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Operational Issues to Get Your Company Up and Running
1. Opera&onal
Issues
to
Get
Your
Company
Up
and
Running
Where
do
you
start
a;er
you
have
the
idea
January
21,
2014
Download
slides:
bit.ly/tcnLifeSci2014
#TCNlive
1
2. The
Panel
• Moderator:
– Mirena
Bagur,
CONTeXO
• Panelists:
• Corey
McCann,
consultant/VC/entrepreneur,
MPM
Capital
• Bret
Siarkowski,
CEO
of
Biofficient
Inc.
Download
slides:
bit.ly/tcnLifeSci2014
#TCNlive
2
3. Top
Line
•
•
•
•
•
•
Funding
Plan:
Product/Strategy/Market
Team
Planning/Milestones
Important
To-‐Do’s
Addendum
Download
slides:
bit.ly/tcnLifeSci2014
#TCNlive
3
4. Funding
• Funding
strategy:
– Funding
to
what
milestone
and
amount
needed
– Runway
– Key
value
inflec&ons
along
the
way
– How
much
to
exit
or
break-‐even
• Subsequent
rounds
• 5
year
budget
• Stage
of
Development
– Target
firms
–
sector;
stage;
round
size;
total
capital
requirements;
exper&se
• Know
where
they
are
in
their
fund
• Talk
to
Strategic
Partners
early
–
develop
rela&onship
(Cau&on)
Download
slides:
bit.ly/tcnLifeSci2014
#TCNlive
4
5. Deal
Size,
Funding
Sources
and
the
Company
Lifecycle
Deal
Size
PE;
II
VCs
Early
VCs
Angels
FF
Idea
Alpha
Beta
Source:
CONTeXO
Group,
Spring
2011
1.0
Commercial
Rollout
#TCNlive
2.0,
expansion
Lifecycle
Stages
5
6. Business
Plan
Overview
• Describe
the
business
– Therapeu&c,
diagnos&c,
device,
IT
– Prepare
business
plan
/
presenta&on
• Will
we
develop
ourselves
or
with
a
partner
(outsource)
• What
does
the
market
look
like
• Current
and
historical
regulatory
landscape
• What
are
the
barriers
to
entry
• What
are
the
comparables
that
show
our
model
will
work
• What
is
the
financing
necessary
to
get
to
exit
• What
is
the
exit
Download
slides:
bit.ly/tcnLifeSci2014
#TCNlive
6
7. Team
• You
cannot
do
it
alone:
Lose
“I”
from
vocabulary
– Get
the
right
people
on
the
bus
–
define
roles
and
responsibili&es
• Core
competency,
can
they
handle
uncertainty,
flexibility,
perseverance,
same
vision
and
alignment
– Experience
(complementary)
for
founding
team,
KOLs
and
advisors
• Consider
Virtual
Model
where
possible
– Allows
flexibility
to
hire
the
best
and
most
experienced
for
a
variable
cost
– Sets
an
appropriate
pace
for
growth
• Key
ques&on
about
choosing
team
members:
– Personality
fit:
Do
you
like
them?
Download
slides:
bit.ly/tcnLifeSci2014
#TCNlive
7
8. The
Team
“The
right
team”
(2-‐4
people)
– Strong
technical
founder
• More
than
just
an
idea
person
• Has
to
understand
the
whole
thrust
behind
the
technology
and
the
industry
dynamic
around
it.
– A
sales-‐oriented
entrepreneur
• Drives
the
other
parts
of
the
business
and
sells
the
vision
to
investors
and
other
stakeholders
– Full
&me
employees
(FTEs)
– Partners
– Poten&al
customers
Download
slides:
bit.ly/tcnLifeSci2014
#TCNlive
8
10. Regulatory
• Major
Factor
in
Success
and
Funding
• Credible
exper&se
– Avoid
landmines
– Know
the
challenges
• Define
risk
mi&ga&on
strategy
• Iden&fy
Path:
– Therapeu&c,
device,
diagnos&c,
IT
• IND,
PMA,
510(k)
Download
slides:
bit.ly/tcnLifeSci2014
#TCNlive
10
11. Planning
Considera&ons
Sector
Device
(drug
delivery,
implanted,
valves,
monitoring;
etc)
DiagnosGc
TherapeuGc
(drugs,
vaccines,
biologics)
Some
drug
delivery
Healthcare
IT
/
Services
IP
Yes
-‐
FTO
YES
Patent
Life
Important
10
years
to
develop
Countries
Know
How
Design
/
Method
Regulatory
PMA/510K
Companion?
510K/PMA;
CLIA
IND
HIPAA
Stark
Law
Prototype/
Demonstra&on
√√√√
(seeing
is
believing)
Depends
on
diagnos&c
No
√√√
demonstra&on
–
talk
to
end
user
Animal
Data
YES
YES
MUST
N/A
Publica&on
Important
Important
MUST
N/A
Scale
Up
Manufacturer
?
GMP
Manufacturer?
GMP
CMC
–
manufacturing
GMP
Must
have
or
clear
path
Reimbursement
Current
or
new
CPT
HCPCS
Compara&ve
Effec&veness
YES
Federal
and
State
Distribu&on
Think
through
–
alone
or
partner;
countries
Important
–
Central
Labs
Think
through
-‐
alone
or
partner;
by
Countries
Must
have
Launch/Market
trajectory
US/EU/ROW
Adop&on
-‐
uptake
US/EU/ROW
Adop&on
-‐
uptake
#TCNlive
11
12. Important
“To
Do’s”
– Human
Resources
– Legal
– Accoun&ng
– Insurance
• Bank:
need
an
account
before
applying
for
grants
• File
with
D&B
for
D-‐U-‐N
•
•
•
•
– Necessary
to
apply
for
grants
with
NIH/Government
(non-‐
dilu&ve!)
Website/Email
-‐
secure
domain
name
Company
name/logo
–
Corporate
Iden&ty
Business
Cards
Networking
–
both
for
content
and
context
Download
slides:
bit.ly/tcnLifeSci2014
#TCNlive
12
13. Addendum
Plan
Overview
Development
Plan
Legal
–
Corporate
and
IP
Download
slides:
bit.ly/tcnLifeSci2014
#TCNlive
13
14. Plan
Overview
• Describe
the
business
– Therapeu&c,
diagnos&c,
device,
IT
– Prepare
business
plan
/
presenta&on
• Will
we
develop
ourselves
or
with
a
partner
(outsource)
• What
does
the
market
look
like
• Current
and
historical
regulatory
landscape
• What
are
the
barriers
to
entry
• What
are
the
comparables
that
show
our
model
will
work
• What
is
the
financing
necessary
to
get
to
exit
• What
is
the
exit
Download
slides:
bit.ly/tcnLifeSci2014
#TCNlive
14
15. Development
Plan
• Extremely
important
for
you
and
investors
• GANTT-‐
&me
and
resources
– Iden&fy
key
milestones
that
drive
demonstrable
value
inflec&on
($$$
-‐
how
much
necessary
for
each
point)
•
•
•
•
•
•
Prototype
–
device/IT
CMC
Animal
data
FDA
discussion
IND
Phase
1
• How
will
you
execute
– CRO
– Joint
development
–
strategic
discussions
-‐
stage
Download
slides:
bit.ly/tcnLifeSci2014
#TCNlive
15
16. Legal
–
Corporate
Structure
• Incorpora&on
–
C
Corp,
LLC
– Form
of
company
may
affect
who
you
target
for
funds
• Capitaliza&on
Table:
ownership
split
with
founders
– Op&on
plan
/
agreement
(plan
ahead)
• Key
documents
– Employment
agreements
– MA
Law
• Key
Filings
– Delaware
– Tax
Download
slides:
bit.ly/tcnLifeSci2014
#TCNlive
16
17. Legal
-‐
IP
• Intellectual
Property
firm
not
always
the
same
as
Corporate
• Licensed
IP
in?
Op&on
Agreement
• Review
terms
closely
• Cost
/
&me
period
for
op&on
agreement
• Addi&onal
IP
needed
• Provisional
patents/Filed
patents
–
expense
• What
is
the
short
/
long
term
IP
strategy
Download
slides:
bit.ly/tcnLifeSci2014
#TCNlive
17
