Growth Opportunities for Entrepreneurs in Clinical Research Services

Clinical Innovation +
Personalized Medicine:
Growth Opportunities in
Clinical Trial Execution
Craig Lipset
@craiglipset
February 2020
© Clinical Innovation Partners LLC 2019

My Affiliations
Confidential: Clinical Innovation Partners LLC
Managing Partner, Clinical Innovation Partners LLC
Board of Directors, People Centered Research Foundation (PCORnet)
Board of Directors, Foundation for Sarcoidosis Research
Board of Directors, MedStar Health Research Institute
Board of Directors, Circuit Clinical / TrialScout
Venture Partner, Boston Millennia Partners

Clinical trials
are vital for developing
new medicines
but they are broken

RETURN ON
DEVELOPMENT INVESTMENT
($2.6 billion USD Capitalized
Investment per Successful Drug)
source: Deloitte Healthcare
GLOBAL SPENDING ON
PHARMA R&D
source: Tufts CSDD

PERCENTAGE OF ALL DRUGS
ENTERING CLINICAL TESTING
THAT FAIL TO RECEIVE
APPROVAL
source: Tufts CSDD
PROBABILITY OF
RECEIVING REGULATORY
APPROVAL BY DISEASE
source: Tufts CSDD

AVERAGE NUMBER OF YEARS
IN DEVELOPMENT
source: Tufts CSDD
10 YEAR CHANGE IN
PROTOCOL DESIGN
source: Tufts CSDD

Clinical Trial Trends
➔ Experience Matters
Increasing attention and investment in
participant & investigator experience
➔ Digitization
Supporting patient experience/access,
innovative data capture, and
process automation
➔ Data-Driven
Fully leveraging diverse in-house
study data (clinical & operational) as well
as externally acquired real world data

MY CLINICAL TRIAL FORECAST
DECENTRALIZED,
DISTRIBUTED,
DEMOCRATIZED, and
DISRUPTIVE

Clinical trials will be decentralized

Drug trial (tolterodine tartrate)
Fully remote/virtual
REMOTE Trial
REMOTE:
Research on Electronic Monitoring
of
OAB Treatment Experience
Safety & efficacy of Detrol LA
for overactive bladder
600 patients from 10 states
California, Texas, Illinois, Florida,
Pennsylvania, Michigan, Georgia,
North Carolina, New Jersey & Virginia
2 lab assessments
5 mobile based e-diary
assessments

REMOTE Trial

INDUSTRY ENGAGEMENT
2015 2016 2017 2018 2019
Sanofi and
eClinicalHealth initiate
Verkko trial evaluating
Mendor digital diabetes
monitor enrolling 60
patients in Europe
Science 37 raises $6.5M
series A including dRx
AOBiome and Science
37 initiate virtual Ph2b
trial of microbiome acne
treatment enrolling 372
patients in 10 states
Mytrus selected for
ADAPTABLE Aspirin
Trial to enroll 20,000
patients
GSK announces
ResearchKit study in
rheumatoid arthritis
Science 37 raises
$31M series B including
Sanofi
Mytrus to be acquired
by Medidata
Science 37 raises
$35M series C
including Amgen and
Google Ventures
Novartis announces
partnership for 10 trials
with Science 37
IQVIA launches virtual
research solutions
Boehringer Ingelheim
announces partnership
with Science 37
JnJ and Apple
announces plans for
HEARTLINE study in A-
fib to enroll 150,000
Transparency Life
Sciences launches
VISITOR study
Science 37 raises
additional $35M
(led by PPD)
Verily announced Study
Platform collaboration
with four pharma

ENABLING “LOCATION-FLEXIBILITY”
Brick-and-Mortar Sites
Conventional investigator site visits
Hybrid Studies
Some visits scheduled at home
Fully Virtual
All visits from the home
Above options still dictate to the patient how to participate
Ideal target: Allow the patient to choose where to participate

patents like
their
treating
physician
research
participants
like their
sites
majority of
physicians
are employed
by health
systems
Average physician rating
of 4.4 on HealthGrades
CISCRP reports over 90% of
research participants feel their
care during a study was the
same or better than their
standard of care
AMA reports 47.4% patient
care physicians employed
by health systems
(vs. 45.9% self-employed)
ROADS IN US LEAD TO HEALTH SYSTEMS

Central PI
ROADS IN US LEAD TO HEALTH SYSTEMS

Clinical trials will be distributed

RISE OF THE MASTER PROTOCOLS

RESEARCH AROUND THE PATIENT
Master
Protocols
All-Comer
Big-Data
Observational
Studies
One app for multiple studies
One set of tasks across all studies
Access and share health data across studies
Apple Research app

We must fix the
MISALIGNED INCENTIVES
to enable
CLINICAL RESEARCH AS A CARE OPTION
so all patients can have research
opportunities presented
at their point of care.

Clinical trials will be democratized

REAL WORLD EVIDENCE

As the use of real world evidence increases,
there will be growing urgency to ensure
that PRECISION MEDICINE and
PATIENT-CENTRICITY do not pull in
opposite directions.

Patients in full control of their
PERSONAL HEALTH DATA will be a
KEY ENABLER of the future.

Clinical trial will be democratized

HOW CLINICAL TRIAL SERVICES ARE
PURCHASED WILL BE DEMOCRATED
THROUGH MARKETPLACES

Clinical trials will be disruptive
Entire stakeholders considered vital
today may be displaced tomorrow

THERE IS A POTENTIAL FUTURE WHERE
ANY STAKEHOLDER MAY BE DISPLACED
• Will process automation eliminate the need for
service providers based on manpower?CRO
• Will remote/decentralized trials eliminate the
role of local “brick and mortar” sites?Investigator Site
• Will DIY R&D empower patients to biohack,
crowdfund, and data-share the future of
medicine development?
Sponsor
• Will synthetic controls, digital twins, and
simulations/modeling eliminate the need for
patients to participate in clinical trials?
Patient

ENABLING DISPLACEMENT

Entrepreneur Considerations
Bring focused
solutions
General “analytics” and “AI”
are too vague to buy;
Solve for a known business
challenge to connect with
R&D leaders
Plan accessible
entry points
Create a simple ask with the
minimum burden and lift
needed to go from
presentation to
experimentation

The KPI teams really
care about
(but will never admit):
% of weeknights I get
home for dinner with my
family
Pharma R&D
Downsizing
source: PharmaProjects

Entrepreneur Considerations
Is the CRO my
friend?
CROs need partners to help
differentiate their proposals,
but only entrepreneurs that are
providing a solution to the CRO
as a customer are those that
will be fully supported
All the fuel is
spent on the
“pilot”
Risks nothing left “in the tank”
to support the change
required for scaled adoption

Preparing for
Innovation Adoption
Why are we surprised when the pilot is delivered?
The book
that
doesn’t
exist!
WHAT TO
EXPECT
WHEN YOU’RE
PILOTING
================
The all-in-one guide for
scaling clinical trial
innovations.

ADDITIONAL INFORMATION

DIGITAL IMPACT IN DEVELOPMENT
access to information
pre-trial, during-trial, post-trial
sharing results & data
access to participation
travel, virtual/remote, location-flexible
ACCESS
improve existing
measurement
enable new
endpoints
MEASURE
process automation
remove tasks
improve quality
AUTOMATE

INCREMENTAL DIGITAL TOUCH POINTS
study
planning
patient
engagement
study
conduct
analysis &
reporting
crowdsourcing
data-driven
AI-informed
protocol-fueled
automation
data-driven matching
electronic consent
location-flexibility
digital concierge support
self-tracked & self-reported data
patient aggregated data
sharing results & data
data ownership
remote monitoring
digital/AI biomarkers
electronically sourced data
RWD/RWE
synthetic controls
process automation
reporting automation
deliverables to participants

Pre-Study During Study Post-Study
Awareness
Diversity &
Representative
participation
Shared-decision
making
Electronic informed
consent
Digital tools to
support
participation &
information sharing
Making trials
accessible
Patient-friendly
study results
Participant access
to individual
electronic clinical
data from study
Clinical trial alumni
community
Patient-Facing Initiatives

Growth Opportunities for Entrepreneurs in Clinical Research Services

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