What`s in a Game?

FOCUS ON...
Outsourcing
What’s in a Game?
A Familiar Board Game Offers Lessons for Drug Development
by Peter Soelkner
N
ot long ago, I was playing the
popular board game Snakes
and Ladders (also known as
Chutes and Ladders) with my
son. Based on an ancient Indian board
game, it has over the years become a
worldwide classic. The game is rather
simple to play: Two or more players
place their tokens on a game board
that has numbered, gridded squares.
They take turns rolling a single die to
move their tokens by the number
indicated by the die, following a fixed
route marked on the gameboard. A
number of ladders and snakes (or
chutes) are pictured on the board,
each connecting two specific board
squares.
The object of the game is to
navigate your game piece from start to
finish, helped or hindered by ladders
and snakes, respectively. If, on
completion of a move, you land on the
lower-numbered square with a ladder,
you can move their token up to the
higher-numbered square. If you land
on the higher-numbered square with a
snake (or chute), you must move your
token down to the lower-numbered
square. The winner is the player
whose token first reaches the last
square of the track.
Like most board games, the
historic version of Snakes and Ladders
has roots in morality lessons. A
player’s progression up the board
represents a life journey affected by
virtues (ladders) and vices (“snakes”).
The game of Snakes and Ladders
22 BioProcess International
10(3)
M arch 2012
captures the eternal truth that for
every “ladder” you hope to climb, a
“snake” may be waiting just around
the corner. Conversely, for every
“snake” a “ladder” will compensate.
As I played the game with my son, I
kept thinking about how today’s
biotechnology industry, perhaps more
so than ever before, can be like a game
of Snakes and Ladders. The “snakes” on
this game board include the everincreasing costs of development,
exceedingly high cost of active
pharmaceutical ingredients, and ever
more rigorous oversight by regulatory
agencies.
For unprepared or underfunded
companies, those “snakes” may be
lying in wait on every square of the
biotechnology game board and
looking to put a company back
numerous spaces. In the worst of
circumstances, such peril could even
lead to the very “death” of a company.
To avoid those “snakes” demands that
companies within the
biopharmaceutical world play the
game ever more carefully, being
especially time-efficient and judicious
with capital expenditures. This is
especially true for smaller
biotechnology companies that often
face limited financial resources,
expertise, people, and equipment. For
them, the “snakes” on the game board
take on a greater level of risk. They
cannot play the “game” alone. So
finding the right partners is critical. A
careful screening process should help
reduce the risk of choosing the wrong
ones.
Ready to Play?
When partnering is in your company’s
future, the following suggestions may
help you navigate the biotechnology
game board. These suggestions will
help you avoid the “snakes” that will
almost certainly result in sending your
company back in the game. In many
circumstances they may provide you
with some ladders to save you time
and valuable resources.
Your first move on the game board
is critical. You must decide whether to
partner with several companies that
can help you achieve early goals
through a step-by-step process or
partner with a full-service contract
development and manufacturing
organization (CDMO) that can help
your drug progress from clinical
development into commercial
manufacturing. Developing and
manufacturing innovative drugs
involves considerable risk, particularly
financial ones. Finding a suitable
partner can free up the company to
concentrate its efforts and resources on
core competencies such as research
and development. If out-licensing is
part of the overall strategy of a
company, a CDMO that has already
positioned itself as a preferred partner
for biotechnology companies can add a
significant degree of perceived and
real value. That applies not only to a
company’s compound (by helping to
raise investment capital) but also to a
company itself. Such efforts will help
attract future investors and licensing
opportunities.
Thus, selecting the right CDMO
as your company’s partner will be
critical to moving forward and may
even help you to “charm the snakes”
you encounter. The right CDMO can
also act as a “ladder” — helping you
move your token up to a highernumbered square of success.
Ladders That Lead to Success
To assist you in selecting a CDMO
suitable for your business, determine
key attributes of the CDMO
candidate. Some are described below.
Level of Experience: CDMOs with
a high level of expertise and
experience in development and
manufacture of complex biotechnology
compounds provide “ladders” that
assist you and help you achieve
success. Be diligent and persistent in
your selection. Once you have
identified a candidate, you must be
assertive and ask questions that help
you determine how long the company
has been in business and what kinds
of work it has undertaken.
Determine whether the company
has experience in supporting your
drug development steps, including
clinical filling and possible later
commercial manufacturing and
market supply. Extensive knowledge
of and experience in navigating
domestic and international regulations
will also be the ladders that help move
your drug ahead in the development
process.
Experience and expertise provide a
greater likelihood of success and help
ease the collaboration process. Well24 BioProcess International
10(3)
M arch 2012
trained teams of scientists and
engineers will support a competent and
creative approach to your program and
help solve problems that might arise.
That helps speed time to clinic. Teams
that are well versed in this “game” can
work more efficiently because they will
have comprehensive expertise about
possible process-related challenges and
support the organization at each step.
So they make optimal use of budget,
time, and human resources.
Finally, determine how well
positioned a CDMO is internationally.
Most countries have their own
regulatory systems and national
specifications. A CDMO that has
already supported companies in
international product approvals has
likely developed significant experience
that has been integrated into its
processes. Having an established, solid
working relationship with regulatory
agencies such as the US Food and
Drug Administration and the
European Medicines Agency will act
as a supportive “ladder” to move you
ahead.
Agility and Flexibility:
Encountering a “snake” is never a
good thing. But early drug
development by its very nature will
present surprises. Be ready for them
by engaging a CDMO that can act
quickly and make adjustments.
Experienced Project Managers:
Find a CDMO outfitted with
“ladders” in the form of experienced
project managers who understand your
business. Doing so ensures that each
project is handled properly and
communication channels remain open.
Regular team meetings should involve
individuals from all technical areas
and be a part of every relationship.
This helps ensure that each party is
fully informed of potential “snakes” or
roadblocks in the process. Proper
documentation of processes and the
establishment of joint performance
measures that can be easily quantified
using objective dating is critical to
success.
Because small biotechnology
companies often have less experience
in assembling their own project
management teams, a CDMO will be
essential in helping to create a team
•
Teams that are well
versed in this “game”
can work more
efficiently,
because they will
have comprehensive
expertise about
possible processrelated challenges
and support the
organization at each
step.
that meets the needs of a small
company’s project. That allows the
company’s staff to focus their efforts
where their expertise is required.
Confidence that your partner is
sharing the right information and
knowledge will result in a trusting
partnership, which is the true core of
a successful relationship.
Creative Moves
A “nose to the grindstone” approach
to your business goes a long way. But
a CDMO should offer a range of
services that demonstrate creativity
and solutions that actually address the
changing needs of the market.
Lifecycle management is an important
consideration. Usually, if a drug is to
hit the clinic fast in a first cycle, it
will most likely be in a vial. For later
clinical phases, a syringe may be the
desired delivery mechanism. A viable
CDMO will have capabilities that
offer proactive approaches to the
various challenges at each stage.
Lifecycle management, if planned
early enough, can make all the
difference in the real success of a drug
in the face of upcoming competition.
Services That Consistently Meet
International Quality Standards
Because aseptic manufacturing is
becoming increasingly more rigorous
and demanding, regulatory agencies in
the United States, Europe, and Japan
are demanding that CDMOs stay
abreast of new and emerging rules and
regulations. And because rigorous
standards are being enforced, the
technology for a facility itself must
remain cutting edge. Providing highquality yield of valuable product is a
must.
Financial Stability
Makes for a Strong Partner
Manufacturing biotechnology
compounds is a long process. A drug
product can take an extended period
from process development to
manufacturing. So the relationship
you develop with a CDMO is a
long-term one. Be certain that your
partner can demonstrate that it has
independent financial standing. A
CDMO with a history of organic,
consistent growth will prove to be a
strong ally. If you encounter a “snake”
— and you most likely will — you
want to know your CDMO has the
financial strength to deal with it.
Ensure That Everyone Is
On the Same Game Board
Developing a solid working
relationship with the right CDMO
can help you avoid or possibly “charm”
the “snakes” on the board. They will
also help you find as many “ladders”
as possible. But like any game, it
requires investment by both parties,
particularly in the area of
communications.
Factors that can affect good
communication among team members
and peers include differences in
corporate cultures and business models
and varying levels of knowledge and
experience throughout the
organization. Here, I’ve discussed a
few issues that can make
communication among parties more
difficult.
The Right Partner
If you have decided that a partnership
with a CDMO is in your company’s
future, my suggestions should help get
you started. Remember that with
whom you partner is a fundamental
business decision that is best made in
the early phases of biopharmaceutical
product development. The development
of biotechnology drugs is a difficult
game, and the right selection of one or
several partners to help increase your
chance of success is critical to the
future of your company. •
Peter Soelkner is managing director of
Vetter Pharma International GmbH,
Eywiesenstraße 5, 88212 Ravensburg,
Germany; 49-751-3700-3729; [email protected]; www.vetter-pharma.com.
To order reprints of this article, contact
Rhonda Brown ([email protected])
1-800-382-0808. Download a low-resolution
PDF online at www.bioprocessintl.com.