrations: When should they be ordered, and what to do with the results?” Clin Gastroenterol Hepatol. 2016 ;14(9):1302-9
  65. Garrett M, Taylor T, Mould DR, Amantea MA, Chen Y, Ingrosso A, Pithavala YK*. “Lack of effect of smoking on axitinib pharmacokinetics in non-small cell lung cancer patients.” Br J Clin Pharmacol 2016;78(6):1131-1141
  66. Chan P*, Mould DR, Abu Tarif M, Reynolds L, LaCreta F, Bertz R, Bifano M. “Using Population Pharmacokinetic and Pharmacodynamic Analyses of Entecavir in Pediatric Subjects to Simplify Dosing Recommendations.” Clin Pharmacokinet. 2016 Dec;55(12):1559-1572
  67. Pushkin R*, Iglesias-Ussel M, Darouiche R, Stolarski E, Berkowitz R, Kreuzer H, MacLauchlin C, Mould DR, Oldach D, Fernandez P. A Randomized Study “Evaluating Oral Fusidic Acid (CEM 102) in Combination with Oral Rifampin Compared with Standard of Care Antibiotics for Treatment of Prosthetic Joint Infections: A Newly Identified Drug-Drug Interaction.” Clin Infect Dis 2016 15;63(12):1599-1604
  68. Muntau AC*, Burlina A; Eyskens F, Freisinger P, De Laet C, Leuzzi V, Rutsch F, Sivri HS; Vijay S, Orquidea Bal M, Gramer G, Pazdírková R, Cleary M, Lotz-Havla AS; Munafo A, Mould DR; Moreau-Stucker F, Rogoff D. “Efficacy, safety and population pharmacokinetics of sapropterin in PKU patients <4 years: results from the SPARK trial.” Orphanet Journal of Rare Diseases. 1:47-58 2017
  69. Dubinsky MC*, Phan BL, Singh N, Rabizadeh S, Mould DR. “Pharmacokinetic dashboard recommended dosing is different than standard of care dosing in infliximab treated pediatric IBD patients.” AAPS J. 2017 ;19(1):215-222
  70. Nguyen THT, Mouksassi S, Comets E, Freedman I, Hooker A, Holford NHG, Jyothy J, Karlsson MO, Mould DR, Pérez Ruixo J, Plan EL, Savic R, van Hasselt JCG, Weber B, Zhou C, Mentré F*. “Model evaluation of continuous data pharmacometric models: metrics and graphics.” CPT:PSP 2017;6(2):87-109
  71. Brandse JF*, Mould DR, Ashruf YK, Smeekes OS, Kuin S, van den Brink GR, D’Haens GR. “A Real-life Population Pharmacokinetic Study Reveals Factors Associated with Clearance and Immunogenicity of Infliximab in Inflammatory Bowel Disease.” Inflam Bowel Dis. 2017 ;23(4):650-660
  72. Nijenhuis CM*, Lucas L, Rosing H, Huitema AD, Mergui-Roelvink M, Jamieson GC, Fox JA, Mould DR, Schellens JH, Beijnen JH. “Metabolism and disposition of the anticancer quinolone derivative vosaroxin, a novel inhibitor of topoisomerase II.” Invest New Drugs. 2017 Aug;35(4):478-490
  73. Jacobs FMJ*, Mould DR. “The role of FcRn in the pharmacokinetics of biologics in patients with multiple myeloma.” Letter. Clin. Pharmacol. Ther. 2017;102(6):903-904
  74. Hanley MJ*, Mould DR, Taylor TJ, Gupta N, Suryanarayan K, Neuwirth R, Esseltine DL, Horton TM, Aplenc R, Alonzo TA, Lu X, Milton A, Venkatakrishnan K. “Population Pharmacokinetic Analysis of Bortezomib in Pediatric Leukemia Patients: Model-Based Support for Body Surface Area-Based Dosing Over the 2- to 16-Year Age Range.” J Clin Pharmacol. 2017;57(9):1183-1193
  75. Wojciechowski J*, Upton RN, Mould DR, Wiese MD, Foster DJR. “Infliximab Maintenance Dosing in Inflammatory Bowel Disease: an Example for In Silico Assessment of Adaptive Dosing Strategies.” AAPS J. 2017;19(4):1136-1147.
  76. Vande Casteele N*ould DR, Coarse J, Hasan I, Gils A, Feagan B, Sandborn WJ. “Accounting for Pharmacokinetic Variability of Certolizumab Pegol in Patients with Crohn’s Disease.” Clin Pharmacokinet. 2017; 56(12):1513-1523
  77. Mould DR*, Hutson PR. “Critical Considerations in Anticancer Drug Development and Dosing Strategies: The Past, Present and Future.” J Clin Pharmacol. 2017;57 Suppl 10:S116-S128
  78. Zhou X*, Mould DR, Takubo T, Sheldon-Waniga E, Huebner D, Milton A, Venkatakrishnan K*. “Global population pharmacokinetics of the investigational Aurora A kinase inhibitor alisertib in cancer patients: Rationale for lower dosage in Asia” Br. J Clin Pharmacol. 2018; 84(1):35-51
  79. Zhou X* Nemunaitis J, Pant S, Bauer TM, Patel M, Sarantopoulos J,Lockhart AC, Goodman D, Huebner D, Mould DR, Venkatakrishnan K. “Effect of alisertib, an investigational Aurora A kinase inhibitor on the QTc interval in patients with advanced malignancies.” Invest. New Drugs 2018; 36(2):240-247
  80. Anderson CM*, Allen BG, Sun W, Agarwala SS, Lee CM, Venigalla ML, Greenberg L, Adkins D, Chen Y, Zhen W, Mould DR, Holmlund J, Brill J, Sonis ST, Buatti J. Phase 1b/2a “Trial of Superoxide Dismutase Mimetic GC4419 to Reduce Chemoradiotherapy-induced Oral Mucositis in Patients with Oral Cavity or Oropharyngeal Carcinoma” Int J Radiation Oncology*Biology*Physics. 2018;100(2):427-435
  81. Mulugeta L Y*, Mould DR, Jacobs B, Florian J, Smith PB, Sinha V, Barrett J. “Leveraging Big Data in Pediatric Development Programs: Proceedings from the 2016 American College of Clinical Pharmacology Annual Meeting Symposium.” Clin Pharmacol Ther. 2018; 104(1):81-87
  82. Eser A, Primas C, Vogelsang H, Novacek G, Mikulits A, Reinisch S, Papay P, Lichtenberger C, Brehovsky S, Mould DR, Reinisch W*. “Prediction of individual serum infliximab concentrations in inflammatory bowel disease by a Bayesian dashboard system.” J Clin Pharmacol 2018; 58(6):790-802
  83. Kevans D*, Murthy S, Mould DR, Silverberg MS. “Accelerated Clearance of Infliximab is Associated with Treatment Failure in Patients with Corticosteroid Refractory Acute Ulcerative Colitis.” J Crohns Colitis. 2018; 12(6):662-669
  84. Priestley T,* Chappa A, Mould DR, Upton RN, Shusterman N, Passik S, Tormo V, Camper S. “Converting From Transdermal to Buccal Formulations of Buprenorphine: A Pharmacokinetic Meta-Model Simulation in Healthy Volunteers.” Pain Medicine 2018; 19(10):1988-1996
  85. Mould DR*, Upton RN, Wojciechowski J, Phan BL, Tse S, Dubinsky MC. “Dashboards For Therapeutic Monoclonal Antibodies: Learning and Confirming.” AAPS J 2018;20(4):76 [epub]
  86. Strik AS, Wang Y-M C, Ruff L, Yashar W, Messmer B, Mould DR. “Individualized Dosing of Therapeutic Monoclonal Antibodies – A Changing Treatment Paradigm” AAPS J 2018; 20(6):99 [epub]
  87. Mukherjee A*, Hazra A, Smith M, Martin S, Mould Dr, Su C, Niezychowski W. “Exposure-response characterization of tofacitinib efficacy in moderate to severe ulcerative colitis: Results from a dose-ranging phase 2 trial.” Br J Clin Pharmacol. 2018;84(6):1136-1145
  88. Cho Y-K, Irby D, Li J, Sborov D, Mould DR, Badawi M, Dauki A, Lamprecht M, Rosko A, Fernandez S, Hade E, Hofmeister C, Poi M, Phelps M*. “Pharmacokinetic-Pharmacodynamic Model of Neutropenia in Myeloma Patients Receiving High-Dose Melphalan for Autologous Stem Cell Transplant.” Clin Pharmacol Ther Syst Pharmacol. 2018 Nov;7(11):748-758
  89. Suri A*, Mould DR, Liu Y, Jang G, Venkatakrishnan K. “Population PK and Exposure–Response Relationships for the Antibody-Drug Conjugate Brentuximab Vedotin in CTCL patients in the Phase III ALCANZA study” Clin Pharmacol Ther. 2018;104(5):989-999
  90. Turner D*, Griffiths A, Wilson DC, Mould DR, Baldassano R, Russell RK, Dubinsky MC, Heyman MB, de Ridder L, Hyams JS, Martín-de-Carpi J, Conklin LS, Faubion WA, Koletzko S, Bousvaros A, Ruemmele FM. “Designing clinical trials in pediatric inflammatory bowel diseases – a PIBDnet commentary.” GUT 2019; epub.
  91. Suri A*, Mould DR, Song G, Collins GP, Endres CJ, Gomez-Navarro J, Venkatakrishnan K. “Population Pharmacokinetic Modeling and Exposure-Response Assessment for the Antibody-Drug Conjugate Brentuximab Vedotin in Hodgkin Lymphoma in the Phase 3 ECHELON-1 study.” Clin Pharmacol Ther. 2019; 106(6):1268-1279
  92. Garner RM, Mould DR, Chieffo C, Jorkasky DK*. “Pharmacokinetic and Pharmacodynamic Effects of Oral CXA-10, a Nitro-Fatty Acid, After Single and Multiple Ascending Doses in Healthy and Obese Subjects.” Clin Translational Sci 2019;12(6):667-676.
  93. Faessel HM*, Mould DR, Zhou X, Faller DV, Sedarati F, Venkatakrishnan K. “Population pharmacokinetics of pevonedistat alone or in combination with standard of care in patients with solid tumours or haematological malignancies.” Br J Clin Pharmacol. 2019;85(11):2568-2579
  94. Vinks AA, Peck RW, Neely M, Mould DR. “Bedside precision dosing 2030 – Development and implementation of electronic health record integrated clinical decision support tools for the precision dosing of drugs.” Clin Pharmacol Ther. 2020; 107(1):129-135
  95. Mukai M, Maeda H Narushima K, Mould DR Greene D. “Population Pharmacokinetic Modeling of Mogamulizumab in Adults with Cutaneous T-cell Lymphoma or Adult T-cell Lymphoma.” J Clin Pharmacol. 2020;60(1):58-66
  96. Mukai M, Mould DR Maeda H, Narushima K, Greene D. “Exposure-Response Analysis for Mogamulizumab in Adults with Cutaneous T-cell Lymphoma.” J Clin Pharmacol. 2020;60(1):50-57
  97. Oketch-Rabah HA, Hardy ML,Patton AP, Chung M, Sarma ND, Yoe C, Shiva Ayyadurai VA, Fox MA, Jordan SA, Mwamburi M, Mould DR, Osterberg RE, Hilmas C, Tiwari R, Valerio L Jr., Jones D, PA Giancaspro GI. “Multi-Criteria Decision Analysis Model for Assessing the Risk from Multi-Ingredient Dietary Supplements (MIDS).” J Dietary Suppl. Published online: 22 Apr 2020
  98. Gerds AT, Savona MR, Scott BL; Talpaz M, Egyed M, Harrison CN, Yacoub A; Vannucchi A, Mead AJ, Kiladjian J-J, O’Sullivan J, García-Gutiérrez V, Bose P, Rampal RK, Miller CB, Palmer J, Oh ST, Buckley SA, Mould DR, Ito K, Tyavanagimatt S, Smith JA, Roman-Torres K, Sirin A. Kahrs18; Devineni S, Craig AR, Mascarenhas JO. “Determining the recommended dose of pacritinib: results from the PAC203 dose-finding trial in advanced myelofibrosis.” Blood Adv. 2020;4(22):5825-5835.
  99. Suri A, Mould DR, Song G, Kinley J, Venkatakrishnan K. “Population Pharmacokinetics of Brentuximab Vedotin in Adult and Pediatric Patients with Relapsed/Refractory Hematologic Malignancies: Model-Informed Hypothesis Generation for Pediatric Dosing Regimens” J Clin Pharm J Clin Pharmacol. 2020;60(12):1585-1597
  100. Dave MB, Dherai AJ, Desai DC, Mould DR, Ashavaid TF. “Optimization of Infliximab therapy in Inflammatory Bowel disease using a Dashboard approach – An Indian experience” Eur J Clin Pharmacol 2021;77(1):55-62
    Eser A, Reinisch W, Schreiber S, Ahmad T, Boulos S, Mould DR. Increased Induction Infliximab Clearance Predicts Early Antidrug Antibody Detection. J Clin Pharmacol. 2021;61(2):224-233.
  101. Strik AS*, Löwenberg M, Mould DR, Berends SE, CI Ponsioen CI, van den Brande J, Jansen JM, Hoekman DR, Brandse JF, Mathôt RA, D’Haen GR. Dashboard driven versus conventional dosing of infliximab in inflammatory bowel disease patients: the PRECISION trial. Scand J Gastroenterol. 2021;56(2):145-154.
  102. Pariser DM*, Lain EL, Mamelok R, Drew J, Mould DR. Limited Systemic Exposure with Topical Glycopyrronium Tosylate in Primary Axillary Hyperhidrosis Clin Pharmacokinet 2021;60(5):665-676
  103. Irby DJ, Ibrahim ME, Dauki AM, Badawi MA, Illamola SM, Chen M, Wang Y, Liu X, Phelps MA, Mould DR. Approaches to handling missing or “problematic” pharmacology data: Pharmacokinetics. CPT Pharmacometrics Syst Pharmacol. 2021 Apr;10(4):291-308
  104. Zhou X, Mould DR, Yuan Y, Weigel B, Fox E, Greengard E, Faller DV, Venkatakrishnan K. Population Pharmacokinetics and Exposure-Safety Relationships of Alisertib in Children and Adolescents With Advanced Malignancies J. Clin. Pharmacol. 2022;62(2):206-219.
  105. Dubinsky MC*, Phan BL, Tse SS, Mould DR. “Dashboard-Driven Accelerated Infliximab Induction Dosing Increases Infliximab Durability and Reduces Immunogenicity.” IBD J. 2022 ;28(9):1375-1385
  106. Primas C, Reinisch W, Panetta JC, Eser A, Mould DR, Dervieux T. “Model Informed Precision Dosing Tool Forecasts Trough Infliximab and Associates with Disease Status and Tumor Necrosis Factor α Levels of Inflammatory Bowel Diseases” J. Clin. Med . 2022 ;11(12):3316.
  107. Desai DC, Dherai AJ, Strik A, Mould DR. Personalized dosing of infliximab in patients with Inflammatory Bowel Disease using a Bayesian approach: a next step in therapeutic drug monitoring. J. Clin Pharmacol. epub 2022
    Zhou X, Richardson DL, Dowlati A, Goel S, Sahebjam S, Strauss J, Chawla S, Wang S, Mould DR, Samnotra V, Faller DV, Venkatakrishnan K, Gupta N. Effect of Pevonedistat, an Investigational NEDD8-Activating Enzyme Inhibitor, on the QTc Interval in Patients With Advanced Solid Tumors. Clin Pharmacol. Drug Dev. 2023;12(3):257-266
  108. Atia O, Shavit-Brunschwig Z, Mould DR, Stein R, Matar M, Aloi M, Ledder O, Focht G, Urlep D, Hyams J, Broide E, Weiss B, Levine J, Russell RK, Turner D. Outcomes, dosing, and predictors of vedolizumab treatment in children: results from the prospective, multicenter VEDOKIDS cohort. Lancet Gastro in press 2023
  109. Nguyen, A, Upton R. Mould DR. Sparrow M. Application of an Algorithm-based Precision-dosing Model to a Real World Cohort of Patients on Infliximab Maintenance Therapy: Implications for Drug Usage and Cost. J Crohns Colitis Submitted 2023
  110. Huynh GH, Carroll MW, Griffiths AM, El-Matary W, Petrova A, Prosser C, Kluthe C, deBruyn JC, Tomalty D, Mould DR, Wine E, Huynh HQ. A Multi-Centre Prospective Infliximab Dose to Level Pharmacokinetic Study During Induction in Pediatric Crohn’s Disease Drafted 2020
  111. Qi Y, Chan ML, Mould DR, Larimore K, Fisheleva E, Cherukuri A, Day J, Savariraya R, Irving M, Bacino CA, Hoover-Fong J, Ozono K, Mohnike K, Wilcox WR, Bober1 MB. Development of a Weight-Band Dosing Approach for Vosoritide in Children with Achondroplasia Using a Population Pharmacokinetic Model. Clin Pharmacokinet Accepted 2024
  112. Agachi S, Beloukhova M, Mould DR, Lemak M, Grishin S, Samsonov M. Disease–Mediated Drug Interactions of Olokizumab and Cytochrome P450 Activities in Patients with Rheumatoid Arthritis Clin Pharmacokinet. Submitted 2023
  113. Kutschera M, Primas C, Reinisch S, Novacek G, Lichtenberger C, Dervieux T, Kim SH, Lee SH, Lee JH, Mould DR, Reinisch W. Targeting early, rapid clearance of infliximab using Bayesian model-guided dosing in patients with inflammatory bowel disease. Aliment Pharmacol. Ther Submitted 2024
  114. Maccecchini ML, Mould DR. Pharmacokinetics of Posiphen in Mouse, Rat, Dog and Human. Biomolecules Accepted 2024
  115. Zhou X, Mould DR, Franklin ARK, Gore L, Bai1 X, Gupta N. Population Pharmacokinetics and Exposure-Response to Support Body Surface Area-Based Dosing of Brentuximab Vedotin in Pediatric Patients with Advanced Hodgkin Lymphoma Clin Pharmacol Ther Drafted 2024
  116. Mould DR, Upton RN. “Getting the Dose Right”—Revisiting the Topic with Focus on Biologic Agents, Clin. Pharmacol. Therap. Accepted 2024
  117. Huynh GH, Carroll MW, Griffiths AM, El-Matary W, Petrova A, Prosser C, Kluthe C, deBruyn JC, Tomalty D, Mould DR, Wine E, Huynh HQ. A Multi-Centre Prospective Infliximab Dose to Level Pharmacokinetic Study During Induction in Pediatric Crohn’s Disease Drafted 2020

Peer Reviewed Abstracts

Peer Reviewed Abstracts
  1. S.D. Black and D.R. Mould “Development of Hydrophobicity Parameters to analyze proteins which bear post- or co-translational modifications”. ASBMB/AAI Conference 1990.
  2. S.D. Black and D.R. Mould “Advances in the Prediction of Protein Structure.  Hydrophobicity Parameters for the side chains of Modified Physiological Amino Acids”.  Second Annual Ohio State Biotechnology Conference March 1990.
  3. D.R. Mould, I.H. Patel, R. Ginsberg, D. Chang, F. Rubio, and R. Limjuco “The Pharmacokinetics of Ro 23-9424 – A Novel Antimicrobial Agent”.  AAPS Conference November 1991.
  4. D. Chang, F. Rubio, D. Mould and C. Town “Identification and Preliminary Pharmacokinetics of Metabolites of Ro 23-9424 in Human Plasma and Urine”.  ASPET Annual Meeting July 1992.
  5. M.H. Binger, D.R. Mould, H. Satoh, R. Chizzonite, C. Anasetti, and T. Waldmann  “Humanized Anti-TAC: Therapeutic Applications of an Anti-IL2R Monoclonal Antibody”.  Antibody Engineering: New Technology and Application Implications DEC. 1992
  6. C. Anasetti, M.-H. Binger, T. Waldmann, D. Mould, H. Satoh, F.R. Appelbaum, H.J. Deeg, K. Doney, P.J. Martin, R. Nash, R. Storb, K.M. Sullivan, R.P. Witherspoon and J.A. Hansen “Treatment of Acute Graft-Versus-Host Disease with a Humanized Monoclonal Antibody Specific for the IL-2 Receptor”.  American Society for Hematology Dec. 1992.
  7. D.R. Mould, T.M. DeFeo, S. Teller and J.W. Massarella “Population Pharmacokinetic Analysis of DDC”.  AAPS Annual Conference (PPDM) Nov. 1992.
  8. D.R. Mould, T.M. DeFeo, I.H. Patel and T.M. Ludden “Population Pharmacokinetic Analysis of Fleroxacin”.  AAPS Annual Conference (PPDM) Nov. 1992.
  9. J.W. Massarella, D.R. Mould and I.H. Patel  “Influence of Body Weight on the Kinetics of Dideoxycytidine”.  ASCPT  94th Annual Conference March 1993.
  10. D.R. Mould, T.M. DeFeo, P.P. Soni, S.B. Reele, G. Milla, R.A. Limjuco, T. Crews, N. Choma and I.H. Patel “Use of DSST Methodology to Assess Pharmacokinetic-Pharmacodynamic Relationships of Midazolam and Diazepam”.  ASCPT 94th Annual Conference March 1993.
  11. F. Vincenti, M. Lantz, J. Birnbaum, M. Garovoy, S. Su, D. Mould, M. Litchman, and S. Light  “A Phase I Trial of Humanized AntiTAC With Standard Imunosuppression for the Prevention of Rejection in Renal Transplant Recipients”.  The 32 Annual Meeting of the European Dialysis and Transplant Association Annual Congress June 1995
  12. F. Vincenti, M. Lantz, J. Birnbaum, M. Garovoy, S. Su, W. Amend, S.Tomlanovich, D. Mould, M. Litchman, and S. Light  “A Phase I Trial of Humanized AntiTAC With Standard Immunosuppression for the Prevention of Rejection in Renal Transplant Recipients”.  The American Society of Transplant Physicians 14th Annual Meeting May 1995
  13. AM Solinger, T Olejnik, C Gardner, M Elliot, CB Davis, and DR Mould  “Results of a Placebo-Controlled Dose Escalating Trial Using a Primatized, Non-Depleting IgG4 Monoclonal Antibody (IDEC-151) In The Treatment of Rheumatoid Arthritis  EULAR 1997
  14. CB Davis, DR Mould, EA Minthorn, DC Kwok, M Elliot, ME Luggan, and AM Solinger  “Pharmacokinetics and Pharmacodynamics of IDEC-151 (SB217969), A Primatized Anti-Human CD4 Monoclonal Antibody (IgG4) In Patients With Rheumatoid Arthritis”  British Society of Rheumatology, Brighton UK 1997
  15. DR Mould, JB Aluri, MC Chapelsky, JG Granett, R Samuels”A Population PK (PPK) and Logistic Regression (LR) Analysis of Lotrafiban (L) in Patients” ASCPT March 1999
  16. S. Akhtar, RA. Beckman, DR. Mould, SZ Fields, J Wright.  “A Phase I, Open-Label, Two Period, Cross-Over Study to Compare the Bioavailability of a Single Dose of Oral Topotecan in the Presence or Absence of Ranitidine. “ ASCO 1999
  17. Consistency of NONMEM Parameter Estimates Across Platforms and Compilers PL. Bonate, Contributors: VA Bhattaram, D Bourne, RC. Brundage, D Fabre, L Gibiansky, N Holford, A Huitema, SJ. Hutcheson, M Hutmacher, I-J Jang, A Kaibara, T Klitgaard, K Kowalski, C Laveille, L Levasseur, S Liao, B Meibohm, DR Mould, AI Nichols, DE. Nix, O Nordle, MC. Peterson, V Piotrovsky, GJ. Robbie, M Sale, DA. Russell, GA. Thompson, A Thomson, U Wählby, G Williams, A Xiao, and X Zhang  AAPS Annual Meeting  Toronto Canada 2002
  18. Tannenbaum SJ, Mould DR, Holford NHG “A Novel Method of Combining Both Continuous and Discrete Categorical Covariates in a Single Joint Function for Generation of Realistic Virtual Patients in a Clinical Trial Simulation” AAPS Annual Meeting  Toronto Canada November 2002
  19. D.R. Mould, N.H.G. Holford, J.H.M. Schellens, J.H. Beijnen, P.R. Hutson, H. Rosing, W.W. ten Bokkel Huinink, EK Rowinsky, J.H. Schiller, M Russo, and G Dane MBChB “Population Pharmacokinetic Analysis and Simulation of topotecan in the treatment of solid tumors”  Hycamtin Global Investigators Workshop Hollywood Florida December 6,7 2002
  20. JVS. Gobburu,NHG. Holford, DR. Mould “Implications of Including and Excluding Correlation of Random Effects in Hierarchical Mixed Effects Pharmacokinetic (PK) Models”  ASCPT Washington DC April 2003
  21. Tannenbaum SJ, Mould DR, Holford NHG “A Novel Method of Combining Both Continuous and Discrete Categorical Covariates in a Single Joint Function for Generation of Realistic Virtual Patients in a Clinical Trial Simulation” ASCPT Washington DC April 2003
  22. NHG. Holford, JVS. Gobburu, DR. Mould “Implications of Including and Excluding Correlation of Random Effects in Hierarchical Mixed Effects Pharmacokinetic Models”  PAGE Verona Italy June 2003
  23. Blair EYL, Mould DR, Rivory LP, Clarke SJ, McLachlan Aj “Population pharmacokinetics of raltitrexed in cancer patients” Poster 45 p 111 Proc Aust Pharm Sci Assoc. Conference Sydney Australia December 2003
  24. K Nieforth, DR Mould, X Zhang, M Salgo, and IH. Patel “Population pharmacokinetic analysis of enfuvirtide in HIV-1-infected patients” ASCPT Miami FL March 2004
  25. T Taylor, DR Mould LJ Benincosa “Population Pharmacokinetics and Pharmacodynamics of CP-101,606 Following a 72-hour Infusion in Acute Ischemic Stroke Patients” ASCPT Miami FL March 2004
  26. E.Y.L. Blair, D.R. Mould, S.J. Clarke, L.P. Rivory, A.J. McLachlan “Pharmacokinetic-Pharmacodynamic Modelling of Raltitrexed in Patients with Advanced Solid Tumours”  PAGE Uppsala June 2004
  27. EY Blair, DR Mould, LP Rivory, SJ Clarke, AJ McLachlan “Factors affecting haematologic adverse effects of raltitrexed in patients with advanced solid tumours”  CPT Australia August 2004
  28. M Krams, DR Mould, LJ Benincosa “Model Based Evaluation of Neurological Stroke Scale Scores”  AAPS Baltimore MD November 2004
  29. C McRobie, K Sweeney, DR Mould, J Legg, and LJ Benincosa “One-Stage vs Two-Stage Analysis of ECG Data.”   AAPS Baltimore MD November 2004
  30. EY Blair, DR Mould, LP Rivory, SJ Clarke, AJ McLachlan “Population PK/PD and Simulation Studies for Dose Optimisation of Raltitrexed in Cancer Patients” APSA Sydney Australia 2004
  31. EYL Blair, DR Mould, SJ Clarke, LP Rivory, AJ McLachlan “Exploring Pharmacokinetic-Pharmacodynamic Relationships of Raltitrexed in cancer Patients”  PAGANZ Brisbane Australia February 2005
  32. F. Lacreta, DR Mould, M. Bifano, D Grasela, M. Pfister “Simulation-Based Support of Dose Recommendations of Entecavir for Renally Impaired Subjects” ASCPT Orlando Florida March 2005
  33. S. Tannenbaum, N. Holford, H. Lee, C. Peck, and D. Mould “A Novel Method for Simulation of Correlated Continuous and Categorical Variables Using a Single Multivariate Distribution” PAGE Pamplona Spain June 2005
  34. PL. Bonate, M. Keating, S. Weitman, P. Hillmen, and DR. Mould “Population Pharmacokinetics of Alemtuzumab in Patients with Hematologic Malignancies”  AAPS Nashville TN November 2005
  35. R. Narwal, DR. Mould, S. Rosenbaum “Development of Population Pharmacokinetic Model for Topotecan Lactone ”  AAPS Nashville TN November 2005
  36. P L. Bonate, M Keating, S Weitman, P Hillmen, and DR Mould  “Population Pharmacokinetics-Pharmacodynamics of Alemtuzumab in Patients with Hematologic Malignancies”.  American Society of Hematology 2006
  37. C Cronenberger, D R Mould, H-J Roethig, and M Sarkar “Carboxyhemoglobin Levels in Adult Smokers. “  ASCPT Baltimore MD March 2006
  38. E. Shang, MA Gibbs, J Landen, NG Denman, M Krams, T Russell, and DR Mould “Model Based Analysis of Placebo Response in Major Depression” ACCP Cambridge MA September 2006
  39. N Denman, D Mould, S Duffull, “Study Designs to Assess the Placebo Response (PBO-R) for Hamilton Depression (HAMD) Scores for Depression” AAPS San Antonio Texas October 2006
  40. J. Alderman, T. Tensfeldt, D. Mould, J. Miceli, “Relevance of Ziprasidone Cmax to the Treatment of Schizophrenia”  AAPS San Antonio Texas October 2006
  41. OA. O’Connor, PA. Hamlin, E Neylon, CH. Moskowitz, CS. Portlock, DJ. Straus, A Noy, B MacGregor-Cortelli, AD. Zelenetz,  M Fleisher, DR Mould, FM. Sirotnak, S Horwitz  “Clinical Experience with Pralatrexate (10-Propargyl-10-deazaaminopterin (PRX)), a Novel Antifolate with High Affinity for the Reduced Folate Carrier, in Patients with Chemotherapy Refractory Lymphoproliferative Malignancies.”  EORTC Prague 2006
  42. DR Mould, K Sweeney, S Duffull, E Neylon, and OA O’Connor “A Population Pharmacokinetic and Pharmacodynamic Evaluation of Pralatrexate in Patients with Hematologic Malignancies”  ASH Atlanta GA December 2007
  43. M Cohen M, DR Mould, A Roy A, M Mandava, and MP Pfister “A population pharmacokinetic analysis of ixabepilone in patients with cancer” ASCO Chicago IL May 30-June 3 2008
  44. OA O’Connor, P Hamlin, C Moskowitz, C Portlock, D Sarasohn, O Dumetrescu, E Neylon, M Patterson, A Zelenetz, ME Saunders, P Cagnoni, DR Mould, M Fleischer, A Califano, F Sirotnak, and S Horwitz  “Pralatrexate (PDX) Produces a High and Durable Complete Response Rate in Patients with Chemotherapy Resistant Precursor and Peripheral T-Cell Lymphomas ” 9th International Conference on Malignant Lymphoma Lugano Switzerland June 8-11 2008
  45. C Scholz, T Wyant, T Leach, S Sankoh, D Mould, M Patella, A Parikh, I Fox, L von Moltke “Clinical pharmacology of vedolizumab (MLN0002) in patients with active Ulcerative Colitis” ECCO Annual Meeting Hamburg Germany Feb 5 2009
  46. DR. Mould, PhD; S Aronson; J Dasta; H Franklin.  “Comparison of the Pharmacokinetics and Pharmacodynamics of Clevidipine and Nicardipine” Soc Cardiovascular Anaesth.  April 18-22, 2009  San Antonio, Texas
  47. H. Pitot, D. Mould, J. Maleski, L. Leopold. “Analysis of a phase I pharmacokinetic (PK)/food effect study of AT-101 in patients with advanced solid tumors.”  ASCO Orlando FL May 29 – June 2, 2009
  48. DR. Mould, P Nandy, IG. Girgis, E Cox, S Ness, L Ford. “Population Pharmacokinetic Modeling and Simulation in Treatment of Seizures in Infants with Topiramate”  ACoP Meeting Mystic CT October 4-7, 2009
  49. JJ Perez Ruixo, B Green, S Doshi, Y-M Wang, DR Mould “Characterization of Platelet Cell Turnover in Thrombocytopenic Adults with ITP using a KPD Model”. ACoP Meeting Mystic CT October 4-7, 2009
  50. P Ravva, R Upton, DR Mould, A Hazra “Population pharmacokinetic model of sulopenem and an oral prodrug, sulopenem etzadroxil, in man, including interaction with probenecid.”. ACoP Meeting Mystic CT October 4-7, 2009
  51. DR Mould, LE Weisman, B Bloom, F Eyal, M Polak, J Fretz, C Sei, JJ Mond, JF Kokai-Kun “Population Pharmacokinetic (PK) Modeling to Guide Dosing of Pagibaximab in Very Low Birth Weight (VLBW) Premature Infants” ASCPT March 17-20 Atlanta GA 2010
  52. DR Mould, LE Weisman, B Bloom, F Eyal, M Polak, J Fretz, C Sei, JJ Mond, JF Kokai-Kun “Predicted and Measured Pagibaximab Serum Levels in High-Risk Neonates” Pediatric Academic Societies’ Annual Meeting Vancouver Canada May 4-8 2010
  53. DR Mould, LE Weisman, B Bloom, F Eyal, M Polak, J Fretz, C Sei, JJ Mond, JF Kokai-Kun “Predicted and Measured Pagibaximab Serum Levels in VLBW Infants” ESPID meeting Nice France May 4-8 2010
  54. A. Gupta, DR Mould, L. Ryderman, J. Wanders, D. Shuster, Z. Hussien, M. Jansen “A population pharmacokinetic-pharmacodynamic analysis of safety and efficacy of eribulin mesylate in patients with metastatic or locally advanced breast cancer” 35th ESMO Congress Milan Italy October 8-12 2010
  55. JHM Schellens, L Reyderman, J. Wanders, DR Mould, A. Gupta, Z. Hussien “Eribulin dosing in patients with advanced solid tumors and hepatic impairment” EORTC 2010
  56. LA Devriese, PO Witteveen, EE Voest, E Overkleeft, M Langenberg, JH Beijnen, L Reyderman, J Wanders, DR Mould, A Gupta, Z Hussein, JHM Schellens.  “Eribulin dosing in patients with advanced solid tumors and hepatic impairment” ASCO National Meeting Chicago IL June 3-7 2011
  57. V Kumar, K Sweeney, D Mould, J Liu.  “Development of an Integrated Population Pharmacokinetic Model for Immediate Release and Controlled Release Formulations of an Investigational Compound in Healthy Subjects and Schizophrenia Patients”.  ACoP National Meeting 2011 San Diego CA
  58. K Venkatakrishnan, P Meyers, DR Mould, B Green, TW. Synold, C Oliva, P Anderson. “Pharmacokinetics and Pharmacodynamics of Liposomal Mifamurtied in Patients with Osteosarcoma”.  ESMO National Meeting 2011
  59. Amantea M, Mould D, Upton R, Pearce S, Hsyu P-H.  “Pharmacodynamic Analysis of Bosutinib in Patients with Chronic Myelogenous Leukemia”.  ASH National Meeting 2012
  60. Pan W-J, Gibbs M, Frame B, and Mould DR. Model Based Meta Analyses of Disease Metrics in Patients with Crohn’s Disease.  ACCP National Meeting 2012 Chicago IL
  61. Li Z, Mould DR, Hard M, von Moltke L. “A Population (Pop) Pharmacokinetic (PK)/Pharmacodynamic (PD) Analysis of Mipomersen (Mipo)”  ASCPT Annual Meeting 2012 Washington DC
  62. Li Z, Mould DR, Hard M, Heaton J, von Moltke L. “Clinical Population Pharmacokinetic-Pharmacodynamic Assessment of the Relationships of Plasma Exposure and Efficacy Outcomes of Mipomersen.”  EAS National Meeting 2012
  63. K Venkatakrishnan, X Zhou, J Ecsedy, H Danaee, H Xiao, H Shi, DR Mould, H Fingert, E Benaim, R Kleinfield, A Milton. “Clinical pharmacologic considerations for the phase 2/3 dose/regimen of the investigational Aurora A kinase (AAK) inhibitor alisertib (MLN8237): pharmacokinetics (PK), pharmacodynamics (PD), and exposure-safety relationships” ASCO National Meeting 2012
  64. Z Xu, DR Mould, C Hu, J Ford, M Keen, H M Davis, H Zhou “A Population-Based Pharmacokinetic Pooled Analysis of Infliximab in Pediatrics” ACCP National Meeting 2012 San Diego CA.
  65. X Gao, DR Mould, S Krishnaswami, MK Smith, A Mukherjee “A Population Pharmacokinetic Model From a Phase 2 Study of Tofactinib (CP-690,550), an Oral Janus Kinase Inhibitor in Active Ulcerative Colitis” DDW Meeting 2012 May San Diego CA
  66. HS Kuan, N Gupta, K Venkatakrishnan, A Milton, S Girgis, S Poggesi,  DR Mould “Population Pharmacokinetic Modelling of Bortezomib After Bolus Intravenous Injection in Cancer Patients”  PAGE Meeting 2012 June Venice Italy
  67. Zhao Q, Tensfeldt TG, Chandra R, Mould DR. “Population Pharmacokinetics of Azithromycin and Chloroquine in Healthy Adults and Pediatric Malaria Subjects Following Oral Administration of Azithromycin and Chloroquine Tablets” ASCPT National Meeting March 2013 Indianapolis IN
  68. Ogden A, Liu J, Comery TA, Mould DR, “Longitudinal Analysis of Vabicaserin and Olanzapine Treatment Effects on PANSS Total Scores Using an Informed Dropout Model” American Conference of Pharmacometrics May 12-15 2013 Fort Lauderdale FL.
  69. Dotan I, Ron Y, Yanai H, Becker S, Fishman S, Yahav L, Ben Yehoyada M, Mould Dr. “Population Pharmacokinetic Evaluation of Infliximab Reveals Patient Factors that Increase Infliximab Clearance and Shorten Half-Life in Inflammatory Bowel Disease Patients.”  DDW Annual Meeting May 19 2013 Orlando FL
  70. Liu P, Mould DR. “Population Pharmacokinetic (PK) Analysis of Voriconazole (VOR) and Anidulafungin (ANID) in Adult Patients with Invasive Aspergillosis (IA)” ICCAC Annual Meeting September 10 2013 Denver CO
  71. Dotan I, Ron Y. Yanai H, Becker S, Fishman S, Yahav L,Ben Yehoyada M, Mould D. “Population Pharmacokinetic Evaluation of Infliximab Reveals Patient Factors That Increase Infliximab Clearance and Shorten Half-Life in Inflammatory Bowel Disease Patients.”  UEG Week  October 12 to 16, 2013 Berlin, Germany
  72. Dotan I, Yanai H, Ron Y, Kariv R, Fishman S, Yahav L, Ben Yehoyada M, Santo E,  Mould DR. Population Pharmacokinetic Evaluation of Adalimumab Reveals Patient Factors that Increase Adalimumab Clearance and Shorten Half-Life in Inflammatory Bowel Disease Patients. June 3-5 2014 DDW Chicago IL USA
  73. Qi Y, Mould DR, Zhou H, Merilainen M, Musson DG. A Prospective Population Pharmacokinetic (PK) Analysis of Sapropterin Dihydrochloride in Infants and Young Children with Phenylketonuria (PKU).  PAGE June 2014 Alicante Spain
  74. Eser A, Vogelsang H, Novacek G, Mikulits A, Reinisch S, Primas C, Lichtenberger C, Brehovsky S, Mould DR, Reinisch W.  “Information Necessary to Predict Individual Infliximab (IFX) Pharmacokinetics (PK) in Patients with IBD” UEGW October 2014 Vienna Austria
  75. Melmed GY, Irving PM, Jones J, Kaplan GG, Kozuch PL, Velayos FS, Baidoo L, Sparrow MP, Bressler B, Cheifetz AS, Devlin SM, Harrell LE, Vande Casteelle N, Mould DR, Dubinsky M, Colombel JF, Sandborn WJ, Siegel CA.  “The Appropriateness of Testing and Interpretation of Anti-TNF Drug and Antibody Concentrations: When Should They be Ordered and What to Do With the Results?”  UEGW October 2014 Vienna Austria
  76. Melmed GY, Irving PM, Jones J, Kaplan GG, Kozuch PL, Velayos FS, Baidoo L, Sparrow MP, Bressler B, Cheifetz AS, Devlin SM, Harrell LE, Vande Casteelle N, Mould DR, Dubinsky M, Colombel JF, Sandborn WJ, Siegel CA.  “Interpretation of anti-TNF Drug Concentration and Antibody Levels: What to do with the results in different clinical scenarios?”  ACG October 2014 Philadelphia PA
  77. Mould DR, Morrow L, Pichotta P, Hompesch M, Krasner A, DeSouza E. “Pharmacokinetic (PK) and Pharmacodynamic (PD) Modelling Predict Similar Dosing Frequencies for U-400 Ultra Rapid-Acting Insulin BIOD-531 Compared to Marketed Prandial-Basal Insulins” American Diabetes Association 2015 Boston MA
  78. Vande Casteele N, Mould DR, Tops S, Vandenbroeck K, Ballet V, Ferrante M, Van Assche G,  Gils A, Vermeire S, Baert F. “Initial Adequate Trough Concentrations during Induction Therapy Correlate with Sustained TNF Suppression and Predict Remission with Adalimumab in Anti-TNF Naïve Crohn’s Disease Patients” ECCO 2015 Barcelona Spain
  79. Brandse JF, Mould DR, Ashruf YK, Smeekes OS,  Löwenberg M, Ponsioen CY, van den Brink GR, D’Haens GR. “Antibodies to infliximab, weight and low serum albumin levels increase clearance of infliximab, a population pharmacokinetic study in 324 IBD patients” ECCO 2015 Barcelona Spain
  80. Dubinsky M; Singh N; Mould DR. “Using a pharmacokinetic dashboard to forecast infliximab levels and predict individualized dosing regimens in IBD patients” ECCO 2015 Barcelona Spain
  81. Vande Casteele N, Mould DR, Tops S, Vandenbroeck K, Ballet V, Ferrante M, Van Assche G,  Gils A, Vermeire S, Baert F. “Initial Adequate Trough Concentrations during Induction Therapy Correlate with Sustained TNF Suppression and Predict Remission with Adalimumab in Anti-TNF Naïve Crohn’s Disease Patients” DDW 2015 Washington DC
  82. Brandse JF, Mould DR, Ashruf YK, Smeekes OS,  Löwenberg M, Ponsioen CY, van den Brink GR, D’Haens GR. “Antibodies to infliximab, weight and low serum albumin levels increase clearance of infliximab, a population pharmacokinetic study in 324 IBD patients” DDW 2015 Washington DC
  83. Dubinsky M; Singh N; Mould DR. “Using a pharmacokinetic dashboard to forecast infliximab levels and predict individualized dosing regimens in IBD patients” DDW 2015 Washington DC
  84. C Anderson, B Allen, W Sun, S Agarwala, C Kunos, M  Venigalla, L Greenberg, D Adkins, Y Chen, W Zhen, D Mould, J Holmlund, J Brill, S Sonis, J Buatti. “Phase 1 trial of superoxide (SO) dismutase (SOD) mimetic GC4419 to reduce chemoradiotherapy (CRT)-induced mucositis (OM) in patients (pts) with mouth or oropharyngeal carcinoma (OCC).”  MASCC/ISOO Annual Meeting 2015 Copenhagen Denmark
  85. X Zhou, J Nemunaitis, S Pant, T Bauer, M Patel, J Sarantopoulos, A C Lockhart, D Goodman, C D Ullmann, D Mould, K Venkatakrishnan. “Effects of alisertib (MLN8237), an investigational Aurora A kinase inhibitor (AAKi), on the QTc interval in patients (pts) with advanced malignancies” ESMO Annual Meeting Vienna, Austria, 29 September 2015
  86. AC Muntau, W Uhl, DR Mould, A Munafo “Population pharmacokinetic analysis of sapropterin dihydrochloride in 0–4 year-old children with phenylketonuria: results from the SPARK study”  SSIEM Annual Meeting September 2015 Lyon France
  87. JF Brandse, DR. Mould, Y Ashruf, O Smeekes, GR van den Brink, GR D’Haens “Antibodies to infliximab, body weight and low serum albumin levels increase clearance of infliximab, a population pharmacokinetic study in 322 IBD patients.  UGEW Barcelona Spain 24-28 October 2015
  88. G. Nagdeep, R Upton, D.R. Mould, C.L. Bello, M. A. Amantea. “Population Pharmacokinetic Model (PopPK) for Dacomitinib (Dac) and its Metabolite PF-05199265 (Met) in Healthy Volunteers and Patients with Advanced Solid Tumors” ACoP6 Meeting Crystal City, VA, October 4-7, 2015
  89. P. Chan, Phyllis, M. AbuTarif, L, Reynolds, R Bertz, J. Wen, K. Emerick, M-H. Chang, M. R. Harley,  D.R Mould. M. Bifano. “Population Pharmacokinetic and Pharmacodynamic Analyses of Entecavir in Pediatric Subjects” reporting results from Entecavir AI463-028; AI463-189, AI463-004, AI463-005, AI463-014” ACoP6 Meeting Crystal City, VA, October 4-7, 2015
  90. N Vande Casteele, DR Mould, R Oliver, G Kosutic, M Spearman, B Feagan, WJ Sandborn. “Refinement of Population Pharmacokinetic Model of Certolizumab Pegol in Patients with Crohn’s Disease to Account for Time Varying Nature of Covariates”.  CCFA Advances in IBD Congress 2015 Orlando FL
  91. MJ. Hanley, N. Gupta1, K. Suryanarayan, R. Neuwirth, D-L. Esseltine, T. Horton, R. Aplenc, TA. Alonzo, X. Lu, A. Milton, DR. Mould, K. Venkatakrishnan “Population pharmacokinetic (PK) analysis of bortezomib in pediatric leukemia patients: support for body surface area (BSA)-based dosing in patients aged 2–16 years”.  ASCPT Annual Meeting 2016 March, San Diego CA
  92. HM. Faessel, DR. Mould, BJ. Dezube, S Santillana, K Venkatakrishnan. “Population Pharmacokinetics (PK) of the Investigational NAE Inhibitor Pevonedistat (TAK-924/MLN4924) Administered Alone or in Combination with Azacitidine in Patients with Solid or Hematologic Malignancies” AACR-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics Annual Meeting 2016
  93. CM Anderson, BG Allen, W Sun, C Lee, SS Agarwala, C Kunos, ML Venigalla, L Greenberg, D Adkins, Y Chen, W Zhen, DR Mould, J Holmlund, JM Brill, ST Sonis, JM Buatti. Phase 1b trial of superoxide (SO) dismutase (SOD) mimetic GC4419 to reduce chemoradiotherapy (CRT)-induced oral mucositis (OM) in patients (pts) with oral cavity or oropharyngeal carcinoma (OCC). ASCO Annual Meeting 2016 Chicago IL
  94. Giri N, Upton RN, Mould DR, Bello C, Amantea MA. “Correlation of Dacomitinib and its Metabolite (PF-05199265) Exposure with Key Adverse Events.” ASCPT Annual Meeting March 2016 San Diego CA
  95. Garrett M, Taylor T, Mould DR, Amantea MA, Chen Y, Ingrosso A, Pithavala YK. Lack of effect of smoking on axitinib pharmacokinetics (PK) in non-small cell lung cancer (NSCLC) patients (pts) ASCPT Annual Meeting March 2016 San Diego CA
  96. Stewart, MJ; Dubinsky M; Morganstern B; Vasiliauskas E; Targan ; Ippoliti A; Shih DQ; Mould DR; McGovern D; Melmed, GY. The Steady-State Pharmacokinetics of Adalimumab: Do We Need to Drink From the “Trough”? DDW Annual Meeting 2016
  97. Anderson C, Allen B, Sun W, Agarwala S, Lee CM, Venigalla M, Greenberg L, Adkins D, Chen Y, Zhen W, Mould DR, Holmlund J, Brill J, Sonis S, Buatti J. Phase 1 trial of superoxide (SO) dismutase (SOD) mimetic GC4419 to reduce chemoradiotherapy (CRT)-induced mucositis (OM) in patients (pts) with mouth or oropharyngeal carcinoma (OCC). MASCC Annual Meeting June 23-25 2016,  Adelaide, Australia
  98. Thieroff-Ekerdt RI, Mould DR. Differentiated pharmacokinetics of levoketoconazole (COR-003), the single 2S,4R-enantiomer of ketoconazole, a new investigational drug for the treatment of Cushing’s syndrome. ECE 2016 Munich Germany.
  99. MJ Stewart, M Dubinsky, B Morganstern, E Vasiliauskas, S Targan, A Ippoliti, DQ Shih, D Mould, D McGovern, GY.Melmed. “The Steady-State Pharmacokinetics of Adalimumab:  Do We Need to Drink From the “Trough?”.  DDW 2016 San Diego CA
  100. J.F. Brandse, D.R. Mould, Y.K. Ashruf, O. Smeekes, S. Kuin, A. Strik, G.R. van den Brink, G.R. D‘Haens. “Therapeutic Drug Monitoring in Inflammatory Bowel Disease”. DDW 2016 San Diego CA
  101. T Priestley, A Chappa, DR Mould, N Shusterman, S Passik, V Tormo, S Camper.  “Converting from transdermal to buccal formulations of buprenorphine – a pharmacokinetic metamodel simulation”  Pain Week 2016 Las Vegas NV
  102. W Reinisch, A Eser, S Schreiber, DR Mould. Body weight and rapid clearance determine early formation of anti-drug antibodies against Infliximab. UGEW 2017 Barcelona Spain
  103. A Suri, DR Mould, Y Liu, G Jang, D Huebner, K Venkatakrishnan. Exposure-Response Relationships of Brentuximab Vedotin Efficacy and Safety in Cutaneous T-cell Lymphoma Patients. EADV 2017 Geneva Switzerland
  104. Rutsch F, Burlina A, Eyskens F, Freisinger P, De Laet C, Leuzzi V, Sivri HS, Vijay S, Bal MO, Gramer G, Pazdírková R, Cleary M, Lotz-Havla AS, Mould DR, Lane P, Alvarez I, Muntau AC. “Long Term Efficacy and safety of sapropterin in PKU patients <4 years: extension of SPARK open-label, multicentre, randomized phase IIIb trial”. ACMG 2018 Charlotte NC USA
  105. W Reinisch, A Eser, S Schreiber, H-C Kwon, DR Mould. Reduction of dosing intervals is the preferable dose optimization strategy for infliximab to suppress formation of anti-drug antibodies 2018 ECCO Vienna Austria
  106. Strik A, Berends S, Mould DR, Mathôt R, Ponsioen C, van den Brande J, Jansen J, Hoekman D, Brandse J, Löwenberg M, D’Haens G. Dashboard driven versus conventional dosing of infliximab in inflammatory bowel disease patients: the PRECISION trial 2019 ECCO Copenhagen Denmark
  107. Dave MB, Dherai AJ, Desai DC, Mould DR, Ashavaid TF.  Efficacy of iDose dashboard forecast for individualizing Infliximab therapy – An Indian Experience 2019 ECCO Copenhagen Denmark
  108. Strik A, Berends S, Mould DR, Mathôt R, Ponsioen C, van den Brande J, Jansen J, Hoekman D, Brandse J, Löwenberg M, D’Haens G. Dashboard driven versus conventional dosing of infliximab in inflammatory bowel disease patients: the PRECISION trial 2019 DDW San Diego CA USA
  109. Petrova A, Wine E, Griffiths AM, El-Matary W, Huynh GH, Prosser C, Kluthe C, Mould DR, Carroll MW, Huynh HQ. Infliximab clearance at and post induction predicts clinical and endoscopic outcomes at 1 year in children with Crohn´s disease treated with Infliximab 2019 PIBD Budapest Hungary
  110. Pariser D, Lain E,  Mamelok R, Drew J, Mould DR. Limited Systemic Exposure with Topical Glycopyrronium Tosylate across Multiple Studies in Healthy Volunteers and Patients with Primary Axillary Hyperhidrosis. 2019 EADV Madrid Spain
  111. Suri A, Mould DR, Song G, Kinley J, Venkatakrishnan K. Brentuximab vedotin population pharmacokinetic (POPPK) modelling in adult and paediatric patients (pts) with relapsed/refractory (R/R) hematologic malignancies. 2019 ICML Lugano Switzerland
  112. Pariser DM, Lain EL, Mamelok R, Drew J, Mould DR. Systemic Exposure with Topical Glycopyrronium Tosylate across Multiple Studies in Healthy Volunteers and Patients with Primary Axillary Hyperhidrosis 2019 EADV Madrid Spain

Journal Review Work

  1. AAPS Journal – Special Theme Issue Editor and Reviewer
  2. Clinical Pharmacology and Therapeutics – Editorial Board Member and Reviewer
  3. Clinical Pharmacology and Therapeutics Pharmacometrics and Systems Pharmacology – Editorial Board Member and Reviewer
  4. Journal of Clinical Pharmacology – Member Publication Committee and Reviewer
  5. European Journal of Pharmacology – Reviewer
  6. Clinical Pharmacokinetics – Reviewer
  7. Journal of Pharmacokinetics and Pharmacodynamics – Editorial Board Member and Reviewer
  8. International Journal of Pharmaceutical Medicine – Reviewer
  9. Cancer Chemotherapy and Research – Reviewer
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