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MIRA Medicine
Empowering complex clinical decisions

Lean Launch Pad for the Life Sciences
UCSF – Fall 2013
Team:
PA Gourraud
Raphaelle Loren
Jason Crane
team

PA Gourraud - Analytics Lead
Hustler, Hacker, Biostatistician

Raphaelle Loren - Business Lead
Hustler, Product, Marketer

Jason Crane - Software Lead
Hacker, Imaging Software
LLP JOURNEY

GENESIS
MULTIPLE SCLEROSIS: a case study

Challenge #1

Evaluating the disease
Challenge #2

Selecting the right
treatment at the right time

Bonus challenge

Education and communication
with the patient
MS Economics

500,000 patients in North America
18,000 neurologists
$7.8B in drugs prescribed every year for MS
Total cost to society $28B/year
Competitive market for therapies
Mira Medicine Final Presentation
BEFORE LLP: Memorable quotes
If you can show
pharmacoeconomics, payors will be
really interested

Dr. G, UCSF Neurology

This would be a great tool to monitor
individual trajectories during clinical
trials

This is a great telemedicine tool!

T.M., J&J

Head of Innovation, Sanofi

Dr. S., community MD & entrepreneur

We’d be really interested in testing a
tool like this for Alzheimer’s
A RICH MAN’S PROBLEM

PRODUCT OR SERVICE COMPANY?

MS OR MULTI-DISEASE FOCUS?
Mira Medicine Final Presentation
BMC #1
What did we learn?

LESSON #1

Our solution elicits advice and new ideas from almost
all interviewees
What did we learn?
What did we learn?

LESSON #1 - Our solution elicits advice and new ideas from almost all
interviewees

LESSON # 2

Focusing on a specific set of customers at a time will
give us more insights into their needs
1 step back for 3 steps forward

visualize data

personalize
guidance

quicker
assessment

facilitate
patient/clinician
collaboration

improve
outcomes

Takes pride
in art of
medicine

See more
patients

Enhance
relationship
with
patients
Slow down
MS even
more
assess
history

explain
options

MS Bioscreen

10 min saving
per consult

simplify data
access

trial and
error

# of
options
1/3 visit is
about disease
education

no
personalized
guidance

Recommend tx
+ disease
management
tools/services

keeping up with
latest research
What did we learn?
Mira Medicine Final Presentation
Key Alpha customer: Clinical researcher

Research Lab Director & MD
• Translational focus, lots of data
• Financially independent

• Can initiate clinical trials
Memorable quotes from LLP interviews

I can’t wait to see our research
on here. When can we install this
in our clinic?

Prof Miravalle, University of CO

I would love to test this tool
for epilepsy

Prof Steinman, Stanford

[I see] this tool as a fundamental step
into optimizing therapies in MS and will
lead the implementation here.

Dr P, UCSF
What did we learn?

LESSON #1 - Our solution elicits advice and new ideas from almost all
interviewees
LESSON # 2 - Focusing on 1 specific set of customers at a time will give us
more insights
KEY TAKE AWAYS
1. Validated of initial target audience for the existing tool
2. Our Holy Grail is the predictions and treatment recommendations
1. We can create value before we get to that Holy Grail
Vision 5-8 year

Prescriptive
Predictive
Comparative

Descriptive

MS

Parkinson’s

Psychiatric
disorders

Alzheimer’s

Brain Tumor

Transplantations

Prostate Cancer

Complex
diseases
New Market

Precision Medicine
$2B+
Analytics tools for
Clinical Care
$200M+

Bio-informatics
Knowledge
Management
$215M+

Target market 8-10 years
100-200M
What are we doing next?

• Partner with Alpha customers
• Pursue Customer Discovery
• Design validation studies for each of our key value props
Investment readiness
MIRA Medicine
Empowering complex clinical decisions

Thank you
2015

Cash reserve

2014

2016

2017

Series A

Series C

Series B

Product dev
Data +
analytics

MIRA MS custom installs

IP

MIRA MS
marketable
product

MIRA MS
2nd release

Pilot studies

US Pivotal Clinical Trials

US Interim Trials
Clinical trials

Research Ctrs
EMRs
Comparative

1st gen predictive & reco

2nd gen predictive & reco

Technology
Licensing
Provisional patents

Regulatory
/ IP

Multi-disease cognitive
system platform

3rd disease

2nd disease beta

1 disease beta

2018

IDE
from
IRB

Cat III
CPT

Algos patents

FDA – Class III –
510(k) with Clinical
Trials

CPT
codes

3rd gen predictive & reco
Mira Medicine

Custom tools for therapeutic decision-making in complex neurological disease

•
•
•
•
•
•

EMRs?
Data analytics company
Imaging processing
partner
Data aggregation
platform?
Pilot studies partners
(Med Center)
Design firm/data viz guru

-

Algorithm development
Imaging processing
Software design and
development
UI design and development
Data curation (at later
phase for baseline)
Sales, marketing, customer
development

Development team
AI team
Designer

Provider: Multi-data type
decision-making tool

Dedicated personal assistance
Co-creation of some of the IP?

Pharma = recruit new patients
and keep them on therapy
CROs: carefully design
studies with deep experts.
Recruit patients faster

Custom solution to visualize
individual health data in
context
- Reduce overall costs
- Improve efficiency of
clinical trials
- personalized tracking
- Provide personalized
therapeutic guidance
(pilots)

•
•
•
•
•

Medical Centers
Pharmas
VA
EMRs?
CROs (for targeted
therapies)

DIRECT
Awareness: conferences,
papers, online
Eval, purchase:
Bus dev 1:1 (initially PAG +
RDL)
INDIRECT: Partners such as
McKesson? Bundled with an
EMR? CROs? OEMs

Value-driven model (high personalization of offering)
Fixed costs low (no major cap ex to get started, and some costs are proportionate
to growth, while others are reduced through economies of scale.)
Cash-flow should be watched tightly at the beginning (net 30 after submission of
first invoice, unless we can negotiate % upfront)

Platform as a Service (+ 10-20% custom work)
Fee for service: Custom software development contract
Data curation services
Subscription: Maintenance/support contract
Business Model Canvas: MIRA
Key Partners
Problem
Image processing
IP attorney
CPA/CFO
Med Center for
studies/validation
NMSS

Key
Solution
Activities
Algos

Unique Value
Proposition

Software design and dev
Image processing
Customer development
Validation & pilots

1. Improved patient
outcome by
identification of optimal
treatment paths
2. Saves time
3. Improves relationship

Key Activity
Key

KOLs, case studies
Patient stories,
community
Expert dedicated project
lead
Thought-leadership

Customer
Segments
MS Neurologists
MS Patients
Medical Centers
CROs

AI team
DB and mobile dev team
Designer
Product
Regulatory

Channels

Pharma

4. Increases compliance

Resources

Channels

Payors

5. Increases probability of
success of clinical trial
(patient id)

OEM/Mobile tool
provider ePocrates?
NMSS

Cost Structure

Direct sales 1:1

Revenue Streams

Core team
Dev tools
Licensing from UCSF (equity at end of Series A)

Date: 06/05/2013

Customer
Unfair
Relationships
Advantage

Version Name: v02

- Pay per use (cash or credits) (Credits are
earned for sharing data)
- Fee for custom development
- Maintenance /upgrade subscription
Business Model Canvas: MIRA (bold items are validated)
Key Partners
Problem
Image processing
Med Center for
studies/validation
Data generating devices
NMSS
EMR

Key
Solution
Activities
Algos

Unique Value
Proposition

Software design and dev
Image processing
Customer development
Validation & pilots

1. Improved patient
outcome by
identification of optimal
treatment paths

2. Saves time
3. Improves relationship

Key Activity
Key
Resources
AI team
DB and mobile dev team
Designer
Product
Regulatory

4. Improve patient
retention; ROI on
infrastructure; decrease
penalties (MU2)

Customer
Segments

Get: Awareness
campaign (Conferences,
KOLs, articles)

MS Neurologists

Keep & Grow: Expert
dedicated project lead

Channels

Medical Centers
Purchasing
Pharma
Payers
Clinical researchers

Channels
APIs/existing systems

5. Visualize their own
data; realize translational
promise

Cost Structure

Direct 1:1 sales

Revenue Streams

Core team
Dev tools
Licensing from UCSF (equity at end of Series A)

Date: 06/05/2013

Customer
Unfair
Relationships
Advantage

Version Name: v02

- Pay per use (cash or credits) (Credits are
earned for sharing data)
- Fee for custom development
- Maintenance /upgrade subscription

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Mira Medicine Final Presentation

  • 1. MIRA Medicine Empowering complex clinical decisions Lean Launch Pad for the Life Sciences UCSF – Fall 2013 Team: PA Gourraud Raphaelle Loren Jason Crane
  • 2. team PA Gourraud - Analytics Lead Hustler, Hacker, Biostatistician Raphaelle Loren - Business Lead Hustler, Product, Marketer Jason Crane - Software Lead Hacker, Imaging Software
  • 4. MULTIPLE SCLEROSIS: a case study Challenge #1 Evaluating the disease Challenge #2 Selecting the right treatment at the right time Bonus challenge Education and communication with the patient
  • 5. MS Economics 500,000 patients in North America 18,000 neurologists $7.8B in drugs prescribed every year for MS Total cost to society $28B/year Competitive market for therapies
  • 7. BEFORE LLP: Memorable quotes If you can show pharmacoeconomics, payors will be really interested Dr. G, UCSF Neurology This would be a great tool to monitor individual trajectories during clinical trials This is a great telemedicine tool! T.M., J&J Head of Innovation, Sanofi Dr. S., community MD & entrepreneur We’d be really interested in testing a tool like this for Alzheimer’s
  • 8. A RICH MAN’S PROBLEM PRODUCT OR SERVICE COMPANY? MS OR MULTI-DISEASE FOCUS?
  • 11. What did we learn? LESSON #1 Our solution elicits advice and new ideas from almost all interviewees
  • 12. What did we learn?
  • 13. What did we learn? LESSON #1 - Our solution elicits advice and new ideas from almost all interviewees LESSON # 2 Focusing on a specific set of customers at a time will give us more insights into their needs
  • 14. 1 step back for 3 steps forward visualize data personalize guidance quicker assessment facilitate patient/clinician collaboration improve outcomes Takes pride in art of medicine See more patients Enhance relationship with patients Slow down MS even more assess history explain options MS Bioscreen 10 min saving per consult simplify data access trial and error # of options 1/3 visit is about disease education no personalized guidance Recommend tx + disease management tools/services keeping up with latest research
  • 15. What did we learn?
  • 17. Key Alpha customer: Clinical researcher Research Lab Director & MD • Translational focus, lots of data • Financially independent • Can initiate clinical trials
  • 18. Memorable quotes from LLP interviews I can’t wait to see our research on here. When can we install this in our clinic? Prof Miravalle, University of CO I would love to test this tool for epilepsy Prof Steinman, Stanford [I see] this tool as a fundamental step into optimizing therapies in MS and will lead the implementation here. Dr P, UCSF
  • 19. What did we learn? LESSON #1 - Our solution elicits advice and new ideas from almost all interviewees LESSON # 2 - Focusing on 1 specific set of customers at a time will give us more insights KEY TAKE AWAYS 1. Validated of initial target audience for the existing tool 2. Our Holy Grail is the predictions and treatment recommendations 1. We can create value before we get to that Holy Grail
  • 21. New Market Precision Medicine $2B+ Analytics tools for Clinical Care $200M+ Bio-informatics Knowledge Management $215M+ Target market 8-10 years 100-200M
  • 22. What are we doing next? • Partner with Alpha customers • Pursue Customer Discovery • Design validation studies for each of our key value props
  • 24. MIRA Medicine Empowering complex clinical decisions Thank you
  • 25. 2015 Cash reserve 2014 2016 2017 Series A Series C Series B Product dev Data + analytics MIRA MS custom installs IP MIRA MS marketable product MIRA MS 2nd release Pilot studies US Pivotal Clinical Trials US Interim Trials Clinical trials Research Ctrs EMRs Comparative 1st gen predictive & reco 2nd gen predictive & reco Technology Licensing Provisional patents Regulatory / IP Multi-disease cognitive system platform 3rd disease 2nd disease beta 1 disease beta 2018 IDE from IRB Cat III CPT Algos patents FDA – Class III – 510(k) with Clinical Trials CPT codes 3rd gen predictive & reco
  • 26. Mira Medicine Custom tools for therapeutic decision-making in complex neurological disease • • • • • • EMRs? Data analytics company Imaging processing partner Data aggregation platform? Pilot studies partners (Med Center) Design firm/data viz guru - Algorithm development Imaging processing Software design and development UI design and development Data curation (at later phase for baseline) Sales, marketing, customer development Development team AI team Designer Provider: Multi-data type decision-making tool Dedicated personal assistance Co-creation of some of the IP? Pharma = recruit new patients and keep them on therapy CROs: carefully design studies with deep experts. Recruit patients faster Custom solution to visualize individual health data in context - Reduce overall costs - Improve efficiency of clinical trials - personalized tracking - Provide personalized therapeutic guidance (pilots) • • • • • Medical Centers Pharmas VA EMRs? CROs (for targeted therapies) DIRECT Awareness: conferences, papers, online Eval, purchase: Bus dev 1:1 (initially PAG + RDL) INDIRECT: Partners such as McKesson? Bundled with an EMR? CROs? OEMs Value-driven model (high personalization of offering) Fixed costs low (no major cap ex to get started, and some costs are proportionate to growth, while others are reduced through economies of scale.) Cash-flow should be watched tightly at the beginning (net 30 after submission of first invoice, unless we can negotiate % upfront) Platform as a Service (+ 10-20% custom work) Fee for service: Custom software development contract Data curation services Subscription: Maintenance/support contract
  • 27. Business Model Canvas: MIRA Key Partners Problem Image processing IP attorney CPA/CFO Med Center for studies/validation NMSS Key Solution Activities Algos Unique Value Proposition Software design and dev Image processing Customer development Validation & pilots 1. Improved patient outcome by identification of optimal treatment paths 2. Saves time 3. Improves relationship Key Activity Key KOLs, case studies Patient stories, community Expert dedicated project lead Thought-leadership Customer Segments MS Neurologists MS Patients Medical Centers CROs AI team DB and mobile dev team Designer Product Regulatory Channels Pharma 4. Increases compliance Resources Channels Payors 5. Increases probability of success of clinical trial (patient id) OEM/Mobile tool provider ePocrates? NMSS Cost Structure Direct sales 1:1 Revenue Streams Core team Dev tools Licensing from UCSF (equity at end of Series A) Date: 06/05/2013 Customer Unfair Relationships Advantage Version Name: v02 - Pay per use (cash or credits) (Credits are earned for sharing data) - Fee for custom development - Maintenance /upgrade subscription
  • 28. Business Model Canvas: MIRA (bold items are validated) Key Partners Problem Image processing Med Center for studies/validation Data generating devices NMSS EMR Key Solution Activities Algos Unique Value Proposition Software design and dev Image processing Customer development Validation & pilots 1. Improved patient outcome by identification of optimal treatment paths 2. Saves time 3. Improves relationship Key Activity Key Resources AI team DB and mobile dev team Designer Product Regulatory 4. Improve patient retention; ROI on infrastructure; decrease penalties (MU2) Customer Segments Get: Awareness campaign (Conferences, KOLs, articles) MS Neurologists Keep & Grow: Expert dedicated project lead Channels Medical Centers Purchasing Pharma Payers Clinical researchers Channels APIs/existing systems 5. Visualize their own data; realize translational promise Cost Structure Direct 1:1 sales Revenue Streams Core team Dev tools Licensing from UCSF (equity at end of Series A) Date: 06/05/2013 Customer Unfair Relationships Advantage Version Name: v02 - Pay per use (cash or credits) (Credits are earned for sharing data) - Fee for custom development - Maintenance /upgrade subscription

Editor's Notes

  1. [[ SLIDE 1 TITLE ]] We Are MIRA Medicine a Spin- off from UCSF Neuroloogy and a first genetration of precision medicine application in complex diseaseWe deliver aster more precise clinical decision at low cost !
  2. [[ SLIDE 2 Presentation ]] I am Raphy Loren Business Lead I am PA Gourraud analytics leads I am Jason Crane Software Lead
  3. [[ SLIDE 3 STARTING POINT ]] [Raphaelle] Starting the LLP we had a rich man’s Problem ! We had developed a workingprototype, and almost each time we would demo it, our audience would come up with new opportunities – from augmenting the physician-patient relationship to We couldn’t choose between the 2 problems we were proposing to solve: helping patients with MS and solve the flood of data from modern medicine to change practiceThe problemturned into a bit of schizophrenia: are we a product company OR are we a Service company ? Offering what we did for MS as a Service for other research centers?Or build a MS-centered product to respond to the needs of community neurologists?--- [PA] “ an Application “ [Jason] OR a data analytics platform for all the complex diseases --[Raphaelle] We adopted the Steve Blanks’ s Method – Go and ask people outsdie the Lab ! And answer where is value in the platform of in the data you analysed but also when is the value ?Now with the protot or later with more than the proto . Are we a service company or a product company? [May not have to choose] A platform and an app? How do we provide value now and later? [Tiered model]What is our disease focus? [Neurological? Auto-immune conditions?
  4. Complex, life-long diseases are very difficult to assess, predict, and treat efficiently.Multitude of factors to assess diseaseDeluge of data on each factorLack of visibility in disease progression at individual level and trends at population levelLow-reproducibility of assessment (primary score is aggregate)Frustrating and costly trial and error (increasing number of DMTs)Knowledgegap between specialty centers and community providers
  5. average lifetime cost of treatment $1.2M+ trends from other industries (patients and physicians benefit from visualizations in other fields : travel, finance, education, real estate)
  6. [[ SLIDE 3 STARTING POINT ]] [Raphaelle] Starting the LLP we had a rich man’s Problem ! We had developed a workingprototype, and almost each time we would demo it, our audience would come up with new opportunities – from augmenting the physician-patient relationship to We couldn’t choose between the 2 problems we were proposing to solve: helping patients with MS and solve the flood of data from modern medicine to change practiceThe problemturned into a bit of schizophrenia: are we a product company OR are we a Service company ? Offering what we did for MS as a Service for other research centers?Or build a MS-centered product to respond to the needs of community neurologists?--- [PA] “ an Application “ [Jason] OR a data analytics platform for all the complex diseases --[Raphaelle] We adopted the Steve Blanks’ s Method – Go and ask people outsdie the Lab ! And answer where is value in the platform of in the data you analysed but also when is the value ?Now with the protot or later with more than the proto . Are we a service company or a product company? [May not have to choose] A platform and an app? How do we provide value now and later? [Tiered model]What is our disease focus? [Neurological? Auto-immune conditions?
  7. [[SLIDE 6]] We wanted to develop this great know-how for everyone TOO MANY VALUE PROP for TOO MANY CUSTOMER SEGMENTS So what did we learn from our interviews ? Pharmas, Clinicians. Researchers etcetc
  8. Prisoners of our own solution:this existing solution was constraining us in finding needsToo many directions! Our BMC is a mess! Let’s narrow down to who has the biggest pain points and can pay for our offering, whether it’s a product or a service
  9. Let’s narrow down to who has the biggest pain points and can pay for our offering, whether it’s a product or a servicewe refined the Value Proposition and Started chopping out the Customer Segments We excluded the MS patients, not because there is not demand but because we did not want to become a 23 and me for MS patients, too many regulatory problems.
  10. Identify the best match between the Value Propositions and the multiple customer segments in order to find the easiest customer relations and channelsFeeling better Categorize interest and started to clarify it
  11. We need validation!
  12. PresentMIRA Spin off from UCSF NeurologyFirst product MIRA MS is the extension of the research tool MS BioscreenMarket: research centers, medical centers, and ACOs for MSVision for the future. Product vision MS: Augment the MS DB by 20x in 2 years Develop analytics for comparison and prediction Other diseases: Port model to Parkinson’s, RA, Alzheimer’s, Cognitive system platform for complex diseases by 2018
  13. [[SLIDE 5 Our MARKET ]] [Raphaelle] With this Prototype we have a pretty clear MARKET POSITIONNING. “ Our offering places MIRA at the convergence of precision medicine, bioinformatics (knowledge management tools), and clinical care markets – each poised for exponential growth. The healthcare decision support market represented $202 million in 2012 and rapidly growing, thanks to mutually reinforcing factors, including: the dramatic reductions in costs of human genome sequencing; innovation and dramatic cost reductions in cloud-based data storage and parallel computing; new regulations such as the HIGHTECH Act of 2009, specifically the Meaningful Use incentives and requirements, are powerful drivers for adoption and use of Electronic Medical Records systems; consumer expectations of access to information and demand for quality of care; new reimbursement models based on quality of care and outcome, including Accountable Care Organizations. The nascent Clinical Care market is focused on providing tools that can be used by physicians at the point of care to amplify their expertise by complex, data-driven analyses, and is estimated at $100M in 2015. MIRA’s initial focus is on Multiple Sclerosis which has an incidence of 500,000 patients in the United States and 20,000 new cases identified every year. A life-long disease, Multiple Sclerosis has no cure, and currently approved Disease Modifying Therapies (DMTs) cost between $20-60,000 per patient per year. The MS therapeutics market, where 9 currently approved and 5 additional DMTs seeking FDA clearance are competing, is worth $7B per year in the US alone.If MIRA were to focus exclusively on MS, we would estimate our market size to 15-25M. By expanding to additional complex diseases and offering a platform, we estimate our market size at $100-200M.
  14. …- It is already happening We are coached by a VC We have a research parternwho just got 900,000 awarded …
  15. [[ SLIDE 1 TITLE ]] We Are MIRA Medicine a Spin- off from UCSF Neuroloogy and a first genetration of precision medicine application in complex diseaseWe deliver aster more precise clinical decision at low cost !
  16. Value prop for physicians/cliniciansData-driven, personalized view supports patient education and communication (data-driven and visual) and shared decision makingVisual cues leads to better information retentionBetter retention and shared decision making lead to better adherence and hence efficacy and outcome.
  17. Value prop for physicians/cliniciansData-driven, personalized view supports patient education and communication (data-driven and visual) and shared decision makingVisual cues leads to better information retentionBetter retention and shared decision making lead to better adherence and hence efficacy and outcome.