Continuing Education

Integration of Toxicology and Pathology in Drug Discovery and Development

Registration is now live!

Integration of Toxicology & Pathology in Drug Discovery & Development
10th Industrial Toxicology and Pathology Short Course

August 14-16, 2019 at Lilly Research Laboratories
307 E. Merrill Street, Building 98B, Indianapolis, IN 46225 USA

Register Now

Course Co-Directors:
Drs. Wanda M. Haschek-Hock, BVSc, PhD, DACVP, DABT, FIATP, Department of Pathology, University of Illinois (whaschek@illinois.edu) and Katie Heinz-Taheny, DVM, PhD, DACVP, DABT, Senior Research Advisor — Pathology, Eli Lilly (heinztahenykm@lilly.com).

  • August 14, 2019

    Session 1: Target Identification Through Candidate Selection

    7:00-8:00 amBreakfast
    8:00-8:10 am Welcome
    8:10- 9:10 amOverview of Drug Discovery and Development
    Gary Krishnan, MS, PhD
    Senior Research Fellow Biotechnology and Immunology Research
    Eli Lilly

    This session will outline the drug discovery process and will highlight the assessment of benefit/risk throughout the drug discovery and development continuum.
    9:10- 10:10 amEarly Discovery Activities, Strategies, and Tools in the Pharmaceutical Industry
    Richard Westhouse,  DVM, PhD, DACVP (Anatomic Pathology)
    Senior Principal Veterinary Pathologist
    Bristol-Myers Squibb

    This session will discuss the expanding role of the toxicologist and pathologist within early Drug Discovery
    with the recurring theme of contributing beyond the typical skill set and engaging with other scientists in a
    matrixed organization on a deeper basis. Examples in target selection, lead selection from in vitro to
    efficacy models, and translational strategies will be presented.
    10:10- 10:30 amBreak
    10:30-11:30 amEarly Safety Assessment in Lead Identification and Optimization
    Dan Rudmann, DVM, PhD, DACVP, FIATP
    Senior Veterinary Pathologist
    Charles River Laboratories

    In this presentation, the potential approaches for increasing probability of technical success by incorporating safety assessment in the research phases of drug development will be described.  Key questions and decisions for the Lead Identification and Optimization stages will be highlighted with respect to the overall objectives of the project team as well as the Safety Assessment organization.  Both traditional and emerging experimental approaches will be presented using both published case studies and the presenter’s experiences in the pharmaceutical industry.   The considerable value gained by the active engagement of the toxicologist and pathologist and characterizing safety signals early will be demonstrated.
    11:30- 12:15 pmBreak-Out Session 1: Early Safety Assessment and Lead Optimization Assessment of Drug Candidates of Interest
    Paul Cornwell, PhD, DABT
    Principal Research Scientist Toxicology
    Eli Lilly
    Wei Wang, PhD, DABT
    Senior Research Scientist Toxicology
    Eli Lilly

    Participants will be given data from a hypothetical drug development program that is very early in development.  They will be asked to analyze the data and discuss the decisions that a toxicologist would typically have to make at that point in development.
    12:15- 1:15 pmLunch

    Session 2: Nonclinical Repeat Dose Safety Studies

    1:15- 2:15 pmSmall Molecule Nonclinical Toxicology from Drug Candidate to Patient
    Katie Heinz-Taheny, DVM, PhD, DACVP, DABT
    Senior Research Advisor Pathology
    Eli Lilly

    This session will define the principles of Good Laboratory Practice and give a brief overview of the general process of nonclinical development.
    2:15-2:45 pmBreak-Out Session 2: Candidate Evaluation
    Paul Cornwell, PhD, DABT
    Principal Research Scientist Toxicology
    Eli Lilly
    Wei Wang, PhD, DABT
    Senior Research Scientist Toxicology
    Eli Lilly

    Participants will be given data from a hypothetical drug development program that is later in clinical development (post phase 1).  They will be asked to analyze the data and discuss the decisions that a toxicologist would typically have to make at that point in development.
    2:45-3:30 pmDrug Absorption, Disposition, Metabolism, Excretion (ADME)/ Pharmacokinetics Pharmacodynamics (PKPD)
    David Stresser, PhD
    Principal Research Scientist
    AbbVie

    This presentation will focus on basic ADME principles as it relates to pharmacokinetics, pharmacodynamics, and drug to drug interactions.  Important concepts include therapeutic index, potential activity/toxicity of metabolites, and whether drugs may induce or inhibit drug metabolizing enzymes and/or transporter proteins will be discussed.
    3:30- 4:30 pmDifferences in Nonclinical Safety Assessment of Biotherapeutics Versus Small Molecules
    Michael Leach, DVM, PhD, DACVP
    Drug Safety R&D Licensing Lead and Biologics Safety Lead
    Pfizer

    There are fundamental differences in the nonclinical development studies to support biotherapeutics compared with small molecules. This session will discuss these differences and provide strategies for the successful development of biotherapeutics.
    4:30- 5:30 pmBreak and Tour
    5:30- 7:30 pmReception and Social

    August 15, 2019

    Session 3: Nuts and Bolts of Repeat Dose Studies: Toxicology and Pathology Perspectives

    7:00- 8:00 amBreakfast
    8:00- 8:10 amWelcome
    8:10- 9:10 amClinical Pathology for Drug Safety Studies
    Adam Aulbach, DVM, DACVP
    Scientific Director in Clinical Pathology/Biomarkers
    Charles River Laboratories

    This session will review current clinical pathology testing practices used in drug safety studies with an emphasis on appropriate application and study design principles. It will also highlight the importance of using an integrated approach when incorporating clinical pathology findings into nonclinical toxicology studies.
    9:10- 10:10 amArt and Science of Anatomic Pathology
    Ken Schafer, DVM, PhD, DACVP
    Senior Pathologist
    StageBio

    The anatomic pathology assessment of a nonclinical toxicology study is often a black box to outside observers. This presentation will attempt to demystify what it is that anatomic pathologists do and why they do things in a particular way. This will include discussions of digital images, study evaluation, peer review, and pathology working groups.
    10:10- 10:30 amBreak
    10:30- 11:00 amAdversity Calls and No Adverse Effect Level (NOAEL) Determination
    Brad Bolon, DVM, MS, PhD, DACVP, DABT, FATS, FIATP, FRCP
    President and Pathologist
    GEMpath

    This talk will briefly introduce the concepts of findings vs. lesions and the factors that are considered when
    defining whether or not a change should be considered non‐adverse or adverse.
    11:00- 11:45 amBreak-out Session: NOAEL
    Ken Frazier, DVM, PhD, DACVP, DABT, FIATP
    Director of Pathology and Sr. Science Fellow
    GlaxoSmithKline

    A real world case study will be presented in which individuals will be asked to determine which toxicities are adverse and then to determine what the NOAEL is for the study and to discuss clinical implications based on this data.
    11:45- 12:45 pmLunch
    12:45- 1:30 pmPanel Discussion on Team Assignments of NOAELs
    Brad Bolon, DVM, MS, PhD, DACVP, DABT, FATS, FIATP, FRCP
    President and Pathologist
    GEMpath
    Ken Frazier, DVM, PhD, DACVP, DABT, FIATP
    Director of Pathology and Sr. Science Fellow
    GlaxoSmithKline

    This team‐based interactive session will provide practical tips from experienced toxicologic pathologists
    regarding assignment of adversity and determining NOAELs.
    1:30- 2:10 pmThe Design and Writing of the Nonclinical Study Report
    Mike Sievert, PhD, DABT
    Study Director
    Covance Laboratories

    In this session, we will look at the information that goes into a nonclinical study report that will be used for regulatory submission and the steps that are taken in the report compiling.
    2:10- 3:00 pmTranslatability of Nonclinical Studies to Clinical Human Safety Outcomes
    Ken Frazier, DVM, PhD, DACVP, DABT, FIATP
    Director of Pathology and Sr. Science Fellow
    GlaxoSmithKline

    In drug development, target organ toxicity may be encountered as preclinical findings in animal toxicity studies or as clinical adverse events in human trials. The clinical translatability of nonclinical findings may vary markedly depending on the type and nature of the drug-induced injury. This lecture will focus on how to put preclinical findings in proper perspective and to list the limitations that may alter the clinical risk assessment. Differences in species susceptibility, pre-existing disease or concurrent medications, organ distribution of drug, clearance and metabolism all can have a major effect on drug disposition, and this may affect susceptibility of organ toxicity in patients in clinical trials. Organ systems such as kidney, liver, or heart are examples where there are direct clinical implications of nonclinical toxicities, whereas other examples such as immune complex disease or lesions in rodent bones or teeth are presented with reasons why they are of much less clinical concern.
    3:00-3:30 pmBreak
    3:30- 4:15 pmThe Role of Toxicology in Drug Development: Support of Clinical Trials and Human Safety
    Maggie Dempster, PhD, DABT
    Director, Biopharmaceutical Projects, Nonclinical Safety Projects
    GlaxoSmithKline

    This presentation will discuss how nonclinical safety assessment studies are needed to generate sufficient safety data to progress into the clinic and will include why toxicology studies are needed, what type of studies are required for both small and large molecules, and when these studies are conducted with respect to the clinical development of a product.
    4:15- 5:15 pmA Regulatory Viewpoint on Nonclinical Submissions
    Deepa B. Rao, BVSc, MS, PhD, DABT, DACVP, FIATP
    Toxicologist/Veterinary Pathologist

    This presentation will include an overview of the content, review, and evaluation of nonclinical information in New Drug Applications (small molecules). Relevant guidance documents, variables impacting review and evaluation of nonclinical data and some pointers for toxicologists and pathologists will be highlighted.
    5:15-6:15 pmToxicologist and Pathologist Perspectives from Pharma, Contract Research Organization (CRO), and Small Biotech Roundtable
    Mike Sievert, PhD, DABT
    Study Director
    Covance Laboratories
    Tara Arndt, DVM, DACVP (Clinical), DACVP (Anatomic)
    Staff Pathologist
    Covance Laboratories
    Robert Johnson, DVM, PhD, DABT, DACVP
    Research Advisor Pathology
    Eli Lilly
    Kevin Donnelly, DVM, PhD, DABT
    Research Advisor Toxicology
    Eli Lilly

    Panel discussion on the life of a Toxicologist/Pathologist in the industry.
    7:00 pmDinner TBD

    August 16, 2019

    Session 4: Additional Safety Assessments

    7:00- 8:00 amBreakfast
    8:00- 8:10 amWelcome
    8:10- 8:50 amSafety Pharmacology
    Derek Leishman, PhD, DSP
    Senior Research Fellow Toxicology
    Eli Lilly

    The presentation will focus on what is safety pharmacology, what are the regulatory requirements, and which studies are commonly carried out and when.  The history of the discipline of safety pharmacology will be illustrated as the presentation unfolds.  What is known about translation between animals and man is a key issue and will be part of the presentation.  Future developments in the field involving quantitative modeling will finish off the presentation.
    8:50- 9:30 amAbuse Liability Assessment
    Lorrene Buckley, MS, PhD, DABT, FATS
    Senior Research Fellow Toxicology
    Eli Lilly

    Drug abuse liability assessments are required as part of the nonclinical safety assessment of CNS active drugs.  In addition to understanding the target biology of these drugs, specific studies, usually in rodents, include physical dependence, drug discrimination, and self-administration.  FDA guidance (Jan 2017) provides some detail regarding the design and conduct of these studies, although a significant amount of judgement is still needed.  Some clinical assessment of DAL is also typically required.
    9:30- 10:30 amDevelopmental and Reproductive Toxicology, Juvenile Studies, and Special Considerations for Pediatric Indications
    George Parker,  DVM, PhD, DACVP, DABT
    Senior Scientific Director, Global Pathology Department
    Charles River Laboratories

    Studies involving developmental and reproductive issues, as well as studies involving juvenile animals that may be undergoing postnatal organ development, represent a special subset of toxicology studies that require specific background knowledge on the part of the study pathologist. This presentation is intended to provide a general overview of the requisite background knowledge.
    10:30- 11:00 amBreak
    11:00- 12:00 pmCarcinogenicity Studies
    Tom Larsen, DVM, DACVP
    Senior Pathologist
    Covance Laboratories

    This presentation will focus on current animal carcinogenicity models, study design, neoplastic and non-neoplastic background findings, and the pathologic and statistical interpretation of background and toxicologic data generated from carcinogenicity studies.
    12:00- 1:00 pmLunch
    1:00- 1:30 pmVeterinary Pharmaceutical Discovery and Preclinical Assessment
    David Garcia-Tapia, DVM, MS, PhD, DACVP
    Research Advisor Pathology
    Eli Lilly

    Discussion of the basis of toxicological assessment and regulatory safety requirements for the development of drugs for veterinary use (pharmaceutical and biopharmaceuticals for the use in companion and/or food production animals).
    1:30- 1:50 pmBreak
    1:50- 2:20 pmMedical Devices: A Different Pathway Towards Establishing Safety and Efficacy
    Lyn Wancket, DVM, PhD, DACVP
    Veterinary Pathologist
    Charles River Laboratories

    Medical devices present unique challenges during the safety assessment and regulatory approval processes. This talk will use the details of a recent recall of a category of medical devices to illustrate key steps in medical device testing, approval, and clinical use.

    Session 5: Clinical Trials to Postmarketing

    2:20- 3:10 pmPrincipals of Clinical Research
    Aimee Bence Lin, PhD
    Senior Research Advisor
    Eli Lilly

    The principles of clinical research, including Good Clinical Practice (GCP), dose selection, and clinical trial design will be discussed.
    3:10- 3:40 pmBreak
    3:40- 4:40 pmRegulatory Submission, Registration, and Product Launch
    Maggie Dempster, PhD, DABT
    Director, Biopharmaceutical Projects, Nonclinical Safety Projects
    GlaxoSmithKline

    This presentation will focus on the later stages of the nonclinical safety assessment development of a product needed to support registration, construction of the regulatory documents, and answering regulatory question following submission. In addition, this presentation will discuss support of the product following launch.
    4:40- 5:30 pmLate Stage Attrition in Drug Dvelopment: Causes and Potential Solutions
    Ken Frazier, DVM, PhD, DACVP, DABT, FIATP
    Director of Pathology and Sr. Science Fellow
    GlaxoSmithKline

    The number of drug candidate compounds in development has increased enormously in the last decade, but paradoxically the average number of new drugs approved by the FDA per year has declined in the same period. Countless candidates have been withdrawn during drug discovery and clinical trial phases due to poor pharmacokinetic properties, lack of safety and efficacy, commercial interests, market competition, and other factors. This lecture will focus on drug attrition related to safety concerns and will describe recent important efforts on behalf of the pharmaceutical industry to prevent late stage drug attrition and instead to identify the best drug candidates early in the discovery phase prior to huge resource investments. These methods include early targeted safety reviews, improved and clinically-relevant animal models, off-target profiling by transcriptomic or protein binding analysis, and emphasis on selective drug targeting and in vitro cell based predictive systems.

     

    Program Planning Committee:

    • Tara Arndt, DVM, DACVP (clinical), DACVP (Anatomic), Covance Laboratories, Madison, WI, USA
    • John R Foster BSc, PhD, DipRCPath, FRCPath, FIATP, HonFBTS, ToxPath Sciences Ltd., UK
    • Ken Frazier, DVM, PhD, DACVP, DABT, FIATP, GlaxoSmithKline, King of Prussia, PA, USA
    • Sabine Francke, DVM, Dr.vetmed., PhD, DABT, FIATP, CFSAN/FDA, College Park, MD, USA
    • Warren E. Glaab, PhD, Merck Research Laboratories, West Point, PA, USA
    • Wanda M. Haschek-Hock, BVSc, PhD, DACVP, DABT, FIATP, University of Illinois, Urbana, IL, USA
    • Katie Heinz-Taheny, DVM, PhD, DACVP, DABT, Eli Lilly, Indianapolis, IN, USA

    Register Now

  • Participants must pre-register for the event. No onsite registration available.

    Early Registration

    On or before July 7, 2019 

    STP Member: $850
    Non-STP Member: $1,000
    Toxicology or Pathology Student: $50
    Other Student Attendees: $250

    Late Registration

    July 7, 2019 – August 8, 2019

    STP Member: $1,000
    Non-STP Member: $1,250
    Toxicology or Pathology Student: $75
    Other Student Attendees: $275

    Cancellation Policy

    Full refunds, less a 10 percent cancellation fee, will be given if written notification is received by the applicable early registration deadline. Written cancellation should be sent to ope@vetmed.illinois.edu or to the same mailing address to which registrations are sent. Registrations are transferable. After the applicable early registration deadline, refunds will not be made. We reserve the right to cancel sessions and to change speakers if necessary. In the event of cancellation, all registrants will receive a full refund. The University is not responsible for travel expenses in the event of a cancellation or date change.

    Continuing Education

    Veterinarians will be able to earn 22 CE credits for this event. Participants will receive continuing education verification at the end of the event.

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  • The rates listed below are discounted for this course.

    SpringHill Suites (The link will take you to a special reservation website for this event.) 
    $149
    601 W Washington St, Indianapolis
    Contact: 317-860-5800
    Reservation Deadline: Monday, July 15, 2019

    Fairfield Inn and Suites (The link will take you to a special reservation website for this event.) 
    $139
    501 W Washington St, Indianapolis
    Contact: 317-860-5800
    Reservation Deadline: Monday, July 15, 2019

    Staybridge Suites
    $109
    535 S West St, Indianapolis
    Contact: 317-536-7500
    Reservation Deadline: Sunday, July 14, 2019

    Holiday Inn Indianapolis Downtown
    $109
    410 S. Missouri, Indianapolis
    Contact: 317-822-6400
    Reservation Deadline: Sunday, July 14, 2019

  • Lilly Research Laboratories

    307 E. Merrill Street
    Building 98B
    Indianapolis, IN 46225 USA

    Click here for driving directions to Eli Lilly Global Headquarters.

    Parking

    Gated onsite visitor parking is limited and available on a first come, first serve basis. Carpooling with other participants or utilizing any available hotel shuttle service is recommended. Additional public parking is available within the area for a fee.

  • Fundamentals of Toxicologic Pathology, Third Edition
    Wallig, M. A., Haschek, W. M., Rousseaux C. G., Bolon, B, Mahler, B.W..eds. (2017) “Fundamentals of Toxicologic Pathology.” 3rd Edition, Elsevier.

    Handbook of Toxicologic Pathology 3rd Edition
    Haschek, W. M., C. G. Rousseaux and M. A. Wallig, eds. (2013) “Haschek and Rousseaux’s Handbook of Toxicologic Pathology”, 3rd Edn. Elsevier Inc., Academic Press.

    Toxocologic Pathology: Nonclinical Safety Assessment, Second Edition
    Sahota, P S., Popp J A.et al.,  (2018) “Toxocologic Pathology: Nonclinical Safety Assessment, Second Edition,” CRC Press. 

 

Contact: ope@vetmed.illinois.edu, 217-333-2907,  or check go.illinois.edu/ITP for upcoming information.