Pathology in Transition: Trends and Innovations in Academia and Industry

1. Joint Academia/Industry Presentation “Changing World : Changing Pathology” Drs. Chris Zink (Johns Hopkins) and Esther Trueblood (Amgen) Co-Chairs Drs. Joe Mankowski (Johns Hopkins), Vince Meador (Covance), Lance Perryman (Colorado State), Leah Schutt(Genentech), and Lauren Tierney (GlaxoSmithKline) Panelists

2. Agenda • 3:45 Chris Zink—Introduction • 3:50 Vince Meador—Mergers and Acquisitions in Industry • 3:57 Lance Perryman—Veterinary Pathology in Academia and Departmental Mergers • 4:04 Joe Mankowski—Comparative Pathology in Academic Medical Centers • 4:11 Lauren Tierney—Technology Innovations, Data Sharing, and Harmonization • 4:18 Leah Schutt—The Future of Veterinary Pathology • 4:25Audience Participation

3. Vincent MeadorMergers and Acquisitions in Industry • DVM, PhD from Iowa State University • Veterinary Medical Officer, USDA, National Animal Disease Center • Principal Research Pathologist, Schering-Plough Research • Director Toxicology and Pathology, Lilly Research Laboratories • Collaborating Professor, Iowa State University • Executive Director, Amgen Inc • Visiting Professor, National Chengdu Center for Safety Evaluation of Traditional Chinese Medicine, China • VP and CSO, Covance Inc

4. Mergers and Acquisitions • Mergers - Example • Acquisitions – Example of Acquiring portion of Staff and Laboratory Toxicology Laboratories

5. Affects on Pathology • Positions • Decreased number of positions in Pharma • Change in living location • Focus • Pharma decreasing GLP study work • Contract to CROs • Many Pharma retain Discovery and Lead Optimization • Shifts balance of GLP experience and expertise to CRO’s

6. Lance PerrymanVeterinary Pathology in Academia and Departmental Mergers • DVM, PhD from Washington State University • Professor, Department of Veterinary Microbiology and Pathology, Washington State University • Associate Dean for Research and Graduate Education, and Director of the Animal Health Research Center, College of Veterinary Medicine, Washington State University • Professor and Head, Department of Microbiology, Pathology, and Parasitology, College of Veterinary Medicine, North Carolina State University • Dean, College of Veterinary Medicine and Biomedical Sciences, Colorado State University

7. Veterinary Pathology in Academia and Departmental Mergers Lance Perryman College of Veterinary Medicine & Biomedical Sciences Colorado State University

8. Trends in Academia • Reduced state support constrains college and departmental budgets • Response - Merge Pathology with other disciplines and form large departments • CSU combined seven departments into four in 2001 • Non-pathologists (and non-veterinarians) often chair these large departments • Pathologists may lose identity and visibility in large multidisciplinary departments

9. Microbiology, Immunology and Pathology (MIP) at CSU – a merged department • Formed in 2001 by merging the former Department of Pathology with the former Department of Microbiology

10. Microbiology, Immunology and Pathology (MIP) at CSU – a merged department • Mission • Participate heavily in the DVM curriculum • Deliver an undergraduate degree in Microbiology • Engage in graduate education (MS and PhD degrees) • Conduct residency training (anatomical and clinical pathology, microbiology) • Staff most of the CSU Diagnostic Laboratory for the State of Colorado • Conduct research, primarily infectious diseases

11. Characteristics of CSU Microbiology, Immunology and Pathology Department • Personnel • Faculty - 69 • Staff - 20 • Research Associates, Postdocs - 108 • Grad students, Residents - 35 • DVM and undergraduate students • DVM students - 138 • Microbiology undergrad students - 201

12. Characteristics of CSU Microbiology, Immunology and Pathology Department • Research portfolio >$30M annually

13. MIP Leadership 2001- Present • Steve Benjamin, DVM, PhD, DACVP • Interim Head, 2001-2003 • Jeff Wilusz, PhD • Head, 2003 – 2007; NIH-funded investigator • Ed Hoover, DVM, PhD, DACVP, UDP • Head 2008 – 2011; NIH-funded investigator • Gregg Dean, DVM, PhD, DACVP • Head, 2011 – present; NIH-funded investigator

14. Observations on merged departments • Require skilled leadership, often administered through teams • Department Heads lead by example – MIP faculty expect the Head to direct a strong research program funded by NIH • My preference for department head • DVM, PhD, DACVP credentials • Supported by grant funds from NIH

15. Joseph MankowskiComparative Pathology in Academic Medical Centers • DVM, Cornell University • PhD Johns Hopkins University, • Associate Professor, Johns Hopkins University • Department of Molecular & Comparative Pathobiology • Department of Pathology • Department of Neurology • Visiting Scientist, University of Southampton, UK

16. Comparative Pathology In Academic Medical Centers

17. Opportunities A spectrum of classic Comparative Medicine roles • Clinical diagnostic support – partnership with LAM • Teaching mission – DVM , MD, PhD • Collaborative research teams: experimental pathology • Translational science - cutting edge interdisciplinary teams • Principal Investigator role

18. Challenges • Funding for research and training programs • NCRR uncertainty • Recruiting trainees with a passion for research • Recruiting and retaining faculty

20. Lauren TierneyTechnology Innovations, Data Sharing, and Harmonization • DVM from Tufts University • PhD from University of New Mexico, Inhalation Toxicology • Residency Johns Hopkins University, NSRA service grant • Director of Pathology, GlaxoSmithKline

21. The Future of Veterinary Pathology Technology Innovations, Data Sharing and Harmonization ACVP/STP Coalition Symposium 2011 • Lauren Tierney DVM, PhD, DACVP • GlaxoSmithKline

22. The Future of Veterinary Pathology • Technology Innovations: Digital Pathology • Data Sharing: SEND (The Future of Electronic Data Submissions) • Harmonization: INHAND Initiative

23. Technology Innovations: Digital Pathology • Scanning of glass slide content into digital slide images • New generation digital microscopes with server interface ImageScope/Scanscope • Challenges: limiting bandwidth, slow refresh rate; acceptance; validation requirement for whole slide imaging in regulated environments • Opportunities: Facilitates/Accelerates interaction at remote sites/emerging R&D centers; allows slide review without travel (remember Icelandic volcano?); No CITES permit requirement (NHP material) • Digital Pathology Association ((http://digitalpathologyassociation.org) • “Validation of Digital pathology systems in the regulated nonclinical environment “

24. Technology Innovations: continued Will it be possible to submit digitally “read” studies to regulatory agencies ? FDA digital pathology workforce • Concerns about the accuracy and reproducibility of digital slide images vs. glass slides • Currently categorizes whole slide imaging devices as Class III (sufficient information not available to insure safety and effectiveness through the application of general and specific controls) • Concern for patient safety if digital slide is read incorrectly (primarily clinical concern but has similar implications in digital peer review of regulated nonclinical studies) • Awaiting Final decision!

25. Harmonization: INHAND The New Nomenclature Project • International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice • Global initiative ESTP, RITA,STP,BSTP,JSTP • GESC • Organ Working Groups • STP members!!

26. Data Sharing: SEND Standard for Exchange of Nonclinical Data • The Future of Electronic Data Submissions (including nonclinical pathology tabular data) • Proposed regulatory Standard for Exchange of Nonclinical Data sponsored by a data interchange standards consortium (CDISC).  • Goal to have standards for nonclinical data exchange, not just with the regulatory agencies but also between laboratories • FDA is recommending, although not yet required • FDA and INHAND Steering Committee ongoing discussions on potential use of INHAND terminology as preferred terminology for SEND • Potential benefits • Streamlined process from report to submission, quicker regulatory review, ability to incorporate external data in-house study data warehouse, more efficient way to share data with the various consortium, • Logistics of translating existing data streams into the SEND format

27. Leah SchuttThe Future of Veterinary Pathology • DVM, DVSc from University of Guelph, ON, Canada • ACVP/STP Coalition Fellowship, • Industry Sponsor Genentech • Scientist, Genentech Inc