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Ryan Tubbs
Paul Slater
Accelerating
Innovation in Clinical
Research
It takes 12 years at
an average cost of
$2.6B
to bring new life-saving
drugs to market,
causing thousands
of deaths annually
Life sciences penetration rarely touches the
value chain of discovery, development and
commercialization
Our industry segmentation prevents us from
tying together the various parties in clinical
research
We have not engaged fully with KOLs across
industry and academia
Our platform is not considered “best of breed”
in life sciences
We lack the industry depth to be fully credible
in specific use cases.
We have not engaged with disruptors,
particularly startups
Governments are unable to control drug
prices, and maintain public health effectively.
Pharma companies have seen the cost of drug
development rise 10,000% since the 1950s
CROs are unable to provide efficient research
services and find their business model
threatened.
50% of medical centers (sites) enroll one or
zero patients in trials
97% of patients do not access clinical research,
despite the fact that it produces better health
outcomes
Research Institutions cannot reproduce results
from prior studies
Regulators cannot provide consistent guidance
on which new approaches to research meet
safety requirements.
Societal Problem Microsoft ProblemsIndustry Problems
The $65B clinical trials
market needs a makeover.
CBInsights
On behalf of Bayer and Accenture, I would like to thank you all
for taking the time and effort to conduct such a remarkable
product overview, where you’ve demonstrated specific
domain knowledge in clinical trial and nailed every use
case we discussed beforehand. The RFP will be delivered
before next Monday
Szu-Le Lee, Accenture Digital
This project is going to lead a large increase in PRA’s Azure
consumption and will displace AWS in the account. PRA’s
team has met with IBM, Google/ Verily and AWS and they
have selected to move forward with Microsoft based on the
work of the Clinical Research Innovation Hub
Michael Perriello, Account Executive
In partnership with Microsoft, Veradigm is committed to a
holistic approach to developing the platform that supports
integrated clinical research. The teams are prepared to work
with the industry and regulators; bringing the practice of
clinical research into the 21st Century.
Tom Langan, CEO of Veradigm
PRA – Full digital transformation
to enable clinical research as a
care option for all patients.
Veradigm – Development of an Integrated
Research Network, designed to enable all
clinicians to conduct research.
CDISC – Enable end to end standards-based flow of
research data from conduct to analytics and reporting;
Azure is platform of choice.
Duke/Swift – Generate clinical phenotypes
from EMR Data to exceed current gold
standard in populating registries
$600k
estimated
monthly ACR
impacted
$10M
in H2
customer
pipeline
$80M
in total pipe
186
new
industry leads
16
industry
partners
46
partners in
recruit pipeline
4
strategic
partnerships
(PR moments)
9
event
presentations
(2 keynotes)
11
net new
success
engagements
2
new industry
memberships/
sponsorships
CRIH BY THE NUMBERS
Early Wins
Global Scalable Cloud Platform
Agile Team,
focused on
problem,
not industry
segment
Reference
Architecture for
Clinical Research
Curated Partner
Ecosystem
BRAND: Altruistic CEO,
trusted data steward,
& non-threatening
mission statement
Why it’s working
30%
10%
20%
40% on premise
and legacy systems
Historical State (BCRIH)
31%
5%
4%
60% on premise
and legacy systems
55% on premise
and legacy systems
Clinical Research cloud adoption trajectory
25%
10%
15%
MICROSOFT has less
than 2% share
40%
Cloud-based
platforms
45%
Cloud-based
platforms
60%
Cloud-based
platforms
Win the decadeDo Nothing Execute 3-year strategy
16%
2%
2%
80% on premise
and legacy systems
20%
Cloud-based
platforms
https://youtu.be/0OxruYyf0p4
https://youtu.be/11Z2B9lIf_0
Technology
Proprietary
Gifts / Big Bets
Industry
Reputation
Tagline
AWS GCP Azure
Pill Pack, Partnership
with JP Morgan
Verily, Project Baseline MS Healthcare, CRIH
De facto choice Most innovative Most trusted
Anticipated
Healthcare Disruptor
Life Sciences
Disruptor
Empowering Clinical
Research innovation
CTMS
ePro
EDC
Regulatory
information management
Safety
management
Recruitment
Best of Breed
Customer Benefits
Safe choice for IT departments
Customer Concerns
Their disruption of life sciences
supply chains makes them a threat
Customer Benefits
Deep domain knowledge from targeted hiring
and long-term partnerships
Customer Concerns
How Alphabet monetizes data
Reference
Architecture
Partner
Ecosystem
Agile Team
& Process
Customer Benefits
Trusted technology partner who is
not trying to compete with me
Customer Concerns
Microsoft’s long-term commitment
Clinical research innovation hub slides for kelly

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Clinical research innovation hub slides for kelly

  • 2. It takes 12 years at an average cost of $2.6B to bring new life-saving drugs to market, causing thousands of deaths annually Life sciences penetration rarely touches the value chain of discovery, development and commercialization Our industry segmentation prevents us from tying together the various parties in clinical research We have not engaged fully with KOLs across industry and academia Our platform is not considered “best of breed” in life sciences We lack the industry depth to be fully credible in specific use cases. We have not engaged with disruptors, particularly startups Governments are unable to control drug prices, and maintain public health effectively. Pharma companies have seen the cost of drug development rise 10,000% since the 1950s CROs are unable to provide efficient research services and find their business model threatened. 50% of medical centers (sites) enroll one or zero patients in trials 97% of patients do not access clinical research, despite the fact that it produces better health outcomes Research Institutions cannot reproduce results from prior studies Regulators cannot provide consistent guidance on which new approaches to research meet safety requirements. Societal Problem Microsoft ProblemsIndustry Problems The $65B clinical trials market needs a makeover. CBInsights
  • 3. On behalf of Bayer and Accenture, I would like to thank you all for taking the time and effort to conduct such a remarkable product overview, where you’ve demonstrated specific domain knowledge in clinical trial and nailed every use case we discussed beforehand. The RFP will be delivered before next Monday Szu-Le Lee, Accenture Digital This project is going to lead a large increase in PRA’s Azure consumption and will displace AWS in the account. PRA’s team has met with IBM, Google/ Verily and AWS and they have selected to move forward with Microsoft based on the work of the Clinical Research Innovation Hub Michael Perriello, Account Executive In partnership with Microsoft, Veradigm is committed to a holistic approach to developing the platform that supports integrated clinical research. The teams are prepared to work with the industry and regulators; bringing the practice of clinical research into the 21st Century. Tom Langan, CEO of Veradigm
  • 4. PRA – Full digital transformation to enable clinical research as a care option for all patients. Veradigm – Development of an Integrated Research Network, designed to enable all clinicians to conduct research. CDISC – Enable end to end standards-based flow of research data from conduct to analytics and reporting; Azure is platform of choice. Duke/Swift – Generate clinical phenotypes from EMR Data to exceed current gold standard in populating registries $600k estimated monthly ACR impacted $10M in H2 customer pipeline $80M in total pipe 186 new industry leads 16 industry partners 46 partners in recruit pipeline 4 strategic partnerships (PR moments) 9 event presentations (2 keynotes) 11 net new success engagements 2 new industry memberships/ sponsorships CRIH BY THE NUMBERS Early Wins Global Scalable Cloud Platform Agile Team, focused on problem, not industry segment Reference Architecture for Clinical Research Curated Partner Ecosystem BRAND: Altruistic CEO, trusted data steward, & non-threatening mission statement Why it’s working
  • 5. 30% 10% 20% 40% on premise and legacy systems Historical State (BCRIH) 31% 5% 4% 60% on premise and legacy systems 55% on premise and legacy systems Clinical Research cloud adoption trajectory 25% 10% 15% MICROSOFT has less than 2% share 40% Cloud-based platforms 45% Cloud-based platforms 60% Cloud-based platforms Win the decadeDo Nothing Execute 3-year strategy 16% 2% 2% 80% on premise and legacy systems 20% Cloud-based platforms
  • 7. Technology Proprietary Gifts / Big Bets Industry Reputation Tagline AWS GCP Azure Pill Pack, Partnership with JP Morgan Verily, Project Baseline MS Healthcare, CRIH De facto choice Most innovative Most trusted Anticipated Healthcare Disruptor Life Sciences Disruptor Empowering Clinical Research innovation
  • 8. CTMS ePro EDC Regulatory information management Safety management Recruitment Best of Breed Customer Benefits Safe choice for IT departments Customer Concerns Their disruption of life sciences supply chains makes them a threat
  • 9. Customer Benefits Deep domain knowledge from targeted hiring and long-term partnerships Customer Concerns How Alphabet monetizes data
  • 10. Reference Architecture Partner Ecosystem Agile Team & Process Customer Benefits Trusted technology partner who is not trying to compete with me Customer Concerns Microsoft’s long-term commitment

Hinweis der Redaktion

  1. Our “universe” will become a key focus point of this as we will aim to show what the universe will look like in Horizon 1, Horizon 2, and Horizon 3. With that, we can clearly articulate the “theme” of each Horizon and by extension what bets and investments we need to make to realize that vision. Of course when you consider the timeline, it’s vital we show that we do need to make some investments in H2 and H3 NOW in order to enable them to ultimately come to fruition. Objective: Story to tell and
  2. Today it takes an average of 12 years and $2.6Bn to bring a new therapy to market, and for the last 70 years that trend has been moving in the wrong direction. As a result, thousands of people die every day from diseases for which there is a known cure. Meanwhile, technology is advancing at an exponential rate. While many sub-domains of Healthcare and Life Sciences (e.g. drug discovery) are taking advantage of these technologies (and by extension growing exponentially themselves), clinical research is not. This disconnect between technology and research is literally costing people their lives. The $65B clinical trials market needs a makeover. – CBInsights New technology approaches have the potential to make a huge difference to this equation – something we have confirmed through our own research and in collaboration with experts from both industry and academia. Many current processes are over 40 years old, and past attempts to modernize discrete aspects of the process – while noble in their own right – have actually created more complexity; leading to an even more fragmented and protracted process. Primarily, this is because disrupting the end-to-end process of research is an enormous effort only a few companies are capable of undertaking. We’re one of them. We have received copious market validation that Microsoft is a welcomed disrupter in this space and viewed as significantly less of a threat than Google or Amazon. A few statements: (Industry)Problem of Clinical Research (problem hierarchy) 12 years/2 billion dollar investment to get into market (How we are addressing) Problem of being unknown in the market (as a platform option), not working with disruptors, and not establishing partnerships with start-ups, not engaging with influencers with academic Shifting spending to VC (from internal R&D to external—smaller more agile organizations that are not on the MS platform) Investor mindset: Why are we promoting this, when there are sellers in place ATUs, industry marketing teams etc Not being met by traditional account teams, work we have done has introduced to execs Kick starting an explosive growth, hypos? Opportunity vs. Problem Uniqueness is obsession as problem centricity (part of our brand) Motivated by threats than opportunities
  3. 2 rounds: 1.3M, 915K
  4. Do nothing – the work we’ve done to date has already increased our share by 2% which has an estimated value of $76M Short term investment (this round) – has the potential to unlock an additional 11% of share valued at: $418M Get ahead of Google but still behind AWS Executing full 3 year strategy has the potential of grabbing the lion’s share of cloud, beating Amazon and Google. Valued at: $1.14B Assumptions: The industry as a whole spends $54Bn on IT Microsoft has got around 2% of that historically The industry spends around 170Bn on R&D This is estimated to be about 20% of overall revenue - https://www.statista.com/statistics/265100/us-pharmaceutical-industry-spending-on-research-and-development-since-1990/ If we assume that the R&D budget equates to 20% of the overall budget and that IT spend in R&D budget would at least be at least as large as in operational areas (it is absolutely more, but we don’t have the data by how much), then use 10.8Bn as the TAM for total R&D. We are focused on clinical development, which we can assume is at least 35% of the overall costs, as shown in our original value chain assessment So that now yields us a deeply conservative TAM of 3.8Bn.
  5. De-facto Choice for biotechs and startups driving innovation in research
  6. Google: https://cloud.google.com/solutions/life-sciences/?tab=tab3https://aws.amazon.com/health/biotech-pharma/clinical-trials/?p=bp’ AWS: https://aws.amazon.com/health/biotech-pharma/clinical-trials/?p=bp Paul’s CDISC keynote: https://www.linkedin.com/pulse/cdisc-us-interchange-2019-keynote-address-full-paul-slater/
  7. Empower (mission statement) Accelerate Focus…on the process Enable Research Discover a molecule that has some reaction in the human model (research) Design a trial (human being writing something down) Group of people (watch them and report results) Data set that you get out of the trial **image needs to look complicated and labor intensive, too many systems Try this Discover a molecule in the human body – research with microscope Authoring the trial Clinical trials Data from trials Google clinical trial for inspiration