DOES YOUR COMPANION
DIAGNOSTIC STRATEGY BEST
POSITION YOU FOR SUCCESS?
History has Demonstrated that Sub-optimal CDx Strategies
can Impact Drug Success
Real-World Examples
1st Year Sales
Increased complexity of current
testing + Unclear benefit of
testing
Xalkori + ALK
NSCLC
NSCLC
HIV
Source: Company Websites, Press Releases,
Bionest Partners
Expected
Sales
$2.1B
*
$566M
1st Year Sales
$150M
*
= Overall Poor Market Perception
+ Insufficient Field Force
* Note: Facts described are potential contributors to
the sales figures; other factors may have contributed
Bionest CDx Capabilities
May 2016 – Slide 2
Actual
Sales
2015 Sales
= Unexpected Lower Drug
Prescription vs. Competitor
Misalignment between Pfizer and
its Dx partner (e.g., on data, level
of resources to involve)
Selzentry + EGFR
$123M
*
= High Confusion Around Test
Quality & Low Testing Rates
Required PD-L1 CDx on label vs.
competitor’s (BMS’ Opdivo)
“informative only” CDx
Keytruda + PD-L1
$225M
$24M
Expected
Sales
Actual
Sales
Keys to a Successful CDx Strategy
BUILD COMPETITIVE DIFFERENTIATION
THROUGH YOUR CDX STRATEGY
CDx strategy can be a potential differentiator in a crowded competitive space
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 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 3
What Can Bionest Do For You?
Bionest Can Provide Insights to Address all Key Aspects of Your CDx Strategy
SUCCESS KEY
SUCCESS KEY
SUCCESS KEY
Build CDx
Competitive
Advantage
Ensure Seamless
Fit in Patient
Journey
Build Clear CDx
Commercialization
Plan
Bionest Project: CDx
Competitive
Landscape
Bionest Project: Testing
Journey and Scenario
Planning
Bionest Project: CDx
Commercialization
Roadmap
Key Insights
Key Insights
Key Insights
 Competitor biomarker /
CDx strategies
 Current & future testing
journey
 Biomarker / CDx future
scenarios & impact on
drug positioning
 How testing for can be
integrated in the current /
future journey
 Avenues to leverage CDx
to support competitive
differentiation
 Identification of various
biomarker and future
journey scenarios
 Potential CDx-related
barriers to drug
prescription by country
Bionest CDx Capabilities
May 2016 – Slide 4
 Global to local countryspecific 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
What is Our Track Record?
Bionest Has Worked Extensively on CDx Strategies
In Various Therapeutic Areas...
CNS
Oncology
Infectious Diseases
Immunology
Orphan Diseases
Respiratory
Metabolic
… And Across Multiple Technology Platforms
Next Generation
Sequencing
ImmunoHistoChemistry
Polymerase Chain
Reaction
Signature Panels
POC Testing
FISH / CISH
Hand-held Testing
ELISA
Circulating Tumor
DNA
Etc.
Numerous Companies Have Trusted Bionest With Their CDx Projects
Companion Diagnostics Projects
over the Past Few Years
Bionest also leverages its expertise in diagnostics from projects with Dx companies:
Projects with Dx
Companies in Recent
Years
Bionest CDx Capabilities
May 2016 – Slide 5
Selected Project Examples
CDx Strategic Planning
in Breast Cancer
CDx Competitive Advantage
 CDx competitive landscape in
breast cancer
Competitive Landscape
Prioritization Approach
 Profile of each biomarker scenario
and potential impact on drug
prescription
 CDx prioritization options
Current and Future
Testing Journey and
Scenario Planning in
Asthma
Fit in Patient Journey
Testing Journey
 Current testing journey in asthma
CDx Commercialization Plan
 Roadmap with action points and
triggers for the team
Commercial Lab
Strategy for PD-L1
Testing in NSCLC &
Melanoma
 Lab visits to understand lab level
testing journey and lab landscape
mapping
CDx Competitive Advantage
Fit in Patient Journey
CDx Commercialization Plan
Roadmap of Key
Initiatives
 Potential future testing journey
scenarios and CDx-related barriers
associated with each scenario
 Critical success factors for PD-L1
test
 Risk mitigation plan for critical
commercial scenarios
Bionest CDx Capabilities
May 2016 – Slide 6
Lab Landscape
Lab Testing Processes
Bionest has Developed Specific Expertise in Companion
Diagnostics
Bionest’s Key Published Articles
“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”
“How to Optimize Personalized
Medicine R&D & Commercialization
Decision-Making”
“Quantifying factors
for the success of
stratified medicine”
“Will CDx Save the
Next-Generation
IOs?”
Science, Dec. 2011
Nature, Nov. 2011
2016
In
Progress
To read these articles and more, visit http://bionest.com/publications/publications/
Bionest CDx Capabilities
May 2016 – Slide 7
Bionest is a Global Consulting Firm with an Experienced
Management Team
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.
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
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
Mary Koto
Founder, San Diego
Melinda Kutzing
Manager, New York
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
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
Additional Strategic partners in
South America, Japan & China
Bionest Professional Staff
Majority of team have a Ph.D. and / or MBA degree
Bionest CDx Capabilities
May 2016 – Slide 8
380 Lexington Avenue
43rd Floor
New York, NY 10168
USA
Tel: +1 646 619 8717
19, rue du Général Foy
75008 Paris
France
Tel: +33 1 58 05 14 00
Fax: +33 1 58 05 14 09
[email protected]
www.bionest.com
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