Curriculum Vitae

1. AREAS OF EXPERTISE

  • Clinical Drug Development
  • Clinical Pharmacology & Pharmacokinetics 
  • Pharmacometrics (Modeling & Simulation)
  • Clinical Trials
  • Multiple Therapeutic Areas
  • Rare Genetic Disorders
  • Regulatory Submissions
     

2. EDUCATION

  • M.D.,  Clinical Medicine, Shanxi Medical University, 2018
  • Ph.D., Pharmacokinetics, University of Witten-Herdecke, 1994
  • M.S.,  Pharmaceutical Chemistry & Molecular Modeling, Shanxi University, 1988
  • B.S., Pharmaceutical Chemistry, Shanxi University, 1983


3. CURRENT AND PREVIOUS POSITIONS

  • CEO and President, XP Pharma Consulting, LLC, Stoneham, MA, Consultation services are provided in Clinical Development, Clinical Pharmacology, Pharmacokinetics, Pharmacodynamics, Pharmacometrics, Clinical Studies, and Regulatory Submissions. 2019- present
  • Sr. Consultant-Clinical Pharmacology and Pharmacometrics, Nuventra Pharma Sciences, Inc. Cambridge, MA, 2019-present
  • Sr. Director- Clinical Pharmacology and Pharmacometrics, Alnylam Pharmaceuticals, Inc. Cambridge, MA, 2017-2019
  • Clinical Pharmacology Director / Clinical Pharmacology Team Leader, Alexion Pharmaceuticals, Inc. New Haven, CT, 2015-2017
  • Clinical Director / Head of Clinical Pharmacology, Kyowa Hakko Kirin Pharma, Inc. Princeton, NJ, 2012-2015
  • Clinical Director / Head Clinical Pharmacology-Inflammation, Hoffmann-La Roche, Inc. Nutley, NJ, 2001-2012


4. PUBLICATIONS [Seventy (70) including the following selected papers]

    

  1. Zhang, X, Goel V, et al. Pharmacokinetics of patisiran, the first approved RNA interference (RNAi) therapy, in patients with hereditary transthyretin-mediated amyloidosis. J Clinical Pharmacology. 2019 Nov 27. doi: 10.1002/jcph.1553. [Epub ahead of print]
  2. Zhang, X., Goel V, et al."Patisiran pharmacokinetics, pharmacodynamics, and exposure–response analyses in the phase 3 APOLLO trial, in patients with hereditary transthyretin-mediated (hATTR) amyloidosis. J Clinical Pharmacology.Published ahead of print.  https://doi.org/10.1002/jcph.1480; July 19, 2019. 
  3. Mahadevan, D, Zhang, X, et al. Phase I study of samalizumab in chronic lymphocytic leukemia and multiple myeloma: Blockade of the immune checkpoint CD200.J.Immunother.Cancer. 7(1):227;2019.
  4. Mukai, M., Zhang X., et al. Effects of rifampin on the pharmacokinetics of a single dose of istradefylline in healthy subjects. J. of Clinical Pharmacology. 58(2); 193-201;2018.
  5. Zhang X., Imel E.A. et al. Population pharmacokinetic and pharmacodynamic analyses from a 4-Month intra-dose escalation and its subsequent 12-month dose titration studies for a human monoclonal anti-FGF23 antibody (KRN23) in adults with X-linked hypophosphatemia. J Clinical Pharmacology. 56(2): 176-185;2016.
  6. Ruppe MD, Zhang X, et al. Effect of four monthly doses of a human monoclonal anti-FGF23 antibody (KRN23) on quality of life in X-linked hypophosphatemia. Bone Reports. 5:158–162;2016. 
  7. Abdallah, H., Zhang X, et al. Pharmacokinetic and pharmacodynamic analysis of subcutaneous tocilizumab in patients with rheumatoid arthritis from two randomized controlled trials: SUMMACTA and BREVACTA. J Clinical Pharmacology. 57(4):459-468;2017.
  8. Whitley C.B., Zhang X., Results of the phase 1/2, open-label clinical study of intravenous recombinant human N-acetyl-α-D-Glucosaminidase (SBC-103) in children with mucopolysaccharidosis IIIB. Molecular Genetics and Metabolism. 126(2);131-138;2019.
  9. Zhang X, Peyret T, et al. Population pharmacokinetic and pharmacodynamic analyses from a 4-month intra-dose escalation and its subsequent 12-month dose titration studies for a human monoclonal anti-FGF23 antibody (KRN23) in adults with X-linked hypophosphatemia. J Clin Pharmacology.56(4):429-38;2016.
  10. Sarantopoulos J, Zhang X, et al. Phase 1 Study of monotherapy with KHK2866, an anti-heparin-binding epidermal growth factor-like growth factor monoclonal antibody, in patients with advanced cancer. Targeted Oncology. 11(3):317-27; 2016.
  11. Duvic, M, Zhang X, et al. Phase I/II study of mogamulizumab (KW-0761), a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous or peripheral T-cell lymphoma. Blood. 125(2): 1883-1889; 2015.
  12. Imel EA, Zhang X, et al. Prolonged correction of serum phosphorus in adults with X-linked hypophosphatemia using monthly doses of KRN23. J Clin Endocrinol Metab. 100(7):2565-73, 2015.
  13. Carpenter TO, Zhang X, et al. Randomized trial of the anti-FGF23 antibody KRN23 in X-linked hypophosphatemia. J Clin Invest. 124(4):1587-97. 2014.
  14. Zhang X, Rowell L, et al. Assessment of disease-drug-drug interaction between single-dose tocilizumab and oral contraceptives in women with active rheumatoid arthritis. Int J Clin Pharmacol Ther. 52(1):27-38; 2014.
  15. Zhang X, Brennan B. Disease-drug-drug interaction assessments for tocilizumab – a monoclonal antibody against interleukin-6 receptor to treat patients with rheumatoid arthritis. In Drug-Drug Interaction for Therapeutic Proteins (H. Zhou and B.Meibohm, eds.), ISBN 978-1-118-03216-9. WILEY Wiley-Blackwell Publisher. 2013.
  16. Zhang X, Chen Y.-C, et al. Clinical study to investigate pharmacokinetics, pharmacodynamics, efficacy, and safety of tocilizumab after subcutaneous administration weekly or every 2 weeks in patients with rheumatoid arthritis. Int J. of Clin Pharmacol &Ther. 51(8); 620-630; 2013.
  17. Zhang X, Chen YC, and Terao K. Clinical pharmacology of tocilizumab for the treatment of polyarticular-course juvenile idiopathic arthritis. Expert Rev. Clin. Pharmacol. 10(5):471-482;2017.
  18. Zhang X, Georgy A., Rowell L. An Open-label, single-center study investigating pharmacokinetics and pharmacodynamics of tocilizumab, a humanized anti–interleukin-6 receptor monoclonal antibody, following single-dose administration by subcutaneous and intravenous routes to healthy subjects. Int. J Clin Pharmacol &Ther. 51(6);443-455;2013.
  19. Morcos P, Zhang X. Pharmacokinetics and pPharmacodynamics of single subcutaneous doses of tocilizumab administered with or without rHuPH20 in healthy volunteers. Int. J Clin Pharmacol &Ther. 51(7); 537-548; 2013.
  20. Zhang X, Morcos P, Terao K. Clinical Pharmacology of Tocilizumab for the Treatment of Patients With Systemic Juvenile Idiopathic Arthritis. Expert Rev. Clin. Pharmacol. 6(2), 123–137; 2013 
  21. Zhang X, Chen Y-C, et al. A Clinical study to investigate pharmacokinetics, pharmacodynamics, efficacy, and safety of tocilizumab after subcutaneous administration weekly or every two weeks in patients with rheumatoid arthritis. Clin.Pharmacol. Ther. 91 (Suppl 1): S117 (PIII-60);2012.
  22. Zhang X, Peck R. Clinical pharmacology of tocilizumab for the treatment of patients with rheumatoid arthritis. Expert Rev. Clin. Pharmacol.4(5):539–558; 2011.
  23. Schmitt C, Kuhn B, Zhang X, Kivitz A, Grange S. Tocilizumab has no clinically relevant effects on methotrexate pharmacokinetics in patients with rheumatoid arthritis. Int. J. of Clin Pharmacol Ther. 30(3):218-223;2011.
  24. Grange S, Schmitt C, Banken L, Kuhn B, Zhang X. Thorough QT/QTc study of tocilizumab after single-dose administration at therapeutic and supratherapeutic doses in healthy subjects. Int. J. of Clin Pharmacol Ther. 49(11):648-55;2011.
  25. Zhang, X. et al. Pharmacokinetics and pharmacodynamics of tocilizumab in systemic juvenile idiopathic arthritis. Clin. Pharmacol.Ther. 89, S36–S37;2011.
  26. Zhang X, Jordan P, et al. Thorough QT/QTc study of ritonavir-boosted saquinavir following multiple-dose administration of therapeutic and supratherapeutic doses in healthy participants. J Clin Pharmacol.52(4):520-529;2012.
  27. Zhang X, Fettner S, et al. Pharmacokinetic interaction study of ritonavir-boosted saquinavir in combination with rifabutin in healthy subjects. Antimicrob. Agents Chemother. 55(2): 680–687;2011.
  28. Zhang X, Fettner S, et al. Metabolism and excretion of a novel p38 MAP kinase inhibitor pamapimod in healthy male subjects. Int. J. of Clin Pharmacol Ther, 49(6): 345-352;2011.
  29. Zhang X, Huang Y, et al. A Proof-of-concept and drug-drug interaction study of pamapimod, a novel p38 MAP kinase inhibitor, with methotrexate in patients with rheumatoid arthritis. J. Clin Pharmacol. 50(9):1031-8;2010.
  30. Zhang X, Silkey M, Schumacher M, Wang L, Raval H, Caulfield JP. Period correction of the QTc of moxifloxacin with multiple predose baseline ECGs is the least variable of 4 methods tested. J. Clin Pharmacol. 49(5):534-9;2009.
  31. Jamois C, Zhang X., et al. Effect of saquinavir/ritonavir (1000/100 mg bid) on the pharmacokinetics of methadone in opiate-dependent HIV-negative patients on stable methadone maintenance therapy. Addiction Biology.14(3): 321-327;2009.
  32. Kaeser K., Zhang X. et al. Drug-drug interaction study of ketoconazole and ritonavir-boosted saquinavir. Antimicrob. Agents Chemother. 53(2): 609–614;2009.
  33. Zhang X, Lin T, et al. Population pharmacokinetics of enfuvirtide in HIV-1-infected pediatric patients over 48 weeks of treatment. J Clin Pharmacol. 47(4):510-7;2007.
  34. Patel IH, Zhang X, Nieforth K, Salgo M, Buss N. Pharmacokinetics, pharmacodynamics and drug Interaction potential of enfuvirtide. Clin Pharmacokinet. 44(2):175-86;2005.
  35. Mould DR, Zhang X, Nieforth K, et al. Population pharmacokinetics and exposure-response relationship of enfuvirtide in treatment-experienced human immunodeficiency virus type 1-infected patients. Clin Pharmacol Ther. 77(6):515-28;2005.
  36. Ruxrungtham K, Zhang X, et al. Lack of Interaction between enfuvirtide and ritonavir or ritonavir-boosted saquinavir in HIV-1-infected patients. J Clin Pharmacol. 44(7):793-803;2004.
  37. Zhang X, Lalezari JP, et al. Assessment of drug-drug interaction potential of enfuvirtide in human immunodeficiency virus type 1-infected patients. Clin Pharmacol Ther. 75(6):558-68;2004.
  38. Boyd MA, Zhang X, et al. Lack of enzyme-inducing effect of rifampicin on the pharmacokinetics of enfuvirtide. J Clin Pharmacol. 43(12):1382-91;2003
  39. Lalezari JP, Patel IH, Zhang X, et al. Influence of subcutaneous injection site on the steady-state pharmacokinetics of enfuvirtide (T-20) in HIV-1-infected patients. J Clin Virol. 28(2):217-22;2003.
  40. Zhang X, Nieforth K, et al. Pharmacokinetics of plasma enfuvirtide after subcutaneous administration to patients with immunodeficiency virsus: Inverse Gausian Density absorption and 2-compartment disposition. Clin. Pharmacol Ther. 72(1):10-19;2002. 

image3

Click Below To Download The Complete CV

Xiaoping Zhang_CV (pdf)

Download