Website: http://pharmacy.buffalo.edu/phc/faculty/MAGER.HTML
Email: dmager@buffalo.edu

1. Integrative and Systems Pharmacology of Anti-Platelet and Anti-Cancer Drugs

2. Development and experimental validation of quantitative structure-pharmacokinetic/pharmacodynamic (PK/PD) relationships (QSPR) to optimize drug design, development, and therapeutic application of anti-cancer compounds.

3. Integration of QSPR and mechanistic PD models developed with several drugs to predict in vivo PK/PD profiles of chemically related compounds.

4. Development of models of pharmacological target-mediated drug disposition and dynamics, and the experimental validation of the primary determinants of PK/PD profiles of drugs that exhibit such phenomena.

5. Development of non-deterministic models such as neural networks, alone or in combination with traditional adaptive feedback control methods, for individual optimization of complex pharmacotherapeutic regimens.

6. Incorporation of biomedical signal processing tools into PK/PD models for characterizing the pharmacology of drugs that alter spontaneous variability of signals of the cardiovascular and autonomic nervous systems.

Brief Statement of Experience

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Awards and Honors

Visiting Professor, University Paris Descartes, January 2012

Visiting Professor, University Paris Descartes, January 2011

Visiting Professor, University Paris Descartes, January 2010

Fellow, American College of Clinical Pharmacology, May 2009

Visiting Professor, University Paris Descartes, January 2009

RESEARCH

Published Intellectual Contributions

Journal Article, Academic Journal (Published April (2nd Quarter/Spring) 2012 Peer-Reviewed/Refereed)

Harrold, J. M., Straubinger, R. M., & Mager, D. E. (2012). Combinatorial chemotherapeutic efficacy in non-Hodgkin lymphoma can be predicted by a signaling model of CD20 pharmacodynamics. Cancer Res, 72, 1632-1641.

Journal Article, Academic Journal (Published March 2012 Not Peer-Reviewed/Refereed)

Iyengar, R., Zhao, S., Chung, S.-W., Mager, D. E., & Gallo, J. M. (2012). Merging systems biology with pharmacodynamics. Science Translational Medicine, 4(126), 126ps7.

Journal Article, Academic Journal (Published March 2012 Not Peer-Reviewed/Refereed)

Katrissios, H., Walker, J. R., Carrothers, T. J., Kshirsagar, S., Khariton, T., Habtemariam, B., Mager, D. E., & Rohatagi, S. (2012). Population Pharmacokinetic Model for a Novel Oral Hypoglycemic Formed In Vivo: Comparing the Use of Active Metabolite Data Alone Versus Using Data of Upstream and Downstream Metabolites. J Clin Pharmacol, 52, 404-415.

Journal Article, Academic Journal (Published February 2012 Peer-Reviewed/Refereed)

Kagan, L., Turner, M., Balu-Iyer, S. V., & Mager, D. E. (2012). Subcutaneous absorption of monoclonal antibodies: role of dose, site of injection, and injection volume on rituximab pharmacokinetics in rats. Pharm Res, 29, 490-499.

Journal Article, Academic Journal (Published November 2011)

Marathe, D. D., Marathe, A., & Mager, D. E. (2011). Integrated model for denosumab and ibandronate pharmacodynamics in postmenopausal women. Biopharmaceutics & Drug Disposition, 32, 471-481.

Journal Article, Academic Journal (Published June 2011)

Kosloski, M., Peng, A., Varma, P., Miclea, R. D., Mager, D. E., & Balu-Iyer, S. V. (2011). Immunogenicity and pharmacokinetic studies of recombinant Factor VIII containing lipid cochleates. Drug Delivery, 8 (2011), 246-253.

Journal Article, Academic Journal (Published June 2011)

Abraham, A. K., Maurer, T. S., Kalgutkar, A. S., Gao, X., Li, M., Healy, D. R., Petersen, D. N., Griffith, D. A., & Mager, D. E. (2011). Pharmacodynamic model of parathyroid hormone modulation by a negative allosteric modulator of the calcium-sensing receptor. AAPS J, 13, 265-273.

Journal Article, Academic Journal (Published June 2011)

Kagan, L., Gershkovich, P., Wasan, K. M., & Mager, D. E. (2011). Physiologically based pharmacokinetic model of amphotericin B disposition in rats following administration of deoxycholate formulation (fungizone®): pooled analysis of published data. AAPS J, 13, 255-264.

Journal Article, Academic Journal (Published April (2nd Quarter/Spring) 2011)

Marathe, A., Van Wart, S., & Mager, D. E. (2011). Impact of dose selection on parameter estimation using a rapid binding approximation model of target-mediated drug disposition. J Pharmacokinet Pharmacodyn, 38, 223-235.

Journal Article, Professional Journal (Published February 2011)

Goldberg, M. E., Torjman, M. C., Schwartzman, R. J., Mager, D. E., & Wainer, I. W. (2011). Enantioselective pharmacokinetics of (R)- and (S)-ketamine after a 5-day infusion in patients with complex regional pain syndrome. Chirality, 23, 138-143.

Journal Article, Academic Journal (Published January (1st Quarter/Winter) 2011)

Xu, C., & Mager, D. E. (2011). Quantitative structure-pharmacokinetic relationships. Expert Opin Drug Metab Toxicol, 7, 63-77.

Journal Article, Academic Journal (Published December 2010)

Yan, X., Mager, D. E., & Krzyzanski, W. (2010). Selection between Michaelis-Menten and target-mediated drug disposition pharmacokinetic models.. Journal of Pharmacokinetics and Pharmacodynamics.

Journal Article, Academic Journal (Published September 2010)

D'Argenio, D. Z., & Mager, D. E. (2010). Bridging pharmacology and pathophysiology via systems modeling. J Clin Pharmacol, 50(9 Suppl), 56S-57S.

Journal Article, Academic Journal (Published September 2010)

Kagan, L., Dreifinger, T., Mager, D. E., & Hoffman, A. (2010). Role of p-glycoprotein in region-specific gastrointestinal absorption of talinolol in rats. Drug Metab Dispos, 38, 1560-1566.

Journal Article, Academic Journal (Published August 2010)

Houze, P., Mager, D. E., Risede, P., & Baud, F. J. (2010). Pharmacokinetics and toxicodynamics of pralidoxime effects on paraoxon-induced respiratory toxicity. Toxicol Sci, 116, 660-672.

Book, Chapter in Textbook-New (Published August 2010)

Balogh, L., Mager, D. E., & Khan, M. K. (2010). Synthesis and biodisposition of dendrimer composite nanoparticles. In V. Torchilin & M. M. Amiji (Eds.), Handbook of Materials for Nanomedicine (pp. 255-290). Pan Stanford Publishing Pte Ltd.

Journal Article, Professional Journal (Published July (3rd Quarter/Summer) 2010)

Goldberg, M. E., Torjman, M. C., Schwartzman, R. J., Mager, D. E., & Wainer, I. W. (2010). Pharmacodynamic profiles of ketamine (R)- and (S)- with 5-day inpatient infusion for the treatment of complex regional pain syndrome. Pain Physician, 13, 379-387.

Journal Article, Academic Journal (Published July (3rd Quarter/Summer) 2010)

Abraham, A. K., Kagan, L., Kumar, S., & Mager, D. E. (2010). Type I Interferon Receptor is a Primary Regulator of Target-mediated Drug Disposition of Interferon-{beta} in Mice. J Pharmacol Exp Ther, in press.

Journal Article, Academic Journal (Published May 2010)

Kagan, L., Abraham, A. K., Harrold, J. M., & Mager, D. E. (2010). Interspecies scaling of receptor-mediated pharmacokinetics and pharmacodynamics of type I interferons. Pharm Res, 27, 920-932.

Journal Article, Academic Journal (Published May 2010)

Abraham, A. K., Kumar, S., & Mager, D. E. (2010). Type I interferon receptor is a primary regulator of target-mediated drug disposition of interferon-β in mice. J Pharmacol Exp Ther, 334, 327-332.

Journal Article, Academic Journal (Published March 2010)

Siluk, D., Mager, D. E., Kim, H. S., Wang, Y., Furimsky, A. M., Ta, A., Iyer, L. V., Green, C. E., & Wainer, I. W. (2010). Pharmacokinetics and metabolism of (R,R)-methoxyfenoterol in rat. Xenobiotica, 40, 195-206.

Journal Article, Academic Journal (Published March 2010)

Dhindsa, S., Miller, M. G., McWhirter, C. L., Mager, D. E., Ghanim, H., Chaudhuri, A., & Dandona, P. (2010). Testosterone Concentrations in Diabetic and Non-Diabetic Obese Men. Diabetes Care, 33, 1186-1192.

Journal Article, Academic Journal (Published January (1st Quarter/Winter) 2010)

Yang, J., Mager, D. E., & Straubinger, R. M. (2010). Comparison of two pharmacodynamic transduction models for the analysis of tumor therapeutic responses in model systems. AAPS Journal, 12, 1-10.

Journal Article, Academic Journal (Published January (1st Quarter/Winter) 2010)

Zhou, R., Mazurchuk, R. V., Tamburlin, J. H., Harold, J. M., Mager, D. E., & Straubinger, R. M. (2010). Differential pharmacodynamic effects of paclitaxel formulations in an intracranial rat brain tumor model. J Pharmacol Exp Ther, 332(2), 479-88.

Journal Article, Academic Journal (Published December 2009)

Hilmer, S. N., Mager, D. E., Simonsick, E. M., Ling, S. M., Windham, B. G., Harris, T. B., Shorr, R. I., Bauer, D. C., & Abernethy, D. R. (2009). Drug burden index score and functional decline in older people. Am J Med, 122, 1142-1149.

Journal Article, Academic Journal (Published June 2009)

Abraham, A. K., Ramanathan, M., Weinstock-Guttman, B., & Mager, D. E. (2009). Mechanisms of interferon-beta effects on bone homeostasis. Biochem Pharmacol, 77, 1757-1762.

Journal Article, Academic Journal (Published May 2009)

Marathe, A., Krzyzanski, W., & Mager, D. E. (2009). Numerical Validation and Properties of a Rapid Binding Approximation of a Target-Mediated Drug Disposition Pharmacokinetic Model. J Pharmacokinet Pharmacodyn, 36, 199-219.

Journal Article, Academic Journal (Published April (2nd Quarter/Spring) 2009)

Abraham, A. K., Mager, D. E., Gao, X., Li, M., Healy, D. R., & Maurer, T. S. (2009). Mechanism-based pharmacokinetic/pharmacodynamic model of parathyroid hormone-calcium homeostasis in rats and humans. J Pharmacol Exp Ther, 330, 169-178.

Journal Article, Academic Journal (Published January (1st Quarter/Winter) 2009)

Mager, D. E., Woo, S., & Jusko, W. J. (2009). Scaling Pharmacodynamics from In Vitro and Preclinical Animal Studies to Humans. Drug Metab. Pharmacokin., 24(1), 16-24.

Presentations Given

Lecture (Academic Invited)

Mager, D. E. (2012, May). Pharmacokinetics & Pharmacodynamics of Biological Therapeutics. Presented at the Msc Program, Webinar.

Conference Presentation (Academic Invited)

Mager, D. E. (2012, April). Probing Drug Exposure-Response Relationships in Inflammatory Bone Loss with Translational Pharmacodynamic Systems Modeling. Paper presented at the Bridging Bench and Bedside with Quantitative Model-Based Translational Pharmacology, New York, NY.

Lecture (Academic Invited)

Mager, D. E. (2012, April). Towards Enhanced Pharmacodynamic Modeling in Oncology. Presented at, Buffalo, NY.

Poster Presentation (Academic Peer-Reviewed)

Ait-Oudhia, S., Straubinger, R. M., & Mager, D. E. (2012, April). Mathematical Analysis of Paclitaxel-induced Tumor Priming That Leads to Enhanced Deposition and Efficacy of Nanoparticulate Doxorubicin. Poster presented at the American Association for Cancer Research, Chicago, IL.

Lecture (Academic Invited)

Mager, D. E. (2012, March). Cell Signaling Model of CD20 Agonism for Predicting Efficacy of Combination Chemotherapy for non-Hodgkins Lymphoma. Presented at, Kentucky, IL.

Lecture (Academic Invited)

Mager, D. E. (2012, January). Introduction to Pharmacodynamic Principles. Presented at the ACDRS Workshop Session 2: Learning Trials: From Discovery to First in Humans, Washington, DC.

Conference Presentation (Academic, invited)

Mager, Donald (Author & Presenter), Indiana Clinical and Translational Sciences Institute Symposium on Disease and Therapeutic Response Modeling, "Network-based Analysis for Enhancing PK/PD Modeling in Oncology", University of Indiana, Indianapolis, IN.

Short Course (Academic, invited)

Mager, Donald (Presenter), AAPS Annual Meeting, "Conceptual Framework of Models Used for PK/PD Modeling of Biologics", AAPS, Washington, DC.

Short Course (Academic, invited)

Mager, Donald (Presenter), AAPS Annual Meeting, "PK/PD Systems Analysis: Hands-on Modeling with ADAPT5", AAPS, Washington, DC.

Conference Presentation (Academic, invited)

Mager, Donald (Author & Presenter), ISSX 17th North American Meeting, "Translation of Pharmacodynamics: Concepts and Examples", ISSX, Atlanta, GA.

Conference Presentation (Academic, invited)

Mager, Donald (Author & Presenter), Applied Pharmaceutical Analysis Annual Meeting, "PK/PD Systems Analysis in Translational Research", APA, Cambridge, MA.

Conference Presentation (Academic, invited)

Mager, Donald (Author & Presenter), 2nd Annual PaSiPhIC, "Probing Drug Exposure-Response Relationships Through Translational PK/PD Modeling", PaSiPhIC, San Luis Obispo, CA.

Conference Presentation (Academic, invited)

Mager, Donald (Author & Presenter), Gordon Research Conference on Drug Metabolism, "Bridging PK/PD and Systems Pharmacology Modeling in Oncology", GRC, Holderness, NH.

Conference Presentation (Academic, invited)

Mager, Donald (Author & Presenter), AAPS NBC, "Pharmacodynamic Modeling of Biomarkers in Drug Development", AAPS, San Francisco, CA.

Panel Member (Academic, invited)

Mager, Donald (Author & Presenter), AAPS NBC, "Target-mediated Drug Disposition Models: Theory and Parameterization", AAPS, San Francisco, CA.

Lecture (Academic, invited)

Mager, Donald (Presenter), Msc Program, "Pharmacokinetics & Pharmacodynamics of Biological Therapeutics", University of Manchester, Webinar..

Conference Presentation (Academic, invited)

Mager, Donald (Author & Presenter), 4th APISSX, "Pharmacokinetics and Pharmacodynamics of Monoclonal Antibodies", APISSX, Tainan, Taiwan.

Lecture (Academic, invited)

Mager, Donald (Author & Presenter), Seminar, "CD20 Receptor Occupancy-driven Cell Signaling Model for Predicting in vivo Combination Chemotherapy", Mount Sinai School of Medicine, New York, NY.

Lecture (Non-Academic, invited)

Mager, Donald (Author & Presenter), Seminar, "Chemotherapy and Translational PK/PD Modeling", Merrimack Pharmaceticals, Cambridge, MA.

Lecture (Academic, invited)

Mager, Donald (Author & Presenter), ACDRS Workshop Session 2: Learning Trials: From Discovery to First in Humans, "Introduction to Pharmacodynamic Principles", UCSF, San Francisco, CA.

Conference Presentation (Academic, invited)

Mager, Donald (Author & Presenter), ASCPT Annual Meeting, "Theoretical Considerations of the Target-Mediated Disposition of Therapeutic mAbs", ASCPT, Dallas, TX.

Conference Presentation (Academic, invited)

Mager, Donald (Author & Presenter), Drug Safety Workshop: Pharmacological Mechanism-Based Drug Safety Assessment and Prediction, "Small Systems Models for Bridging Exposure-Response Relationships", FDA, Silver Spring, MD.

Conference Presentation (Non-Academic, invited)

Mager, Donald (Author & Presenter), Model-Based Drug Development Workshop, "Basic Concepts of PK/PD Modeling and Translational Pharmacology", Johnson & Johnson, New Brunswick, NJ.

Webinar (Non-Academic, invited)

Mager, Donald (Author & Presenter), Conference Call, "Towards Integrating Systems Pharmacology and PK/PD Models", Pfizer, Webinar.

Conference Presentation (Academic, invited)

Mager, Donald (Author & Presenter), 13th Annual Land O'Lakes Conference, "Overview of the Importance of Drug Interactions with Biologics", Merrimac, WI.

Conference Presentation (Academic, invited)

Mager, Donald (Author & Presenter), Annual Meeting of the American College of Clinical Pharmacology, "Modeling and Simulation to Develop Therapeutic Proteins", American College of Clinical Pharmacology, Baltimore, MD.

Conference Presentation (Academic, invited)

Mager, Donald (Author & Presenter), Quantitative and Systems Pharmacology Workshop II, "Occupancy-driven Cell Signaling Model of CD20 Agonists to Predict Combination Chemotherapy in Mice", NIH, Bethesda, MD.

Conference Presentation (Academic, invited)

Mager, Donald (Author & Presenter), University at Buffalo, SUNY, "Whither Systems Pharmacology Modeling?", Department of Pharmaceutical Sciences, Buffalo, NY.

Conference Presentation (Academic, invited)

Mager, Donald (Author & Presenter), Delaware Valley Drug Metabolism Discussion Group, "Pharmacokinetics and Exposure-Response Relationships of Biologics", Longhorne, PA..

Lecture

Mager, Donald (Presenter), Advancing New Therapeutics to Clinical Trials Workshop, "Pharmacodynamic Modeling of Anticancer Agents", SUNY Upstate Cancer Research Institute, Syracuse, NY.

Lecture (Academic, invited)

Mager, Donald (Presenter), Msc Program, "Pharmacokinetics & Pharmacodynamics of Biological Therapeutics", University of Manchester, Webinar..

Conference Presentation (Academic)

Mager, Donald (Presenter), KSCPT-ASCPT Joint Conference, "Model-Based Approaches for Metabolic Disorders", KSCPT and ASCPT, Seoul, Korea.

Panel Member

Mager, Donald (Discussant), AAPS Annual Meeting, "Postdoctoral Positions in Academia and the NIH", AAPS, Los Angeles, CA.

Conference Presentation

Mager, Donald (Presenter), AAPS Annual Meeting, "Scaling Pharmacokinetics/Pharmacodynamics from Animal Studies to Humans", AAPS, Los Angeles, CA.

Lecture

Mager, Donald (Presenter), Workshop: PK/PD Modeling in Drug Discovery and Translational Research: A Building Block for Quantitative Model-based Drug Development, "PK/PD Modeling and Simulation: History and Basic Principles", AAPS, Los Angeles, CA.

Co-Chair

Mager, Donald (Session Chair), American Conference on Pharmacometrics, "Applications of Modeling over the Development  Life Cycle of Biologics", ACoP, Mystic, CT.

Keynote Presentation

Mager, Donald (Presenter), ISSX Annual Meeting, "Overview of Pharmacokinetics and Pharmacodynamics of Biologics", ISSX, Baltimore, MD.

Conference Presentation

Mager, Donald (Presenter), ACCP Annual Meeting, "Novel Biomarkers and Disease Models: Why?", ACCP, San Antonio, TX.

Webinar

Mager, Donald (Presenter), AAPS Clinical Pharmacology and Translational Research Webinar, "Role of Target and Mechanism Biomarkers in Translational Research", AAPS, Webinar.

Sunrise Session

Mager, Donald (Presenter), AAPS National Biotechnology Conference, "Basic Principles and Approaches to Predicting FIH Doses for MAbs", AAPS, Seattle, WA.

Poster Presentation (Academic, peer-reviewed)

Mager, Donald (Author), Abraham, Anson (Author & Presenter), Kumar, Sarmishtha (Author), AAPS National Biotechnology Conference, "Receptor-Mediated Drug Disposition of Recombinant Native Interferon-β in Wild-type and Interferon α/βR-/- Knockout Mice", American Association of Pharmaceutical Scientists, Seattle, WA.

Roundtable Discussion Leader

Mager, Donald (Presenter), AAPS National Biotechnology Conference, "Role of Target and Mechanism Biomarkers in Translational Research", AAPS, Seattle, WA.

Lecture

Mager, Donald (Presenter), "Integrated Bone Homeostasis Model for Denosumab Pharmacodynamics in Multiple Myeloma", Pfizer, Inc, Global PK/PD Teleconference.

Lecture

Mager, Donald (Presenter), "Model-Based Approaches for Metabolic Disorders", Bristol-Myers Squibb, Princeton, NJ.

Lecture

Mager, Donald (Presenter), MOSAIC, "Model-Based Approaches for Metabolic Disorders and Biologic Therapeutics", Bridgewater, NJ.

Lecture

Mager, Donald (Presenter), UB - Pfizer Strategic Alliance Annual Meeting, "Preclinical PK/PD Modeling of Anticancer Agents", Pfizer, Inc, Groton, CT.

Conference Presentation (Academic, invited)

Mager, Donald, Current Topics in Drug Metabolism and Pharmacokinetics: Biologics and Transporters – What’s New?, "Mechanism-Based Pharmacokinetic/Pharmacodynamic Modeling of Biologics", North Jersey ACS Drug Metabolism Discussion Group, Somerset, NJ..

Poster Presentation (Academic, peer-reviewed)

Mager, Donald (Author), Hong, Ying (Author & Presenter), Dingemanse, Jasper (Author), Sidharta, Patricia (Author), ASCPT Annual Meeting, "Population Modeling of Hyperglycemic Clamp and Meal Tolerance Tests in Patients with Type 2 Diabetes Mellitus", American Society of Clinical Pharmacology and therapeutics, Washington, DC.

Lecture (Academic, invited)

Mager, Donald, Clinical Pharmacology Review Course, "Mechanistic Pharmacokinetic/Pharmacodynamic Models", American Society of Clinical Pharmacology and therapeutics, Washington, DC.

Keynote Presentation (Non-Academic, invited)

Mager, Donald, 3rd Roche-Novartis Modeling & Simulation Meeting, "Integrating Pharmacodynamics into Models of Target-Mediated Drug Disposition", Novartis, Basel, Switzerland.