1. Partnerships Between Academic Pathology and Biotech/Biopharma
Jeffrey S. Ross, MD
Department of Pathology and Laboratory Medicine
Albany Medical College, Albany, NY
Foundation Medicine, Inc., Cambridge, MA

2. Partnering with Pharma and Biotech (First Decade
1989: AMC Pathology in dire need of specimen increases to enable sub- specialization
Roche Biomedical Labs
1992: Image Analysis grows in popularity
Roche Image Analysis Systems
1994: FISH Technique Emerges
Oncor
HER2 in Breast Cancer
Aneusomy in bladder cancer
1998: Herceptin and Herceptest Approved Together
Genentech
Ventana Medical Systems

3. Partnering with Pharma and Biotech (Second Decade)
1999: Transcriptional Profiling Emerges
Millennium Pharmaceuticals
“Personalized Medicine” at Millennium Predictive Medicine
FDA Approval of Bortezomib (Velcade)
2003: Liquid Biopsy Emerges
Veridex-J&J
2006: Companion Diagnostics
Genentech
Bristol Myers Squibb
Pfizer
Daiichi-Sankyo
Boehringer-Ingelheim

4. Partnering with Pharma and Biotech (Third Decade)
2009: Comprehensive Genomic Profiling Era is Launched
Foundation Medicine

5. Possible Reasons for an Academic Pathology Department to Partner with the Pharma/Biotech Industry (1)
Access to technology
More important for smaller departments in smaller, less well funded academic health sciences centers
Get closer to the “Cutting Edge”
Department research support
Pharma/Biotech needs access to annotated clinical samples
Faculty and Technician support possible
Obtain Clinical Trials and Regulatory Agency Experiences
Principle investigator opportunities for faculty
Experience in 510k and PMA application process

6. Possible Reasons for an Academic Pathology Department to Partner with the Pharma/Biotech Industry (2)
Create data for:
Abstract generation for National meetings
Preliminary data for NIH, VA, DoD and other Federal and non-Federal grants
Generate Peer-Reviewed Publications
Pathology literature
Non-pathology literature (Oncology, Cardiovascular, etc.)
Intellectual Property Creation
Patents
Royalties
Equity

7. Possible Reasons for an Academic Pathology Department to Partner with the Pharma/Biotech Industry (3)
Education and Training Opportunities
Pathology resident/fellow participation in data analysis and abstract/full-length manuscript generation
On site rotations and fellowships for pathology residents/fellows
Exposure to technology not available at the training program site
Residents/fellows learn about career opportunities in Industry
Development of Pharma/Biotech “incubator facilities”
On campus entrepreneurial programs
New and “spin-off” company startups based on faculty discoveries
University Marketing and “Public Relations”
Local job creation
Ultimate State and Local Tax payments
Public informed of “cutting edge” partnerships between University and Industry

8. FOUNDATION MEDICINE
HISTORY
Founded in 2010 by Scientists and Clinicians from the Broad Institute of MIT
Began patient testing in 2011
Has issued >90,000 clinical reports
CLIA, CAP, and NYSDOH certified and accredited
Offers multiple tests to assist in the care of cancer patients
Covered by Medicare and numerous national health insurance providers
Roche acquired majority stake in 2015
Anticipating FDA Approval as a Clinical Diagnostic Test and Universal Companion Diagnostic in 2017 by Parallel Review

9. FOUNDATION MEDICINE
MILESTONES
First to adapt Illumina Hybrid Capture HiSeq system to FFPE samples on a large scale
Discovery of numerous genomic alterations associated with cancer
RET and NTRK gene fusions in NSCLC
ESR1 mutations in hormonal therapy refractive ER+ metastatic breast cancer
BRAF fusions in Spitzoid melanomas
FGFR alterations in cholangiocarcinoma
ERBB2 alterations in many non-breast cancer tumor types
Total mutational burden linked to responses for immune checkpoint inhibitors
Release of >1,800 complete genomic profiles of pediatric cancers
Release of 18,000 complete genomic profiles of adult cancers to the NCI as part of the Cancer Moonshot Program