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The intent of the first MSL role, created in 1967 by the Upjohn Company, was to create a position within the pharmaceutical company that could interact with academiabased physicians and researchers. In the 1970s, the trend grew, with other companies mostly implementing MSL hir ing from within their own sales organizations. According to attorney Mark DuVal, president of DuVal & Associates, MSLs started out in “fairly purist functions” but over time, the role was altered, and sales and education were brought together in the same function. In 2002, the Office of Inspector General changed the landscape of the MSL arena by imple menting strict regulations requiring a clear separation between R&D and sales and marketing. “Today, MSLs are completely separate from the sales and marketing departments and are high level healthcare professionals who can speak in depth to other healthcare professionals on a high ly scientific and technical level,” says Robin WinterSperry, M.D., president and CEO of Scientif ic Advantage LLC and MSL Advantage LLC. “MSL is an evolving specialty and is attracting highlevel candidates with advanced science degrees.” The core principal function of the MSL is to provide medical science information on a peerto peer basis. The need to deliver that information has increased over the years. While roles are solid ifying in terms of compliance and the separation from sales gets clearer, there is still room for expanding duties.
BY ROBIN ROBINSON
New exciting roles await the MSLs of the future EVOLUTION of SKILLS T The medical science liaison role was born almost 40 years ago, and in this time it has undergone many transformations.Today, as MSLs continue to be an integral component of the communication link between pharma companies and healthcare providers, they also face new opportunities and challenges. 0208issue FINAL 1/18/08 5:34 PM Page 26 27 PharmaVOICE F e b r u a r y 2 008 MSLs of the future “This trend may help keep MSLs happier in their positions,” says Erin Albert, Pharm.D., president and CEO of Pharm LLC. “MSLs often say they feel as if they are stuck in a career culdesac, but the future holds many more roles that are engaging and intellectual ly stimulating, which is the primary motiva tor for MSLs. The wider array of offerings pro vided to them, the higher likelihood of innovations, and the higher level of MSL job satisfaction, as well as customer satisfaction, make for a winwin career.” Subject to Business Trends Over the years, the evolution of the MSL has followed the course of the industry as a whole, responding to tightening regulations and the changing needs of healthcare providers. MSLs can look forward to a multi tude of challenges and responsibilities, all dependent on the company, a product’s life cycle, the therapeutic category, and the level of specialty the product requires. “With salesforces being reduced and physi cian access diminishing, the industry is focus ing on resource deployment,” Dr. Winter Sperry says. “As a resource, MSLs can address many different needs, the most important being to answer healthcare provider questions. This information is critical for improving patient care and patient outcomes and it is essential for companies to have someone who functions as a fieldbased medical resource.” As the commercial pharmaceu tical environment enters into another period of change, with an increasing number of hospitals limiting or completely eliminating access to sales representatives, and some states considering legislation that would require licensing of representatives, companies must continue to adjust their business models, says Brian Best, VP of marketing at Medicure Inc. “All of these adjustments will expand the role of the MSL, who serves as the primary vehicle for dissemination of information about industrydriven, cutting edge medical advances,” he says. “As traditional channels of com munication with customers become less viable, the MSL will continue to enjoy access to deci sionmakers and key opinion leaders.” According to Wayne Pines, president, regu latory services and healthcare, at APCO World wide, and senior regulatory counselor to Scien tific Advantage, as smaller pharma and biotech companies begin to implement MSL programs — a new trend over the past few years — oppor tunities for MSLs will continue to increase. “MSLs are going to have increasingly more important responsibilities within drug and device companies and they will become an even more essential resource for healthcare professionals,” Mr. Pines says. In some companies, MSLs take on respon sibilities that include medical education and investigator recruitment. Whatever the duties, Mr. Pines says he believes the MSL function will play an increasingly central role in the pharmaceutical and device industries’ outreach and education programs. While there have been some layoffs of MSLs in the industry recently, these are mostly due to product lifecycle management decisions rather than costreduction efforts, Dr. Albert says. “There has been some downsizing, but most of the reductions are pipeline driven,” she says. “Layoffs were related to drugs not receiving approval. Recruiters are telling me they still have open positions to fill.” According to Bruce Armon, partner at Saul Ewing, if a com pany is tightening its R&D spend, there could be some cor relation in terms of the MSL function. “In some respect the MSL function is a microcosm of what is taking place at the company level — expanding when there are growth opportunities and contracting when a company might experience an R&D road block,” he says. Downsizing may not be all bad news. Cut backs in larger companies may open up oppor tunities for MSLs to join small emerging com panies where the roles may be more unique. No matter what happens, experts agree that the MSL role is here to stay. “The need for MSLs will continue to grow,” says Joy Morrell, VP and managing director of MSLs are a talented group of academic individuals who hold very highlevel positions, YET THEY HAVE LITTLE STANDARDIZATION TO GUIDE THEM. MSLs always knew what their roles and responsibilities were, BUT OFTEN THEY WERE FORCED BY THE ORGANIZATION TO MORPH INTO A QUASISALES ROLE. Mark DuVal,DuVal & Associates Joy Morrell,The Therapeutics Institute MSL IS AN EVOLVING SPECIALTY AND IS ATTRACTING CANDIDATESWITH ADVANCED SCIENCE DEGREES. 0208issue FINAL 1/18/08 5:35 PM Page 27 28 F e b r u a r y 2008 PharmaVOICE MSLs of the future The Therapeutics Institute. “The demand for a rich scientific exchange between pharma com panies, brand executives, thought leaders, and healthcare providers will increase as companies look for ways to optimize patient outcomes.” To prepare for what Dr. Albert calls the “musical chair” effect in the industry, she sug gests MSLs expand their knowledge beyond one therapeutic area so they can adapt to the changing environment. “My advice to MSLs is to not box them selves into a niche,” she says. Another factor that may prove to be chal lenging for tomorrow’s MSL is the shrinking hiring window, which is the opportunity between prelaunch and launch. “Back in the day, a company might hire MSLs to talk and learn about the therapeutic category and the disease state 18 months to 24 months before the drug was approved,” Dr. Albert says. “Because the FDA is not approv ing as many compounds and has tightened regulatory requirements, companies are hesi tant to invest in MSLs until it appears likely that the drug will be approved.” The Future Looks Bright Companies that are not allowing MSLs to expand their role are missing out on the full potential MSLs can bring to the table. Accord ing to Dr. Albert, one of those opportunities includes engaging preclinical researchers in meaningful dialogues during preclinical development. “There is a huge opportunity for MSLs to talk to Ph.D. benchlevel researchers who are doing in vitro and small animal studies to sup port the initiatives through investigatoriniti ated research.” Another way to expand the MSL role is for MSLs to gain access to executive management. “MSLs should be reporting what they are hearing from key opinion leaders,” Dr. Albert says. “MSLs understand the voice of the cus tomer better than anybody else in the company. They are the closest to the academic thought leaders, the movers and shakers of the therapeu tic area. This is why they should be talking to managers at the top levels of the company.” Dr. Albert says more aggressive pharma companies are leveraging MSLs for these types of dialogues, but in some companies, MSLs never even meet the CEO. “Getting MSLs in front of executive man agement is critical because it not only bridges the gap but provides another venue for high level executives to understand the value of the MSL team,” she adds. Similarly, MSLs need to be involved in dia logues centered around investigator initiated trials. Many companies are leaving the MSL outside discussions involving funding selec tion, so he or she never gets to justify or explain what the investigator is hoping to accomplish with the trial. Dr. Albert says often a centralized group reviews the request, which can disappear into a “black hole” for six to 24 months, with no word getting back to the MSL. “In this situation the academic thought leader may get frustrated for lack of an answer and the MSL who is out of the loop is power less to provide an answer,” she explains. “If MSLs were included in the approval group as nonvoting members, they could at least con tribute by explaining the concept from a research standpoint.” Another area where the MSL role is grow ing stronger is in smaller emerging pharma and biotech companies. MSLs, in this case, act as the proverbial front line for the company, not only providing education about the sci ence but introducing the company to thought leaders and the market. SERVICES MSLS PROVIDE Thought leader development A link between medical affairs and clinical Positioning the science for the brand Scientific resource for the company with managed markets PARTNERSHIPS FORTHEMSL ROLE Act as internal stakeholders, for example, to bridge the relationship between commercial and clinical Establish external relationships with KOL and academic institutions Collaborate between each other to drive standardization STRATEGIC ROLES OFTHE MSL FUNCTION Position the accuracy of the science from early to late development Position the company and the brand for leadership and success, which leads to improved clinical and economic outcomes for patients Source: Joy Morrell,The Therapeutics Institute, Somerset,N.J.For more information, visit inventivhealth.com. MSL Services, Partnerships, and Roles MSL programs pay their MSLs a base annual salary in the range of $100,000 to $150,000. MSL teams continue to have strong crossfunctional interactions with marketing and sales teams. MSL involvement in preclinical and early clinical development is rare; most MSL activity occurs from Phase II forward. Most MSL program leadership communicates with executive stakeholders about the status of their fieldmedical activities on a monthly basis. Justification of MSL headcount is based on unmet need,numerical justification of unmet need, salestoMSL personnel ratio, and other factors. Source:Medical Science Liaison Institute LLC, Redondo Beach,Calif. For more information, visit mslinstitute.com. MSL Metrics and Trends If MSL leaders don’t collaborate on some basic standards for the role, THE ROLE IN THE FUTURE COULD BE TENUOUS. Dr. Erin Albert, Pharm LLC 0208issue FINAL 1/18/08 5:35 PM Page 28 Pharmaceutical companies deliver so much more than medicine. That’s why they partner with HealthEd. Our strategies support the individual needs of patients, their families, and the treatment teams who care for them. Our passion is the whole patient. Educating Patients Building Brands ph 908.654.4440 w w w . H e a lt h E d . c o m 2007 HealthEd ” It’s my diagnosis, but it’s not just me living with HIV.” 30 F e b r u a r y 2008 PharmaVOICE MSLs of the future “In this case, the MSL has the task of not only making sure the science is translated cor rectly from the clinicaltrial results to health care providers, but educating healthcare providers and market influencers about the new company,” Ms. Morrell says. “Essentially, they are launching the product as they launch the company. This is an important and some times new role for the MSL. It is important for the company to support these MSLs with good clinical data as well as the business acumen needed to establish longterm relationships with healthcare providers, thereby lining up the company’s goals and the brand’s direc tion.” Some MSLs are being asked to scope out both commercial and scientific opportunities for the company. They are often the first line of inquiry when it’s time to review current trends Sound Bites from the Field PHARMAVOICE ASKED INDUSTRY EXPERTSTO PROVIDETHEIR OPINIONS ONHOWTHE ROLE OFTHEMEDICAL SCIENCE LIAISON (MSL) WILL EVOLVE INTHE INDUSTRY INTHE FUTURE. STANBERNARD,M.D., MBA, is President of Bernard Associates LLC,Far Hills,N.J.,a healthcare industry management consulting firm.For more information, visit bernardassociatesllc.com. ” The MSL role will expand in breadth and depth reflecting two evolving industry trends. First, there are new,powerful stakeholders beyond traditional physician KOLs.Second, novel,potent technologies are transforming the pharmaceutical landscape.These emerging stakeholders and technologies will determine the adoption and use of pharmaceutical products.Consequently,MSLs will evolve from a physician KOL influencer to a scientific consultant representing companies.They will be responsible for understanding new scientific and medical technologies as they emerge in the marketplace and identifying how they may impact not only KOLs but also other key stakeholders,such as payers,policymakers,and the media. Scientifically trained MSLs will help to translate,communicate,and demonstrate the value of emerging technologies,such as biotechnology,pharmacogenomics,and nanotechnology. ” DAVIDBEST,M.D.,MBA, is President of The Doctor’s Channel,NewYork,an educational physician Website.For more information, visit thedoctorschannel.com. ” In 1989,at BMS, I wason the team that interfacing constituents beyond clinical and commercial functions.For any MSL team to succeed as an internal consulting unit,the individuals must be able to anticipate organizational needs and understand the value chain to create a differentiationdrive competitive advantage.This requires MSL teams of the future to clearly define objectives, monitor progress,and appropriately measure the outcomes of their activities. ” BETHPRICE is ExecutiveVP of Science Oriented Solutions (SOS),Kennesaw,Ga.,which focuses onmedical affairs outsourcing,most notably, the provision of credentialed, trained,and managed fieldbased MSLs.For more information,visit medicalaffairs.com. ” As companies continue to develop more complex products,MSLs have,by necessity, become increasingly more specialized.This specialization will continue into the future,not only in terms of product and disease state,but also specific to the stakeholder mix,where peertopeer communications will require a targeted scientific approach.For example,the need to educate primary investigators and their site personnel is critical to recruiting appropriate patient types and advancing a company’s clinical program.To address this need,a newbreed of MSLs,called clinical trial liaisons,has evolved,targeting these specialty healthcare providers and providing them with site specific support and resources. ” started the first scientifically credentialed MSLgroup in the industry.There were only two objectives at that time.Objective No.1 was to increase sales and No.2 was to enhance the image of commitmentonbehalf of the pharmaceutical company. Today objective No.1 has changed to `enhance medical education effectiveness.’One thing that has remained steady is increased physician accessibility.The value the MSLbrings to the physician is demonstrated by data that suggest the average call is from 30 to 45 minutes and the ongoing desire of the physician to see the MSL is on average four times per year.MSLs have fulfilled their promise by delivering the medical message at a high scientific level,colleague to colleague,and they will continue to do so in the future. ” JANECHIN,PH.D., is President of Medical Science Liaison Institute, Redondo Beach,Calif.,which advances the role of fieldbased MSLs in the biopharmaceutical industry.For more information, visit mslinstitute.com. ” MSLshave traditionally focused ondeveloping thought leaders as part of their role in representing the scientific face of their organizations. I expect that MSL teams will become internal consulting units within healthcare organizations and support their internal stakeholders as much as they support external stakeholders. In other words,a future sustainable MSL role should truly embody the liaison concept to bridge the industry with As traditional channels of communication with customers become less viable, THE MSLWILL CONTINUE TO ENJOY ACCESS TO DECISIONMAKERS AND KEY OPINION LEADERS. Brian Best, Medicure 0208issue FINAL 1/18/08 5:35 PM Page 30 She’s solved complex problems for decades ~ Imagine how quickly she can solve your clinical trial challenges today Accelerating & improving site selection, study training & patient recruitment Lisa La Luna, V.P. of Corporate Development 20 Year Industry Veteran, Passionate Problem Solver www.epharmasolutions.com (610) 8329915 32 F e b r u a r y 2008 PharmaVOICE MSLs of the future in medicine, for example, evidencebased medicine, patient therapy and treat ment, and identifying unmet patient needs, Dr. WinterSperry says. There are also commercial appli cations, as MSLs can research new areas for development and thera peutic agent acquisitions. A similar role that is expected to grow in the industry is that of the clin ical trial liaison, or CTL. CTLs assist with the com pletion of clinical trials by helping support patient recruitment initiatives and developing successful sites and investigators. “I continue to see an increasing role for MSLs in the conduct of Phase II and Phase III clinical studies, where a hightouch equals highoutput model can drastically improve the costeffective ness of clinical research,” Mr. Best says. “The MSL or clinical trial liaison can improve study start up timelines, facilitate increased enroll ment of appropriate patients, and help build relationships that will successfully transition the product from clinical studies to commercializa tion.” A CTL position could be a next step for an MSL who is looking for a different type of opportunity, Dr. Albert says. The role is more project management based than therapeutical ly related, but could be an appro priate move for an MSL with the right skills. CTLs can help speed a drug’s approval, which can mean substantial savings as well as increased revenue. CTLs are oncall 24 hours a day. They are charged with responding immediately to physicians’ inquiries about patient suitability for trials. “This role is most important in helping companies reach patient enrollment deadlines and milestones that can drive the overall suc cess of a clinical trial,” Ms. Morrell says. “The ability to develop products today that help patients reach better outcomes and improve quality of life can be greatly influenced by using a CTL at the point of care who helps facilitate recognition of who meets the inclu sion criteria and would be willing to partici pate in the clinical trial.” The Need for Standards One of the biggest challenges for the MSL of today is the lack of standardization throughout the field. The role of the MSL differs greatly from company to company and the incongruity creates confusion and frustration among both MSLs and the healthcare providers they service. Leaders in the field believe MSLs need to advocate for themselves by creating a coalition that will set standards for the profession and solidify the role, bringing more consistency to operating procedures. “Standardization is key and until this happens the industry is putting itself at risk,” Dr. Albert says. “Academic customers are perplexed by the varying responsibilities of their MSLs.” Dr. Albert explains that an MSL from one company may be able to help the healthcare provider conduct investigator initiated trials and provide CME support, whereas an MSL from another company might not be able to assist the healthcare provider with any of those services. “Thought leaders are frustrated, and if MSL leaders don’t get together and collaborate to set some basic standards there could be trou ble in the future,” she says. Ms. Morrell agrees, adding MSLs could benefit by creating their own organization and influencing the direction of their role and responsibilities. “MSLs are a talented group of academic individuals who hold highlevel positions, yet they have little standardization to guide them,” she says. This lack of standards extends even further. Determining where the line is to be drawn between sales and science in the field is clear ly understood these days, but internally this distinction can still be blurry. Even though it has been more than five years since the OIG required the separation of sales and MSLs, Mr. DuVal says some companies still put political pressure on their MSLs. “There are still some vestiges of indirect internal political or financial pressure being placed on MSLs, whether it be through perfor mance reviews, salesrelated bonuses, reporting structures, or myriad other ways,” he says. “Companies may have eliminated the connec tion to sales on paper, but in reality, in some cases, it still exists. The big challenge is getting sales and marketing to disengage from thinking THE NEED FOR FIELDBASED MSLS HAS GROWNOVER THEYEARS with the increasing complexity of therapeutic agents. Device and biotech companies also are embracing the role and launching their own teams. Dr. Robin WinterSperry, Scientific Advantage There are many people entering the growing medical science liaison field. BEING AN MSL IS AVERY EXCITING CAREER RIGHT NOW. Wayne Pines, APCO ACTL POSITION COULDBEANEXT STEP FORANMSL WHO IS LOOKING FOR ADIFFERENTTYPE OF OPPORTUNITY. 0208issue FINAL 1/18/08 5:35 PM Page 32 33 PharmaVOICE F e b r u a r y 2 008 MSLs of the future they have control over the MSL function,” Mr. DuVal says. “Companies need to create a Chi nese wall around the MSL function so these experts can operate in a pure medical and scien tific capacity.” Another internal challenge is how to effec tively delineate the lines of authority and accountability for the MSL team. In larger pharma companies, the lines are more clearly drawn, with the teams residing under medical affairs, but a smaller institution might require an MSL to wear more hats and take on more responsibilities, which may blur the lines of accountability. Dr. WinterSperry says because the industry has limited resources, strategically compa nies must do more with less, which can be challenging for MSLs. “There used to be room for broader strokes, and more time to get to the end result, but those days are gone,” she says. “Every compa ny is facing the challenge of doing more with limited resources, which means that an MSL’s activities need to be laser focused and that the strategy is appropriately on point.” Mr. Armon notes that opportunities and challenges facing the industry are often the same for MSLs. External challenges include the practice of outsourcing, physician access, and compliance. Internal hurdles include creating a clear expectation of roles and responsibilities, compliance, and retaining qualified staff. “More companies are turning to third party vendors to acquire skilled and experi enced MSLs to help with discrete projects,” he says. Ms. Morrell adds that the outsourcing trend is growing because the industry has come a long way in being willing to share science information with staff from the outside. “Allowing a nonemployee to be involved in the positioning of the science in the marketplace is a huge step in the indus try,” she says. Another challenge is the diminishing access to key opinion leaders (KOLs). “Times are changing and it might become more difficult if a KOL’s employer, for example an academic medical center, suddenly changes its policies to prevent relationships between the institution and faculty members and a pharma company,” Ms. Morrell says. “This practice would greatly impede the degree of regular and routine access allowed to an MSL for knowledge and information gathering.” # PharmaVOICE welcomes comments about this article.Email us at email@example.com. ERIN ALBERT,PHARM.D.,MBA.President and CEO,Pharm LLC, Fishers, Ind.; Pharm LLC provides services around employee retention; strategies for hiring, growing, and enhancing MSL job satisfaction; providing career development;and increasing productivity. For more information, visit pharmllc.com. BRUCE ARMON.Partner and Chair, the Life Sciences Practice Group,Saul Ewing LLP, Philadelphia; Saul Ewing is a fullservice law firm with 275 lawyers in nine offices throughout the midAtlantic region.For more information, visit saul.com. BRIANBEST.VP,Marketing,Medicure Inc., Winnipeg,Manitoba,Canada;Medicure is a cardiovascular drug discovery and Experts on this topic development company focused on effective therapeutics for unmet needs.For more information,visit medicure.com. MARKDUVAL. President,DuVal &Associates PA,Minneapolis;DuVal &Associates is a law firm focused on pharmaceutical,medicaldevice, biotech,and nutritional supplement companies. For more information,visit duvalfdalaw.com. JOYMORRELL.VP and Managing Director, TheTherapeutics Institute, Somerset,N.J.; TheTherapeutics Institute, an inVentiv Health company,helps to build advocacy,educate healthcare professionals,and sensitize markets to novel therapies.For more information, visit inventivhealth.com. WAYNEPINES.President,Regulatory Services and Healthcare,APCO Worldwide,Washington, D.C.; APCO provides public affairs services to the pharmaceutical and other industries.Mr. Pines is also a Senior Regulatory Counselor, Scientific Advantage LLC,Bernardsville,N.J.; Scientific Advantage is a consulting firm specializing in MSL and medical affairs. For more information,visit apcoworldwide.com or scientificadvantage.com. ROBINWINTERSPERRY,M.D. President and CEO,Scientific Advantage LLC and MSL Advantage,Bernardsville,N.J.; Scientific Advantage is a consulting firm specializing in MSL and medical affairs, and MSL Advantage offers fulltime and parttime contract solutions for medical affairs and MSLs.For more information, visit scientificadvantage.com. The MSL function is in part dictated by the evolution of research and products being developed,BUT AS LONG AS THEY INVOLVE SOPHISTICATED SCIENCE,MSLS WILL ALWAYS HAVE AN IMPORTANT ROLE IN SHARING KNOWLEDGE AND INFORMATION. Bruce Armon,Saul Ewing MSLS HAVE LITTLE STANDARDIZATION TOGUIDETHEM. To access a FREE Podcast featuring Dr. Robin WinterSperry go to pharmavoice.com/podcasts. 0208issue FINAL 1/18/08 5:35 PM Page 33