DeciBio Perspectives on Pain Points, Unmet Needs, and Disruption in Precision Oncology

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1
Perspectives on Pain Points, Unmet Needs,
and Disruption in Precision Oncology
DeciBio Consulting, LLC
725 Arizona Ave, Suite 202
Santa Monica, CA 90401
Phone: (310) 451-4510
Email: info@decibio.com
www.decibio.com
DeciBio Contacts:
Andrew Aijian: aijian@decibio.com
Colin Enderlein: enderlein@decibio.com
Companion Diagnostics Forum 2019 – Presented Oct. 29th, 2019
Princeton, NJ
Disclaimer
Some of the companies listed in this document may be
DeciBio Consulting Clients or Customers; However, this
project is entirely self funded by DeciBio Consulting

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2
DeciBio’s mission is to provide insights that drive disruption and innovation in the precision medicine and life
science industries; to this end we conducted internal research to assess the following two questions
1. What are key pain-points and unmet
needs in the precision medicine ecosystem
today and how do these translate into
opportunities for precision medicine
stakeholders?
2. What are potential scenarios for the
evolution of the precision medicine
landscape and what are the potential
implications for various stakeholders in
these scenarios?

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3
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Landscape Vertical Business Function
N = 22N = 22
Dx Specialist
Tx Specialist
Director
Clinician / Patient
Specialist
VP / CXO
Clinical /Patient
Journey
Specialist
We conducted >20 stakeholder interviews with senior executives, oncologists, and KOLs in a variety of settings
Example Interviewee Demographics (N = 22)*
Notes: * Multiple stakeholders were able to speak firsthand about several landscape verticals; not all organizations shown
Source: DeciBio Interviews
RWD /
RWE
Specialist
DrugDev.
Specialist
RWD/RWE
Specialist
Clinical/Pt
Journey
Spec.
Dx
Specialist

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4
science industries; to this effect we conducted internal research to assess the following two questions
stakeholders?
these scenarios?

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5
Unmet
Need /
Opportunity
Demand
(High)
Supply
(Lowi)
Favorable Economics
Supply
(High)
Demand
(Lowi)
Less Favorable Economics
Ideal Innovation Scenario (“First Principles Innovation”) Less Ideal Innovation Scenario (“Reverse Innovation”)
Many companies with innovative technologies or approaches have a hard time gaining market traction due to
poor visibility of market needs or inability to find a “key application”; the objective of this research is to identify
unmet needs in precision medicine to help drive “first principles innovation”
Need?
Need?
Need?
Need?
Solution
(technology,
product,
service)
Solution
(technology,
product,
service)

To pinpoint precision medicine painpoints, we first created a map of the precision medicine landscape,
highlighting the key steps and processes, and pressure-tested it with interviewees from various backgrounds
Care Team Journey
Basic R&D
Translational R&D
Clinical Trials
Regulatory
Reimb. / Coverage
Regulatory
Reimb. / Coverage
Clinical Trials
Translational R&D
Basic R&D
Dev. Timeline /
Resource Coordination
Deal / Partnership
Terms Management
Partner Identification
Planning/
Design
Recruit./
Enrollment
Biomarker/
CDx
Dev.
Data
Management
& Analysis
Planning/
Design
Recruit./
Enrollment
Biomarker/
CDx
Dev.
Data
Management
& Analysis
Clinical Trial
Diagnosis
Primary Care /
Screening
CDx / Treatment
Selection
Treatment Response
Monitoring
Surveillance
Sample
Collection
Sample
Prep
Analysis
Reporting
Decision
Making
Coverage /
Reimb.
Sample
Collection
Sample
Prep
Analysis
Reporting
Decision
Making
Coverage /
Reimb.
Treatment
Availability
Auth. /
Coverage
Dosing
Treatment
Administration
Toxicity
management
Response
Evaluation
Resistance
detection /
Testing
Ongoing
response
evaluation
MRD
monitoring
/ detection
RWD/E
Generation
RWD/E
Analysis
RWD/E
Integration
RWD/E Privacy
Protection /
Management
Implementation
of RWE into R&D
Physician
Education /
Training
Patient
Communication
Care Team
Coordination /
Communication
Patient
Data
Management
Palliative
Care /
Other
Dx. Mfr.
Drug Mfr.
Drug/DiagnosticCo-Development
Drug Development
Diagnostics Development
Patient Journey
RWD/EManagement

Data
management
& analysis
Basic R&D
Translational R&D
Clinical Trials
Regulatory
Reimb. / Coverage
Regulatory
Reimb. / Coverage
Clinical Trials
Translational R&D
Basic R&D
Dev. timeline /
resource coordination
Deal / Partnership
Terms Management
Partner Identification
Planning/
Design
Recruit./
Enrollment
Biomarker/
CDx
dev.
Data
management
& analysis
Planning/
Design
Recruit./
Enrollment
Biomarker/
CDx
dev.
Clinical Trial
Diagnosis
Primary Care /
Screening
CDx / Treatment
Selection
Treatment Response
Monitoring Surveillance
Sample
Collection
Sample
Prep
Analysis
Reporting
Decision
Making
Coverage /
Reimburse
ment
Sample
Collection
Sample
Prep
Analysis
Reporting
Decision
Making
Coverage /
Reimbursement
Treatment
Availability
Auth. /
Coverage
Dosing
Treatment
Administrati
on
Tox.
management
Response
Evaluation
Resistance
detection /
Testing
Ongoing
response
evaluation
MRD
monitoring /
detection
RWD/E
Generation
RWD/E
Analysis
RWD/E
Integration
Health Data Privacy
Protection /
Management
Implementation
of RWE into R&D
Physician
Education /
Training
Patient
Communication
Care Team
Coordination /
Communication
Patient Data
Management
Dx Mfr.
Drug Mfr.
Care Team Journey
Drug/DiagnosticCo-Development
Drug Development
Diagnostics Development
Patient Journey
RWD/EManagement
Stakeholder feedback reveals multiple pain points and unmet needs distributed throughout the precision
medicine landscape, the needs / pain are fragmented with no single “node” representing a large majority
6
1
Pain Point /
Need Mentions
Significance
Weight
100
0

1 The models we use to study cancer and discover new therapies and biomarkers are too simplistic
2 Precision medicine creates unique, and increasingly challenging, barriers to clinical trial participation
3
The current commercial and technological health IT infrastructures are fundamentally incapable of
enabling of the potential of RWD/E
4 The tools and methods for educating clinicians on precision medicine are lacking or inadequate
5
Numerous siloes exist within and between the different branches of the precision medicine landscape
impeding progress
Aggregating feedback from interviewees reveals key pain point and unmet need themes, and thus,
opportunities, for stakeholders in the precision medicine landscape
High-Level Paint Point / Unmet Need Takeaways

• Cancer research models are too simplistic
o The lack of in-vitro models that reflect systems biology hinders drug discovery
▪ “…2D tissue culture is worthless, 3D spheroids are better, and organoids are
even better, but these are still not sufficient…”
▪ Gene expression and multi-omics tools are a step in the right direction, but
price and TAT are too high and data analysis is too intensive to support high-
volume use necessary for dynamic, iterative testing of a systems model
❑ Complex data sets and intensive analytical pipelines can create
disconnects between the people asking the questions (biologists) and
those analyzing the data (bioinformaticians), creating inefficiencies
• Advancements in proteomics have not kept pace with genomics
o “…Proteins are the ground truth, but we still can’t do a 10,000 plex protein assay;
some aptamer techs get us partially there, but we need advancements in
proteomics to make strides in discovery…”
• Research sample acquisition and management is inefficient
o Even major pharmaceutical and biotech companies have difficulty securing and
managing (accurately annotated) research samples; sample challenges can add
weeks to months to research project timelines
▪ “…Everyone talks about cool analytical technologies, but samples are a huge
problem…liquid biopsy compounds this because now you have to acquire
and track samples from multiple time points…”
9 / 22
interviewees identified drug
and / or diagnostic
translational research as
pain points
~14%
Of the total weight of all
the pain points identified
1
Drug and diagnostic translational R&D represents one of the biggest collective pain point areas, driven
primarily by the need for better disease models and diagnostic tools that capture systems biology complexity

• Precision medicine clinical trials are-, and will become, increasingly
challenging to execute
o Increasingly complex biomarkers and trial protocols will raise the burden of
clinical trial participation on patients, making enrollment more challenging
o More complex biomarker and treatment strategies (e.g., rare / composite /
multiplex markers and rational combination therapies) require more patients
to reach data significance, increasing the time and cost of trials (and drugs)
▪ “…We need to do rational combinations for cancer like we do for
antibiotics, but the current clinical trial and regulatory frameworks are
not built to support the types of trials we need for precision medicine…”
• However, fundamental barriers exist for clinical trial enrollment
o Despite the promise to facilitate trial enrollment, the quality and quantity of
RWD/E is lacking; access to data is hampered by red-tape, legalese
▪ “…Drug developers have a poor line of sight into clinical trial recruitment
due to lack of good data / access to data… ”
o Additionally, more importantly, many patients have a negative perception
and / or limited access to clinical trials
▪ “…Many patients think a clinical trial means they have a 50% of getting
nothing more than a placebo; they see it as being a guinea pig…”
o Patients prefer to be treated in their communities; for the most part, a patient
is willing to travel up to 50 – 80 miles to participate in a trial; doing so
creates a large burden on the patient and their family
8 / 22
interviewees identified
clinical trial-related activities
as pain points
~9%
Aggregate enrollment targets for newly initiated
cancer trials in the U.S. have averaged ~500,000
patients annually over the past 3 years,
corresponding to 25 – 30% of all newly diagnosed
cancer patients in the U.S.;
Current enrollment rates are 4 – 6%
The rising stakes and requirements for precision medicine trials erect barriers that exacerbate an already
challenging patient recruitment problem; the current trial system may not support the types of trials needed
2
v

2
0 - 509
510 – 1,650
1,651 – 5,000
5,001 – 17,800
17,801 – 115,000
While access to precision medicine testing is generally considered good, access to precision medicine care /
treatment is limited, to a large extent, geographically
Population by Zip Code
Trial site willingness
to travel radius
(max ~80 miles)
While many companies focus on clinical trial matching, there is a large share of the population that does not have easy access to
precision medicine clinical trials, creating a huge need for remote clinical trial solutions
Phase 1
Phase 1/2
Phase 2
Phase 3
Trial Phase
Map of Currently-Recruiting “IDH1” Trials*
* Note: Excluding AML, for which an FDA-approved therapy is available; Source: ^ doi: 10.1016/j.conctc.2018.08.001
This distribution of trials
is representative of many
other precision therapies
“…There is a last mile problem in
precision medicine…”
Studies suggest that 25% of trials failed to enroll
a sufficient number of patients, and 18% of trials
closed with less than half of the target number of
participants after 3 or more years^
Match
Match

• The current health IT infrastructure is not designed for RWD/E
o “…EMRs were primarily designed to facilitate billing, not cataloging and
sharing medical information, and are fundamentally incapable of enabling
the full potential of RWD; we need systems built specifically to capture
and share clinical data…”
o Numerous barriers exist to the utilization of RWD
▪ EHR interfaces are not designed for efficient, standardized data
collection
▪ Clinicians do not have the time / incentivization to enter data into
charts / EHRs in an RWD-friendly way
❑ “…In one study, we found >70 different ways clinicians referred
to or mentioned ‘leukocytes’…”
▪ Almost every stop on the patient journey has a custom / different
EHR, which doesn’t easily speak to any other EHR
• Numerous competing commercial interests are erecting barriers to the
advancement of RWD/E
o “…HCPs are becoming increasingly possessive of their data for
commercial reasons, making it hard to access…”
o The commercial fragmentation leads to data fragmentation, and varying
degrees of data quality; this lack of standardization and quality may
“poison the well” for RWD if it creates more confusion than clinical value
The current commercial and technological health IT infrastructures are perceived as fundamentally incapable
of capturing and integrating health information in a way that enables the realization of the potential of RWD/E
3
12 / 22
interviewees identified drug
and / or diagnostic
translational research as
pain points
~8%
KOLs believe we are 3 -
5 years away from
achieving the scale and
quality of RWD
necessary to start
realizing meaningful
clinical value

Ref
Lab 2
• For the most part, the patient journey is highly decentralized, with data being generated across multiple different sites and EHRs
o “…At each handoff much of the valuable data generated is lost; there is a lot of redundancy in data generation because care
providers don’t seek out, can’t access, or don’t trust data generated in previous steps in the patient journey…”
• Many RWD/E aggregators rely on a network of partnerships with individual hospitals of providers, however, any given hospital / provider
in the network likely represents only a small slice of a patient’s data
o Much of the emphasis is placed on acquiring and integrating clinico-genomic data, but there are many other untapped data sets
Ref
Lab 1
Most RWD/E efforts rely on stitching together disparate clinical and genomic data sets with varying degrees
of overlapping patient data; this approach does not generate a comprehensive picture of a patient’s RWD
Summary of Common RWD Aggregation Approach Current Focus of RWD Aggregation
3
Radiologist
PCP /
Specialist
Surg. Onc Pathologist
• Family history
• Clinical chemistry labs
• Baseline vitals
• Symptomatic vitals
• Physical health
• Scans / images • Operative reports
(gross tumor data,
surgical staging)
• Path reports
(diagnosis, staging,
typing, biomarker
expression)
• Slide images
Each of these providers may be at a different site with a
different EHR / PACS / LIMS system
• Treatment data
• Response /
outcomes data
• Toxicity data
Med /
Rad Onc
• Biomarker data • Biomarker data
RWD
Aggregator

9 / 22
interviewees identified CDx /
Treatment Selection and
Physician Education as pain
points
~11%
• The pace of change in oncology is too high for clinicians to keep up with
o “…many community oncologists are generalists and see multiple cancers, it
is almost impossible to stay up to date with every change to the SOC…”
▪ Precision medicine leads to many “grey areas” for clinicians; e.g.,:
❑ “…Start patient on chemo while waiting for CGP test results?...”
❑ “…What if there are 2 potentially clinically-actionable variants?...”
❑ “…What if you have a VUS in a known oncogene?...”
▪ Currently, clinician education efforts are more passive (e.g., websites
and webinars) than proactive (e.g., field medical people in the offices)
▪ Additionally, hospital labs, which are often perceived as cost centers,
are not receiving the resources necessary to execute on the
accelerating demands of the precision medicine imperative
• There is a lot of marketing “noise” from precision medicine test vendors
o “…There are too many test options, each with a salesperson pitching a
different story / value proposition; it is difficult to tell what is necessary and
unnecessary and what is validated, reimbursed, etc.…”
o The lack of clear guidance / standardization on how to implement precision
medicine creates a barrier to adoption (no one makes treatment decisions
they are not well-informed of)
The inability of providers to keep pace with the clinical and financial resources necessary to support
precision medicine limits broad adoption; better tools are needed to support clinician decision-making
4
v
In 2019 YTD there
have been 92 updates
to 26 different NCCN
guidelines, an average
of ~3.5 per guideline
per year (so far)

Significant siloes persist throughout the precision medicine ecosystem; these siloes create inefficiencies and
friction that hinders advancement and adoption of precision medicine
Drug/DxCo-Development
Care Team Journey
• Misaligned incentives and timelines, and challenging partnership
coordination can create tension between drug and diagnostic co-developers
o Some stakeholders perceive precision medicine to be largely reactionary
(e.g., only when needed) rather than a proactive effort by drug-developers
o Delayed dialog / engagement between drug and diagnostic developers around
CDx development creates multiple issues:
▪ Dx vendor / technology evaluation is rushed, potentially resulting in the
selection of a suboptimal technology in terms of performance or
accessibility
▪ Inability to align on terms and timelines can force drug developers to take
on risk and proceed without a biomarker to get to market sooner
▪ “…The timeline is fast.…each party has different internal timelines and
multiple siloes of teams that delay decision making; almost all deals are
de-novo with little leverage provided from previous deals…”
• Similarly, misalignment between oncologists and pathologists can lead to
suboptimal, delayed, or unnecessary (i.e., redundant) care
o “…The care journey is very fragmented, a lot of people switch care throughout
their journey, and at every handoff, all of the valuable information is lost.…”
o There is a disconnect between the person who orders the test (oncologist)
and the person who implements the test (pathologist), which creates
confusion
Only ~33% of all pain
points identified were
outside of interviewees’
own branches of
participation
5
12 / 22
interviewees identified these
siloed areas as pain points
~15%

Disease models that better capture
systems biology
Decentralized clinical trial solutions;
clinical trial patient education
Patient-centric RWD management
solutions
Multi-source / multi-modal RWD
integration (beyond genomics + clinical)
Sample access, information, and
management solutions
Next-generation proteomics tools
Interfaces that better support RWD
capture
Despite the paint points that exist, all stakeholders interviewed are optimistic overall about the future of
precision medicine; the pain points and unmet needs represent tangible opportunities for market participants
Opportunities for Precision Medicine Stakeholders

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science industries; to this effect we conducted internal research to assess the following two questions
stakeholders?
these scenarios?

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Considering what changes will occur in the distant horizon (5-10 years) is a valuable lens through which to
understand where growth will most rapidly occur vs where we may see ongoing bottlenecks
Future Changes: In 5-10 years, where do you expect to see the most significant changes?
Specific Interview Questions
• Which verticals / nodes of the precision
oncology landscape do you expect to
change most in 5-10 years? Change least?
• What will be the key drivers of change
across each of the verticals?
• How will future changes address /
exacerbate current pain points?
• Who will benefit most from these future
changes? Who will benefit least /
experience new barriers?
• Will any nodes be added or removed from
this landscape map?
• Under your vision for the future landscape,
what are some potential scenarios
highlighting these changes?

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Across precision medicine, the Dx space is expected to see most evolution over 5-10 years; RWE / health AI
changes expected, but long-term vision still abstract
Stakeholder Feedback Highlighting Key Changes / Trends
Expected for Precision Medicine in a 5-10 Year Timeframe
# of Mentions Theme* Precision Med. Vertical
12 Dx Improvement Dx
11 Tx Improvement Tx
11 Screening Dx
10 Patient Empowerment Clin
9 Multi-Modal Data Linking RWE
9 Trial Improvement Tx, Dx
8 Bearish on Precision Med. All
7 RWE Drives Research Engine RWE
6 Pharma as key Precision Med Driver Tx
5 Cost / Payer Access Improves All
5 Organic Precision Med Expansion All
5 Value Based Care RWE
5 Other All
5 LBx Emerges as Standard of Care Dx
4 Trend of Healthcare Consolidation Clin
4 Physician Education Clin
4 Tumor Agnostic Movement Tx, Dx
4 Dx / Tx Parallel Development Tx; Dx
3 Dx Precision Med Tools Reflexive Clin
2 EMR Improvement RWE
2 Trial Headwinds Tx 0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Distribution of Expected
Changes by PM Vertical**
Dx
Changes
Tx
Changes
Clin
Changes
RWE
Changes
Key Takeaway – Significant disruption is expected across all verticals of precision medicine; however, key areas with defined evolutionary steps map closely to
current pain points (i.e. Dx, Tx), while changes in other areas are less concrete
Note: * Themes in Orange will be explored further; ** Expected changes have been normalized based on total stakeholder distribution by precision medicine vertical
Source: DeciBio analysis, Primary Research

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20
The Dx space is not only expected to see the most changes, but changes were highlighted by specialists
from each vertical
~35% of Key Changes
Expected in Dx Space*;
~75% of Claims Come
from Non-Dx Specialists
~25% of Key Changes
Expected in Tx Space*;
~80% of Claims Come
from Non-Tx Specialists
~20% of Key Changes
Expected in Clin / Pt Journey
Space*; ~55% of Claims Come
from Non-Clin Specialists
~15% of Key Changes
Expected in Clin / Pt Journey
Space*; ~65% of Claims Come
from Non-RWE Specialists
Note: * Expected changes have been normalized based on total stakeholder distribution by precision medicine vertical
Bubble size corresponds to
# of key change mentions

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Dx & Tx improvements were the most identified changes, with implications spanning all precision medicine;
while changes are expected, stakeholders are uncertain about funding mechanisms
Dx Development RWE / Health AITx Development Clinical / Patient
TopLandscapeChangesKeyScenario
• Screening to become routine, driving
detection of earlier stage disease
• Improved Dx frontloads data for
multiple Tx lines
• Algorithm refinements may be basis
of Dx dev. given WES availability
More Tx’s will enter the market,
particularly tumor-agnostic ones
guided by mutation markers;
expanding PM* access across
settings as more Txs reimbursed
~51 Mentions of
Change in this Space
Diagnostics overall will improve,
driving an increase in CDx
offerings, which will be key to
expanded Tx access; mutation
panels may trend towards WES
~38 Mentions of
• The need for physician education
rises amidst more Tx / Dx choices
• Tumor agnostic marker approvals
will emerge
• Precision medicine will expand in
community settings
~28 Mentions of
Patients will become increasingly
empowered to guide care journeys;
better education and advocacy
groups are driving patients to
proactively request PM*
• An increasingly holistic medical
approach will be expected, with
improved continuity of care
• Patient brand awareness becomes
driver of product adoption
• Physicians expected to field more
questions
~21 Mentions of
Linking the multitude of data sources
from individuals & populations
increasingly prioritized; EMR
improvements key, and data
consolidation likely pharma driven
• EMRs may focus on pt. data /
outcomes vs billing
• Pt. data from wearables and lifestyle
factored in
• New outcome measures / biomarkers
emerge
Dx Stakeholder Tx Stakeholder RWE Stakeholder Clin. Stakeholder
0 20 40 60
Note: * PM = Precision Medicine; ** CH = Community Hospitals
Mentions by
Stakeholder
Type
17 13 10 11
0 20 40 60
13 6 10 9
0 20 40 60 0 20 40 60
6 5 4 13 6 4 7 4

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22
Following diagnostics improvements, key developments include screening expansion that could drive a shift
towards earlier cancer treatment, and large panel / whole exome tests see expanded use
Dx Development
Key Change – Diagnostics Improvements –
Identified by 12 Stakeholders
Subtopic 1 - Screening for Early /
Pre-Cancer Expands
Routine screening will be performed in
primary care settings (perhaps as a
liquid biopsy); cancer will be detected at
earlier stage and can be quickly referred
Subtopic 2 - Large Panel Testing
Becomes Standard
Comprehensive genomic profiling /
WES may become routine for all
mutation-based testing; a single test
could inform multiple rounds of Tx

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23
Increased screening is one of the most expected outcomes to emerge from upcoming Dx improvements;
cancer will be detected earlier, directly impacting future Tx & Dx development towards earlier stage disease
Dx Development
Sub Theme – Dx Developments Lead to Expanded Early Screening
Screening for
Early / Pre-
Cancer
Expands
Pharma
Catching patients with earlier disease could shrink
the metastatic population for systemic therapies;
refocus into adjuvant or pretreatment
Large potential screening
population may force payors to put
pressure on screening assay prices
Market for adv. Cancer CDx testing may face
pressure, driving Dx developers to pursue new
tests (i.e. recurrence monitoring, site-of-origin)
Screening could be key in shifting treatment from systemic to localized approaches; overdiagnosis poses key risks
Likely / Near-Term Somewhat Likely / Mid-Term Uncertain / Long-Term
Dx
Investment in new metastatic cancer
drugs may decline; precision treatments
for early cancer could expand
Payors
Patients
Increased screening could actually lead
to overdiagnosis; patients may undergo
costly & unnecessary follow-up / Tx
Overall cost per patient could
increase as cancer is treated like
a chronic vs acute illness
“…Rather than adjuvant, use tests to tailor Tx or change
course will be key; great opportunities for neo-adjuvant or
maintenance Tx as we detect earlier cancer…”
-SVP, Guardant Health
Current technical limitations (namely
test specificity) could lead to 10s-100s
of thousands of misdiagnosed patients

DRAFT
24
Large panel testing will frontload tremendous amounts of patient data, allowing multiple Tx lines to be
determined early; the technical requirements will like continue driving testing into centralized settings
Dx Development
Sub Theme – Dx Developments Lead to Expanded Use of Large Panels / WES
Large Panel
Testing
Becomes
Standard
Pathologists
All data needed for future Dx
development derived from
existing panels; new tests
based on algorithm refinement
Test / bioinformatics capabilities leads to
increased test centralization and
decreased in-house pathology
Future Dx development may focus on scalability and algorithm refinement vs platform / chemistry; cost may gate access
Health AI
“…WES & WTS will remove need for anything more to characterize cancer;
maybe the whole Dx process would disappear in place of signature refinement…”
-VP, Personalis
Patients
Single large test becomes
standard at first line, informing
multiple lines of Tx without retesting
Added data could help ID
patients eligible for trials
Pan tumor TKI’s see increased use as
more patients have known mutations
Pharma
Pharma fully underwrites CDx testing
as pricing per test becomes increasingly
marginal compared to Tx expense
Dx
Development priorities refocus on
batching and scalability for core labs
rather than decentralized workflows
“…Tx companies will start carrying strategy burden that Dx companies usually have;
lack of Dx uptake will limit their drugs, but they have resources to remove barriers…”
-KOL, Third Rock Ventures

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25
Therapeutic Improvements are expected to drive access across care settings and improve survival, but could
also enhance education burden and create reimbursement complexities if payers are outpaced
Tx Development
Key Change – Therapeutics Improvements –
Subtopic 1 - Increase in the Number
of Tumor Agnostic Drugs / Indications
The number of new available drugs and
combination regimens will increase; new
approvals will be based on biomarkers
rather than tumor origin
Subtopic 2 - Improved Efficacy &
Survivorship
New treatments and catching earlier
disease will boost efficacy and extend
survivorship; cancer may be increasingly
viewed as a recurrent lifelong vs acutely
terminal disease

DRAFT
26
Even when patients have druggable mutations, they frequently cannot receive therapies if the tumor origin is
off-label; more agnostic approvals will expand therapy access and drive broader mutation testing
Tx Development
Sub Theme – Therapeutic Developments Lead to More Tumor Agnostic Approvals
Increase in
the Number
of Tumor
Agnostic
Drugs /
Indications
Physicians
Community settings will have a vastly
expanded Tx arsenal; trials will not
be the only option for late line Tx
The pressure and complexity for ongoing
physician education (especially oncologists in
community settings) will increase
Precision medicine could see uptick in community settings, driven by pan-tumor Tx; may increase education burden
Dx
Large panel tests will be ordered with
more regularity regardless of tumor origin
Pharma
More pan-tumor basket
studies will be initiated
Health AI
RWE will drive future R&D; speeds
time to clinical stages and pivotal
to guiding basic R&D strategy
Future pathologists could play the role of
key advisors on tumor boards as test
options become increasingly complex
“…The role of the pathologist will
become more important in driving
responsible testing; also educating
different stakeholders on findings …”
-CXO, PathGroupOverall cost of Dx expected to increase
as low-plex technologies replaced

DRAFT
27
Therapies will naturally become more efficacious, boosting survivorship and become curative vs palliative;
treating cancer as a disease you will fight at several points in your life is new for payor discussions
Sub Theme – Tx Developments Leads to Improved Long-term Survivorship
Improved
Efficacy &
Survivorship
Patients
More patients will be subjected to long-term
maintenance Tx and monitoring; could
increase cost per patient given prolonged Tx
Patient advocacy groups could swell in
numbers, helping drive education that
will propel patient empowerment
Payors and physicians will need to make fundamental changes to accommodate curative/long-term vs palliative treatment
Payors
Insurance providers struggle with expense
for minimal survival in late stage disease;
reimbursement discussions will refocus on
long-term vs acute care
Physicians
Primary care physicians will play
increasing role in long-term follow-up
care; education burden falls on them
Tx Development
Pharma
Drug development focuses on
further maintenance &
recurrence Tx development
Payors may not tolerate exponential price increases for
incremental survival benefits; possible that drugs only
covered if years rather than months of life added

DRAFT
28
Patient Empowerment through education and growing advocacy groups present growth opportunities as
patients proactively request precision medicine
Clinical / Patient
Key Change – Patient Empowerment –
Subtopic 1 - Patient Education / Advocacy
Will Drive Precision Medicine Demand
Increasing resources will be available to
patients at all stages of care; improved
survivorship will drive growth of both
established and rare cancer advocacy groups
Subtopic 2 - Patient Data Ownership &
Generation Sees Growth
New direct to consumer offerings for
testing and wellness (i.e. 23&Me, FitBit)
will serve as data sources; patients are
eager for clinical actionability of their data

DRAFT
29
An increasing number of resources are becoming available to patients, leading to proactive requests for
certain procedures or Txs; the onus will fall on clinicians to help facilitate care based on clinical evidence
Sub Theme – Patient Empowerment Through Education / Patient Advocacy
Patient
Education
Will Drive
Precision
Medicine
Demand
Patients
As patients conduct more research,
they are more likely to be influenced
by brand name tests & treatments
Patient education & advocacy could add some burdens, but will ultimately be a strong driver for precision medicine uptake
“…Telehealth will come online and play a big role in
expanding access to expert care teams regardless of
location; Consultations could be decentralized…”
-Patient Advocate
Physicians
Patients requesting specific treatments
/ tests could add further pressure to
ongoing physician education
Large panel testing could increase
/ become reflexive as patients
increasingly request advanced tests
to understand all Tx Options
Dx
Payors
Patient willingness to pay out of
pocket for additional information/
clinical actionability may increase
Clinical / Patient
Patients may expect increased
responsiveness from physicians; this will
add to clinician burden; offers opportunities
for software solutions
Software
Devs.
“…More patient becoming aware of precision med. options;
they will see commercials and ask for specific tests / Txs…”
-Oncologist KOL, USC
Patient advocacy groups could act as valuable
call-points for trial enrollment; endorsements
present new marketing opportunities

DRAFT
30
Driven by increased overall education and more technical resources, the rate at which patient data is
generated will continue to accelerate, creating new opportunities and challenges across the landscape
Sub Theme – Patient Empowerment Through Expanded Data Ownership
Patient Data
Ownership &
Generation
Sees Growth
Patients will play a larger role as RWD generators; handling these data will require EMR and education advancements
Clinical / Patient
Dx
Diagnostics / test developers will have
an increasing number of offerings to
generate data at all stages of care
Patient
Trends towards wellness and
medical education will drive
patients to acquire more data
from tests and self reporting
New digital biomarkers could emerge
as sufficient data from wearables and
lifestyle factors are consolidated
Health AI
EMRs will need to evolve in
order to accommodate these data
Physician
Pharma
Opportunities for Tx developers to
offer holistic care (i.e. pre-
cancer) will emerge as broader
patient data enters the ecosystem
Physicians will be ill-equipped to handle
self-reported patient data without better
tools (i.e. health data tracked on phone)
“…Current EHR is system fundamentally
flawed in ability to collect RWD & follow-
up; it Needs to be rebuilt from scratch…”
Some patients will want to
commoditize their data;
others will be wary of security

DRAFT
31
It is generally agreed that vast amounts of useful clinical information are already generated; multi-modal data
linking is the next step to unlocking new therapy R&D
RWE / Health AI
Key Change – Multi-Modal Data Linking–
Subtopic 1 - EMRs Evolve to Accommodate
New Inputs
Data from internal clinical channels (i.e.
pathology, radiology) sees better integration;
clinical notes and outcomes more closely
tracked in a curated format
Subtopic 2 - Value Based Care
Becomes Expected
As Tx costs continue to soar, public &
private payers will increasingly demand
‘value based pricing’; health outcomes
beyond clinic are more actively tracked

DRAFT
32
EMRs are a known chokepoint in the expansion / actionability of RWD; improvements to handle multi-modal
data inputs while reducing physician workload are a known need
Sub Theme – Multi-Modal Data Linking Supported by EMR Evolution
EMRs
Evolve to
Accommodate
New Inputs
EMR’s to be modified / rebuilt to be
based around data collection /
analysis, rather than billing
Few EMR improvements are expected to occur near-term; significant disruption may be needed to drive advancement
Payors
RWE / Health AI
Software
Devs.
Physician
New platforms ideally streamline
physician data entry by integrating
natural language processing
Patients
Data may become patient rather
than hospital centric, smoothing
referral, reducing redundancy
Payors to more proactively track
biomarkers and their links to efficacy;
potential to adjust premiums based on risk
Payors develop their own
EMRs; Track outcomes and risk
factors to proactively make
recommendations to patients
Pharma
As data landgrab
continues, legitimacy
around what constitutes
‘gold standard RWE’
becomes obscured
“…Could create a parallel EHR system; we can’t stay
in context in billing but need to make it actually
focused patients and what tests are conducted…”

DRAFT
33
Payers and patients will increasingly demand greater value in the face of increasing drug prices; RWE has
the potential to demonstrate added value, but will also increase pressure on pharma to deliver improvements
Sub Theme – Multi-Modal Data Linking Enables Value Based Care Assessments
Value-Based
Care
Becomes
Expected
Payors
Payers could be key advocates of
post Tx surveillance / monitoring
test development, improving
efficacy vigilance
Factors like adverse events and quality of
life may be tracked more closely as new
therapies enter with incremental efficacy
Incremental survival may no longer be acceptable to payors as RWE makes its way into health econ. evaluations
Dx
RWE / Health AI
RWE rather than clinical guidelines
used to set reimbursement prices
More confusion about
recommended clinical
steps / Tx expense
Pharma
New clinical outcomes / trial endpoints will need
to be adopted as incremental survival benefits are
no longer accepted by payers at list price
Physicians
Greater bifurcation
occurs as advanced
settings consolidate
RWE and entry
barriers grow
“…As more data is generated and consolidated by Drs., leads to bifurcation; the educated
get smarter and more tuned into care, but others feel more distant from overall Tx…”
-Patient Journey Expert
Predictive biomarkers to be improved at the
expense of further limiting patient populations
Predictive biomarkers to be improved at the
expense of further limiting patient populations

DRAFT
34
Following changes that will permeate every level of precision medicine, there are several key considerations
for developers to keep in mind as they work towards future innovations
Physician Education Burden – Many precision medicine advancements risk adding to physician education / time
burden
Key Considerations for Precision Medicine Developers
1
Pricing for Long-Term vs Acute Cancer Care –Treatment may become episodic vs acute; adverse events less
acceptable, and value-based care will be key
2 Shift Towards Earlier Stage Disease – be prepared to treat healthier patients in community settings with localized
rather than systemic interventions
3
Data at All Points of Patient Journey Captured – Care needs to be taken to generate / record data in a
standardized manner; software needs to enable this
4
Care Decentralizes / Testing Centralizes – Patients increasingly expect care with minimal traveling; technical /
bioinformatics requirements consolidate future testing
5

DRAFT
35
Thank you for your time and attention – We are happy to answer any questions
Special Thanks To:
• Tom Fare and the PlanetConnect team
• Colleagues at DeciBio who contributed to this analysis
o Stephane Budel – Partner
o David Cavanaugh – Partner
o Fanny Anderson – Associate
o Seth Schachter – Associate
• All stakeholders who participated in primary research
For more information about DeciBio, visit us at www.DeciBio.com;
These slides will be made available via PlanetConnect; Please connect directly with us for additional insights

DeciBio Perspectives on Pain Points, Unmet Needs, and Disruption in Precision Oncology

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