Partnering for Cures: Janssen/MGH Collaboration – Transforming Cancer Care Craig Sutton

Worldwide Business Development and CTC Program Leader

Janssen Research & Development, LLC

Agenda

• Organization Background

• Circulating Tumor Cells

• Collaboration with Mass General Hospital

• Lessons Being Learned

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Agenda

• Organization Background

• Circulating Tumor Cells

• Collaboration with Mass General Hospital

• Lessons Being Learned

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J&J Pharmaceuticals Businesses: A New Common Identity

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Creating Value Beyond the Pill

Drugs/Diagnostics

Biomarkers

Integrative Informatics

Scientific Knowledge

Early Diagnosis

Prevention

Small Molecules

Large Molecules

Vaccines Customer-Centric Healthcare Solutions

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Success Requires a New Model

Pharmaceutical

Development and Marketing

Diagnostics

Development and Marketing

Focus on the drug New Model

Focus on Total Solution for the Patient

Focus on the diagnostic

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What’s in it for Janssen? Companion Diagnostics Value Creation Through…

• Early diagnosis of disease

• Selection of optimal therapies

• Monitoring of response/toxicity to therapies

• Markers to predict medicine safety

Enhanced probability of creating new, more

targeted and better therapeutic solutions

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Agenda

• Organization Background

• Circulating Tumor Cells

• Collaboration with Mass General Hospital

• Lessons Being Learned

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Circulating Tumor Cells

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CTC Analyses Can Improve Outcomes in Oncology Drug Development?

• CTCs have unique properties that make them useful as cancer biomarkers:

– Non-invasive access to tumor cells

– Opportunity for repetitive sampling to monitor molecular pathology during tumor progression and as response to therapy

– CTC enumeration is a prognostic biomarker

Partnering with FDA to validate CTC normalization as a surrogate for clinical benefit in prostate cancer drug development

– CTCs are matrices for biomarker characterization and molecular profiling

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Veridex – At the Forefront of CTC Technology

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• Pioneering the automated detection, capture, and enumeration of CTCs

– 150+ patents and 600+ applications

• Leading through industry firsts

– First and only regulatory-cleared product for detection of CTCs in metastatic prostate, metastatic breast and metastatic colorectal cancers

• Setting the standard

– CellSearch® System technology is cited in nearly 100 clinical applications

– Placed in many of the Top 25 National Cancer Institutions

CellSearch®

CellSearch® • Launched 2004

• FDA approvals for metastatic breast, prostate and colorectal cancer

• Designed for ENUMERATION

• Partnering with other sponsors conducting phase III prostate cancer registration trials to validate CTCs as a biomarker to predict improved survival

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CellSearch® Recognition

Award-winning technology:

• In 2009, the CellSearch® System received the first ever Prix Galien USA Award for Best Medical Technology

– Awarded on the basis of the innovative nature of the development, applicability of the technology and future biomedical potential

– Considered the industry’s highest accolade for pharmaceutical R&D

• Ranked as the top medical innovation for 2009 by the Cleveland Clinic

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Agenda

• Organization Background

• Circulating Tumor Cells

• Collaboration with Mass. General Hospital

• Lessons Being Learned

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Why Replace CellSearch?

Competitive Landscape: Developing CTC Technology

• CellSearch coming to the end of its technology lifecycle

• Many new oncology-targeted therapies require molecular analyses of CTCs to monitor

• Growing competition from early stage competitive platforms for CLIA-lab testing of CTCs

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Next Generation System Vision

Molecular characterization

Cytology Actionable mutations

Ex-vivo pharmacology

Enable real-time monitoring of therapies for all metastatic cancers via a

“liquid biopsy”

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Next Gen Platform – What is it?

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Enumeration

Molecular

Characterization

CTC

Capture

Results/

Informatics

Reagents

Image-Based

Characterization

Next Gen System: Conceptual Overview

Microfluidic sorting

to isolate CTCs

from a whole blood

sample

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Why MGH?

CTC Technology

• Extensive experience in microfluidics

• Developed three generations of CTC platforms

• Immunomagnetic separation

Biological and Clinical Trial Capabilities

• Well-pedigreed blood samples

• Rapid implementation in clinical trials

• Deep cancer biology expertise

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Agenda

• Organization Background

• Circulating Tumor Cells

• Collaboration with Mass General Hospital

• Lessons Being Learned

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Status

• On Track and On Budget

• Raising Issues as Warranted

• Solving Technical and Organizational Challenges

• Governance Structure Functioning

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“Viewed by MGH as a model for their future collaborations”

Why It Is Working

• Aligned vision to transform cancer care

• Milestone-based deal structure

• Communications

– Frequent face-to-face meetings

– Candid conversations

• Complimentary skill sets

• MGH’s focus on delivering a product, not just research

• Senior management alignment/interaction

• Trust

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