th
STP 37th Annual
Symposium
STP 37
Annual Symposium

KEEPING IT

Indianapolis, Indiana

June 16–21, 2018 | JW Marriott Indianapolisor quantitatively different between species. This session will coverclinical pathology alterations common to various biotherapeutics,
using didactic presentations, mechanistic discussions, and caseexamples to deliver a comprehensive discourse on this challenging
topic.

Saturday, June 16
9:00 AM–4:30 PM

NTP Satellite Symposium: Pathology
Potpourri

8:00 AM–8:05 AM

Chair: Susan A. Elmore, MS, DVM, DABT, FIATP, DACVP,NTP and NIEHS, Research Triangle Park, NC

Introduction

The objective of this interactive symposium is to provide continuing
education on interpreting pathology slides, to generate lively andproductive conversation, and to have a good time. During eachtalk, the speakers will project a series of images of lesions on one
screen with a choice of diagnoses/answers on a separate screen.
The members of the audience will then vote using wireless keypads
and the results will be displayed on the screen. Time is allowed for
discussion after each voting session.

8:05 AM–8:55 AM

Sunday, June 17

John L. Vahle, DVM, PhD, DACVP, Eli Lilly & Company, Indianapolis, IN

Effects of Biologic Drug Modalities on Peripheral
Blood Cells
Nancy E. Everds, DVM, DACVP, Seattle Genetics, Bothell, WA
8:55 AM–9:45 AM

Immunogenicity and Immune Complex Disease in
Preclinical Safety Assessment Studies: Challenges forAssessing Human Safety

Career Development Session (Sunday AM)

9:45 AM–10:15 AM

Break

8:00 AM–12:00 Noon

10:15 AM–11:05 AM

Practical Strategies for Navigating Toxicologic
Pathology in One’s Early Career…and Beyond!

Complement Activation, Cause and EffectWilliam Siska, DVM, MS, DACVP, Charles River Laboratories, Reno, NV

Co-Chairs: Vinicius Carreira, DVM, PhD, DACVP, DABT, Janssen
R&D —Johnson & Johnson, La Jolla, CA; and Gopinath Palanisamy,
BVSc, MS, PhD, DACVP, Genentech, South San Francisco, CA

11:05 AM–11:55 AM

Immunophenotyping and Cytokines, Considerations andCase Examples

Toxicologic Pathology is a unique and exciting field with anever-increasing demand for professionals. But what exactly do
toxicologic pathologists bring to the table, where do they work,and how do you function effectively as one? These questions andmore shall be answered in this session, complete with overviewsof career preparation, roles in various sectors of the industry,bases of safety toxicology, logistics of GLP work, anatomic andclinical pathology data analysis, and a discussion of the scientifictools available to support the toxicologic pathologist in his or
her journey.

Ellen W. Evans, DVM, PhD, DACVP, Pfizer, Inc., Groton, CT
11:55 AM–12:00 Noon

Panel Discussion

CE 2 (Sunday AM)
8:00 AM–12:00 Noon

Scientific and Regulatory Considerations in Safety
Evaluation of Gene Therapy Products in PreclinicalStudies

CE 1 (Sunday AM)
8:00 AM–12:00 Noon

Co-Chairs: Basel T. Assaf, BVSc, PhD, DACVP, Pfizer, Inc., Andover, MA;
and Laurence O. Whiteley, DVM, PhD, DACVP, Pfizer, Inc., Andover, MA

Clinical Pathology of Biotherapeutics

Progress in understanding the molecular bases of human healthand disease in recent decades has flourished the field of Gene
Therapy (GT) to offer new possibilities for treating, and evencuring, a plethora of medical conditions such as monogenic
disorders and metabolic diseases. GT is a therapeutic intervention
to genetically alter or modify living cells by means of gene delivery
achieved using either viral vectors or non-viral vectors, with theformer constituting market share majority. Although gene therapy
is conceptually attractive, adverse and even fatal iatrogenic
complications have marred the initial enthusiasm of clinicalsuccesses. The properties of investigational viral vector-based

Co-Chairs: Allison Vitsky, BS, DVM, DACVP, Pfizer Global Research andDevelopment, San Diego, CA; and Tara P. Arndt, DVM, DACVP, Covance,
Madison, WI

Biologic drug modalities are rapidly expanding in number andcomplexity, and this expansion has been accompanied by theobservation of equally complex effects, both expected andunexpected, in nonclinical safety studies. The increasing emphasis on
immunotherapeutic agents has further complicated matters, suchthat interpreting clinical pathology data has become a challenging
endeavor requiring heightened comprehension of immunology, anda working understanding of responses which may be qualitatively
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STP 37th Annual Symposium
gene therapy product (VGTP), such as their integration potentials,
pose safety concerns unique from those of small moleculedrugs and other macromolecule biologics. These products carryrisks associated with ectopic or unregulated expression of thetransgene, genotoxicity and cell transformation associated withintegrative vectors, immunogenicity and inflammatory host tissue
responses, long term persistence, and off-target distribution.
These risks are generally evaluated in preclinical studies as part ofa comprehensive preclinical safety program prior to administrationin humans. However, safety assessment for these products canbe challenging due to the lack of standardized approaches. A
primary goal of this session is to introduce this product class tothe toxicologic pathology community and provide a forum fordiscussion of the scientific and the regulatory considerations in theevaluation of host responses to GT products.

Peripheral Nervous System (PNS) toxicity evaluation is relatively
less well-defined compared to Central Nervous System (CNS)
toxicity evaluation in routine animal toxicology studies. PNS
toxicity is often encountered in patients treated with therapeutic
agents (e.g., cancer chemotherapeutics), or, as a result of exposure
to environmental chemicals (e.g., industrial solvents). Available
literature, guidance, and translation between animal studies tohuman risk assessment is generally limited. This half-day course
is designed to familiarize participants with PNS toxicologic
histopathology. Topics will include an overview of PNS biology,
classic methods, and current best practices for PNS sampling,
preparation, and evaluation, commonly observed lesions andartifacts in the PNS, and, examples and mechanisms of PNS
toxicity. A final presentation of three case studies will conclude intoa platform session with the audience for an open discussion withall speakers.

8:00 AM–8:05 AM

Introduction

1:30 PM–1:35 PM

Introduction

8:05 AM–8:40 AM

Gene Therapy: From Discovery to Translational Research

1:35 PM–1:45 PM

Biology of the PNS

Guangping Gao, PhD, University of Massachusetts Medical School,
Worcester, MA

Brad Bolon, DVM, MS, PhD, DACVP, DABT, ATS, FIATP, GEMpath, Inc.,
Longmont, CO

8:40 AM–9:15 AM

A Pathologist’s Approach to Characterizing the Safety
Profile of AAV-Based Gene Therapy

1:45 PM–2:20 PM

Laurence O. Whiteley, DVM, PhD, DACVP, Pfizer, Inc., Andover, MA

Mark Butt, DVM, Tox Path Specialists, LLC, Frederick, MD

9:15 AM–9:50 AM

2:20 PM–2:35 PM

US FDA/CBER Regulatory Considerations in the
Preclinical Evaluation of GT Products

Bernie Jortner, VMD, Virginia Tech, Blacksburg, VA

Anatomic Assessment and Review of Best Practices

Common Structural Lesions and Artifacts in the PNS

Sandhya Sanduja, PhD, US FDA/CBER, Silver Spring, MD

2:35 PM–3:05 PM

Break

9:50 AM–10:20 AM

Break

3:05 PM–3:40 PM

10:20 AM–10:55 AM

Peripheral Neurotoxicants: Agents and Mechanisms

Animal Models to Assess the Immunogenicity of AAV
Vectors

William M. Valentine, DVM, PhD, DABT, DABVT, Vanderbilt University
Medical Center, Nashville, TN

Hildegund C.J. Ertl, MD, The Wistar Institute, Philadelphia, PA

3:40 PM–4:15 PM

Electrophysiological Methods for Evaluating the PNS

10:55 AM–11:30 AM

Joseph C. Arezzo, PhD, Albert Einstein College of Medicine, Bronx, NY

Advancing GT into the Clinic; In-Depth Experienceon the Interaction with Regulatory Agencies and theAdvancement to Clinical Trials of GT Products

4:15 PM–5:10 PM

Case Studies in PNS Neurotoxicity

Katherine A. High, MD, Spark Therapeutics, Philadelphia, PA

Ingrid D. Pardo, DVM, MS, DACVP, Pfizer, Inc., Gales Ferry, CT; Deepa B.
Rao BVSc, MS, PhD, DABT, DACVP, US FDA, Silver Spring, MD; and Alok K.
Sharma, BVSc, MVSc, MS, PhD, DACVP, DABT, Covance Laboratories Inc.,
Madison, WI

11:30 AM–12:00 Noon

Panel Discussion

CE 3 (Sunday PM)

5:10 PM–5:30 PM

Panel Discussion

1:30 PM–5:30 PM

Toxicologic Pathology of the Peripheral Nervous
SystemCo-Chairs: Ingrid D. Pardo, DVM, MS, DACVP, Pfizer, Inc., Gales Ferry,
CT; and Deepa B. Rao, BVSc, MS, PhD, DABT, DACVP, US FDA, Silver
Spring, MD

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KEEPING IT
CE 4 (Sunday PM)

Monday, June 18

1:30 PM–5:30 PM

8:00 AM–8:10 AM

The Breakthrough of Oligonucleotide
Therapeutics: What Is Happening in between
Small and Large Molecules?

Symposium Welcome

Sponsored by the American College of Toxicology (ACT)

Kendall Frazier, DVM, PhD, DACVP, DABT, GlaxoSmithKline, King ofPrussia, PA

8:10 AM–8:25 AM

Fundamentals of Glomerular Anatomy and Physiology

Co-Chairs: Sven Korte, PhD, Covance Preclinical Services GmbH,
Münster, Germany; and Brian Vuillemenot, PhD, DABT, Adverum
Biotechnologies, Inc., Menlo Park, CA

8:25 AM–9:25 AM

Keynote Address: Glomerulonephritis
J. Charles Jennette, MD, UNC Hospitals, Chapel Hill, NC

The course is aimed for toxicologists and pathologists, but equallyprovides a great summary for pharmaceutical and regulatory
experts. This is a rare chance to get guided through this field by avariety of world leading experts. This CE course will define different
classes of oligonucleotide-based therapeutics on the basis ofmechanism of action and summarize the history of this compoundclass. Furthermore, characterization of the pharmacokinetics andtoxicology of Antisense Oligonucleotide (ASO) therapeutics will
be presented and it will be described how toxicology testing
strategies might differ from typical small molecule development.
This course will also provide in-depth knowledge to conduct
intrathecal screening and chronic lumbar or port catheter studies
in juvenile and mature cynomolgus monkeys. Finally, the session
will help you to understand the clinical relevance of toxicity
findings, pathologic alterations that may be seen in nonhumanprimates given repeated subcutaneous or intrathecal doses ofsingle stranded antisense oligonucleotides and discuss recent
advancements in the antisense field, allowing a look into the futureof this technology platform.

Session 1
9:25 AM–12:00 Noon

Glomerular Grab Bag
Co-Chairs: Kendall Frazier, DVM, PhD, DACVP, DABT,
GlaxoSmithKline, King of Prussia, PA; and Rachel Cianciolo, VMD, PhD,DACVP, The Ohio State University, Columbus, OH

The Monday morning session entitled “Glomerular Grab Bag”
begins with a short introduction on “Glomerular Anatomy andPhysiology” by Dr. Ken Frazier of GSK, which is followed by theplenary session on “Glomerulonephritis” by renowned nephrologist
and researcher Dr. J. Charles Jennette from the University of North
Carolina hospital at Chapel Hill. The plenary is followed by a talkon “Integrated Diagnostic Approach as a Basis for Nonclinical to
Clinical Translation and Biomarkers” by Dr. Rachel Cianciolo of
The Ohio State University. Following the break, Dr. Frazier gives
another seminar on drug-induced glomerulonephritis entitled“The Problem of Biotherapeutic and Antisense Oligonucleotide
Immune Activation in the Kidney”, and the session closes with aninteresting translational lecture by Dr. Brad Rovin of The Ohio State
University on “Lupus Nephritis, a Clinician’s Experience”.

1:30 PM–1:45 PM

Introduction
1:45 PM–2:25 PM

Oligonucleotide Therapeutics: A Historical Perspective
Laurence O. Whiteley, DVM, PhD, DACVP, Pfizer, Inc., Andover, MA

9:25 AM–10:00 AM

2:25 PM–3:15 PM

Integrated Diagnostic Approach As a Basis for
Nonclinical to Clinical Translation and Biomarkers

US Regulatory Experience with Oligonucleotide-Based
Therapeutics

Rachel Cianciolo, VMD, PhD, DACVP, The Ohio State University,
Columbus, OH

Ronald L. Wange, BS, PhD, US FDA, Silver Spring, MD

10:00 AM–10:30 AM

3:15 PM–3:45 PM

Break

Break

10:30 AM–11:10 AM

3:45 PM–4:20 PM

The Problem of Biotherapeutic and Antisense
Oligonucleotide Immune Activation in the Kidney

Toxicopathology of Single Stranded Antisense
Oligonucleotides

Kendall Frazier, DVM, PhD, DACVP, DABT, GlaxoSmithKline, King ofPrussia, PA

Jeffery A. Engelhardt, DVM, PhD, Ionis Pharmaceuticals, Carlsbad, CA
4:20 PM–4:55 PM

11:10 AM–12:00 Noon

Conduct and Design of NHP Studies for First-in-Man
Studies

Lupus Nephritis, a Clinician’s Experience
Brad Rovin, MD, The Ohio State University, Columbus, OH

Sven Korte, PhD, Covance Preclinical Services GmbH, Münster, Germany
4:55 PM–5:30 PM

When Your Cup Runneth Over: Advances in Antisense
Chemistry, Targeting, and Mechanisms
Scott P. Henry, PhD, Ionis Pharmaceuticals, Carlsbad, CA
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STP 37th Annual Symposium
Career Development Lunchtime Session

1:40 PM–2:10 PM

12:30 PM–1:30 PM

Torrie A. Crabbs, DVM, DACVP, Experimental Pathology Laboratories,
Inc., Research Triangle Park, NC; and Zaher A. Radi, DVM, MSc, MBA, PhD,DABT, DACVP, Pfizer Inc., Andover, MA

DIKI and INHAND and SEND Nomenclature Review

The Standard for the Exchange of Nonclinical Data
(SEND): Challenges and Promise
Co-Chairs: Kimberly Maratea, DVM, PhD DACVP, AstraZeneca,
Waltham, MA; and Shambhunath Choudhary, BVSc, PhD, DACVP,Charles River Laboratories, Spencerville, OH

2:10 PM–3:00 PM

Renal Hemodynamics, Microcirculation, and Tubular
Ischemia: It’s All about the Blood Flow

SEND is an implementation of the Study Data Tabulation Model(SDTM) for nonclinical studies that enables the US FDA tomodernize and streamline the review process. In this session, apanel of experts including pathologists, IT professionals familiar
with the SEND submission process, and US FDA reviewers will
discuss obstacles that challenge implementation of SEND inroutine submissions to US FDA’s Center for Drug Evaluation
and Research (CDER) and Center for Biologics Evaluation andResearch (CBER). Panelists and audience members will also havean opportunity to discuss the benefits of standardization andhow they outweigh the perceived disadvantages. The goal of
the panel discussion will be to create greater familiarity among
STP members about SEND, including the steps, obstacles,
and mistakes to avoid in its implementation during routine
submissions.

Bruce A. Molitoris, MD, Indiana University, Indianapolis, IN
3:00 PM–3:30 PM

Break
3:30 PM–4:20 PM

Advances and Challenges on New Therapies and ClinicalTargets of AKI
Brad Rovin, MD, The Ohio State University, Columbus, OH
4:20 PM–5:00 PM

Immunopathologic Responses in AKI
Zaher A. Radi, DVM, MSc, MBA, PhD, DABT, DACVP, Pfizer Inc.,
Andover, MA

5:30 PM–6:30 PM

Session 2

Town Hall

1:15 PM–5:00 PM

Tuesday, June 19

Acute Kidney Injury (AKI): Toxicologic
Pathologist’s Constant Companion

Session 3

Co-Chairs: Torrie A. Crabbs, DVM, DACVP, Experimental Pathology
Laboratories, Inc., Research Triangle Park, NC; and Zaher A. Radi, DVM,
MSc, MBA, PhD, DABT, DACVP, Pfizer Inc., Andover, MA

8:00 AM–12:00 Noon

Chronic Kidney Disease: Mechanisms andProgression

Acute Kidney Injury (AKI): The Toxicologic Pathologist’s ConstantCompanion is the theme of Session 2, which will commence on
Monday afternoon by covering the fundamentals of tubule andinterstitial anatomy and physiology by Dr. Kevin McDorman ofCharles River. This will be followed by a review of DIKI, INHAND,
and SEND nomenclature in the renal arena which will be copresented by Dr. Torrie Crabbs of EPL and Dr. Zaher Radi of Pfizer.
As a leading expert in AKI pathogenesis, Dr. Bruce Molitoris from
Indiana University, will then give a talk on “Renal Hemodynamics,
Microcirculation, and Tubular Ischemia: It’s All about the Blood
Flow.” Dr. Brad Rovin, The Ohio State University, will give a seminarafter the break that will discuss “Advances and Challenges on New
Therapies and Clinical Targets of AKI.” Session 2 will close with aseminar by Dr. Radi on “Immunopathologic Responses in AKI.”

Co-Chairs: Gordon Hard, BVSc, PhD, DSc, ATS, Tairu, New Zealand;
and Kevin S. McDorman, DVM, PhD, DACVP, Charles River,Frederick, MD

The Tuesday morning scientific session will build on the information
presented earlier in the meeting on acute kidney injury, and will
focus on chronic kidney disease progression. Mechanisms of chronic
kidney disease will be presented by Dr. Agnes B. Fogo, Professor
and John L. Shapiro Chair of Pathology at Vanderbilt University
Medical Center, and an expert in glomerulsclerosis with and authorof 280 research articles and reviews as well as two textbooks onrenal pathology. Dr. Samuel M. Cohen, Professor and Havlik-Wall
Professor of Oncology at the University of Nebraska Medical Center,
will then discuss the relationship between crystalluria and chronic
kidney disease. Following a break providing the opportunity for
networking and visiting the exhibit hall, Dr. Charles Wood, Research
Biologist and Pathologist at the United States Environmental
Protection Agency, will present chronic kidney disease associatedwith environmental toxins and exposures. The concluding talkof the session will be a current state and understanding of renal
carcinogenesis mechanisms in rodents delivered by Dr. Gordon
Hard, renowned expert renal pathology consultant with over 40
years of experience in chemical carcinogenesis and toxicology
research, specializing in renal toxicologic pathology.

1:15 PM–1:20 PM

Introduction
1:20 PM–1:40 PM

Fundamentals of Tubule and Interstitial Anatomy andPhysiology
Kevin S. McDorman, DVM, PhD, DACVP, Charles River, Frederick, MD

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KEEPING IT
Models of Kidney Diseases” focusing on the benefits of thesemodels in understanding the mechanisms of disease, potential
targets for therapy, and candidate therapies as a critical step
towards the patient in the clinic. Dr. Eric McDuffie of Janssen, will
follow with “Assessment of Compound-Induced Acute Kidney
Injury Using Animal Models and In Vitro Platforms”. After a short
break, internationally recognized nephrologist Dr. Agnes Fogo of
Vanderbilt University will present “From Mice to Humans—Kidney
Disease Challenges”. The session will conclude with Dr. Shannon
Harlan presenting “Similarity of Animal Models to Human Diseases
Based on Microarray mRNA”.

8:00 AM–8:10 AM

Introduction
8:10 AM–9:10 AM

Mechanisms of Chronic Kidney Disease Progression
Agnes Fogo, MD, Vanderbilt University, Nashville, TN
9:10 AM–9:55 AM

Chronic Kidney Disease: Mechanisms and Progression
Samuel D. Cohen, MD, PhD, University of Nebraska Medical Center,
Omaha, NE

8:00 AM–8:05 AM

9:55 AM–10:25 AM

BreakIntroduction

10:25 AM–11:15 AM

8:05 AM–8:45 AM

Sweet! Diabetic Kidney Disease Models

Chronic Kidney Disease Associated with Environmental
Toxins and Exposures

Kathleen Heinz-Taheny, DVM, PhD, DACVP, DABT, Eli Lilly & Company,
Indianapolis, IN; and Bruce L. Homer, DVM, PhD, DACVP, Consultant,
Ashburn, VACharles Wood, DVM, PhD, DACVP, US EPA, Research Triangle Park, NC
11:15 AM–12:00 Noon

8:45 AM–9:25 AM

Renal Carcinogenesis Mechanisms

Can We Get to the Clinic Using Mice and Organoids As
Preclinical Models of Kidney Diseases

Gordon Hard, BVSc, PhD, DSc, ATS, Tairu, New ZealandStuart J. Shankland, MD, MBA, FRCP, University of Washington,
Seattle, WA

12:30 PM–1:30 PM

Lunchtime Talk

9:25 AM–10:00 AM

Speaker: Mark D. Seaton, US FDA, Silver Spring, MD

Assessment of Compound-Induced Acute Kidney Injury
Using Animal Models and In Vitro Platforms

Afternoon

Free Time

J. Eric Duffie, BS, PhD, MBA, Janssen Pharmaceutical Companies ofJohnson & Johnson, San Diego, CA

7:00 PM–9:00 PM

10:00 AM–10:15 AM

Mystery Slide Session

Student Speaker

Sponsored by HistoTox Labs

10:15 AM–10:45 AM

BreakRenal: Mystery Renal Slide Session

10:45 AM–11:30 AM

Chair: Jerrold M. Ward, DVM, PhD, DACVP, Global Vet Pathology,
Montgomery Village, MD

From Mice to Humans—Kidney Disease Challenges
Agnes Fogo, MD, Vanderbilt University, Nashville, TN

Wednesday, June 20

11:30 AM–12:00 Noon

Session 4

Similarity of Animal Models to Human Diseases Based on
Microarray mRNA
Shannon M. Harlan, PhD, Eli Lilly & Company, Indianapolis, IN

8:00 AM–12:00 Noon

12:30 PM–1:30 PM

Animal Models of Kidney Disease: Literal
Translation or Lateral Transgression

Evaluation of Stem Cell-Derived Cellular Therapy
Products

Co-Chairs: Kathleen Heinz-Taheny, DVM, PhD, DACVP, DABT, Eli Lilly& Company, Indianapolis, IN; and Bruce L. Homer, DVM, PhD, DACVP,
Consultant, Ashburn, VA

Sponsored by IATP and STP
Co-Chairs: Darlene Dixon, DVM, PhD, DACVP, FIATP, NIEHS/NTP,
Research Triangle Park, NC; and Robert R. Maronpot, DVM, MS, MPH,DACVP, DABT, FIATP, Maronpot Consulting, LLC, Raleigh, NC

The Wednesday morning session explores animal models andtranslation to the human condition, entitled “Animal Modelsof Kidney Disease: Literal Translation or Lateral Transgression”.
Session co-chairs, Drs. Katie Heinz-Taheny of Eli Lilly and Bruce
Homer, consultant, will co-present “Sweet! Diabetic Kidney Disease
Models” focusing on rodent DKD models. Renowned nephrologist
Dr. Stuart Shankland of the Kidney Research Institute will present“Can We Get to the Clinic Using Mice and Organoids as Preclinical

Speaker: Alys Bradley, BSc, BVSc, MAnimSc, DipRCPath, FRIPH, MRCVS,FRCPath, FIATP, Charles River Laboratories, Edinburgh, United Kingdom

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STP 37th Annual Symposium
Session 5

Thursday, June 21

1:15 PM–5:00 PM

Session 6

Bridging Nonclinical to Clinical Translation Using
Emerging Science

8:00 AM–12:00 Noon

New Frontiers: Approaches to Understand the
Mechanistic Basis of Renal Toxicity

Co-Chairs: Shashi Ramaiah, DVM, MVSc, PhD, DACVP, DABT, Pfizer
Global Research and Development, Cambridge, MA; and Paul W. Snyder,
DVM, PhD, DACVP, FIATP, EPL. Inc., West Lafayette, IN

Co-Chairs: Mary Nabity, DVM, PhD, DACVP, Texas A&M University,
College Station, TX; and Warren E. Glaab, PhD, Merck ResearchLaboratories, West Point, PA

The Wednesday afternoon session “Bridging Nonclinical to ClinicalTranslation Using Emerging Science” will be co-chaired by Shashi
Ramaiah from Pfizer and Paul Snyder from EPL Inc. The session
begins with a brief overview on “Traditional Renal Biomarkers
and New Approaches to Diagnostics” by Dr. Mary Nabity from
Texas A&M University followed by a talk from Dr. Mireia Fernandez
Ocana from Pfizer on “Emerging Mass Spectrometry Analytical
Approach to Assess Glomerular Injury”. After the break, there will
be a student presentation followed by a talk from Dr. Vishal Vaidya
from Pfizer on “High-Throughput In Vitro Screening Approach to
Detect Nephrotoxicants”. The session closes with an emerging
therapeutic modality topic by Dr. Jessica Quimby from The Ohio
State University on “Stem Cell Therapy for Chronic Kidney Disease
in Cats”.

The Thursday morning session entitled “New Frontiers: Approaches
to Understand the Mechanistic Basis of Renal Toxicity” begins witha presentation on urinary miRNAs to monitor kidney injury and thepotential to provide mechanistic insight of such injury by Dr. Vishal
Vaidya from Pfizer, followed by a presentation by Dr. Joseph Pollifrom GSK on the role and impact of kidney membrane transporters
in drug-induced kidney toxicity. The third presentation from Dr.
Angela Hughes-Earle will present the use of MALDI imaging mass
spectrometry to quantify drug distribution in the kidney and therelationship of this distribution to drug-induced kidney injury.
Following the break, Dr. Andrzej Krolewski will give the final
presentation of the session on monitoring progressive kidney
injury in diabetic nephropathy.

1:15 PM–1:20 PM

Introduction

8:00 AM–8:05 AM

1:20 PM–2:15 PM

Introduction

Traditional Renal Biomarkers and New Approaches toDiagnostics

8:05 AM–9:05 AM

Urinary miRNAs As Biomarkers of Kidney Toxicity to
Provide Mechanistic Insight into the Location of Induced
InjuryMary Nabity, DVM, PhD, DACVP, Texas A&M University, College Station, TX
2:15 PM–3:00 PM

Vishal S. Vaidya, PhD, Pfizer, Boston, MA

Emerging Mass Spectrometry Analytical Approach toAssess Glomerular Injury

9:05 AM–10:05 AM

Mireia Fernandez Ocana, PhD, Pfizer Inc., Andover, MA

The Role of Kidney Membrane Transporters in Drug
Development and Impact on Drug-Induced Kidney
Toxicity

3:00 PM–3:30 PM

Break

Joseph W. Polli, GlaxoSmithKline, Research Triangle Park, NC

3:30 PM–3:45 PM

10:05 AM–10:35 AM

Student Speaker

Using MALDI Imaging Mass Spectometry to Quantify
Drug Distribution in Kidney and Relationship toDrug-Induced Kidney Injury

3:45 PM–4:25 PM

High-Throughput In Vitro Screening Approach to Detect
NephrotoxicantsAngela R. Hughes-Earle, DVM, GlaxoSmithKline, King of Prussia, PA

Vishal S. Vaidya, PhD, Pfizer, Boston, MA

10:35 AM–11:05 AM

4:25 PM–5:00 PM

Break

Stem Cell Therapy for Chronic Kidney Disease in Cats

11:05 AM–12:00 Noon

Jessica M. Quimby, DVM, PhD, DACVIM, The Ohio State University,
Columbus, OH

Monitoring Progressive Kidney Injury in Diabetic
Nephropathy
Andrzej S. Krolewski, MD, PhD, Joslin Diabetes Center, Boston, MA

12:00 Noon

Meeting Adjourned

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