Clinical Communications Programs with Healthcare Professionals and Patients

A Multichannel Approach Clinical Communications Programs with Healthcare Professionals and Patients A Publicis Touchpoint Solutions White Paper Best Practices Series 2011 Publicis Touchpoint Solutions, Inc.

2 Clinical Communications Programs with Healthcare Professionals and Patients: A Multichannel Approach Introduction Thelifesciencesindustryiscontinuingtoexpandtheclinicalcommunicationsfunction.Despiteindustry wide restructuringandongoingbudgetconsolidation,in2011 nearlyone thirdofcompaniesanticipateanincrease inmedicalaffairsfundingofmorethan10%. 1 Thiswhitepaperexplores: Themarketforcesthataredrivingtheexpansionofclinicalcommunicationsprograms, Themostcommonclinicalcommunicationstasksandroles, Guidelinesforavoidinglegalandregulatorypitfallsinaclinicalcommunicationsprogram,and Optionsforoutsourcingtheclinicalcommunicationsfunction corporate life sciences leaders across the country and around the world are searching for a new business model that will replace the 50-year-old blockbuster-based system that served the industry so well in the past.

3 Powerful Market Forces Are Driving Clinical Communications Growth The current business environment presents a host of difficult challenges for traditional company to healthcare professional (HCP) and company to patient interactions: Poor public perception of life sciences companies Restricted access to many institutions and some HCPs Significant restructuring and reduction of life sciences sales forces Rapid rise of Risk Evaluation and Mitigation Strategy (REMS) programs Complex state and local regulations and reporting requirements In response to these challenges, corporate life sciences leaders across the country and around the world are searching for a new business model that will replace the 50 year old blockbuster based system that served the industry so well in the past. While there are no simple answers, recent expert opinions yield three strategies that may help point the way: (1) mitigate key ongoing risks, (2) strengthen relationships with specialists and key opinion leaders (KOLs), and (3) intensify the focus on patients and health outcomes. Mitigate Key Ongoing Risks According to Christopher Bowe, US healthcare analyst for Informa s Scrip Intelligence, the new business model that emerges will be the one that is best able to mitigate key ongoing risks, including regulatory, safety, communication, public policy, and manufacturing risks. 2 A well developed clinical communications program can help mitigate at least four of these five risks: 1. Regulatory 2. Safety 3. Communication 4. Public policy Strengthen Relationships With Specialists and KOLs A second way of developing a new business model is through the lens of stakeholder influence, which is undergoing a seismic shift. As detailed in Big Pharma s Market Access Mission, a 2011 Monitor white paper, Many of today s patients are deeply engaged in their own health care, as evidenced by dramatic increases in patient-driven research and communication, patient-initiated self-diagnosis, and patient-guided prescribing. As a result, the empowered patient has become a dominant industry force.

cost controls and strict formularies are causing a significant shrink in the influence of primary care physicians (PCPs). But not all HCPs are seeing their influence wane. On the contrary, medical specialists and KOLs continue to wield significant influence over drug access; in fact, KOL influence is growing rapidly. 3 (See Figure 1 below.) For life sciences companies, this shift highlights how important it will be going forward to strengthen relationships with specialists and KOLs. And, of course, this is one of the primary functions of many clinical communications programs. 4 Intensify the Focus on Patients and Health Outcomes Many of today s patients are deeply engaged in their own health care, as evidenced by dramatic increases in patient driven research and communications, patient initiated self diagnosis, and patient guided prescribing. As a result, the empowered patient has become a dominant industry force. According to James Datin, executive VP and managing director of the Life Sciences Group at Safeguard Scientifics, which provides capital to entrepreneurial life sciences companies, The two major events in the last 10 years that created a shift in the life sciences industry were the rise of consumer advertising and the Internet s effect on patients. 4 There is little doubt that the industry s new business model will compel life sciences companies to focus on patients. Clinical communications programs directly support this objective. In an effort to take a step toward the new business model, many life sciences companies are working overtime to mitigate risks, strengthen relationships with specialists and KOLs, and focus on patients. One of the strategies that can help accomplish these goals is to create a strong team of clinical communications specialists.

5 Clinical Communications Specialists Tasks and Roles Awell developedteamofclinicalcommunicationsspecialistscanexecuteavarietyoftasks: IdentifyingandinteractingwithKOLs Placingandsupportingclinicaltrials Improvinghealthoutcomesandadherence/retentionbyeducatingHCPs,patients,andcaregivers Supportingbrandsthroughtheentirelifecycle:prelaunch,launch,growth,andmaturity Respondingtoshort termopportunitiesandthreats Providingsupporttokeyspecialistsinmetroareas,institutions,andwhitespace ParticipatinginRiskEvaluationandMitigationStrategy(REMS)strategies ThethreemostcommonclinicalcommunicationsrolesareMedicalScienceLiaisons(MSLs),ClinicalHealth Educators(CHEs),andinsideClinicalHealthAssociates(CHAs):

6 Medical Science Liaisons MSLs are credentialed health professionals (including MD, PhD, PharmD, RPh, RN, etc) who interact with targeted HCPs in a nonpromotional manner. MSLs are most often field based, locally focused, full time team members. However, some companies are beginning to deploy MSLs in less traditional work settings; some MSLs work part time schedules, and others conduct all or part of their HCP interactions remotely (via teleconference, online, or live video). Regardless of their schedules or geographic settings, all MSLs work to accomplish a variety of goals: KOL and specialist education Clinical trial support Speaker training and support Managed markets support REMS and safety program participation Cost effectiveness and outcomes research Clinical Health Educators CHEs are credentialed life sciences professionals (eg, nurses, diabetes educators, respiratory therapists, dietitians, etc, depending on the disease state being supported) who interact with HCPs and patients in a nonpromotional manner. Like MSLs, CHEs are often field based, locally focused, full time team members. However, some CHEs work part time schedules, and others conduct some or all of their HCP and patient interactions remotely (via teleconference, online, or live video). Regardless of their schedules or geographic settings, all CHEs work to accomplish a variety of goals: HCP education Patient and caregiver education Advocacy group education Adherence and persistency program support REMS and safety program participation As they develop clinical communications programs, life science companies must take steps to avoid legal and regulatory pitfalls.

7 Inside Clinical Health Associates Inside CHAs are non credentialed communications specialists who interact with HCPs and patients in a nonpromotional manner. Inside CHAs conduct all of their HCP and patient interactions remotely (via teleconference, online, or live video). CHA responsibilities and work schedules are highly project specific. For instance, some situations call for all or mostly outbound communications, while others require all or mostly inbound communications. Inside CHAs can also work in conjunction with both field based and inside CHEs as part of a comprehensive clinical health communications program. Depending on the specific need, CHAs typically work to accomplish one or more of several goals: Patient education Patient support Help desk staffing and triage Adherence and persistency program support Together, proficient teams of MSLs, CHEs, and CHAs can add significantly to a company s return on education (ROE). But before those ROE gains can be realized, significant implementation challenges must be negotiated successfully.

8 Guidelines for Implementing a Clinical Communications Program As they develop clinical communications programs, life science companies must take steps to avoid legal and regulatory pitfalls. McGuireWoods, a law firm with expertise in this area, provides eight important guidelines that directly support this need. 5 Although the McGuireWoods guidelines are specifically addressed to MSL teams, they can be applied to the entire range of clinical communications roles: 1. Establish Communication Specific Standard Operating Procedures (SOPs) SOPs are particularly useful in three key communication situations: (1) interactions with the sales force, (2) interactions regarding the company s investigator initiated trial program, and (3) interactions at continuing education events. 2. Correctly Align Reporting Responsibility Although the Office of Inspector General (OIG) does not dictate reporting responsibilities, many companies decide it is best for their clinical communications teams to report to the medical affairs department. If clinical communications personnel report to a company s commercial operation, critics may mischaracterize the team s tasks. In contrast, responsibility to medical affairs more clearly evidences the nonpromotional communications role. 3. Establish SOPs for Dissemination of Off Label Information Companies should ensure that their off label dissemination policies address activities conducted by the clinical communications team and incorporate the latest FDA guidance. 4. Routinely Examine Compensation Methodologies Clinical communications personnel should never be compensated based on sales performance or prescription volume goals. Companies should constantly monitor compensation methodologies to eliminate any metrics that critics could say improperly reward clinical communications staff for questionable conduct. 5. Create Guidelines Applicable to Information Exchange Regarding Unapproved Drugs Clinical communications team members must be made aware of the promotional restrictions surrounding unapproved drugs, and caution must be exercised to avoid engaging in promotional activity. Those team members who are allowed to discuss pipeline products should be given all available information regarding the pipeline, both positive and negative. an increasing number [of companies] are choosing to employ an outsourced partner to provide [the clinical communications] function.

9 6. ReviewInteractionsBetweenSalesForceandClinicalCommunicationsSpecialists LifesciencecompaniesshouldconsiderestablishingclearinteractionSOPsbothforthesalesforceand forclinicalcommunicationsstaff.clinicalcommunicationspersonnelmustneverbeallowedtoserve(or appeartoserve)asatoolofthesalesdepartment. 7. CreateGuidanceforInteractionsRegardingInvestigator InitiatedTrial(IIT)Programs WhilenotallclinicalcommunicationsteammemberswillhaveroutineinvolvementwithIITs,clear guidanceisnecessary.teammembersmustavoid seeding trialideaswithkols. 8. AvoidInvolvementinPromotionalContext Companiesshouldtakestepstodistancetheirclinicalcommunicationspersonnelfrompromotional activities.forexample,clinicalcommunicationsstaffshouldbediscouragedfromjoiningsalesforce personnelatgrouppromotionalevents.similarly,theyshouldusuallybediscouragedfromjoiningthe salesforceonsalescalls. Asevidencedbytheseguidelines,theproperestablishmentofaclinicalcommunicationsprogramcanbea dauntingchallenge.despitethenumeroushurdles,somecompaniescontinuetomanagetheirclinical communicationsteamsinternally.however,anincreasingnumberarechoosingtoemployanoutsourced partnertoprovidesomeofthisfunction.

10 Outsourcing Clinical Communications Teams Lifesciencescompaniesbeganseveralyearsagotoincreasinglyrelyonoutsourcedprovidersforclinical researchandformanufacturing;thesetrendscontinueunabated.anotherbusinessfunctionthatiswell suitedtooutsourcingisnon promotionalcommunications,includingthoseinwhichmsls,ches,andchas areinvolved. Theidealclinicalcommunicationsoutsourcingsolutionistoworkwithapartnerthatprovidesatrue multichannelarrayofclinicalcommunicationsofferings.amultichannelpartnerofferstwoimportant advantages: 1. Theabilitytoimplementflexibleclinicalcommunicationsprogramming includingmsls,ches,and CHAs thatcanrespondtoavarietyofneedsthroughouttheentireproductlifecycle 2. Theabilitytoprovideimportantsupportservices,includingclinicaloperations,recruiting,training,and informationtechnology(eg,ipad/androidtablets,othermobiledevices,onlineapplicationsand communities,etc) Whileseveraloutsourcingcompaniesprovidestand aloneteamsofmsls,ches,orchas,onlyafewoffertrue multichannelprogrammingandsupportservices.

11 Summary Many life sciences companies deploy MSLs, CHEs, and CHAs to mitigate risk, develop strong relationships with specialists and KOLs, and intensify the focus on patients and health outcomes. Life sciences companies must take steps to avoid legal and regulatory pitfalls in designing and implementing their clinical communications programs. Many are using outsourced partners to deploy MSLs, CHEs, and CHAs. For those who wish to outsource these roles, the ideal solution is to work with a clinical solutions partner that provides a true multichannel array of clinical communications offerings. References 1. 2011 Best Practices, LLC press release. http://biomedreports.com/2011042266241/pharmaceutical medical affairs functions geta boost in budget staffing.html. Accessed May 30, 2011. 2. Primary Challenges in the Pharmaceutical Industry. A Forum white paper. 2011, 3. Big Pharma s Market Access Mission, a Monitor white paper, 2011. 4. The ABCs of Marketing Advertising, Branding, and the CUSTOMER. PharmaVoice. March 2011, 5. Part 1: http://www.mcguirewoods.com/news resources/item.asp?item=2397. Part 2: http://www.mcguirewoods.com/newsresources/item.asp?item=2413. 2011, McGuireWoods Web site. Accessed May 30, 2011.

12 Publicis Touchpoint Solutions, Inc. 1000 Floral Vale Blvd. Suite 400 Yardley, PA 19067 866-616-4777 impact@touchpointsolutions.com www.touchpointsolutions.com 2011 Publicis Touchpoint Solutions, Inc. 001-080811