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 4:25 Audience Participation

3 Vincent Meador Mergers 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

6 Lance Perryman Veterinary 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 Perryman College of Veterinary Medicine & Biomedical Sciences Colorado 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  Grad students, Residents - 35  DVM and undergraduate students  DVM students  Microbiology undergrad students - 201

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

MIP Leadership Present  Steve Benjamin, DVM, PhD, DACVP  Interim Head,  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

15 Joseph Mankowski Comparative 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

20 Lauren Tierney Technology 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 Pathology Technology Innovations, Data Sharing and Harmonization ACVP/STP Coalition Symposium 2011 Lauren 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 ((  “ 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

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