MAGNATAS AUGUST 2015

Introduc)on
to

MAGNATAS,
LLC

AUGUST,
2015

1
Introduc+on
to
Magnatas,
LLC

2

3

Our
Competencies

4

Our
Clients

Our
Case
Studies

AGENDA

Magnatas,
LLC

•  Magnatas
is
short
for
“Magnanimitas”
which
means
“striving

for
greatness”
in
the
work
we
do
and
the
character
we
display

•  Our
scien+ﬁc
exper+se
and
commercial
experience
allows
a

convergent
scien+ﬁc
and
commercial
approach

•  Our
goal
is
to
support
ins+tu+ons
that
focus
on
advancing

healthcare
through
innova+ve
science
and
service

•  We
help
entrepreneurs
develop
appropriate
business

prac+ces
that
allow
for
coordinated
growth
of
their

organiza+on

•  We
are
part
of
a
global
consor+um
to
develop
and
execute

plans
without
borders

Magnatas,
LLC

•  Science
has
provided
signiﬁcant
new
targets
for
therapies

resul+ng
in
unprecedented
numbers
of
molecules
in

development

–  There
are
over
4,500
compounds
in
pre-‐clinical
development

–  Close
to
1,000
compounds
are
in
Phase
I,
more
than
twice
the
number

than
20
years
ago
(PharmaFutures)

•  The
paradigm
shiR
towards
evidence-‐based
medicine
requires

a
greater
science
–
commercial
convergence
during
product

development
and
proof
of
value
at
+me
of
launch

The
Paradigm
ShiR

Value
is
not

new

technology

Value
is
not

a
code
for

cost

reduc)on

“Achieving
High

Value
for
Pa)ents

must
become
the

overachieving
goal
of

health
care
delivery”

Michael
E.
Porter,

NEJM
12/23/2010

“Four
to
five
years
ago,
external

assets
were
defined
by
scien+fic

merits.

However,
today,
asset

value
is
driven
by
the
ability
to

differen+ate
and
demonstrate

pa+ent
benefit”.

Comments by Major Pharma to
entrepreneurs.
Center of Entrepreneurial
Development annual meeting
(2/2011)

Mission
and
Vision

•  MAGNATAS,
LLC
provides
strategic
guidance
and
consulta+on

that
can
be
implemented
by
clients
who
want
to
thrive.

•  We
use
a
convergent
approach
that
brings
scien+ﬁc
and

commercial
data
together
on
a
+mely
basis
for
beer
decision

making

•  Our
“thinking
and
doing”
approach
makes
us
a
true
ally
for

innovators
and
those
who
support
them

•  The
Business
Accelerator/Mentorship
Process
allows
the

entrepreneur
to
focus
on
the
technical
task
at
hand
in

developing
the
asset
or
services

Mission
and
Vision

•  Mission:
MAGNATAS,
LLC
will
provide
proven
scien+ﬁc

exper+se,
experienced
business
leadership
and
mentorship
to

Life-‐Sciences
Companies,
Venture
Firms
and
Service

Companies
on
an
as
needed
basis
allowing
our
customers
to

thrive
in
their
ﬁeld
of
exper+se

•  Vision:

We
are
in
the
business
of
realizing
the
dreams
of

entrepreneurs,
scien+sts,
investors
and
companies.

All
our

ac+ons
are
measured
by
their
success

Magnatas,
LLC

Magnanimitas,
La)n
for
“Striving
for
Greatness”

Scien)ﬁc
Exper)se

•  Trained
in
basic
research
and

problem
solving
in
the
area
of

immunology

•  Fogarty
Interna)onal
NIH
Fellow

•  Authored
and
co-‐authored
32
ar)cles

and
abstracts

Commercial
Experience

•  Strategy
Development

•  Opera)onal
Excellence

•  High-‐performance
team
approach

•  Organiza)onal
infra-‐structure

development

•  New
commercial
model

development

•  Our
commercializa)on
strategy
is
based
on
a
deep
understanding
of
the
scien)ﬁc

plaWorm
and
its
resul)ng
posi)oning
in
the
treatment
paradigm

•  We
have
a
network
of
industry
experts
in
the
areas
of
market
research,
business

strategy
development,
real
life
data,
payer
exper)se,

global
expansion
that
can

be
involved
as
the
situa)on
requires.

Our
Goal

•  Provide
a
rigorous
scien+fic
approach
towards

commercializa+on

•  Develop
new
commercial
approaches
that
are
effec+ve
and

efficient
while
adhering
to
GPP

•  Provide
experienced
business
leadership
in
the
life
sciences
to

develop
a
sustainable
growth
plan
for
our
clients

•  Serve
as
a
Fully
Integrated
Business
Network
to
provide

answers
to
any
commercializa+on
ques+ons
on
a
+mely
basis

•  Develop
insights
in
a
+mely
manner
to
make
decisions
with

the
right
informa+on
at
the
appropriate
+me

•  Allow
every
company
to
maximize
their
efficiency
in
the

u+liza+on
of
scarce
resources

Preclinical

R&D
Clinical
Development

Regulatory

Submission

Post-‐Approval

Leveraging
integrated
strategies
to
answer
increasingly
complex
set
of
ques+ons

drives
program
value
through
eﬃciency,
faster
market
uptake,
and
higher
peak
sales

Developing
an
Asset
is
a
Complex
Process

Performance
Op+miza+on

Go-‐to-‐Market

Strategy

Evidence
Plan

Op+miza+on

Asset
Strategy

Who
are
the
stakeholders,

what
are
their
levers,
and
how

do
they
inﬂuence
the
market?

What
will
the
market

look
like
when
we

launch?

What
evidence
will
we

need
to
prove
our

product's
value
at

launch?

What
endpoints
to

measure?

Which
clinical
trial

design?

Which
popula)on
to

study?

What
is
the
overall

launch
strategy?

What
is
our
market

development
strategy?

What
is
our
lifecycle

strategy?

Strategic
Development
Approach

Development
Timeline

Ongoing
KOL
Interac)on

Ini+al
Data

Analysis
and

Research

Full
Gap

Analysis

Product

Dev.

Plan

Execu+on
and
Delivery

Assessment

Monitoring
&

Repor)ng

Adapta)on

Target

Product

Proﬁle

Drug
Dev.

Strategy

Ac)ons
to
date

•  Assessed
high-‐level

landscape

•  Ini+al
KOL

discussions

Planned
steps

•  Engage
KOLs,

outside
experts

•  Comp.
analysis

•  POC/PC
review

Process

•  Select
indica+on(s),
create
TTP,
develop
strategy,

create
PDP,
and
manage
program
execu+on

•  Con+nually
review
data
and
apart
plans

Protocols

Ongoing
Risk
Assessment

Example
process
ﬂow
highlights
an
integrated
delivery
process

1 2 3 4

The
Strategic
Planning
Framework

14

What
are
we
gebng

into?

Where
do
we
want

to
be
and
how
do
we

get
there?

What
ac)on
do
we

need
to
take
when?

What
does
success

look
like?

Stage
1:

Environmental

Context

Phase
2:

Strategy

Development

Phase
3:

Implementa+on

Phase
4:

Results
/

Performance

Measurement

•  Environmental
/

Compe++ve
Assessments

•  Pa+ent
proﬁling

•  HC
stakeholder
analysis

•  Scenario
Planning

•  Opportunity
Analysis

•  Archetype
Projec+on

•  Mission

•  Vision

•  Strategic
Intent

•  Goals,
metrics,
targets

•  Capabili+es
and
key

rela+onships

•  Cri+cal
Success
Factors

•  Poten+al
Product

Posi+oning

•  Processes

•  Resources

•  Implementa+on
Plan
and

Timing

•  Budgets

•  Forecasts

•  Data
tracking,
collec+on

and
repor+ng

•  Feedback
mechanisms
for

improvement

•  Balanced
Scorecard

Key
Ques+ons:
Areas
to
Explore

Objec+ve:
Implementable
strategies
speciﬁc
to
the
client’s
organiza+on

Key
Components
of
a
Successful
Product
Launch

•  Serve
as
a
Center
of
Excellence
for
Business
Solu+ons
to
life-‐
sciences
companies
and
the
Investment
Community.

Thoughjul

Strategic

Plan

Focused

Execu+on

High

Performing

Team

Success

Due
Diligence
Mindset

Our
Competencies

• Business
Strategy/Planning
and
Development

• Commercializa+on
Planning/new
model
development

• Government
and
Key
stakeholder
strategies

• Product
Development
strategies

Business
Strategy
• Organiza+onal
Eﬀec+veness/Quality/Processes.

• Developing
High
Performance
Teams

• Leadership
Development

Implementation

• CEO/COO/CMO
Services

• Board
of
Director
Services

• Commercializa+on
Planning/New
Commercial
Models

• Clinical/commercial
convergence

Operational
Excellence
• Scien+ﬁc
and
commercial
evalua+on

• Opportunity
Analysis

• Pre-‐investment
assessment

• Post-‐investment
organiza+onal
consul+ng

Due
Diligence

Our
Customers

•  Start-‐up
life
sciences
companies
focusing
on
the
Rx
or
OTC

market.

•  Universi+es,
especially
offices
of
technology
transfers

•  Venture
Firms
who
seek
help
in
providing
due
diligence
or

oversight
in
their
investment

•  Private
and
state
offices
promo+ng
the
commercializa+on
of

life
sciences.

•  Companies
who
need
to
improve
their
opera+ng
efficiency

and
leadership
training

•  Companies
seeking
new
commercial
approaches/models

Due
Diligence
of
Investment

Case Study: Venture Capital
  Background

Company:

Venture
Firms

Situa)on:

A
group
of
Venture
Firms
needed
an

independent
assessment
of
one
of

their
investments
(breast
cancer

diagnos+c)
as
it
was
not
progressing
to

plan

Objec)ve
of
the
project:

•  Perform
due
diligence
to
determine

the
progress
of
the
diagnos+c

development

•  Report
on
the
+meline
to

commercializa+on

•  Assess
data
gaps

•  Develop
a
+meline
and
to
ac+vi+es

to
commercializa+on

•  Recommenda+on
next
steps

  Ac)on

Approach

•  Performed
secondary
research
to

understand
the
scien+ﬁc
plajorm

•  Primary
interviews
to
assess
the

strength
of
the
commercial
process

•  Company
documents
around

regulatory
and
customer
feedback

•  Company
Dynamics
and
capability

Assessment

  Outcome

•  Our
recommenda+ons
were
accepted

•  The
science
did
not
support
the
theory

•  Company
ceased
opera+ons
in
2011

  Recommenda)on

Board
Report

•  Address
scien+ﬁc
gaps
through
NIH

fund
rather
than
Investment
capital

•  Revisit
the
regulatory
route
and

gain
feedback
to
the
design
of
the

registra+on
studies

•  Place
commercial
experts
on
the

Board

•  Outsource
the
automa+on
of
the

staining
procedure

•  Replace
the
CEO
with
a
strong

leader
who
can
change
the
team

dynamics
and
company
culture

Launch
Budget
Development

Case Study: Medium Pharmaceutical Company
  Background

Company:

Medium-‐sized
pharma
company

Situa)on:

•  The
company
requested
to
assess

the
cost
of
a
good
launch

•  Help
develop
a
launch
budget

Objec)ve
of
the
project:

•  Analyze
launch
successes
and

launch
failures

•  Based
on
the
available
internal
data

and
external
assessment,
build
a

launch
budget
segmented
by
pre-‐
approval,
post-‐approval/
before

launch
and
post-‐launch

  Ac)on

Approach

•  We
performed
secondary
and

primary
analysis
of
successful
and

failed
launches

•  Determined
the
product
archetype

to
assess
its
compe++ve
posi+oning

•  Aligned
the
CSF
and
stakeholder

interac+ons
with
the
archetype

•  Established
+meline
for
execu+on

around
key
stakeholders

•  Develop
the
budget
by
stakeholder

group
along
the
execu+on
+meline

  Outcome

•  The
posi+oning
as
well
as
the
budget
were
accepted
and
used
for
implementa+on

•  The
product
is
in
full
pre-‐launch
implementa+on

•  One
medical
person
called
it
the
best
consul+ng
group
they
had
ever
worked
with.


•  The
client
was
advised
to
develop
a

strategy
more
like
a
specialty/
oncology
product.

•  Heavy
emphasis
on
Thought
Leader

educa+on.

•  Developed
a
tac+cal

implementa+on
plan
iden+fying
the

number
of
required
touch
points

with
key
stakeholder.

•  Developed
the
budget
aligned
with

the
requested
+me
segments

Building
the
Architecture
of
a
Reimbursement
and
Access
Organiza+on

  Background

Company:

Medium-‐sized
pharma
company

Situa)on:

•  The
company
wanted
to
improve

their
reimbursement
and

access(R&A)
capabili+es

Objec)ve
of
the
project:

•  Assess
Best
in
Class
reimbursement

organiza+ons,
their
coverage,

pa+ent
processes
as
well
as
internal

versus
outsourcing
components

•  Develop
an
architecture
and

footprint
including
internal

capability
development
and

appropriate
outsourcing
model

  Ac)on

Approach

•  We
studied
12
R&A
programs

through
secondary
and
primary

research.

•  We
assessed
internal
capabili+es

and
performed
a
gap
analysis

versus
Best
in
Class
organiza+ons

•  Assessed
various
Hub
organiza+ons

fill
the
capability
gaps.

•  Developed
the
final
architecture

including
the
linkages
between

internal
oversight
and
external

vendors
to
look
like
one
team
in

front
of
the
customer.

  Outcome

•  The
implementa+on
of
the
recommenda+on
is
on-‐going


•  The
recommenda+on
was
to
keep

many
of
the
customer-‐facing
front-‐
end
ac+vi+es
in-‐house
but

outsource
all
the
back-‐end
ac+vi+es

such
as
pa+ent
eligibility

considera+ons
and
implementa+on

around
co-‐pay
assistance
and

Pa+ent
Assistance
programs.

•  U+lized
the
exper+se
of
Hub

providers
to
develop
a
turn-‐key,

scalable
back-‐office.

•  Also
highlighted
the
importance
of

differen+a+on
through
non-‐
financial,
pa+ent
focused
programs,

which
required
the
company
to
get

back
and
assess
their
knowledge
of

the
target
pa+ents.

Case Study: Medium Pharmaceutical Company

Transforming
an
Organiza+on
into
a
High
Performing
Team

Case Study: Medical Communication Organization
  Background

Company:

Small
communica+ons
organiza+on

Situa)on:

•  The
organiza+on
was
trying
to

reverse
its
declining
business(NNB,

revenue
and
Profits)

Objec)ve
of
the
project:

•  The
Medical
Communica+ons

organiza+on
was
targeted
for

poten+al
sale
or
shut-‐down.

•  The
goal
was
to
assess
whether
the

value
of
this
organiza+on
could
be

improved.

  Ac)on

Approach

•  Assessed
the
Business
Development

func+on
and
clearly
defined
roles

and
responsibili+es
for
the

leadership
team

•  Assessed
the
financial
performance

to
iden+fy
the
reasons
for
the

declining
profitability

•  Ini+ated
a
change
agenda
to

redirect
the
team
to
focus
on

profitability.

•  Developed
quarterly
expense

targets
+ed
to
revenue.

  Outcome

•  The
organiza+on
set
a
new
record
in
NNB,
revenue
and
profit.

•  Achieved
double
digit
New
Business,
Revenue
growth
and
triple
digit
profit
growth
versus
the
previous
year.
Contribu+on

margin
and
Profit
improved
by
6
and
8
percentage
points
respec+vely.


•  Re-‐organized
the
leadership
from
a

regional
to
a
global
structure

•  Increased
the
percentage
of
billable

hours
by
elimina+ng
unnecessary

mee+ngs

•  Segmented
the
business
and

developed
specific
BD
targets
for

each
segment.

•  Developed
metric
to
track

performance

•  Communicated
on
a
monthly
basis

to
the
whole
team
progress
and

celebrated
successes

Developing
a
Client
Services
Organiza+on

Case Study: Nurse Educator Service Provider
  Background

Company:

•  Small
organiza+on
providing
nurse

educator
services

Situa)on:

•  Organiza+on
struggled
financially

and
called
me
to
make
an

independent
assessment
of
the

root-‐cause

Objec)ve
of
the
project:

•  Assess
GAPS

•  Recommend
and
implement

changes

  Ac)on

Approach

•  Performed
overall
company

assessment,
processes,
outputs

•  Assessed
the
compe++ve
landscape

regarding
services
offered,

promo+onal
approach,
adver+sing

focus

•  Made
recommenda+on
regarding

services
offered,
customer

interac+on
approach,
impact

demonstra+on

•  Focused
heavily
on
Account

Management

  Outcome

•  The
organiza+on
has
a
more
resona+ng
pitch
deck
thanks
to
a
heavier
focus
on
data
to
demonstrate
impact

•  Have
a
proac+ve
and
focused
measurement
plan
in
place
for
every
RFP

•  Expanded
the
contact
network
with
accounts

•  Developed
a
pipeline
of
future
opportuni+es
and
signed
~
>
$1M
of
new
Brands
so
far
in
2015.


•  Currently
leading
the
Client
Services

Group
as
well
as
the
Analy+cs
and

Insights
effort.

•  Developed
measurement
plan

along
the
pa+ent
journey
and

analyzed
all
the
2014
data
to

demonstrate
impact
of
client’s

nursing
services

•  Developed
an
Account

Management
Process
that
focused

on
maximizing
revenue/client,

defined
roles
and
responsibili+es

between
Client
Services
and
Client

Opera+ons

We
have
a

Network
of
Experts

Magnatas,

LLC

Legal

Global

Assessment

Finance

IP
Strategy

Market

Research

Regulatory

Pricing/
Reimbursement/
Access

IT

Solu)ons

Global

Assessment

As
a
Fully
Integrated
Business
Net
Provider,
MAGNATAS,
LLC
can

help
answer
any
commercializa+on
ques+ons

The
Team

•  Dr.
Michael
Ackermann
is
the
prac+ce
leader

–  Over
thirty
years
of
healthcare
experience
from
basic

research
to
commercial
product
launches
and
General

Management

–  NIH
Research,
pharmaceu+cals,
healthcare
services

–  Strategic
development,
opera+ons,
and
sales
&
marke+ng

•  Depending
on
the
scope
and
need,
Mike
will
assemble
and

lead
a
team
of
experts
from
the
consor+um

–  Right
people,
right
+me,
right
insights

Selected
accomplishments:

  Guided
Lilly’s
largest
Business
Unit
from
ﬂat
performance
to

19%
growth

  Build,
developed
and
led
high
performance
teams
in
the

areas
of
sales,
Business
Units
and
strategic
groups
in
the

pharmaceu+cal
product
as
well
as
services
industry

  Launched
two
highly
successful
products
with
Cymbalta
and

Straera

  Developed
a
new
commercial
strategy
around
clinical/
commercial
convergence
that
contributed
$100M
in
NNB.

  Achieved
a
complete
turnaround
of
a
Medical

Communica+ons
Company

  Guest
lecturer
on
healthcare
topics
at
Indiana’s
Kelly
School

of
Business

  Fogarty
Interna+onal
Fellow
at
NIH/NIEHS

  Authored
32
scien+ﬁc
research
ar+cles
and
abstracts
in
the

areas
of
immunology
and
immunotoxicology

Educa)on

  PH.D.
Immunology,
Drexel
School
of
Medicine

  MBA,
The
Kenan-‐Flagler
School
of
Business
at
the
University

of
North
Carolina
at
Chapel
Hill

  B.S.
Hampden-‐Sydney
College
in
Virginia

  Bilingual
(German
and
English)

Next
Steps

•  For
addi+onal
informa+on,
please
contact

Dr.
Michael
F.
Ackermann

macker1156#@sbcglobal.net

919-‐279-‐5475

Thank
You

MAGNATAS AUGUST 2015

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