About Dr. Diane Mould
DIANE R. MOULD
535 Springview Lane
Phoenixville, PA. 19460
(610)-917-0238
Email: 
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
Academic Honors:
National Honor Society, Dean's List (1979-1983)
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
Professional Honors:
Roche Management Incentive Bonus Award (2) 1992, 1994
SmithKline Beecham Bronze Impact Award (2) 1997
SmithKline Beecham Special Award - Top 1% Productivity 1997
SmithKline Beecham Silver Impact Award (1) 1998
Professional Organizations:
AAPS, ACCP, DIA, New York Academy of Sciences
Research Experience:
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
Special Undergraduate Research Project
Synthesis of Beta-Lactam antibiotics. IR, GC-MS, NMR TLC and other chromatography techniques.
Research Assistant
Enzyme and Protein assay work, electrophoresis, isoelectric focusing.
Teaching Experience:
9/04-Present
University of Rhode Island Providence RI
College of Pharmacy Adjunct Professor
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
8/2008
Modeling and Simulation in Drug Development
University of Montreal, Montreal Canada
6/2005
SUNY Buffalo
Topics in Population PK PD Analysis
9/10/2004
University of Rhode Island
College of Pharmacy
Introduction to Population Pharmacokinetic Methods
1/2003
Ohio State University
College of Pharmacy
Introduction to Population Pharmacokinetics - Hands On Workshop
2/2001-2/2010
NIH Bethesda MD
Clinical Pharmacology Course
Modeling the Progression of Disease
Bethesda Medical Center
12/2001
SUNY Buffalo
College of Pharmacy
Modeling the Progression of Disease
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
9/87-6/89
The Ohio State University, Columbus, Ohio 43210
Graduate Teaching Assistant, Department of Pharmaceutics
Private Tutor for all undergraduate Pharmaceutics courses.
9/85-6/86
The Ohio State University, Columbus, Ohio 43210
Graduate Teaching Assistant, Department of Engineering Instructor for Introduction to Fortran Programming.
Taught approx. 60 students per academic period.
Special Skills:
Programming Languages: Fortran 77, Basic, SAS, Pascal, C
Foreign Languages: French (read), Latin (read)
Hobbies:
Painting, Music, Hiking, Flying, Biking, Sailing, Windsurfing, Photography, Skiing, Weight Lifting, Car Racing - Viper Racing League
References:
Available upon request
PUBLICATIONS
See publications page
BOOK CHAPTERS
- 1. J. Hakimi, D. R. Mould, T. Waldman, C. Anasetti, and S. E. Light in Antibody Therapeutics, Chapter 12: "Development of Zenapax™: 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
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 "Deconvolution and Precursor Order Determination: Applications in Industry". Lecture, Rutgers University, New Brunswick, NJ 1992.
5. D.R. Mould "Population Pharmacometric Analysis and Its Application in the Development Process of Biopharmaceutical Agents". Invited Speaker, FDA/CBER Bethesda, MD 1994
6. 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.
7. 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.
8. D.R. Mould and B.R. Patel "Population Pharmacokinetic Analysis of Paxil". Podium Session, NONMEM Users' Group Workshop, San Francisco, CA 1997.
9. 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
10. 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
11. DR Mould "Approaches In Population PK/PD Modeling" PAWS Auckland NZ Jan 1998
12. DR Mould, CB Davis, J Urbansky, D Citerone "A Population PK/PD Model for Drug X, a Novel Hematopoietic Cytokine" PAGANZ Auckland NZ Jan1998
13. 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
14. DR Mould “A Population PK Analysis of Topotecan in Patients”, PAGANZ Brisbane Queensland Australia Jan 2000
15. DR Mould “Modeling the Population Pharmacokinetics and Pharmacodynamics of Therapeutic Monoclonal Antibodies” Center for Drug Development Sciences Georgetown University March 2000
16. 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
17. 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
18. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Feb 2001
19. DR Mould “Integrating Pharmacokinetics-Safety Analysis Into the Clinical Drug Development Process” Joint FDA/DIA Meeting Washington DC April 2001
20. DR Mould “A Population PK/PD Analysis of Topotecan in Patients”, Hycamtin World Wide Investigators Meeting June 2001
21. DR Mould “Clinical Trial Simulation in Cancer Chemotherapy” 5th Annual Cancer PKPD Meeting, Sea Island Georgia Sept 2001
22. DR Mould “The Population Pharmacokinetics and Pharmacodynamics of Lotrafiban in Patients” PAGANZ Christchurch NZ 2001
23. DR Mould “Using Pharmacokinetic/Pharmacodynamic Modeling to Evaluate Hematopoietic Factors” AAPS Denver Colorado Oct 2001
24. DR Mould “Approaches for the Implementation of Bayesian Analysis” AAPS Denver Colorado Oct 2001
25. DR Mould “Clinical Trial Simulation Course” Course Assistant AAPS Denver Colorado Oct 2001
26. DR Mould “Using Population Analysis for the Development of Disease Progression Models” State University of New York Dec 2001
27. DR Mould “Using Clinical Trial Simulation to Improve Cancer Chemotherapy” PAGANZ Queenstown Australia Feb 2002
28. DR Mould “Introduction to Population Pharmacokinetic and Pharmacodynamic Analysis” CMIC Tokyo Japan Feb 2002
29. DR Mould “Using Pharmacokinetic/Pharmacodynamic Analysis to Facilitate Decision Making In Drug Development” CMIC Tokyo Japan Feb 2002
30. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2002
31. DR Mould “Application of Bayesian Approaches Using NONMEM” PAGE Bayesian workshop Course Assistant June 2002
32. DR Mould “Using Clinical Trial Simulation in the Development of New Oncology Agents” IIR Clinical Trial Simulation Workshop Washington DC August 19-23 2002
33. DR Mould “Covariate Distribution Models” CDDS Clinical Trial Simulation Workshop Washington DC August 18 2002
34. DR Mould “Using PKPD to Evaluate and Optimize Dose for Hematopoietic Factors” PAGANZA Capetown South Africa November 2002
35. 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
36. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2003
37. DR Mould “Pharmacokinetics and Pharmacodynamics of Therapeutic Monoclonal Antibodies – Scientific Considerations” AAPS Biotech Roundtable Salt Lake City Utah October 2003
38. DR Mould “Modeling Discrete Data” PAGANZJ Tokyo Japan September 2004
39. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2004
40. 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
41. 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
42. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2005
43. DR Mould “PKPD models for white cell responses to hematopoietic stimulation with and without chemotherapy” ASCPT Orlando Fl March 2-5 2005
44. DR Mould “Meet the Experts” Population Pharmacokinetics Roundtable AAPS Nashville TN November 2005
45. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC Feb 2006
46. DR Mould “Modeling Disease Progression” Symposium Chair ASCPT Baltimore MD March 2006
47. DR Mould “Modeling Disease Progression” EAHP Congress meeting Geneva Switzerland March 2006
48. DR Mould “Using Nonmem to Evaluate Dose Proportionality and Drug Interactions” Canadian Society of Pharmacological Sciences Ottawa Canada May 2006
49. DR Mould “The Pharmacokinetics and Pharmacodynamics of Therapeutic Monoclonal Antibodies” AAPS Biological Sciences Meeting Boston Mass June 2006
50. 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
51. 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
52. DR Mould “The Pharmacokinetics and Pharmacodynamics of Therapeutic Biological Agents” Land O Lakes Conference Wisconsin September 2006
53. 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
54. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC March 2007
55. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC February 2008
56. DR Mould “Modeling and Simulation in Drug Development” University of Montreal Canada August 2008
57. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC February 2009
58. DR Mould “Pharmacokinetics and Pharmacodynamics of Biopharmaceuticals” University of Rhode Island course April 2009
59. DR Mould “Population Pharmacokinetic-Pharmacodynamic Modeling of Biological Agents: When Modeling Meets Reality” ACoP Mystic CT October 2009
60. DR Mould “Modeling and Simulation tools for Development of Biopharmaceutical Agents” PMx Meeting Beijing October 2009
61. DR Mould “Population Pharmacokinetic Modeling” Principles of Pharmacology Course Beijing China November 2009
62. DR Mould “Overview of Disease Progression Modeling” Principles of Pharmacology Course Beijing China November 2009
63. DR Mould “Obesity – Impact on Drug Development and Dose Selection” AAPS National Meeting Los Angeles CA November 2009
64. DR Mould “Application of Disease Progress Modeling in Drug Development” Joint ASCPT/KSCPT Meeting Seoul Korea December 2009
65. DR Mould “Pharmacokinetics and Pharmacodynamics of Biopharmaceuticals” University of Rhode Island course December 2009
66. DR Mould “Disease Progression Models and Clinical Trial Simulation” Principles of Clinical Pharmacology NIH Course Washington DC January 2010
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
JOURNAL REVIEW WORK
- 1. AAPS Journal - Special Theme Issue Editor and Reviewer
2. Clinical Pharmacology and Therapeutics - Reviewer
3. European Journal of Pharmacology - Reviewer
4. Clinical Pharmacokinetics - Reviewer
5. Journal of Pharmacokinetics and Pharmacodynamics - Reviewer
6. International Journal of Pharmaceutical Medicine - Reviewer
7. Cancer Chemotherapy and Research - Reviewer
POST-GRADUATE EDUCATION
- 1. The Seventh One-Week Workshop on Advanced Methods in Pharmacokinetics and Pharmacodynamics San Francisco CA April 1990
2. NONMEM and Population Pharmacokinetics - University of Texas at San Antonio Health Sciences Center. Dr. T. Ludden instructor. August 1990
3. Progress in Cancer Chemotherapy (Biotechnology Review) New York NY 1993
4. ASCPT Annual Review Session Pharmacology New Orleans LA March 1994
5. NONMEM Intermediate Users' Group Workshop San Francisco CA 1995
6. Advanced Methods in Pharmacodynamics SUNY at Buffalo NY 1995
7. NONMEM Intermediate Users' Group Workshop San Francisco CA 1997
8. ESTEVE Foundation Meeting Barcelona Spain 2000
9. NONMEM Intermediate Users Group Workshop Washington DC 2007
10. NONMEM Introduction to Nonmem 7 Princeton NJ May 2009
