Joseph P. Balthasar PhD
Joseph P. Balthasar
PhD
David and Jane Chu Endowed Chair in Drug Discovery and Development, Professor of Pharmaceutical Sciences, Director of the Center for Protein Therapeutics, Executive Director of University Research Initiatives
Department of Pharmaceutical Sciences
Specialty/Research Focus
Antibody-Drug Conjugates; Autoimmunity; Drug Targeting; Immunopharmacology; Mathematical Modeling; Monoclonal Antibodies; Pharmacodynamics; Pharmacokinetics; PK/PD; Preclinical Research
Professional Summary:
Research focuses on the utilization of pharmacokinetic and pharmacodynamic analyses and mathematical modeling to guide the discovery and development of new immunotherapies for cancer and autoimmunity.
Research Interests and Projects:
Research Interests and Current Projects:
1. Development of antibody conjugates for targeted, intra-cellular delivery of macromolecular toxins (CA204192)
2. Pharmacokinetic Strategies to Increase Monoclonal Antibody Uptake, Distribution, and Efficacy for Treatment of Solid Tumors (CA246785)
3. Inverse targeting strategies to decrease the off-site toxicity of antibody drug conjugate therapies for cancer (CA256928, CA261343)
4. Engineering monoclonal antibodies for improved pharmacokinetic properties
5. Investigation of sources of inter-individual variability in monoclonal antibody pharmacokinetics
6. Development of improved mathematical models for predicting the disposition and effects of monoclonal antibody drugs
7. Investigation of the role of FcRn in the absorption, distribution, and elimination of IgG antibodies
8. Development of antibody-based therapies to treat and prevent infection. Efforts are currently focused on prevention of infection by Treponema denticola (DE023080), S. aureus, and A. baumannii
9. Optimization of bispecific T-cell engagers, with primary focus on the application of PKPD modeling to guide discovery and development
Education and Training:
- PhD, State University of New York at Buffalo (1996)
- BS, State University of New York at Buffalo (1991)
Employment:
- Executive Director, Research Initiatives, University at Buffalo, Office of the Vice President for Research and Economic Development (2019-present)
- Professor, Pharmaceutical Sciences, University at Buffalo, School of Pharmacy and Pharmaceutical Sciences (2008-present)
- Associate Dean for Research, SPPS, University at Buffalo, School of Pharmacy and Pharamceutical Sciences (2011–2019)
- Associate Professor, Pharmaceutical Sciences, University at Buffalo, School of Pharmacy and Pharmaceutical Sciences (2003–2008)
- Assistant Professor, Pharmaceutical Sciences, University at Buffalo, School of Pharmacy and Pharmaceutical Sciences (1999–2003)
- Assistant Professor, Pharmaceutics and Pharmaceutical Chemistry, University of Utah, College of Pharmacy (1997–1999)
- Clinical Assistant Professor, Pharmaceutics, University at Buffalo, School of Pharmacy (1996–1997)
Awards and Honors:
- BIOMED Lecturer (2012)
- Elected AAPS Fellow (2010)
- UNC / Eisai Distinguished Lecturer in Drug Delivery (2010)
- Outstanding Manuscript in Modeling and Simulation (2009)
- University at Buffalo, Top 100 Federal Grantee, 2005 (2005)
- University at Buffalo, Young Investigator Achievement Award (2002)
- University at Buffalo, Top 100 Federal Grantee (2002)
- AAPS PPDM Annual Meeting Travel Award (2001)
- AACP New Investigator Award (1999)
- AACP New Investigator Award (1998)
- University of Utah, College of Pharmacy Distinguished Teaching Award (1998)
- AACP New Investigator Award (1997)
- AAPS / Eli Lilly Graduate Symposium Award (1995)
- AFPE Pre-doctoral Fellowship
- New York State Regents Scholarship
- Western New York Science Congress, Bronze Medal
- Rho-Chi Honor Society
- Schering-Plough Pre-doctoral Fellowship
- SUNY at Buffalo Department of Pharmaceutics Graduate Scholar Award
- SUNY at Buffalo School of Pharmacy Scholarship
Research Expertise:
- Monoclonal Antibodies: Experienced in the development, production, purification, and PKPD characterization of monoclonal antibody drugs.
- Pharmacokinetics and Pharmacodynamics: The utilization of pharmacokinetic and pharmacodynamic analyses and mathematical modeling to develop and evaluate rational approaches of optimizing drug therapy.
Research Centers:
- Center of Excellence in Bioinformatics and Life Sciences
UB 2020 Strategic Strengths:
- Molecular Recognition in Biological Systems and Bioinformatics
Grants and Sponsored Research:
- June 2020–May 2025
Pharmacokinetic Strategies to Increase Monoclonal Antibody Uptake, Distribution, and Efficacy for Treatment of Solid Tumors
NCI
Role: Principal Investigator
$1,814,481 - September 2018–August 2023
The role of oral spirochete virulence factors in the impairment of neutrophil response
NIH
Role: Co-Investigator
$1,894,065 - December 2016–November 2021
Catch and Release Immunotoxins: CAR-Bombs for cancer
NIH, National Cancer Institute
Role: Principal Investigator
$1,827,130 - September 2019–August 2020
Evaluation of mAb conjugate strategies for targeted delivery of anti-cancer siRNA
Center for Protein Therapeutics
Role: Principal Investigator
$100,000 - September 2019–August 2020
Evaluation of the effects of cell penetrating peptides and endosomal escape peptides on the pharmacokinetics of anti-cancer monoclonal antibodies
Center for Protein Therapeutics
Role: Principal Investigator
$100,000 - September 2019–August 2020
Evaluation of the therapeutic selectivity of anti-CEA SN38 antibody-drug conjugates (ADC) and antibody drug fragment complexes (FDC)
Center for Protein Therapeutics
Role: Principal Investigator
$100,000 - September 2017–August 2018
Investigation of differences in the disposition of 8C2 mAb and scFv in select brain regions of control mice and in a mouse model of Alzheimer’s disease
Center for Protein Therapeutics
Role: Principal Investigator
$100,000 - September 2017–August 2018
Dynamic contrast enhanced magnetic resonance imaging for the prediction of monoclonal antibody tumor disposition
Center for Protein Therapeutics
Role: Principal Investigator
$100,000 - September 2017–August 2018
Physiologically-Based Modeling for T-cell Engaging Bispecific Antibodies
Center for Protein Therapeutics
Role: Principal Investigator
$100,000 - June 2014–May 2016
Investigation of the utility of LC/MS for characterization of the plasma and tissue PK of a novel series of antiCEA monocolonal antibodies.
Hoffmann-La Roche Inc
Role: Principal Investigator
Patents:
- ANTI-FcRn ANTIBODIES FOR TREATMENT OF AUTO/ALLO IMMUNE CONDITIONS Docket Number: 5832 Type: Provisional (2008)
- ANTI-FcRn ANTIBODIES FOR TREATMENT OF AUTO/ALLO IMMUNE CONDITIONS Docket Number: 5832 Type: Other Other Type: PCT (2007)
- ANTI-FcRn ANTIBODIES FOR TREATMENT OF AUTO/ALLO IMMUNE CONDITIONS Docket Number: 5832 Type: Other Other Type: Japan (2006)
- ANTI-FcRn ANTIBODIES FOR TREATMENT OF AUTO/ALLO IMMUNE CONDITIONS Docket Number: 5832 Type: Other Other Type: Canada (2006)
- ANTI-FcRn ANTIBODIES FOR TREATMENT OF AUTO/ALLO IMMUNE CONDITIONS Docket Number: 5832 Type: Other Other Type: Japan (2006)
- ANTI-FcRn ANTIBODIES FOR TREATMENT OF AUTO/ALLO IMMUNE CONDITIONS Docket Number: 5832 Type: Other Other Type: Continuation-in-Part (2006)
- ANTI-FcRn ANTIBODIES FOR TREATMENT OF AUTO/ALLO IMMUNE CONDITIONS Docket Number: 5832 Type: Other Other Type: Europe (2006)
- ANTI-FcRn ANTIBODIES FOR TREATMENT OF AUTO/ALLO IMMUNE CONDITIONS Docket Number: 5832 Type: Other Other Type: Europe (2006)
- ANTI-FcRn ANTIBODIES FOR TREATMENT OF AUTO/ALLO IMMUNE CONDITIONS Docket Number: 5832 Type: Other Other Type: Canada (2006)
- ANTI-FcRn ANTIBODIES FOR TREATMENT OF AUTO/ALLO IMMUNE CONDITIONS Docket Number: 5832 Type: Provisional (2006)
- ANTI-FcRn ANTIBODIES FOR TREATMENT OF AUTO/ALLO IMMUNE CONDITIONS Docket Number: 5832 Type: Other Other Type: PCT (2004)
- ANTI-FcRn ANTIBODIES FOR TREATMENT OF AUTO/ALLO IMMUNE CONDITIONS Docket Number: 5832 Type: Regular (2004)
- ANTI-FcRn THERAPY FOR TREATMENT OF AUTO-ALLO IMMUNE CONDITIONS Docket Number: 5832 Type: Provisional (2003)
- ANTI-CHEMOTHERAPEUTIC AGENT ANTIBODIES AND THEIR USE Docket Number: 5721 Type: Provisional (2001)
- ANTI-CHEMOTHERAPEUTIC AGENT ANTIBODIES AND THEIR USE Docket Number: 5720 Type: Provisional (2001)
Journal Articles:
- Chung CY, Wang Q, Yang S, Chough S, Seo Y, Cipollo JF, Balthasar JP, Betenbaugh MJ. The impact of sialylation linkage-type on the pharmacokinetics of recombinant butyrylcholinesterases. Biotechnol Bioeng. 2020; 117(1).
- Thomas VA, Balthasar JP. Understanding Inter-Individual Variability in Monoclonal Antibody Disposition. Antibodies (Basel). 2019; 8(4).
- Glassman PM, Balthasar JP. Physiologically-based modeling of monoclonal antibody pharmacokinetics in drug discovery and development. Drug Metab Pharmacokinet. 2019; 34(1).
- Li T, Balthasar JP. Development and Evaluation of a Physiologically Based Pharmacokinetic Model for Predicting the Effects of Anti-FcRn Therapy on the Disposition of Endogenous IgG in Humans. J Pharm Sci. 2019; 108(1).
- Li T, Balthasar JP. Application of Physiologically Based Pharmacokinetic Modeling to Predict the Effects of FcRn Inhibitors in Mice, Rats, and Monkeys. J Pharm Sci. 2019; 108(1).
- Amidon GE, Anderson BD, Balthasar JP, Bergstrom CAS, Huang SM, Kasting G, Kesisoglou F, Khinast JG, Mager DE, Roberts CJ, Yu L. Fifty-Eight Years and Counting: High-Impact Publishing in Computational Pharmaceutical Sciences and Mechanism-Based Modeling. J Pharm Sci. 2019; 108(1).
- An B, Zhang M, Pu J, Shen S, Qu Y, Chen YJ, Huo S, Wang X, Polli JR, Balthasar JP, Herzog D, Ferrari L, Staack RF, Richter WF, Otteneder MB, Benincosa LJ, Zhou S, Vazvaei F, Qu J. High-Throughput, Sensitive LC-MS Quantification of Biotherapeutics and Biomarkers Using Antibody-Free, Peptide-Level, Multiple-Mechanism Enrichment via Strategic Regulation of pH and Ionic and Solvent Strengths. Anal Chem. 2019; 91(5).
- Polli JR, Engler FA, Balthasar JP. Physiologically Based Modeling of the Pharmacokinetics of "Catch-and-Release" Anti-Carcinoembryonic Antigen Monoclonal Antibodies in Colorectal Cancer Xenograft Mouse Models. J Pharm Sci. 2019; 108(1).
- Li T, Balthasar JP. FcRn Expression in Wildtype Mice, Transgenic Mice, and in Human Tissues. Biomolecules. 2018; 8(4).
- Engler FA, Polli JR, Li T, An B, Otteneder M, Qu J, Balthasar JP. "Catch-and-Release" Anti-Carcinoembryonic Antigen Monoclonal Antibody Leads to Greater Plasma and Tumor Exposure in a Mouse Model of Colorectal Cancer. J Pharmacol Exp Ther. 2018; 366(1).
- Wang-Lin SX, Balthasar JP. Pharmacokinetic and Pharmacodynamic Considerations for the Use of Monoclonal Antibodies in the Treatment of Bacterial Infections. Antibodies (Basel). 2018; 7(1).
- Zhang M, An B, Qu Y, Shen S, Fu W, Chen YJ, Wang X, Young R, Canty JM, Balthasar JP, Murphy K, Bhattacharyya D, Josephs JL, Ferrari L, Zhou S, Bansal S, Vazvaei F, Qu J. A sensitive, high-throughput and robust Trapping Micro-LC-MS strategy for quantification of biomarkers and antibody biotherapeutics. Anal Chem. 2017.
- Wang-Lin SX, Olson R, Beanan JM, MacDonald U, Balthasar JP, Russo TA. The Capsular Polysaccharide of Acinetobacter baumannii Is an Obstacle for Therapeutic Passive Immunization Strategies. Infect Immun. 2017; 85(12).
- Yang Y, Li TR, Balthasar JP. Investigation of the Influence of Protein-Losing Enteropathy on Monoclonal Antibody Pharmacokinetics in Mice. AAPS J. 2017; 19(6).
- Qu M, An B, Shen S, Zhang M, Shen X, Duan X, Balthasar JP, Qu J. Qualitative and quantitative characterization of protein biotherapeutics with liquid chromatography mass spectrometry. Mass Spectrom Rev. 2017; 36(6).
- Glassman PM, Balthasar JP. Physiologically-based modeling to predict the clinical behavior of monoclonal antibodies directed against lymphocyte antigens. MAbs. 2017; 9(2).
- Glassman PM, Balthasar JP. Physiologically-based pharmacokinetic modeling to predict the clinical pharmacokinetics of monoclonal antibodies. J Pharmacokinet Pharmacodyn. 2016; 43(4).
- Thomas VA, Balthasar JP. Sorafenib Decreases Tumor Exposure to an Anti-carcinoembryonic Antigen Monoclonal Antibody in a Mouse Model of Colorectal Cancer. AAPS J. 2016; 18(4).
- Glassman PM, Balthasar JP. Application of a catenary PBPK model to predict the disposition of "catch and release" anti-PCSK9 antibodies. Int J Pharm. 2016; 505(1-2).
- Qu M, An B, Shen S, Zhang M, Shen X, Duan X, Balthasar JP, Qu J. Qualitative and quantitative characterization of protein biotherapeutics with liquid chromatography mass spectrometry Mass Spectrom Rev. 2016.
- Engler FA, Balthasar JP. Development and validation of an enzyme-linked immunosorbent assay for the quantification of gelonin in mouse plasma. J Immunoassay Immunochem. 2016; 37(6).
- Glassman PM, Chen Y, Balthasar JP. Scale-up of a physiologically-based pharmacokinetic model to predict the disposition of monoclonal antibodies in monkeys. J Pharmacokinet Pharmacodyn. 2015; 42(5).
- Glassman PM, Abuqayyas L, Balthasar JP. Assessments of antibody biodistribution. J Clin Pharmacol. 2015; 55 Su.
- Shin MC, Zhang J, Min KA, Lee K, Moon C, Balthasar JP, Yang VC. Combination of antibody targeting and PTD-mediated intracellular toxin delivery for colorectal cancer therapy. J Control Release. 2014; 194.
- Conner KP, Rock BM, Kwon GK, Balthasar JP, Abuqayyas L, Wienkers LC, Rock DA. Evaluation of near infrared fluorescent labeling of monoclonal antibodies as a tool for tissue distribution. Drug Metab Dispos. 2014; 42(11).
- Engler FA, Zheng B, Balthasar JP. Investigation of the influence of nephropathy on monoclonal antibody disposition: a pharmacokinetic study in a mouse model of diabetic nephropathy. Pharm Res. 2014; 31(5).
- Shah DK, Balthasar JP. PK/TD modeling for prediction of the effects of 8C2, an anti-topotecan mAb, on topotecan-induced toxicity in mice. Int J Pharm. 2014; 465(1-2).
- Nouri-Nigjeh E, Zhang M, Ji T, Yu H, An B, Duan X, Balthasar J, Johnson RW, Qu J, Balthasar JP. Effects of calibration approaches on the accuracy for LC-MS targeted quantification of therapeutic protein. Anal Chem. 2014; 86(7).
- Glassman PM, Balthasar JP. Mechanistic considerations for the use of monoclonal antibodies for cancer therapy. Cancer Biol Med. 2014; 11(1).
- Shah DK, Balthasar JP. Predicting the effects of 8C2, a monoclonal anti-topotecan antibody, on plasma and tissue disposition of topotecan. J Pharmacokinet Pharmacodyn. 2014; 41(1).
- Cao Y, Balthasar JP, Jusko WJ. Second-generation minimal physiologically-based pharmacokinetic model for monoclonal antibodies. J Pharmacokinet Pharmacodyn. 2013; 40(5).
- Abuqayyas L, Balthasar JP. Investigation of the role of FcγR and FcRn in mAb distribution to the brain. Mol Pharm. 2013; 10(5).
- Abuqayyas L, Zhang X, Balthasar JP. Application of knockout mouse models to investigate the influence of FcγR on the pharmacokinetics and anti-platelet effects of MWReg30, a monoclonal anti-GPIIb antibody. Int J Pharm. 2013; 444(1-2).
- Abuqayyas L, Balthasar JP. Application of knockout mouse models to investigate the influence of FcγR on the tissue distribution and elimination of 8C2, a murine IgG1 monoclonal antibody. Int J Pharm. 2012; 439(1-2).
- Abuqayyas L; Balthasar JP. Pharmacokinetic mAb-mAb Interaction: Anti-VEGF mAb Decreases the Distribution of Anti-CEA mAb into Colorectal Tumor Xenografts.. AAPS Journal. 2012; 14.
- Duan X; Dai L; Chen S; Balthasar JP; Qu J. Nano-scale liquid chromatography/mass spectrometry and on-the-fly orthogonal array optimization for quantification of therapeutic monoclonal antibodies and the application in preclinical analysis. Journal of Chromatography A. 2012; 1251.
- Duan X; Abuqayyas L; Dai L; Balthasar JP; Qu J. High-throughput method development for sensitive, accurate, and reproducible quantification of therapeutic monoclonal antibodies in tissues using orthogonal array optimization and nano liquid chromatography/selected reaction monitoring mass spectrometry.. 2012.
- Girish S; Han C; Berglund EG; Huang SM; Joshi A; Martin SW; Peterson MC; Zhang LK; Zhao H; Balthasar JP; Evers R; Zhou H; Klunk L. AAPS Workshop Report: Strategies to Address Therapeutic Protein-Drug Interactions during Clinical Development. AAPS J. 2011.
- Shah DK; Veith J; Bernacki RJ; Balthasar JP. Evaluation of combined bevacizumab and intraperitoneal carboplatin or paclitaxel therapy in a mouse model of ovarian cancer.. Cancer Chemother Pharmacol. 2011.
- Shah DK; Balthasar JP. Physiologically based pharmacokinetic model for topotecan in mice.. J Pharmacokinet Pharmacodyn. 2011.
- Shin BS; Bulitta JB; Balthasar JP; Kim M; Choi Y; Yoo SD. Prediction of human pharmacokinetics and tissue distribution of apicidin, a potent histone deacetylase inhibitor, by physiologically based pharmacokinetic modeling.. Cancer Chemother Pharmacol. 2010.
- Urva SR; Yang VC; Balthasar JP. Physiologically based pharmacokinetic model for T84.66, a monoclonal anti-CEA antibody. Journal of Pharmaceutical Sciences. 2010; 99.
- Urva SR; Balthasar JP. Target mediated disposition of T84.66, a monoclonal anti-CEA antibody: Application in the detection of colorectal cancer xenografts. Mabs. 2010; 2.
- Urva SR, Yang VC, Balthasar JP. An ELISA for quantification of T84.66, a monoclonal anti-CEA antibody, in mouse plasma. J Immunoassay Immunochem. 2010; 31(1).
- Urva SR; Yang VC; Balthasar JP. Development and validation of an enzyme linked immunosobent assay for the quantification of carcinoembryonic antigen in mouse plasma. J Immunoassay Immunochem. 2009; 30.
- Garg A; Balthasar JP. Investigation of the influence of FcRn on the distribution of IgG to the brain. AAPS Journal. 2009; 11.
- Garg A, Balthasar JP. Investigation of the influence of FcRn on the distribution of IgG to the brain. AAPS J. 2009; 11(3).
- Shah DK; Shin BS; Veith J; Toth K; Bernacki RJ; Balthasar JP. Use of an anti-vascular endothelial growth factor antibody in a pharmacokinetic strategy to increase the efficacy of intraperitoneal chemotherapy. 2009.
- Shin BS; Yoon CH; Balthasar JP; Choi BY; Hong SH; Kim HJ; Lee JB; Hwang SW; Yoo SD. Prediction of drug bioavailability in humans using immobilized artificial membrane phosphatidylcholine column chromatography and in vitro hepatic metabolic clearance. 2009.
- Urva SR; Shin BS; Yang VC; Balthasar JP. Sensitive high performance liquid chromatographic assay for assessment of doxorubicin pharmacokinetics in mouse plasma and tissues. 2009.
- Urva SR, Yang VC, Balthasar JP. Development and validation of an enzyme linked immunosorbent assay for the quantification of carcinoembryonic antigen in mouse plasma. J Immunoassay Immunochem. 2009; 30(4).
- Wang W, Wang EQ, Balthasar JP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther. 2008; 84(5).
- Chen J; Lu Q; Balthasar JP. Mathematical modeling of topotecan pharmacokinetics and toxicodynamics in mice.. Journal of Pharmacokinetics and Pharmacodynamics. 2007; 34.
- Garg A; Balthasar JP. Physiologically-based pharmacokinetic (PBPK) model to predict IgG tissue kinetics in wild-type and FcRn-knockout mice. J Pharmacokinetics and Pharmacodynamics. 2007; 34.
- Deng R; Balthasar JP. Pharmacokinetic/pharmacodynamic modeling of IVIG effects in a murine model of immune thrombocytopenia. 2007.
- Deng R; Balthasar JP. Comparison of the effects of antibody-coated liposomes, IVIG, and anti-RBC immunotherapy in a murine model of passive chronic immune thrombocytopenia. 2007.
- Shin BS; Choi JW; Balthasar JP; Hong DK; Kim JJ; Yoo SD. Determination of roxatidine in human plasma by liquid chromatography/electrospray mass spectrometry and application to a clinical pharmacokinetic study. 2007.
- Wang T, Yang Z, Emregul E, David A, Balthasar JP, Liang J, Yang VC. Strategies for improving the functionality of an affinity bioreactor. Int J Pharm. 2005; 306(1-2).
- Emregul E, David A, Balthasar JP, Yang VC. A GPIIb/IIIa bioreactor for specific treatment of immune thrombocytopenic purpura, an autoimmune disease. Preparation, in vitro characterization, and preliminary proof-of-concept animal studies. J Biomed Mater Res A. 2005; 75(3).
- Deng R, Balthasar JP. Investigation of antibody-coated liposomes as a new treatment for immune thrombocytopenia. Int J Pharm. 2005; 304(1-2).
- Jin F, Balthasar JP. Mechanisms of intravenous immunoglobulin action in immune thrombocytopenic purpura. Hum Immunol. 2005; 66(4).
- Getman KE, Balthasar JP. Pharmacokinetic effects of 4C9, an anti-FcRn antibody, in rats: implications for the use of FcRn inhibitors for the treatment of humoral autoimmune and alloimmune conditions. J Pharm Sci. 2005; 94(4).
- Chen J, Balthasar JP. High-performance liquid chromatographic assay for the determination of total and free topotecan in the presence and absence of anti-topotecan antibodies in mouse plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2005; 816(1-2).
- Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. 2004; 93(11).
- Hansen RJ, Balthasar JP. Mechanisms of IVIG action in immune thrombocytopenic purpura. Clin Lab. 2004; 50(3-4).
- Tayab ZR, Balthasar JP. Development and validation of enzyme-linked immunosorbent assays for quantification of anti-methotrexate IgG and Fab in mouse and rat plasma. J Immunoassay Immunochem. 2004; 25(4).
- Wang EQ, Balthasar JP, Fung HL. Pharmacodynamics of in vivo nitroglycerin tolerance in normal conscious rats: effects of dose and dosing protocol.. Pharm Res. 2004; 21(1).
- Lobo ED, Balthasar JP. Pharmacokinetic-pharmacodynamic modeling of methotrexate-induced toxicity in mice. J Pharm Sci. 2003; 92(8).
- Hansen RJ, Balthasar JP. Intravenous immunoglobulin mediates an increase in anti-platelet antibody clearance via the FcRn receptor. Thromb Haemost. 2002; 88(6).
- Hansen RJ, Balthasar JP. Effects of intravenous immunoglobulin on platelet count and antiplatelet antibody disposition in a rat model of immune thrombocytopenia. Blood. 2002; 100(6).
- Lobo ED, Balthasar JP. Pharmacodynamic modeling of chemotherapeutic effects: application of a transit compartment model to characterize methotrexate effects in vitro. AAPS PharmSci. 2002; 4(4).
- Hansen RJ, Balthasar JP. Pharmacokinetics, pharmacodynamics, and platelet binding of an anti-glycoprotein IIb/IIIa monoclonal antibody (7E3) in the rat: a quantitative rat model of immune thrombocytopenic purpura. J Pharmacol Exp Ther. 2001; 298(1).
- Lobo ED, Balthasar JP. Highly sensitive high-performance liquid chromatographic assay for methotrexate in the presence and absence of anti-methotrexate antibody fragments in rat and mouse plasma. J Chromatogr B Biomed Sci Appl. 1999; 736(1-2).
- Hansen RJ, Balthasar JP. An ELISA for quantification of murine IgG in rat plasma: application to the pharmacokinetic characterization of AP-3, a murine anti-glycoprotein IIIa monoclonal antibody, in the rat. J Pharm Biomed Anal. 1999; 21(5).
- Bauer JA, Balthasar JP, Fung HL. Application of pharmacodynamic modeling for designing time-variant dosing regimens to overcome nitroglycerin tolerance in experimental heart failure. Pharm Res. 1997; 14(9).
- Balthasar JP, Fung HL. Inverse targeting of peritoneal tumors: selective alteration of the disposition of methotrexate through the use of anti-methotrexate antibodies and antibody fragments. J Pharm Sci. 1996; 85(10).
- Balthasar JP, Fung HL. Pharmacokinetic and pharmacodynamic optimization of intraperitoneal chemotherapy. Life Sci. 1996; 58(7).
- Balthasar JP, Fung HL. High-affinity rabbit antibodies directed against methotrexate: production, purification, characterization, and pharmacokinetics in the rat. J Pharm Sci. 1995; 84(1).
- Balthasar J, Fung HL, Balthasar JP. Utilization of antidrug antibody fragments for the optimization of intraperitoneal drug therapy: studies using digoxin as a model drug. J Pharmacol Exp Ther. 1994; 268(2).
Books and Book Chapters:
- Deng R; Balthasar JP. Immune Complex Therapies for Treatment of Immune Thrombocytopenia. Developmentof Antibody-Based Therapeutics. 2012.
- Shin BS; Shah D; Balthasar JP. Pharmacodynamics. Preclinical Development Handbook: ADME and Biopharmaceutical Properties. 2008.
- Chen J; Balthasar JP. Development and characterization of high-affinity anti-topotecan IgG and fab fragments. Handbook of Pharmaceutical Technology. 2007.
Evaluative Studies and Case Reports:
- Urva SR, Yang VC, Balthasar JP. Physiologically based pharmacokinetic model for T84.66: a monoclonal anti-CEA antibody. J Pharm Sci. 2010; 99(3).
Professional Memberships:
- American Association of Phamaceutical Scientists
- American Association of Colleges of Pharmacy
- American Association of Pharmaceutical Scientists
- American Society for Pharmacology and Experimental Therapeutics
- American Association for the Advancement of Science; American Association for the Advancement of Science
- American Society of Hematology; American Society of Hematology
Presentations:
- "Application of mechanistic modeling to support the discovery and development of therapeutic antibodies" University of Pittsburgh (2017)
- "Pharmacokinetics and Pharmacodynamics of Antibodies (lecture series)" Roche, Basel SWITZERLAND (2017)
- "Monoclonal Antibody Pharmacokinetics" Merck, Upper Gwynedd, Pennsylvania (2017)
- "Nanoparticles: Disruptive Technologies" Pfizer, Boston, Massachusetts (2017)
- "Antibody Pharmacokinetics (lecture series)" Boehringer Ingelheim, Biberach, GERMANY (2017)
- "Mechanistic Modeling and Avidity Effects" Sanofi, Bridgewater, New Jersey (2017)
- "Protein Pharmacokinetics (lecture series)" Genentech, San Francisco, California (2017)
- "Antibody Pharmacokinetics Lecture Series" University at Buffalo, Niagara Falls, New York (2017)
- "Tissue distribution and PBPK modeling" AAPS National Biotechnology Conference, San Diego, California (2017)
- "Monoclonal Antibody Pharmacokinetics (lecture series)" Amgen, San Francisco, California (2017)
- "Use of pH-dependent, “Catch-and-Release” antibodies for enhanced biological persistence and increased tumor exposure" University of Pennsylvania, School of Medicine, Philadelphia, Pennsylvania (2017)
Service Activities:
- Research Committee; Chair (2014–present)
- Conflict of Interest Committee; Member (2013–present)
- Radiation Safety Committee; Chair (2013–present)
- Associate Dean for Research (2011–present)
- Executive Committee; Member (2011–present)
- Student Academic Affairs Committee; Member (2011–present)
- Recovery Act Limited Competition Grant Review Commitee; Member (2009)
- Center for Protein Therapeutics; Director (2008–present)
- Director of Graduate Studies; Other (2006)
- Facutly Search Committee; Other (2005)
- Radiation Safety Committee; Other (2004)
- Faculty search Commitee; Other (2003)
- Curiculum Committee; Member (2000)
- Graduate Affairs Committee; Member (2000)
- Radiation Safety Committee; Member (2000)
- AAPS Biotech Section Planning Committee 2005 National Biotechnology Conference; AAPS; Other
- AAPS Biotech Section Planning Committee 2006 National Biotechnology Conference; AAPS; Other
- AAPS National Biotechnology Conference Planning Commitee; AAPS; Other
- Expert Panel on Complex Activities; United States Pharmacopoeia; Other
- Interdisciplinary Research Development Fund (IRDF) Review Committee; Member
- National Institues of Health; NIH; Other
- Paul Dawson Biotechnology Award Selection Committee; American Association of Colleges of Pharmacy; Other