This document is a market analysis proposal from Harrison Hayes to Company X for research on establishing a business case for using Company X's Product X Pump for convection enhanced delivery (CED) of drugs locally in organs. The objectives are to help Company X identify advantages of CED over systemic delivery, potential applications and extensions to other diseases, target markets, regulatory requirements, competitors and more. Harrison Hayes would use qualitative research methods including input from key innovation leaders to provide insights into building the case for this local organ delivery approach.

1.
Pump
for
Convection
Enhanced
Delivery
Market
Analysis
Proposal

2.
Company
X:
Product
X
Pump
for
CED
2
Market
Analysis
Proposal
-­‐
Confidential
November
29,
2010
Dear
Richard,
Per
our
conversations,
Harrison
Hayes
has
incorporated
valuable
feedback
from
Company
X
and
is
pleased
to
present
this
PRODUCT
X
Pump
for
Convection
Enhanced
Delivery
(CED)
Research
Proposal.
In
this
proposal,
we
present
a
review
of
the
objectives,
scope,
and
qualitative
market
research
of
this
project.
We
will
also
go
into
more
detail
regarding
the
qualitative
research
methodology
that
Harrison
Hayes
will
utilize
to
obtain
unique
insights
into
building
the
business
case
for
Local
Organ
Delivery
using
the
PRODUCT
X
pump
for
CED.
We
are
highly
confident
that
our
ideation
methodology
and
insightful
results
will
exceed
your
expectations.
To
complement
our
work
on
this
project,
Harrison
Hayes
will
rely
on
a
dynamic
network
of
KILs
(Key
Innovation
Leaders)
who
have
deep
domain
expertise
and
are
well
respected
in
their
specific
disciplines.
This
assures
that
our
research,
ideation
and
points
of
view
are
of
the
highest
value.
We
would
like
to
thank
you
for
considering
Harrison
Hayes
as
your
business
solution
and
look
forward
to
a
great
working
relationship.
Sincerely,
Bill
Smith
Managing
Director
Harrison
Hayes,
LLC
Charlotte,
NC

3.
Company
X:
Product
X
Pump
for
CED
3
Market
Analysis
Proposal
-­‐
Confidential
OBJECTIVES
The
primary
objective
of
this
research
project
is
to
assist
Company
X
in
establishing
a
clear,
yet
strategic,
business
case
for
Local
Organ
Delivery
using
the
PRODUCT
X
pump
for
Convection
Enhanced
Delivery
(CED).
This
research,
while
utilizing
Harrison
Hayes’
qualitative
research
methodology,
will
also
help
provide
Company
X
with
insights
into
identifying
extensions
of
local
and/or
systemic
CED
applications.
To
obtain
this
data,
Harrison
Hayes
will
focus
on
the
assessment
in
the
following
areas:
The
following
includes
a
sample
of
areas
of
assessment:
• Build
the
business
case
for
the
intra-­‐organ
delivery
PRODUCT
X
pump
vs.
systemic
delivery
• Identify
Advantages
to
a
CED
system
in
relation
to
traditional
therapeutic
approaches
• Identify
the
target
market
disease
states
to
generate
biggest
revenue-­‐accretive
value
of
just
the
Glioblastoma
segment
and
value
based
on
the
number
of
Glioblastomas
in
the
marketplace
• Identify
Emerging
Markets
by
identifying
worldwide
countries
to
target
based
on
economics
and
market
size
• Determine
the
time
interval
for
Fast
Track
of
FDA
approval
of
the
novel
device
to
expedite
product
launch
• Identify
Benefits
vs.
High
Cost-­‐
$100
M
goal
• Identify
Competitors
• Identify
Vendors
to
include
all
Pharma
companies
including
Phase
II
and
Phase
III
drugs
that
did
not
make
it
to
market
• Evaluate
Compliance
and
Regulatory
Measures
to
include
additional
studies
needed
for
FDA
approval
and
extended
uses
• Determine
the
extent
that
CED
system
can
be
extended
to
other
medical
offerings
by
identifying
other
disease
states
where
small
dose
rates,
over
time,
methods
of
treatment
are
present
for
future
growth
(i.e.
non-­‐brain
tumor
oncology,
diabetes,
endocrine,
obesity,
and/or
autoimmune
diseases)

4.
Company
X:
Product
X
Pump
for
CED
4
Market
Analysis
Proposal
-­‐
Confidential
BACKGROUND
Because
primary
brain
tumors
treated
with
surgery,
radiation
therapy,
and
chemotherapy
have
a
poor
prognosis,
this
has
led
investigators
to
develop
new
innovative
therapies
such
as
targeted
toxins.
These
large
molecules
do
not
cross
the
blood
brain
barrier
and
must
be
delivered
into
the
brain
by
a
technique
known
as
Convection-­‐enhanced
delivery
(CED).
1
CED
is
the
continuous
injection
under
positive
pressure
of
a
fluid
containing
a
therapeutic
agent.
This
technique
was
proposed
and
introduced
by
researchers
from
the
US
National
Institutes
of
Health
(NIH)
in
the
early
1990s
to
deliver
drugs
that
would
otherwise
not
cross
the
blood-­‐brain
barrier
into
the
parenchyma
and
that
would
be
too
large
to
diffuse
effectively
over
the
required
distances
where
they
simply
deposited
into
the
tissue.
Despite
the
many
years
that
have
elapsed,
this
technique
remains
experimental
because
of
both
the
absence
of
approved
drugs
for
intraparenchymal
delivery
and
the
difficulty
of
guaranteed
delivery
to
delineated
regions
of
the
brain.
During
the
first
decade
after
the
NIH
researchers
founded
this
analytical
model
of
drug
distribution,
the
results
of
several
computer
simulations
that
had
been
conducted
according
to
more
realistic
assumptions
were
also
published,
revealing
encouraging
results.
In
the
late
1990s,
one
of
the
authors
of
the
present
paper
proposed
the
development
of
a
computer
model
that
would
predict
the
distribution
specific
to
a
particular
patient
(brain)
based
on
obtainable
data
from
radiological
images.
Several
key
developments
in
imaging
technology,
and
in
particular,
the
relationships
between
image-­‐
obtained
quantities
and
other
parameters
that
enter
models
of
the
CED
process
have
been
required
to
implement
this
model.
Note
that
delivery
devices
need
further
development.2
Advantages
A
potential
advantage
of
the
CED
system
is
the
ability
of
the
agent
to
reach
cells
that
have
invaded
the
peritumoral
region
and
beyond,
making
it
possible
to
offer
hope
of
significantly
reducing
the
spread
of
the
disease.
For
large
molecules
having
a
50,000-­‐D
or
greater
mass,
the
diffusive
spread
will
often
extend
less
than
1
mm
in
a
day
and
only
that
large
if
metabolic
and
other
loss
mechanisms
do
not
flush
it
from
the
parenchyma.
The
flow
of
such
a
fluid
co-­‐injected
with
a
drug
can
carry
such
molecules
much
farther,
however,
and
in
certain
idealized
scenarios
can
fill
the
intervening
region
with
a
full
concentration
of
drug
per
unit
of
available
volume.
Volume
of
Distribution
Diffusive
spread
results
in
exponentially
decreasing
concentrations
away
from
a
source.
When
administering
these
agents,
there
are
a
number
of
pharmacokinetic
considerations
that
must
be
considered
that
will
directly
affect
the
volume
of
distribution
of
the
drug
being
administered
and
ultimately
the
therapeutic
effect
of
the
agent.
A
number
of
different
catheter
types
have
been
used
to
perform
CED
with
a
hollow
fiber
design
offering
several
advantages
over
other
variations.
Specific
parameters
have
been
developed
to
optimize
the
placement
of
the
drug
delivery
catheters
in
order
to
enhance
drug
distribution
in
the
brain.
Considerable
effort
has
been
expended
to
identify
a
reliable
way
to
image
the
distribution
of
targeted
toxins
administered
by
CED
using
a
combination
of
magnetic
resonance
imaging
and
single
photon
emission
computed
tomography.
Unfortunately,
many
infusions
performed
in
tumor
patients
are
unsuccessful
due
to
ventricular/subarachnoid
leak
or
pooling
of
the
drug
in
necrotic
tumor
tissue.
To
date,
no
targeted
toxin
clinical
trial
has
demonstrated
statistically
significant
clinical
results
leading
to
the
universal
acceptance
of
this
treatment.
Other
agents
such
as
standard
chemotherapy
or
liposomal
1 Hall
WA.
Convection-­‐Enhanced
Delivery:
Neurological
Issues.
Current
Drug
Targets.
2009;10(2):126-­‐30(5).
2 Raghavan
R,
Brady
ML,
et
al.
Convection-­‐Enhanced
Delivery
of
Therapeutics
for
Brain
Disease,
and
Its
Optimization.
Neurosurg
Focus.
2 Raghavan
R,
Brady
ML,
et
al.
Convection-­‐Enhanced
Delivery
of
Therapeutics
for
Brain
Disease,
and
Its
Optimization.
Neurosurg
Focus.
2006;20(4):E12.

5.
Company
X:
Product
X
Pump
for
CED
5
Market
Analysis
Proposal
-­‐
Confidential
preparations
have
been
delivered
by
CED.
Non-­‐neoplastic
neurological
diseases
are
being
considered
for
treatment
by
CED
and
treating
different
locations
of
the
brain
other
than
the
cerebral
hemispheres
are
under
investigation.
Relevant
Research
Studies
In
2005,
Peregrine
Pharmaceuticals
Inc.
developed
Cotara,
a
monoclonal
antibody
specific
for
tumor
necrosis
factor
(TNF)
linked
to
radioactive
iodine
131.
It
was
designed
to
target
TNF
associated
with
dead
or
dying
tissue
usually
found
inside
tumors.
Once
the
conjugate
is
attached
to
the
TNF,
the
radioactive
isotope
kills
neighboring
cells.
Peregrine
received
regulatory
approval
in
India
in
2006
for
a
new
clinical
trial
of
the
candidate
in
Glioblastoma
multiforme,
a
deadly
form
of
brain
cancer.
The
goal
of
the
trial
was
to
provide
clinical
data
that
could
be
combined
with
the
dosimetry
and
safety
data
being
gathered
from
the
ongoing
US
study
to
speed
up
clinical
and
commercial
development
of
the
agent.
The
study
enrolled
40
Glioblastoma
patients
who
had
experienced
their
first
relapse.
They
were
given
a
single
infusion
of
Cotara
directly
into
the
brain
tumor,
using
a
CED
system.
Primary
endpoints
were
to
confirm
safety
and
determine
median
survival
time
and
median
time
to
progression.
In
2006,
NeoPharm
Inc.
conducted
a
Phase
III
clinical
trial
of
its
cintredekin
besudotox
(IL13-­‐
PE38QQR)
candidate
for
treating
recurrent
Glioblastoma
multiforme
(GBM).
Sandeep
Kunwar
of
the
University
of
California
at
San
Francisco
(UCSF)
presented
updated
results
of
Phase
I/II
studies
and
results
from
a
Phase
I/II
subset
analysis
at
the
74th
Annual
Meeting
of
the
American
Association
of
Neurological
Surgeons
in
San
Francisco
on
April
24,
2006.
The
data
showed
that
GBM
patients
in
the
trials
continued
to
experience
prolonged
survival.
The
candidate
was
a
conjugate
of
interleukin-­‐13
(IL-­‐13)
and
a
truncated
form
of
Pseudomonas
bacterial
exotoxin.
The
IL-­‐3
portion
of
the
recombinant
protein
targets
the
molecule
to
cancer
cells,
which
the
toxin
kills.
Updated
data
for
the
45
GBM
patients
treated
in
the
Phase
I/II
intraparenchymal
setting
showed
an
overall
median
survival
time
of
44.0
weeks,
with
survival
increasing
to
53.6
weeks
for
the
26
patients
with
two
or
more
optimally
placed
catheters.
Also,
in
a
long-­‐term
follow-­‐up
Phase
I
study
22
GBM
patients
treated
with
cintredekin
besudotox
via
convection
enhanced
delivery
had
a
median
survival
of
more
than
one
year
(57.4
weeks).
Sixteen
of
these
patients
with
two
or
more
optimally
placed
catheters
had
a
median
survival
of
69.9
weeks.
In
addition,
four
patients
at
UCSF
remain
alive
with
a
median
follow-­‐up
of
more
than
three
and
half
years
(188
weeks),
including
one
patient
with
a
follow-­‐up
of
almost
five
years
(244
weeks)
who
is
still
progression
free.
An
independent
statistical
analysis
of
the
Phase
I/II
data
confirmed
that
catheter
placement
was
a
key
prognostic
factor
related
to
prolonged
survival.
Information
from
these
trials
was
incorporated
into
the
design
of
the
pivotal
Phase
III
trial.
Being
able
to
comprehend
intracranial
conditions
is
critical
to
patients
who
have
had
traumatic
brain
injury
(TBI).
Parameters
that
are
typically
monitored
in
TBI
patients
include
blood
pressure,
intracranial
pressure,
local
brain
tissue
oxygen
tension,
and
jugular
venous
oxygen
saturation.
Even
in
advanced
institutions,
other
physiological
metrics
(brain
glucose,
lactate,
pyruvate,
and
pH)
that
are
prone
to
affect
patient
outcomes
are
usually
monitored
intermittently.
A
new
development
at
the
University
of
Cincinnati
promises
to
shed
more
light
on
the
brain
by
means
of
a
‘lab-­‐on-­‐a-­‐
tube’
(LOT)
device.
This
device
is
capable
of
draining
cerebrospinal
fluid
(CSF)
during
the
process
of
monitoring
parameters
such
as
pressure,
oxygen
content,
temperature,
and
glucose
within
the
intracranial
space.
This
LOT
has
several
benefits
over
current
brain
monitoring
techniques,
including
low
invasiveness
as
it
requires
only
one
hole
to
be
drilled
into
the
skull.
Next,
the
tube’s
diameter
can
be
contracted
or
expanded
to
adjust
to
intracranial
and
intravascular
locations
and
helps
mitigate
trauma
associated
with
existing
techniques.
The
spirally-­‐rolled
microchannels

6.
Company
X:
Product
X
Pump
for
CED
6
Market
Analysis
Proposal
-­‐
Confidential
enable
in
vivo
calibration
of
the
biosensors
with
the
added
advantage
of
allowing
convection-­‐
enhanced
and
targeted
drug
delivery.
PRODUCT
X
Pump
The
PRODUCT
X
Pump
was
developed
by
Company
X
in
2008
as
a
new
alternative
for
intra-­‐organ
CED
of
active
agents,
specifically
in-­‐brain
drug
delivery
for
patients
with
Glioblastoma.
The
goal
of
the
PRODUCT
X
Pump
is
to
demonstrate
feasibility
and
therapeutic
interest
of
a
microfluidic
injection
module
for
low
flow
and
low
pressure
delivery
of
an
active
agent
in
the
cerebral
tissue
through
an
intraparenchymal
catheter.
Initial
evaluation
of
therapeutic
performance
was
on
an
experimental
pathological
animal
model
(swine
with
Glioblastoma).
Company
X
has
partnered
with
CEA-­‐Leti,
INSERM,
Vetagro
Sup,
and
Tronics
for
the
animal
studies.
The
PRODUCT
X
Pump
implements
a
micropump-­‐based
fluidic
module
(MEMS)
technology,
a
chip
made
from
2
bonded
silicon
wafers,
assembled
with
piezo-­‐electric
ceramic
for
actuation.
The
pump
itself
is
slim
(3x1
cm2),
ultra
light
(0.5g),
flexible
(up
to
100µl/min,
resolution
200
nl),
has
a
viscosity
compatibility
up
to
10
cps,
and
a
flow
rate
stable
on
a
wide
range
of
inlet
and
outlet
pressure
(up
to
+/-­‐
250mbar).
It
is
biocompatible
-­‐
the
drug
is
in
contact
with
silicon
oxide
(glass)
and
the
fluidic
interface
is
made
of
biocompatible
polymer
and
UV-­‐cured
glue.
The
intra-­‐organ
delivery
offered
by
the
PRODUCT
X
Pump
is
desirable
over
systemic
delivery
because
of
lower
peripheral
drug
concentration,
leading
to
decreased
systemic
toxicity
and
side
effects.
This
poses
the
potential
for
increased
or
decreased
dosages,
as
needed.
CED
has
the
ability
to
overcome
intratumoral
pressure,
eliminating
backflow
and
tissue
resistance,
resulting
in
higher
intratumoral
and
peritumoral
active
agent
concentrations.
The
continuous
positive
pressure
infusion
allows
treatment
of
larger
tumor
volume.
On
site
back-­‐pressure
measurement
is
thought
to
enable
on
site
localization
of
catheter
tip,
possibility
to
have
real-­‐time
follow-­‐up
of
infusion,
and
the
capability
to
detect
infusion
issues
and/or
overpressure
inside
the
tumor.
Local
CED
is
an
important
development
in
treating
primary
or
metastatic
brain
tumors
because
the
blood/brain
barrier
cannot
be
overcome
by
most
molecules
delivered
systemically.
There
is
currently
no
successful
treatment.
Higher
local
concentrations
of
active
principles
can
induce
stronger
therapeutic
effects
(i.e.
tumor
stabilization
or
regression);
local
delivery
means
lower
peripheral
concentration/less
detrimental
side
effects
as
compared
to
systemic
delivery.
Glioblastoma
is
the
current
target
for
PRODUCT
X
Pump
utilization.
This
type
of
tumor
has
a
nearly
100%
fatal
prognosis.
The
average
life
expectancy
after
diagnosis
is
less
than
1
year
due
to
its
infiltrative
nature
and
high
proliferation/growth/recurrence
rates.
There
is
no
known
curative
treatment
and
it
has
not
been
properly
addressed
by
traditional
treatments
(i.e.
surgery,
radiotherapy,
chemotherapy).
While
Glioblastoma
is
the
main
focus
for
the
PRODUCT
X
Pump,
there
are
many
extensions
of
local/systemic
CED
in
other
therapeutic
areas
that
are
worth
exploring
(See
Appendix).
One
important
emerging
targeted
therapy
is
Roche’s
monoclonal
antibody,
Avastin,
which
was
recently
withdrawn
by
the
FDA
due
to
toxic
side
effects.
The
PRODUCT
X
Pump
offers
hope
to
therapies
such
as
Avastin,
as
it
offers
a
new
delivery
method
that
may
allow
patients
exposure
to
the
full
concentration
of
the
active
agent
while
minimizing
exposure
to
the
toxic
side
effects.

7.
Company
X:
Product
X
Pump
for
CED
7
Market
Analysis
Proposal
-­‐
Confidential
PROJECT
SCOPE
It
is
our
understanding
that
Company
X
would
like
an
independent
review
of
market
entry
and
expansion
options
for
its
intra-­‐organ
convection-­‐enhanced
delivery
(CED)
of
active
agents,
intended
for
in-­‐brain
delivery
for
the
treatment
of
Glioblastoma.
Harrison
Hayes
will
provide
an
in-­‐depth
market
analysis
into
this
area
including
identification
and
assessment
of
market
entry,
impact
and
expansion,
barriers
and
inhibitors
into
market
entry,
acceptance,
and
penetration;
market
transition;
adoption
drivers
and
inhibitors,
and
potential
for
adoption;
life
cycle
management;
competitive
intelligence
and
reaction;
economic
impact;
reimbursement
issues
including
pricing
elasticity
and
reaction;
and
make
specific
recommendations
as
to
mechanisms
to
improve
Company
X’s
value
generation
from
this
product.
METHODOLOGY
Primary
Research
Harrison
Hayes
proposes
to
begin
the
project
by
meeting
with
the
Company
X
project
team
to
conduct
due
diligence
and
review
currently
available
research.
The
purpose
of
this
meeting
is
to
verify
the
scope
of
the
assignment,
answer
questions,
and
review
the
timeline.
Harrison
Hayes
actively
engages
our
clients
in
collaborative,
interactive
dialogue
throughout
the
project.
We
suggest
weekly
meetings
to
review
and
assess
the
direction
and
progress
of
the
project.
Primary
research
for
this
project
will
be
divided
into
two
(2)
modules.
Module
I
will
be
comprised
of
a
panel
of
Key
Innovation
Leaders
(KILs)
and
Module
II
will
consist
of
a
Voice
of
the
Customer
(VOC)
survey.
These
two
primary,
qualitative
Research
Modules
will
serve
as
the
foundation
of
the
project
as
a
whole
and
best
allow
Harrison
Hayes
to
fulfill
the
project’s
objectives.
METHODOLOGY
Module
I
Research
Module
I
will
begin
by
identifying
and
recruiting
a
customized
panel
of
Key
Innovation
Leaders
(KILs)
(Table
1)
and
developing
a
project
specific
study
guide/questionnaire.
The
Key
Innovation
Leader
(KIL)
questionnaire
will
be
developed
through
a
collaborative
effort
with
Company
X
in
order
to
ensure
that
the
focus
of
this
project
is
being
addressed.
The
questionnaire
is
to
be
used
as
a
platform
for
exploration
and
discussion.
All
interviews
will
be
conducted
directly
by
Harrison
Hayes’
Principals
and
Research
Team
who
have
the
autonomy
to
probe
deeper
and
maneuver
through
unique
issues
that
arise
during
discussion
with
the
KILs
–
what
we
refer
to
as
improvisational
interviewing.
Our
Research
Team
is
able
to
select
the
most
appropriate
questions
to
ask
each
KIL
due
to
our
extensive
knowledge
and
involvement
with
the
project’s
goals.
These
interviews
are
conducted
individually,
which
allows
us
to
focus
directly
on
the
expertise
that
each
KIL
possesses.
Improvisational
interviewing
yields
valuable
qualitative
interview
data
unlike
structured
interview
surveys.
Instead
of
merely
moving
from
question
to
question,
our
Research
Team
is

8.
Company
X:
Product
X
Pump
for
CED
8
Market
Analysis
Proposal
-­‐
Confidential
able
to
adapt
based
on
KILs’
response
to
questions,
thus
obtaining
additional
insight.
To
complement
our
Primary
Qualitative
KIL
research
we
will
concurrently
perform
secondary
research
from
syndicated,
internal,
and
public
sources.
We
believe
secondary
research
will
provide
us
with
useful
data
regarding
the
identification
and
assessment
of
barriers
to
market
entry
and
expansion
including
competitive
reaction,
risks
of
cannibalization,
and
reimbursement
issues.
We
will
also
look
to
uncover
social
(e.g.,
regulatory
policy
changes)
and
economic
trends.
Our
Secondary
Research
Methodology
and
its
role
in
the
project’s
outcome
are
discussed
in
further
detail
below.
Harrison
Hayes
believes
that
through
the
effective
marrying
of
primary
KIL
insight
and
secondary
research
–
along
with
our
partnership
with
the
Company
X
project
team
–
we
can
obtain
uncommon
insight
into
the
potential
for
tactical
market
entry
and
expansion
within
the
CED
space.
Examples
of
Key
Innovation
Leaders
(KILs)
• Health
Care
Providers
(e.g.
Oncologists,
Internists,
etc.)
• Public
Health
and
Forecasting
Experts
• Public
Health
Law
and
Policy
Experts
• Regulatory
Experts
• Managed
Care
Experts
• Medical
Reimbursement
Experts
• Medical
Insurance
Experts
• Academic
Researchers
and
Experts
in
Personalized
Medicine
and
Healthcare
• Academic
Researchers
and
Experts
in
Oncology
Examples
of
Potential
Questions
for
Selected
Key
Innovation
Leaders
(KILs)
1.) What
applications
or
disease
states
would
benefit
most
to
utilize
a
Product
X
pump?
2.) What
are
the
advantages
to
the
CED
system?
3.) Will
intracranial
infusion
become
the
treatment
of
choice
for
intracranial
tumors?
4.) Will
Nanotechnology
allow
for
the
segregation
of
tumors
from
systemic
circulation
to
reduce
exposure
of
chemotherapy
and
thus,
side
effects?
5.) How
safe
is
the
product?
6.) What
are
the
possible
side
effects?
7.) How
will
infections
be
prevented
from
the
indwelling
catheter?

9.
Company
X:
Product
X
Pump
for
CED
9
Market
Analysis
Proposal
-­‐
Confidential
8.) Will
using
host
specific
stem
cells
translate
to
treating
cancer
in
the
host?
9.) How
do
you
monitor
therapeutic
effect
and
measure
“real-­‐time”
therapy?
10.) What
will
be
the
effects
of
CED
placement
regarding
pain,
length
of
stay?
11.) Will
CED
treatment
be
inpatient
or
outpatient?
12.) How
would
you
prove
a
lower
drug
concentration
is
possible?
13.) Would
a
lower
drug
concentration
decrease
systemic
toxicity?
14.) What
is
the
predicted
success
rate?
15.) How
do
you
monitor
regression
of
tumor
or
remission?
16.) Can
this
be
game
changing
for
all
future
treatments
of
tumors?
17.) What
will
be
the
impact
of
selective
gene
therapy
on
CED’s?
18.) How
will
stem
cells
impact
the
treatment
of
cancer?
19.) How
will
stem
cells
impact
other
disorders?
20.) How
do
you
overcome
hurdles
to
high
cost?
21.) What
is
the
price
point
to
make
a
profit?
22.) How
do
you
get
“buy-­‐in”
from
surgeons?
23.) How
will
Oncologists
feel
about
this
type
of
treatment?
24.) What
types
of
Vendors
do
you
use?
25.) What
are
the
targeted
countries
to
launch
the
product?
26.) What
does
the
clinical
data
show
in
humans?
27.) What
are
the
regulatory
issues
with
nanoscaffolds?
28.) Will
the
FDA
approve
a
Fast
Track
application
for
Glioblastoma
due
to
the
severe
outcome
and
limited
effective
treatment
options?

10.
Company
X:
Product
X
Pump
for
CED
10
Market
Analysis
Proposal
-­‐
Confidential
Table
1:
Examples
of
Key
Innovation
Leaders
Person's
Name
Title/Expertise
Amy
Achter
Director
Corporate
Innovation,
Kimberly
Clark.
Andrea
S.
Hunt
Vice
President
of
Innovation
and
Strategic
Initiatives,
Baxter.
Andreas
A.
Linninger
Professor
at
University
of
Illinois
at
Chicago;
Department
of
Bioengineering
and
Chemical
Engineering.
Author
of
"Prediction
of
convection-­‐enhanced
drug
delivery
to
the
human
brain."
Andrew
N.
Pollak,
MD
Chief
of
Orthopaedic
Traumatology
and
Associate
Director
of
Trauma
at
the
R
Adams
Cowley
Shock
Trauma
Center,
University
of
Maryland
Medical
Center
Antonio
Fioravanti,
PhD
Department
of
Neurosurgery,
Bellaria-­‐Maggiore
Hospital,
Azienda
USL
of
Bologna,
Italy
and
author
of
"Treatment
Options
for
Recurrent
Glioblastoma:
Pitfalls
and
Future
Trends."
Ariel
Gilert,
PhD
Faculty
of
Biotechnology
and
Food
Engineering,
Technion
Israel
Institute
of
Technology,
Haifa,
Israel.
Author
of
"Nano
to
micro
delivery
systems:
targeting
angiogenesis
in
brain
tumors."
Arun
Bhatia
Sr.
Manager,
Marketing
and
Corporate
R&D
Innovation
at
Baxter
Healthcare.
Bakhtiar
Yamini,
MD
Dr.
Bakhtiar
Yamini
specializes
in
neuro-­‐oncology,
and
he
is
an
expert
in
minimally
invasive
neurosurgery
for
children
and
adults.
This
includes
using
sophisticated
stereotactic
techniques
that
allow
for
three-­‐dimensional
surgical
planning.
Dr.
Yamini
also
has
a
strong
interest
in
vascular
neurosurgery
and
spine
surgery
at
the
University
of
Chicago
Medical
Center.
Becky
Walter
Director
Innovation
Design
and
Testing,
Kimberly
Clark.
Brad
A.
Ward,
MD
Dr.
Ward
is
a
board-­‐certified
neurosurgeon
who
has
extensive
experience
in
the
treatment
of
disorders
of
the
brain,
spine
and
peripheral
nerves.
He
is
in
private
practice
at
The
Center
for
Orthopedic
and
Neurosurgical
Care
and
Research
in
Bend,
Oregon.
Currently
serving
as
this
organization's
president.
Catherine
G.
Hawthorne,
MD
President
of
Orthopaedic
Rehabilitation
Association.
Catherine
Jacobson
(Rush
University
Medical
Center,
Chicago,
Ill.).
Ms.
Jacobson
is
CFO
and
treasurer
at
Rush
University
Medical
Center
in
Chicago.
Ms.
Jacobson,
whose
career
at
Rush
began
in
1996,
previously
served
as
vice
president
for
program
evaluation,
assistant
to
the
president
and
chief
compliance
officer
for
Rush
before
being
named
acting
CFO
in
2002.
Charles-­‐Marc
Samama,
MD,
PhD
Professor
and
Chairman
in
the
Department
of
Anaesthesiology
and
Intensive
Care
of
the
Hotel-­‐Dieu
University
Hospital
in
Paris,
France.
He
is
board
certified
to
practice
anaesthesiology
and
intensive
care
medicine.
Ching-­‐iao
Tsai,
MD
Professor,
Neurological
Institute,
Taipei
Veterans
General
Hospital
and
National
Yang-­‐Ming
University,
Taiwan.
Delegate
of
The
World
Federation
of
Neurology.
Christopher
T.
Born,
MD
Chief
of
Orthopedic
Trauma
at
Rhode
Island
Hospital
within
the
Department
of
Orthopaedic
Surgery
of
Brown
University.
Claude
Ecoffey,
MD
Department
of
Anesthesiology
and
Surgical
Intensive
Care,
Bicetre
Hospital,
Le
Kremlin
Bicetre,
France.

11.
Company
X:
Product
X
Pump
for
CED
11
Market
Analysis
Proposal
-­‐
Confidential
Person's
Name
Title/Expertise
Claudette
Yasell
President
of
the
American
Brain
Tumor
Association.
A
certified
medical
editor
and
writer
and
active
member
of
the
American
Medical
Writer’s
Association,
Yasell’s
professional
career
reflects
her
passion
for
communication
and
medicine.
Colleen
Blye
(Catholic
Health
Initiatives,
Denver).
Ms.
Blye
was
named
senior
vice
president
of
finance
and
treasury
and
CFO
in
January
for
78-­‐hospital
CHI.
Ms.
Blye
joined
CHI
in
1989
and
previously
served
as
vice
president
of
financial
services.
Before
that
she
was
CFO
for
St.
Joseph
Medical
Center
in
Reading,
Pa.
Her
first
job
in
healthcare
finance
was
as
an
auditor
with
Ernst
&
Young
in
Philadelphia.
D.
David
Glass,
MD
Chair,
Foundation
for
Anesthesia
Education
and
Research.
Darell
D.
Bigner,
MD,
PhD
He
is
the
Edwin
L.
Jones,
Jr.
and
Lucille
Finch
Jones
Cancer
Research
Professor,
Director
of
the
Preston
Robert
Tisch
Brain
Tumor
Center
at
Duke,
and
Director
of
the
Pediatric
Brain
Tumor
Foundation
Institute
at
Duke.
Dr.
Bigner
is
also
Co-­‐Program
Leader
of
the
Duke
Comprehensive
Cancer
Center’s
Neuro-­‐Oncology
Program,
Vice-­‐
Chairman
of
Investigative
Pathology,
Director
of
the
Preuss
Laboratory
for
Brain
Tumor
Research,
Editor-­‐in-­‐Chief
of
the
Journal
of
Neuro-­‐Oncology,
and
Chairman
of
the
Scientific
Review
Board
of
the
National
Cancer
Center,
the
Brain
Tumor
Society,
and
the
Pediatric
Brain
Tumor
Foundation.
David
A.
Reardona,
MD
Preston
Robert
Tisch
Brain
Tumor
Center,
Duke
University
Medical
Center,
and
author
of
"Therapeutic
Advances
in
the
Treatment
of
Glioblastoma:
Rationale
and
Potential
Role
of
Targeted
Agents."
David
N.
Louis,
MD
Pathologist-­‐in-­‐Chief-­‐Massachusetts
General
Hospital.
Dr.
Louis'
own
pathology
practice
and
research
focuses
on
brain
tumors,
with
an
emphasis
on
the
application
of
molecular
diagnostics
to
glioma
classification.
He
has
contributed
over
300
original
articles,
reviews
and
chapters
to
the
literature.
His
laboratory
was
the
first
to
demonstrate
that
molecular
approaches
could
subdivide
malignant
gliomas
biologically
and
that
molecular
approaches
could
predict
the
response
of
malignant
gliomas
to
therapies.
Dawn
Houghton
Senior
Director
Corporate
Innovation
at
Kimberly-­‐Clark.
Dean
G.
Sotereanos,
MD
Co-­‐Director,
Hand
and
Upper
Extremity
Surgery
Fellowship;
Vice
Chairman,
Orthopaedic
Network
Development;
Professor
of
Orthopaedic
Surgery.
Member
of
more
than
a
dozen
professional
and
scientific
societies
and
has
served
on
many
of
their
national
committees
for
educational
and
research
activities.
He
is
internationally
renowned
as
an
upper
extremity
surgeon
and
currently
focuses
on
the
hand,
elbow
and
shoulder.
Donald
D.
Trunkey,
MD
Professor
of
Surgery,
Section
of
Trauma/Critical
Care,
Oregon
Health
&
Science
University
and
Chair
of
The
American
Association
for
the
Surgery
of
Trauma.
Doug
Dietz
Industrial
designer
/
Global
Design
at
GE
Healthcare.
Douglas
W.
Laske,
MD
Douglas
W.
Laske,
MD
works
at
Fox
Chase
Cancer
Center
as
a
member
of
the
Fox
Chase
Temple:
Neuro-­‐Oncology
Program.
Author
of
"Convection-­‐enhanced
delivery
of
macromolecules
in
the
brain"
article.
He
is
one
of
the
inventors
of
and
has
a
patent
on
Convection-­‐enhanced
drug
delivery.

12.
Company
X:
Product
X
Pump
for
CED
12
Market
Analysis
Proposal
-­‐
Confidential
Person's
Name
Title/Expertise
Ángel
Rubio,
MD
Full
Professor
of
Condensed
Matter
Physics,
Nano
Bio
Spectroscopy
Group,
Dpt.
F´ısica
de
Materiales,
Facultad
de
Qu´ımicas
and
Centro
F´ısica
de
Materiales
CSIC-­‐UPV/EHU,
leading
expert
in
the
treatment
of
Glioblastoma
Multiforme.
Gregory
I.
Bain,
MD,
PhD
He
exclusively
practices
upper
limb
surgery.
He
is
a
member
of
the
Australian
Hand
Surgery
Society,
the
Australian
Shoulder
and
Elbow
Society
and
the
Australian
Sports
Medicine
Federation
as
well
as
a
number
of
International
Associations.
E.
.I
Gusev,
MD
Resident
of
the
Russian
Society
of
Neurologists,
Department
of
Neurology,
Russian
State
Medical
University,
Moscow,
Russia.
E.
Antonio
Chiocca,
MD,
PhD
Professor
of
Neurosurgery,
Chairman,
Department
of
Neurosurgery,
Dardinger
Family
Endowed
Chair
in
Oncological
Neurosurgery,
James
Cancer
Center
&
Solove
Research
Institute,
Ohio
State
University
Medical
Center.
Edward
H.
Oldfield,
MD
He
joined
the
Department
of
Neurosurgery
at
the
University
of
Virginia
in
2007
where
he
leads
a
multidisciplinary
effort
in
the
treatment
of
pituitary
tumors
and
contributes
to
the
research
program
in
the
Department
of
Neurosurgery.
He
holds
the
Crutchfield
Chair
in
Neurosurgery
and
is
a
Professor
of
Neurosurgery
and
Internal
Medicine.
Enrico
Franceschi
Department
of
Medical
Oncology,
Bellaria-­‐Maggiore
Hospital,
Azienda
USL
of
Bologna,
Italy
and
author
of
"Treatment
Options
for
Recurrent
Glioblastoma:
Pitfalls
and
Future
Trends."
Eric
C.
Holland,
MD,
PhD
Vice
Chair,
Translational
Research,
Department
of
Neurosurgery
Director,
Brain
Tumor
Center,
Emily
Tow
Jackson
Chair
in
Oncology,
Memorial
Sloan
Kettering
Cancer
Center.
Erik
Kemper
Interaction
&
User
Centered
Designer
/
Global
Design,
GE
Healthcare.
Ernest
B
Marsolais,
MD
Fellow
of
the
American
Academy
of
Orthopaedic
Surgeons.
Computerworld
Smithsonian
Science
Award
in
Medicine
presented
June
6,
1994,
Washington,
D.C.
Erwin
Van
Meir,
PhD
Professor
of
Neurosurgery,
Hematology
and
Medical
Oncology,
Emory
University
Winship
Cancer
Institute.
Fred
H.
Hochberg,
MD
Associate
Professor,
Department
of
Neurology,
Massachusetts
General
Hospital.
G.
Yancey
Gillespie,
PhD
Professor
of
Surgery,
Microbiology,
Cell
Biology,
University
of
Alabama
at
Birmingham.
Giorgio
Ivani,
MD
Chairman,
Division
Pediatric
Anesthesiology
and
Intensive
Care,
Regina
Margherita
Children's
Hospital,
Italy.
Past
President
of
The
European
Society
of
Regional
Anesthesia
and
Pain
Therapy.
Helmut
Trimmel,
MD
Director,
Department
for
Anesthesiology,
Emergency
Medicine
and
Intensive
Care
General
Hospital
of
Wiener
Neustadt,
Austria.
Henry
S.
Friedman,
MD
Deputy
Director,
The
Preston
Robert
Tisch
Brain
Tumor
Center
at
Duke.
Henry
S.
Friedman,
MD,
is
an
internationally
recognized
neuro-­‐oncologist
with
a
career-­‐long
interest
in
the
treatment
of
children
and
adults
with
brain
and
spinal
cord
tumors.
He
has
written
hundreds
of
articles
on
both
the
clinical
and
laboratory
investigation
of
these
neoplasms.

13.
Company
X:
Product
X
Pump
for
CED
13
Market
Analysis
Proposal
-­‐
Confidential
Person's
Name
Title/Expertise
Hideo
Yamamura
M.D.,
Ph.D.,
F.R,C.A.,
F.I.C.A.E.
Prof.
Emeritus,
School
of
Medicine,
Tokyo
University;
Former
President,
All
Japanese
Acupuncture
Associations;
Former
Dean,
School
of
Medicine,
Tokyo
University;
Former
Chairman,
Dept.
of
Anesthesiology,
School
of
Medicine,
Tokyo
University,
Japan.
Hiroshi
Ueda,
PhD
Professor,
Division
of
Molecular
Pharmacology
and
Neuroscience
Nagasaki
University
Graduate
School
of
Biomedical
Sciences,
Nagasaki,
Japan.
Howard
Fine,
MD
Chief
of
the
neuro-­‐oncology
branch
at
the
NCI’s
Center
for
Cancer
Research.
He
has
treated
Glioblastoma
for
22
years.
Hugo
van
Aken,
MD
Chairperson
of
the
National
Anaesthesiology
Societies
Committee,
professor
and
chairman
of
the
Department
of
Anaesthesiology
and
Intensive
Care
Medicine,
University
Hospital
Westfälische
Wilhelms-­‐Universität
Münster/Germany.
Editor-­‐in-­‐
Chief
for
Current
Opinion
in
Anaesthesiology
and
Editor
for
Baillière's
Best
Practice
in
Research
and
Anaesthesiology.
Issam
A.
Awad,
MD
Isaam
has
expertise
in
neurosurgery.
He
is
skilled
in
the
surgical
management
of
neurovascular
conditions
affecting
the
brain
and
spinal
cord,
including
cerebral
aneurysms,
cerebrovascular
malformations,
and
hemorrhagic
stroke
and
skull
base
tumors
at
the
University
of
Chicago
Medical
Center.
J.
Tracy
Watson,
MD
Professor,
Orthopaedic
Traumatology,
Fellowship
Director
and
Chief
of
the
Orthopaedic
Traumatology
Division
James
Ausman,
MD,
PhD
Expert
in
cerebrovascular
diseases,
complex
neurosurgical
problems
and
microsurgery.
Physician
of
Neurological
surgery
at
Ronald
Regan
UCLA
Medical
Center.
James
B.
Powell
Jr.,
MD
Professor
of
Neuro-­‐Oncology
at
Duke
University.
James
P.
Stannard,
MD
Chair
of
the
Department
of
Orthopaedic
Surgery,
J.
Vernon
Luck
Sr.
Distinguished
Professor
in
Orthopaedic
Surgery
at
University
of
Missouri
Health
System.
Jan
C.
Buckner,
MD
Professor
of
Oncology,
Chair,
Division
of
Medical
Oncology,
Mayo
Clinic,
author
of
"Evolving
Therapeutic
Concepts
in
Glioblastoma:
Augmenting
Chemoradiation."
Jasti
Sambasiva
Rao,
PhD
Head,
Department
of
Cancer
Biology
&
Pharmacology
at
University
of
Illinois
College
of
Medicine
at
Peoria
(UICOM-­‐P).
Jeffrey
N.
Bruce,
MD,
FACS
Director,
Bartoli
Brain
Tumor
Research
Laboratory,
Co-­‐Director,
Brain
Tumor
Center
Columbia
University
College
of
Physicians
and
Surgeons.
José
De
Andrés,
MD,
PhD
Associate
Professor
of
Anesthesia,
Valencia
University
Medical
School;
Chairman,
Department
of
Anesthesiology
and
Critical
Care;
Director
of
the
Multidisciplinary
Pain
Management
Center.
K.
Y.
Mok,
MD
Treasurer
of
The
Hong
Kong
Neurological
Society,
Department
of
Medicine-­‐
Ruttonjee
Hospital,
Hong
Kong.
Kathleen
Lamborn,
MD
Adjunct
Professor
Emeritus
of
Neurological
Surgery.
Principal
Investigator,
Brain
Tumor
Research
Center.
Dr.
Lamborn,
a
biostatistician,
works
with
Brain
Tumor
Research
Center
(BTRC)
investigators
and
trainees
in
the
design
and
analysis
of
BTRC
research
studies.
Katie
Szyman
Senior
Vice
President-­‐Strategy
and
Innovation,
Medtronic.
Kenneth
D.
Aldape,
MD
Professor
of
Pathology,
Division
of
Pathology
and
Laboratory
Medicine
at
UTMD
Anderson
Cancer
Center.

14.
Company
X:
Product
X
Pump
for
CED
14
Market
Analysis
Proposal
-­‐
Confidential
Person's
Name
Title/Expertise
Kevin
Brennan
(Geisinger
Health
System,
Danville,
Pa.).
Mr.
Brennan
is
executive
Vice
President
and
CFO
at
Geisinger
and
is
treasurer
of
the
Geisinger
Foundation.
Mr.
Brennan
previously
served
as
CFO
of
the
Penn
State
Geisinger
Health
System
and,
before
joining
Geisinger,
as
regional
vice
president
of
finance
and
vice
president
of
managed
care
with
the
Franciscan
Health
System
with
responsibilities
covering
eight
hospitals
and
affiliates
in
its
Mid-­‐Atlantic
Region.
Kim
(Guenther)
Menard
Senior
Medical
Communications
Officer
at
the
University
of
Pennsylvania
School
of
Medicine.
Kim
joined
Penn
Medicine
following
nearly
four
years
in
the
healthcare
practice
of
a
leading
public
relations
agency
in
Chicago,
where
she
specialized
in
a
range
of
therapeutic
areas,
including
oncology,
hematology,
neurology,
infectious
diseases
and
pediatric
obesity.
She
has
broad
experience
in
media
and
advocacy
relations
and
led
medical
communications
surrounding
numerous
data
publications,
medical
meeting
presentations,
and
regulatory
announcements.
Krystof
Bankiewicz,
MD,
PhD
Currently
professor
in
the
Neurosurgery
and
Neurology
Departments
at
UCSF
(San
Francisco,
CA).
Throughout
his
career,
he
has
maintained
a
strong
focus
on
the
development
of
practical
approaches
to
gene
and
cell
replacement
therapies,
and
has
displayed
a
remarkable
ability
to
synthesize
several
individual
technologies
into
powerful
new
approaches
to
the
treatment
of
such
serious
disease
as
brain
cancer
and
neurodegenerative
disorders
of
the
brain,
including
Parkinson's
disease.
Linda
M.
Liau,
MD,
PhD
Researcher
at
Jonsson
Comprehensive
Cancer
Center
at
UCLA.
Maciej
S.
Lesniak,
MD,
MHCM
Dr.
Maciej
Lesniak
is
one
of
the
nation’s
leading
experts
in
neuro-­‐oncology.
Dr.
Lesniak
is
the
director
of
neurosurgical
oncology
and
neuro-­‐oncology
research
in
the
University
of
Chicago
Brain
Tumor
Center.
He
is
the
professor
of
Surgery
and
Director
of
Neuro-­‐oncology
Research
at
the
University
of
Chicago
Medical
Center.
Mahadevabharath
R
Somayaji,
PhD
Dr.
Mahadevabharath
R.
Somayaji
received
his
PhD
degree
in
Chemical
Engineering
in
2008
from
University
of
Illinois
at
Chicago.
The
focus
of
his
doctoral
research
was
in
the
development
of
a
novel
computational
platform
for
predicting
drug
distribution
in
the
human
brain
and
optimal
design
of
personalized
brain
drug
delivery.
Author
of
"Prediction
of
convection-­‐enhanced
drug
delivery
to
the
human
brain."
Marc
Van
de
Velde,
MD,
PhD
President
of
The
European
Society
of
Regional
Anaesthesia
and
Pain
Therapy,
Department
of
Anesthesiology,
UZ
Leuven,
Belgium.
Marcelle
Machluf,
PhD
Faculty
of
Biotechnology
and
Food
Engineering,
Technion
Israel
Institute
of
Technology,
Haifa,
Israel.
Author
of
"Nano
to
micro
delivery
systems:
targeting
angiogenesis
in
brain
tumors."
Martin
Tramèr,
PhD
Editor-­‐In-­‐Chief,
European
Journal
of
Anaesthesiology.
Maurizio
Solca,
MD
Anaesthesia
and
Intensive
Care
Medicine,
Azienda
Ospedaliera
de
Melegnano,
Presi
Sul
Naviglio,
Ospedale"A.
Ubedlo",
Cernusco
sul
Naviglio,
Italy
and
Council
Member
of
the
European
Society
of
Anaesthesiology.

15.
Company
X:
Product
X
Pump
for
CED
15
Market
Analysis
Proposal
-­‐
Confidential
Person's
Name
Title/Expertise
Michael
Andrew
Rogawski
PhD
Professor
and
chairman
of
the
Department
of
Neurology
at
the
University
of
California,
Davis
School
of
Medicine.
Inventor
of
Apparatus
and
Methods
for
Treating
Epilepsy
Using
Convection-­‐Enhanced
Delivery.
He
is
a
member
of
the
editorial
boards
of
Molecular
Pharmacology,
CNS
Neuroscience
&
Therapeutics,
Current
Neuropharmacology,
BMC
Pharmacology,
and
Cellular
and
Molecular
Neurobiology.
He
is
executive
editor
of
Neuropharmacology;
co-­‐editor
of
Epilepsy
Currents,
the
official
journal
of
the
American
Epilepsy
Society;
and
associate
editor
of
Neurotherapeutics,
the
journal
of
the
Americans.
Michael
Blaszyk
Catholic
Healthcare
West,
San
Francisco.
Mr.
Blaszyk
is
executive
vice
president
and
CFO
for
CHW.
Mr.
Blaszyk,
who
has
30
years
of
healthcare
experience,
provides
financial
oversight
for
more
than
$10.6
billion
in
annual
spending.
Prior
to
joining
the
system,
he
was
senior
vice
president
and
CFO
at
University
Hospitals
Health
System
in
Cleveland
and
before
that
he
served
as
managing
partner
of
the
Northeast
Region
Health
Care
Provider
Consulting
Practice
for
William
Mercer
and
as
executive
vice
president
of
Boston
Medical
Center.
Michael
D.
Prados,
MD
Director
of
the
Department's
Translational
Research
Program,
Dr.
Prados
has
over
20
years'
experience
at
UCSF
in
treating
and
supervising
the
treatment
of
both
adults
and
children
who
have
brain
tumors.
The
National
Cancer
Institute's
North
American
Brain
Tumor
Consortium,
which
sponsors
trials
of
treatment
regimens
for
brain
tumors,
is
based
at
UCSF
under
Dr.
Prados'
leadership,
and
he
is
principal
investigator
of
the
Pediatric
Brain
Tumor
Consortium
site
at
UCSF.
Michael
Hüpfl,
MD
Chief
Physician,
St.
John
Ambulance
Service
Vienna,
Medical
University
of
Vienna,
Department
of
Anaesthesiology
Intensive
Care
and
Pain
Medicine
Austria.
Michael
L.J.
Apuzzo,
MD
Michael
L.J.
Apuzzo
is
the
Jr.
Professor
of
Neurological
Surgery
and
Radiation
Oncology,
Biology,
and
Physics
at
the
Keck
School
of
Medicine
of
USC.
He
is
director
of
neurosurgery
at
the
USC
Kenneth
Norris,
Jr.
Cancer
Hospital
and
is
director
of
the
Center
for
Stereotactic
Neurosurgery
and
Associated
Research
there.
Apuzzo
established
one
of
the
world's
first
central
nervous
system
tumor
immunology
laboratories
and
simultaneously
developed
programs
for
the
study
of
refinements
of
microsurgical
techniques
of
intra-­‐
and
trans
cerebral
surgeries
for
the
management
of
intracranial
neoplasms.
Michael
Weller,
MD
Department
of
Neurology-­‐University
Hospital
Zurich.
Development
of
novel
approaches
of
immunotherapy
for
malignant
brain
tumors;
Definition
of
resistance
mechanisms
of
cancer
stem
cells
to
irradiation
and
chemotherapy;
Initiation
and
conduct
of
clinical
trials
in
Neuro-­‐Oncology
Mitchel
S.
Berger
MD
Professor
and
Chairman,
Department
of
Neurological
Surgery;
Director,
Brain
Tumor
Surgery
Program;
Director,
Neurosurgical
Research
Centers,
Brain
Tumor
Research
Center.
Dr.
Berger's
main
clinical
interests
are
the
treatment
of
brain
and
spinal
cord
tumors
in
adults
and
children
and
of
epilepsy
related
to
brain
tumors.
Dr.
Berger
is
Director
of
the
Adult
Hydrocephalus
and
Shunt
Program,
and
he
also
practices
in
the
Neuro-­‐Oncology
Program
and
the
Radiosurgery
Program.

16.
Company
X:
Product
X
Pump
for
CED
16
Market
Analysis
Proposal
-­‐
Confidential
Person's
Name
Title/Expertise
Nicholas
Peppas,
PhD
Director
of
Departments
of
Chemical
Engineering
and
Biomedical
Engineering,
and
Division
of
Pharmaceutics
at
University
of
Texas
at
Austin.
Nicholas
Peppas
was
the
recipient
of
the
2010
Acta
Biomaterialia
Gold
Medal
Award,
one
of
the
most
prestigious
awards
in
biomaterials
science
recognizing
“excellence
in
research
and
development”.
He
was
elected
President
of
the
Biomedical
Engineering
Council
of
Chairs.
Nicolás
Samprón,
MD
Specialist
in
Neurosurgery
at
The
Hospital
Universitario
Donostia
and
has
incorporated
a
new
Glioblastoma
multiforme
treatment
protocol.
Paolo
Pelosi,
MD,
PhD
Associate
Professor
in
Anesthesia
and
Intensive
Care,
Universita'
dell'Insubria
Varese
Italy
-­‐
Visiting
Professor
at
University
of
Aachen
and
President
of
the
European
Society
of
Anaesthesiology.
Patrick
Y.
Wen,
MD
Center
for
Neuro-­‐Oncology,
Dana
Farber/Brigham
and
Women’s
Cancer
Center,
Boston
and
author
of
"Therapeutic
Advances
in
the
Treatment
of
Glioblastoma:
Rationale
and
Potential
Role
of
Targeted
Agents"
Paul
Borron
Business
Development
-­‐
Biochemist
&
Immunologist
at
RTI
Health
Solutions.
Grant
Reviewer
at
National
Institutes
of
Health.
Paul
R.
Knight
III,
M.D.,
Ph.D.
Chair,
American
Society
of
Anesthesiologist
Committee
on
Research.
Peter
C.
Burger,
MD
Professor
of
Pathology;
Professor
of
Neurological
Surgery;
Professor
of
Oncology;
Pathology
Department
at
John
Hopkins
Hospital.
Peter
M.
Black,
M.D.,
Ph.D.
Dr.
Peter
Black
has
been
Neurosurgeon-­‐in-­‐Chief
at
both
the
Brigham
and
Women's
Hospital
and
the
Children's
Hospital
since
1987.
He
is
also
the
Franc
D.
Ingraham
Professor
of
Neurosurgery
at
Harvard
Medical
School.
Phyllis
Lantos
(New
York-­‐Presbyterian
Hospital,
New
York
City,
N.Y.).
Ms.
Lantos
is
executive
vice
president,
treasurer
and
CFO
at
New
York-­‐Presbyterian
Hospital.
Ms.
Lantos
joined
the
system
in
2000
as
senior
vice
president
and
CFO
and
was
named
executive
vice
president
in
2007.
She
previously
served
as
deputy
chief
operating
officer
at
Yale
University
School
of
Medicine
and
as
vice
president
of
financial
management
services
at
Montefiore
Medical
Center.
Ms.
Lantos
earned
both
her
undergraduate
and
master’s
degrees
from
the
Massachusetts
Institute
of
Technology.
Mahmoud
Hafez,
MD
Dr.
Mahmoud
Hafez
the
head
of
the
Orthopaedic
Unit
at
October
6
University,
Egypt.
He
has
a
track
record
in
research
with
more
than
35
international
publications
including
11
book
chapters.
Raymond
Sawaya,
MD
Dr.
Raymond
Sawaya
has
been
the
Chairman
of
the
Department
of
Neurosurgery
at
the
University
of
Texas
M.
D.
Anderson
Cancer
Center
in
Houston
since
the
department
was
established
in
1990.
He
also
serves
as
the
Director
of
the
Brain
Tumor
Center
at
M.
D.
Anderson
and
since
2005
has
served
as
Professor
and
Chairman,
Department
of
Neurosurgery,
at
Baylor
College
of
Medicine.
Dr.
Sawaya
is
the
recipient
of
numerous
awards,
including
the
Anne
C.
Brooks
&
Anthony
D.
Bullock,
III,
Distinguished
Chair
in
Neurosurgery.
Raymond
Tak-­‐Fai
Cheung,
MD
Delegate
of
the
World
Federation
of
Neurology,
University
Department
of
Medicine,
Queen
Mary
Hospital,
Hong
Kong.

17.
Company
X:
Product
X
Pump
for
CED
17
Market
Analysis
Proposal
-­‐
Confidential
Person's
Name
Title/Expertise
Ricardo
Díez
Valle,
PhD
Department
of
Neurosurgery,
The
Department
of
Neurosurgery
at
Clínica
Universidad
de
Navarra.
The
use
of
a
fluorescence
microscope
enabled
one
of
the
most
aggressive
types
of
brain
tumor
to
be
completely
removed
in
83%
of
the
cases,
according
to
the
results
obtained
in
a
series
of
patients
with
Glioblastoma
that
were
treated
by
the
Clínica’s
neurosurgeons,
the
conclusions
of
which
have
been
published
in
the
Journal
of
Neuro-­‐Oncology.
Richard
Kdolsky,
MD
Associate
Professor
of
the
Department
for
Trauma
Surgery
in
the
Medical
University
of
Vienna,
Austria.
Richard
Rothberger
(Scripps
Health,
San
Diego).
Mr.
Rothberger,
who
has
logged
30
years
of
healthcare
financial
experience,
is
corporate
executive
vice
president
and
CFO
for
Scripps,
a
position
he
assumed
in
2001.
Robert
A.
Probe,
MD
Chair,
Department
of
Orthopedic
Surgery,
Director,
Division
Orthopaedic
Trauma
at
Scott
and
White
Healthcare.
Robert
Sneyd,
MD,
MA,
MB,
Bchi,r
FRCA
Vice-­‐Dean
and
Professor
of
Anaesthesia
at
Peninsula
College
of
Medicine
and
Dentistry
based
in
Plymouth
within
the
UK.
Elected
Consultant
Member
of
The
Royal
College
of
Anaesthetists.
Russell
Lonser,
MD
He
is
Chair
of
the
Surgical
Neurology
Branch
in
NINDS
and
Program
Director
for
the
NINDS
Neurological
Surgery
Residency
Training
Program.
His
laboratory
studies
drug
delivery
for
treatment
of
neurologic
disorders,
as
well
as
investigates
tumor
biology
and
treatment.
Sarah
J.
Nelson,
PhD
Margaret
Hart
Surbeck
Distinguished
Professor,
Department
of
Radiology
and
Biomedical
Imaging,
Co-­‐Chair,
Department
of
Bioengineering
and
Therapeutic
Sciences.
Director,
Center
for
Non-­‐Invasive
Imaging
and
Metabolomics
and
the
Surbeck
Laboratory
of
Advanced
Imaging,
University
of
California,
San
Francisco.
Sergey
A.
Klyushnikov,
MD
Institute
of
Neurology,
Dept.
of
Neurogenetics,
Russian
Academy
of
Medical
Sciences,
Russia.
Sonia
Tejada,
PhD
Department
of
Neurosurgery,
The
Department
of
Neurosurgery
at
Clínica
Universidad
de
Navarra.
The
use
of
a
fluorescence
microscope
enabled
one
of
the
most
aggressive
types
of
brain
tumor
to
be
completely
removed
in
83%
of
the
cases,
according
to
the
results
obtained
in
a
series
of
patients
with
Glioblastoma
that
were
treated
by
the
Clínica’s
neurosurgeons,
the
conclusions
of
which
have
been
published
in
the
Journal
of
Neuro-­‐Oncology.
Stephan
Kapral,
MD
Professor
of
Anesthesiology
and
Intensive
Care
Medicine
Department
of
Anesthesiology
and
General
Intensive
Care,
UKH
Linz,
Austria.
Stephen
Walulik
Sr.
Director
of
Operations,
Biomet
Spine
and
Trauma.
Susann
Brady-­‐Kalnay,
PhD
Associate
professor
of
molecular
biology
and
microbiology
at
Case
Western
Reserve
University.
Terry
Magnuson,
PhD
Sarah
Graham
Kenan
Professor,
Vice
Dean
for
Research,
School
of
Medicine
Chair,
Department
of
Genetics,
University
of
North
Carolina
at
Chapel
Hill.

18.
Company
X:
Product
X
Pump
for
CED
18
Market
Analysis
Proposal
-­‐
Confidential
Person's
Name
Title/Expertise
Theodore
Miclau
III,
MD
He
currently
serves
on
the
Board
of
Directors
for
the
Orthopaedic
Trauma
Association
(OTA),
Orthopaedic
Research
Society,
and
the
American
Academy
of
Orthopaedic
Surgery.
He
is
the
third
vice
president
of
the
Orthopaedic
Research
Society.
He
also
serves
on
the
Board
of
Directors
of
the
Foundation
for
Orthopaedic
Trauma,
where
he
was
a
founding
member,
and
the
San
Francisco
General
Hospital
Foundation.
Timothy
Cloughesy,
MD
Director,
UCLA
Neuro-­‐Oncology
Program;
Clinical
Professor.
Timothy
J.
Bray,
MD
Clinical
Professor
of
Orthopaedic
Surgery
at
UCD
Medical
Center
and
maintains
a
clinical
affiliation
with
the
University
of
Nevada
School
of
Medicine.
President,
Orthopaedic
Trauma
Association.
Victor
A.
Levin,
MD
World-­‐renowned
expert
in
brain
tumor
research
and
treatment.
Dr.
Levin
has
authored
almost
400
publications
in
his
40-­‐year
research
career.
He
developed
and
edited
a
multidisciplinary
textbook
of
neuro-­‐oncology
titled
Cancer
in
the
Nervous
System.
He
is
likely
responsible
for
coining
the
term
"neuro-­‐oncology".
Dr.
Levin
is
the
founder
and
first
president
(1995-­‐97)
of
the
Society
for
Neuro-­‐Oncology.
Vladimir
P.
Torchilin,
PhD
Director,
Center
for
Pharmaceutical
Biotechnology
and
Nano
medicine
at
Northeastern
University,
Boston,
Mass.
Wai-­‐Kwan
Alfred
Yung,
MD
Chairman
and
Professor
of
Neurology,
Margaret
&
Ben
Love
Chair
in
Clinical
Cancer,
Department
of
Neuro-­‐Oncology,
Division
of
Cancer
Medicine,
The
University
of
Texas
MD
Anderson
Cancer
Center,
Houston,
TX.
Warren
M.
Zapol,
MD
Director,
Anesthesia
Center
for
Critical
Care
Research,
Emeritus
Anesthetist-­‐in-­‐Chief,
Massachusetts
General
Hospital.
Webster
K.
Cavenee,
PhD
Professor
of
Medicine,
Cancer
Genes
and
Genome,
Program
Director,
Ludwig
Institute
for
Cancer
Research,
University
of
California,
San
Diego.
Yasuhiko
Tabata,
MD
Department
of
Biomaterials,
Field
of
Tissue
Engineering,
Institute
for
Frontier
Medical
Sciences,
Kyoto
University,
Japan.
Bob
Blendon,
PhD
Professor
of
Health
Policy
and
Political
Analysis
in
both
the
Harvard
University
School
of
Public
Health
and
the
John
F.
Kennedy
School
of
Government.
Kerry
Weems
Senior
Vice
President
and
General
Manager,
Health
Solutions,
formerly
held
the
position
of
Administrator
of
the
Centers
for
Medicare
and
Medicaid
Services
and
was
also
Vice
Chairman
of
the
American
Health
Information
Community.
Jacob
Hacker,
PhD
Stanley
B.
Resor
Professor
of
Political
Science
at
Yale
University,
and
a
Resident
Fellow
at
the
Institution
for
Social
and
Policy
Studies.
He
is
also
a
Fellow
at
the
New
America
Foundation
in
Washington,
D.C.,
and
a
former
Junior
Fellow
of
the
Harvard
Society
of
Fellows.
He
is
an
expert
on
the
politics
of
U.S.
health
and
social
policy.
Len
Nichols,
PhD
Highly
respected
healthcare
economist,
headed
New
America's
Health
Policy
Program
from
1995
until
2010,
when
he
left
to
become
a
professor
of
health
policy
and
director
of
the
Center
for
Health
Policy
Research
and
Ethics
at
George
Mason
University
Arnold
Milstein,
PhD
Consultant
and
Chief
Physician
at
Mercer
Health
&
Benefits
and
Medical
Director
of
the
Pacific
Business
Group
on
Health
(PBGH).
His
work
focuses
on
health
care
purchasing
strategy,
the
psychology
of
clinical
performance
improvement,
and
clinical
innovations
that
reduce
total
health
care
spending
and
improve
quality.
He
was
elected
to
the
Institute
of
Medicine,
is
a
Congressional
MedPAC
Commissioner
and
is
a
faculty
member
at
UCSF’s
Institute
for
Health
Policy
Studies.
John
M.
Welton,
PhD,
RN
Associate
professor
in
the
College
of
Nursing
at
the
Medical
University
of
South
Carolina
in
Charleston.
His
research
interests
include
the
financial
and
business
aspects
of
nursing
care,
nursing
intensity,
and
performance
and
quality
of
inpatient
nursing
care.
Don
Muse,
PhD
Associate
at
Muse
&
Associates,
formerly
with
the
Congressional
Budget
Office,
the
Center
for
Medicare
and
Medicaid
Services
(CMS),
and
the
U.S.
Senate
Finance
Committee.

19.
Company
X:
Product
X
Pump
for
CED
19
Market
Analysis
Proposal
-­‐
Confidential
METHODOLOGY
Module
II
Research
Module
II
will
include
the
identification
and
recruitment
of
Key
Customers
and
developing
a
project
specific
Voice
of
the
Customer
(VOC)
questionnaire.
VOC
studies
measure
current
unmet
needs
and
near-­‐term
emerging
opportunities,
but
do
not
address
futuristic
needs.
We
will
look
to
these
Key
Customers
to
provide
valuable
insight
into
the
stated
and
unstated
unmet
needs,
emerging
opportunities,
and
potential
business
gaps
as
they
pertain
to
Company
X’s
Product
X
CED
system.
Like
the
KIL
study,
the
VOC
questionnaire
will
be
developed
through
a
collaborative
effort
with
Company
X
in
order
to
ensure
that
the
focus
of
this
project
is
being
properly
addressed.
The
questionnaire
will
be
used
as
a
platform
for
exploration
and
discussion.
All
interviews
will
be
conducted
directly
by
Harrison
Hayes’
Principals
and
Research
Team
utilizing
improvisational
interviewing
where
the
Team
has
the
autonomy
to
probe
deeper
and
maneuver
through
unique
issues
that
arise
during
discussions
with
the
Key
Customers.
Improvisational
interviewing
again
yields
valuable
qualitative
interview
data,
as
our
Research
Team
is
able
to
adapt
based
on
the
Key
Customers’
response
to
questions,
thus
obtaining
valuable
additional
insight
into
the
Key
Customer’s
perspective.
Our
Research
Team
selects
the
most
appropriate
questions
to
ask
each
Key
Customer
due
to
our
extensive
knowledge
and
involvement
with
the
project’s
goals.
Examples
of
Key
Customers
• Purchasing
and
Procurement
Executives
at
Cancer
Centers
and
Hospitals
specializing
in
Oncology
• Practicing
Oncologists
with
a
specialty
in
Glioblastoma
• Sales
Representatives
for:
Company
X,
Novartis,
Pfizer,
Merck,
Medtronic,
etc.
METHODOLOGY
Secondary
Research
&
Trend
Spotting
Harrison
Hayes
has
an
extensive
proprietary
database
of
secondary
research
that
will
add
exceptional
value
to
obtaining
a
complete
understanding
of
market
opportunities,
barriers,
and
inhibitors
within
the
CED
market
space.
Subsequent
content
will
provide
some
interesting
findings
uncovered
from
preliminary
secondary
research.
Syndicated
Harrison
Hayes
has
established
relationships
with
a
variety
of
syndicated
information
providers.

20.
Company
X:
Product
X
Pump
for
CED
20
Market
Analysis
Proposal
-­‐
Confidential
Publicly
Available
Harrison
Hayes
conducts
significant
market
research
within
the
public
domain.
We
have
expertise
in
identifying
key
market
data
through
journal
and
trade
publications,
online
subscription
databases,
market
research
data
hubs,
proprietary
data
sources
and
archival
research.
Internal
One
of
Harrison
Hayes’s
key
assets
is
the
market
research
previously
conducted
that
resides
“in-­‐house.”
Our
ability
to
leverage
this
data
significantly
reduces
the
time
constraints
associated
with
providing
the
required
deliverables.
TREND
SPOTTING
&
ANALYSIS
Trending
analysis
focuses
on
identifying
market
viability,
interest,
acceptance
and
penetration,
and
barriers
to
entry
and
expansion,
and
requires
primary
and
secondary
research
to
uncover
emerging
patterns
and
opportunities
for
a
drug-­‐device
combination
within
the
CED
market
space.
We
do
not
guess
trends;
we
detect,
analyze,
and
evaluate
them
to
make
evidentially
supported
projections.
Because
Company
X’s
KIL’s
have
significant
insight
into
the
current
state
of
CED
market
space
issues,
they
are
on
the
cutting
edge
of
trends
and
function
as
a
valuable
resource
for
understanding
the
commercial
innovation,
viability,
and
drug-­‐device
product-­‐
and
technology-­‐specific
market
trends.
Examples
of
trends
that
we
will
uncover
include:
• Assessment
of
the
market
reaction
and
acceptance
for
Local
Organ
delivery
using
the
PRODUCT
X
pump
within
the
CED
space
• Changing
trends
in
drug,
device,
and
drug-­‐device
regulatory
and
reimbursement
environment
• Adoption
drivers
for
innovative
drug-­‐device
products
• Lag
time
between
early
adopters,
late
adopters
and
others
• Changing
trends
in
use
of
systemic
vs.
local
applications
Trending
research
is
an
integral
part
of
a
successful
research
initiative,
and
Harrison
Hayes
is
confident
that
our
trend
spotting
methods
will
afford
Company
X
the
necessary
insight
on
CED
space
market
dynamics.

21.
Company
X:
Product
X
Pump
for
CED
21
Market
Analysis
Proposal
-­‐
Confidential
FINAL
REPORT
Strataject
Report™
Our
final
deliverable
for
this
project
is
an
Internalized
Strategy
Report
(Strataject
Report™).
This
report
is
the
culmination
of
all
primary
and
secondary
research
and
activities
that
have
taken
place
over
the
duration
of
the
engagement.
This
report
serves
as
an
action
plan
illustrating
key
areas
for
life
cycle
management;
competitive
intelligence
and
reaction
and
the
risks
of
cannibalization;
market
entry,
expansion,
impact,
reaction,
acceptance,
and
penetration;
barriers
and
inhibitors
to
market
entry,
acceptance,
and
penetration;
market
transition;
and
reimbursement
issues
including
pricing
elasticity
and
reaction.
We
will
do
the
same
for
customer
segments
including
timing
of
adoption,
previously
unidentified
adopters,
and
lag
time
between
adoption
by
different
segments,
competitive
reaction,
and
market
penetration.
Harrison
Hayes
will
make
a
recommendation
of
actions
within
each
of
these
areas
to
improve
Company
X’s
position
and
improve
value
generation.
Harrison
Hayes
will
schedule
a
time
to
present
and
discuss
our
findings
and
recommendations
to
Company
X.
During
this
meeting,
we
will
discuss
in
detail
our
front-­‐end
research,
findings,
and
recommendations
for
Company
X
supported
by
both
primary
and
secondary
research.

22.
Company
X:
Product
X
Pump
for
CED
22
Market
Analysis
Proposal
-­‐
Confidential
PROJECT
FEES
Option
A:
Modular
Breakdown
of
Project
Plan
Activities/Deliverables:
Option
B:
Modular
Breakdown
of
Project
Plan
Activities/Deliverables:
Activity Weeks Fee
Key Innovation Leader Study
20-25 KIL Interviews
6-8 $65,000
Voice of the Customer Study
10 VOC Interviews (Concurrent with KILs)
4-6 $37,500
Secondary Research (Concurrent with KIL/VOC) 2-4 $25,000
Final Report 1-2 $10,000
Total Project Duration and Fee 10-12 $137,500
Activity Weeks Fee
Key Innovation Leader Study
35 KIL Interviews
6-8 $85,000
Voice of the Customer Study
20 VOC Interviews (Concurrent with KILs)
4-6 $65,500
Secondary Research (Concurrent with KIL/VOC) 2-4 $25,000
Final Report 1-2 $10,000
Total Project Duration and Fee 10-12 $185,500

23.
Company
X:
Product
X
Pump
for
CED
23
Market
Analysis
Proposal
-­‐
Confidential
Travel
expenses
will
be
billed
at
cost.
Company
X
will
approve
all
travel
expense
prior
to
incurring
any
costs.
Company
X
Harrison
Hayes,
LLC
Signature:
_________________________
Signature:
______________________
Name:
____________________________
Name:
_________________________
Title:
_____________________________
Title:
__________________________
Date:
_____________________________
Date:
__________________________

24.
Company
X:
Product
X
Pump
for
CED
24
Market
Analysis
Proposal
-­‐
Confidential
APPENDIX
Figure
1:
Project
Layout
Possible
Extensions
of
CED’s
The following is a list of potential extensions of the CED application that may be explored to identify
other therapeutic areas that may benefit from its development.
• Glioblastoma
1. Local
Infusion
of
Chemotherapy
(CpG)
2. Local
infusion
of
Lymphokine
Activated
Killer(LAK)
cells
• Other
Oncology
1. Already
Encapsulated
tumors
2. Encapsulate
Tumors
§ Nanoscaffold/Macropores
• Encapsulate
• Interconnect
Latticework
• Connect
to
CED
• Infuse
with
Chemo
• Extension
of
CED
1. Chronic
Pain
§ Epidural
§ Peripheral
Nerve
§ Joint
§ Post
surgical
• Selective
Nerve
rather
than
wound
Glioblastoma implantation and local
infusion of monoclonal antibody
Specifications
definition