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I-Corps from the Trenches

Conversations with I-Corps Alum

December 8, 2016
(0 SBIR&STTRCOMING UP LATER TODAY

NCI SBIR
lWITTERCHAT
WITH PROGRAM MANAGER
CHRISTIE CANARIA
THURSDAY, DECEMBER 8, 2016
2 • 3 PM EASTERN TIME
@NCISBIR #SBIRCHAT
2
Q&A

sbir.cancer.gov/icorps 

Submit your questions through the Q&A chat box

Please submit your questions via the chat box. We will
be answering your questions throughout the webinar,
with additional time dedicated at the end of the
session.
Slides will be made available after the webinar event.
Michael Weingarten
NCI/NIH I-Corps
Christie Canaria
NCI/NIH I-Corps
David Charron
Lead Instructor
Brett Noel
Sr Scientist at Kinasense
White House Demo Day

“We’re scaling up the National Science Foundation’s successful
Innovation Corps program at six more federal agencies so we
can help more of our scientists move their ideas out of the lab
and into the marketplace.”
– President Obama (August 4, 2015)
https://www.whitehouse.gov/the-press-office/2015/08/04/remarks-president-white-house-demo-day
5
(0 SBIR&STTRI-Corps™ Training Program

Program Description
• Intensive Entrepreneurial Immersion course aimed at
providing teams with skills and strategies to reduce
commercialization risk
• Curriculum emphasizes Reaching out to Customers to test
hypotheses about the need and market for the technology
being developed.
• Each team is expected to conduct over 100 interviews over
8 weeks.
• Format is focused on Experiential Learning.
@NCIsbir #iCorps

6
Business Model Canvas

“ Product-Market Fit ”

#ICorpsNIH
7
Customer Development
Hypotheses Testing and Insight…

8
(0 SBIR&STTRI-Corps™ at NIH

SBIR/STTR Phase II grant applications
have two components
1.The Research Strategy
2.The Commercialization Plan
•Phase II applicants often focus on #1
•The strongest Phase II applications focus on both

Important goal of I-Corps™ at NIH is to
inform the Commercialization Plan
9
Focus on Learning

Customer development is NOT sales!
•	 Teams are not pitching their product or technology
•	 Teams are listening to potential customers and other
stakeholders and learning about:
•	 What customers want and need
•	 Pain points in their customers’ daily routines
•	 Features of a technology that would provide value
10
From I-Corps™ at NIH

3 cohorts to date
• 57 teams conducted 6,362 customer discovery interviews
• >90% found the program “very good” or “excellent”
• >90% would recommend I-Corps™ at NIH to other companies
“We clarified the value propositions, who
our target customers would be, revenue
streams, customer relationships…”
11
“After going through I-Corps we understand we
have to focus on a small subset [of customers] and
prioritize segments based on their value
propositions.”
Business Model Canvas Knowledge

Spring 2016 Cohort
#ICorpsNIH
12
Life Science Commercialization
Knowledge
Spring 2016 Cohort
#ICorpsNIH
13
Status of Technology and Future Plans

Spring 2016 Cohort
#ICorpsNIH
14
2011-2014 teams:
324 companies
$93.8M raised
3 acquisitions
As of November
2016:
872 I-CorpsTM Teams
4% 4%
27% 1%

21%
41%
2%
Type of $93.8M
Raised, by Percentage:
SBIR/STTR Phase 1
Corporate
SBIR/STTR Phase 2
Debt
VC Investment
Angel Investment
State Investment
NSF MPS-funded chemists developed imaging agents for biomedical applications

October 2011 – NSF I-Corps participants
June 2012 - NSF SBIR Phase I recipient
April 2014 - NSF SBIR Phase II recipient
State of Nebraska investment
Series A VC investment
June 2016 – Series B VC investment
PI - Stephen DiMagno - Professor at

University of Nebraska-Lincoln

EL - Keil Neumann - current postdoc at UCSF

IM - Allan Green - CEO of Ground Fluor
I-Corps Case Study

A new drug to restore function
after spinal cord injury (SCI)
Before I-Corps

• November 2012 -
Dr. Travis Stiles'
discovery published
in Journal of Cell
Science
• August 2014 -
Phase I NIH grants
awarded to develop
drugs for SCI and
stroke
Novoron at I-Corps

• December 2014 -
Novoron completes
I-Corps at NIH
I-Corps at NIH
Learnings & Pivot
Low interest in
early-stage SCI drugs
…but customer
segments are
interested in
Multiple Sclerosis
After I-Corps

• December 2015 - Novoron
Awarded NIH Grant to Evaluate
New Treatments for Multiple
Sclerosis (MS)
• MS work led to increased
interest in new indications
• Entered multiple strategic
partnerships with focus on
negotiating 1 deal
• February 2016 - Xconomy
Recognizes Novoron as San Diego
Life Science Startup to Watch in
2016
• June 2016 - Patent issued
16
17 Participating ICs in 2017
•	 National Cancer Institute (NCI)
•	 National Center for Complementary and 

Integrative Health (NCCIH)

•	 National Heart, Lung, and Blood Institute (NHLBI)
•	 National Human Genome Research Institute 

(NHGRI)

•	 National Institute on Aging (NIA)
•	 National Institute on Alcohol Abuse and 

Alcoholism (NIAAA)

•	 National Institute of Allergy and Infectious 

Diseases (NIAID)

•	 Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD)
•	 National Institute of Dental and Craniofacial Research (NIDCR)
•	 National Institute on Drug Abuse (NIDA)
•	 National Institute of Environmental Health Sciences (NIEHS)
•	 National Institute of Mental Health (NIMH)
•	 National Institute of Mental Health (NIMH)
•	 National Institute of Neurological Disorders and Stroke
(NINDS)
•	 National Center for Advancing Translational Sciences (NCATS)
•	 National Center for Injury Prevention and Control (NCIPC/CDC)
•	 National Institute for Occupational Safety and Health
(NIOSH/CDC)
#ICorpsNIH
PA-16-414 I-Corps at NIH Administrative Supplement
$50,000 budget cap
Application Due Date January 9, 2017
Phone Interview (estimated) February 13-17, 2017
Notice of Award (estimated) March 17, 2017
Course Kick-off April 23-26, 2017
Web-Ex Courses
(1-5PM ET)
May 2
May 9
May 16
May 23
May 30
June 6
Course Close-out/
Lessons Learned
June 12-13, 2017
Cohort Size 24 teams
http://grants.nih.gov/grants/guide/pa-files/PA-16-414.html
#ICorpsNIH
(0 SBIR&STTR
. .·. ...
Apply to I-Corps using ASSIST

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Table of Contents
P-r111 1 o,~11 l-'!w 11 r 11 ui.;ilin 1
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Secticn I. FJndinc JDJor:un t1 0-estrption
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Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Background
,m,~rico'$prc!.peritv ho!.oroinotoc n oort from:he obilitvto COD t)lizc·~coromi•:)IIY01 Qround ,reo:ikin•J di~coveri·~~ fr,Jm !·Ci·~ncc ~rd crQirceri1c ·eseo:ir:1. Si11u t)ncou~'i. o
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oJr comi:e1111vee<:1,Je 1r :ne rnure.
(0 SBIR&STTR
WITH PROGRAM MANAGER
CHRISTIE CANARIA
DON’T FORGET TO JOIN US FOR…

20
I-Corps @ NIH

David Charron

@
@

Welcome from the I-Corps Team
Albus Imaging: Week 1, Team 41
•
ISFJ
The Defender
Specialty:
Bioinformatics &
Health Information
Ph.D., Vanderbilt
University
Yaorong Ge, PhD
Industry Expert
The Problem
Today's cancer patient
becomes tomorrow's
heart failure patient
Heart fa ilure is the leading cause
of death of cancer survivors
•
INTP
The Logician
Specialty:
Cardiovascular
monitoring
M BA, MIT
Holly Goodwin, MBA
Principle Investigator
The Solution (i.e. our product)
A diagnostic tool that
identifies who is susceptible
to cardiotoxicity
Early detect ion of
cardiotoxicity = earlier
intervention= heart
injury prevention
ESFJ
ALBUS lMAGING
The Consul
Specialty:
Cardiology & cardiac
imaging
MD, Medical College
of VA
Greg Hundley, MD
C-Level Executive
Who is the customer?
• Physicians
Oncologists
Cardiologists
Other Physicians:
Radiologists
• Patients
• Payors (Healt h Insur Cos., Govt
HC Admins, ACOs, Health Systems)
• FDA
• Pharma Companies@
What we learned

• SBIR
– Phase I to II requires a “plan”
• Business outcomes
– Founders “want” to go beyond SBIR
• Learning
– Entrepreneurial skills are “required”
@
The Entrepreneurial Venture

FOUR PERIODS of DEVELOPMENT

I
 II
 IV

Cash
Flow
III
Time
Customer Development is 

how you search for the model
The Entrepreneurial Venture

FOUR PERIODS of DEVELOPMENT
Time
Cash
Flow
II III IVI
BUSINESS 

PLAN 

, -...011...·-"'"'•o.-tt•~--IOOtllW
1ti0t1•-·
•
Business Models
-
 BUSINESS 

PLAN 

,-• I
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Lean Startup 

Agile Engineering
+Part 3
Part 1

+
Part 2

Agile Engineering
Building the Nation’s I-Corps
“Innovation Fabric”
I-Corps Nodes
I-Corps Sites
I-Corps Teams
I-Corps Mentors
What you will get and produce

• Your team will
– Be trained in lean startup methods
– Develop answers to your business questions
• You will produce
– A learning journey associated with customers and
the business model canvas – in LPC
– A final presentation and a final video
@
Evidence-based Entrepreneurship
Framing
Hypotheses
Customer
Discovery 1 week before
Product
Mentorship
Mandatory Office Hours with Partners, a Mentor dedicated to team,
uses LPC for review, Advisors as domain experts
Education /
Community
Team presents weekly in front of cohort, formal curriculum,
Optional: Office space, weekly dinners w/guest speakers
Lessons
Learned
What we thought, what we did, what we found, what’s next.
Continual Revisions to MVP based on Customer Discovery
Application by BMC, Initial Canvas, Updated Weekly Canvases
10-15 customer interviews/week, present results in front of peers
Mutual Expectations
• Relentless
– Urgent and intense activity for 7 weeks

• Direct
– Honest and clear communication
• Hypothesis driven
– Hypothesis: Here’s What We Thought 

– Experiments: So Here’s What We Did 

– Results: So Here’s What We Found
• Customer discovery
– 100 interviews in 7 weeks
@
Expect us to be 

RELENTLESS

and

DIRECT

@
Albus Imaging: Team Members

Goal: Collaborative

and Productive Team

Observe / 

Active Bystander /

Adjudicator

Yaorong Ge,PhD
Industry Expert
• ComputerScientist
&Bioinformatics
Greg Hundley,MD
C-Level Executive
• Cardiologist
• Cardiovascular
ImagingExpert
Move	
Debating society
Oppose
Holly Goodwin,MBA
Principle Investigator
• Translationalresearch
• Commercialization of
Cardiovascular
monitoring technologies
So here’s what we did….

We got out of the
building!
• We interviewed:
₋ 58Cardiologists
₋ 53Oncologists
ACOs, Payers,
₋ 31Others HCPs, RNs
• Weekly average = 20
₋ 12 =Min
₋ 31 =Max
₋ 20 =Median
₋ 15 =Mode
Plus 10 places in Europe

We always asked who else the interviewee thought
we should talk to <<-- this was very fruitful!
ALBUS lMAGlNG
So Here’s What We Are Going ToDo
for the next week!
Just kidding!

We have 10 interviews scheduled for Thursday & Friday.
Company 47

Brett Noel, Ph.D.

PI

Steve Ouellette, Ph.D.

C-level

Isaac Schumman, MBA
“Industry Expert”
Product: Preclinical assays to characterize new oncology
therapies
Customers: Biopharma, academics, and preclinical CROs
Why: Save money and time on characterizing candidates in
lead optimization
Interview
Count
TOTAL 102 36 5 61
Academia Number
Professor 11
Lab Director 7
Post-Doc 5
Grad Student 4
Administrator 1
Biotech/Pharma
Scientist 24
Exec.
Leadership
Bus. Dev.
17
7
CRO
Scientist 3
Exec.
Leadership
Bus. Dev.
3
1
Distributors
Bus. Dev. 6
Sales 2
Consultants
Drug Discovery 11
Team Profile

Steve Ouellette - Chief Technology Officer & Co-founder
• Ph.D. in Cancer Biology and Molecular Signaling (Purdue)
• Experience at preclinical CRO startup for in vitro toxicity
• Entrepreneurial training and developer of KS biz plan
• Coordinate overall effort of I-Corps team
Brett Noel – Senior Scientist
• Ph.D. in Cancer Biology and Molecular Signaling (Purdue)
• Expertise in core technology and development strategy
• I-Corps – Focus on technically oriented interviews
Isaac Schumann – Business Development Manager
• MBA from Krannert School of Management (Purdue)
• Experience at biochem CRO (Food, paper and biofuels)
• I-Corps – Focus on commercialization oriented interviews
Business Model Canvas – Day 1

Original company hypothesis:

There is a market need for technologies to measure cell-based,

endogenous tyrosine kinase activity in preclinical drug development and clinical

diagnostic markets.
Senseor kinase inhibitor therapies
The Original Business Model

B.usiness Mo,del
Reagent
Design
Reagent
Validation
Reagent
Optimization
• Diagnostic:s Partners
-
1
Cl'inical hials
- FID.A r,egulatory hurdles
R,e,imbursment
• DnJ,g o·isco,verry Partners
- Pre·-clinical services ond
products
- Early Revenue
Our first lesson…

Nancy
Scott Patterson
Changes in Strategy and 

Philosophy on Business Models

Drop the clinical applications…for now
Drug Discovery
Re-segment
Changes in Strategy and 

Philosophy on Business Models

Drop the clinical applications…for now
Drug Discovery
Re-segment
Drug Discovery Clinical
Many business models
The Big Pivot:

Revenue Model

Bob Lowery
CEO, Bellbrook Labs
Brian Murphy


Director, Axiogenesis
Revenue Model:

What We Learned

We had to build…
 Product / Kit
Service / Data
Sense
How to Reach the

Paying Customers?
Promoting Adoption in 

the Ecosystem
There is a Community Effort Involved 

in Driving Adoption

Partners Assay Companies
David Drewry Bill Zuercher Jon Elkins
KOLs
• Publish
• Co-develop

• Endorse
• Present
Complementary Products
Pilot Studies with Potential
Customers
In Summary We Learned…

Focus Pivot Community
Final company hypothesis: Kinase inhibitor researchers in preclinical drug

discovery need KinaSense assays to measure kinase activity directly in cellular 

models for reducing the time it takes to move a candidate drug from preclinical

development into clinical trials.
Future Plans 

•	 Continue building the platform as a research tool
•	 Establish KOL relationships and collaborations
•	 Customer discovery and the interview method of learning
will become SOP at KinaSense
•	 Explore larger market opportunities of the technology
Activities
Phase II Submission Phase II submission expected second half of 2017
Phase I Submission At least 2 additional Phase I applications based on I-
Corps learning
Next 3 months Partnerships with KOLs
License IP to strengthen Phase I application
3rd party funding No plans to pursue before Phase II submission
Acknowledgements

Teaching Team
David Charron
Aileen Huang-Saad
Edmund Pendleton
Nancy Kamei
Todd Morrill
Bob Storey
TA
Lauren Sheridan
Cohort Teams
NIH
Michael Weingarten
Christie Canaria
VentureWell
Future Plans- 4 month Follow up

•	 Continue building the platform as a research tool
•	 Establish KOL relationships and collaborations
•	 Customer discovery and the interview method of learning will become SOP at
KinaSense
•	 Explore larger market opportunities of the technology
Activities
Phase II Submission Phase II submission expected second half of 2017
On Track
Phase I Submission At least 2 additional Phase I applications based on I-
Corps learning On Track (One scored well after I-
Corps insights)
Next 3 months Partnerships with KOLs
License IP to strengthen Phase I application
Finalizing Deals
3rd party funding No plans to pursue before Phase II submission
Have had offers for outside funding
Future Plans- 4 month Follow up

•	 Continue building the platform as a research tool
•	 Establish KOL relationships and collaborations
• Finalizing a contract with major pharmaceutical company
•	 Will fund company for at least 1 year
•	 Customer discovery and the interview method of learning will become SOP at
KinaSense
•	 Explore larger market opportunities of the technology
Activities
Phase II Submission Phase II submission expected second half of 2017
On Track
Phase I Submission At least 2 additional Phase I applications based on I-
Corps learning On Track (One scored well after I-
Corps learnings)
Next 3 months Partnerships with KOLs
License IP to strengthen Phase I application
Finalizing Deals
3rd party funding No plans to pursue before Phase II submission
Have had offers for outside funding
Future Plans- 4 month Follow up

•	 Continue building the platform as a research tool
•	 Establish KOL relationships and collaborations
•	 Finalizing a contract with major pharmaceutical company
•	 Will fund company for at least 1 year
•	 Customer discovery and the interview method of learning will become SOP at
KinaSense
•	 Currently in contact with at least 1 other major pharmaceutical company
•	 Explore larger market opportunities of the technology
Activities
Phase II Submission Phase II submission expected second half of 2017
On Track
Phase I Submission At least 2 additional Phase I applications based on I-
Corps learning On Track (One scored well after I-
Corps learnings)
Next 3 months Partnerships with KOLs
License IP to strengthen Phase I application
Finalizing Deals
3rd party funding No plans to pursue before Phase II submission
Have had offers for outside funding
I-Corps Lessons

•	 I-Corps is time-consuming
• 40 hours/week
• Research will slow down
• Can you afford to participate in I-Corps?
I-Corps Lessons

•	 I-Corps is time-consuming
• 40 hours/week
•	 Research will slow down
•	 Can you afford to participate in I-Corps?
•	 Customer discovery is a skill that needs development
•	 Academic articles can be very misleading
•	 Interviews with customers and key opinion leaders are most important data
points
•	 Networking leads to an understanding of your market ecosystem
I-Corps Lessons

•	 I-Corps is time-consuming
• 40 hours/week
•	 Research will slow down
•	 Can you afford to participate in I-Corps?
•	 Customer discovery is a skill that needs development
•	 Academic articles can be very misleading
•	 Interviews with customers and key opinion leaders are most important data
points
•	 Networking leads to an understanding of your market ecosystem
• Teaching team and industry mentors are valuable resources
• Experienced entrepreneurs and are invested in your success
I-Corps Lessons

•	 I-Corps is time-consuming
• 40 hours/week
•	 Research will slow down
•	 Can you afford to participate in I-Corps?
•	 Customer discovery is a skill that needs development
•	 Academic articles can be very misleading
•	 Interviews with customers and key opinion leaders are most important data
points
•	 Networking leads to an understanding of your market ecosystem
• Teaching team and industry mentors are valuable resources
• Experienced entrepreneurs and are invested in your success
•	 Almost every team pivoted in some way
•	 KinaSense focused early on, accelerated company development timeline by
1-2 years
•	 Reassessed new SBIR opportunities
•	 High score on a previously low-priority project
•	 Many companies made MAJOR pivots
I-Corps Lessons

•	 I-Corps is time-consuming
• 40 hours/week
•	 Research will slow down
•	 Can you afford to participate in I-Corps?
•	 Customer discovery is a skill that needs development
•	 Academic articles can be very misleading
•	 Interviews with customers and key opinion leaders are most important data
points
•	 Networking leads to an understanding of your market ecosystem
• Teaching team and industry mentors are valuable resources
• Experienced entrepreneurs and are invested in your success
•	 Almost every team pivoted in some way
•	 KinaSense focused early on, accelerated company development timeline by
1-2 years
•	 Reassessed new SBIR opportunities
•	 High score on a previously low-priority project
•	 Many companies made MAJOR pivots
Can you afford NOT to participate in I-Corps?
Q&A

sbir.cancer.gov/icorps 

Submit your questions through the Q&A chat box

Please submit your questions via the chat box. We will
be answering your questions throughout the webinar,
with additional time dedicated at the end of the
session.
Slides will be made available after the webinar event.
#ICorpsNIH

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I-Corps_at_NIH_Dec8_Final_508

  • 1. I-Corps from the Trenches Conversations with I-Corps Alum December 8, 2016
  • 2. (0 SBIR&STTRCOMING UP LATER TODAY NCI SBIR lWITTERCHAT WITH PROGRAM MANAGER CHRISTIE CANARIA THURSDAY, DECEMBER 8, 2016 2 • 3 PM EASTERN TIME @NCISBIR #SBIRCHAT 2
  • 3. Q&A sbir.cancer.gov/icorps Submit your questions through the Q&A chat box Please submit your questions via the chat box. We will be answering your questions throughout the webinar, with additional time dedicated at the end of the session. Slides will be made available after the webinar event.
  • 4. Michael Weingarten NCI/NIH I-Corps Christie Canaria NCI/NIH I-Corps David Charron Lead Instructor Brett Noel Sr Scientist at Kinasense
  • 5. White House Demo Day “We’re scaling up the National Science Foundation’s successful Innovation Corps program at six more federal agencies so we can help more of our scientists move their ideas out of the lab and into the marketplace.” – President Obama (August 4, 2015) https://www.whitehouse.gov/the-press-office/2015/08/04/remarks-president-white-house-demo-day 5
  • 6. (0 SBIR&STTRI-Corps™ Training Program Program Description • Intensive Entrepreneurial Immersion course aimed at providing teams with skills and strategies to reduce commercialization risk • Curriculum emphasizes Reaching out to Customers to test hypotheses about the need and market for the technology being developed. • Each team is expected to conduct over 100 interviews over 8 weeks. • Format is focused on Experiential Learning. @NCIsbir #iCorps 6
  • 7. Business Model Canvas “ Product-Market Fit ” #ICorpsNIH 7
  • 9. (0 SBIR&STTRI-Corps™ at NIH SBIR/STTR Phase II grant applications have two components 1.The Research Strategy 2.The Commercialization Plan •Phase II applicants often focus on #1 •The strongest Phase II applications focus on both Important goal of I-Corps™ at NIH is to inform the Commercialization Plan 9
  • 10. Focus on Learning Customer development is NOT sales! • Teams are not pitching their product or technology • Teams are listening to potential customers and other stakeholders and learning about: • What customers want and need • Pain points in their customers’ daily routines • Features of a technology that would provide value 10
  • 11. From I-Corps™ at NIH 3 cohorts to date • 57 teams conducted 6,362 customer discovery interviews • >90% found the program “very good” or “excellent” • >90% would recommend I-Corps™ at NIH to other companies “We clarified the value propositions, who our target customers would be, revenue streams, customer relationships…” 11 “After going through I-Corps we understand we have to focus on a small subset [of customers] and prioritize segments based on their value propositions.”
  • 12. Business Model Canvas Knowledge Spring 2016 Cohort #ICorpsNIH 12
  • 14. Status of Technology and Future Plans Spring 2016 Cohort #ICorpsNIH 14
  • 15. 2011-2014 teams: 324 companies $93.8M raised 3 acquisitions As of November 2016: 872 I-CorpsTM Teams 4% 4% 27% 1% 21% 41% 2% Type of $93.8M Raised, by Percentage: SBIR/STTR Phase 1 Corporate SBIR/STTR Phase 2 Debt VC Investment Angel Investment State Investment NSF MPS-funded chemists developed imaging agents for biomedical applications October 2011 – NSF I-Corps participants June 2012 - NSF SBIR Phase I recipient April 2014 - NSF SBIR Phase II recipient State of Nebraska investment Series A VC investment June 2016 – Series B VC investment PI - Stephen DiMagno - Professor at University of Nebraska-Lincoln EL - Keil Neumann - current postdoc at UCSF IM - Allan Green - CEO of Ground Fluor
  • 16. I-Corps Case Study A new drug to restore function after spinal cord injury (SCI) Before I-Corps • November 2012 - Dr. Travis Stiles' discovery published in Journal of Cell Science • August 2014 - Phase I NIH grants awarded to develop drugs for SCI and stroke Novoron at I-Corps • December 2014 - Novoron completes I-Corps at NIH I-Corps at NIH Learnings & Pivot Low interest in early-stage SCI drugs …but customer segments are interested in Multiple Sclerosis After I-Corps • December 2015 - Novoron Awarded NIH Grant to Evaluate New Treatments for Multiple Sclerosis (MS) • MS work led to increased interest in new indications • Entered multiple strategic partnerships with focus on negotiating 1 deal • February 2016 - Xconomy Recognizes Novoron as San Diego Life Science Startup to Watch in 2016 • June 2016 - Patent issued 16
  • 17. 17 Participating ICs in 2017 • National Cancer Institute (NCI) • National Center for Complementary and Integrative Health (NCCIH) • National Heart, Lung, and Blood Institute (NHLBI) • National Human Genome Research Institute (NHGRI) • National Institute on Aging (NIA) • National Institute on Alcohol Abuse and Alcoholism (NIAAA) • National Institute of Allergy and Infectious Diseases (NIAID) • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) • National Institute of Dental and Craniofacial Research (NIDCR) • National Institute on Drug Abuse (NIDA) • National Institute of Environmental Health Sciences (NIEHS) • National Institute of Mental Health (NIMH) • National Institute of Mental Health (NIMH) • National Institute of Neurological Disorders and Stroke (NINDS) • National Center for Advancing Translational Sciences (NCATS) • National Center for Injury Prevention and Control (NCIPC/CDC) • National Institute for Occupational Safety and Health (NIOSH/CDC) #ICorpsNIH
  • 18. PA-16-414 I-Corps at NIH Administrative Supplement $50,000 budget cap Application Due Date January 9, 2017 Phone Interview (estimated) February 13-17, 2017 Notice of Award (estimated) March 17, 2017 Course Kick-off April 23-26, 2017 Web-Ex Courses (1-5PM ET) May 2 May 9 May 16 May 23 May 30 June 6 Course Close-out/ Lessons Learned June 12-13, 2017 Cohort Size 24 teams http://grants.nih.gov/grants/guide/pa-files/PA-16-414.html #ICorpsNIH
  • 19. (0 SBIR&STTR . .·. ... Apply to I-Corps using ASSIST •> P,H&-414dnnovcton C X ~ C © grarits-,nih.,~ v/grarts/guidg/pa-files/=>A-16-4:4.h:ml ii .:,00..., ..,..., ,o,v:a ii OCCOOii I . .. ....... ( IC :.,,o;,,a,u .:,p;;.. I C iiVii.JC( IO i voe;,:.,,:; I O h l .110,.. .. , ...v , ,ppuvc.,,c .. v:.,oc, IO iiOh . ..... p,c91w h i -:.:.occ, ... i IJ(,0¥ 00 IJ. ....-.:,p,·~ ·(il·,:::,-.:i·, =Q""l'>O(C,vlUj,l) wnh tnGH instructions may De aela}lea or not acceptGCI ror rG'19W. r ,ere a·e several o:itior3tost.bmi:·1,:>urao:ilicaton toihe aaencvth·oJat C.ran1s.<1•:>v. Ycu canuse :heAG[l[ ,Ts.vste11toprepare. 3U:>mitand t·a,; <,,ourai:olica:i,:m 01lire.YoJ ca, d,:,wn o~d ~n OPP icoticn i:ock~oc fr,:,m Gr~nt$.COV. cornplctc tic 'orrre offlin,). ~1..bmil :he ccmi:l,Jtcd for1l$ toGr~nt:;.cov~nd trocl~ycur ~:ii:I cotio1 in c~A C,:,mmon~ Or.vcu con u::;c ,Jth,)r "· '$tern !,Olt.t 00$ t,:, prcp~rc ond $Ub11it ycur ~,i:I cotion to Gl".)nt.90·1~n,j tr~·:kyou· opplic~:ior n cRI Gcmm,:m~. Le~·n moc. Apply U'l>i11g O~u!oadal.11,,_. F1.1u n'l> ~ g11.S-SIST $ho1..l,j be dir,~cte,j to 1tc cRI Service O~~ Proble1l$ cownloa::1ci1g for~ !·hOJld tc ci·eclcd toGr~nt$.govCu:;:orr,cr SUi:po1. Table of Contents P-r111 1 o,~11 l-'!w 11 r 11 ui.;ilin 1 P;:irt? Full TF)foflt-P. .6.nn">11rrP.mP.nl Secticn I. FJndinc JDJor:un t1 0-estrption Gecticn 11./warj Information Gecticn Ill. Oici:>ilit'(lr b rma1io, Sccticn rJ. ,pplic~1ion ~,d S1..bmi% on ln'orn.:rticn SectlCn ~ ,c..pp11cat1Cn He·, ew 1rr:,rma1101 SectlCn '1. /JJIJ3r<J A<:1m1r10:r.;ton 1n·ormat1en secticn v11. Ai~ntyco1tat 1s sect1env111. o:ner nrcnna:1Jr Part 2. Full Text of Announcement Section I. Funding Opportunity Description Background ,m,~rico'$prc!.peritv ho!.oroinotoc n oort from:he obilitvto COD t)lizc·~coromi•:)IIY01 Qround ,reo:ikin•J di~coveri·~~ fr,Jm !·Ci·~ncc ~rd crQirceri1c ·eseo:ir:1. Si11u t)ncou~'i. o kn,JV1lcd9eotl·~, cr,~otivc LI.S.w,Jr<'orcc ho!. 11~nbin,~c :he ccun:ry'!. 910,~I le~ccr~tip ir ,: ·iticol ore~$ cft.~ctnolcgy. - h·~~c mpcrt~,t dis-:,:,vcrc$ ond cop~,1ew,:,rkfcrcc ·e$U toe tom su,sta1t1a1sJstained 11vest11ent1n science ano er91neen1g.A strongcapacity 1cr le'er; g1ng run,::1amer ta1sc1e1ur1c d s.cove·1es into powe1UI eng neser1nrova:1,Jn 1s esser t a11c 11a1nta1n oJr comi:e1111vee<:1,Je 1r :ne rnure.
  • 20. (0 SBIR&STTR WITH PROGRAM MANAGER CHRISTIE CANARIA DON’T FORGET TO JOIN US FOR… 20
  • 21. I-Corps @ NIH David Charron @
  • 22. @ Welcome from the I-Corps Team
  • 23. Albus Imaging: Week 1, Team 41 • ISFJ The Defender Specialty: Bioinformatics & Health Information Ph.D., Vanderbilt University Yaorong Ge, PhD Industry Expert The Problem Today's cancer patient becomes tomorrow's heart failure patient Heart fa ilure is the leading cause of death of cancer survivors • INTP The Logician Specialty: Cardiovascular monitoring M BA, MIT Holly Goodwin, MBA Principle Investigator The Solution (i.e. our product) A diagnostic tool that identifies who is susceptible to cardiotoxicity Early detect ion of cardiotoxicity = earlier intervention= heart injury prevention ESFJ ALBUS lMAGING The Consul Specialty: Cardiology & cardiac imaging MD, Medical College of VA Greg Hundley, MD C-Level Executive Who is the customer? • Physicians Oncologists Cardiologists Other Physicians: Radiologists • Patients • Payors (Healt h Insur Cos., Govt HC Admins, ACOs, Health Systems) • FDA • Pharma Companies@
  • 24. What we learned • SBIR – Phase I to II requires a “plan” • Business outcomes – Founders “want” to go beyond SBIR • Learning – Entrepreneurial skills are “required” @
  • 25. The Entrepreneurial Venture FOUR PERIODS of DEVELOPMENT I II IV Cash Flow III Time
  • 26. Customer Development is how you search for the model
  • 27. The Entrepreneurial Venture FOUR PERIODS of DEVELOPMENT Time Cash Flow II III IVI
  • 28. BUSINESS PLAN , -...011...·-"'"'•o.-tt•~--IOOtllW 1ti0t1•-·
  • 30. - BUSINESS PLAN ,-• I -1 kt)' i ¥fy '·::wr 4JvM 2c,~ri~1~'',MJij,S ...ivrt,~S ~C161lt?.$ .~M.> , , ~~ 3.~f.9$"·~v;;€5 q, ColT~ !"~~~~ . ot"•·-·..~:-­ .,_....,=",..,....... - - - - - - - - - - - , ('U{Ton~ Cu[Tb"1e/!.I- --H-->.,~( uf77Jt1~ {oMPAW t(S"~/€'~/9' V&11JA.1ior. cf6A-TiotJ BvtWIN6 1 11/DT r
  • 31. Lean Startup Agile Engineering +Part 3 Part 1 + Part 2 Agile Engineering
  • 32. Building the Nation’s I-Corps “Innovation Fabric” I-Corps Nodes I-Corps Sites I-Corps Teams I-Corps Mentors
  • 33. What you will get and produce • Your team will – Be trained in lean startup methods – Develop answers to your business questions • You will produce – A learning journey associated with customers and the business model canvas – in LPC – A final presentation and a final video @
  • 34. Evidence-based Entrepreneurship Framing Hypotheses Customer Discovery 1 week before Product Mentorship Mandatory Office Hours with Partners, a Mentor dedicated to team, uses LPC for review, Advisors as domain experts Education / Community Team presents weekly in front of cohort, formal curriculum, Optional: Office space, weekly dinners w/guest speakers Lessons Learned What we thought, what we did, what we found, what’s next. Continual Revisions to MVP based on Customer Discovery Application by BMC, Initial Canvas, Updated Weekly Canvases 10-15 customer interviews/week, present results in front of peers
  • 35. Mutual Expectations • Relentless – Urgent and intense activity for 7 weeks • Direct – Honest and clear communication • Hypothesis driven – Hypothesis: Here’s What We Thought – Experiments: So Here’s What We Did – Results: So Here’s What We Found • Customer discovery – 100 interviews in 7 weeks @
  • 36. Expect us to be RELENTLESS and DIRECT @
  • 37. Albus Imaging: Team Members Goal: Collaborative and Productive Team Observe / Active Bystander / Adjudicator Yaorong Ge,PhD Industry Expert • ComputerScientist &Bioinformatics Greg Hundley,MD C-Level Executive • Cardiologist • Cardiovascular ImagingExpert Move Debating society Oppose Holly Goodwin,MBA Principle Investigator • Translationalresearch • Commercialization of Cardiovascular monitoring technologies
  • 38. So here’s what we did…. We got out of the building! • We interviewed: ₋ 58Cardiologists ₋ 53Oncologists ACOs, Payers, ₋ 31Others HCPs, RNs • Weekly average = 20 ₋ 12 =Min ₋ 31 =Max ₋ 20 =Median ₋ 15 =Mode Plus 10 places in Europe We always asked who else the interviewee thought we should talk to <<-- this was very fruitful!
  • 39. ALBUS lMAGlNG So Here’s What We Are Going ToDo for the next week! Just kidding! We have 10 interviews scheduled for Thursday & Friday.
  • 40. Company 47 Brett Noel, Ph.D. PI Steve Ouellette, Ph.D. C-level Isaac Schumman, MBA “Industry Expert” Product: Preclinical assays to characterize new oncology therapies Customers: Biopharma, academics, and preclinical CROs Why: Save money and time on characterizing candidates in lead optimization Interview Count TOTAL 102 36 5 61 Academia Number Professor 11 Lab Director 7 Post-Doc 5 Grad Student 4 Administrator 1 Biotech/Pharma Scientist 24 Exec. Leadership Bus. Dev. 17 7 CRO Scientist 3 Exec. Leadership Bus. Dev. 3 1 Distributors Bus. Dev. 6 Sales 2 Consultants Drug Discovery 11
  • 41. Team Profile Steve Ouellette - Chief Technology Officer & Co-founder • Ph.D. in Cancer Biology and Molecular Signaling (Purdue) • Experience at preclinical CRO startup for in vitro toxicity • Entrepreneurial training and developer of KS biz plan • Coordinate overall effort of I-Corps team Brett Noel – Senior Scientist • Ph.D. in Cancer Biology and Molecular Signaling (Purdue) • Expertise in core technology and development strategy • I-Corps – Focus on technically oriented interviews Isaac Schumann – Business Development Manager • MBA from Krannert School of Management (Purdue) • Experience at biochem CRO (Food, paper and biofuels) • I-Corps – Focus on commercialization oriented interviews
  • 42. Business Model Canvas – Day 1 Original company hypothesis: There is a market need for technologies to measure cell-based, endogenous tyrosine kinase activity in preclinical drug development and clinical diagnostic markets.
  • 43. Senseor kinase inhibitor therapies The Original Business Model B.usiness Mo,del Reagent Design Reagent Validation Reagent Optimization • Diagnostic:s Partners - 1 Cl'inical hials - FID.A r,egulatory hurdles R,e,imbursment • DnJ,g o·isco,verry Partners - Pre·-clinical services ond products - Early Revenue
  • 45. Changes in Strategy and Philosophy on Business Models Drop the clinical applications…for now Drug Discovery Re-segment
  • 46. Changes in Strategy and Philosophy on Business Models Drop the clinical applications…for now Drug Discovery Re-segment Drug Discovery Clinical Many business models
  • 47. The Big Pivot: Revenue Model Bob Lowery CEO, Bellbrook Labs Brian Murphy Director, Axiogenesis
  • 48. Revenue Model: What We Learned We had to build… Product / Kit Service / Data
  • 49. Sense How to Reach the Paying Customers?
  • 50. Promoting Adoption in the Ecosystem
  • 51. There is a Community Effort Involved in Driving Adoption Partners Assay Companies David Drewry Bill Zuercher Jon Elkins KOLs • Publish • Co-develop • Endorse • Present Complementary Products Pilot Studies with Potential Customers
  • 52. In Summary We Learned… Focus Pivot Community Final company hypothesis: Kinase inhibitor researchers in preclinical drug discovery need KinaSense assays to measure kinase activity directly in cellular models for reducing the time it takes to move a candidate drug from preclinical development into clinical trials.
  • 53. Future Plans • Continue building the platform as a research tool • Establish KOL relationships and collaborations • Customer discovery and the interview method of learning will become SOP at KinaSense • Explore larger market opportunities of the technology Activities Phase II Submission Phase II submission expected second half of 2017 Phase I Submission At least 2 additional Phase I applications based on I- Corps learning Next 3 months Partnerships with KOLs License IP to strengthen Phase I application 3rd party funding No plans to pursue before Phase II submission
  • 54. Acknowledgements Teaching Team David Charron Aileen Huang-Saad Edmund Pendleton Nancy Kamei Todd Morrill Bob Storey TA Lauren Sheridan Cohort Teams NIH Michael Weingarten Christie Canaria VentureWell
  • 55. Future Plans- 4 month Follow up • Continue building the platform as a research tool • Establish KOL relationships and collaborations • Customer discovery and the interview method of learning will become SOP at KinaSense • Explore larger market opportunities of the technology Activities Phase II Submission Phase II submission expected second half of 2017 On Track Phase I Submission At least 2 additional Phase I applications based on I- Corps learning On Track (One scored well after I- Corps insights) Next 3 months Partnerships with KOLs License IP to strengthen Phase I application Finalizing Deals 3rd party funding No plans to pursue before Phase II submission Have had offers for outside funding
  • 56. Future Plans- 4 month Follow up • Continue building the platform as a research tool • Establish KOL relationships and collaborations • Finalizing a contract with major pharmaceutical company • Will fund company for at least 1 year • Customer discovery and the interview method of learning will become SOP at KinaSense • Explore larger market opportunities of the technology Activities Phase II Submission Phase II submission expected second half of 2017 On Track Phase I Submission At least 2 additional Phase I applications based on I- Corps learning On Track (One scored well after I- Corps learnings) Next 3 months Partnerships with KOLs License IP to strengthen Phase I application Finalizing Deals 3rd party funding No plans to pursue before Phase II submission Have had offers for outside funding
  • 57. Future Plans- 4 month Follow up • Continue building the platform as a research tool • Establish KOL relationships and collaborations • Finalizing a contract with major pharmaceutical company • Will fund company for at least 1 year • Customer discovery and the interview method of learning will become SOP at KinaSense • Currently in contact with at least 1 other major pharmaceutical company • Explore larger market opportunities of the technology Activities Phase II Submission Phase II submission expected second half of 2017 On Track Phase I Submission At least 2 additional Phase I applications based on I- Corps learning On Track (One scored well after I- Corps learnings) Next 3 months Partnerships with KOLs License IP to strengthen Phase I application Finalizing Deals 3rd party funding No plans to pursue before Phase II submission Have had offers for outside funding
  • 58. I-Corps Lessons • I-Corps is time-consuming • 40 hours/week • Research will slow down • Can you afford to participate in I-Corps?
  • 59. I-Corps Lessons • I-Corps is time-consuming • 40 hours/week • Research will slow down • Can you afford to participate in I-Corps? • Customer discovery is a skill that needs development • Academic articles can be very misleading • Interviews with customers and key opinion leaders are most important data points • Networking leads to an understanding of your market ecosystem
  • 60. I-Corps Lessons • I-Corps is time-consuming • 40 hours/week • Research will slow down • Can you afford to participate in I-Corps? • Customer discovery is a skill that needs development • Academic articles can be very misleading • Interviews with customers and key opinion leaders are most important data points • Networking leads to an understanding of your market ecosystem • Teaching team and industry mentors are valuable resources • Experienced entrepreneurs and are invested in your success
  • 61. I-Corps Lessons • I-Corps is time-consuming • 40 hours/week • Research will slow down • Can you afford to participate in I-Corps? • Customer discovery is a skill that needs development • Academic articles can be very misleading • Interviews with customers and key opinion leaders are most important data points • Networking leads to an understanding of your market ecosystem • Teaching team and industry mentors are valuable resources • Experienced entrepreneurs and are invested in your success • Almost every team pivoted in some way • KinaSense focused early on, accelerated company development timeline by 1-2 years • Reassessed new SBIR opportunities • High score on a previously low-priority project • Many companies made MAJOR pivots
  • 62. I-Corps Lessons • I-Corps is time-consuming • 40 hours/week • Research will slow down • Can you afford to participate in I-Corps? • Customer discovery is a skill that needs development • Academic articles can be very misleading • Interviews with customers and key opinion leaders are most important data points • Networking leads to an understanding of your market ecosystem • Teaching team and industry mentors are valuable resources • Experienced entrepreneurs and are invested in your success • Almost every team pivoted in some way • KinaSense focused early on, accelerated company development timeline by 1-2 years • Reassessed new SBIR opportunities • High score on a previously low-priority project • Many companies made MAJOR pivots Can you afford NOT to participate in I-Corps?
  • 63. Q&A sbir.cancer.gov/icorps Submit your questions through the Q&A chat box Please submit your questions via the chat box. We will be answering your questions throughout the webinar, with additional time dedicated at the end of the session. Slides will be made available after the webinar event. #ICorpsNIH