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`Quinney, Sara Kay
`Assistant Professor
`Department of OB/GYN
`Indiana University School of Medicine
`Indianapolis, IN
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`EDUCATION:
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`Doctor of Pharmacy (Pharm.D.)
`Purdue University, West Lafayette, Indiana
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`Ph.D. in Pharmacy Practice
`Purdue University, School of Pharmacy, West Lafayette, IN
`Advisors: Daryl J Murry, Pharm.D.; William Bosron, Ph.D.
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`FURTHER EDUCATION:
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`Postdoctoral Fellowship, Clinical Pharmacology
`Indiana University Division of Clinical Pharmacology
`Mentor: Stephen Hall, Ph.D.
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`Postdoctoral Fellowship, Bioinformatics & Biostatistics
`Indiana University, Department of Biostatistics
`Mentor: Lang Li, Ph.D.
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`May, 2000
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`August, 2004
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`2004-2007
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`2007-2009
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`2009-2013
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`2011-present
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`2013-present
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`2013-present
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`2013-present
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`2015-present
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`APPOINTMENTS:
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`Assistant Research Professor
`Department of Obstetrics and Gynecology
`Indiana University School of Medicine
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`Indiana Institute of Personalized Medicine
`Indiana University School of Medicine
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`Assistant Professor
`Department of Obstetrics and Gynecology
`Indiana University School of Medicine
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`Assistant Professor
`Division of Clinical Pharmacology, Department of Medicine
`Indiana University School of Medicine
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`Center for Computational Biology and Bioinformatics
`Indiana University School of Medicine
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`Associate Director
`Indiana CTSI Disease and Therapeutic Modeling Program
`Indiana University School of Medicine
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

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`Sara Quinney, PharmD, PhD
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`2015-present
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`2000-present
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`Associate Member
`Indiana University Melvin and Bren Simon Cancer Center
`Indiana University School of Medicine
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`LICENSURE, CERTIFICATION, SPECIALTY BOARD STATUS:
`Indiana Pharmacist
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`License Number: 26020156A
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`PROFESSIONAL ORGANIZATION MEMBERSHIPS:
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`2000-2006
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`American Pharmaceutical Association (APhA)
`2005-2006; 2013
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`International Society for the Study of Xenobiotics (ISSX)
`2004-present
`American Society for Clinical Pharmacology and Therapeutics (ASCPT)
`Special Populations Community (Translational and Precision Medicine Network)
`Pharmacometrics & Pharmacokinetics Community (Quantitative Pharmacology Network)
`Systems Pharmacology Community (Quantitative Pharmacology Network)
`Translational Informatics (Quantitative Pharmacology Network)
`American Society of Pharmacometrics (ASOP)
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`2011-2012
`International Society of Pharmacometrics (ISOP; formerly ASOP)
`2012-present
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`Quantitative Systems Pharmacology Special Interest Group
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`PROFESSIONAL DEVELOPMENT:
`5th Annual Summer Institute in Maternal-Fetal Pharmacology (SI - Pharmacology)
`Title:
`Sponsor:
`Canadian Institutes of Health Research - Institute of Human Development, Child and
`Youth Health (CIHR-IHDCYH) and the National Institute of Child Health and Human
`Development (NICHD) of the National Institutes of Health
`7/12-17/2009
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`Date:
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`Scientific Writing from the Readers Perspective
`Indiana University School of Medicine
`8/2009
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`Write Winning Grants
`Indiana University School of Medicine
`9/21/2010
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`Hands-on Experience with Model-based drug development: Incorporating population
`variability into mechanistic prediction of PK and modeling PK-PD
`Simcyp
`10/11-15/2010
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`Teaching Skills in International Research Ethics (TaSkRIII)
`Indiana University School of Medicine
`April 12-14, 2011
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`Facilitating Pediatric Research with Modeling and Simulation
`2
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

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`Sara Quinney, PharmD, PhD
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`The Children’s Hospital of Philadelphia
`4/23-25/2012
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`Leadership in Academic Medicine Program (LAMP)
`Indiana University School of Medicine
`8/2012 – 5/2013
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`Women in Medicine and Science Conference: Your Map, Your Goals
`Indiana University School of Medicine
`10/2/ 2012
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`Hands-on Experience with Model-based Drug Development: Incorporating population
`variability into mechanistic prediction of PK and modeling PK-PD
`Simcyp/Certera
`10/29/2012 – 11/2/2012
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`R for Pharmacometrics
`Metrum Research Institute, Online Course
`2/2013-6/ 2013
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`Introduction to Research Ethics
`Indiana University School of Medicine
`8/2013 – 12/ 2013
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`Simcyp focused workshop: Best Practice in PBPK Model Building
`Simcyp/Certera
`8/14/2016 – 8/15/2016
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`Simcyp focused workshop: Discovery
`Simcyp/Certera
`8/16/2016 – 8/17/2016
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`Getting started with Bayesian PKPD modeling using STAN
`Metrum Research Group at ACoP7
`10/23/2016
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`Simcyp focused workshop: Biologics
`Simcyp/Certera
`3/18/2019-3/19/2019
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`Simcyp focused workshop: Transporters
`Simcyp/Certera
`3/20/2019-3/21/2019
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

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`Sara Quinney, PharmD, PhD
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`TEACHING:
`TEACHING ASSIGNMENTS;
`UNDERGRADUATE
`Pharmacology for Physical Therapists
`Course:
`AHLTP570
`Role:
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`Lecturer; Provided 2 didactic lectures
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`Term:
`Summer, 2004
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`GRADUATE
`Course:
`Role:
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`Term:
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`Enrollment:
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`Foundation of Clinical Therapeutics
`93M1710
`Small Group Discussion Facilitator
`March, 2006
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`Foundation of Clinical Therapeutics
`93M1710
`Small Group Discussion Facilitator
`March, 2010
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`Foundation of Clinical Therapeutics
`93M1710
`Small Group Discussion Facilitator
`March, 2011
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`Foundation of Clinical Therapeutics
`93M1710
`Small Group Discussion Facilitator
`March, 2013
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`Foundation of Clinical Therapeutics
`93M1710
`Small Group Discussion Facilitator
`March, 2017
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` Bios598 Nonlinear Mixed Effects Models
`Co-Director
`Fall, 2009
`10
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`G747 Principles of Clinical Pharmacology
`Lecturer on basic pharmacokinetic concepts
`Spring, 2010
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`Physiological Disposition of Drugs
`Lecturer on basic pharmacokinetic concepts
`Spring, 2011
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`F813 Clinical Pharmacokinetics
`Lecturer
`Spring, 2012
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`Informatics Research Rotation
`INFO I-790
`Project director for Parth Kothiya
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`4
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

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`Sara Quinney, PharmD, PhD
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`MENTORING:
`Individual:
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`Program:
`Dates:
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`Role/Project:
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`Fall 2016
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`Project in Health Informatics
`INFO B-691
`Project director for Shilpa Katta
`Fall 2016 - Spring 2017
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`Project in Health Informatics
`INFO B-691
`Project director for Haritha Alturi
`Spring 2017
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`Project in Health Informatics
`INFO B-691
`Project director for Naga Mallika Sriramula
`Summer – Fall 2018
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`Project in Health Informatics
`INFO B-691
`Project director for Keshav Vellure
`Fall 2018
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`Undergraduate Student/ Bridges to the Baccalaureate Program, IUSM
`Summer, 2010
`Laboratory mentor; developing HPLC assay for betamethasone
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`Jayanti Clay, MD
`Medical Research Student, IUSM
`November, 2010 – March, 2011
`Research mentor; nifedipine analysis for OPRU study; drug pharmacokinetics in
`pregnancy
`Current position: OB/GYN at Semar Community Health Center, Seattle, WA
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`Emmary Butler
`Medical Research Student (93GO70), IUSM
`December, 2011
`Pharmacokinetic studies in pregnancy; clinical chart review of nifedipine for preterm
`labor
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`Kate Delany
`Summer Undergraduate Research Student, IUSM
`Summer, 2012
`Evaluation of depression in pregnancy
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`Maria Vandenberg, MD
`OB/GYN Resident, IUSM
`2010-2012
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`5
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

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`Sara Quinney, PharmD, PhD
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`Resident research project mentor; Hydrocodone in breast milk, pharmacogenetics, and
`neonatal outcomes
`Current position: OB/GYN at Women’s Care of Wisconsin, Madison, WI
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`Katie Towels, MD
`OB/GYN Resident, IUSM
`2012-2013
`Resident research project mentor; Restless leg syndrome in pregnancy
`Current position: OB/GYN at Franciscan Health, Lafayette, IN
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`Nadia Falah
`Clinical Pharmacology Fellow, IUSM
`2012-2014
`Mentor; estriol as a biomarker for betamethasone response
`Current position: Clinical Geneticist at Nicklaus Children’s Hospital, Miami, FL
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`Megan Schellinger, D.O.
`Maternal Fetal Medicine Fellow, IUSM
`2012-2014
`Research mentor and thesis committee member; effect of oral hypoglycemic agents on
`placental gene expression
`Current position: OB/GYN, Maternal Fetal Medicine, GHS Greenville Memorial Hospital,
`Greenville, SC
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`Tara Benjamin, M.D.
`Maternal Fetal Medicine Fellow, IUSM
`2013-2015
`Research mentor and thesis committee member; metabolism of progesterone by
`cytochrome P450 enzymes
`Current position: OB/GYN, Maternal Fetal Medicine, Indiana University School of
`Medicine, Indianapolis, IN
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`Rebecca Pierson, M.D.
`Clinical Pharmacology Fellow, IUSM
`2013-2016
`Mentor and committee member; pharmacogenomics of ovulation induction agents
`Current position: OB/GYN, University of Louisville Physicians, Louisville, KY
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`Alice Wang
`Undergraduate Research Student
`Summer 2014, 2015
`Mentor; expression and activity of drug metabolizing enzymes in placenta
`Current position: PharmD Candidate, Purdue University College of Pharmacy, West
`Lafayette, IN
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`Meredith Dorr, M.D.
`OB/GYN Resident, IUSM
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

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`Sara Quinney, PharmD, PhD
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`2013-2014
`Co-mentor on research project on misoprostol for labor induction
`Current position: OB/GYN, HealthNet, Indianapolis, IN
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`Rachel Towns, M.D.
`OB/GYN Resident, IUSM
`2013-2014
`Co-mentor on research project on misoprostol for labor induction
`Current position: OB/GYN, Care for Women, Kingwood, TX
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`Anna Schwartz Thomas, M.D.
`Neonatology and Pediatric Clinical Pharmacology Fellow, IUSM
`2013-2015
`Provided mentorship for her project relating neonatal and post-natal methadone
`pharmacokinetics to neonatal abstinence syndrome
`Current position: Assistant Professor of Clinical Pediatrics, Indiana University School of
`Medicine, Indianapolis, IN
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`Nimita Dave, Pharm.D., Ph.D.
`Clinical Pharmacology Fellow, IUSM
`2015-2016
`Provide mentorship on pharmacokinetic modeling for determining brain uptake
`Current position: Senior Clinical Pharmacokineticist II, Abbvie, North Chicago, IL
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`Brandon Gufford, Pharm.D., Ph.D.
`Clinical Pharmacology Fellow, IUSM
`2015-2017
`Committee member; provide mentorship on pharmacokinetic modeling
`Current position: Pharmacokineticist II, Covance; Adjunct Assistant Professor of Clinical
`Pharmacology, Indiana University School of Medicine, Indianapolis, IN
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`Fernanda de Lima Moreiera
`Visiting Scholar; PhD Candidate, Pharmaceutical Sciences, Sao Paulo University, Brazil
`2015-2017
`Mentor; in vitro drug interactions of CYP2D6 substrates
`Current position: Doutora em Ciências Farmacêuticas - FCFRP-USP Ribeirão Preto
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`Kundan Kunapareddy
`Masters student, Health Informatics, IUPUI
`2016-2017
`Physiologic Based Pharmacokinetic Modeling of Imatinib
`Current position: Data Analyst, Indiana University Health
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`Melissa Paulen, M.D.
`OB/GYN Resident, IUSM
`2016-2017
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

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`Sara Quinney, PharmD, PhD
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`Mentor on resident research project on continuation of long acting reversible
`contraceptives
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`Parth Kothiya
`PhD Student, Bioinformatics, IUPUI
`2016-present
`Thesis mentor
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`Ingrid Ferreira Metzger
`Postdoctoral Fellow, IUSM
`2016-2018
`Pharmacokinetic Modeling and Data Anlysis; Projects Included Methadone
`Pharmacokinetics in Pregnant Women and Risk of Neonatal Abstinence Syndrome;
`Alzheimer’s Disease Preclinical Trial Core
`Current position: Professor Adjunto at University of Barilia; Adjunct Assistant Professor
`of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, IN
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`Justin Lee
`Indiana Medical Student Program for Research and Scholarship (IMPRS)
`Summer 2017
`Development of Pharmacokinetic Analysis Platform for Alzheimer’s Disease Preclinical
`Trial Core
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`Stephanie Liu
`Clinical Pharmacology Fellow, IUSM
`2017-present
`Committee member; provide mentorship on pharmacokinetic modeling
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`Violetta Rodriguez Romero
`Postdoctoral Fellow
`ICTSI Disease and Therapeutic Response Modeling Program
`2015-2018
`Training/Mentoring in Pharmacometrics
`Methotrexate Pharmacokinetic Model Development
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`Jagdeep Podichetty
`Postdoctoral Fellow
`ICTSI Disease and Therapeutic Response Modeling Program
`2017-present
`Training/Mentoring in Pharmacometrics
`Basiliximab population pharmacokinetic modeling; PBPK model of Hops components
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`Keshav Velore
`Masters of Health Informatics student, IUPUI
`2017 – 2018
`Capstone project mentor; Text mining pharmacokinetic data on pregnancy and lactation
`from the literature
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

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`Sara Quinney, PharmD, PhD
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`Priyanka Muppidi
`Masters of Health Informatics student, IUPUI
`2017 – 2018
`Retrospective Collection of Data on Long Acting Reversible Contraception from
`Electronic Medical Record Data
`Current Position: Pharmacy Analyst, AmeriHealth Caritas, Philadelphia, PA
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`Naga Mallika Sriramula
`Masters of Health Informatics student, IUPUI
`2017-2018
`Capstone mentor; Association between medication use and adverse events in women
`enrolled in the Numom2B study
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`Kimberly Collins
`Fellow, Division of Nephrology, IUSM
`2017
`Mentor; PK/PD modeling
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`Rakesh Gullapelli
`Masters student, Health Informatics, IUPUI
`Review of Omics Data from Studies of Pre-Term Labor
`Correlated Monte Carlo simulation to validate the Model-AD Preclinical Trial Core Drug
`Selection Criteria (DSC)
`2017-2019
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`Christina Ulibarri, MD
`OB/GYN Resident, IUSM
`2017-2018
`Mentor on resident research project, maternal estriol as a predictor for neonatal
`respiratory distress syndrome
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`Carla Biesdorf, PhD
`Postdoctoral Fellow
`ICTSI Disease and Therapeutic Response Modeling Program
`2018-present
`Mentor
`MODEL-AD Preclinical Trials Core; population pharmacokinetic model of misoprostol for
`induction of labor
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`Anh Duong
`Clinical Pharmacology Fellow, IUSM
`2018-present
`Committee member; provide mentorship on pharmacokinetic modeling
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`Irin Tanaudommongkon
`Clinical Pharmacology Fellow, IUSM
`9
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

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`Sara Quinney, PharmD, PhD
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`2018-present
`Provide mentorship on pharmacokinetic modeling
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`Maayan Leroy-Melamed, MD
`Clinical Pharmacology Fellow, IUSM
`2018-present
`Committee member
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`Alia Rawden
`Pregmed Fellow
`2018 - present
`Mentor committee
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`Misty McDowell, MD
`Maternal Fetal Medicine Fellow, IUSM
`2017-present
`Research mentor and thesis committee member
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`Sai Priyanka Vedullapalli
`Masters of Health Informatics student, IUPUI
`Spring 2019
`Capstone project mentor
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`Ashritha Dandam
`Masters of Health Informatics student, IUPUI
`Spring 2019
`Capstone project mentor
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`Priyanka Errabelly
`Masters of Health Informatics student, IUPUI
`Spring 2019
`Capstone project mentor
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`Masters Thesis Committee Member
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`Haritha Alturi
`Master student, Health Informatics, IUPUI
`2016-2017
`Project Mentor: Population pharmacokinetic analysis of nifedipine in preterm labor
`tocolysis
`Current position: Senior Data Analyst, Partnership Health Plan of California
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`Shilpa Katta
`Masters student, Health Informatics, IUPUI
`2016-2017
`Project mentor: Text mining approaches to identifying pregnancy pharmacokinetics
`data
`Current position: Data Analyst, 4C Health Solutions, VA
`10
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

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`Sara Quinney, PharmD, PhD
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`Akhil Pampana
`Masters of Bioinformatics, IUPUI
`2017
`Mining PubMed abstracts to find evidence for drug herb interactions using N entity
`recognition and machine learning techniques
`Current position: Bioinformatics Specialist, Massachusetts General Hospital, Boston, MA
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`Sukumar Aithem
`Masters of Health Informatics, IUPUI
`2017
`Medication reconciliation and its impact on patient safety
`Current position: RLI Administrator, Covance Central Lab Services, Indianapolis, IN
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`Manika Praveenkumar Maheshwari
`Masters of Health Informatics, IUPUI
`2017
`A smart mHealth app to improve adherence to prescribed medications for chronic
`illnesses design, implementation & evaluation of medication adherence app to manage
`chronic conditions in elderly population
`Current position: Data Science Analyst, CopperPoint Insurance, Phoenix, AZ
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`Pooja Chandra
`Masters of Bioinformatics, IUPUI
`2018
`Integration of genomic copy number variations and chemotherapy-response biomarkers
`in pediatric sarcoma cell lines and tumor biopsies
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`Ph.D. Thesis Committee Member
`Student:
` Ahmed Nader Mohammed, Pharm.D.
`Program:
`Ph.D. Pharmacy Practice, Purdue University
`Date:
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`2010-2013
`Role:
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`Served as co-mentor and thesis committee co-chair
`Current position: Assistant Director, Clinical Pharmacology and Pharmacometrics,
`Abbvie, North Chicago, IL; Adjunct Assistant Professor of Clinical Pharmacology, Indiana
`University School of Medicine, Indianapolis, IN
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`Xan (Eileen) Hu
`Ph.D. Pharmacology and Toxicology, IUSM
`2010-2014
`Served as wet laboratory mentor for in vitro CYP450 studies and thesis committee
`member
`Current position: Consultant, Health Economics and Outcomes Research, IQVIA,
`Fairfax, VA
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`Christina Chung, Pharm.D.
`Ph.D. Pharmacy Practice, Purdue University
`11
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

`

`Sara Quinney, PharmD, PhD
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`2013-2015
`Committee member
`Current position: Assistant Professor of Clinical Pharmacy, Kyung Hee University, Seoul,
`South Korea
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`Samar Binkheder
`PhD Student, Health Informatics, IUPUI
`2015 – Present
`Committee member
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`Elena Tomaselli, Pharm.D.
`Ph.D. Candidate Pharmacy Practice, Purdue University
`2016 – Present
`Committee member
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`Parth Kothiya
`PhD Student Bioinformatics, IUPUI
`2016-present
`Thesis Mentor
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`Ebony Shaw-Williams
`PhD Student, Medical and Molecular Genetics, IUPUI
`2018 – present
`Committee member
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`TEACHING ADMINISTRATION AND CURRICULUM DEVELOPMENT
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`Revision of cases for fourth year medical student Clinical Pharmacology elective (part of
`93M1710), 2010, 2011, 2013
`MFM Fellows Didactics. I participated in discussion of variety of topics relating to MFM;
`presented lectures on obstetric clinical pharmacology principles (3/25/2014); pregnancy
`related hypertension (3/4/2015); and maternal adaptation in pregnancy (10/10/2012)
`MFM/Perinatal Conference “Antenatal Indomethacin” February 20, 2013
`Redcap Training for IUSM OB/GYN Residents; August 23, 2013
`IUSM Department of OB/GYN Grand Rounds presentation “Obstetrical clinical
`pharmacology: why is it important?” November 6, 2013
`IUSM Department of OB/GYN Grand Rounds presentation “Physiologic changes in
`pregnancy” October 29, 2014
`IUSM Division of Clinical Pharmacology and Indiana Institute of Personalized Medicine
`Seminar Series, “PBPK Modeling of Nanoparticles” November 4, 2014
`IUSM Division of Clinical Pharmacology and Indiana Institute of Personalized Medicine
`Seminar Series, “Dried Blood Spots in Pharmacokinetic Studies” November 17, 2015
`12
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

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`Sara Quinney, PharmD, PhD
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`Clinical Pharmacology Journal Club. I participate in the Division of Clinical
`Pharmacology’s journal club which consists of presentations of recent journal articles by
`a group consisting of 2 trainees and 1 faculty mentor. I am responsible for overseeing 2-
`3 group presentations annually and contribute expertise during weekly (2009-2015) or
`bi-monthly (2016-present) discussions.
`Pharmacokinetic training course for Clinical Pharmacology Fellows & Students and
`Purdue University Graduate Students: I co-led this discussion course which is part of the
`Clinical Pharmacology T32 didactics series in 2012, 2014, and 2017. Each year, the
`course was re-evaluated and modified to accommodate learners of varying experience.
`Developed Translational Systems Pharmacology course as a component of proposed
`Translational Bioinformatics PhD program, Fall 2017. Development of the degree path
`has been delayed but I hope to implement components of this course in a proposed
`Quantitative Biomedical Sciences PhD program.
`Introduction to Nonlinear Mixed Effects Analysis for Population PK/PD. I led seven
`discussion sessions for IUSM Division of Clinical Pharmacology fellows/students and
`Purdue University Pharmacy Practice PhD students to learn the basics of nonlinear
`mixed effects analyses using NONMEM, February – May, 2017.
`IUSM Division of Clinical Pharmacology and Indiana Institute of Personalized Medicine
`Seminar Series, “Towards Personalized Therapy in Pregnancy” May 16, 2017
`Basic Concepts in Physiologically Based Pharmacokinetic (PBPK) Modeling. IUSM
`Division of Clinical Pharmacology fellows and Purdue University Pharmacy Practice PhD
`students will be introduced to PBPK modeling through journal readings and application
`to individual research projects. This group meets weekly for 2 hours with the first hour
`focused on review of fundamental concepts and the second discussing individuals’
`research projects utilizing PBPK modeling. May 2018-August 2018
`Physiologically Based Pharmacokinetic (PBPK) Modeling. Purdue Course #CLPH690
`Fellows from the Division of Clinical Pharmacology, Disease and Therapeutic Response
`Modeling Program, and Purdue University Pharmacy Practice PhD students. Course
`covers basic concepts in PBPK modeling including model structure, in vitro in vivo
`extrapolation, drug and system-specific parameters, and model verification. August
`2018 – December 2018
`Improving Preclinical Translation of Alzheimer’s Disease Research October 21-26, 2018
`Jackson Laboratories, Bar Harbor, ME
`Provided lectures on pharmacokinetic concepts and modeling considerations for
`preclinical studies. Participated in discussion sessions with faculty and students
`regarding considerations for drug development in Alzheimer’s disease.
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`GRANTS
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`ACTIVE GRANTS
`(Stacey Rizzo, PI)
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`1 R13 AG060708-01
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`NIH/NIA
`Improving Preclinical Translation of Alzheimer’s Disease Research
`Co-Investigator
`2018-2021
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`$148,347
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`13
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

`

`Sara Quinney, PharmD, PhD
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`
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`This week-long intensive course at Jackson Laboratories, Bar Harbor, ME, will provide
`an overview of tools and techniques utilized in the MODEL-AD Preclinical Trials Core
`(PTC) program. I am responsible for 2-4 hours of didactic lectures and hands-on
`activities that provide an overview of pharmacokinetic concepts and interpreting
`pharmacokinetic/pharmacodynamic data to understand brain and plasma exposure with
`examples from the MODEL-AD Alzheimer’s disease research program.
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`RESEARCH/CREATIVE ACTIVITY
`GRANTS/FELLOWSHIPS IN RESEARCH
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`ACTIVE RESEARCH GRANTS
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`(Lang Li)
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`R01
`Ohio State/NIH (prime)
`Translational pharmacoinformatics approaches in predicting adverse drug events
`Co-I, 10%; IU PI
`$15,740 (IU subcontract)
`12/01/2018 – 11/30/2023
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`(Sara Quinney)
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`1RO1 GM117206-01
`NIH/NIGMS
`Integrated bioinformatic and pharmacokinetic models of high-dimensional drug
`interactions
`PI, 44%
`$1,389,276
`1/1/2016-12/31/2018
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`(David Haas)
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`1R01 HD088014-01
`NIH/NICHD
`Pharmacokinetics and modeling of betamethasone therapy in threatened preterm birth
`Co-investigator, 6%
`$2,376,714
`3/1/2016 – 3/31/2021
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`(Bruce Lamb)
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`NIH/NIA 1U54 AG054345-01
`The IU/JAX Alzheimer’s Disease Precision Models Center
`Co-investigator, 5%
`$4,837,674
`10/1/2016 – 9/30/2021
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`(Matthew Allen, PI)
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`VA Merit Grant
`Treating bond deterioration associated with chronic kidney disease
`Consultant
`$1,050,563
`1/1/2016 – 12/31/2020
`13th percentile
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`(Betty Caan)
`
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`Kaiser Permanente/NIH (prime)
`Resistance training to reduce chemotoxicity in colon cancer
`Co-Investigator (IU PI), 10%
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`14
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

`

`Sara Quinney, PharmD, PhD
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`$68,062 (IU Subcontract)
`07/01/2017-06/30/2022
`Score: 10, 1st percentile
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`(Desta)
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`1R01 GM121707-01A1
`NIH/NIGMS
`Mechanisms Underlying Stereoselective Bupropion Metabolism and Complex Drug
`Interactions
`Co-Investigator, 10%
`$308,287
`07/01/2017 – 06/30/2021
`
` (Senthil Sadhasivam, PI)
`R21 HD094311
`NIH/NICHD
`Bedside prediction of opioid-induced respiratory depression in children with
`pupillometry
`Co-I, 3%
`$275,000
`9/1/17-8/31/19 (original dates; awaiting institute funding)
`9th percentile
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`(Senthil Sadhasivam, PI)
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`R01
`NIH/NICHD
`Effects of Opioid Use Disorder in Pregnancy on Long-Term Maternal and Child Outcomes
`Co-I , 5% (years 4 & 5)
`$3,961,030
`07/01/2018 – 06/30/2023
`Impact Score 24
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`09/15/2018 – 06/30/2023
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`1R01HD096800-01 (Sadhasivam)
`Year 1 direct costs $436,842 – 5% effort yrs 4-5
`NIH/NICHD & NINDS
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`Effects of Opioid Use Disorder in Pregnancy on Long-term Maternal and Child Outcomes
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`12/18- 6/2020
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`IU Addictions Grand Challenge Pilot Project (Yamamoto)
`The Long-term Consequences of Opioid Neonatal Abstinence Syndrome
`10X genomics/CTSI
`pilot proposal
`(Quinney)
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`10/18-12/18
`Single cell RNA sequencing of human placentas: identifying individuals from pooled
`samples
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`COMPLETED RESEARCH GRANTS
`Agency:
`NIH/NIGMS
`5T-32 GM008425
`Title:
`Clinical Pharmacology Training Grant
`Role:
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`Fellow
`Dates:
`8/1/2004 – 7/1/2007
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`(Dave Flockhart)
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`(Lang Li)
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`RO1 GM74217-01
`NIH/NIGMS
`Bayesian tools for physiologically-based pharmacokinetics models in drug-drug
`interaction research
`Fellow
`11/1/2007 – 8/31/2009
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`15
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

`

`Sara Quinney, PharmD, PhD
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`(Dave Flockhart)
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`(Sharon Moe)
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`(Jamie Renbarger)
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`1RC1CA146882
`NIH/NCI
`Developing a prediction model for vincristine-induced peripheral neuropathy
`Co-Investigator, 17%
`$986,304
`9/1/2010-8/31/2012
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`Indiana CTSI Pilot Funding for Research Use of Core Facilities
`Nifedipine LC/MS/MS Assay and pharmacokinetics in pregnancy
`PI
`$9,340
`7/1/2011 – 6/30/2013
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`1U10HD063094
`NIH/NICHD
`Indiana Pregmed
`Co-investigator
`$4,163,563
`2/1/2010 – 12/31/2014
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`CTSI – CTR pilot grant
`A Pig Model of Chronic Kidney Disease
`Co-investigator
`$40,952
`7/1/2015 – 6/30/2016
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`5K23HD071134
`NIH/NICHD
`Individualization of Nifedipine Dosing for Preterm Labor
`PI, 75% (reduced to 50% 1/1/16)
`$628,005
`7/1/2012 – 6/30/2017
`(Lang Li)
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`NIH/NIGMS
`1R01 GM104483
`A Translational Bioinformatics Approach in Drug Interaction Research
`Co-Investigator, 8%
`$1,913,016
`9/1/2014 – 5/31/2018
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`University of Illinois Chicago / NIH/NCCIH
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`5P50 AT000155-17
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`(Richard van
` Breeman)
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`Botanical Dietary Supplements for Women's Health
`Co-Investigator (IU PI), 2%
`$25,000 (IU Subcontract)
`09/01/2017 – 08/31/2018
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`PENDING RESEARCH GRANTS
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`NIH SBIR New York R&D Center for Translational Medicine and Therapeutics, Inc (Leong,
`Sun)
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`16
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

`

`Sara Quinney, PharmD, PhD
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`Botanical drug for spontaneous osteoarthritis
`Co-I, IU PI
`(IU subcontract)
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`NIH NIA (Lamb)
`Administrative supplement to MODEL-AD to evaluate PK/PD of AD drugs in rat models
`Co-I, 5%
`10/1/2020-9/31/2021
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`Peter Joseph Pappas Research Grant Application (Sing, Sasser)
`A novel extracorporeal biodevice as a safe therapeutic intervention to prevent placenta
`and organ dysfunction due to severe preeclampsia.
`Co-I
`1/1/109-12/31/20
`$87,676
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` (Haas)
`Burroughs Wellcome Fund
`Utilizing circulating microparticles as windows into the biology of preterm parturition
`Co-I (5%)
`Year 1 direct costs $125,000
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`(Palkowitz)
`(U54 NIA
`IUSM Alzheimer’s Disease Discovery Drug Discovery Center
`Co-I, 2.5%
`$29,650,911
`9/1/19-8/31/24
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`U54 NIA
`AD New Meds
`Co-I
`9/1/19-8/31/24
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`Columbia University (Territo IU PI)
`U54 NIA
`The Alzheimer Drug Accelerator Network
`Co-I (5% effort years 3-5)
`$7,205 (year 1 direct cost at IU) $688,831 (total direct cost all years at IU)
`9/1/19-8/31/24
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`UNC (Territo IU PI)
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`Exploring the Known and Unknown of Drug Metabolism in Pregnancy: The Utility of
`Pharmacokinetic Modeling
`Butler University College of Pharmacy
`November 12, 2012
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`INVITED PRESENTATIONS
`LOCAL
`
`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

`

`Sara Quinney, PharmD, PhD
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`
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`Leveraging Literature and Clinical Data to Construct Pharmacokinetic Models of CYP3A
`Substrates: Focus on Drug Interactions and Effects of Pregnancy
`Center for Computational Biology and Bioinformatics, IUSM
`April 22, 2013
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`Clinical pharmacology in pregnancy
`IUSM Division of Clinical Pharmacology and Indiana Institute of Personalized Medicine
`Seminar Series
`June 4, 2013
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`Physiologically Based Pharmacokinetics
`Virtual Human for Drug Testing Mini-Symposium, Purdue University Weldon School of
`Biomedical Engineering
`August 5, 2014
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`PKPD Modeling in the Digital Human
`Symposium on Digital Human for Drug Development (DHD2), Purdue University Weldon
`School of Biomedical Engineering
`February 24, 2015
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`Physiologically Based Pharmacokinetic Model Development
`Symposium on Digital Human for Drug Development (DHD2), Purdue University Weldon
`School of Biomedical Engineering
`April 11, 2016
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`Towards Personalized Therapy in Pregnancy
`Department of Molecular Pharmacology and Experimental Therapeutics Seminar
`Mayo Clinic, Rochester, MN
`May 19, 2017
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`Global analysis of CYP3A4 and CYP3A5 genotype on in vivo clearance of CYP3A
`substrates
`American Society for Clinical Pharmacology and Therapeutics Annual Meeting,
`Indianapolis
`March 16, 2012
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`In vitro and in silico approaches to interrogating high-dimensional drug interaction
`mechanisms
`Indiana Clinical and Translational Sciences Symposium on Disease and Therapeutic
`Response Modeling, Indianapolis
`November 5, 2015
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`REGIONAL
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`NATIONAL
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`INTERNATIONAL
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`Utilizing Simcyp® to estimate metabolic changes in pregnancy
`Simcyp® Webinar
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`18
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`AMN1063
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

`

`October 17, 2013
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`Sara Quinney, PharmD, PhD
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`
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`How can we individualize drug disposition models?
`Symposium on Digital Human for Drug Development (DHD2); Korea Institute of Science
`and Technology (KIST)
`September 16, 2015
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`SERVICE:
`UNIVERSITY SERVICE:
`DEPARTMENT
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`UNIVERSITY
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`OB/GYN Resident Research Committee Member and Mentor
`2011-present
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`Search Committee Member, Molecular Genetics Faculty Position, Dept. of Medical and
`Molecular Genetics; February 2015
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`Biomedical Research Grant Review Committee ad hoc Member
`October 2016; February, 2017; June 2017; February 2018; June 2018
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`Indiana CTSI Core Pilot Project Grant Review Committee
`July 2014; November, 2014; July 2015; July, 2016; November, 2017
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`Indiana University Health Values Grant Review Committee; February 2016
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`Indiana CTSI Therapeutic and Disease Modeling Program
`External Advisory Board Meeting Organizer; November 3, 2015
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`Associate Director, Indiana CTSI Disease and Therapeutic Response Modeling Program
`2015 – present
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`Organized CTSI Modeling Program Workshop “Population Pharmacokinetic Analysis