Med Ad News A

MedAdNews
VOL. 28, NO. 8 • AUGUST 2009
Written and submitted by Darius Naigamwalla, Kuyler Doyle, and Michael Turner of Campbell Alliance
Top 10 launch challenges and
how to manage them
A
s a majority of product
managers will take part
in only one or two major
launches during their
careers, many do not have
a wealth of personal launch experience
to draw upon when preparing for the
daunting job at hand. Brand managers
will face 10 major challenges during
the course of planning and executing
a product launch. Some challenges
are external, while others are internal
to the organization. By becoming
familiar with the critical challenges,
product managers can take necessary
steps to plan accordingly and be better
equipped to prevent or manage issues
effectively, thereby increasing the
prospects of a successful launch.
Challenge 1: Increased
regulatory uncertainty
The Food and Drug Administration
Amendments Act (FDAAA) of 2007
ushered in increased regulatory
authority for drug safety enhancement,
including requirements for label
changes, post-marketing studies,
and a Risk Evaluation and Mitigation
Strategy. Although an increased focus
on safety is a positive development,
it can also make it more difficult
to get products through regulatory
hurdles.
The increased regulatory
responsibilities have burdened the
existing FDA staff and led to numerous
approval delays as the agency
struggled to meet its Prescription
Drug User Fee Act (PDUFA) goals
in 2008. A lengthened regulatory
approval process delays launch and
leads to costly setbacks for companies;
smaller companies, with more limited
cash on hand (a major factor given
today’s uncertain economic climate),
can be particularly affected by these
delays.
To minimize surprises and facilitate
adherence to timelines, brand
managers should proactively maintain
open lines of communication with
regulatory officials. Pre-submission
interactions with regulatory authorities
can assist in adequate preparation for
the application process and can help
evade oversights that cause delays.
Brand managers should coordinate
cross-functional teams to anticipate
questions from regulatory authorities
and prepare for advisory committees
and label negotiations to minimize
turnaround time by conducting “mock
FDA review” meetings with regulatory
experts and key opinion leader
panels. Risk management processes
should also be developed early in the
application process, as creation and
negotiation of these programs could
require a considerable amount of time
when deemed necessary.
Challenge 2: Increased
competition
In many therapeutic areas, multiple
products have flooded the market.
A crowded market poses additional
challenges as it is considerably more
difficult to enter and successfully gain
share. If the differentiating attributes
of the product are not clearly
communicated and a sustainable,
credible, and compelling positioning
not established in the physician’s
mind, market penetration will likely
be low and lead to a disappointing
launch.
When entering into any market,
especially a crowded one, brand
managers need to work with the
development team to ensure the
design of clinical trials will result in
data that adequately differentiates
the product from its competitors. If
the standard of care will be difficult
to replace, either niche populations
should be sought to avoid direct
competition, or, depending on the risk
tolerance of the organization, headto-head safety and efficacy trials can
be conducted to clearly demonstrate
improvements.
Brand managers must also
identify the best means of reaching
patients to effectively communicate
the competitive advantages of their
products and differentiate them
from existing therapies. As various
proposals are debated regarding
increased regulation of direct-toconsumer (DTC) advertising – and
in parallel, pharma companies
debate whether or not an acceptable
ROI can still be realized with this
route – brand managers must come
up with novel means to convey
their messages to consumers. In
addition to the traditional Web-based
approaches, including disease-state
education and branded Websites,
companies need to try alternative
approaches (i.e., partnering with
advocacy organizations and other
patient foundations) to reach the
target consumer.
Challenge 3: Decreasing
access to physicians
With increased perceptions that
pharmaceutical sales representatives
are providing limited value to physicians
and potentially even corrupting the
integrity of the healthcare system,
access of sales representatives
to physicians has become more
restricted. Some practices, hospitals,
health systems, and academic medical
institutions have gone so far as to ban
sales representative visits altogether.
In addition, busier practices simply
have less available time for a sales
visit and are thereby limiting access
to pharmaceutical company sales
personnel.
Execution of an effective launch
strategy is clearly dependent on the
successful relay of core messaging
regarding the product to stakeholders.
As such, the restricted access to
physicians can be problematic to an
accelerated uptake of a drug.
To address this issue, the launch
team must first ensure that all
personnel who are representing the
company – sales reps, medical science
liaisons, clinical research specialists,
etc. – understand the needs and
sensitivities of target stakeholders,
including physicians, nurses, office
managers, and billing managers. More
importantly, company representatives
must deliver and maximize the
“value add” with each interaction.
To achieve this objective, company
representatives must be thoroughly
trained on the customer situation,
the market landscape within the
disease state of interest, product risks
and benefits, and how the product
compares with competitors in order
to relay valuable information that can
benefit the practicing physician. With
restricted access, brand managers
must also work to find alternate touch
points for reaching the physician
and distribute the key messages
through multiple channels, including
speaker programs, Websites, direct
mail, and more modern “e-detailing”
approaches.
Challenge 4: Increased payer
scrutiny
Payers can clearly have a decisive
impact on the commercial
performance of a product. Little
could be more disappointing than
adequate commercial preparation
for product launch that is tainted by
poor uptake due to unforeseen market
access challenges. Recently, this
hurdle has become more difficult to
clear as payers become increasingly
discriminating in their reimbursement
practices.
2
Although spending on healthcare
typically continues to increase during
economic contractions, the growth of
prescription drug sales has recently
slowed significantly. The trend toward
reduced prescription spending is
due largely to payer pressure toward
increased use of low-cost generic
drugs, and further includes the heavy
discounts on generics found at chain
stores. These trends could make it
more challenging for a new branded
drug to enter into an existing market
and gain significant market share
unless compelling evidence exists
to differentiate it from lower cost
offerings.
To adequately prepare for launch,
brand managers must work to ensure
that the groundwork for a strong access
and reimbursement strategy is laid
early and key data requirements are
embedded in the overall development
plan. Sound value propositions must
be fully developed and effectively
communicated. As payers are
relying on more information to make
formulary decisions, a product value
dossier should be developed that
details the pharmacoeconomics,
quality of life, and outcomes
information related to the drug and
to justify the price established.
Challenge 5: The sub-optimal
label
Heightened competition is creating
the need to significantly differentiate
new entrants in the market. As such,
proper design of clinical studies is
fundamental to launch success.
Commercial managers are
sometimes given a product data
package that is sub-optimal in its ability
to provide data that differentiates the
product at launch. If the development
process was primarily focused on
securing regulatory approval with
less emphasis on creating clear
competitive advantages, then the
product’s commercial viability may
be compromised.
To avoid this situation, companies
must involve commercial decisionmakers throughout the development
process to ensure that the data
generation process is designed to
demonstrate competitive advantages
that will enhance uptake by all
stakeholders – patients, physicians,
and payers. Otherwise, launch
managers may be stuck trying
to make lemonade out of rotten
lemons. Of course, it is possible that
the competitive landscape changed
significantly since the beginning
of clinical trials. In this case,
differentiation studies, including the
possibility of Phase IIIb and Phase
IV programs, should be considered
to distinguish the product in current
market conditions.
Challenge 6: Cross-functional
collaboration
With involvement of many stakeholders
– both internal and external – planning
a successful launch is a daunting task.
With a global launch, some decisions
(e.g., sales force size or fulfillment
solutions) must be made on a regional
level, adding to the complexity. The
first step in ensuring cross-functional
collaboration is to clearly identify
and actively communicate the
brand strategy throughout the entire
organization. The strategy needs to
include the proposed positioning
(the space in a physician’s mind that
we want to occupy), the branded
message platform (how we are going to
differentiate the product and occupy
that space) and the critical success
factors/strategic imperatives (the 3 to
5 items we absolutely must accomplish
for launch to be successful).
Once the strategy has been defined,
the next step is to create a solid crossfunctional launch plan to translate the
strategy into reality. Key components
of the launch plan include:
• Identification of sub-teams and
key work streams
• Determination of key deliverables
• Definition of timelines for each
deliverable
• Assignment of individual
accountability
• Identification and characterization
of interdependencies
Following the development of the
launch plan, it is essential to ensure
that it is broadly shared across the
organization so team members
MedAdNews, August 2009
clearly understand the overall
picture and their individual roles and
responsibilities.
In the absence of a clearly defined
cohesive launch plan, teams will plan
and execute their duties under their
own timeframes and expectations.
This can lead to confusion or
unfortunate delays when teams do
not deliver key required deliverables
within needed timelines.
Challenge 7: Implementation
chaos
Once the plan has been constructed
and launch team members are
aware of their roles, responsibilities,
deliverables, and timelines, they
must also be properly managed.
Proper launch team management
requires well-executed coordination
and communication between all
functional groups and stakeholders
to identify and proactively address
issues before they become crises; the
responsibility for facilitating this falls
on the brand team.
Brand managers can keep
everyone on track and moving the
launch plan forward by establishing
a launch process that encourages
cross-functional collaboration
and communication. This should
be accomplished through regular
interactions where cross-functional
stakeholders are brought together for
status updates. During these meetings,
sub-team leaders are requested to
provide an update on key completed
and ongoing activities, discuss
any issues they have encountered,
and identify critical decisions/
inputs needed. Web-based project
management tools are frequently used
to share required key deliverables
and track project progress in real
time. In between these regularly
scheduled launch team meetings,
sub-teams should have sufficient
time to make progress before being
required to report back to the launch
team.
In the absence of a clearly defined
launch management process, teams
will be unable to react nimbly to
launch issues as they emerge and
will transition into a reactive mode of
“fighting fires” on a daily basis rather
than focusing on the right deliverables
at the right time.
Challenge 8: Senior
management interference
Clearly, a successful launch is vital
to the company and will attract the
attention of senior management.
However well-intentioned, senior
management can become a process
hindrance when they micromanage
as a result of not being kept properly
informed of progress, or when they
are not confident in their team’s
ability to succeed. When senior
management “gets into the weeds”
and starts questioning decisions made
by the team, launch progress can
easily stall as team members feel their
contributions are not being valued or
endorsed.
To avoid the “assistance” of
senior management, brand managers
must provide a clear and logical
plan of action up front to senior
managers. Appropriate buy-in from
senior management for the plan
must be secured early. Once senior
management has endorsed the plan,
the brand team needs to provide
regular “flash reports,” which update
management on the progress made
and identify the key issues/ decisions
requiring senior management
involvement. Conducting regularly
scheduled updates allows senior
management to feel they “own” the
launch and maintain confidence that
the plan is on track.
Challenge 9: Resource
constraints
Large companies – both pharma and
biotech – have been implementing
layoffs as a result of the challenging
market landscape that we find
ourselves in. Given the recent
economic climate and an increase in
M&A activities, managers are being
asked to do more with less.
The key to offsetting resource
limitations and “doing more with less”
is to increase efficiency in launch
preparation. By carefully mapping
out the launch plan, the brand
manager can minimize unnecessary
redundancies. Smart investments
in technological advances, such
as Web-based tools for CRM and
e-detailing, should also be used to
reduce workload on personnel and
streamline processes. Innovative
programs should also be evaluated
and selectively piloted within the
launch window. Launch management
software packages can help facilitate
the mapping of work streams and
keep track of accountability.
Challenge 10: Allocating the
budget appropriately
A solid launch plan needs a carefully
considered budget. Unfortunately
there is no “one-size-fits-all”
approach to the amount of money
needed for a successful launch and
how it should be allocated. Several
conditions surrounding the launch
need to be considered when making
those decisions.
A key driver in determining
budget allocation is the competitive
landscape. For example, the spend
and allocation required for a novel
first-in-class drug addressing a major
unmet medical need with significant
“buzz” is likely to be quite different
than a “me too” product entering a
crowded market with expectations
of capturing 5% to 7% market share.
Additionally, the organization needs
to look closely at the requirements
for commercialization. For instance,
the field force costs required to
launch a primary care product will be
significantly greater than a specialty
product.
Proper budgeting and allocation of
resources can have a major impact on
the success at launch. If the budget is
too low for the market conditions or if
allocations are incorrectly dispersed,
then market penetration will suffer
greatly as will launch revenue.
Editor’s note: This is one of an
occasional series of guest columns.
Darius Naigamwalla is senior VP
and global practice area lead, brand
management practice, Campbell
Alliance. Kuyler Doyle, is principal
consultant, thought leadership,
Campbell Alliance. Michael Turner
is VP, brand management practice,
Campbell Alliance. Campbell
Alliance (campbellalliance.com)
is a management consulting firm
specializing in the pharmaceutical
and biotech industry.
Reprinted with permission from MedAdNews, August 2009.
Copyright 2009 by Canon IMM, Inc. All rights reserved.