I-Corps @ NIH

2. Dr.
Dina
Uzri
Dr.
Bradley
Messmer
Dr.
Peter
Haberz
PI,
Founder
&
CEO
PhD,
Rockefeller
Univ.
3
yrs
industry
experience
20
yrs
academic
experience
Inventor
of
IP
Loco
Pescador
CSO
PhD,
Harvard
Univ.
3
yrs
industry
experience
10
yrs
academic
experience
Pisces
Industry,
Co-­‐Founder
&
CFO
PhD,
Max
Planck
InsNtute
3
yrs
industry
experience
10
yrs
academic
experience
Deckhand

3. Is
your
expensive
drug
real?

4. Week
2

5. We
were
fishing
for
customers

6. We
found
the
ones
we
were
looking
for
+13

7. Market:
Validated!
But
this
market
is
mostly
overseas

8. Week
5

9. New
problems
=
New
market
The
world
today
Innovator
Drug
Maker
(e.g.
Genentech)
Specialty
Distributors
Infusion
Center/
Hospital
PaNent
The
world
in
a
few
years
Biosimilar
makers
(e.g.
Mylan,
Celltrion,
Hospira,
Biocon,
Amgen,
Merck,
Baxter,
Actavis,
Sandoz)
Distributors
?

10. What
they
need
Pre-­‐drug
approval
Post-­‐drug
approval
Preclinical
R&D
cGMP
manufacturing
Manufacturing
lot
tesNng
AuthenNcaNon
MarkeNng
Blood
tests
(separate
STTR)
Preclinical
PK
Clinical
trial
PK
&
ADA
Phase
4
PK
dosing
Assay
cerNficaNon
required
Medical
Device
–
FDA
regulated
PK
straNficaNon/
dosing
+14

11. New
customer
on
the
hook
+14

12. Week
11

13. Need
refined
MVP
Is
your
expensive
drug
real?

14. Problem:
High
dose
hook
10mg/ml
1mg/ml
100ug/ml
10ug/ml
1ug/ml
HercepMn
flow
SoluMon:
DeNAno

15. MVP
for
Use
Case
#1:
law
enforcement
agents,
staff
at
smaller
clinics,
overseas
paNents
Readout:
semi-­‐quanNtaNve

16. MVP
for
Use
Case
#2:
biosimilar
drug
makers
and
large
medical
center
pharmacies
QuanMtaMve
Readout

17. 101
A
busy
two
months

18. Tangible
Results
• New
Partners:
– Buchanan
Ingersoll
&
Rooney
in
DC
– 3
consultants
– ZDT
digital
reader
partner
– License
deal
with
UCSD
• Deals
in
the
works
– MedSci

Chinese
FDA
– Cipla
Biologics,
biosimilar
developer
in
India
– Alava
Biopharm
Partners
LLC,
biologic
CMO
– MBL
InternaNonal
CorporaNon
(Japan)
– Oncology
group
within
Clinical
Services
Group
of
HCA
Healthcare

19. 15
of
101
interviewees
wrote
lefer
of
support
for
Phase
II
SBIR

20. Investment
readiness
level
6
9.
Validate
Metrics
That
Mafer
8.
Validate
Rest
of
Canvas
7.
Prototype
High
Fidelity
MVP
6.
Validate
Right
Side
of
Canvas
5.
Validate
Product/Market
Fit
4.
Prototype
Low
Fidelity
MVP
3.
Problem/SoluNon
ValidaNon
2.
Mkt
Size/CompeNNve
Analysis
1.
Complete
First-­‐Pass
Canvas
3
On
our
way
to
high
fidelity
MVP
–
IRL
7

21. Equity
Investors
2015
2016
2017
2018
mAb
150K
PK
dosing
220K
mAb
1.5M
PK
dosing
1.5M
LPS
220K
Grants
150K
2-­‐4M
MuDPAQ
225K
MuDPAQ
1.5M
Sample
sparing
U24
1.6M
DeNAno
R33
900K
LPS
1.5M

22. Now
we
need
to
fill
the
boat

23. So
long,
and
thanks
for
all
the
fish
I-­‐Corps
video
hfps://www.youtube.com/watch?v=lcxh6I89dqw&feature=youtu.be