Part of the Life Science Venture Fast Track: http://www.thecapitalnetwork.org/programs/life-science-venture-fast-track/

1. TCN
Life
Science
Venture
Fast
Track
Does
Your
Company
Have
The
Big
Three:
Intellectual
Property,
Regulatory,
and
Reimbursement?
January
21,
2014

2. Panelists
Therapeu(cs
Device
Leslie
Williams
President
and
CEO
ImmusanT
Nancy
Briefs
CEO
InfoBionic
Emily
Walsh
Principal
Tremont
TherapeuPcs
ConsulPng
Nandini
Murthy
Regulatory
Consultant
ENEM
ConsulPng
Moderator:
KonstanPn
Linnik
Partner,
Intellectual
Property
NuSer
McClennen
&
Fish
Download slides: bit.ly/tcnLifeSci2014

3. The
Big
Three
IP
Market
Exclusivity
(Patent
&
Regulatory
ExclusiviPes)
Regulatory
Safety
&
Efficacy
Payors
Value
ProposiPon
(Pricing,
Reimbursement
&
Market
Access)
Download slides: bit.ly/tcnLifeSci2014

4. Patent Exclusivity
Loss of
Exclusivity (LOE)
FDA Exclusivity
$
Development
7-15 years
Generic entry
Download slides: bit.ly/tcnLifeSci2014

5. $
IP
-­‐
Market
Exclusivity
Ave.
Exclusivity
~12.5
yrs,
ave.
Exclusivity
necessary
for
ROI
is
at
least
12
yrs
Regulatory
-­‐
Safety
Efficacy
50%
of
Phase
III
trials
fail
for
lack
of
efficacy
over
placebo
Payors
-­‐
Value
ProposiPon
3
out
of
4
approved
drugs
are
not
profitable
Download slides: bit.ly/tcnLifeSci2014

6. The
Big
Three:
The
EssenPals
1. To
get
reimbursed,
the
use
must
be
on
the
label;
can’t
rely
on
off-­‐label
use
or
off-­‐label
promoPon
2. There
must
be
no
generic
subsPtute
available;
automaPc
subsPtuPon
is
o_en
required
by
law
or
by
payors
3. To
get
adequate
exclusivity,
patent
claims
must
cover
the
approved
use
4. Clinical
trials
must
be
designed
to
support
the
label
and
the
value
proposiPon
to
payors
Download
slides:
bit.ly/tcnLifeSci2014

7. Examples
1. Biogen’s
BG-­‐12
(MS
or
Psoriasis?)
2.
Sepracor’s
Lunesta
(US)
v
Imovane
(Europe)
Download slides: bit.ly/tcnLifeSci2014

8. Panelists
Therapeu(cs
Device
Leslie
Williams
President
and
CEO
ImmusanT
Nancy
Briefs
CEO
InfoBionic
Emily
Walsh
Principal
Tremont
TherapeuPcs
ConsulPng
Nandini
Murthy
Regulatory
Consultant
ENEM
ConsulPng
Moderator:
KonstanPn
Linnik
Partner,
Intellectual
Property
NuSer
McClennen
Fish
Download slides: bit.ly/tcnLifeSci2014

9. IP
ProtecPon
1.
2.
3.
4.
5.
6.
7.
File
early…don’t
wait
It’s
all
about
the
disclosure
Know
the
prior
art
ArPculate
your
patent
strategy
Reserve
funds
to
perform
a
freedom
to
operate
ASAP
Prepare
for
compePtors
to
use
ambiguiPes
in
the
patent
system
to
their
advantage
Don’t
skimp
on
choosing
a
law
firm
IP….without a strategy, you won’t get funded
Nutter McClennen Fish
LLP • www.nutter.com
9

10. Reimbursement
1.
2.
3.
4.
5.
6.
7.
8.
9.
Link
with
PaPent
Groups
–
they
can
put
pressure
on
Washington
ArPculate
a
sound
comparaPve
effecPveness
argument
Know
if
you
can
use
exisPng
codes
or
need
a
new
code
Hire
a
consultant
if
you
need
to
It
will
take
3+
peer
reviewed
publicaPons
(with
significant
numbers)
to
convince
payors
to
grant
coverage
You
must
show
a
reducPon
in
cost
to
the
system
Determine
if
private
pay,
Medicare
or
Medicaid
cover
your
paPent
populaPon
Start
dialogue
with
Payers
including
self-­‐insured
(large
employers)
early
Find
a
champion
early
Reimbursement….without a strategy, you won’t get funded
Nutter McClennen Fish
LLP • www.nutter.com
10

11. Regulatory
1.
2.
3.
Understand
your
desired
path
to
approval
Hire
a
consultant
if
you
need
one
Communicate
with
the
FDA
early
and
o_en
if
possible
-­‐
look
for
guidance
documents
4.
5.
6.
7.
8.
Understand
and
research
the
group
at
the
FDA
that
will
be
responsible
for
the
product
Know
your
device
will
work
clinically
before
submiong
to
the
US
FDA
Don’t
short
cut
criPcal
aspects
of
development–
go
slow
to
go
fast
Budget
appropriately
(Pme
money)
MITIGATE
RISK
wherever
possible
Regulatory….without a strategy, you won’t get funded
Nutter McClennen Fish
LLP • www.nutter.com
11

12. Regulatory Path
Preclinical
Toxicology
Clinical
InvesPgaPonal
New
Drug
ApplicaPon
Phase
I
safety
Approval
safety
dosing
efficacy
Phase
III
New
Drug
ApplicaPon
Phase
IV
/
Postmarket
surveillance
0.6
to
2
years
Phase
II
Market
11
to
14
years
safety
efficacy
side
effects
Expenses
$15.2
million
$23.4
million
$86.5
million
Time
21.6
months
25.7
months
30.5
months
1
to
6
years
6
to
11
years
Overall
probability
of
success
30%
14%
9%
8%
75%
48%
64%
90%
CondiPonal
probability
of
success
40%
Sources:
Dimasi,
Hansen,
and
Grabowski
(2003).
Notes:
The
line
marked
“Overall
probability
of
success”
is
the
uncondiPonal
probability
of
reaching
a
given
stage.
For
example,
30
percent
of
drugs
make
it
to
phase
I
tesPng.
The
line
marked
“CondiPonal
probability
of
success”
shows
the
probability
of
advancing
to
the
next
stage
of
the
process
condiPonal
on
reaching
a
given
stage.
For
example,
the
probability
of
advancing
to
Phase
III
tesPng
condiPonal
on
starPng
Phase
II
tesPng
is
48
percent.

13. Overview

14. MedTech
Regulatory
Overview
Nandini
Murthy
Regulatory
Consultant
Email:
nmurthy@enemconsulPng.com
Phone
#
(781)
710-­‐5378

15. Typical VC Questions
• Did you have a Pre-Sub Meeting with FDA?
• Did the FDA identify any concerns or risks?
• If the path is 510(k), what is the predicate? Traditional or
•
•
•
•
•
De Novo?
Indications for use? Aligns with business plan or
reimbursement strategy?
Does it need a clinical? If so, what is the study design?
RCT? Observational? OUS studies suffice?
Primary endpoints in the study? Will it support
reimbursement? Early adoption?
Timeline for US approval? After CE Mark?
Names of Legal Counsel, Regulatory Experts
Copyright ENEM Consulting LLC
15

16. Regulatory versus reimbursement
•
•
•
•
•
Majority of devices come to market via 510(k)
Primary premise is one of Substantial Equivalence to
predicate devices
Regulatory Strategy potentially counter to IP and
Reimbursement goals, where novelty of device may be
emphasized.
Claims of benefit or superiority are limited when pursuing a
510(k) clearance path
The broader and more bold the claims, typically the longer
and more complex the regulatory process
Copyright ENEM Consulting LLC
16

17. Common missteps
•
•
•
•
Confusing the marketing need for regulatory requirement for
a clinical study
o Devices are designed with intent, sometimes bench or
animal studies are adequate for 510(k)
Starting the Clinical study prematurely, before regulatory
strategy has been identified
o Is it an equivalence study? RCT? Single Arm?
o Against a Gold standard?
o What is the patient population (intended use)?
Aligning Clinical study endpoints to marketing needs instead
of regulatory validation
Assuming that Clinical Studies conducted OUS to satisfy EU
launch will suffice for FDA. They might, but need to plan
accordingly.
Copyright ENEM Consulting LLC
17

18. Regulatory Summary
• Regulated environment
• Moving target
• Details matter
• Planning and execution is critical
• Many FDA Submission requirements typically not
subject to negotiation (e.g. cannot negotiate an
exemption from biocompatibility tests for patient-contact
devices because of timeline commitments to investors)
• There will be surprises during testing. Rely on
experienced Regulatory and Project personnel
• Manage expectations throughout process
Copyright ENEM Consulting LLC
18

20. OUR VISION
Develop
a
proprietary
plaNorm
for
remote
pa(ent
monitoring
which
leverages
the
cloud
to
reduce
opera(ng
costs
Data
not
Device
Company

21. OUR MISSION
Disrupt
the
$3B
arrhythmia
detec(on
market
with
a
lower
cost,
high
quality
cloud-­‐based
SaaS
solu(on
for
cardiologists

22. COMPANY FACTS
• Founded
March
2011
–
M2D2
UMass
Lowell,
MA
• Team
–
Serial
Successful
Entrepreneurs
• Exis(ng
$3B
Global
Arrhythmia
Detec(on
Market
• Innova(ve
Proprietary
Technology
-­‐
MoMe™
• Reimbursement
–
ExisPng
Codes
in
place
• Regulatory
–
– CE
Mark
– 510(k)
filed

23. MoMe™ Platform
Cloud-­‐Based
solu(on
Continuous
Streaming ECG,
Respiration, Motion

24. INTELLECTUAL PROPERTY
US Patent 8,478,418 (July 2013)
Mul(-­‐pass
Algorithm
Analysis

25. US Patent 8,620,418 B1
(Dec 2013)
• Systems
and
methods
for
processing
and
displaying
pa(ent
electrocardiograph
data
ABSTRACT
• A
method
is
disclosed
for
displaying
paPent
ECG
data.
The
method
includes
receiving
ECG
data
including
an
ECG
waveform;
receiving
analyzed
ECG
data
including
arrhythmic
events;
generaPng
an
indicia
of
the
detected
arrhythmic
event;
and
displaying
the
indicia
of
the
detected
arrhythmic
event
in
relaPon
to
the
ECG
waveform
at
a
posiPon
associated
with
a
Pme
of
the
detected
arrhythmic
event.
A
system
for
displaying
paPent
ECG
data
is
also
disclosed.

26. US REIMBURSEMENT
Larchmont Strategic Advisors
• CPT
Codes
available
and
applicable
•
Holter,
Event
MCT
• Medicare
reimburses
all
monitoring
• Private
Payors
reimburse
for
Holter,
Event
and
~85%
reimburse
for
MCT

27. Reimbursement for
Arrhythmia Detection Monitoring

28. REGULATORY
OUS
-­‐
CE
Mark
– Successful
NoPfied
Body
Audit
– CerPficate
December
2013
US
-­‐
510(k)
Submission
• Pre-­‐IDE
MeePng
August
2012
• No
Human
Clinical
Required
• Clinical
TesPng
against
recognized
Data
Bases
• Filed
‘Q4
2013