9
DOES YOUR COMPANION DIAGNOSTIC STRATEGY BEST POSITION YOU FOR SUCCESS?
DOES YOUR COMPANION
DIAGNOSTIC STRATEGY BEST
POSITION YOU FOR SUCCESS?
Bionest CDx Capabilities May 2016 – Slide 2
Real-World Examples
History has Demonstrated that Sub-optimal CDx Strategies can Impact Drug Success
Selzentry + EGFR
ExpectedSales
ActualSales
$225M
$123M
* Note: Facts described are potential contributors to
the sales figures; other factors may have contributed
Increased complexity of current
testing + Unclear benefit of
testing
= High Confusion Around Test
Quality & Low Testing Rates Xalkori + ALK
ExpectedSales
ActualSales
$150M
$24M
Keytruda + PD-L1
Required PD-L1 CDx on label vs.
competitor’s (BMS’ Opdivo)
“informative only” CDx
= Unexpected Lower Drug
Prescription vs. Competitor
Misalignment between Pfizer and
its Dx partner (e.g., on data, level
of resources to involve)
= Overall Poor Market Perception
+ Insufficient Field Force
1st Year Sales
1st Year Sales
Source: Company Websites, Press Releases, Bionest Partners
$2.1B
$566M
2015 Sales
*
*
*
NSCLC
NSCLC
HIV
Bionest CDx Capabilities May 2016 – Slide 3
Keys to a Successful CDx Strategy
ENSURE CDX FITS SEAMLESSLY WITHIN PATIENT JOURNEY
Unhindered drug prescription requires a clear understanding of how the journey for all key stakeholders will evolve and the identification of potential
barriers to the use of your CDx
BUILD COMPETITIVE DIFFERENTIATION
THROUGH YOUR CDX STRATEGY
CDx strategy can be a potential differentiator in a crowded competitive space
BUILD CLEAR COMMERCIALIZATION PLAN, FROM GLOBAL TO
LAB LEVEL
Development of a robust, integrated, commercialization strategy with functional initiatives that address CDx-related challenges will maximize test
penetration from global to lab level
Bionest CDx Capabilities May 2016 – Slide 4
What Can Bionest Do For You?
Bionest Can Provide Insights to Address all Key Aspects of Your CDx Strategy
Bionest Project: Testing Journey and Scenario
Planning
Current & future testing journey
How testing for can be integrated in the current / future journey
Identification of various biomarker and future journey scenarios
Potential CDx-related barriers to drug prescription by country
Key Insights
Ensure Seamless Fit in Patient
Journey
SUCCESS KEY
Bionest Project: CDx Commercialization
Roadmap
Global to local country-specific initiatives to alleviate potential barriers
Action items assigned by function and with associated timing
Responsibility breakdown between Rx company and CDx partner
Definition of key success measurements
Key Insights
Build Clear CDx Commercialization
Plan
SUCCESS KEY
Bionest Project: CDx Competitive Landscape
Competitor biomarker / CDx strategies
Biomarker / CDx future scenarios & impact on drug positioning
Avenues to leverage CDx to support competitive differentiation
Key Insights
Build CDx Competitive Advantage
SUCCESS KEY
Bionest CDx Capabilities May 2016 – Slide 5
Companion Diagnostics Projects over the Past Few Years
Numerous Companies Have Trusted Bionest With Their CDx Projects
In Various Therapeutic Areas...
Bionest also leverages its expertise in diagnostics from projects with Dx companies:
What is Our Track Record?
… And Across Multiple Technology Platforms
Next Generation Sequencing
ImmunoHisto-Chemistry
Polymerase Chain Reaction
Signature Panels
POC Testing
FISH / CISH
Circulating Tumor DNA
Etc.
Bionest Has Worked Extensively on CDx Strategies
Infectious Diseases
Immunology
Respiratory
CNS Oncology
Projects with Dx Companies in Recent
Years
Metabolic
Orphan Diseases Hand-held Testing ELISA
Bionest CDx Capabilities May 2016 – Slide 6
Selected Project Examples
Current and Future Testing Journey and Scenario Planning in
Asthma
Commercial Lab Strategy for PD-L1 Testing in NSCLC &
Melanoma
CDx Strategic Planning in Breast Cancer
CDx competitive landscape in breast cancer
Profile of each biomarker scenario and potential impact on drug prescription
CDx prioritization options
Current testing journey in asthma
Potential future testing journey scenarios and CDx-related barriers associated with each scenario
Roadmap with action points and triggers for the team
Lab visits to understand lab level testing journey and lab landscape mapping
Critical success factors for PD-L1 test
Risk mitigation plan for critical commercial scenarios
Competitive Landscape
Testing Journey
Lab Landscape
Prioritization Approach
Lab Testing Processes
Roadmap of Key Initiatives
Fit in Patient Journey
CDx Commercialization Plan
CDx Competitive Advantage
CDx Commercialization Plan
Fit in Patient Journey
CDx Competitive Advantage
Bionest CDx Capabilities May 2016 – Slide 7
Bionest’s Key Published Articles
Bionest has Developed Specific Expertise in Companion Diagnostics
To read these articles and more, visit http://bionest.com/publications/publications/
“How to Optimize Personalized
Medicine R&D & Commercialization
Decision-Making”
Science, Dec. 2011
“Quantifying factors
for the success of
stratified medicine”
Nature, Nov. 2011
“When Illumina Buys Roche: the Dawning of the Era of
Diagnostics Dominance”
IN VIVO, Jul. 2014
“A great opportunity is at hand to turn data acquisition and
analysis into medical knowledge. But few if any pharma or
diagnostics companies appear poised to take advantage”
In Progress
“Will CDx Save the
Next-Generation
IOs?”
2016
Bionest CDx Capabilities May 2016 – Slide 8
Bionest is a Global Consulting Firm with an Experienced Management Team
Additional Strategic partners in South America, Japan & China
Mary Koto
Founder, San Diego
Mary has contributed to CDx projects in oncology, CNS, and respiratory. She has also worked on numerous Dx assignments across various areas. Mary also has
operating experience in Dx as Vice President of Marketing at Accumetrics
Olivier Lesueur
Managing Director, New York
Olivier has been helping biopharma clients tackle CDx challenges for 5+ years, across various areas (oncology, respiratory, CNS, etc.) with expertise ranging from long-term Dx transformative trends to CDx commercial strategy at lab level
Bob Easton
Co-Chairman, New York
Bob has a deep Dx background with managing / development positions within IVD companies, followed by 30+ years consulting for wide range of Dx companies & pharma developing drugs with CDx, on market entry, scenario planning, target selection, etc.
Melinda Kutzing Manager, New York Melinda leverages expertise from PhD in Biomedical Engineering to address key aspects of CDx strategy for a variety of clients in various therapeutic areas, including commercialization strategy and fit in patient journey
Alain Gilbert
Co-Chairman, Paris
Alain offers the unique combination of experience as a leader and manager of businesses in a cross- section of pharma, medical devices, and diagnostic areas,
including top management positions within Abbott and Medtronic
Bionest Professional Staff Majority of team have a Ph.D. and / or MBA degree
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