RETURN ONSCIENCE - alfresco.ubm-us.netalfresco.ubm-us.net/alfresco_images/pharma/2014/08/22/a9fca881-eb... · the Medical Science Liaison (MSL) ... advisory boards and KOL ... This

GLOBALIMPACT

Defining and MeasuringMSL Accountabilities

Clinical Trial Liaisons:A New Approach

Assessing Your Field-basedMedical Program Throughthe Eyes of the Customer

RETURNONSCIENCE

V O L U M E 2

GLOBALIMPACT

Medical Science LiaisonsMedical Science Liaisons

The wrong addition can weaken any team.Our MSLs are the perfect fit.

Whether your company needs one Medical Science Liaison or an entire team, SOS can help you find the right people. Finding great people who are highly qualified and expertly trained is our only business. To learn more contact Beth Price or EvanDemestihas, MD at 770-693-9300, or visit our web site at www.MedicalAffairs.com.

DEARREADER

www.medica laf fa irs .com ❘ 3

The first volume of Return on Science focused on the emergence ofthe Medical Science Liaison (MSL) role as a valuable function withina pharmaceutical company for the proper and authoritativedissemination of clinically relevant information to the medicalcommunity. The role of the Contract Medical Organization (CMO)in meeting the needs of our industry by providing contract MSLs wasalso introduced and explored. SOS feels it is time to take anotherlook at how the role of the MSL is evolving to face the challenges of adynamic marketplace, and look closely at the needs of the keystakeholders in the industry and how they now view this function.

The focus of Return on Science Volume 2 is three-fold. The first is globalizationof MSL activities. Products now require a greater worldwide harmonization andcoordination of efforts towards advocacy development. Many important issuesand potential pitfalls need to be considered when MSLs “go global.” I’m sureyou will agree that this information is timely and relevant in today’s unifiedglobal marketplace.

The second discussion focuses on the trend towards the specialization of MSLs.Return on Science Volume 1 discussed how no two MSL programs are alike. Thishas now evolved, however, into some very specialized and highly defined rolesfor certain types of “MSLs.” We discuss the roles of the Clinical Trial Liaison(CTL) and Field-based Outcomes Research Manager (FORM), which are bothadvanced roles utilizing a specialized subset of skills derived from the traditionalMSL role.

Finally, we focus on how best to analyze and clearly quantify the value andbusiness contributions of the MSL role. Not an easy task and very differentfrom company to company and from product to product. Two articles explorethis issue. SOS understands the importance of cost-effective deployment of thisvaluable resource, and we believe these articles will provide significantinformation for executives making this key investment decision. We areespecially pleased to present an article from our colleagues at ScientificCommercialization, the recognized leaders in MSL consulting services.

On behalf of SOS, I hope you find these articles informative and useful in yourfuture business decisions. Feel free to contact any of us directly should you haveany questions or comments.

Sincerely,

Evan Demestihas, MD, RPhPresident/[email protected] member of the Publicis Healthcare Communications Group

CONTENTS4 A Global Opportunity

by Ian Bancroftby Evan Demestihas, MD, RPh

8 Clinical Trial Liaisonsby Chuck Brauer

10 MSL TeamAccountabilitiesby Paul F. Souney, RPh, MSby Daniel J. Cushing, PhD, FCPby Daniel J. Leonard, MSby Bill W. Massey, PhD

19 Through the Eyes of the Customerby Beth A. Priceby Kyle Kennedy

Managing Editor:Jennifer Chalk

Art Director:Kate Haywood

Visit MedicalAffairs.com andtell us what you think.

4 ❘ www.medica laf fa irs .com

hile the global pharmaceuticalmarket is dominated by the UnitedStates with a value of almost US$

250 billion in 2004, and the US is a coremarket for many pharmaceutical companies,it is the ex-US markets that account for morethan half (54%) of the total in worldwidepharmaceutical sales and represent asignificant future growth opportunity for the

industry (Figure 1).(1) Over the years, one of the biggest challenges for the US-basedindustry has been the increase in regulatory restrictions over the marketing ofpharmaceuticals. One of the most successful responses to that challenge has been theinvestment by US companies in field-based medical support programs, which utilize theexpertise of Medical Science Liaisons (MSLs) to interact with healthcare professionals,clinical investigators and key decision makers at a peer-to-peer level to ensure that bothexternal customer needs and internal corporate objectives are effectively met. (2,3,4)

A successful MSL model has been developed and implemented within the US, and onemight consider it a simple task to transplant the same model into the overseas market. However,it is critical that ex-US MSL programs are not over-engineered for the local international mar-kets. Overseas markets may be easily confused or distracted by MSL programs if they are notimplemented in a simple and clearly understandable fashion.

The goal of this article is to provide the reader with the key essentials to rolling out a successfulinternational local market MSL program. In addition to reviewing the three core models fordeveloping MSL programs overseas, the article also discusses key insights into program alignmentand governance, appropriate clarification of the MSL role, issues concerning prelaunch MSLactivities, and the effective deployment of MSLs in overseas markets.

DEVELOPING AN EFFECTIVE MODEL FOR GLOBAL FIELD-BASED MSL PROGRAMSThe importance of global field-based MSL programs cannot be underestimated, as they

provide a key mechanism to achieve corporate goals within local markets. Successultimately depends on consistent application of initiatives across different settings, whileallowing for inherent market differences and avoiding over-engineered implementation.

There are three widely-adopted and well-accepted models for development of globalMSL programs (Figure 2). The first model is characterized by corporate funding andcorporate direction, with central appointment of MSLs. Although this facilitates controland consistency across markets, it is often limited in that it garners affiliate objections,risks not meeting local market needs, and stalls due to lack of local cooperation.

Experience clearly demonstrates that the second model is the most effective method forestablishing global field-based MSL programs. This model provides central funding for locally-driven programs and reflects corporate confidence in affiliate companies by allowing them to

Author:Evan Demestihas, MD, RPhPresident/COOSOS

Author:Ian BancroftVice PresidentMSL Global ProgramsSOS

Introduction

W

Field-Based Medical Science

Liaison Programs


take responsibility for the direction oftheir respective markets.

The third model allows individualcountries complete autonomy overboth the budget and direction of MSLprograms and is possibly the mostcommonly adopted global MSLmodel. However, it is also the modellargely responsible for why ex-USmarkets lag so notably behind the USin terms of MSL development; ingeneral, local markets are unwilling toinvest their limited budgets in pre-launch initiatives when there areseemingly more pressing concerns.

THE IMPORTANCE OF ALIGNMENTChoosing a valid model for MSL

program development is only the firststep in ensuring program success.Indeed, the key to implementing acorporate program and making itsucceed at a local level is proper

recognition and cooperation of bothcorporate and local stakeholders(Table 1). Key representatives includeglobal and regional medical directors,who are likely to be responsible formanaging the direction of the MSLprogram, and global and regionalmarketing leads who may administerthe financial direction of the program.It is also essential to gain the supportof, and effectively communicate with,the R&D, medical affairs, andmarketing departments, the clinicalresearch group, the medicalcommunications department, as wellas human resources and IT.

DEFINING THE MSL ROLE

The role of the MSL isoften confused with thatof a medical advisor,particularly in the ex-USmarkets. However, theseroles are almost polar opposites interms of their approach to thecommunication of data in support ofproduct introductions (Table 2). TheMSL role is almost always external,with programs being deployed withinthe pre- and peri-launch periods of thedrug. It is of considerable importancethat MSLs are perceived by keyopinion leaders (KOLs) as crediblescientific contacts; therefore, their roleshould be data-based and non-promotional. Generally, MSLs have amedical or scientific background andare excellent communicators.(2) Holtand colleagues (4) described a uniqueglobal program of locally-basedmedical manager-consultants whowere both highly clinically trained(MDs, or clinical PhDs or PharmDs)and had business training (MBA) or experience.

Specific tasks of global MSLsinclude KOL development activities,scientific support at congresses,competitive intelligence,reimbursement and formularydecision support, development ofclinical practice guidelines, educationand training.(2,3) Appropriateperformance metrics should also bedeveloped and used to measure thesuccess of MSL-related activities.

Value of the World’s Pharma Market $B’sFIGURE 1

Aligning globally

developed strategies

and local medical

marketing tactics is key.

IMS Health ’05

Worldwide Pharmaceutical Market 2000 - 2004

North America 157.3 183.8 205.5 229.1 247.7

Europe 85.0 91.2 103.0 133.4 156.6

Africa, Asia& Australia

93.2 88.6 92.2 105.4 118.4

Latin America 22.8 22.8 20.6 21.7 24.5

Total World Market ($B)

358.3 386.4 421.2 489.6 545.2

Growth Over Previous Year

7.8% 9.0% 16.2% 11.4%

REGION VALUE ’00 $B VALUE ’01 $B VALUE ’02 $B VALUE ’03 $B VALUE ’04 $B

A GLOBALOPPORTUNITY


PRE-LAUNCH OPPORTUNITIES FOR GLOBAL MSL INITIATIVESThe pre-launch period is critical to ensuring the successful uptake of a drug in

the market.(4) It is within this period that MSLs can develop important networkswith KOLs and decision makers to ensure that the product lifecycle begins in themost favorable manner. One important objective is to raise company awareness,given that many top US pharmaceuticaland biotechnology companies may notbe as well known in other markets. Inaddition, it is important to increasedisease state awareness among KOLs toensure that there is understanding of thedisease pathways that are being targeted.MSLs also play a role in clinical trialprograms, particularly at a phase III level.Although phase III trials may be administered centrally, local support from MSLscan aid patient recruitment and retention as well as data analysis. Furthermore,local MSL programs can focus on the development of publications based on localstudy sub-populations. Other pre-launch opportunities include facilitation ofadvisory boards and KOL education and development programs.

OVERSEEING THE GLOBAL MSL PROGRAMA simple and consistent split between corporate and local markets is ideal when

overseeing a global MSL program. Ideally, the global agenda and strategic goals ofthe program should be developed centrally to ensure a consistent direction acrossmarkets. Local countries should then be able to deploy MSLs to achieve thesegoals. This structure facilitates appropriate compliance with country-specificregulatory and promotional guidelines, customization of materials for marketsubtleties, administration to meet employment policies and integration withclinical, medical and marketing at a country level.

GLOBAL MSL DEPLOYMENTGlobal MSL deployment can involve contracted MSLs, internal MSLs or a

mix of both. Outsourcing as a means of allowing companies to focus on theircore competencies is becoming increasingly common across all businessorganizations, and the pharmaceutical industry is no exception.(5) In particular,

A HUMAN RESOURCES PERSPECTIVE…

“Once a global opportunity is identified

for rolling out an overseas MSL pro-

gram, there are many factors to con-

sider, not only from an operational

standpoint, but also from a human

resources perspective. Unlike the US,

where many employment laws are

similar across the states, each coun-

try/province overseas has their own

set of rules and regulations. Some

helpful hints that have proven

resourceful during the planning and

executing stages of an ex-US MSL

program are:

■ Research and review of local countrylaws, public policies, and trends thatpertain to the employment process. Thisincludes but is not limited to recruiting,paid time off, compensation, discipline,termination, & employment contracts.

■ Understand the differences in healthand welfare benefits offered and howthey are sponsored.

■ Review all protocols of employmentwith legal counsel from the country inquestion to ensure compliance andreduce liability.

■ Time management is key. In addition togeneral content of what is needed, dueto time zone differences andunderstanding cultures, things may takelonger than accustomed to.”

Global MSL Program ModelsFIGURE 2

GlobalMedicalLiaisonProgram

CORPORATEFUNDING

CORPORATEFUNDING

LOCALFUNDING

LOCALDIRECTION

CORPORATEDIRECTION

LOCALDIRECTION

Contract field-basedmedical liaison teamscan implement the consistent localization of global strategies.

Jennifer KingVice President, OperationsSOS


many companies choose to outsourceat least part of their MSL programs tominimize risks and limit investment inrecruiting, training and infrastructure,while exploiting the services of expertswithin this field.

Internationally, MSLs are generallydeployed to support leading nationalacademic centers and healthcareinstitutions in order to interface withKOLs in specific therapeutic areas.(2)Furthermore, relationships are oftendeveloped between MSLs andrepresentatives in key governmentagencies, such as the United KingdomNational Institute for ClinicalExcellence or the Canadian Office forHealth Technology Assessment, whichhave a major impact on drugutilization in their respective countries.

In the US, MSL programs aregenerally initiated 12 to 18 monthsprior to the launch of a product, whilein Europe, this may be as early as threeyears in advance of drug launch.Organizations that contract MSLprograms can provide to thecontracting pharmaceutical companythe planning and logistic supportnecessary for that product launch.

THE IMPORTANCE OF APPLYINGBEST PRACTICE

Global governance of thedevelopment and deployment of MSL

programs ensures thatbest practices (largelylearned from the USmarket) are shared tooptimize programoutcomes andmaximize internationaleffectiveness. Bestpractice includes:country keystakeholder alignment;integration withclinical, medical andmarketing; andinitiating KOLactivities, including

advisory boards, speaker training,workshops, formulary submissionsand appropriate communicationmaterials. The importance of MSLprofiling and sourcing is also a keybest practice learning, with effectiveMSLs often being people withmedical or scientific experienceaugmented by broad experiencewithin the pharmaceutical industry.

SUMMARYField-based global MSL programs

present a significant opportunity toachieve corporate goals at a locallevel by facilitating the developmentof strategic relationships with KOLsand decision makers. At present, ex-US markets lag behind the US withregard to MSL development anddeployment, leaving those marketsat risk of underutilizing an effectivemedical resource and thereby notrealizing their full potential.Implementation of a simple andtransferable model, which utilizescorporate support for local activitiesand is delivered in a consistentmanner in accordance with bestpractices, will ensure that corporategoals are able to be met worldwide.Furthermore, exploiting theexpertise of contract MSLs is aneffective means of minimizing riskand allowing pharmaceuticalcompanies to focus on their core competencies.

TABLE 1

Roles of Global MSLs Compared With Medical AdvisorsTABLE 2

MEDICAL LIAISON MEDICAL ADVISOR

• Predominantly external• Focus on pre/peri-launch• Frequent KOL contacts• Non-promotional • Clinical trial input, with

communication of pre-publishedstudies to top KOLs

• Generally medical/sciencebackground

• Release data via corporate• Predominantly internal• Focus through lifecycle• Infrequent KOL contacts• Legal responsibility/on-label• Clinical trial localization and

responsibility for phase IIIB/IV trials• Generally medical background• Release data to sales and marketing

Global and regional medical directors

Global and regional marketing

R&D/medical/marketing interface

Clinical trial management

Medical communications

Human resources

Information Technology

Key Corporate and Local Stakeholders for Developmentof a Global MSL Program

REFERENCES1. IMS Health 2005.2. Morgan DK, Domann DE,

Collins GE, Massey KL,Moss RJ. History and evo-lution of field-based med-ical programs. Drug Info J2000; 34: 1049-52.

3. Wolin MJ, Ayers PM, Chan

EK. The emerging role ofmedical affairs within themodern pharmaceuticalcompany. Drug Info J2001; 35: 547-55.

4. Holt RJ, Finnegan PW,Alexander JC. Making mar-kets and the global medical

information imperative: theheat is on! Drug Info J2001; 35: 225-30.

5. Firth N, Davis LJ, MurrayKM, Graves DA. Outsourc-ing industry medical infor-mation services. Drug Info J2000; 34: 1105-13.

8 ❘ www.cl in ica lso lut ionsonl ine.com

eploying CTLs to help accelerate thesuccessful completion of clinical trials is arelatively new concept. The basic principlesof this approach have proven effective in

other areas of pharmaceutical communications, such asMedical Science Liaison (MSL) programs. In fact,existing MSLs are frequently utilized to supportpatient recruitment initiatives (see adjoining column).

Physicians who see patientswith non-responsive diseaseoften seek additional treatmentoptions. One such option maybe participating in a clinicaltrial offering an alternative drugtherapy that otherwise is notavailable. Surveys indicatephysicians are willing to referpatients to studies if they areaware of them and have a basicunderstanding of thecompound and study protocol.In fact, it’s not uncommon for60% of patients enrolled intrials to come from physicianreferrals.(1)

Certainly, traditionalcommunications techniquessuch as advertising, direct mail,media relations, internetinitiatives and physician dinnermeetings are effective indelivering messages that createawareness of clinical trials andencourage physician referrals.However, in today’s highlycompetitive drug developmentenvironment over 80% of all

trials are not completed on time.(2)These delays cost sponsor companiesup to $1.3 million a day in lostrevenue.(3) There needs to be a moreeffective and expedient method ofconnecting physicians withappropriate studies.

An increasingly viable method forcommunicating with physicians isthe deployment of an outsourcedCTL team. The CTL who possess aminimum qualification of an RN orMS and expertise in the particulartherapeutic area meets with referringphysicians in close proximity of eachsite to review study parameters andthe value of participating in aspecific trial.

Author:Chuck BrauerDirector, BusinessDevelopmentSOS

D

Applying Proven MSL Techniques to Connect Physicianswith Study Opportunities

CLINICAL TRIALLIAISONS

The CTL ProcessFIGURE 1

Clinical trials are becoming more difficult toestablish and complete, particularly in suchareas as oncology, HIV, or neurology, whererecruitment and retention of patients can bechallenging. Further, recent FDA decisionsmake it likely that clinical trials will come underincreased scrutiny in the future. If so, the costsof these trials may increase exponentially.

A well-trained Clinical Trial Liaison (CTL), asa therapeutic specialist in a field-basedposition, can work closely with a sponsoringcompany’s home office and Clinical ResearchAssociates (CRAs) in presenting a unifiedmessage to primary investigative sites. Whilenot removing the need or significance of theCRA, the educational background of thesespecialized individuals facilitates peer-to-peerrelationships and offers opportunities thatcannot be realized in a long-distancerelationship. CTLs can provide education tostaff members at the investigative sites, whichis particularly important if the clinical trial is in anovel therapeutic area. Although manycompanies focus on specific therapeutic tracks,the CTL can also provide scientific support forother agents in the company’s portfolio.

CTLs are uniquely positioned to provide alink between the sponsoring company andinvestigative sites. In one recent example, acompany that had developed a therapeuticvaccine for treating advanced prostate cancercontacted SOS to provide a team of field-basedclinicians to educate primary care urologistsabout this new product. Since the drug was inphase III trials at the time, the team’s roleexpanded to include active recruitment forclinical trials at multiple locations across thecountry. These CTLs worked closely with CRAsat the company’s home office on field-basedadministrative issues, and they acted as asource of scientific information. The CTLsbecame the primary point of contact forurologists making patient referrals toinvestigative sites. They also helped urologistsestablish and manage study inclusion criteria,trained provider’s office staff on chart review,and worked with primary investigators oncommunity outreach to generate awareness ofthe trial. In several cases CTLs were successfulin identifying primary urology practices to beconsidered as expansion sites for the phase IIItrials, a role more typically seen withinvestigator-initiated studies.

The need to educate is as important as theneed to recruit and retain patients in any drugtrial, and CTLs have the ability to do both.Further, the incremental costs associated withCTLs can be offset by the increased value thatthey bring to the investigators in drivingpatient recruitment and retention.

John M. White, RPhVice President, MSL ProgramsSOS

www.cl in ica lso lut ionsonl ine.com ❘ 9

THE CTL PROCESSThe CTL follows a focused and

logical process to interact withreferring physicians and facilitate theenrollment of eligible patients (Figure1).(1) The process includes:• Developing a list of recognized

physicians by disease state in each market

• Contacting physician offices toschedule appointments

• Meeting with the physicians to discussthe protocol, inclusion/exclusioncriteria and share the support toolsavailable to successfully enroll patientsinto the study (as appropriate,secondary staff including physicianassistants, nurse practitioners andclinical coordinators are included inthese meetings )

• Providing each medical practicevisited with access to a secure,interactive internet site where slides,trial guidelines and clinically basedresources can be accessed

• Facilitating opportunities forphysicians to interact online or onthe telephone with healthcareprofessionals who will answerquestions related to specific patients

• Opening communication channelsbetween the referring physician and theprimary investigator at the local site

• Coordinating activities with ClinicalResearch Associates to insure studygoals are being met

• Assisting sites in retaining patients instudies after they have enrolled.While the process and function

described above provide a goodframework for a viable program, it isadvisable to customize the strategy andtactics for each program to insure thatall opportunities are maximized andall potential obstacles are addressed.

REFERENCES1. CenterWatch Survey, 2003

2. CenterWatch Survey 2000, 2004

3. The Monitor/ACRP, Fall 2004

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10 ❘ www.scientificcommercialization.com

ne of the persistent challenges for field-based medical programs (FBMP)across the pharmaceutical industry isthe identification of transparent,

relevant, and valid metrics that reflectthe team’s contribution to organizationalbusiness objectives and differentiate theFBMPs specific contribution from that ofother customer-facing roles in achievingspecific business outcomes. Efforts todefine such metrics often produce acollection of activity measures without aclear link to expected outcomes (number ofcustomer contacts, number of investigatorsponsored studies submitted, number ofpresentations, etc.). Stakeholders criticizesuch efforts as irrelevant to understandingteam performance and contributions to thebusiness. FBMP members criticize theseefforts as “micromanaging,” “big brother”and /or ineffective for defining the value ofthe work that they do. However, all partiesgenerally agree that specific measuresreflective of accountability are essential.

Metrics are necessary tools forunderstanding performance progress todefined objectives. They may be useful incapturing credit for the team’s contributionto business successes, evaluating gaps thatmay account for business shortfalls, andshaping appropriate corrective action plansor revised business strategy. Meaningfulmetrics inform teams as to where they arerelative to defined objectives (on target,behind planned timeline, etc.). Metrics arealso critical tools when competing withother functional areas for resources.

Authors: Paul F. Souney, RPh, MSPrincipal

Daniel J. Cushing, PhD, FCPManaging Partner

Daniel J. Leonard, MSManaging Partner

Bill W. Massey, PhDManaging Partner

Scientific Commercialization LLC

Introduction

O

An Approach to Defining and Measuring Field-Based

MEDICALSCIENCE LIAISON TEAMACCOUNTABILITIES

www.scientificcommercialization.com ❘ 11

Preparedness in defining the businesscase and the resource requirementsproposed for the FBMP isstrengthened by transparent, objectivemetrics that are easily understood byorganizational leaders. Mostfunctional areas have well-definedmetrics directly linking performanceto financials (i.e., sales). Organizationalleaders often interrogate resourcerequests by asking, “How does returnon this resource compare to that of asales representative?” where ROI iswell defined. In today’s environment,leaders are often asking what resourcescan supplant today’s sales paradigmand produce improved returns to thecompany and increase value in themedical community “under siege” bylarge numbers of sales representatives.In this environment, it is of littlewonder why sales representatives areencountering decreasing access to andtime with the customers theycompete to see.

We believe well-defined metrics thatappropriately and effectively measurebusiness process outcomes, builtaround objective and easily defineddeliverables or outcomes that areconsistently collected and accuratelydescribe a team’s contribution, arecritical tools for successful FBMPs. Theobjective of this paper is to describe aprocess to generate FBMP objectives,identify and integrate appropriate

metrics, and discuss how a structuredapproach supports both leadership andteam members (Figure 1).

FACTORS THAT SHAPE THE FBMP OBJECTIVES/ENVIRONMENTAL ANALYSIS

Assessing the business environmentis a critical step in objective planning.Four categories of information helpto inform the process of teamobjective planning: FBMPcapabilities and lifecycle positioning,internal stakeholder objectives,customer expectations, andmarket/competitor influences.

FBMP capabilities and lifecyclepositioning frame the work on whichthe team will focus. Field-basedMedical Science Liaisons (MSLs) havegreat success at gaining access tophysicians that will not see a salesrepresentative. The core activities ofthe FBMPs are geared towardsachieving the “gold standard” peer-level relationship with key opinionleaders (KOLs) and decision makers.Core skills focus on deliveringknowledge around complex scientificissues, clinical trial/research support,publication support, and presentationsupport. Typically FBMPs have adiverse mix of MSLs with basicscience/research, clinical practice,and/or pharmaceutical industryexperience. The most effective and

well-regarded FBMPs have acquiredthe competence to leverage theserelationships to support customerneeds related to the products,therapeutic areas and disease statesthat are corporate priorities. Inaddition to their activities withexternal customers, MSLs can providevalue within the company supportingthe development and registrationprocess, training local salesrepresentatives on disease state,therapeutic area and productknowledge, as well as engaging in thebusiness and account planningprocesses. Keep in mind thatindividuals within the team may be atdifferent levels of development for keycompetencies, and this variability mayimpact the teams overall approach anddelegation of responsibilities.

Understanding of internalstakeholder objectives is fundamentalto insuring that the work that theFBMP is contributing is aligned withorganizational expectations.Organizations employ FBMPs becausethey anticipate that such teams willimprove business performance;specific expectations may vary, usuallyrelated to life cycle position ofproducts for which FBMP support hasbeen recruited. Pre-launchexpectations may include outcomesrelated to improving developmentperformance (enrollment of


investigators, shortened time lines for patient recruitment,investigator performance to timelines/patient enrollmentobjectives, potential authors, consultants, etc.) or marketpreparation activities (education of KOLs and decisionmakers, product awareness, KOL relationship development,etc.). Generally, company expectations for pre-launchactivities are primarily related to achieving more rapidapproval, and quicker time to market. Support duringlaunch and post-launch periods often are accompanied byexpectations of more rapid brand uptake in the market andhigher peak sales than expected with sales support alone.FBMP are expected to establish relationships with KOLsand leverage these relationships to align company needswith KOL skills/interests (authors, speakers, investigators,consultants); engagement early in a brand life cycle mayensure access from discovery throughout the brand’scommercial life, and subsequent transition to successorbrands. Additionally, a frequent expectation is that therelationships and partnerships that FBMPs forge areexpected to establish customer loyalty towards thepharmaceutical company and/or the related brand(s).

Customer expectations also influence FBMP planning.FBMP’s customer base includes KOLs and decision makersimpacting drug therapy choices. It is necessary tounderstand organizational expectations regarding “who”the FBMP is accountable for engaging; some teams focusonly on KOLs with national or international impact, whileother teams may target regional and local opinion leaders.This mix may have a significant impact on the overall“expectations” of the FBMP’s customers. KOL

expectations and needs may vary on their scope ofinfluence, but all customers targeted should value scientificexchange and the engagement of the FBMP. In allcompanies, MSLs are a relatively scarce resource, and thislimited resource should focus on those customers thatvalue the partnership. Such appreciation may have to beearned by the liaison and is not always immediatelyapparent. How much an MSL should invest is directlyrelated to the potential magnitude of the asset the KOLmay provide. A critical part of understanding customerneeds and expectations is customer feedback. This can begained by talking directly with the customer and/or formalsurveys that request structured feedback. Needs should beassessed for the customer population as well as individualKOLs, and objectives established that address both. Informal customer surveys, KOLs report that they most valuescientific discussions with individuals that arescience/disease oriented (not product oriented), non-promotional, educators/providers of educational resources,provide new, unbiased scientific information (no“infomercials”), research oriented and can act as the KOLconnection to the company.(1) These attributes may varyin importance to different KOL populations.

Plans for these customers need to reflect FBMPcommitments to organizational objectives. Efforts withindividual customers may need to be modified asorganizational needs change. Each customer plan shoulddefine what you hope to achieve with each customer.Some customer targets may change during a planningcycle, the intensity of support to individuals may be

FBMP Planning/Assessment StrategyFIGURE 1

Company InternalStakeholder Objectives

• Establish MSL team and individualobjectives that drive KOL outcomes

• Establish activities required to achieveobjectives

• Assess capacity

• Target/deploy resources

• Establish/manage scorecard

• Assess performance to outcomeachieved and impact

MSL Team Capabilities

Market/CompetitorInfluences

KOL Expectations

Continuousassessment


modified, and some may become“inactive” if their interests/skills arenot currently needed.

A number of market/competitorissues have had significant influenceon the current MSL role. Thenumber of pharmaceutical companiesutilizing FBMPs has exploded over thepast few years. A primary driver forthis is company efforts to gainmeaningful time with key customersand other health care providers whoinfluence selection of drug therapy.Traditional representatives struggle tosecure time with many prescribers;typical call length reportedly is 2.4minutes for “drop-ins” and 6.3minutes with an appointment.(2)MSLs average 45 minutes or more perinteraction with KOLs. This providesgenerous time for physician/healthcareprofessional education aroundtargeted scientific issues, and providesan opportunity for broader scientificexchange. Improved understandingdecreases the information gap andimproves product marketpenetration. (Figure 2).(3)

Just as the market has becomecrowded for traditional sales

representatives, the increasing presenceof FBMPs is increasing competitionfor customer time. As the number ofMSLs increases, customers are“assessing” the value of theseindividuals to their practice, and areincreasingly selective in defining value.This dynamic increases theimportance of assessing FBMPperformance from the customer’sperspective. Understanding thecustomer’s view of service quality,relationship quality, value of specificservices, and attributes of a successfulMSL is important to building andmaintaining a successful team. KOLshave access to an increasing number ofMSLs, and they will choose withwhom they will engage based on thevalue they provide.

The presence of competitors/competitive brands introduces otherfactors that may impact FBMPplanning. Assessing the scientificmessaging of competitors mayimpact customer perspectiveregarding therapeutic issues.Understanding competitor activity isfundamental to maintaining aninformed position with KOLs. They

hear from all playersand expect that MSLsare at least aware ofcompetitor activity, andexpect that MSLs cancommunicate theircompany position aswell as interrogatescientific integrity ofrelated issues. It is alsoimportant to accountfor emerging issues andproducts in thecompetitor landscape:emerging science,clinical studies, futureproducts/indicationsand emerging leaders(KOLs). Effectivemanagement ofcompetitor intelligence

is a competency that may impactteam accountabilities.

Significant regulatory challengesthroughout the industry haveimpacted FBMP practice. Although ithas been believed by some that FDA’s“safe harbor” clause provided forMSLs to proactively disseminate off-label information, this is clearly notthe case. FDA representatives havecommonly indicated that the agencydoes not authorize FBMPs to promoteoff-label information. The Office ofthe Inspector General (OIG) hasnoted in its 2005 work plan that itintends to scrutinize off-labelpromotion. Corporate compliancepolicies are more clearly addressingFBMP practices than policies of thepast. Input from these sources hasresulted in a more uniforminterpretation that FBMP mayrespond to unsolicited requests for off-label information. Dissemination ofinformation should adhere toscientific rigor, be unbiased, and notpresented in a manner that misbrandsa product. Two-way informationexchange is permitted if it is bona-fidescientific information exchange, andfair balance is provided in eachresponse to an unsolicited request.Although this guidance is not uniqueto MSLs, their competencies andaccessibility by physicians and otherhealthcare professionals make themqualified resources for thisresponsibility. Compliance with thesepolicies is an important accountabilityfor FBMPs.

Other legal and ethical challengeshave impacted industry reputationsoverall, and have also impactedbusiness practices by FBMPs.Practices that empowered MSLs withrelatively broad discretionary spendinghave been tightened up across theindustry. Decisions regardingawarding research grants andeducational spending, and other“unrestricted educational” awards are

Economies of Information (3)FIGURE 2

InformationGap

Product Uptake


managed by more formal, rigorousreview processes that minimizeperceptions that such awards areissued to influence practitioneropinions. More objective assessmentsof “merit/quality” are beingimplemented. These practicesminimize MSL involvement inshaping content of educationalforums, as well as MSL influence onawarding research grants. Roles arefocused on customer partnering thatpromotes high quality submissionsand meets administrative requirementsthat might otherwise delayconsideration. Guidance on suchpractices reflecting OIG and PhRMAGuidelines is part of mostcompliance policies.

Significant drug safety issues havealso impacted industry reputations(Vioxx®, Bextra®, Tysabri®, etc).These issues have been confounded byfailure to share results of research thatclinicians perceive as early evidence ofsafety concerns, that may haveinfluenced their decisions to prescribethese drugs, and possibly avoidedadverse events that followed. Whilesuch recent high-profile events haveshaken the public’s and medicalcommunity’s confidence in thepharmaceutical industry and the FDA(e.g., COX2 inhibitors andcardiovascular safety), FBMPs createan opportunity for reliable, credible,balanced sources of drug information.MSLs have demonstrated the ability toestablish peer-level or colleague levelrelationships with KOLs and otherpractitioners. Scientific informationexchange is core to creating theserelationships. MSLs can provideinformation and educate practitionersabout emerging issues, as well asprovide customer feedback toappropriate company channels(concerns, research ideas, relevantclinical vignettes, etc.)

Finally, the public’s perception ofdrug costs and experience with

reimbursement issues has furtherfueled industry criticism. Effectivelydefining drug value based on scientificdata and clinical outcomes can helpprovide perspective concerning relativevalue. Communicating clinical andpharmacoeconomic data may also helpbalance such concerns.

Globalization of pharmaceuticalcompanies has introduced a newdimension to FBMPs. The success ofFBMPs in the United States has ledto implementation of similarprograms globally that resemble theUS model. As such globalizationcontinues, opportunities to shareresources, best practices andcompetitive intelligence betweencountry-specific affiliate officesshould be considered. Integrationwith global partners may createincreased efficiencies such as bettercommunication of investigatorinitiated trials occurring in ex-USmarkets, shared development ofstandard responses, and morecoordinated customer managementwith international KOLs.

ESTABLISH FBMP OBJECTIVESTHAT DRIVE KOL OUTCOMES

Fundamental to planning is havinga clear understanding of team strategyand how it supports organizationalstrategy. This helps provide a linkthat relates the team’s work toorganizational business.

Once the environmental analysishas been completed, objectiveplanning can proceed. Objectiveplanning is the starting point forcreating a business plan. Considerwhat needs to be accomplished by theteam: who are the customers that needto be engaged, what outcomes need tobe delivered, what needs to be done toachieve these outcomes, how willperformance be measured, and what isthe timeline for delivery. Sincedemand for FBMP services oftenexceeds capacity, an approach toprioritization may be required. Allobjectives should support the strategy.

Objectives are intended to enablecontrol over your business plan, helpmotivate individuals and teams toreach a common goal, and provide an

KOL PerspectiveFIGURE 3

110.0

100.0

90.0

80.0

70.0

60.0

50.0

40.0

30.0N= 79 79 132 132 130 130 112 112 60 60 27 27 29 29

>Once a month

Once a month

Once a quarter

Twice a year

Once a year

<Once a year

Once every two months

Contact Frequency

95% CI

*lower scores reflect morepositive customer assessment

SERVPERF RELSCORE

Relationship between contact frequency and servicequality and relationship quality from KOL perspective(1)


agreed, consistent focus for allfunctions of an organization. TheFBMP should build team objectives,which will help define individual MSLobjectives, which will furtherdetermine individual KOL objectives.

One widely used approach iscreating SMART (Specific,Measurable, Achievable, Relevant,Time-based) objectives.(4)

Specific means that an observableaction, behavior or achievement isdescribed which is linked to a rate,number, percentage or frequency. Isthere a specific outcome, which islinked to a clear metric?

Measurable indicates that a methodor procedure exists which allows thetracking and recording of the behavioror action upon which the objective isfocused. Is there a reliable system inplace to measure progress towards thedesired outcome identified?

Achievable means that the definedobjective is feasible. There is alikelihood of success, but this does notmean easy or simple. Objectives needto be a stretch and agreed upon by theparties involved. With a reasonableamount of effort and application canthe objective be achieved?

Relevant requires that the goal ortarget being set with the individual issomething upon which they canactually impact or change. The goalalso needs to be important to theorganization. Can the people withwhom the objective is set make animpact on the situation? Do theyhave the necessary knowledge,authority, and skill?

Time-based simply requires that theobjective have a start date (if it isongoing) and/or a target completiondate (if it is short term or projectrelated). FBMP responsibilities haveboth strategic and tactical dimensions;time targets need to properly considerthis perspective.

Most managers know what SMARTmeans in relation to objective setting,

yet most remain challenged to complywith all these criteria. Keeping thisscheme in mind, helps produce good,effective objectives.

Outcome measures frequentlytargeted by FBMPs includepublications, presentations,investigations, and prescribing.Individual KOL objectives includeassessment of KOLs curent capabilityto achieve a specific outcome,identifying a plan (activities) that willimprove the KOLs currentperformance level, defining thespecific outcome (that contributes toindividual MSL and team objectives)you hope to achieve in the definedtime frame, and metric that addressesprogress to goal.

ESTABLISH ACTIVITIES REQUIREDTO ACHIEVE OBJECTIVES

An understanding of keyproductivity drivers and how theyrelate to the MSL is necessary tooptimize performance. Outcomes areachieved by a combination of activitiesthat lead to successful conclusion.

Scientific (knowledge) exchange isan interaction that focuses on two-wayexchange of information on scientificissues. This activity fundamentallycontributes to successful delivery ofvirtually all FBMP targeted outcomes.It is an activity consistently highly-valued by MSL customers.Relationship building relates toengaging the KOL and nurturing therelationship, with knowledge exchangenot being the focus.

Leveraging KOL interests andprofessional needs is the basis forseveral activities, all of which mayindirectly contribute to overallrelationship quality. Meeting theseneeds requires partnering with theKOL to work toward solutionsimproving the KOLs diseasemanagement practices or drug therapychoices. Such activities might includepatient education materials, drug

administration guidelines that maysimplify or standardize therapy choicesin their practice environment, ormedical utilization evaluation tools.Coaching by MSLs may be a usefulactivity targeted toward improvingKOL skills. Coaching may includeimproving speaker skills, explainingscientific issues related to speakerslides, grant writing, or skills related toimproving investigator skills. MSLsmay also engage in activitiesspecifically intended to assess thecapabilities of a practice site orpractitioner for participation incompany sponsored clinical trials orinvestigator initiated research.

A major opportunity for MSLs isrecruiting KOL to participate incompany sponsored events or activitiesas a speaker, author, investigator, orconsultant. This activity leverages theMSL relationship with the KOL toalign company needs with the KOLskills and interests.

Categorizing such activities providesa basis for tracking time dedicated tospecific functions that may beimportant data for capacity planning.

ASSESS CAPACITYCreating a business plan always

requires a review of the team’scapacity to deliver on objectives. Inorder to determine the amount oftime available for engaging incustomer interactions, one mustdetermine the number of days theMSL has available to meet withcustomers. The customer time mustaccount for meeting planning, timewith the customer and time requiredto accomplish work related tocustomer commitments.

Other MSL activities also need tobe considered. Travel time is directlyrelated to territory size and is thegreatest determinant of the number ofinteractions that can be accomplishedby a MSL. Additionally, time forknowledge acquisition/management,

project management (protocol review,headquarter projects, etc.),administrative activities (CustomerRelationship Management data input,expenses, routing/scheduling, etc.).Other elements to consider are totalnumber of workdays, professionaland/or team/company meetings,vacation and holiday time.

Common distribution for FBMPstargets approximately 3 days forcustomer activities and 2 days forother business responsibilities for afive-day period. Annual calculationsmust consider available potentialworking days over the one-year period(often approximates 70% of MSLtotal time).

More detailed capacity planning canbe accomplished with good dataconcerning time requirements relatedto key activities. For example, duringthe days identified, how manycustomer contacts can beaccomplished? Further, utilization ofcustomer surveys can generate data onquality of relationships and customerperceptions of service quality andrelate such scores to number ofcustomer contacts. This can provideobjective insight into the level of worknecessary to achieve the desired levelof customer satisfaction (Figure 2).(1)

TARGET/DEPLOY RESOURCESTargeting specific KOLs is based on

alignment of KOL interests andattributes with business needs. Whatdoes the FBMP/MSL need to deliverto meet objectives?

The MSL role should be centeredon creating value for members of themedical community who influenceother physicians and healthcareprofessionals. Potential targets includeindividuals with the attributes tocontribute to priority outcomes(presentations, publications,investigators, formulary support, etc.)Although everyone in the medicalcommunity must keep informed on

the latest scientific advances, MSLsshould target individuals who arereceptive to scientific exchange andcontribute attributes that are requiredto meet FBMP objectives.

Objective assessments are available toprioritize KOLs with multiple attributes,and assign specific weights to individualattributes to support the sponsor’scustomer management strategy tooptimize desired outcomes.(5) Attributeweights may change depending onbusiness priorities or product(s) positionin lifecycle.

There are two common strategiesfor deployment of MSL resources.The most common approach isalignment with commercial regions.This approach aligns MSL supportwith commercial teams, providingscientific support for “on demand”customer support, sales training, andbusiness planning. A second approachis based on workload and geographicaldispersion of targeted KOLs. Thisapproach optimizes coverage ofgeographic concentrations of KOLs.This approach is most often usedwhen the MSL resource is limited.Decisions about deployment aredriven by capacity, business priorities,and FBMP strategy.

ESTABLISH/MANAGE SCORECARDAt its highest level, the balanced

scorecard is a framework that helpstranslate strategy into operationalobjectives that drive behavior andperformance. The scorecard asks youto think of your mission and strategyfrom four key perspectives:1) How do customers see us?(Customer perspective)- the scorecardshould incorporate specific measures ofwhat customers receive in terms of timequality, performance, service and cost.2) What internal processes must weexcel at? (Internal perspective) Focus oncore competencies, processes, decisionsand actions that have the greatestimpact on customer satisfaction.

MEASUREMENT TOOL TO CAPTURECONTRIBUTIONS AND VALUE OF MEDICAL SCIENCE LIAISON TEAMS

Creating metrics for measuring what Med-

ical Science Liaisons (MSLs) do is not as

daunting a task as one might think. The

more challenging aspects involve success-

fully setting achievable yet challenging

goals, applying suitable resources, and

importantly, utilizing the proper tool to

measure performance. As the MSL team

supports several stakeholders in the

organization, including medical, marketing,

sales, and regulatory, each group’s input

needs to be considered. Once goals are

agreed upon, the MSL team needs to be

evaluated for capacity and ability, and

appropriate adjustments implemented.

Finally, to measure success, today’s soft-

ware models offer myriad tools that can be

customized to capture relevant activities,

track against goals, assign weighting, cre-

ate reports, and act as repositories for

slides and other documents. Companies

have successfully employed web-based

relationship management databases for

MSL teams that are customizable and

user-friendly. This streamlines the process

of measuring team progress, and has the

flexibility to permit changes when outside

influences alter the direction of the team.

Periodic review of progress ensures proper

alignment with company strategy and key

messages. The effective MSL manager

employs active communication to set

goals, provides ongoing leadership to

deploy an effective team, and utilizes the

right tool to measure success.

Rich Murphy, RPhVice President, MSL ProgramsSOS



3) How can we continue to improveand create value? (Innovation andlearning perspective) Measures in thisarea indicate future and sustainsuccess. They measure continualimprovements to existing productsand processes and introduction of newproducts or services. 4) How do we look to stakeholders?(Financial perspective) Indicatewhether the three previous categorieshave been correctly identified andconstructed.(6)

No single measure can provide aclear performance target or focusattention on the critical areas ofFBMP business. The scorecard helpsteams focus on measures that are mostcritical. When building a scorecard,tailor the measures to fit yourcompany’s/team’s specific challenges.The scorecard can be viewed as adashboard accessible to the team,stakeholders, and organizationalleadership. It should focus onmeasures that define your progress toobjectives, provide insight to theFBMPs contributions to the business,and reflect value of thosecontributions. The scorecard’soverarching purpose should be to helpthe team evaluate the effectiveness ofspecific efforts, rather than gaugeprogress. The team must play a leadrole in designing its own scorecard tooptimize buy-in and ownership.

ASSESS PERFORMANCE TO OUTCOMES/IMPACT

The evaluation phase examinesmetrics of different categories from avariety of sources. These sourcesinclude the FBMP scorecard reportingperformance in defined areas,stakeholder reports related to areas ofFBMP targeted work (investigatorenrollment, research protocolsubmissions, speaker support,formulary status of supported brands,stakeholder satisfaction surveys, etc.),various forms of customer feedback,and commercial reports. This phaseconsiders evaluating performance toplanned objectives, but also begins toassess overall impact on organizationalbusiness objectives. Concepts hereinclude FBMP impact on achievingregistration benchmarks, productapproval, and time to market.Commercial impact may also beconsidered. Although often the focusof spirited debate in the field-basedmedical community, FBMPs oftencontribute significantly to commercialsuccess by adding value, whichincreases customer confidence andloyalty. Most teams are created toestablish relationships with KOLs anddrug therapy decision makers thatinfluence quality of developmentdeliverables, and drug therapy choicesby KOL peers and institutionalformularies. The MSL interaction

with KOLs shapes KOL opinionsabout scientific issues including drugtherapy choices. This results in twolevels of impact on product selection.First, direct impact reflects the decisionof the MSL’s targeted customer toprescribe specific product choices.Although this is not considered aprimary reason to employ FBMPs,these customers often contributesignificant prescription volume. Morecommonly, FBMPs are believed totarget customers valued for their abilityto influence prescribing of otherpractitioner groups. This is indirecteffect; the MSL influences the KOL toinfluence drug therapy choices ofothers. The source of MSL influence iseffective scientific exchange.

SUMMARY AND CONCLUSIONSDeployment of FBMPs by the

pharmaceutical industry hasincreased substantially in the last fiveyears. As pressures on the industrychallenge profits, all organizationalfunctions are challenged to improvemeasures of accountability anddemonstrate the relative value of theirfunctional contributions. Objective,transparent, valid metrics are criticalto sound planning, execution andperformance assessment.

REFERENCES1. Souney PF. Customer Relationship

Development. The Art of RelationshipDevelopment for Medical Liaisons. Presentedat: Drug Information Associated AnnualMeeting, San Antonio TX, 2003.

2. Shalo S. Out to Lunch? Successful SalesManagement Supplement, PharmaceuticalExecutive, May 2005.

3. Holt RJ, Finnegan PW, Alexander JC.Making markets and the global medicalinformation imperative: the heat is on! DrugInfo J 2001; 35: 225-30.

4. Smart Objectives. www.marketingteacher.com

5. US Patent Application – 20040177071,http://www.uspto.gov

6. Kaplan RS, Norton DP. The balancedscorecard- measures that drive performance.Harvard Business Review, January-February1992. (product no. 4096)

Today’s managed care environment dictates that decision-makersanalyze and incorporate cost-effectiveness into their product coverageprocess. The completion of critical outcomes research studies defining the“real-world” value of these products is essential for corporate success.

SOS can assist your company in the timely communication of this data to keycustomers through the deployment of Field-based Outcomes ResearchManagers, skilled healthcare professionals capable of balancing clinical knowl-edge with business and health outcomes expertise.

SOS is the industry’s premier Contract Medical Organization (CMO), dedicatedto providing clients with strategic and flexible field-based scientific programs.

To learn more contact Beth Price, Executive Vice President.

770-693-9300


Field-based medical program (FBMP) managers are often challenged todefine the value of their programs’ contributions to the company’s businessgoals and to external customers. While all parties generally agree that meas-

uring FBMP process outcomes are important, there is a lack of consensus on how bestto capture the value of the varied functions these groups perform. Quantitative meas-ures typically used to assess sales representative performance (i.e., number of physiciancontacts, number of presentations, etc.) overlook the value-added, qualitative aspect toFBMPs. By developing and periodically administering a well-constructed survey toolbased on predefined objectives and outcomes, FBMP managers are able to monitormeasures that are most critical, and gain the all-important internal stakeholder buy-into continuing or expanding their programs.

The objective of this paper is to present a practical, hands-on approach to developing asurvey tool that can be utilized to assess the value of a FBMP to both external and internalcustomers. Specifically, it will focus on how to create and disseminate the survey, and howto use the survey results to foster ongoing support from internal stakeholders. Details willbe presented on the selection of an appropriate survey audience, positive aspects andpotential pitfalls of surveying key opinion leaders (KOLs), critical ingredients of a success-ful survey, the development and evaluation process, assessing time and associated costsagainst the survey, and important feedback implementation strategies. In the end, thereader should have a greater appreciation for how to use the survey as an essential tool toassess the value of FBMP to their external customers and be able to utilise the results tocommunicate that value to internal stakeholders.(1)

“VALUE” – HOW FBMP ARE PERCEIVED BY INTERNAL STAKEHOLDERS AND EXTERNAL CUSTOMERS

Understanding the definition of the word “value” is fundamental to insuring the prop-er utilization of the survey. As defined by Webster,(2) the word “value” may be viewedquantitatively, as in “a relative or assigned worth of importance, monetary or materialworth, and equivalent worth in money, goods or services.” At the other end of the spec-trum, “value” may reflect the softer or more qualitative definition, “to consider or viewhighly,” as in valuing one’s opinion or views. So, why is this distinction important, andwhat does it have to do with surveying customers?

Author:Kyle KennedyExecutive Vice PresidentSOS

Author:Beth A. PriceExecutive Vice PresidentSOS

Introduction

F

Assessing the Value of Field-Based Medical Programs

THROUGH THE EYESOF THE CUSTOMER


Value reflects a spectrum of quantita-tive and qualitative elements. Whenassessing customers’ perceptions of thevalue of FBMPs, it is essential to incor-porate a blend of both quantitative andqualitative measures into the survey.Similarly, when presenting the results onthe value of a FBMP to internal stake-holders, be prepared to respond to thebroad range of interests represented by

stakeholder groups. For example, uppermanagement is likely to be concernedwith value for dollars invested, and thereturn on their investment; marketingmay want to know that the informationconveyed and the relationships devel-oped by the FBMP Medical ScienceLiaisons (MSLs) are building KOL inter-est in their brands; and regulatory maywant to be assured that MSLs are acting

professionally and in line with regula-tions governing their conduct. By ensur-ing that the survey collects a range ofquantitative and qualitative metrics, theresults should effectively communicatethe value that the FBMP brings to thebusiness as a whole.

Understanding the value of theFBMP, or in other words, what the pro-gram is supposed to be recognized for, iscritical to a successful survey. The firststep is to determine who should partici-pate in the survey. There are two broadgroups of customers, internal stakehold-ers and external customers (see Figure 1).Some of the disciplines or functionalareas that represent internal stakeholdersinclude marketing, clinical research,managed care, sales, and regulatory. Ifthe company has a separate pipeline orcommercial development group, theymight also be included. The obviousgoal is to have as many groups as possiblewithin the organization who recognizethe value and utility of the FBMP, thuswanting this MSL group to support theirbusiness activities. Of note, Medical

Who should you survey?FIGURE 1

Internal Customers• Marketing

• Clincal

• Managed Care

• Sales

External Customers• Clincal Investigators

• KOLs(national/regional/local)

• P&T Committees

• HVPs


Affairs is not included in the list of internal customers in Figure 1 because it isassumed that the FBMP are reporting into Medical Affairs, and are already endorsedby that group. It is recognized however, that the group may not be reporting intoMedical Affairs, and if that is the case, Medical Affairs should be considered as aninternal stakeholder.

In most instances, the principal external customer group would be the KOLs,including those with national, regional or local influence. Other external cus-tomers might include clinical investigators, depending on the activities providedby the FBMP. P&T Committee members might be considered, especially if theFBMP has a managed care or managed markets focus. High volume prescribers(HVPs), while potentially more of an interest to the commercial side of the busi-ness, may sit on the cusp of being a local thought leader because of their volumeexperience with a brand or brands. Whether or not they are a focus for the MSLsmay depend on the company. In companies with a distinct separation betweenmedical and commercial, often the MSL group might not know who the HVPsare. In smaller companies, or in rapidly changing disciplines like oncology, theremay be significant overlap between those customers designated as KOLs and those,by virtue of their practice, designated as HVPs.

POSITIVE ASPECTS AND POTENTIAL PITFALLS OF VALUE SURVEYSIt is important to review some of the positive and negative aspects of utilizing a sur-

vey before developing the tool and identifying external customer targets.

Positive aspectsKOLs often represent the most important customer. As such, they are in the best

position to provide invaluable feedback on how they value a FBMP. The surveyresults can assure that the team activities are in line with the external customers’ expec-tations, that is, it can highlight the aspects of the program that are working well andmeeting the customers’ needs. Obviously, when designing the survey, KOL inputshould be included to allow measurement of their expectations against what theFBMP group is providing.

Survey results may provide feedback on a FBMP team’s services compared withother FBMP teams. Often, this occurs without prompting when a KOL feels inclinedto compare one group’s activities with those of another company; they may refer tohigher levels of resources from another company, or they may volunteer that one par-ticular company is light-years ahead of its competitors. However, directly solicitingsuch input from all survey respondents might provide more robust information onwhat is going well and what might be done to improve the level of service.

The survey can be used, in conjunction with other performance indicators, to pro-vide a measurement of MSL knowledge and expertise. While it would not be appro-priate to use a general survey as the only assessment tool to evaluate an individualMSL’s knowledge, it can serve an important role in determining whether or not theamount of technical and scientific training, and the overall conduct and professional-ism is in line with the FBMP’s goals.

Proper geographical deployment of the FBMP team is an ongoing challenge. As itrelates to quantitative and qualitative metrics, deployment of MSLs is often based onproximity to the KOLs and their institutions. Ideally, face-to-face contact with aKOL four to six times a year is desirable, with additional contact by other means ofcommunications. If the response from a KOL is, “Great resource, but I have onlyseen my MSL twice in the past year,” this may be the trigger to critically evaluate thegeographical deployment of the program. Is the location of this MSL hindering the

CUSTOMER SATISFACTIONSURVEYS

An Emerging Method ForMeasuring The Impact OfMedical Science LiaisonPrograms

Pharmaceutical companies havebecome quite adept in developinginternal metrics to measure thevarious activities in which theirMedical Science Liaison (MSL) teamsengage. However, manymanufacturers continue to search foradditional and complementary meansto ascertain the value of their teams.One such method gaining traction isthe customer satisfaction - or KeyOpinion Leader (KOL) - survey. Oneclient recently requested that SOSdesign and initiate such a survey inorder to solicit physician feedback onthe value of its educational offeringsas well as additional areas for servicegrowth. To maximize participation,SOS created a concise, web-basedquestionnaire consisting of 13multiple-choice questions. Invitationscontaining a secure link to the surveywere e-mailed to KOLs with whomthe MSLs had interacted a minimumof 3 times. A response rate ofapproximately 75% was attained bythe end of the two week periodduring which the survey website wasaccessible for completion. Physicianfeedback demonstrated the value oftheir MSL relationships, and,importantly, that the team wasserving a defined educational need.

Scott Kraun, MBAVice President, MSL ProgramsSOS


frequency with which calls can be made?On the other hand, positive responsesaround geographical deployment couldactually confirm that team members arealigned correctly.

Finally, a well-conducted survey canbe a mechanism for fostering internalsupport and possibly expanding theteam. Positive data from a KOL cus-tomer group can provide the impetus forthe director to further champion theprogram within the organization. Dis-seminating positive results from satisfiedexternal customers is likely to generateadditional support from satisfied internalstakeholders. Even external commentslike, “This group is great; they’re a won-derful resource but you know, we justneed a little bit more, we just don’t seethem that much – the four people youhave covering the US is just notenough,” could go a long way to generat-ing support for program expansion.

Potential pitfallsAlongside the positive aspects of sur-

veying KOLs are the potential pitfalls.The challenge is learning how to turnthe pitfall into a positive outcome for the

organization. The first issue is low sur-vey response rates. Obviously, KOLs arebusy individuals and may not feel thatthey have time to complete a survey.Critical thinking is paramount whendeciding which KOLs to include on thesurvey list. For example, there may be aKOL with whom the MSL has built agreat relationship, but knowing inadvance that the KOL is too busy tocomplete the survey could prevent awasted survey. The goal is to identifysurvey recipients most likely to return acompleted survey.

In most instances, the organizationwill be best served by being open aboutthe source of the survey. A blinded sur-vey, with no company or MSL namementioned, might cause confusion for aKOL. A greater response rate can beassured if the survey letter reflects thecompany’s commitment to the KOL andstates the goals of the survey. A cover let-ter or email should state that the goal ofthe survey is to collect data that willallow the company to reinforce the serv-ices currently provided to the KOL,identify any limitations to those services,and improve or expand on those services

to better serve that KOL customer in thefuture. Specific reference to the name ofthe company, and possibly the name ofthe MSL, will ensure that the KOL’scomments are not misdirected.

The survey may identify shortfalls inprogram resources. As mentionedabove, comparative comments aboutwhat one company does versus another,though initially perceived as a negative,can be used proactively to identify whatmight need to be improved or whatresources are needed to make theimprovements. Knowing that there areissues needing improvement actuallyhelps the organization make positivechanges, and once changes are made, canindicate to the KOL that the companyvalues their comments.

Another pitfall is disgruntled respon-dents with comments such as, “Younever provide any funding.” This isprobably one of the most commonresponses in a FBMP survey. Despitethe information and resources providedby MSLs, one of the most sought-afterresources is funding for medical educa-tion or clinical research projects. Whenthe inevitable company comparison


occurs, it may result in a negativeresponse from the KOL merely due tothe company’s budget for this type ofsupport. One response to this dilemmamight be a proactive plan that outlinesthe type of educational grants or investi-gator-initiated studies that can beendorsed and supported, so that theMSL can maintain their credibility andconfidently address those areas that canbe supported.

There may be lack of clarity aroundthe MSL role. The KOL may indicatethat it is difficult to discern the purposeof the MSL among the myriad of othercompany representatives that call on theKOL. The company may have a med-ical representative, an education special-ist, a specialty representative, and a man-aged markets specialist all calling on thesame KOL. Some confusion on the partof the KOL is not surprising in this set-ting; however, more concerning is thatthe KOL might not actually be aware ofthe distinct service that the MSL canprovide. Initially a pitfall, this might beturned into an opportunity for the MSL

to revisit the MSL’s role, objectives andservices offered.

The survey may be used by KOLs todirectly compare individual MSLs. Asmentioned above, there are other toolsand mechanisms better suited to assessan individual MSL’s performance. Sur-vey results may inappropriately comparea good MSL and an exceptional MSL,with the KOL misinterpreting theexceptional performance as the stan-dard. It will be important for the pro-gram director to be able to accuratelyinterpret the results of the survey so thatindividual MSL development needs arenot misrepresented.

Finally, the survey may have beenemployed during times of corporatefinancial scrutiny or bad press. It issaid that timing is everything, andespecially so with survey results.Again, interpretation of the surveywill need to consider whether theresponses reflect a functional issue ofthe FBMP and the MSL team or badtiming of the survey while a corporateissue is being debated.

CRITICAL INGREDIENTS FOR ASUCCESSFUL SURVEY

How do you create a successful sur-vey? Is there a recipe for success? Theanswer is yes, and some of the criticalingredients are outlined in Table 1.Some type of formal communication,such as a letter or an email, summarizingthe survey is highly recommended.This accompanying letter provides agood opportunity to explain the objec-tive of the survey or why the survey isbeing administered, who is endorsingthe survey, i.e., the company name, theMSL name and/or the region, and pro-vides clarification on how the responseswill be utilized. Most physicians willappreciate their input being kept confi-dential, and knowing that their responsewill be used to improve the overall valueof the program might increase responserates. Letters might also be sent via mailwith email follow-up. Resources likewww.zoomerang.com might be used tofacilitate the implementation of the survey.

The survey should be concise anddelivered in a user-friendly format, i.e.,web-based, to facilitate response.Answers are provided with the click of amouse instead of ensuring the survey ismailed back to the company. The surveyshould also be minimally time-invasiveand easy to complete. Make the ques-tions as simple and straight-forward aspossible, using phrases that are easy tounderstand and response systems thatfacilitate responses, i.e., use check boxesor numbers entered onto a rating scale.Some open-ended questions are fine, butmake it easy enough for the KOL towant to complete it. KOLs are undertime constraints, so avoid twenty-minutesurveys; it should not take more than 10minutes to complete the survey. Again,if the survey is web-based, it shouldn’ttake much time.

A reasonable sample size is needed tomake the survey results credible. Oneway to determine sample size is to notethe total number of MSLs in the FBMPand the number of KOLs they are

Critical Ingredients for a Successful SurveyTABLE 1

Accompanying letter/email summerizing:

• Survey objective • Company name • MSL name and/or region • How responses will be used internally

Concise, user-friendly medium – e.g., web-based

Minimally time-invasive, easy to complete

Reasonable sample size

Balanced questions to yield hard data and company perceptions

• Open- and closed-ended questions• Rating scales to facilitate response

Target KOL/physicians with whom MSL has frequently interacted

Content related to resource offerings

Advanced senior management endorsement

Unbiased mode of delivery, e.g., third party

responsible for. For example, with agroup of 10 MSLs who are responsiblefor 50 KOLs each, somewhere between5-10 KOLs per MSL should be a suffi-cient sample size. The survey does nothave to be sent to every KOL.

A balance between of quantitativeand qualitative questions will yield harddata and an impression of how the com-pany is perceived by KOLs. Thereshould also be a mix of closed- andopen-ended questions, taking into con-sideration the time required to completea particular survey. The use of ratingscales within questions can be used tofacilitate responses to survey questions;for example, asking the KOL to indicatetheir response to a statement on anumerical scale of “strongly agree” to“strongly disagree.”

The survey should target theKOL/physician customer audience withwhom the MSL has frequently interact-ed. Effective targeting is key to a success-ful survey. In order to collect useful data,target KOLs that have been seen at leasttwo to three times by their MSL. The

MSLs themselves may be a good sourcefor determining which KOLs to survey;the other option is to randomly selectsurvey recipients from a list of KOLs thathave met a specific call rate threshold.Random selection might eliminate bias,but it might also result in less qualitativeinformation on the program. Also keepin mind that over time, re-surveying theKOL base is a useful method of deter-mining the impact of services delivered.In this regard, the first survey conductedwill represent the baseline upon whichsubsequent surveys will be compared.

Survey content should reflect thecompany’s resources. While it may seemobvious, ensure that the survey questionsaddress the activities and resources thatare actually being provided by the MSLs.That does not mean that open-ended

questions should not probe which servic-es the KOLs might like to see provided,but avoid asking about things that havenothing to do with the group’s current orproposed activities.

Perhaps the most important step inthe process is securing senior manage-ment endorsement of the survey prior toits distribution. The survey should bereviewed by some or all of the internalstakeholders. Prior endorsement of thesurvey instrument by internal stakehold-ers will ensure their buy-in when theresults are disseminated, and avoid issuesof omission after the fact.

Finally, deliver the survey via anunbiased mode of delivery. Thirdparty involvement in survey delivery,i.e., “ABC Research is conducting thissurvey on behalf of XYZ Pharmaceuti-cals,” may offer an additional point ofunbiased credibility in the eyes of theKOL survey recipient.

SURVEY DEVELOPMENT AND ROLL-OUT- A STEPWISE APPROACH

Step1 - The essential first step indeveloping a survey is to verify theFBMP objectives (see Table 2). Thisallows for confirmation of the group’smission and recognition of what thegroup wants to be recognized for, i.e., thevalue associated with the group’s activi-ties. Once the objectives are outlined,they should be reviewed by other inter-nal stakeholders to confirm the intendedvalue of the group from the perspectiveof the rest of the business. The craftingof the survey will be based on the group’sconfirmed objectives.

Step 2 – The intended audienceshould be identified along with a pro-jected sample size. Again, the MSLs may

The survey results can assure that the teamactivities are in line with the external customers’expectations, that is, it can highlight the aspects ofthe program that are working well and meeting thecustomers’ needs.


1. Verify FBMP objectives

2. Identify audience to be polled and determine sample size

3. Develop survey format and identify medium

4. Consider incentive

5. Create survey content. Parameters may include:

• Knowledge • Accessibility • Credibility • Relevance of data to KOL’s practice • Services provided • Expectations • Services/resources compared to other MSL programs

6. Review research design and survey content with senior management prior to distribution

7. Administer the survey

8. Evaluate results and establish baseline for future surveys

9. Disseminate to internal stakeholders ultimately demonstrating “value”

Steps in Survey Development and Roll-outTABLE 2


assist in developing this list, or a randomKOL list could be generated. With arandom list, ensure that MSLs haveactually called on those KOLs on the list.

Step 3 - Develop the survey formatand identify the appropriate medium.Determine the types of questions thatwill be asked, i.e., will they be open- orclosed-ended, or a mix of the two, checkboxes, or with rating scales? Will it beweb-based or mailed, and what will bethe content of the introductory letter?

Step 4 - Consider offering an incen-tive to encourage KOLs to complete thesurvey. Incentive options might includea cash payment or a gift certificate.Whichever incentive you choose, it mustalso comply with pharmaceutical indus-try codes of practice.

Regarding the time and associatedcosts for the first four steps in theprocess, plan for a maximum of twoweeks. The costs associated with thisphase are zero, unless an incentive isincluded for the survey recipient.

Step 5 – Creating the actual surveycontent takes the most time because thisis where the types of questions and thekind of information to be captured bythe survey are determined. To that end,there are a number of parameters to con-sider, and they include.

A) Knowledge of the MSL - howwell-versed is the MSL on thetherapeutic area, products, andcompetition? Does the MSL pres-ent information with fair balance,and what is the MSL’s overallknowledge skill set?

B) Accessibility – is the KOL easy tosee? Does the KOL see the MSLin a timely manner; and is theMSL spending adequate timewith the KOL?

C) Credibility – is the MSL honest?Does the MSL have a command ofthe information being presented?Does the MSL provide balancedinformation? Does the MSLunderstand the whole marketplace?

D) Relevance of data to the KOL’s

practice – To be effective, MSLsmust have mini-medical market-ing plans for each KOL. Whenthe MSL is face-to-face with thecustomer, is the MSL able to cus-tomize that data and informationto meet the specific needs andrequirements of that KOL? Toassess the MSL’s capabilities, tryasking about the relevance of thedata presented by the MSL to theKOL’s knowledge and practice.

E) Services provided – capture morespecific information about servic-es such as the appropriateness ofslides, funding for medical educa-tion or investigator-initiated clini-cal studies, speaking opportunitiesfor the KOL, overall competitiveintelligence, or the provision ofmedical meeting reports. Also,pursue feedback on additionalservices that the KOL would liketo see provided.

F) Expectations - What are the KOL’sexpectations, and are they in linewith what is actually being provid-ed by the MSL?

G) Services/resources compared toother MSL programs.

One suggestion on the survey con-tent is to group similar questions intosections to make it easier for the KOL tomaneuver through the questionnaire.For example, one group of questionsmight relate to MSL conduct, anothermight refer to professionalism, andanother group of questions might explic-itly inquire about knowledge. This willallow the KOL to better organize theirthoughts as they progress through thesurvey, rather than having them strugglethrough what might appear to be a hap-hazard laundry list.

Step 6 - Review the research designand survey content with senior manage-ment prior to its distribution to KOLs.Again, the purpose of this is to fosterearly buy-in by internal stakeholders.For example, looking at the total piechart of MSL activities and their respec-

tive internal stakeholders, one mightfind that the MSL activities dedicatedto managed care/managed markets isonly 10 percent of their time. It isunlikely that the survey content wouldfocus in this area since the results wouldprobably highlight this as a deficientarea. However, by liaising with theinternal managed care stakeholder, it ispossible to identify a way to constructquestions that will help to increaseMSL resources in that area. Alternative-ly, wait until a business case to increaseresources can be presented to the keyinternal stakeholder before addressingthe topic with external customers.

The time associated with step 5, cre-ating the survey content, would be aminimum of two weeks. Internal reviewof the research design, step 6, will likelyrequire at least an additional week, anddepending on the feedback, may requiresome time to incorporate the input intothe revised survey. Again, costs associat-ed with steps 5 and 6 would be zero.

Step 7 – The time associated withadministering the survey will be longerthan previous steps, and is estimated tobe about three weeks. The rate limitingfactor will be the mode of delivery; amail survey will take longer than a web-based survey. Ultimately, a combinationof both methods may necessary. Costswill again be dependent on the materialsinvolved in creating the survey, the modeof delivery, and whether follow-up sur-veys are sent to improve response rates.

Step 8 – Once the survey deadlinehas passed, use the returned surveys tocollate the results, evaluate the data, andestablish a baseline for the group. This

A well-conducted

survey can be a

mechanism for

fostering internal

support and possibly

expanding the team.


can then be used as a comparator for allfuture surveys.

Step 9 – The goal of conducting thesurvey is to be able to disseminate theresults and ultimately to demonstrate thevalue of the FBMP to internal stakehold-ers. Again, with the right results, it willbe easier to translate external customersatisfaction with the program into a satis-fied group of internal stakeholders.

Evaluating the survey results and

establishing the baseline, as well as dis-seminating the results could take anotherthree weeks. In total, all nine steps of theprocess would take an estimated threemonths for completion.

FEEDBACK IMPLEMENTATIONSTRATEGIES

Once the results are disseminated, theprocess is still not finished. Based on thefeedback from the KOLs, new or addi-tional strategies may need to be imple-mented with the program (see Table 3).The results might have identified one ormore deficiencies in the MSL knowledge

base and established the need to deliveradvanced training or reinforce corelearnings for the FBMP group. If thesurvey results showed confusion amongKOLs around the role of MSLs, it mightbe necessary to employ a program toclarify that role and to demonstrate thecommitment that group has to its KOLs,as well as its role as an effective medicalresource for KOLs. If there is an issuewith proximity or frequency of visits,

with MSLs not seeing KOLs oftenenough, or MSLs spending too muchtime on a plane, consider a realignmentof MSL territories. The need to developnew company materials to provideenhanced value may have been identi-fied. This is probably one of the mostimportant areas, as it represents a meansto differentiate the company’s FBMPfrom the competition. It may be as sim-ple as developing new slide kits forKOLs, or providing more literaturesearches. Whatever it is, think about itas a means to enhance the company’sFBMP. One result that may consistently

appear is the need for increased MSLbudgets to support KOL programs. Ifadditional funding is possible, a well-conducted survey can provide the justifi-cation for such increased funding. Ifadditional funding is not feasible, thesurvey results may indicate the need for aconsistent message that MSLs might useto more confidently address the issuewith KOLs. And finally, showing thatthere is considerable value in the FBMP,but not enough MSLs to support thecustomer base, the FBMP directorwould have the data to champion thisconcept to senior management in sup-port of additional head count.

CONCLUSIONFBMP managers are often under

pressure to show the value of the servicesprovided by such teams. A well-con-structed survey tool can provide the typeof information internal stakeholdersneed to make financial decisions. Whendeveloping and implementing a surveyto assess KOL perception of the value ofa FBMP, the survey should be minimallytime-invasive and easy to complete, itshould be distributed to the right cus-tomers and convey a clear objective. Thesurvey should be utilized to assess thevalue of the overall FBMP and not thevalue of an individual MSL. Survey con-tent should encompass the specific activ-ities and resources provided by theFBMP group, and senior managementbuy-in prior to survey distributionwould be optimal. Administration by athird party such as a Contract MedicalOrganization, or via the web, lends cred-ibility to the survey tool.

REFERENCES1. Price B. Assessing the value of your field-based

medical program through the eyes of yourcustomer. Presented at: Drug InformationAssociation Annual Meeting; June 30, 2005:Washington DC.

2. Merriam-Webster Online Dictionary,Retrieved September 24, 2005 from theWorld Wide Web: http://www.m-w.com/cgi-bin/dictionary?book=Dictionary&va=value&x=13&y=14.

Feedback Implementation StrategiesTABLE 3

Prior endorsement of the survey instrument by

internal stakeholders will ensure their buy-in when

the results are disseminated, and avoid issues of

omission after the fact.

• Reinforce and/or deliver advanced MSL training curriculum

• Clearly define and differentiate MSL role from other companyrepresentatives

• Realign territories

• Develop new company materials to provide enhanced value

• Increase MSL budgets for funding, proposals, etc.

• Expand FBMP team

SOS125 TownPark Dr., Suite 240Kennesaw, GA 30144

TELEPHONE770-693-9300

FAX770-693-9301

E-MAILBeth [email protected]

Evan Demestihas, MD, [email protected]

WEB ADDRESSwww.MedicalAffairs.com

Company DescriptionSOS is a full-service, commercial-side medical affairsgroup, established in 1997 as the pharmaceuticalindustry’s first Contract Medical Organization(CMO). SOS delivers comprehensive outsourcing ofmedical affairs activities, including global MedicalScience Liaison (MSL) and medical communicationsservices to pharmaceutical, biotechnology andmedical device companies. We integrate thesecontracted medical affairs activities with our clients’core commercial and marketing objectives. Themission of SOS is to provide high-quality medicaland professional affairs interaction to the medicalcommunity on behalf of our clients. We utilize thescientific knowledge and clinical experience ofphysicians, clinical pharmacists, nurses and otherhealthcare professionals to provide solutions for our clients.

Markets ServedPharmaceutical, Biopharmaceutical, Specialty andMedical Device

Major ProductsSOS is the preeminent provider of outsourcedmedical affairs services, and our contract global MSLs are widely viewed as the best in thebusiness. We provide clients with flexible, turnkey MSL program support that leverages and accelerates each client’s respective commercialization strategies. SOS allows you to tailor your MSL program to your corporateneeds, from fully independent and traditionallyoutsourced programs, to programs that are integrated with existing internal MSL infrastructures. We pride ourselves on identifyingand hiring the right kind of MSL candidate: a healthcare professional that possesses bothclinical and business acumen that can seamlesslyintegrate into a company’s culture. SOS is thepremiere provider of turnkey MSL solutions. From recruitment and training of personnel, to thedirect or indirect management of the program, wehelp you optimize your company’s resources acrossall cycles of your products’ development.

Major ServicesAs a CMO, our only business focus is medicalaffairs outsourcing. Our core competenciesinclude MSL services, medical communications,and drug safety support—critical activitiesnormally associated with a commercial-sidemedical affairs department. This unique servicemodel lets SOS provide clients with strategic,focused and flexible medical affairs solutionsthat best suit their immediate needs.

SOS

MSLs-Domesticand International

Medical Communications

MedicalInformation

Pharmacovigilance

125 TownPark DriveSuite 240

Kennesaw, GA 30144

Phone: 770-693-9300Fax: 770-693-9301

Web: MedicalAffairs.com

A member of the PublicisHealthcare Communications Group

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RETURN ONSCIENCE - alfresco.ubm-us.netalfresco.ubm-us.net/alfresco_images/pharma/2014/08/22/a9fca881-eb... · the Medical Science Liaison (MSL) ... advisory boards and KOL ... This