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 Eli Lilly, Indianapolis, Indiana, 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).

  • Schedule

    DRAFT

    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
    Gary Krishnan, MS, PhD
    Senior Research Fellow- Biotechnology and Immunology Research
    Eli Lilly- Indianapolis, IN
    9:10- 10:10 amRole of Early Toxicologist and Pathologist in Drug Discovery
    Myrtle Davis,  DVM, Ph.D.
    Chief, Toxicology and Pharmacology Branch
    Bristol-Myers Squibb
    10:10- 10:30 amBreak
    10:30-11:30 amEarly safety assessment in lead (drug candidate) identification and optimization (approaches, decisions and integration)
    Dan Rudmann, DVM, PhD, DACVP
    Senior Veterinary Pathologist
    Charles River Laboratories – Ashland, OH
    11:30- 12:15 pmBreak-out Session 1: Early Safety Assessment
    and/or
    Break-out Session 2: Lead Optimization Assessment of Drug Candidates of Interest
    Paul Cornwell, PhD, DABT
    Principal Research Scientist-ToxicologyWei Wang, PhD, DABT
    Senior Research Scientist-Toxicology
    Eli Lilly – Indianapolis, IN
    12:15- 1:15 pmLunch

    Session 2: Nonclinical Repeat Dose Safety Studies

    1:15- 2:15 pmNonclinical Toxicology from Drug Candidate to Patient/ Overview of Pharmaceutical Research and Development Process, Global Regulatory Structure, International Conference on Harmonization (ICH) Guidelines, GLPs and Approval Process
    Katie Heinz-Taheny, DVM, PhD, DACVP, DABT
    Senior Research Advisor-Pathology
    Eli Lilly – Indianapolis, IN
    2:15-2:45 pmBreak-out Session 3: Candidate Evaluation
    Paul Cornwell, PhD, DABT
    Principal Research Scientist-ToxicologyWei Wang, PhD, DABT
    Senior Research Scientist-Toxicology
    Eli Lilly – Indianapolis, IN
    2:45-3:30 pmDrug Absorption, Disposition, Metabolism, Excretion (ADME)/ Pharmacokinetics Pharmacodynamics (PKPD)
    David Stresser, PhD
    Principal Research Scientist
    AbbVie
    3:30- 4:30 pmDifferences in Nonclinical Safety Assessment of Small Molecules versus Biotherapeutics Including Immunotoxicology
    Michael Leach, DVM, PhD
    Drug Safety R & D Licensing Lead and Biologics Safety Lead
    Pfizer
    4:30- 5:30 pmBreak and Tour
    5:30- 7:30 pmReception and Social

    August 15, 2019

    Session 2: Nuts and Bolts of Repeat Dose Studies: Tox and Path 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
    Charles River Laboratories – Mattawan, MI
    9:10- 10:10 amAnatomic Pathology and the Art of the Peer Review
    Ken Schafer, DVM, PhD, DACVP
    Senior Pathologist
    Vet Path Services – Greenfield, IN
    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
    President and Pathologist
    GEMpath – Longmont, CO
    11:00- 11:45 amBreak-out Session: NOAEL

    Brad Bolon, DVM, MS, PhD, DACVP, DABT, FATS, FIATP
    President and Pathologist
    GEMpath – Longmont, CO

    Ken Frazier, DVM, PhD, DACVP, DABT
    Director of Cellular & Molecular Pathology
    GlaxoSmithKline – King of Prussia, PA

    11:45- 12:45 pmLunch
    12:45- 1:30 pmDiscussion on how teams assigned NOAELs

    Brad Bolon, DVM, MS, PhD, DACVP, DABT, FATS, FIATP
    President and Pathologist
    GEMpath – Longmont, CO

    Ken Frazier, DVM, PhD, DACVP, DABT
    Director of Cellular & Molecular Pathology
    GlaxoSmithKline – King of Prussia, PA

    John Vahle, DVM, PhD, DACVP
    Senior Research Fellow, Toxicology and Pathology
    Eli Lilly – Indianapolis, IN

    1:30- 2:10 pmThe Design and Writing of the Non-Clinical Study Report
    Mike Sievert, PhD
    Study Director
    Covance – Madison, WI
    2:10- 3:00 pmHuman Relevance of Nonclinical Tox Findings OR Predictivity of Nonclinical Studies
    Ken Frazier, DVM, PhD, DACVP, DABT
    Director of Cellular & Molecular Pathology
    GlaxoSmithKline – King of Prussia, PA
    3:00-3:30 pmBreak
    3:30- 4:15 pmRole of Toxicology in Drug Development: Support of Clinical Trials and Human Safety
    Maggie Dempster, PhD
    Director, Biopharmaceutical Projects, Non-Clinical Safety Projects
    GlaxoSmithKline – King of Prussia, PA
    4:15- 5:15 pmA Regulatory Viewpoint on Nonclinical Submissions
    Deepa Rao, BVSc, MS, PhD, DABT, DACVP–Pending Confirmation
    FDA Center for Drug Evaluation and Research – Silver Spring, MD
    5:15-6:15 pmToxicologist and Pathologist Perspectives from Pharma, Contract Research Organization (CRO) and Small Biotech Roundtable
    7:00 pmDinner TBD: Trivia Quiz Bowl

    August 16, 2019

    Session 3: Additional Safety Assessments

    7:00- 8:00 amBreakfast
    8:00- 8:10 amWelcome
    8:10- 8:50 amSafety Pharmacology
    Derek Leishman, PhD
    Senior Research Fellow-Toxicology
    Eli Lilly – Indianapolis, IN
    8:50- 9:30 amAbuse Liability Assessment (nonhuman primate, rodent and human studies)
    Lorrene Buckley, PhD, ABT, ATS
    Senior Research Fellow-Toxicology
    Eli Lilly – Indianapolis, IN
    9:30- 10:30 amDevelopmental and Reproductive Toxicology, Juvenile Nonclinical Studies and Special Considerations for Pediatric Indications
    George Parker,  DVM, PhD, DACVP, DABT
    Senior Scientific Director, Global Pathology Department
    Charles River Laboratories – Hillsborough, NC
    10:30- 11:00 amBreak
    11:00- 12:00 pmCarcinogenicity Studies
    Tom Larsen, DVM, DACVP
    Senior Pathologist
    Covance – Chantilly, VA
    12:00- 1:00 pmLunch
    1:00- 1:30 pmVeterinary Pharmaceutical Discovery and Preclinical Assessment
    David Garcia-Tapia, DVM, PhD, DACVP
    Research Advisor-Pathology
    Eli Lilly – Indianapolis, IN
    1:30- 1:50 pmBreak
    1:50- 2:20 pmMedical Devices
    Lyn Wancket, DVM, Ph.D., Diplomate, ACVP
    Veterinary Pathologist
    Charles River Laboratories – Raleigh-Durham, NC

    Session 4: Clinical Trials to Postmarketing

    2:20- 3:10 pmClinical Dose-Selection/Pharmacodynamics; Human Clinical Trials (Phase I through III)/Good Clinical Practices (GCPs)
    Aimee Bence Lin, PhD
    Senior Research Advisor-Early Phase
    Eli Lilly – Indianapolis, IN
    3:10- 3:40 pmBreak
    3:40- 4:40 pmRegulatory Submission, Registration and Product Launch
    Maggie Dempster, PhD
    Director, Biopharmaceutical Projects, Non-Clinical Safety Projects
    GlaxoSmithKline – King of Prussia, PA
    4:40- 5:30 pmDrug Attrition
    Ken Frazier, DVM, PhD, DACVP, DABT
    Director of Cellular & Molecular Pathology
    GlaxoSmithKline – King of Prussia, PA

     

    Program Planning Committee:

    • Tara Arndt, DVM, DACVP, Covance, 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

  • Registration Information

    Early Registration

    On or before July 7, 2019 

    STP Member: $850
    Non-STP Member: $1,000
    Student: $50

    Late Registration

    After July 7, 2019

    STP Member: $1,000
    Non-STP Member: $1,250
    Student: $75

    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 CE credits for this event; the exact number of hours will be determined once the schedule is finalized. Participants will receive continuing education verification at the end of the event.

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  • Hotel Information

    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

    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

    Staybridge Suites
    $109
    535 S West St, Indianapolis
    Contact: 317-536-7500

    Holiday Inn Indianapolis Downtown
    $109
    410 S. Missouri, Indianapolis
    Contact: 317-822-6400

  • Toxicology and Pathology Resources

    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.