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Preparing the Market for a New Drug through

an Effective ‘Medical Affairs Launch’

Gary Tyson, Senior Vice-President, Clinical Development and Medical Affairs Practice Areas
Kuyler Doyle, Principal Consultant, Campbell Alliance

With changes in the pharmaceutical industry, Medical
Affairs has grown into an increasingly critical func-
tion. Access challenges are limiting contact between
sales representatives and physicians at a time
when therapeutic areas are becoming increasingly
crowded. Prescribers want to remain informed, and
pharmaceutical companies are looking for ways to
raise awareness of the attributes of new products to
distinguish them from competitive alternatives.

With the ability to educate key opinion leaders

(KOLs), a well-executed medical affairs launch
strategy can help inform important stakeholders
regarding the promise of an upcoming drug. This
article lays out best practices that Medical Affairs
teams can use to help prepare the market for an
approaching launch.

The Importance of Medical

Affairs at Launch
Recent scrutiny of pharmaceutical marketing and
sales activities has resulted in enhanced signifi-
cance of the Medical Affairs function. Institutional
and office restrictions on sales representatives
have limited the time of the detail to mere minutes,
if permitted at all. Further, reimbursement policies keting practices. All materials distributed through With increasingly crowded therapeutic areas,
from global payers are exerting greater influence on the activities of Medical Affairs should be reviewed manufacturers must vigorously prepare the market
prescribing behaviors, leading companies to shift for compliance with existing regulatory policies. for launch in order to gain market share. To ac-
some of their focus from physicians to managed complish this, companies must find ways to make
care organizations. With the ability to carry out peer-to-peer discus- sure that prescribers are well aware of the new drug
sions, medical science liaisons (MSLs) have fre- and how it is distinguished from competitors in the
Although the roles of Medical Affairs have not been quently been granted greater access than the sales market. Since standard sales force and advertising
altered, the new industry climate has raised the vis- force to physicians and KOLs. Whereas sales rep- promotions for the product are not initiated before
ibility of the functional area, and their activities have resentatives must limit discussion to the product FDA approval of the drug and its product label,
become increasingly critical for communication label of a marketed product, discussions with MSLs companies must use other means to accomplish
with important stakeholders. The role of the Medical center around scientific exchange related to broader this objective. Through established relationships
Affairs function is to educate stakeholders through topics. KOLs look to MSLs to provide information with KOLs who can help prepare prescribers for the
the delivery of the accurate, complete, and unbiased that could benefit their research interests, including arrival of the new product, Medical Affairs can take
information that supports a product. Medical Affairs information on pipeline drugs and the develop- a defined leadership role in ensuring that stakehold-
activities must comply with federal, industry, and ment plans for those drugs. This communication of ers are made aware of the coming product and the
company regulatory policy and are not designed to meaningful information is the foundation of ongoing unmet needs it can fill.
“promote” a product or substitute for Sales and Mar- relationships between KOLs and MSLs.

Preparing the Market for a New Drug through an Effective ‘Medical Affairs Launch’

How to Carry Out a Medical Medical Affairs should also lend support to regis- During Pre-Launch, Medical Information should es-
trational trials. Through its ties with KOLs, Medical tablish an operational plan for the call center func-
Affairs Launch Affairs can contribute to site identification and tion. Medical Information should also monitor trial
patient enrollment when needed. Further, they can data and scientific literature to prepare for specific
Launching a pharmaceutical product requires an provide general support for clinical trials to monitor questions about the product itself as well as general
immense amount of operational planning, and progress. A designated Clinical Trial Liaison (CTL) questions about the competitive space.
effective execution of a medical affairs launch is no may also be assigned to help supervise trial man-
different. As the medical affairs launch is meant agement and keep progress moving forward with The Pre-Launch time frame is appropriate for gen-
to prepare the market prior to entry, many critical minimal delays. eration of an IIS strategy. The process for submis-
activities must take place well in advance of actual sion and review of study proposals needs to be
launch. To facilitate planning, the medical affairs In terms of internal education, Medical Affairs is developed and approved. For registrational trials,
launch needs to be coordinated as a set of activities tasked with helping the new brand team become Medical Affairs should continue to contribute to
divided by time frames prior to and following market familiar with the science of the drug and the disease patient enrollment and support the trials as needed
launch. Time frames are divided into Early Market, area itself. Medical Affairs also needs to keep and appropriate.
Pre-Launch, Launch, and Post-Launch phases, each the Competitive Intelligence section of Marketing
with a set of objectives and activities (See Table). informed by collecting and reporting relevant infor- Internal education during this period should focus
mation from congresses and KOLs on therapeutic on the sales force and the managed markets
Early Market trends in clinical practices related to the disease, function. Clearly, these groups need to know
The Early Market stage of the medical affairs launch current standard of care, and competitive com- information about the indication and the unmet
includes activities that initiate the market planning pounds in development and on the market. needs in the market. These stakeholders should be
and preparation in the time frame greater than 24 well-informed with regard to the disease state, the
months prior to actual launch. At this early stage, Pre-Launch drug in development, trial data, and ongoing studies.
the primary objective of Medical Affairs is to propa- Pre-Launch includes the time between 24 and Market updates related to competitive intelligence
gate thought leader interest in the product. 12 months prior to market. At this stage, Medical should continue to be collected and provided to
Affairs must ensure that key thought leaders who relevant stakeholders.
To begin to generate thought leader interest in the drive treatment guidelines and protocols under-
drug, the Medical Affairs team must first develop a stand the drug. Launch
KOL strategy associated with the product. The strat- The Launch period includes the time from 12
egy will include a detailed list of KOLs to engage, Within the Pre-Launch phase, KOLs who are part months prior to the market launch. During the
based upon their interest in research and education of the defined strategy need to be assessed to Launch phase, the objective of Medical Affairs is to
for the given indication. During early interactions, determine their base knowledge and experience make sure that prescribers have a clear understand-
MSL teams should begin to inform KOLs regarding with the pipeline drug. This baseline measurement ing of the use for the drug.
the science behind the new product, ongoing trials will be critical to monitor increased awareness with
and timelines, and the results of emerging data as continued outreach and facilitate an assessment When in the Launch phase, KOL outreach needs to
they are made public. Of course, it is important of how extensive the scientific exchange will need focus more on the product itself than the general
to reiterate that interactions must comply with to be in order to accomplish desired levels of drug disease state. As such, scientific exchange should
FDA regulations that prohibit the promotion of an knowledge. Further, the interests of the KOLs can be increasingly include information regarding com-
investigational drug as being effective or safe, and assessed during discussions to gauge appropriate pound-specific attributes and physician perceptions
balanced information including both positive and scientific exchange and any potential opportunities of the drug profile. Data from these interactions
negative results should be disclosed. for future investigator-initiated studies (IIS). Again, can help determine strategy for further outreach
to steer clear of any regulatory compliance con- to prepare for market launch. External educational
Further external education activities should also cerns, it is important that trial concepts be derived via congresses and advisory boards should also
take place during the Early Market stage. Scientific from the investigator and not initiated by the MSL. expand the scientific exchange to include further
exchange resources, such as mechanism of disease information regarding the product. Publication of
(MOD) and mechanism of action (MOA) presenta- External educational activities during this stage trial data that differentiate the product from its com-
tions, slides summarizing key data from medical include presentations of appropriate data at key petitors is critical and needs to occur at this stage.
meetings and congresses, and summaries of congresses, advisory boards, and clinical inves-
changes to practice guidelines, should be created tigator meetings. These meetings are imperative With regard to trials, KOL feedback regarding the
to facilitate sharing of information. In addition, to share relevant data with thought leaders and strengths and potential weaknesses of the data
speaker programs can be initiated to raise aware- continue to foster relationships. The Medical Affairs package supporting registration should be collected.
ness of the disease state, current therapeutics, and function responsible for medical communications Review of IIS applications should proceed, and those
current gaps in patient care. During this phase, the should begin publishing and presenting the pivotal that fit into the overall IIS strategy should be accepted.
function within Medical Affairs responsible for medi- trial data as reflected in the timeline of the overall During this period, the generation of a Phase 4 strategy
cal communications should create their publication launch strategy. should also commence to map out studies that can
and congress plans. further differentiate the product post-marketing.

Medical Affairs Objectives and Activities by Time Period

Early Market Pre-Launch Launch Post-Launch

(over 24 months before launch) (24 to 12 months before launch) (from 12 months before until launch) (up to 12 months after launch)

Help generate TL interest in Ensure that key TLs who drive Make sure that there is clear Ensure prescriber questions are
Objectives product treatment guidelines and proto- understanding of the use for answered and that they know
cols understand the drug the drug exactly how to use drug

External Education Activities

Create KOL strategy, profile, and Seek feedback from KOLs related
detailed KOL list to the acceptance of product
Create specific KOL strategy Expand scientific exchange to among various physician special-
related to health economics / Establish appropriate level of include compound-specific attri- ties
KOL Planning and outcomes research scientific exchange to determine butes and physician perceptions Learn, report, and document
Engagement Collaborate about science (e.g., KOL knowledge base, opinions, issues faced by physicians
Support speaker training activities
MOD, MOA), trials, and timelines and interests Continue expansion of scientific
as appropriate
Share emerging data as ap- exchange to include clinical prac-
propriate tice guidelines and additional
areas of study

Create scientific exchange tools Present appropriate data at key Present appropriate data at key Present appropriate data at key
External Education and and resources congresses, advisory boards, congresses, advisory boards, congresses, advisory boards,
Oversee speaker programs on dis- clinical investigator meetings, and clinical investigator meetings, and clinical investigator meetings,
Scientific Exchange ease state, current therapeutics, other appropriate groups other appropriate groups and other appropriate groups
and patient care gaps

Create a publication / congress

strategy and plan
Medical Communications / Disseminate disease state aware- Publish and present pivotal Publish and present pivotal Publish and present pivotal
ness information as appropriate trial data consistent with overall trial data consistent with overall trial data consistent with overall
Publication Planning or needed strategy strategy strategy
Communicate early trial data and
any distinguishing attributes

Establish operational plan for

medical information / call center Respond to patient and physician
Medical Information / function Respond to patient and physician
N/A inquiries
Monitor literature and trial data inquiries
Call Center to prepare for questions about
Generate information to dissemi- Monitor adverse events
nate to patient and physicians
the product and the competitive

Trial Activities
Contribute to site identifica- Contribute to patient enrollment
tion and patient enrollment as Seek KOL feedback on strengths
Registrational Trials as appropriate
appropriate and potential weaknesses of data N/A
Provide general support for clini- supporting registration
Provide general support for clini- cal trials
cal trials

Create IIS strategy and process Review ISS proposals if consistent  eview ISS proposals
with ISS strategy  versee approved IIS progress

Contribute to Phase 4 strategy

and planning
Phase 4 Studies N/A N/A Initiate and oversee Phase 4
Lead or contribute to health studies
economics / outcomes research

Internal Education Activities

Help newly formed brand team Educate sales force and managed Educate sales force and managed
Internal Education get up to speed on science and markets function on disease markets function on disease N/A
disease area state, drug, clinical data, and trials state, drug, clinical data, and trials

Collect and report relevant infor- Collect and report relevant infor-
mation gathered from congresses mation gathered from congresses Collect and report relevant infor- Collect information about how
Market / Competitive and KOLs about clinical practice and KOLs about clinical practice mation gathered from congresses the launched product is being
and therapeutic trends, standard and therapeutic trends, standard and KOLs about perceptions of
Intelligence the product to be launched
of care, and specific compounds of care, and specific compounds
and products and products

Preparing the Market for a New Drug through an Effective ‘Medical Affairs Launch’

The task of informing internal stakeholders during Medical Affairs should continue further review of Although this framework demonstrates best prac-
Launch includes further education of functions IIS proposals and facilitate overseeing the ongoing tices, it is not without challenges. Many Medical
and teams as needed. While in the Launch phase, studies. Affairs groups are already stretched in their abilities
Competitive Intelligence should remain up-to-date to adequately cover the activities related to inline
on perceptions of the product gathered through For competitive intelligence, Medical Affairs should products and are not staffed to allow taking on
congresses and interactions with KOLs. This will maintain the collection of information relating to further responsibilities until they are an absolute
allow brand teams to respond accordingly with how the launched product is being received by phy- imperative. Further, the enhanced roles of Medical
further outreach and marketing campaigns during sicians and patients. These valuable data will help Affairs are still relatively new, and many groups
this critical time. to update marketing efforts as deemed necessary. have not developed programs to optimize effective-
ness prior to launch. In fact, some internal company
Post-Launch policies restrict the ability of the field Medical Affairs
Conclusion teams to discuss pipeline products with thought
The Post-Launch phase of the medical affairs launch
is the time frame up to12 months following market leaders.
With increasingly crowded therapeutic areas in
launch. During this period, Medical Affairs must the pharmaceutical industry and a more restricted
ensure prescriber questions are answered and that To maximize product awareness and uptake as soon
promotional environment, Medical Affairs must in-
they know exactly how to use the product. as it hits the market, there needs to be a shift to-
crease its role in product launch. Clearly, preparing
wards Medical Affairs taking a more proactive role in
the marketplace for new product launch can drive
During Post-Launch, Medical Affairs should seek launch preparation. Since thought leader influence
increased awareness at launch and increase the
feedback from KOLs related to the market launch of over prescribers occurs progressively, the medical
probability of success. Taking a structured approach
the product. Specifically, information must be col- affairs launch must begin early in the planning
to enhance medical affairs activities surrounding
lected regarding acceptance of the product among process, and many key activities must take place
launch can increase the knowledge of thought lead-
prescribers and issues being faced with the drug. well before the actual launch.
ers for the indication, who subsequently educate
Scientific exchange needs to expand to include other physicians.
discussions surrounding clinical practice guide- Preparing for launch is massive exercise in opera-
lines and potential additional indications or areas tional planning. Proper market conditioning through
This article has presented a basic blueprint for how
of study. Further, the product call center should medical affairs activities can have a real impact on
to carry out a medical affairs launch. Of course, this
respond to all patient and physician inquiries and increasing product awareness at launch, but has
is a generalized overview and the specific activities
monitor adverse events reports. largely been neglected in terms of practice. With an
will need to be customized to the therapeutic area
increased focus on medical affairs activities prior
and stakeholders to be targeted. Finding the right
Post-Launch is the appropriate period for com- to launch, the brand team will find physicians more
KOLs is paramount to this exercise, as they can en-
mencement of non-registrational trials. During knowledgeable about the drug and its distinguishing
gage the most likely early adopters of new products.
this stage, IIS and Phase 4 studies can be initiated. characteristics, thereby facilitating early success.
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