EDUCATING LEADERS IN PHARMACY AND PHARMACEUTICAL SCIENCES SINCE 1886
Dhaval K. Shah PhD
Dhaval K. Shah
PhD
Education and Training:
- PhD, University at Buffalo School of Pharmacy and Pharmaceutical Sciences (2010)
- MS, National Institute of Pharmaceutical Education and Reserach (2003)
- BPharm, Gujarat University (2002)
Employment:
- Principle Scientist, Translational Research, PK/PD Modeling and Simulation, Pfizer Inc. (2013)
- Senior Scientist, Translational Research, PK/PD Modeling and Simulation, Pfizer Inc. (2010–2013)
Awards and Honors:
- UB Exceptional Scholar: 2016 Young Investigator Award (2016)
- Outstanding Manuscript in Modeling and Simulation Award - 2014 AAPS annual meeting (2014)
- Individual Performance Awards (2013)
- 2010 AAPS Graduate Student Symposium Award in PPDM and CPTR (2010)
- Who’s Who Among Students in American Universities and Colleges (2009)
- Graduate Scholar Award (2009)
- AAPS Outstanding Manuscript in Modeling and Simulation Award (2009)
- First Prize outstanding podium presentation (2009)
- Best poster and presentation award (2009)
- Cover page of Journal of PKPD
Grants and Sponsored Research:
- May 2015–March 2020
Translational Systems Pharmacokinetic Models of Novel Anticancer Biologics
NIGMS-NIH
Role: Principal Investigator
$1,500,000 - July 2018–December 2019
University at Buffalo School of Pharmacy and Pharmaceutical Sciences Seed Grant Program
University at Buffalo School of Pharmacy and Pharmaceutical Sciences
Role: Co-Investigator
$10,000 - August 2017–July 2018
Center for Protein Therapeutics
UBSPPS
Role: Principal Investigator
$100,000 - August 2017–July 2018
Center for Protein Therapeutics
UBSPPS
Role: Principal Investigator
$100,000 - July 2017–June 2018
Oncolinx Post-Doctoral Fellowship
UBSPPS
Role: Principal Investigator
$87,150 - August 2016–July 2017
Center for Protein Therapeutics
Role: Principal Investigator
$100,000 - August 2015–July 2016
Center for Protein Therapeutics
UBSPPS
Role: Principal Investigator
$100,000 - July 2014–June 2016
Roche Pharmaceutical Post-Doctoral Fellowship
UBSPPS
Role: Principal Investigator
$272,840
Journal Articles:
- Kay K, Dolcy K, Bies R, Shah DK, Bies RR. Estimation of Solid Tumor Doubling Times from Progression-Free Survival Plots Using a Novel Statistical Approach. AAPS J. 2019; 21(2).
- Kay K, Shah DK, Rohan L, Bies R, Bies RR. Physiologically-based pharmacokinetic model of vaginally administered dapivirine ring and film formulations. Br J Clin Pharmacol. 2018; 84(9).
- Singh AP, Shah DK. Measurement and Mathematical Characterization of Cell-Level Pharmacokinetics of Antibody-Drug Conjugates: A Case Study with Trastuzumab-vc-MMAE. Drug Metab Dispos. 2017; 45(11).
- Khot A, Tibbitts J, Rock D, Shah DK. Development of a Translational Physiologically Based Pharmacokinetic Model for Antibody-Drug Conjugates: a Case Study with T-DM1. AAPS J. 2017; 19(6).
- Li Z, Krippendorff BF, Shah DK. Influence of Molecular size on the clearance of antibody fragments. Pharm Res. 2017; 34(10).
- Singh AP, Shah DK. Application of a PK-PD Modeling and Simulation-Based Strategy for Clinical Translation of Antibody-Drug Conjugates: a Case Study with Trastuzumab Emtansine (T-DM1). AAPS J. 2017; 19(4).
- Shah DK. Quantitative systems toxicology. Current Opinion in Toxicology. 2017; 4.
- Singh AP, Sharma S, Shah DK. Quantitative characterization of in vitro bystander effect of antibody-drug conjugates. J Pharmacokinet Pharmacodyn. 2016; 43(6).
- Seigel GM, Sharma S, Hackam AS, Shah DK. HER2/ERBB2 immunoreactivity in human retinoblastoma. Tumour Biol. 2016; 37(5).
- Singh AP, Maass KF, Betts AM, Wittrup KD, Kulkarni C, King LE, Khot A, Shah DK. Evolution of Antibody-Drug Conjugate Tumor Disposition Model to Predict Preclinical Tumor Pharmacokinetics of Trastuzumab-Emtansine (T-DM1). AAPS J. 2016; 18(4).
- Li Z, Krippendorff BF, Sharma S, Walz AC, Lavé T, Shah DK. Influence of molecular size on tissue distribution of antibody fragments. MAbs. 2015; 8(1).
- Shah DK. Pharmacokinetic and pharmacodynamic considerations for the next generation protein therapeutics. J Pharmacokinet Pharmacodyn. 2015; 42(5).
- Khot A, Sharma S, Shah DK. Integration of bioanalytical measurements using PK-PD modeling and simulation: implications for antibody-drug conjugate development. Bioanalysis. 2015; 7(13).
- Singh AP, Shin YG, Shah DK. Application of Pharmacokinetic-Pharmacodynamic Modeling and Simulation for Antibody-Drug Conjugate Development. Pharm Res. 2015.
- Leal M, Sapra P, Hurvitz SA, Senter P, Wahl A, Schutten M, Shah DK, Haddish-Berhane N, Kabbarah O. Antibody-drug conjugates: an emerging modality for the treatment of cancer. Ann N Y Acad Sci. 2014; 1321.
- Shah DK, King LE, Han X, Wentland JA, Zhang Y, Lucas J, Haddish-Berhane N, Betts A, Leal M. A priori prediction of tumor payload concentrations: preclinical case study with an auristatin-based anti-5T4 antibody-drug conjugate. AAPS J. 2014; 16(3).
- 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).
- 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).
- Klinguer-Hamour C, Strop P, Shah DK, Ducry L, Xu A, Beck A. World Antibody-Drug Conjugate Summit, October 15-16, 2013, San Francisco, CA. MAbs. 2014; 6(1).
- Haddish-Berhane N, Shah DK, Ma D, Leal M, Gerber HP, Sapra P, Barton HA, Betts AM. On translation of antibody drug conjugates efficacy from mouse experimental tumors to the clinic: a PK/PD approach. J Pharmacokinet Pharmacodyn. 2013; 40(5).
- Shah DK, Betts AM. Antibody biodistribution coefficients: inferring tissue concentrations of monoclonal antibodies based on the plasma concentrations in several preclinical species and human. MAbs. 2013; 5(2).
- Shah DK, Haddish-Berhane N, Betts A. Bench to bedside translation of antibody drug conjugates using a multiscale mechanistic PK/PD model: a case study with brentuximab-vedotin. J Pharmacokinet Pharmacodyn. 2012; 39(6).
- Parekh JM, Shah DK, Sanyal M, Yadav M, Shrivastav PS. Development of an SPE-LC-MS/MS method for simultaneous quantification of bosentan and its active metabolite hydroxybosentan in human plasma to support a bioequivalence study. J Pharm Biomed Anal. 2012; 70.
- Shah DK, Betts AM. Towards a platform PBPK model to characterize the plasma and tissue disposition of monoclonal antibodies in preclinical species and human. J Pharmacokinet Pharmacodyn. 2012; 39(1).
- Shah DK, Khandavilli S, Panchagnula R. Alteration of skin hydration and its barrier function by vehicle and permeation enhancers: a study using TGA, FTIR, TEWL and drug permeation as markers. Methods Find Exp Clin Pharmacol. 2008; 30(7).
Professional Memberships:
- PK/PD of Novel Biological Construct; Advisory board member (2013–present)
- Bioanalytical Method & Modeling Integration Summit; Advisory board member (2013–present)
- The 3rd Pharmacokinetics & Pharmacodynamics; Advisory board member (2012–present)
- Global PK/PD Network at Pfizer Inc; • Chair (2011–present)
- The Dean’s Student Ambassador (2008–2010)
- UB-Pharmaceutics Graduate Student Association; President & Vice President (2007–2008)
- American Association of Pharmaceutical Scientists; Member (2004–present)
Presentations:
- "Development of Translational PK Model for Characterizing and Predicting Protein Therapeutics Disposition in Brain" The National Academies of Sciences, Engineering, and Medicine’s Forum on Neuroscience and Nervous System Disorders. (2017)
- "Quantitative Characterization of the Bystander Effect of ADCs." 7th World ADC Summit (2017)
- "Bench-to-bedside translation of ADCs using PKPD M&S" World Conference on Pharmacometrics (WCOP) (2016)
- "Model-based Drug Development of Protein Therapeutics" 11th International International Society for the Study of Xenobiotics (ISSX) Meeting (2016)
- "Platform PBPK Model for Biologics and Its Evolution Towards Pediatric Population" Gordon Research Conference on Drug Metabolism (2015)
- "Model Based Development of Antibody Drug Conjugates" Clinical & Pharmaceutical Solutions through Analysis Conference 2014 (2014)
- "Quantitative PKPD Approaches to Guide the Discovery and Development of ADCs" , Green Cross Pharmaceuticals (2014)
- "Preclinical to Clinical Translation of Antibody Drug Conjugate (ADC) Efficacy using PK/PD Modeling and Simulation" 2013 AAPS Webinar Series, CPTR (2013)
- "Development and Validation of a Mechanism Based PK/PD Model for Preclinical to Clinical Translation of ADC Efficacy" PK/PD of Antibody-Derived Molecules: Improving Pre-Clinical Results for Clinical Success, PEGS Inaugural (2013)
- "Development and Validation of the multi-scaled mechanistic PK/PD model for ADCs" PK/PD of Novel Constructs Conference, Cambridge Healthtech Institute (2013)
- "Employing PK/PD modeling and simulation to guide ADC development" 2013 World ADC Summit (2013)
- "Evolving PBPK Modeling to Predict the PK and Appropriate Doses of Biotherapeutics for Pediatric Patients" 2013 AAPS NBC Meeting (2013)
- "Novel Applications of PBPK Models" PK/PD summit (2013)
- "Overcoming PK/PD barriers to link drug levels with the biological effects in a tumor" 2013 Tumor Model Conference (2013)
- "A platform PBPK model to characterize the plasma and tissue disposition of mAbs" The 2012 Rozman Symposium, The Delaware Valley DRUG METABOLISM DISCUSSION GROUP (2012)
- "Bench to Bedside Translation of Antibody Drug Conjugates Using a Multiscale Mechanistic PK/PD Model: A Case Study with SGN-35" 2012 World-Wide Webinars: Impact of Modeling and Simulation in Drug Development., ROSA‘s (2012)
- "Preclinical-to-clinical translation of ADC efficacy using the multi-scaled mechanistic PK/PD model" 3rd Pharmacokinetics & Pharmacodynamics Conference, GTC (2012)
- "Using Mechanistic Preclinical PK/PD Studies to Inform Dose, Dose Regimen Selection and Beyond: Can we make Preclinical Models more Predictive?." World ADC Summit (2012)
- "Mechanistic Modeling for Rational Selection of Clinical Doses for Biologics" , AAPS (2011)
- "Treating ovarian cancer using combination of anti-angiogenic therapy and intraperitoneal chemotherapy" , AAPS (2010)
- "Use of an anti-vascular endothelial growth factor antibody in a pharmacokinetic strategy to increase the efficacy of intraperitoneal chemotherapy" , University at Buffalo, Pharmaceutical Sciences (2009)
- "A Pharmacokinetic Strategy to Increase the Efficacy of Intraperitoneal Chemotherapy" PGSRM (2009)
- "Application of anti-angiogenic therapy to improve drug penetration in solid tumors, following regional chemotherapy" UB/Pfizer monoclonal antibody videoconference (2007)
- "The role of dehydration and transepidermal water loss in skin barriers function" (2003)