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Ping Zhao, Ph.D.
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CURRICULUM VITAE
Ping Zhao, Ph.D.
EDUCATIONAL BACKGROUND
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Ph.D. Pharmaceutics, 1998-2002. Department of Pharmaceutics, School of Pharmacy, University of
Washington, Seattle, WA
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B.S. Pharmacy, 1990-1994. School of Pharmacy, Peking University Medical Center, Beijing, China
PROFESSIONAL EXPERIENCE
 04/2013-present: Scientific Lead, physiologically-based pharmacokinetic modeling (PBPK) program,
Division of Pharmacometrics, Office of Clinical Pharmacology (OCP), Office of Translational Sciences
(OTS), FDA
 06/2008-04/2013: Senior Clinical Pharmacologist, Immediate Office, OCP/OTS, FDA
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REGULATORY REVIEW IN OCP, FDA
 Delivered 100+ PBPK IND/NDA/BLA reviews in 7 years
o Evaluated sponsors’ models, conducted FDA analyses, and used PBPK results to support dose
recommendations in reviews and drug labels (approved NDA/BLA summarized in Table 1)
o Strived to set evidentiary standards for PBPK review through establishment of OCP PBPK knowledgebase
and scientific research (See #2 below)
o Responded and resolved far-reaching, complex review issues related to the effect of multiple
intrinsic/extrinsic factors (e.g., co-medications, organ impairment, pediatrics, food, gastric pH) on drug
exposure and response
o Provided recommendations to review teams and externally to sponsors on the design and analysis of
clinical pharmacokinetic (PK) and pharmacodynamic (PD) studies using clinical pharmacology principles
and standard (e.g., compartmental and population PK/PD) as well as contemporary (e.g., populationbased PBPK) modeling tools
o Authored/co-authored PBPK reviews (Examples available online for drugs listed in Table 1)
 Led PBPK review as a subject expert in modeling and drug disposition
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Determined adequacy of PBPK results and provided labeling recommendations to review teams
Oversaw the use of PBPK modeling tools for support of clinical pharmacology reviews
Supervised direct report and provided scientific directions to colleagues on PBPK reviews
Represented office and the FDA at sponsor meetings concerning clinical pharmacology issues
2. REGULATORY POLICY AND REGULATORY SCIENCE IN OCP, FDA
 Led PBPK research projects and policy development
o Led the development of the first FDA guidance on format of content of PBPK submissions (ongoing)
o Contributed development of clinical pharmacology guidance documents (drug interactions, organ
impairment, pediatrics, pregnancy, pharmacogenomics) and office policy/procedures
o Provided scientific, managerial and technical supervision to fellows, visiting academic scientists, and
visiting drug regulators from other countries to accomplish impactful regulatory research projects (See
Table 2)
o Strived to establish evidentiary standards on the use of PBPK to support review and policy development
through scientific research and publications (See Peer Reviewed Journal Publications)
o Disseminated PBPK regulatory science through teaching and meeting presentations (See Oral
Presentations and Teaching)
o Oversaw the planning and execution of multiple scientific projects (Commissioner’s Fellowship, Critical
Path Initiative, Medical Counter Measure Initiative, Office of Women’s Health)
o Established internal PBPK expertise and organized workshops and trainings
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Ping Zhao, Ph.D.
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 Collaborated with others internally and externally
o Regularly participated in discussions with EMA and PMDA colleagues on the use of PBPK modeling and
simulations in clinical pharmacology drug development and review
o Collaborated with international thought leaders in academia and other regulatory bodies (e.g., Wu,
Pharm Res,, 2014, Jiang, CPT-PSP, 2013, Hsu, Clin Pharmacokinet, 2013, Ke, four publications, Vieira, Clin
Pharmacol Ther 2012, Zhao, J Clin Pharmacol, 2012, Grillo, Biopharm Drug Dispo, 2012, Duan, J Clin
Pharmacol 2011, Zhao, J Clin Pharmacol 2009 under Peer Reviewed Journal Publications)
o Led FDA-PharmaIQC-academic initiative on model-based prediction (e.g., Vieira, Kirby et al, Clin
Pharmacol Ther, 2013, and Einolf et al, Clin Pharmacol Ther 2013 under Peer Reviewed Journal
Publications)
o Coordinated inter-office (Offices of Generic Drugs and New Drugs) and inter-center (CBER, CVM, CFSAN)
training on PBPK
o Served as external adjunct faculty in academic institution and board member/ reviewer for numerous
peer reviewed journals
 02/2008-06/2008: Contract Scientist, Amgen Inc., Seattle, WA (40 hours/week)
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Supported clinical and preclinical pharmacokinetic studies
09/2005-12/2007. Pharmacokineticist, Sonus Pharmaceuticals, Inc. Bothell, WA (40 hours/week)
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Set up, led and supervised preclinical drug metabolism and pharmacokinetics (DMPK) and clinical
pharmacology group to support both early discovery and late phase clinical/nonclinical oncology projects
 10/2002-09/2005. Principal Scientist, Pfizer Inc. La Jolla, CA (40 hours/week)
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Represented DMPK line on multi-disciplinary project teams (Antiviral, oncology and ophthalmology)
Conducted DMPK studies to support clinical pharmacology programs regarding dose section, drug interaction,
and identification of potential liver and eye toxicities of compounds in development
EXTERNAL PROFESSIONAL APPOINTMENTS AND ACTIVITIES
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Adjunct faculty: School of Pharmacy, University of Florida (2012-present)
Council member: Lake Nona Leadership Council, University of Florida Center for Pharmacometrics and
Systems Pharmacology (2012-2013)
Organizing committee member, Land of Lakes Drug Metabolism and Pharmacokinetics Annual Conference
(2009-present)
Organizing committee member, 2017 North American ISSX meeting (2015-2017)
Committee member, ISSX Membership Committee (2011-present)
Advisor to Editor: Journal of Pharmaceutical Sciences
Member of editorial board: Journal of Clinical Pharmacology (2013-present)
Frequent journal reviewer (Clinical Pharmacology Therapeutics (including CPT-Pharmacometrics and Systems
Pharmacology), Bioinformatics, Drug Metabolism and Disposition, Molecular Pharmaceutics,
Biopharmaceutics Drug Disposition, Journal of Clinical Pharmacology, Pharmaceutical Research, Expert
Opinion of Drug Metabolism and Toxicology, Toxicology and Applied Pharmacology, European Journal of
Pharmaceutical Sciences, Clinical Pharmacokinetics).
SELECTED HONORS, AWARDS AND RECOGNITIONS
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2015 FDA CDER Excellence in Mentoring award
2015 FDA CDER Team Excellence Blincyto Review Team
2015 FDA CDER Team Award: Eliglustat Clinical Pharmacology and Clinical Review Team
2015 FDA Group Recognition Clinical Pharmacology Review Team for Ceritinib
2015 CDER Special Recognition Clinical Pharmacology Review Team for Panobinostat
2014 FDA CDER team award: CDER Special Recognition award – OCP Innovation Task Force I
2014 FDA CDER team award: CDER Frances O. Kelsey Drug Safety Excellence award: Clinical Pharmacology
Team for OPSUMIT
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Ping Zhao, Ph.D.
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2014 FDA CDER team award: CDER Regulatory Science Excellence award - Simeprevir Clinical Pharmacology
Review Team
2013 FDA CDER team award: transporter scientific interest group
2012 FDA outstanding service award
2009 FDA CDER Center team awards: FDA-OCP Ambassadors and Staff
2009 FDA CDER Center team awards: CPRSC Faculty and Staff
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2002 AAPS/Eli Lilly Award for Graduate Student Symposium in PPDM/CS, Toronto, Canada
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2001-2002 Merck Fellowship for graduate research, University of Washington, Seattle, WA
MEMBERSHIPS IN PROFESSIONAL SOCIETIES
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1999 – Present: International Society for the Study of Xenobiotics (ISSX), Member
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2007, 2009-2013, 2015-present: American Society for Clinical Pharmacology and Therapeutics (ASCPT),
Member
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2013-present: American College of Clinical Pharmacology (ACCP), Member
Table1. PBPK reviews supporting regulatory decisions and dose recommendations in drug labels
Drug Name (Approval Year)
Sildenafil (2009)
Cabazitaxel (2010)
Praziquantel (2010)
Ketoconazole (2010)
Rivaroxaban (2010)
Vilazadone (2011)
Rilpivirine (2011)
Bosutinib (2012)
Perampanel (2012)
Ponatinib (2012)
Levonorgestrol (2013)
Canagliflozin (2013)
Simeprevir (2013)
Ibrutinib (2013)
Macitentan (2013)
Naloxegol (2014)
Eliglustat (2014)
Ruxolitinib (2014)
Ceritinib (2014)
Rilpivirine (2014)
Belinostat (2014)
Blinatumomab (2014)
Lenvatinib (2015)
Panobinostat (2015)
Aripiprazole Lauroxil (2015)
Osimertinib (2015)
Cobimetinib (2015)
Dolutegravir (2015)
Summary of simulations
Effect of ritonavir on sildenafil exposure
Lack of CYP inhibition by cabazitaxel
Effect of rifampicin co-administration
Lack of CYP inhibition by topically applied ketoconazole
Synergistic effect of drug-disease interaction
Similar drug interaction by ketoconazole under different dosing regimen
Similar drug interaction by ketoconazole at a lower dose of rilpivirine
Support of post-marketing study on effect of moderate CYP inhibitor
Similar drug interaction by ketoconazole under different dosing regimen
The effect of rifampin on ponatinib exposure
Similar drug exposure in adult and adolescent women receiving intrauterine device
Lack of CYP inhibition by canagliflozin
Support of dose recommendations under different drug interaction scenarios and in subjects
with East Asian ancestry
Support of dose recommendations for situations when ibrutinib is co-administered with
various CYP modulators
Support of dose recommendation for the effect of ritonavir on macitentan exposure
Support of dose recommendation for the effect of efavirenz
Support of dose recommendations for situations when eliglustat is co-administered with
various CYP modulators in subjects with different CYP2D6 genotypes
Support of dose recommendations for situations when ruxolitinib is co-administered with
fluconazole
Support of dose recommendations for situations when ceritinib is co-administered with CYP
modulators at steady state
Support of post marketing study of the effect of food at a different dose of ceritinib
Support of dose recommendation for the effect of a moderate CYP inducer on rilpivirine
Support of dose post-marketing study on the effect of UGT polymorphisms
transient effect of “cytokine storm” on comedications that are CYP substrate and supported
duration of hospitalization for patients initiated with biologic treatment
The lack of drug effect on the PK of CYP3A and CYP2C8 substrates
Support of dose recommendations for co-medication that is strong CYP3A inducer and the
lack of the effect of acid reducing agents on panobinostat oral absorption
Support of dose recommendations for situations when the product is co-administered with
various CYP modulators in subjects with different CYP2D6 genotypes
Support of multiple post-marketing requirement trials for drug-drug interaction potential
Support of dose recommendations for comedications that are CYP3A inducers
Support of dose recommendations for comedications that are UGT and/or CYP3A inducers
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Ping Zhao, Ph.D.
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Sonidegib (2015)
Support of dose recommendations for comedications that are CYP3A modulators
Table2. Summary of impactful regulatory science projects completed by supervised fellows
Fellow’s
name
Research title
Wagner C
Predicting the Effect of Intrinsic and Extrinsic Factors on the
Exposure of Antiretroviral Medications
Predictive Performance of Physiologically Based Pharmacokinetic
(PBPK) Models for the Effect of CYP3A Inducers on Substrate
Drugs: Analysis of Submissions to the FDA
Physiologically-based Pharmacokinetic Modeling (PBPK) of
Pitavastatin and Atorvastatin to Predict Drug-drug Interactions
(DDIs)
Applications of Physiologically Based Pharmacokinetic (PBPK)
Model in Predicting acetaminophen Metabolism and
Pharmacokinetics in Children
Application of the FDA PBPK Knowledgebase in Evaluating Model
Predictability for Drug-drug Interactions.
PBPK Models of Renally Eliminated Drugs and Their Application in
Evaluating the Effect of Patient Factors
Wagner C
Duan VP
Jiang X
Pan Y
Hsu V
Jiang X
Application of Physiologically-Based Pharmacokinetic (PBPK)
Model in Predicting Drug Metabolism and Pharmacokinetics in
Pediatric Populations – A Case Study of Acetaminophen
Ke A
Refinement and Validation of a PBPK Model to Predict Disposition
of Drugs in Pregnant Women Cleared via CYP1A2 and CYP3A
Metabolism.
Vieira MLT
Evaluation of FDA and EMA Models’ Cut-off Values for CYP3A
Inhibition Prediction: A Collaborative Effort among Academic,
Regulatory Agencies, and Innovation and Quality Consortium
(IQC) Pharmaceutical Scientists.
Award and recognition
- 2015 ACCP Student Award Winner
- 2015 ASCPT Presidential Trainee Award
and Jason Morrow Trainee Award,
selected abstract for oral presentation
- 2015 ASCPT Presidential Trainee Award
- 2014 ASCPT encore oral presentation
- 2014 ASCPT selected abstract for oral
presentation
- 2014 ASCPT Presidential Trainee Award
and Jason Morrow Trainee Award,
selected abstract for oral presentation
- 2013 ASCPT Presidential Trainee Award,
selected abstract for oral presentation
- 2012 FDA OCP Science Day, 1st Place
Poster Award
- 2012 ASCPT selected abstract for oral
presentation
- 2011 FDA OCP Science Day, 1st Place
Poster Award
- 2012ASCPT Presidential Trainee Award,
selected abstract for oral presentation
PEER-REVIEWED JOURNAL PUBLICATIONS (underlined as corresponding author)
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Pan Y, Hsu V, Grimstein M, Zhang L, Arya V, Sinha V, Grillo JA, Zhao P (2016) The Application of Physiologicallybased Pharmacokinetic (PBPK) Modeling to Predict the Role of Drug Transporters: Scientific and Regulatory
Perspectives. J Clin Pharmacol, Accepted
Yoshida K, Sun B, Zhang L, Zhao P, Abernethy D, Nolin TD, Rostami-Hodjegan A, Zineh I, Huang SM (2016)
Systematic and quantitative assessment of the effect of chronic kidney disease on CYP2D6 and CYP3A4/5. Clin
Pharmacol Ther. [Epub ahead of print]
Jadhav PR, Cook J, Sinha V, Zhao P, Rostami-Hodjegan A, Sahasrabudhe V, Stockbridge N, Powell JR (2015) A
proposal for scientific framework enabling specific population drug dosing recommendations. J Clin Pharmacol.
55:1073-8
Przepiorka D, Ko C, Deisseroth A, Yancey CL, Candau-Chacon R, Chui H-J, Gehrke BJ, Gomez-Broughton C, Kane
RC, Kirshner S, Ricks TK, Schmiel D, Sinha B, Song P, Zhao P, Zhou Q, Farrell AT and Pazdur R (2015) U.S. Food and
Drug Administration Approval: Blinatumomab. Clin Cancer Res. 21:4035-9
Yeung CK, Yoshida K, Kusama M, Zhang H, Ragueneau-Majlessi I, Argon S, Li L, Chang P, Le C, Zhao P, Zhang L,
Sugiyama Y, Huang S-M (2015) Organ impairment - drug-drug interaction database: A tool for evaluating the
impact of renal or hepatic impairment and pharmacologic inhibition on the systemic exposure of drugs. CPT:
Pharmacometrics & Systems Pharmacology, 4:489-94
Wagner C, Pan Y, Hsu V, Sinha V, Zhao P. (2016) Predicting the Effect of CYP3A Inducers on the Pharmacokinetics
of Substrate Drugs Using Physiologically Based Pharmacokinetic (PBPK) Modeling: An Analysis of PBPK
Submissions to the US FDA. Clin Pharmacokinet. 55: 475-83
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Ping Zhao, Ph.D.
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Wagner C , Zhao P, Pan Y, Hsu V, Grillo J, Huang SM, Sinha V (2015) Application of physiologically based
pharmacokinetic (PBPK) modeling to support dose selection: report of an FDA public workshop on PBPK. CPT:
Pharmacometrics & Systems Pharmacology, 4; 226-230
Varma MV, Pang KS, Isoherranen N, Zhao P (2015) Dealing with the complex drug-drug interactions: Towards
mechanistic models. Biopharm Drug Dispos. 36:71-92.
Khozin S, Blumenthal GM, Zhang L, Tang S, Brower M, Fox E, Helms W, Leong R, Song P, Pan Y, Liu Q, Zhao P,
Zhao H, Lu D, Tang Z, Al Hakim A, Boyd K, Keegan P, Justice R, Pazdur R. (2015) FDA Approval: Ceritinib for the
Treatment of Metastatic Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer. Clin Cancer Res.
21:2436-9
Wagner C, Pan Y, Hsu V, Grillo JA, Zhang L, Reynolds KS, Sinha V, Zhao P. (2015) Predicting the effect of
cytochrome P450 inhibitors on substrate drugs: analysis of physiologically based pharmacokinetic modeling
submissions to the US Food and Drug Administration. Clin Pharmacokinet. 54:117-27
Sinha V, Zhao P, Huang SM, Zineh I (2014) Physiologically Based Pharmacokinetic Modeling: From Regulatory
Science to Regulatory Policy. Clin Pharmacol Ther, 95, 478-80
Vieira MdLT, Kim M-J, Apparaju S, Sinha, V, Zineh I, Huang SM, Zhao P (2014) PBPK model describes the effects of
co-medication and genetic polymorphism on systemic exposure of drugs that undergo multiple clearance
pathways. Clin Pharmacol Ther, 95, 550-7
Wu F, Lu G, Zhao P, Jamei M, Huang SM, Bashaw ED, Lee SC (2014) Predicting Nonlinear Pharmacokinetics of
Omeprazole Enantiomers and Racemic Drug Using Physiologically Based Pharmacokinetic Modeling and
Simulation: Application to Predict Drug/Genetic Interactions. Pharmaceutical Res, 31:1919-29
Hsu V, Vieira ML, Zhao P, Zhang L, Zheng JHM, Anna Nordmark A, Gil Berglund E, Giacomini KM, Huang SM
(2014) Towards Quantitative Modeling of the Effect of Renal Impairment and Probenecid Inhibition on Kidney
Uptake and Efflux Transporters using PBPK, Clin Pharmacokinet, 53, 283-93
Ke AB, Rostami-Hodjegan A, Zhao P, Unadkat J (2014) Pharmacometrics in Pregnancy: An Unmet Need, Annual
review of pharmacology and toxicology, 54, 53-69
Jiang XL, Zhao P, Barrett J, Lesko L, Schmidt S (2013) Application of physiologically-based pharmacokinetic
modeling to predict acetaminophen metabolism & pharmacokinetics in children. CPT: Pharmacometrics &
Systems Pharmacology, 2, e80
Vieira MdLT, Kirby B, Ragueneau-Majlessi I, Galetin A, Chien J, Einolf HJ, Fahmi OA, Fischer V, Fretland A, Grime K,
Hall SD, Higgs R, Plowchalk D, Riley R, Seibert E, Skordos K, Snoeys J, Venkatakrishnan K, Waterhouse T, Obach RS,
Berglund EG, Zhang L, Zhao P, Reynolds KS, Huang S-M (2013). Evaluation of Various Static In vitro-In vivo
Extrapolation Models for Risk Assessment of CYP3A Inhibition Potential of an Investigational Drug. Clin
Pharmacol Ther. 95, 189-98
Einolf HJ, Chen L, Fahmi OA, Gibson CR, Obach RS, Shebley M, Silva J, Sinz MW, Unadkat, JD, Zhang L, Zhao P
(2013) Evaluation of various static and dynamic modeling methods to predict clinical CYP3A induction using in
vitro CYP3A4 mRNA induction data. Clin Pharmacol Ther. 95, 179-188
Ke AB, Nallani SC, Zhao P, Rostami-Hodjegan A, Unadkat JD (2014). Expansion of a PBPK Model to Predict
Disposition in Pregnant Women of Drugs Cleared via Multiple CYP Enzymes, Including CYP2B6, CYP2C9 and
CYP2C19. Br J Clin Pharmacol. 77, 554-70
Huang SM, Abernethy DR, Wang Y, Zhao P, Zineh I (2013). The utility of modeling and simulation in drug
development and regulatory review. J Pharm Sci. 102, 2912-23
Zamek-Gliszczynski MJ, Lee CA, Poirier A, Bentz J, Chu X, Ellens H, Ishikawa T, Jamei M, Kalvass JC, Nagar S, Pang
KS, Korzekwa K, Swaan PW, Taub ME, Zhao P, Galetin A (2013). ITC Recommendations for Transporter Kinetic
Parameter Estimation and Translational Modeling of Transport-Mediated PK and DDIs in Humans. Clin Pharmacol
Ther. 94:64-79
Ke AB, Nallani SC, Zhao P, Rostami-Hodjegan A, Isoherranen N, Unadkat JD. (2013) A Physiologically Based
Pharmacokinetic Model to Predict Disposition of CYP2D6 and CYP1A2 Metabolized Drugs in Pregnant Women.
Drug Metab Dispos. 41:801-13
Ke AB, Nallani SC, Zhao P, Rostami-Hodjegan A, Isoherranen N, Unadkat JD. (2012) A PBPK Model to Predict
Disposition of CYP3A-Metabolized Drugs in Pregnant Women: Verification and Discerning the Site of CYP3A
Induction. CPT: Pharmacometrics & Systems Pharmacology 1, Published online 26 September 2012
Zhao P, Rowland M, Huang SM (2012) Best practice in the use of physiologically based pharmacokinetic modeling
and simulation to address clinical pharmacology regulatory questions. Clin Pharmacol Ther. 92:17-20.
Leong R, Vieira ML, Zhao P, Mulugeta Y, Lee CS, Huang SM, Burckart GJ (2012) Regulatory experience with
physiologically based pharmacokinetic modeling for pediatric drug trials. Clin Pharmacol Ther. 91:926-31.
Vieira ML, Zhao P, Berglund EG, Reynolds KS, Zhang L, Lesko LJ, Huang SM (2012) Predicting drug interaction
potential with a physiologically basedpharmacokinetic model: a case study of telithromycin, a time-dependent
CYP3A inhibitor. Clin Pharmacol Ther. 91:700-8
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Ping Zhao, Ph.D.
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Grillo JA, Zhao P, Bullock J, Booth BP, Lu M, Robie-Suh K, Berglund EG, Pang KS, Rahman A, Zhang L, Lesko LJ,
Huang SM (2012) Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively
predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process:
implications for clinical practice. Biopharm Drug Dispos. 33:99-110
Zhao P, Vieira Mde L, Grillo JA, Song P, Wu TC, Zheng JH, Arya V, Berglund EG, Atkinson AJ Jr, Sugiyama Y, Pang
KS, Reynolds KS, Abernethy DR, Zhang L, Lesko LJ, Huang SM (2012). Evaluation of exposure change of nonrenally
eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling
and simulation. J Clin Pharmacol. 52:91S-108S.
Zhang L, Xu N, Xiao S, Arya V, Zhao P, Lesko LJ, Huang SM (2012). Regulatory perspectives on designing
pharmacokinetic studies and optimizing labeling recommendations for patients with chronic kidney disease. J
Clin Pharmacol. 52:79S-90S.
Zhao P, Zhang L, Grillo JA, Liu Q, Bullock J, Moon YJ, Song P, Brar S, Madabushi R, Wu T-C, Booth BP, Rahman NA,
Reynolds KS, Gil Berglund E, Lesko LJ, Huang S-M (2011) Applications of Physiologically-based Pharmacokinetic
(PBPK) Modeling and Simulation During Regulatory Review. Clin Pharmacol Ther. 89:259-67 (Note top 10 cited
article of the journal in 2011)
Duan JZ, Jackson AJ, Zhao P (2011) Bioavailability Considerations in Evaluating Drug-Drug Interactions Using the
Population Pharmacokinetic Approach. J Clin Pharmacol. 51: 1087-1100
Zhang L, Reynolds KS, Zhao P, Huang SM (2010) Drug interactions evaluation: An integrated part of risk
assessment of therapeutics. Toxicol Appl Pharmacol. 243(2):134-45.
Zhao P, Ragueneau-Majlessi I, Zhang L, Strong JM, Reynolds KS, Levy RH, Thummel KE, Huang SM (2009).
Quantitative evaluation of pharmacokinetic inhibition of CYP3A substrates by ketoconazole: a simulation study. J
Clin Pharmacol. 49:351-9.
Zhang L, Zhang YD, Zhao P, Huang SM (2009). Predicting drug-drug interactions: an FDA perspective. AAPS J.
11:300-6.
Bulitta JB, Zhao P, Arnold RD, Kessler DR, Daifuku R, Pratt J, Luciano G, Hanauske AR, Gelderblom H, Awada A,
Jusko WJ (2009) Mechanistic population pharmacokinetics of total and unbound paclitaxel for a new
nanodroplet formulation versus Taxol in cancer patients. Cancer Chemother Pharmacol. 63:1049-63.
Bulitta JB, Zhao P, Arnold RD, Kessler DR, Daifuku R, Pratt J, Luciano G, Hanauske AR, Gelderblom H, Awada A,
Jusko WJ (2009). Multiple-pool cell lifespan models for neutropenia to assess the population pharmacodynamics
of unbound paclitaxel from two formulations in cancer patients. Cancer Chemother Pharmacol.63:1035-48
Zhao P (2008) Review: The utility of hepatocytes in evaluating time-dependent inactivation of P450 in vivo.
Expert Opion Drug Metab Toxicol. 4:151-64.
Bu HZ, Zhao P, Dalvie DK, Pool WF (2007). Identification of primary and sequential bioactivation pathways of
carbamazepine in human liver microsomes using liquid chromatography/tandem mass spectrometry. Rapid
Commun Mass Spectrom. 21:3317-22.
Bu HZ, Zhao P, Kang P, Pool WF, Wu EY, Shetty BV (2007). Evaluation of capravirine as a CYP3A probe substrate:
in vitro and in vivo metabolism of capravirine in rats and dogs. Drug Metab Dispos. 35:1593-602.
Zhao P, Lee CA, Kunze KL. (2007) Sequential metabolism is responsible for diltiazem-induced timedependent loss
of CYP3A. Drug Metab Dispo, 35:704-12.
Bu HZ, Zhao P, Kang P, Pool WF, Wu EY (2006). Identification of enzymes responsible for primary and sequential
oxygenation reactions of capravirine in human liver microsomes. Drug Metab Dispos. 34:1798-802.
Bu HZ, Kang P, Deese AJ, Zhao P, Pool WF (2005). Human in vitro glutathionyl and protein adducts of
carbamazepine-10,11-epoxide, a stable and pharmacologically active metabolite of carbamazepine. Drug Metab
Dispos. 33:1920-4.
Bu HZ, Kang P, Zhao P, Pool WF, Wu EY (2005) A simple sequential incubation method for deconvoluting the
complicated sequential metabolism of capravirine in humans. Drug Metab Dispos. 33: 1438-45.
Zhao P, Kunze KL, Lee CA. (2005) Evaluation of time-dependent CYP3A inactivation in cryopreserved human
hepatocytes. Drug Metab. Dispo .33: 851-63
Zhao P, Slattery JT. (2002) Effects of ethanol dose and ethanol withdrawal on rat liver mitochondrial glutathioneimplication of potentiated acetaminophen toxicity in alcoholics. Drug Metab. Dispo. 30: 1413-1317
Zhao P, Kalhorn TF, Slattery JT. (2002) Selective mitochondrial glutathione depletion by ethanol enhances
acetaminophen toxicity in rat liver. Hepatology 36: 326-335
Zhao P, Dash AK. (1999) A simple HPLC method using a microbore column for the analysis of doxorubicin. J
Pharm Biomed Anal 20:543-8
Saha S, Waugh DJ, Zhao P, Abel PW, Smith DD. (1998) Role of conformational constraints of position 7 of the
disulphide bridge of h-alpha-CGRP derivatives in their agonist versus antagonist properties. J Pept Res 52:112-20
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BOOK CHAPTERS
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Zhao L, Wang D, Zhao P, Shang E, Wang Y, Sinha V (2016) Review: The Critical Role of Clinical Pharmacology in
the Development of Biologics. ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic
Proteins: Applications in Drug Discovery and Development by Zhou H and Theil F, John Wiley & Sons, Hoboken,
NJ, USA
Yeung CK, Zhao P, Shen DD, Thummel KE (2009) Drug Disposition and Drug–Drug Interactions: Importance of
First-Pass Metabolism in Gut and Liver. Enzyme- and Transporter-based Drug-Drug Interactions, by Pang,
Rodrigues, and Raimund, Springer-Verlag New York.
Zhao P, Zhang L, Huang SM (2009) Complex Drug Interactions: Significance and Evaluation. Enzyme- and
Transporter-based Drug-Drug Interactions, by Pang, Rodrigues, and Raimund, Springer-Verlag New York.
Zhao P (2009) Enzyme Inhibition in Various In Vitro Systems. Enzyme Inhibition in Drug Discovery and
Development: The Good and the Bad, by Lu and Li, John Wiley & Sons, Inc.
ORAL PRESENTATIONS AND TEACHING (Underlined are external invitations)
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2016. “Physiologically-based Pharmacokinetic (PBPK) Modeling to Support Decisions in Drug Development” at
Department of Pharmaceutics, University of Florida, Gainsville and Orlando
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2016. Co-chair and presenter at Roundtable: “How Should Simulated DDI Results be Communicated in the
Label?”, ASCPT Annual Meeting, San Diego, CA
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2016. Panelist: FDA CDER Scientific Rounds: “What Happens to Drugs Outside the Body? Dose selection in
children on extracorporeal life support”, Silver Spring, MD
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2015. Chair: Short Course “Maximizing the predictability of PBPK models using top-down approach” 20th North
American ISSX Meeting, Orlando, FL
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2015. “Applications of combining top-down and bottom-up approaches in PBPK models” 20th North American
ISSX Meeting, Orlando, FL
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2015 “From Research to Regulatory Review: Using PBPK Predictions to Support Regulatory Decisions” AAPS
Annual Meeting Orlando, FL
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2015 “Models to Predict PK in Hepatic Insufficiency” AAPS Workshop on Specific Population Drug Dosing
Recommendations: Shifting from Clinical Studies to Predict and Confirm Orlando, FL
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2015. Panelist. Executive Roundtable: “The Value of Modeling in Today’s Drug Development: An Industry and
Regulator’s Perspective” Clinical & Pharmaceutical Solutions through Analysis (CPSA) Shanghai Meeting,
Shanghai, China
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2015. “Current status of using PBPK to support dose selection” CACO Workshop on PBPK modeling, Foster City,
CA
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2015. Panelist. Executive Roundtable: “The Value of Modeling in Today’s Drug Development: An Industry and
Regulator’s Perspective” Clinical & Pharmaceutical Solutions through Analysis (CPSA) Shanghai Meeting,
Shanghai, China
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2014. “Quantitative Predictions and Physiologically Based Pharmacokinetic Modeling of Drug-drug Interactions
Based on Retrospective Literature Data”. 19th JSSX/29th ISSX meeting, San Francisco, CA
2014. Organizer, Ministerial Industry Strategy Group Forum on Physiologically-based Pharmacokinetic (PBPK)
Modelling and Simulation, London, UK
2014. “FDA perspective on PBPK”. 15th International Workshop on Clinical Pharmacology of HIV & Hepatitis
Therapy, Washington DC
2014. Panelist at the workshop “Innovative Approaches to Pediatric Drug Development and Pediatric Medical
Countermeasures: A Role for Physiologically-Based PK?” sponsored by the University of Maryland Center of
Excellence in Regulatory Science and Innovation (M-CERSI) and FDA, Silver Spring, MD
2014. “Learning the Role of Drug Transporters through PBPK Modeling and Simulations” 2014 PKPD Expert
Meeting, Königstein, Germany
2014. Organizer, presenter and panelist at the FDA public workshop on “Application of Physiologically-based
Pharmacokinetic (PBPK) Modeling to Support Dose Selection”: (1) FDA Presentation: Current Status of PBPK
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7
Ping Zhao, Ph.D.
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Applications in Clinical Pharmacology Reviews; (2) Requirement for Regulatory Submissions of PBPK Modeling
and Simulations. Silver Spring, MD
2014. “Perspective on Pediatric Development and Use of PBPK” at ASCPT annual meeting, Atlanta, GA
2013. “Complex DDIs: Maximizing the Use of PBPK Modeling to Support Dosing Recommendations” at AAPS
annual meeting, San Antonio, TX
2013. “Utility of PBPK modeling in assessing DDI risk”. PBSS workshop on drug-drug interactions, Boston, MA
2013. “PBPK Program in the Division of Pharmacometrics”. FDA-PhrMA Spring Roundtable. Silver Spring, MD
2013. “The Use of Physiologically based Pharmacokinetic Modeling and Simulation to Address Clinical
Pharmacology Questions in Regulatory Reviews”. PhUSE Single Day Event in Boston (web-presentation)
2013. Panelist of FDA Office of Clinical Pharmacology Open Forum, ASCPT annual meeting, Indianapolis, IN
2012. “Update of 2012 FDA Draft Guidance on Drug Interactions: Model-based Strategy to Integrate Knowledge
and Quantify Effects”, CACO Workshop on Drug Interactions, Foster City and San Diego, CA
2012. “Predicting Transporter Drug-Drug Interaction Using PBPK: Impact of Variability in In Vitro Data” at AAPS
annual meeting, Chicago, IL
2012. “Model-based Evaluation of Drug Disposition and Drug-drug Interaction Potential of Metabolites” at AAPS
annual meeting, Chicago, IL
2012. “Use of PBPK in Clinical Pharmacology Reviews” at 2nd AIMBE/NIH Summit on Validation and Qualification
of New In Vitro Tools and Models for the Pre-Clinical Drug Discovery Process, Bethesda, MD
2012. “Update of 2012 FDA Draft Guidance on Drug Interactions: Model-based Strategy to Integrate Knowledge
and Quantify Effects” at Land O' Lakes Conference on Drug Metabolism/Applied Pharmacokinetics, Merrimac, WI
2012. “Phase I and Phase II Drug Metabolism, and Drug Transporters Regulatory aspects of PK: Special
populations (renal-hepatic) and drug-drug interactions” at FDA Commissioner’s Fellows 2012 Course:
Introduction to Clinical Pharmacology and Pharmacokinetics. Silver Spring, MD
2012. “Experience in using PBPK models in clinical pharmacology reviews” at AIMBE/NIH Summit on Validation
and Qualification of New In Vitro Tools and Models for the Pre-Clinical Drug Discovery Process, Bethesda, MD
2012. “Regulatory Experience In Physiologically-based Pharmacokinetic (PBPK) Models In Pediatric Submissions”
at FDA CDER Scientific Rounds. Silver Spring, MD
2012. “Application of Physiologically-based Pharmacokinetic Models (PBPK) in Evaluating Intrinsic and Extrinsic
Patient Factors” at Department of Pharmaceutics, University of Florida, Gainsville and Orlando
2012. Co-Chairperson of the “in vitro-in vivo extrapolation symposium” at the 2nd International Transporter
Consortium (ITC) workshop, ASCPT Annual Meeting, National Harbor, MD
2011. Meeting organizer and speaker at FDA-PhrMA IQ Drug-Drug Interaction Prediction Workshop. (1).
Introduction: Model-based DDI prediction and evaluation; (2). Assessing modeling and simulation tools and
methods for predicting metabolic-based DDI. Silver Spring, MD
2011. Assessing modeling and simulation tools and methods for predicting metabolic-based DDI. FDA-PhrMA IQ
Drug-Drug Interaction Prediction Workshop, Silver Spring, MD
2011. Assessing Multiple Patient Factors on Drug Exposure Using PBPK. Delaware Valley Drug Metabolism
Discussion Group, PA
2011. Application of PBPK Modeling and Simulations in Regulatory Reviews of Clinical Pharmacology Issues.
Asian-Pacific ISSX Meeting, Tainan, Taiwan
2011. Scientific perspectives on the utility of PBPK to evaluate multiple patient factors. PK-PD Expert Meeting,
Heppenheim, Germany
2011. Chairperson of Symposium “Drug Dosing in Patients with Hepatic Impairment”, ASCPT Annual Meeting,
Dallas, TX
2011. Co-Chairperson of workshop “Regulatory Guidance on Drug-Drug Interactions: Comparing Draft
Guideline/Guidance Documents by EMA and FDA”, ASCPT Annual Meeting, Dallas, TX
2010. Scientific Perspectives on the use of PBPK to evaluate complex drug-drug interactions. PSWC/AAPS Annual
meeting, New Orleans, LA
2010. Current scientific perspectives on the use of PBPK to predict clinical drug-drug interactions. Applied
Pharmaceutical Analysis Annual Meeting by Boston Society,. Baltimore, MD
2010. Application of PBPK in Clinical Pharmacology Reviews. American Course on Drug Development and
Regulatory Sciences. Washington DC
2010. Model-based Predictions of drug-drug interactions. FDA-PhrMA Spring Roundtable. Silver Spring, MD
2010. Predicting Drug-Drug Interactions Using Physiologically-based Pharmacokinetic Modeling and Simulation.
Walter Reed Army Institute Clinical Pharmacology Lecture Series. Silver Spring, MD
2010. Utility of PBPK in Optimizing Design of Drug Interaction Studies. American Course on Drug Development
and Regulatory Sciences. San Francisco, CA
8
Ping Zhao, Ph.D.
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2010. Evaluating Complex DDI Using Modeling and Simulations: Application and Challenge in Regulatory Review.
Thomas Jefferson University Clinical Pharmacology and Experimental Therapeutics Seminar Series. Philadelphia,
PA
2009. Evaluating Complex DDI Using Modeling and Simulations: Application and Challenge in Regulatory Review.
12th Land O’ Lakes Conference on Drug Metabolism and Applied Pharmacokinetics, Merrimac, WI
2009. Use of Software-based Predictions for Drug Interaction Studies. FDA-PhrMA Spring Roundtable. Rockville,
MD
2009. Evaluation of single dose ketoconazole to obtain maximal CYP3A inhibition. ASCPT annual meeting,
Washington DC
2009. Tutor of OCP group. Hands-on Workshop on IVIVE. Washington DC
2009. Use of PBPK: Design of Drug Interaction Studies and Investigation of Special Populations. PBPK Modeling in
Drug Development and Evaluation Workshop, Alexandria, VA
2008. Introduction to Office of Clinical Pharmacology at CDER, FDA. 2008 OCP ambassador program, University
of Washington, Seattle, WA
2007. Prediction of Time-dependent Inactivation of CYP3A in Hepatocytes: Evaluation of the Use of
Microsomal Parameters to Predict Pharmacokinetic Drug Interactions. 10th International DDI Conference.
Bellevue, WA
2005. PDM Development and Drug Interactions. Pfizer PDM Workshop. San Diego, CA.
2004, 2005. Basic PK Principles. Pfizer Medicinal Chemistry Workshops. Temecula, CA.
2002. Selective Mitochondrial Glutathione Depletion by Chronic Ethanol Consumption Enhances
Acetaminophen Hepatotoxicity. AAPS/Eli Lilly Award Graduate Symposium, Toronto, Canada.
POSTER PRESENTATIONS
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Shord SS, Zhao P, Zhao L, Zhao H, Casey D, Demko S, Keegan P, Booth B, Rahman NA (2016) Labeling
recommendations based on exposure-response relationships to minimize musculoskeletal related adverse
reactions of a Hedgehog inhibitor. ASCO Annual Meeting
Sato M, Liu Q, Yoshida K, Li L, Rekic D, Reynolds K, Zhang L, Huang SM, Sinha V, Zhao P (2015) Evaluation of drug
interaction potential of CYP3A substrates—A tailored approach based on fm,CYP3A. ISSX North America Annual
Meeting, Orlando, FL
Wagner C, Zhao P, Arya V, Mullick C, Struble K, Au S (2015) Predicting the Effect of Intrinsic and Extrinsic Factors
on the Exposure of Antiretroviral Medications. ACCP Annual Meeting, San Francisco, CA (See Table 2)
Yoshida K, Sun B, Zhao P, Zhang L, Huang SM (2015) Greater Reduction of CYP2D6 Activities than CYP3A Activities
in Subjects with Renal Impairment. ACCP Annual Meeting, San Francisco, CA
Wagner C, Zhao P, Arya V, Mullick C, Struble K, Au S (2015) Development of Lopinavir and Darunavir
Physiologically-Based Pharmacokinetic Models Incorporating the Pharmacokinetic Effects of Ritonavir. 16th
HIV/HCV Clinical Pharmacology Workshop, Alexandra, VA
Wagner C, Pan Y, Hsu V, Sinha V, Zhao P (2015) Predictive Performance of Physiologically Based Pharmacokinetic
(PBPK) Models for the Effect of CYP3A Inducers on Substrate Drugs: Analysis of Submissions to the FDA. ASCPT
Annual Meeting, New Orleans, LA (See Table 2)
Duan P, Zhao P, Zhang L (2015) Physiologically-based pharmacokinetic modeling (PBPK) of pitavastatin and
atorvastatin to predict drug-drug interactions (DDIS). ASCPT Annual Meeting, New Orleans, LA (See Table 2)
Yoshida K, Yeung C, Kusama M, Zhang H, Ragueneau-Majlessi I, Argon S, Zhao P, Zhao L, Zineh I, Sugiyama Y,
Huang SM. Analysis of the Effect of Various Degrees of Renal Impairment on the Pharmacokinetics of Nonrenally
Eliminated Drugs. ASCPT Annual Meeting, New Orleans, LA
Yeung C, Kusama M, Zhang H, Ragueneau-Majlessi I, Argon S, Li L, Chang P, Zhao P, Zhang L, Yoshida K, Zineh I,
Sugiyama Y, Huang SM (2014) Assessment of the Impact of Renal or Hepatic Impairment vs Pharmacologic
Inhibition On Systemic Exposure of Drugs. ISSX Annual Meeting, San Francisco, CA
Zheng S, Snoeys J, Schmidt S Lesko LJ, Zhao, P (2014) Inhibitor Models in Predicting Drug-drug interactions Using
PBPK: A Case Study with Fluvoxamine. ASCPT Annual Meeting, Atlanta, GA
Jiang X, Zhao P, Barrett JS, Lesko LJ, Schmidt S (2014) Applications of Physiologically Based Pharmacokinetic
(PBPK) Model in Predicting acetaminophen Metabolism and Pharmacokinetics in Children; ASCPT Annual
Meeting, Atlanta, GA (See Table 2)
Pan Y, Grillo J, Hsu V, Zhang L, Sinha V, Huang SM, Zhao P. (2014) Application of the FDA PBPK Knowledgebase in
Evaluating Model Predictability for Drug-drug Interactions. ASCPT Annual Meeting, Atlanta, GA (See Table 2)
Kim N, Li L, Kim M, Davis D, Huang, S.-M., Zhao L, Zhao P., Soule L, Willett G, Yu C (2014)
9
Ping Zhao, Ph.D.
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Pharmacokinetic and Pharmacodynamic Assessments for Hormonal Contraceptive Drug-drug Interactions. ASCPT
Annual Meeting, Atlanta, GA
Lin L, Chen E.C., Hsu V, Zhao P, Zhang L, Huang SM, Giacomini KM (2014) Mechanisms of Neuraminidase Inhibitor
Transport Across the Blood-Brain Barrier. ASCPT Annual Meeting, Atlanta, GA
Hsu V, Vieira MdeL, Zhao P, Zhang L, Zheng J, Nordmark A, Gil Berglund E, Giacomini KM, Huang SM (2014) PBPK
Models of Renally Eliminated Drugs and Their Application in Evaluating the Effect of Patient Factors. ASCPT
Annual Meeting, Atlanta, GA (See Table 2)
Hsu V, Grillo JA, Pan Y, Zhao P, Bullock J (2014) Evaluating the Effect of Subject Demographics on Rivaroxaban
Exposure Using PBPK Modeling. ASCPT Annual Meeting, Atlanta, GA
Wu F, Zhao P, Lee SH (2013) Predicting Nonlinear Pharmacokinetics of Omeprazole Enantiomers and Racemic
Drug Using Physiologically Based Pharmacokinetic Modeling and Simulation. ASCPT Annual Meeting, Indianapolis,
IN
Jiang X, Zhao P, Lesko LJ, Schmidt S (2013) Application of Physiologically-Based Pharmacokinetic (PBPK) Model in
Predicting Drug Metabolism and Pharmacokinetics in Pediatric Populations – A Case Study of Acetaminophen.
ASCPT Annual Meeting, Indianapolis, IN (See Table 2)
Ke A, Nallani S, Zhao P, Rostami-Hodjegan A, Unadkat JD (2012) Using PBPK Model to Gain Insight into Changes
in Disposition of CYP3A-metabolized Drugs in Pregnant Women: Discerning CYP3A Induction Associated with Gut
vs Liver Metabolism. ASCPT Annual Meeting, National Harbor, MD
Vieira MLT, Zhao P, Kim MJ, Apparaju S, Huang SM (2012) Predicting CYP3A4 Inhibition in CYP2D6 Poor
Metabolizers using PBPK Modeling and Simulation: Fesoterodine as an Example. ASCPT Annual Meeting,
National Harbor, MD
Vieira MLT, Kirby B, Ragueneau-Majlessi I, Chien JY, Fischer V, Fretland A, Galetin A, Grime K, Hall S, Plowchalk
DR, Riley R, Seibert E, Skordos K, Snoeys J, Venkatakrishnan K, Einolf H, Obach S, Zhang L, Zhao P, Reynolds KS,
Gil Berglund E, Huang SM (2012) Evaluation of FDA and EMA Models’ Cut-off Values for CYP3A Inhibition
Prediction: A Collaborative Effort among Academic, Regulatory Agencies, and Innovation and Quality
Consortium (IQC) Pharmaceutical Scientists. ASCPT Annual Meeting, National Harbor, MD (See Table 2)
Vieira MLT, Zhao P, Huang SM (2011) Predicting Drug Interaction Potential of Telithromycin Using a
Physiologically-based Pharmacokinetic (PBPK) Model that Incorporates Time-dependent Enzyme Inhibition
Mechanism Derived from Nonlinear Pharmacokinetics. AAPS Annual Meeting, Washington DC.
Ke A, Nallani S, Zhao P, Rostami-Hodjegan A, Unadkat JD (2011) Refinement and Validation of a PBPK Model to
Predict Disposition of Drugs in Pregnant Women Cleared via CYP1A2 and CYP3A Metabolism. AAPS Annual
Meeting, Washington DC (See Table 2)
Tompkins LT, Zhao P, Zhang L, Huang SM (2011). Differential Effects of Hepatic Insufficiency on Sensitive CYP
Substrates. ASCPT Annual Meeting, Dallas, TX
Vieira MLT, Zhao P, Huang SM (2011). Construction of a PBPK model by integrating drug distribution, metabolism
and transport data to understand the effect of multiple patient factors on drug exposure-telithromycin as an
example. AAPS Transporter Workshop, Bethesda, MD
Zhao P, Zhang L, Lesko LJ, Huang SM (2010) Utility of Physiologically-based Pharmacokinetic Modeling and
Simulation in Drug Development and Challenges in Regulatory Reviews. ASCPT Annual Meeting, Atlanta, GA
Zhao P, Grillo JA, Booth BP, Rahman NA, Zhang L, Gil Berglund E, Lesko LJ, Huang SM (2010) Late Breaking
Abstract - Utility of Integrating Prior Drug Disposition Data into a PBPK Model to Evaluate a Complex Drug-drug
Interaction: CYP/Transporter Inhibition by Ketoconazole in Subjects with Renal Impairments (RI) Taking
Rivaroxaban. ASCPT Annual Meeting, Atlanta, GA
Zhao P, Zhang L, Lesko LJ, Huang SM (2009) Utility of Physiologically-based Pharmacokinetic Modeling and
Simulation in Drug Development and Challenges in Regulatory Reviews. OCP Science Day, Shady Grove, MD
Zhao P, Grillo JA, Booth BP, Rahman NA, Zhang L, Huang SM (2009) PBPK modeling and simulation of systemic
exposure changes of Drug-X under multiple-impairment (concomitant CYP inhibition and renal impairment). OCP
Science Day, Shady Grove, MD
Zhao P, Grillo J, Liu Q, Booth B, Rahman NA, Huang SM (2008) Analysis of a SIMCYP-Based Submission to Justify
Waiving a CYP2C9-Mediated In Vivo Drug Interaction Study. OCP Science Day, Shady Grove, MD
Zhao P, Lee CA, Kunze KL. (2007) Sequential metabolism is responsible for diltiazem-induced timedependent loss
of CYP3A. ISSX meeting, Sendai, Japan
Zhao P, Klocke J, Daifuku R, Kessler D (2007) Development of a robust LC-MS/MS method for 5fluorouracil to study the sequential metabolism of capecitabine. ISSX meeting, Sendai, Japan
Bu HZ, Zhao P, Kang P, Pool WF, Wu EY, Shetty BV (2007) Evaluation of capravirine as a CYP3A probe
substrate: in vitro and in vivo metabolism of capravirine in rats and dogs. ISSX meeting, Sendai, Japan
10
Ping Zhao, Ph.D.
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Bu H-Z, Dalvie DK, Pool WF, Zhao P. (2006) Identification of comprehensive bioactivation pathways of
carbamazepine in human liver microsomes. ISSX Meeting, Rio Grande, Puerto Rico
Zhao P, Klocke J, Kessler D (2006) Evaluation of in vitro metabolism and distribution of CPT-11 and
SN2310: implication of species differences in pharmacokinetics of SN-38. AP ISSX Meeting, Jeju, S.
Korea
Bu H-Z, Kang P, Deese AJ, Zhao P, Pool WF (2005) Identification of bioactivation pathways of
carbamazepine in human liver microsomes. ISSX Meeting, Maui, HI
Zhao P, Kunze KL, Lee C. (2004) Evaluation of time-dependent CYP3A inactivation in cryopreserved
human hepatocytes. Gordon Conference, Plymoth, NH; and ISSX Meeting, Vancouver BC, Canada
Bu H-Z, Kang P, Zhao P, Pool WF. (2004) Sequence, reactivity, and phenotyping of multiple sequential
oxygenation pathways of capravirine in humans. ISSX Meeting, Vancouver BC, Canada
Zhao P, Lalovic B, Ferrero JL, Zhong W-Z. (2004) In vitro-in vivo extrapolation of metabolic clearance
kinetic modeling of substrate disappearance; Smith EB, Zhao P, Chai P, Ferrero JL. (2004) Preclinical
evaluation of delavirdine as a pharmacokinetic modulator of compound A; and Chai P, Zhao P, Lalovic
B, Smith EB, Ferrero JL. (2004) Feasibility of a microdosing study as FIH for compound B – preclinical
evaluation of dose-dependent pharmacokinetics. Pfizer PDM Symposium. Del Mar, CA
Zhao P, Slattery JT. (2002) Selective Mitochondrial Glutathione Depletion by Chronic Ethanol
Consumption Enhances Acetaminophen Hepatotoxicity. AAPS, Toronto, Canada
Zhao P, Slattery JT. (2002) Effects of ethanol dose and ethanol withdrawal on liver mitochondrial
glutathione-implication of enhanced acetaminophen toxicity in alcoholics. ISSX Meeting, Orlando, FL
Zhao P, Slattery JT. (2001) Chronic Ethanol Enhances Acetaminophen (APAP) Toxicity by Selectively
Depleting Mitochondrial GSH and Inducing CYP2E1. ISSX Meeting, Munich, Germany
Zhao P, Slattery JT. (2000) Mitochondrial Specific Glutathione Depletion by Chronic Alcohol
Potentiates NAPQI toxicity. ISSX Meeting, Indianapolis, IN
Zhao P, Dash AK. (1998) An implantable drug delivery system for targeted local delivery of anticancer
drug. 30th Pharmaceutics Graduate Student Research Meeting, Lawrence, KS.
TRAININGS
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2015 FDA Emerging Leaders Program (Apr-Sep, 2015)
2015 SimCYP focused workshops on oral absorption and cardiac safety simulation at the FDA. Silver
Spring, MD
2015 Quantitative Systems Pharmacology: Multiscale Model-Based Drug Development Through
Integrating Systems Biology and Pharmacometrics, ASCPT preconference, New Orleans, LA
2014 Bayer Technologies PK-Sim and MoBi onsite training at the FDA. Silver Spring, MD
2014 Current Considerations in the Clinical Pharmacology of Biologics, ASCPT preconference, Atlanta,
MD
2011 Matlab and Statistic Toolbox training, Silver Spring, MD
2010 Pharsight Phoenix training, Silver Spring, MD
2010 FDA/DER COTR training, Silver Spring, MD
2008-2009 New Course of Clinical Pharmacology for Regulatory Scientists, Silver Spring, MD
2009 DAARTs Training, Silver Spring, MD
2009 DIA workshop on bio-comparablility. Crystal City, MD
2008 DIA workshop on drug transporters. Rockville, MD
2008 PKPD modeling and simulations using SAAMII. Bethesda, MD
2008 Advanced PKPD modeling. Silver Spring, MD
2008 SimCYP training. Silver Spring, MD
2007 Advanced Methods of PK/PD Systems Analysis. BMSR, Marina del Rey, CA
2006 Application of PK/PD mechanistic models in drug development; Drug candidate rescue: selective
optimization of ADMET deficiencies. ISSX meeting, Rio Grande, PR
2006 GLP and 21 CFR part 11 online training, Biotech Learning Institute
11
Ping Zhao, Ph.D.
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2005 Clinical pharmacokinetics and pharmacodynamics bridging. ISSX meeting, Maui, HI
2005 Pfizer NONMEM class, Pfizer Inc., Ann Arbor, MI
2004 Investigator Brochure (IB) training, Pfizer Inc., San Diego, CA
2004 Metabonomics and toxicogenomics. ISSX meeting, Vancouver, BC, Canada
2004 Dr. Jusko Pharmacodynamics workshop at Pfizer Inc., San Diego, CA
2004 Drug transporter workshop, Pfizer Inc., San Diego, CA
2003 Xenobiotic-Induced Hepatotoxicity. ISSX meeting, Providence, RI
2003 Enzyme Kinetics and Allosterism in Drug Metabolism. ISSX meeting, Providence, RI
2003 Biotrasformation Workshop, Pfizer Inc., San Diego, CA
2002 Watson/LIMS training, San Diego, CA
12