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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

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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• 4:25 Audience Participation

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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

Mergers and Acquisitions• Mergers - Example

• Acquisitions – Example of Acquiring portion of Staff and Laboratory Toxicology

Laboratories

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

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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

Veterinary Pathology in Academia and Departmental Mergers

Lance PerrymanCollege of Veterinary Medicine &

Biomedical SciencesColorado State University

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

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

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

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

Characteristics of CSU Microbiology, Immunology and Pathology Department

Research portfolio >$30M annually

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

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

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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

Comparative Pathology In Academic Medical Centers

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

Challenges

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

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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

The Future of Veterinary PathologyTechnology Innovations, Data Sharing and

Harmonization

ACVP/STP Coalition Symposium 2011Lauren Tierney DVM, PhD, DACVP

GlaxoSmithKline

The Future of Veterinary Pathology

• Technology Innovations: Digital Pathology• Data Sharing: SEND (The Future of Electronic Data

Submissions)• Harmonization: INHAND Initiative

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 “

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!

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!!

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

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Leah SchuttThe Future of Veterinary Pathology

• DVM, DVSc from University of Guelph, ON, Canada• ACVP/STP Coalition Fellowship,

– Industry Sponsor Genentech

• Scientist, Genentech Inc