DIANE R. MOULD
8814 Tropical Court
Fort Myers FL 33908
and
535 Springview Lane
Phoenixville, PA. 19460
(703) 919-1715
DRMOULD@PRI-HOME.NET
Current Position and Affiliation: President Projections Research, Inc.
Fields and Areas of Specialization: Pharmacokinetics, pharmacodynamics, pharmacometrics, clinical trial design
Education:
12/89: Ph.D. Degree in Pharmaceutics and Pharmaceutical Chemistry
GPA: 3.8/4.0
The Ohio State University – College of Pharmacy Columbus, Ohio 43210
Dissertation Topic:
The Oral and IV Pharmacokinetics of Ethyl Alcohol in the Fed and Fasted States Using the Dog Model.
5/83: B.S. Chemical Biology GPA: 3.0/4.0
Stevens Institute of Technology, Hoboken, N.J. 07030
Research Topic: Synthesis of Novel Beta Lactam Antibiotics
Previous Positions Held:
1/01-Present Projections Research Inc.
Phoenixville PA 19460
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 20007
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 94040
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 19403
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 93012
Clinical Manager-Clinical Affairs
Write, place and implement clinical trials. Supervise monitoring staff, oversee clinical data handling. Manage grants and budgets. Generate study reports and manuscripts. Arrange and conduct investigator meetings. Prepare regulatory documentation
2/90-10/95 Hoffmann-La Roche
Nutley, NJ 07110-1199
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 43210
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 43210
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. 10092
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. 07030
Synthesis of Beta-Lactam antibiotics. IR, GC-MS, NMR TLC and other chromatography techniques.
Research Assistant
Enzyme and Protein assay work, electrophoresis, isoelectric focusing.
Honors:
National Honor Society, Dean’s List (1979-1983)
Stevens Tech Special Research Project (1982-1983)
Phi Kappa Phi (1985-present)
Rho Chi (1988-present),
AFPE Fellow (1985-1990)
Academic Challenge Fellow (1987-1990)
Sigma Xi (1991-present)
Who’s Who in Science and Engineering 1996
Fellow of the American College of Clinical Pharmacology 2009
Member Editorial Board for Clinical Pharmacology and Therapeutics 2009-present
Jack L Beal Award (OSU) 2010
Member Editorial Board for Journal of Pharmacokinetics and Pharmacodynamics 2012-present
Member Editorial Board for Clinical Pharmacology and Therapeutics: Pharmacometrics and Systems Pharmacology 2012-present
Member Board of Regents American College of Clinical Pharmacology 2013-present
CPT: PSP Award (ASCPT) 2014
Fellow of the American Association of Pharmaceutical Sciences 2014
Recognition:
Roche Management Incentive Bonus Award (first installation and use of Nonmem at Roche) 1992
Roche Management Incentive Bonus Award (use of Nonmem for Megalone filing, for Zenepax filing) 1994
SmithKline Beecham Bronze Impact Award (Population PKPD evaluation of Avandia) 1997
SmithKline Beecham Bronze Impact Award (Population pharmacokinetic evaluation of Topotecan, Paxil) 1997
SmithKline Beecham Special Award – Top 1% Productivity 1997
SmithKline Beecham Silver Impact Award (population PKPD evaluations to assist dose selection for FTIM studies – 3 agents) 1998
Academic Appointments:
Adjunct Professor University of Rhode Island College of Pharmacy
Adjunct Professor The Ohio State University College of Pharmacy
Adjunct Professor University of Florida Pharmaceutics Department
Professional Organizations:
AAPS, ACCP, ASCPT, ASoP, DIA, New York Academy of Sciences
Teaching Experience: Ohio State University
7/10-Present College of Pharmacy Adjunct Professor
Ohio State University
7/11-16/2013 Introduction to Nonmem – Population Pharmacodynamics
Ohio State University
7/11-16/2010 Introduction to Nonmem – Population Pharmacodynamics
Ohio State University
9/87-6/89 Ohio State University
Graduate Teaching Assistant, Department of Pharmaceutics
Private Tutor for all undergraduate Pharmaceutics courses.
9/85-6/86 Ohio State University
Graduate Teaching Assistant, Department of Engineering Instructor for Introduction to Fortran Programming. Taught approx. 60 students per academic period.
Teaching Experience: URI
9/04-Present University of Rhode Island Providence RI
College of Pharmacy Adjunct Professor
3/11/2014 University of Rhode Island
College of Pharmacy
Modeling the Pharmacokinetics and Pharmacodynamics of Biotech Agents
12/11/2009 University of Rhode Island
College of Pharmacy
Modeling the Pharmacokinetics and Pharmacodynamics of Biotech Agents
4/13/2009 University of Rhode Island
College of Pharmacy
Modeling the Pharmacokinetics and Pharmacodynamics of Biotech Agents
9/10/2004 University of Rhode Island
College of Pharmacy
Introduction to Population Pharmacokinetic Methods
Teaching Experience: U Montreal
8/2008 Modeling and Simulation in Drug Development
University of Montreal, Montreal Canada
Teaching Experience: SUNY Buffalo
6/2005 SUNY Buffalo
College of Pharmacy
Topics in Population PK PD Analysis
12/2001 SUNY Buffalo
College of Pharmacy
Modeling the Progression of Disease
Teaching Experience: NIH
2/2001-2/2012
NIH Bethesda MD
Clinical Pharmacology Course
Modeling the Progression of Disease
Bethesda Medical Center
Teaching Experience: Georgetown U
9/00-3/2001 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
Special Skills:
Programming Languages: Fortran, Basic, Pascal,C++, R
Foreign Languages: French (read), Latin (read)
Hobbies:
Painting, Music, Hiking, Flying, Biking, Sailing, Windsurfing, Photography, Skiing, Weight Lifting, Car Racing – Mazda Speed Challenge
References:
Available upon request
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
PEER REVIEWED PUBLICATIONS
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.
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.
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.
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.
D.R. Mould*, T.M. DeFeo, S.B. 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
B.E. Fayer*, 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
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
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
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 PRIMATIZED 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
S. Aktar, R.A. Beckman*, D.R. Mould, 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
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
D.R. Mould*, N.H.G. Holford, J.H.M. Schellens, J.H. Beijnen, P.R. Hutson, H. Rosing, W.W. ten Bokkel Huinink, E.K. Rowinsky, J.H. Schiller, M. Russo, and G. Dane “Pooled Pharmacokinetic and Adverse Event Analysis of Topotecan in Patients with Solid Tumors†Clin. Pharmacol. Ther. 2002 71(5):334-48
D.R. Mould, K. Nieforth, X. Zhang, M. Salgo, I. H. Patel* “Population Pharmacokinetics of Enfuvirtide in Patients with Human Immunodeficiency Virus†Clin. Pharmacol. Ther. 2005 Jun;77(6):515-28
J Martin* and D.R. Mould “Clinical Pharmacology: Drug Action in Progressing Disease†Eur J Hospital Pharm. Practice 2006 12(3):38-39
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
S.J. Tannenbaum*, N.H.G. 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
D.R. Mould* and K.D 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
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
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
O.A. O’Connor*, P. Hamlin, C. Portlock, C. Moskowitz, A. Noy, D. Straus, B. MacGregor-Cortelli, E. Neylon, J. Pappanicolu, O. Dumetrescu, D.R. Mould, M. Fleischer, A.D. Zelenetz, 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
A. Roy*, R. Raymond, D.R. Mould, X-F. Wang, L. Tay 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
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
F. Feillet*, L. Clarke, C. Meli, J. Baker, M. Lipson, J. Bergoffen, A. Morris, P. Harmatz, D.R. Mould, B. Green, A Dorenbaum and M Giovannini for the Sapropterin Research Group “Pharmacokinetics of Sapropterin Dihydrochloride in Patients with Phenylketonuria†Clin Pharmacokinet. 47(12):817-825 2008
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
D.R. Mould*, K. Sweeney, S. Duffull, E. Neylon, P. Hamlin, S. Horwitz, F. Sirotnak, M. Fleischer, M.E. Saunders, and O.A. O’Connor. “A Population Pharmacokinetic And Pharmacodynamic Evaluation of Pralatrexate†Clin Pharmacol Ther 86(2):190-6 2009
O.A. O’Connor*, P. Hamlin, C. Moskowitz, C. Portlock, D. Sarasohn; E. Neylon, J. Mastrella, R. Hamelers, B. Mac-Gregor-Cortelli, M. Paterson, A. D. Zelenetz, F. Sirotnak, M. Fleischer. D.R. Mould, M. Saunders, P. Cagnoni, S. Horwitz. “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
D.R. Mould*, B. Green “Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies: Concepts and Lessons for Drug Development†BioDrugs 24(1):23-39 2010
D. Karhu*, G. Groenewoud, M Potgieter, D.R. Mould. “Dose Proportionality of Once-Daily Trazodone Extended Release Caplets Under Fasting Conditions†J Clin Pharmacol 50(12):1438-49 2010
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
L. Jain, S. Woo, E. R. Gardner, D.R. Mould, W. L. Dahut, E. C. Kohn, S. Kummar, R. Yarchoan, G. Giaccone, J. Venitz, W.D. Figg*. “Population Pharmacokinetic Analysis of Sorafenib in Patients with Solid Tumours.†Br J Clin Pharm 72(2):294-305 2011
A Parikh, T Leach, T Wyant, C Scholz, S Sankoh, DR. Mould, T Ponic, I Fox, BG. Feagan* “Vedolizumab for the Treatment of Active Ulcerative Colitis: A Randomized Controlled Phase 2 Dose-Ranging Studyâ€. Inflam. Bowel Diseases. 18(8):1470-9 2012
I Ordás, DR Mould, BG Feagan, WJ Sandborn*. “Monoclonal Antibodies in Inflammatory Bowel Disease: Pharmacokinetic Based Dosing Paradigms.†Clin. Pharmacol. Ther. 91(4):635-46 2012
J.J. Perez-Ruixo*, B. Green, S .Doshi, Y-M. Wang, D.R. Mould “Development of a Dosing Strategy for Romiplostin to treat patients with Immune (Idiopathic) Thrombocytopenic Purpuraâ€. J. Clin. Pharm.52:(10):1540-1551 2012
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
DR Mould* “Models for Disease Progression – New Approaches and Usesâ€. Clin. Pharmacol. Ther. 92(1):125-131 2012
DR Mould*. “Model-Based Meta-Analysis: An Important Tool for Making Quantitative Decisions During Drug Development†Clin. Pharmacol. Ther. 92(3):283-286 2012
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
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
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
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
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
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
Mould DR*, Moyer B, Amur S, Mukherjee A. “The Impact of New Technologies on the Science of Clinical Care and Drug Developmentâ€. AAPS Magazine December 2013
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
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
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
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
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
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
Mould DR*, Upton R, Wojciechowski J. Dashboard Systems: Implementing Pharmacometrics from Bench to Bedside. AAPS J ePub June 2014
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
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
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
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
Mould DR*, Walz A, Lave T, Gibbs J, Frame B. Developing Exposure/Response Models for Anti-Cancer Drug Treatment: Special Considerations Clin Pharmacol Ther: Pharmacometr and Syst Pharmacol Epub Jan 2015.
Hsyu PH, Mould DR, Abbas R, Amantea M. “Population Pharmacokinetic and Pharmacodynamic Analysis of Bosutinib.†Drug Metab Pharmacokinet. 2014 Dec 25;29(6):441-8
Mould DR*, Dubinsky MC. Dashboard Systems: Pharmacokinetic / Pharmacodynamic Mediated Dose Optimization. J Clin Pharm. 2015;55 Suppl 3:S51-9
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 Accepted 2014
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. Accepted 2014
Mould DR The pharmacokinetics of biologics a primer. Digestive Diseases Accepted 2015
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
Mould DR*, D’Haens G, Upton RN. Clinical Decision Support Tools: The Evolution of a Revolution. Clin Pharmacol Ther. 2016;99(4):405-18
Mould DR*, Meibohm B. Drug Development of Therapeutic Monoclonal Antibodies. BioDrugs 2016;30(4):275-93
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. 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? Clin Gastroenterol Hepatol. 2016 Sep;14(9):1302-9
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
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
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 Dec 15;63(12):1599-1604
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
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 Jan;19(1):215-222
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 Feb;6(2):87-109
Brandse JF*, Mould DR, Ashruf YK, Smeekes OS, Kuin S, van den Brink GR, D’Haens GR. Factors that increase clearance of infliximab: relationship between insufficient infliximab exposure and antidrug antibody formation in IBD, a pharmacokinetic study. Inflam Bowel Dis. 2017 ;23(4):650-660
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
Jacobs FMJ*, Mould DR. The role of FcRn in the pharmacokinetics of biologics in patients with multiple myeloma. Clin. Pharmacol. Ther. 2017;102(6):903-904
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 Sep;57(9):1183-1193
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 Jul;19(4):1136-1147.
Vande Casteele N, Mould 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
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
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
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
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
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
Eser A, Primas C, Vogelsang H, Novacek G, Mikulits A, Reinisch S, Papay P, Lichtenberger C, Brehovsky S, Mould DR, Reinisch w*. An easy-to-use system to predict individual infliximab levels in inflammatory bowel disease. Alimen Pharmacol Ther 2018; 58(6):790-802
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
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. Pain Medicine 2017 [epub]
Mould DR*, Upton RN, Wojciechowsk J, Phan BL, Tse S, Dubinsky MC. Dashboards For Therapeutic Monoclonal Antibodies: Learning and Confirming. AAPS J 2018;20(4):76 [epub]
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. Accepted 2018
Mukherjee A*, Hazra A, Smith M, Martin S, Mould Dr, Su C, Niezychowski W. Tofacitinib Dose and Exposure-Efficacy Relationships In Moderate to Severe Ulcerative Colitis Patients In a Phase 2 Dose-Ranging Induction Study. Br J Clin Pharmacol. Accepted 2018
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. Accepted 2018
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 Submitted 2018
Cohen F*, Lavin P, Mould DR. Abou-Gharbia M. Drug Interaction Potential and Clinical Pharmacology of COR-003 (Levoketoconazole), an Investigational Treatment for Endogenous Cushing’s Syndrome. Brit. J. Clin. Pharmacol. Submitted 2018
Koller M*, Flanagan K, Skov M, Goldblum R, Griffith SG, Mould DR, Taylor T, Barbour RM, Zago W,. Yednock TA, Kinney GG, Ness DK. A first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study of PRX003 in healthy volunteers. JCP. Submitted 2018
Oketch-Rabah HS*, Hardy ML, Patton A, Chung M, Sarma ND, Yoe C, Ayyadurai VAS, Fox MA, Jordan SA, Mwamburi M, Mould DR, Osterberg RE, Hilmas C, Tiwari R, Valerio Jr. LD, Jones D, Deuster P, Giancaspro GI. Multi-Criteria Decision Analysis Model for Assessing the Risk From Multi-Ingredient Dietary Supplements (MIDS) Risk Analysis drafted 2018
PEER REVIEWED BOOK CHAPTERS
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
S.Z. Fields, R. Beckman, D.R. Mould, K. Gossett, R. Johnson Topotecan (Hycamtinâ„¢) Monograph in Therapeutic Drugs Edition 2 1998
NHG Holford, DR Mould and C Peck “Disease Progression Models” in Principles of Clinical Pharmacology, Editor: A. Atkinson Academic Press New York NY 2001
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
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
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
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
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
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
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
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
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
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 2015
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 2015
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
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
D.R. Mould, R.N. Upton and J. Wojciechowski. “Pharmacokinetics-Based Dosing Strategy for Therapeutic Proteins in Inflammatory Bowel Disease”. In Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases Editors H. Chou and DR Mould Wiley 2018
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. Chou and DR Mould Wiley 2018
PEER REVIEWED ABSTRACTS
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.
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.
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.
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.
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
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.
D.R. Mould, T.M. DeFeo, S. Teller and J.W. Massarella “Population Pharmacokinetic Analysis of DDC”. AAPS Annual Conference (PPDM) Nov. 1992.
D.R. Mould, T.M. DeFeo, I.H. Patel and T.M. Ludden “Population Pharmacokinetic Analysis of Fleroxacin”. AAPS Annual Conference (PPDM) Nov. 1992.
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
M Krams, DR Mould, LJ Benincosa “Model Based Evaluation of Neurological Stroke Scale Scores” AAPS Baltimore MD November 2004
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
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
EYL Blair, DR Mould, SJ Clarke, LP Rivory, AJ McLachlan “Exploring Pharmacokinetic-Pharmacodynamic Relationships of Raltitrexed in cancer Patients” PAGANZ Brisbane Australia February 2005
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
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
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
R. Narwal, DR. Mould, S. Rosenbaum “Development of Population Pharmacokinetic Model for Topotecan Lactone ” AAPS Nashville TN November 2005
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
C Cronenberger, D R Mould, H-J Roethig, and M Sarkar “Carboxyhemoglobin Levels in Adult Smokers. ” ASCPT Baltimore MD March 2006
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
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
J. Alderman, T. Tensfeldt, D. Mould, J. Miceli, “Relevance of Ziprasidone Cmax to the Treatment of Schizophrenia” AAPS San Antonio Texas October 2006
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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
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
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
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
K Venkatakrishnan, M Hanley, N Gupta, K Suryanarayan, R Neuwirth, D-L Esseltine, T Horton, R Aplenc, T Alonzo, X Lu, A Milton, D R Mould. Population pharmacokinetic (PK) analysis of bortezomib in pediatric leukemia patients: support for body surface area (BSA)-scaled dosing in patients aged 2-16 years. SIOP 2015 October, Cape Town, South Africa
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
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, 25-29 September 2015
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
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
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
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
Vande Casteele N, Mould DR, Oliver R, Kosutic G, Spearman M, Feagan B, Sandborn WJ. “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
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
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
Anderson CM, Allen BG, Sun W, Lee C, Agarwala SS, Kunos C, Venigalla ML, Greenberg L, Adkins D, Chen Y, Zhen W, Mould DR, Holmlund J, Brill JM, Sonis ST, Buatti JM. 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
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
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
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
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
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.
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
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
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
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
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
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
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
INVITED PRESENTATIONS
D.R. Mould “Deconvolution and Precursor Order Determination: Applications in Industry”. Lecture, Rutgers University, New Brunswick, NJ 1992.
D.R. Mould “Population Pharmacometric Analysis and Its Application in the Development Process of Biopharmaceutical Agents”. Invited Speaker, FDA/CBER Bethesda, MD 1994
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.
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
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
DR Mould “Approaches In Population PK/PD Modeling” PAWS Auckland NZ Jan 1998
DR Mould, CB Davis, J Urbansky, D Citerone “A Population PK/PD Model for Drug X, a Novel Hematopoietic Cytokine” PAGANZ Auckland NZ Jan1998
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
DR Mould “A Population PK Analysis of Topotecan in Patients”, PAGANZ Brisbane Queensland Australia Jan 2000
DR Mould “Modeling the Population Pharmacokinetics and Pharmacodynamics of Therapeutic Monoclonal Antibodies” Center for Drug Development Sciences Georgetown University March 2000
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
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
DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Feb 2001
DR Mould “Integrating Pharmacokinetics-Safety Analysis Into the Clinical Drug Development Process” Joint FDA/DIA Meeting Washington DC April 2001
DR Mould “A Population PK/PD Analysis of Topotecan in Patients”, Hycamtin World Wide Investigators Meeting June 2001
DR Mould “Clinical Trial Simulation in Cancer Chemotherapy” 5th Annual Cancer PKPD Meeting, Sea Island Georgia Sept 2001
DR Mould “The Population Pharmacokinetics and Pharmacodynamics of Lotrafiban in Patients” PAGANZ Christchurch NZ 2001
DR Mould “Using Pharmacokinetic/Pharmacodynamic Modeling to Evaluate Hematopoietic Factors” AAPS Denver Colorado Oct 2001
DR Mould “Approaches for the Implementation of Bayesian Analysis” AAPS Denver Colorado Oct 2001
DR Mould “Clinical Trial Simulation Course” Course Assistant AAPS Denver Colorado Oct 2001
DR Mould “Using Population Analysis for the Development of Disease Progression Models” State University of New York Dec 2001
DR Mould “Using Clinical Trial Simulation to Improve Cancer Chemotherapy” PAGANZ Queenstown Australia Feb 2002
DR Mould “Introduction to Population Pharmacokinetic and Pharmacodynamic Analysis” CMIC Tokyo Japan Feb 2002
DR Mould “Using Pharmacokinetic/Pharmacodynamic Analysis to Facilitate Decision Making In Drug Development” CMIC Tokyo Japan Feb 2002
DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2002
DR Mould “Application of Bayesian Approaches Using NONMEM” PAGE Bayesian workshop Course Assistant June 2002
DR Mould “Using Clinical Trial Simulation in the Development of New Oncology Agents” IIR Clinical Trial Simulation Workshop Washington DC August 19-23 2002
DR Mould “Covariate Distribution Models” CDDS Clinical Trial Simulation Workshop Washington DC August 18 2002
DR Mould “Using PKPD to Evaluate and Optimize Dose for Hematopoietic Factors” PAGANZA Capetown South Africa November 2002
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
DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2003
DR Mould “Pharmacokinetics and Pharmacodynamics of Therapeutic Monoclonal Antibodies – Scientific Considerations” AAPS Biotech Roundtable Salt Lake City Utah October 2003
DR Mould “Modeling Discrete Data” PAGANZJ Tokyo Japan September 2004
DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2004
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
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
DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2005
DR Mould “PKPD models for white cell responses to hematopoietic stimulation with and without chemotherapy” ASCPT Orlando Fl March 2-5 2005
DR Mould “Meet the Experts” Population Pharmacokinetics Roundtable AAPS Nashville TN November 2005
DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2006
DR Mould “Modeling Disease Progression” Symposium Chair ASCPT Baltimore MD March 2006
DR Mould “Modeling Disease Progression” EAHP Congress meeting Geneva Switzerland March 2006
DR Mould “Using Nonmem to Evaluate Dose Proportionality and Drug Interactions” Canadian Society of Pharmacological Sciences Ottawa Canada May 2006
DR Mould “The Pharmacokinetics and Pharmacodynamics of Therapeutic Monoclonal Antibodies” AAPS Biological Sciences Meeting Boston Mass June 2006
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
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
DR Mould “The Pharmacokinetics and Pharmacodynamics of Therapeutic Biological Agents” Land O Lakes Conference Wisconsin September 2006
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
DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC March 2007
DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC February 2008
DR Mould “Modeling and Simulation in Drug Development” University of Montreal Canada August 2008
DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC February 2009
DR Mould “Pharmacokinetics and Pharmacodynamics of Biopharmaceuticals” University of Rhode Island course April 2009
DR Mould “Population Pharmacokinetic-Pharmacodynamic Modeling of Biological Agents: When Modeling Meets Reality” ACoP Mystic CT October 2009
DR Mould “Modeling and Simulation tools for Development of Biopharmaceutical Agents” PMx Meeting Beijing October 2009
DR Mould “Population Pharmacokinetic Modeling” Principles of Pharmacology Course Beijing China November 2009
DR Mould “Overview of Disease Progression Modeling” Principles of Pharmacology Course Beijing China November 2009
DR Mould “Obesity – Impact on Drug Development and Dose Selection” AAPS National Meeting Los Angeles CA November 2009
DR Mould “Application of Disease Progress Modeling in Drug Development” Joint ASCPT/KSCPT Meeting Seoul Korea December 2009
DR Mould “Pharmacokinetics and Pharmacodynamics of Biopharmaceuticals” University of Rhode Island course December 2009
DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC January 2010
DR Mould, B Frame and B Green “Introduction to Population Pharmacokinetics and Pharmacodynamics Course”. The Ohio State University Columbus OH July 2010
DR Mould “Using Pharmacokinetics and Pharmacodynamics of Therapeutic Monoclonal Antibodies to Improve Dose Regimens” IBD Meeting New York NY August 2010
DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC February 2011
DR Mould “Missing covariates and covariates measured with error” PAGANZ Auckland NZ February 2011
DR Mould “Population Pharmacokinetic-Pharmacodynamics: When Modeling Meets Reality” PAGANZ Auckland NZ February 2011
DR Mould “Clinical Pharmacology Development Strategy for Monoclonal Antibodies” ACCP Annual Meeting Chicago IL September 2011
DR Mould “Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies: Concepts for Drug Discovery and Development” AAPS Annual Meeting Sunrise Session Washington DC October 2011
DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC February 2012
DR Mould “Clinical Trial Simulation – What Are We Trying to Do?” PAGANZ Melbourne AUS February 2012
DR Mould “Adaptive Dosing in Clinical Trial Simulation” PAGANZ Melbourne AUS February 2012
DR Mould “Modeling Heterogeneity from International Trials” ASCPT National Meeting Washington National Harbor March 2012
DR Mould “The key PK and PD principles in biologic drugs” IOIBD Annual Meeting Melbourne Australia March 2012
DR Mould “Dose-Response Evaluation Based on Exposure-Response Principles” ACDRS Course Washington DC May 2012
DR Mould “Clinical Perspectives: Part B-PK/PD” Biotech Canada Biosimilarity Summit Ottawa Canada May 2012
DR Mould “Clearance Mechanisms for Biologics” Land O Lakes Conference Wisconsin September 2012
DR Mould “Personalized Medicine, Pharmacometrics and Dashboard Systems” AAPS Pharmacometrics Focus Group AAPS National Meeting Chicago IL October 2012
DR Mould “Pharmacokinetics of Anti-TNF Therapy in IBD: What You Don’t Know, but Should” ACG Symposium Las Vegas NV October 2012
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
DR Mould “Understanding the pharmacokinetics of antibodies” Leading the Change in IBD Madrid Spain January 2013
DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2013
DR Mould “Models for Disease Progression” Pennsylvania State College of Medicine May 2 2013
DR Mould “Immunogenicity and Pharmacokinetics of Biologics” DDW Annual Meeting Orlando FL May 2013
DR Mould “Using Pharmacology, Modeling, and Simulation to Effectively Dose Pediatric and Elderly Patients” AAPS National Biotech Meeting San Diego CA May 2013
DR Mould “Principles for characterising a biologic: The interplay of pharmacokinetics and immunogenicity” EULAR Annual Meeting Madrid Spain June 2013
DR Mould “Biological Therapy Challenges in RA” New Perspectives For RA Treatment Sao Paolo Brazil September 2013
DR Mould “Principles for characterising a biologic: The interplay of pharmacokinetics and immunogenicity” Vancouver Canada November 2013
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
DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Jan 2014
DR Mould “Understanding pharmacokinetics of therapeutic antibodies” IBD Today and Tomorrow, an Innovative IBD Congress Amsterdam April, 2014
DR Mould “Principles of Clinical Pharmacology of Anti-TNF Antibodies” DDW Chicago IL May 2014
DR Mould “The PK/PD of MAbs and considerations for clinical practice in inflammatory conditions” AAPS National Biotech Meeting San Diego CA May 2014
DR Mould “Pharmacokinetics of Monoclonal Antibodies: A Primer” Canada – Future Directions in IBD Toronto Canada Nov 2014
DR Mould “The influence of inflammatory burden on pharmacokinetics of biologicals” ECCO Barcelona Spain February 2015
Mould DR “Pharmacokinetics of biologics: A primer” Falk Symposium Frankfurt Germany March 2015
DR Mould “Disease Progression Models” Principles of Clinical Pharmacology NIH Course Washington DC February 2016
DR Mould “Using Pharmacokinetics to Improve Outcomes” Interdisciplinary Autoimmune Summit NY NY April 2016
DR Mould “General Considerations for Developing Disease-Drug-Trial Models for Assessment of Extrapolation Assumptions” FDA/UMD CERSI Workshop Washington DC May 2016
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
DR Mould “Modeling and Simulation in Clinical Trials and Drug Development: Clinical Application of Bayesian Adaptive Dosing” EMBC Orlando Florida August 2016
DR Mould “Clinical Pharmacology Considerations of Biologics: Important Concepts” ACCP Annual Meeting Bethesda MD September 2016
DR Mould “Combining “Bedside” and Clinical Research Data to Inform Disease Progression and Outcomes/Biomarker Selection” ACCP Annual Meeting Bethesda MD September 2016
DR Mould “Precision Medicine in the Clinic: Dashboard Guided Dosing to Improve Outcomes” AAPS National Meeting Denver CO November 2016
DR Mould “Dose-finding and PK/PD optimization with biologicals” Therapeutic Drug Monitoring of Biologics: Progress in Chronic Inflammatory Diseases Amsterdam NE December 2016
DR Mould “Therapeutic Drug Monitoring Overcoming the hurdles” ASCPT annual meeting Washington DC March 2017
DR Mould “Clinical decision support tools for therapeutic drug monitoring for monoclonal antibodies” ACCP annual meeting San Diego CA September 2017
DR Mould “Disease Progression Models” Principles of Clinical Pharmacology NIH Course Washington DC October 2017
DR Mould “The Impact of Traditional Pharmacometrics During Drug Development of Biologics in Autoimmune Diseases” ACoP annual meeting San Diego October 2017
DR Mould “Why Use TDM and Dashboards for Monoclonal Antibodies? The Promise of Individualized Therapy” IADCTC annual meeting Kyoto Japan October 2017
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
DR Mould “Bayesian Adaptive Dosing: tailoring patient exposure reduces therapeutic failures” Joint Statistical Meeting Vancouver August 2018
PODIUM PRESENTATIONS
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.
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.
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.
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.
D.R. Mould and B.R. Patel “Population Pharmacokinetic Analysis of Paxil”. Podium Session, NONMEM Users’ Group Workshop, San Francisco, CA 1997.
R.N. Upton and D.R. Mould “Investigations of the Representation of Covariate Changes in Nonmem” Podium Session PAGANZ Brisbane AUS 2013
NON-PEER REVIEWED PUBLICATIONS
D.R. Mould, S.A. Molnar and T. Thomas “Modeling and Simulation as Tools to Improve Drug Development” Congressional Modeling and Simulation Website August 2009
JOURNAL REVIEW WORK
AAPS Journal – Special Theme Issue Editor and Reviewer
Clinical Pharmacology and Therapeutics – Editorial Board Member and Reviewer
Clinical Pharmacology and Therapeutics Pharmacometrics and Systems Pharmacology – Editorial Board Member and Reviewer
Journal of Clinical Pharmacology – Member Publication Committee and Reviewer
European Journal of Pharmacology – Reviewer
Clinical Pharmacokinetics – Reviewer
Journal of Pharmacokinetics and Pharmacodynamics – Editorial Board Member and Reviewer
International Journal of Pharmaceutical Medicine – Reviewer
Cancer Chemotherapy and Research – Reviewer
POST-GRADUATE EDUCATION
The Seventh One-Week Workshop on Advanced Methods in Pharmacokinetics and Pharmacodynamics San Francisco CA April 1990
NONMEM and Population Pharmacokinetics – University of Texas at San Antonio Health Sciences Center. Dr. T. Ludden instructor. August 1990
Progress in Cancer Chemotherapy (Biotechnology Review) New York NY 1993
ASCPT Annual Review Session Pharmacology New Orleans LA March 1994
NONMEM Intermediate Users’ Group Workshop San Francisco CA 1995
Advanced Methods in Pharmacodynamics SUNY at Buffalo NY 1995
NONMEM Intermediate Users’ Group Workshop San Francisco CA 1997
ESTEVE Foundation Meeting Barcelona Spain 2000
NONMEM Intermediate Users Group Workshop Washington DC 2007
Introduction to PSN and XPOSE4 Washington DC 2008
NONMEM Introduction to Nonmem 7 Princeton NJ May 2009
