Continuing Education

Integration of Toxicology and Pathology in Drug Discovery and Development

Coming in 2019!

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

July 29- 31, 2019 at Eli Lilly, Indianapolis, Indiana, USA.

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, Eli Lilly (heinztahenykm@lilly.com).

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, Eli Lilly, Indianapolis, IN, USA
  • Schedule

    July 29, 2019

    Session 1: Target Identification Through Candidate Selection

    7:00-8:00 amBreakfast
    8:00-8:10 am Welcome
    8:10- 9:10 amHigh level overview of drug discovery and development, what functions are involved, diverse array of therapeutic modalities (small mol, gene therapy, biologics, etc)
    Gary Krishnan, MS, PhD
    Senior Research Fellow- Biotechnology and Immunology Research
    Eli Lilly- Indianapolis, IN
    9:10- 10:10 amDrug Discovery: How targets are chosen, in vivo and in vitro efficacy models, other tools, role of Discovery pathologist and early tox project leader
    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-Toxicology

    Wei 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-Toxicology

    Wei 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
    John Vahle, DVM, PhD, DACVP
    Senior Research Fellow, Toxicology and Pathology
    Eli Lilly – Indianapolis, IN
    4:30- 5:30 pmBreak and Tour
    5:30- 7:30 pmReception and Social

    July 30, 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

    Ken Frazier, DVM, PhD, DACVP, DABT
    Director of Cellular & Molecular Pathology

    John Vahle, DVM, PhD, DACVP
    Senior Research Fellow, Toxicology and Pathology

    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

    Ken Frazier, DVM, PhD, DACVP, DABT
    Director of Cellular & Molecular Pathology

    John Vahle, DVM, PhD, DACVP
    Senior Research Fellow, Toxicology and Pathology

    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
    FDA – 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

    July 31, 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, Juvi 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

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

To be placed on the waiting list to be alerted when registration opens, please email ope@vetmed.illinois.edu.