L.E.K. Managing Director Alex Vadas spoke at a BDA workshop on "How to Mature Emerging Technologies into Companion Diagnostics?" See his presentation here.

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Opportunities and challenges associated with
novel companion diagnostic technologies
Chennai
December 12, 2013
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© 2013 L.E.K. Consulting LLC. All rights reserved.
Wroclaw

2. L.E.K. introduction
L.E.K. Consulting is a leading global strategy consulting firm
Global Network
Overview
Established in 1983
Clients include 25% of the largest 200
companies globally, as well as innovative
start-ups and leading private equity firms
Areas of expertise include:
Strategy
Transaction Services
Finance
Marketing and Sales
Operations
Organization
London
San
Francisco
Los
Angeles
Chicago
Paris
Boston
New York
Wroclaw
Milan
Munich
Seoul
Beijing
Tokyo
Shanghai
New Delhi
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Worldwide more than 900 professionals,
led by 100 Vice Presidents in 20 offices
In North America more than 350
professionals, led by 40 Vice Presidents,
all heavily involved in delivering client
assignments
São Paolo
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CONFIDENTIAL
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© 2013 L.E.K. Consulting LLC. All rights reserved.

3. Emerging CDx technologies
The big four established players (Roche, Qiagen, Dako and Abbott) have
historically been pharma’s CDx partners of choice
IVD company CDx partnerships (2005 – present)
Percent of total (# of total deals = 86)
31
100
18
7
30
90
Abbott
80
Dako
Qiagen
70
60
50
BioMerieux
Cepheid
40
30
Hologic
Life Tech
Asuragen
MDxHealth
Nanosphere
Sequenom
20
10
Leica
Other - emerging
Incell
5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100
qPCR
Source:
Other - established
BG Medicine
Luminex
Meso Scale Discovery
Saladax
Sysmex (Inostics)
Veridex
0
0
Roche
Alere
Beckman Coulter
BioMerieux
GE
Life Technologies
Ortho-Clinical
Siemens
IHC
FISH / ISH
FDA, company websites, L.E.K. analysis
Other /
Undisclosed
CONFIDENTIAL
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© 2013 L.E.K. Consulting LLC. All rights reserved.

4. Emerging CDx technologies
Biomarker trends are driving the need for novel technologies in CDx
Example biomarker trends

Sample access and analysis:

Peripheral detection
(e.g., for CTCs or ctDNA)

Multiplexing
(e.g., NGS, NanoString, protein arrays,
CyTOF)

Multi-omic
(e.g., RNA FISH, RNA flow, MultiOmyx)

New detection modalities
(e.g., methylation-specific PCR)

POC / near patient
Sample access / availability limitations
Single cell analysis
Sub-population analysis
Systems biology
Small fold changes
Absolute quantitation
Single molecule detection
Biomarker modifications
(phosphorylation, methylation)
Broadening applications:
-
Patient acquisition (rare patient ID,
diagnosis, Rx selection)
Source:

Exploration of nuanced biology:

CDx technology needs
Monitoring
Beyond oncology (e.g., ID, neuro, AI)
L.E.K. analysis
CONFIDENTIAL
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© 2013 L.E.K. Consulting LLC. All rights reserved.

5. Emerging CDx technologies
Most novel technologies reside within emerging companies or companies
with emerging diagnostics capabilities (acquisitions are expected)
Example Emerging CDx Technologies
Emerging Platforms / Examples
NGS
 Illumina
Peripheral
detection
Multiplexing
Multi-omic
Novel
detection
 Qiagen
 Life
Digital PCR
 Life
 RainDance
Arrays
 Inostics / Sysmex
 Bio-Rad
 NanoString
 Boreal Genomics
Epigenomics
 MDxHealth
 Epigenomics
Digital
immunoassay
 Singulex
Proteomic arrays
 Aushon
 MSD
 Luminex
 Theranostics
CTC
 Quanterix
 Veridex
 BioCept
Emerging
cytometry
 DVS
RNA FISH / Flow
 ACD
 Affymetrix
Multi-omic
histology
Source:
 GE / MultiOmyx
L.E.K. interviews and analysis
CONFIDENTIAL
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© 2013 L.E.K. Consulting LLC. All rights reserved.

6. Emerging CDx technologies
Most emerging companies lack a range of important CDx capabilities; even
emerging technologies within established companies may lack infrastructure
and logistics support
Novel CDx technology partner strength
Emerging technology
Emerging company
CDx partner selection criteria
CDx
development
capabilities
Technical capabilities and expertise
Emerging technology
Established company
Core competency
Novel test development experience
Therapeutic area expertise
Regulatory experience
Operational
and
commercial
infrastructure
CE / 510(k); rarely PMA
Testing infrastructure / installed base
Initially limited
Manufacturing infrastructure
Pricing and reimbursement
Sales and marketing
Logistics support
Company
background
Outside of competency
Global footprint
Financial health
BioPharma partnering experience
Relative strength
Source:
L.E.K. analysis
High
Moderate
Low
CONFIDENTIAL
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© 2013 L.E.K. Consulting LLC. All rights reserved.

7. Emerging CDx technologies
CDx access is a significant issue even with established technologies;
access solutions will be critical when working with emerging technologies
Directional
Advanced NSCLC patients
Percent not tested
Drug and test awareness
Negligible
Key risks for emerging CDx technologies:

Sample accession
15-20%
Lab access
Testing and reporting
5-10%
Drug utilization
Negligible
Reimbursement
Test requires significant sample
Test requires non-standard sample
(e.g., fresh tissue in the U.S.)
0-5%
Total
Source:
0-5%
-
5-10%
Test ordering
Sample access:
25-50%
L.E.K. analysis

Lab access:

Limited installed base
Central lab model
Lack of sample logistics support
Lack of established reimbursement
CONFIDENTIAL
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© 2013 L.E.K. Consulting LLC. All rights reserved.

8. Emerging CDx technologies
A range of mitigating strategies may be considered (typically customized for
each situation):
Platform risk
Clinical labs
Partner network
Partnering
excellence

Work with novel reagent companies compatible with cleared platforms

RNA FISH / Flow (e.g., ACD, Affymetrix)
qPCR (e.g., MDxHealth, Epigenomics, Asuragen)
dPCR (Sysmex / Inostics; leverages qPCR and flow)
Work with labs across the R&D and commercial value chain (build, partner, finance, acquire):
-
Technology access (e.g., Myriad, Foundation Medicine)
Site-specific PMAs for accelerated timelines, reduced regulatory risk and lower costs
Commercial support including logistics, S&M, reimbursement (multiple across regions)

Pre-analytical / channel partners for sample access and logistics (e.g., BD, GE Healthcare)

Coalition / consortium efforts with other pharma and stakeholders (e.g., Foundation Medicine
Master Protocol)

Appreciation of partner value drivers, needs and capabilities

Coordination across multiple partners
CONFIDENTIAL
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© 2013 L.E.K. Consulting LLC. All rights reserved.