MSLs have been around for 40 years, and with the evolution of technology, increased regulations and government scrutiny, and the squeeze of the declining salesforce, today the role may be even more crucial to the drug-development and commercialization process. According to Robin Winter-Sperry, M.D., president and CEO of Scientific Advantage and MSL Advantage, MSLs are now identified as a formal component of the commercialization process of a product or therapeutic agent. “MSLs are being recognized as a specialty force and they are an important resource to the company and to the clinicians and healthcare providers who they deal with," she says. One new development in the MSL role is the move toward specialization. In the past, MSLs were inclined to be generalists, but as the role evolves, MSLs are involved in business unit discussions, serve as the voice of the practitioner, and are giving input to brand teams. Their roles could and should expand… Sidebars: Sound Bites From The Field Neil H. Gray is Managing Partner of Healthcare Trends & Strategies LLC, a ­consultancy focused on improving medical science liaison performance, problem solving, and value generation. For more ­information, e-mail [email protected]. Joy Morrell is Senior VP and Managing Director of The Therapeutics Institute, which provides dedicated teams of medical science liaisons and clinical ­educators to create and expand market ­opportunities and achieve business objectives for pharmaceutical and biotech clients. For more information, visit inventivhealth.com. John Pelkowski is Senior Director Client Engagement, Medical Affairs at AstraZeneca, a global pharma ­company. For more information, visit astrazeneca.com. Bryan Vaughan is ­Managing Member of ­Trinetpharma, an equitable talent sourcing company that provides both ­permanent and contract solutions for the placement of MSLs. For more ­information, visit trinetpharma.com. Pre- and Postlaunch Activities Company-Adopted MSL Metrics Experts on this topic Erin Albert, Pharm.d. President and CEO, Pharm LLC, a provider of services for ­employee retention; strategies for hiring, ­growing, and enhancing MSL job satisfaction; and providing career development; and increasing ­productivity. For more information, visit ­pharmllc.com. Jane Chin, Ph.D. Founder, MSL Institute, an executive adviser for MSL directors focused on demonstrating the value of their MSL ­programs and who are ­committed to ­improving the industry ­contribution of their MSL teams. For more information, visit ­mslinstitute.com. Anton Ehrhardt, Ph.d. Senior Medical Director, ­Millennium: The Takeda Oncology Company, a biopharmaceutical company whose ­development and commercialization activities are focused in oncology. For more ­information, visit millennium.com. Dave Fishman. President, Snowfish, which provides insights to healthcare, life-sciences, and biotechnology companies. For more ­information, visit snowfish.net. Rob Nauman. Principal, BioPharma Advisors, a community of ­pharmaceutical ­professionals working ­together to solve ­business issues and ­create organizational changes that maximize revenue and minimize cost. For more ­information, visit biopharmaadvisors.net. Beth Price. Executive VP, The Medical Affairs Company, a provider of strategically aligned and customized MSL programs. For more­ ­information, visit themedicalaffairscompany.com. Robin Winter-Sperry, M.D. President and CEO, Scientific Advantage LLC, a consulting firm specializing in MSL and medical affairs, and MSL Advantage, which offers full-time and part-time contract ­solutions for medical affairs and MSLs. For more information, visit ­scientificadvantage.com. Doug Young, Ph.D. VP, Global Medical Affairs, Bristol-Myers Squibb, a global ­biopharmaceutical company firmly focused on its ­mission to discover, develop, and deliver ­innovative medicines that help patients ­prevail over serious diseases. For more ­information, visit bms.com. SLs have been around for 40 years, and with the evolution of technology, increased regulations and government scrutiny, and the squeeze of the declining salesforce, today the role may be even more crucial to the drug-development and commercialization process. According to Robin Winter-Sperry, M.D., president and CEO of Scientific Advantage and MSL Advantage, MSLs are now identified as a formal component of the commercialization process of a product or therapeutic agent. “MSLs are being recognized as a specialty force and they are an important resource to the company and to the clinicians and healthcare providers who they deal with," she says. One new development in the MSL role is the move toward specialization. In the past, MSLs were inclined to be generalists, but as the role evolves, MSLs are involved in business unit discussions, serve as the voice of the practitioner, and are giving input to brand teams. Their roles could and should expand further, Dr. Winter-Sperry says. “MSLs have an enormous amount to add and they can bring different types of expertise to the table, for example, expanding their portfolio of skills to include REMS support and health literacy," she says. “As a result, MSLs are more involved in cross-functional teams and can assist with creating and maintaining HCP access and patient education on a greater level than ever before." According to Doug Young, Ph.D., VP, global medical affairs, at Bristol-Myers Squibb, the generalist and the specialist MSL role have always coexisted and will continue to do so, but the future environment may trend to more of a specialist role. “In my view, what is being done today is not very different from what has been done in the past," Dr. Young says. “Historically, most MSL teams have typically been narrowly focused in one therapeutic area and this is still largely the case. Today, however, there may be more sub-therapeutic specialization within therapeutic areas, such as hypertension or heart failure within cardiovascular. A less common approach is to have generalist MSLs cover more than one therapeutic area, which allows for smaller territories, but also less depth of therapeutic expertise. “I expect the increasingly complex science, biologics, and medicines that address very serious diseases will make this role increasingly important and the need for specialized teams will continue to grow," he adds. “Specialization is the future for MSLs — period," says Erin Albert, Pharm.D., president and CEO of Pharm LLC. “With genetic testing now at the pharmacy level for novel and/or expensive therapeutics, as an example, MSLs have the opportunity to not only discuss the pharmacotherapeutic issues around a new molecule, but they have a duty to discuss the pharmacogenomic issues around a new molecule as well." Dr. Albert believes that the emergence of personalized medicine will create a tremendous opportunity for MSLs to not only provide education on a molecule, but also provide the genetic advantages and disadvantages and responder/nonresponder data to thought leaders as a way to optimize therapy and stretch the healthcare dollar for patients. To that end, according to Dr. Albert, genetic testing companies have already created their own version of MSLs to help educate clinicians on when to provide genetic testing to their patients. Anton Ehrhardt, Ph.D., senior medical director at Millennium: The Takeda Oncology Company, believes the future of MSLs could shape up a little differently. He predicts that MSLs may have to become either generalists to survive in the future environment of scientific exchange and reactive information support or change the definition of “specialization." “Currently, MSL teams tend to be primarily tasked with support of KOLs and key institutions," he says. “If the need grows for scientific exchange and reactive information support in the community at large, the expansion of MSL teams is likely. These teams will probably be less specialized than current MSL teams though, as there will be more of a need for generalists in that setting." BRINGING VALUE TO THE COMPANY As the MSL role expands beyond scientific exchange, the value to the company increases. According to Dr. Ehrhardt, some organizations are developing teams to address specific functions, such as clinical research support, advocacy, education, etc., while others are becoming specialists for specific customers. Both of these strategies result in more expert MSLs as they can focus deeply on the aspects of their narrower role. Customers have reacted well to this level of expertise, Dr. Ehrhardt says, but the down side is the need for either more bodies to do the needed work, or larger territories for MSLs so that the variety of functions can be provided by the same headcount. “I am aware of MSL teams that, in addition to their normal field activities, have been tasked with full participation on product development teams, and contribute to the writing of clinical development plans," Dr. Ehrhardt says. “I’ve even known teams that have been given control of research programs, such as a registry, and they have overseen those studies in all aspects from managing a CRO through data analysis and publication. Those teams represent the ultimate MSL performance as they bring tangible value to the companies they work for, and they appreciate being treated as scientists too." According to Beth Price, executive VP at The Medical Affairs Company, two variables that may determine the credentials and experience of the type of MSL specialist required include the specific therapeutic area supported by the company and the extent to which education is truly needed to support an unmet need or needs within this area of medicine. “Many companies request that the MSLs they hire have a thorough understanding of the disease states they are supporting as these MSLs will be engaging in highly advanced clinical and technical discussions with their physician stakeholders," she says. “Companies are looking for MSLs who clearly understand the therapeutic area and have established KOL/physician relationships, especially in more complex disease states, including HIV/infectious disease, oncology, transplant, and hematology. But in some categories, such as pain, GI medicine, or osteoarthritis, companies may lean more toward MSLs having a generalist background in pharmacology as they can then provide specific disease state and product training once hired." According to Dr. Ehrhardt, the other difference in specialization relates to the ongoing interplay between regulations and the industry’s interpretation of the rules. “I don’t think there will be less specialization for many teams, but likely it will be categorically different," he says. Jane Chin, Ph.D., president of MSL Institute, believes the real focus should be on the value MSLs bring to the table and not categorizing the MSLs just to create some differentiation in the marketplace. “If companies believe that continuing to specialize the MSL role is a way to differentiate themselves in the marketplace then the executives have become distracted from the real questions, which are: what is the value of the MSL team? How is the value measured? And can the value be agreed upon?" Dr. Chin acknowledges that the expanding roles of MSLs in today’s complex business environment may be leading biopharmaceutical executives to believe they need to create specialized MSL teams. Today’s challenging environment requires scientific and clinical discourse with those whose scientific policies or pharmacoeconomic decisions shape the biopharmaceutical market environment, and therefore, forms of specialization are evolving from that. There are now medical science liaisons who specialize in healthcare outcomes and pharmaeconomics, designated by the acronym HOPE, and health economics and outcomes research, or HEORs. According to Ms. Price, there is now a proliferation of these outcomes-based positions because of the specialization of the stakeholder audience — in other words, payers. A quick search of the help wanted ads shows that many companies are searching for this type of scientist. One recent ad listed the responsibilities of a HOPE MSL as including prioritizing and executing tactics that proactively communicate the value of current and future products to priority healthcare providers and to select payers. The ad also indicated the company was looking for a HOPE scientist to profile managed market accounts and identify opportunities for customer value creation though the dissemination of clinical and health economic information and the identification of health outcomes and pharmacoeconomic research opportunities. Ms. Price says other changes in the landscape will provide further opportunities for an MSL to fine tune his or her specialty. For example, any drug that has a REMS or is an orphan drug will require a very high level of educational experience, which requires an MSL who is an expert in educating physicians on how to comply with REMS and other restrictions. “As personalized medicine increases, the specialized knowledge provided by the MSL field resource is further becoming an integral component of a company’s medical affairs structure and an imperative to providing optimal outcomes for providers and their patients. she says," she says. These new positions further illustrate that the MSL of tomorrow will need to be more than just a learned intermediary. To bring value to a company, an MSL will have to be able to successfully toggle between business and science, Dr. Winter-Sperry says. “A valuable MSL will have the ability to understand the business while operating with the heart of scientist," she says. Creating the Ultimate MSL The ability to build relationships, focus on specific functions, understand the audience, and acquire soft skills all lead to an exceptional medical science liaison. Although today’s MSL role has evolved into a very strategic role with a wide variety of responsibilities, at the core, MSLs need to be able to build relationships to do their jobs. Training on those softer skills has increased, to help the scientists learn how to effectively communicate and recognize social cues. “Scientists are not always known for their soft skills," Dr. Winter-Sperry says. “And these days, more MSLs are getting training on emotional intelligence." Dr. Winter-Sperry, who has been training MSLs for years about the business of being an MSL, recently started to provide training around social and emotional intelligence. MSL training has evolved from basic core skills related to therapeutic data to people skills that enable MSLs to use the valuable scientific information in a higher-level communication. “MSLs are very pragmatic and understand scientific concepts, but they also need to understand the variation of audiences that they deal with, whether these are external or internal customers," she says. “There has been a lot of work lately that goes into teaching MSLs probing skills, negotiation skills, and emotional and social intelligence awareness." While both types of training are important, to nurture the ultimate MSL for the organization, companies need to focus first on hiring a good match for the company, Dr. Young says. “Although these are clearly useful tools, I would be remiss if I didn’t mention how important it is to hire the right individuals initially," he says. “We look for people who have significant scientific and therapeutic knowledge, as well as first-hand clinical experience. Also, prior MSL experience is clearly a plus." According to Dr. Young, there are a number of ways to improve overall MSL performance, including therapeutic and skills training, clear role expectations and internal support systems, including experienced managers and mentors, internal and external feedback, metrics that reflect the overall impact and value of the team and using new and novel technologies to improve both the effectiveness and efficiency of the team. “MSLs work to translate the science into medical practice and to do so, they need to be trusted and respected sources of high-quality scientific and medical information on our R&D activities," Dr. Young says. “In short, MSLs ultimately have to help physicians provide better care to their patients through the information they seek to provide." Using technology is another way MSLs can build on relationships. Not every meeting needs to be face-to-face in this virtual world. The best MSLs find other ways to communicate with thought leaders other than face to face. “Creative MSLs are finding many ways to communicate with their external peers and customers, for example, using video conferencing, Skype, and teleseminars," Dr. Albert says. “While face-to-face meetings may still be the ultimate form of connectivity for the MSL and the thought leader, this will not always be the case and does not always work anymore." Using technology can help boost the number of touch points between MSLs and KOLs, as well as rapidly making pertinent information available to the KOL, which will improve the relationship. As time demands increase for MSL teams, and the ability to simply add more personnel is restricted, most companies are turning to technology to provide support services needed by customers. “Automated, on-demand delivery of drug information materials allows MSLs to provide written responses to physicians’ unsolicited questions essentially in real time," Dr. Ehrhardt says. “This type of responsiveness often gets rolled up into customers’ assessments of the MSLs they are interacting with even though the technology resides in a different function." Successful relationships are created when the needs of the physician and the needs of the company are in alignment, according to Dave Fishman, president, Snowfish. For the physician, access to resources is critical. For the company, the ability to engage KOLs in meaningful research and programs that drive awareness is also paramount. “We recently asked more than 200 physicians what they considered to be the most important factors in driving treatment decisions," Mr. Fishman says. “The results showed that, outside of clinical data, the most important factor was the recommendation from the KOL. A MSL needs to understand the audience in order to bring the company’s goals and KOLs into alignment and using KOL identification and mapping can help by identifying the ideal physicians. This method ensures MSL territories are equally drawn based on the opportunity, not geography, and sets a standard of metrics for measuring performance." Dr. Ehrhardt agrees that quality relationships stem from both parties getting what they need — not necessarily what they want — from the interaction. “Customers of MSLs need information, and they need support, and they need those things provided quickly and concisely and be able to trust the quality of what is provided," he says. “The physician/MSL relationships that are most highly valued are those that are built on good, old-fashioned trust and responsiveness." Regulations and restrictions While there are no widespread restrictions affecting the activities of MSLs who specialize in providing research support, specialists may be restricted by the same regulations that impact their sales counterparts. For example, some companies have fielded teams of “educational" specialists as part of the field medical organization. “In this setting, the education has to be on-label as the regulations don’t distinguish between job titles when defining what industry representatives may do," Dr. Ehrhardt says. “So, the ability of such teams to actually do the job they are tasked with overlaps with their sales and MSL colleagues, and they are restricted by the same access challenges facing sales teams." Rob Nauman, principal of BioPharma Advisors, fears that generalist and specialist MSLs are going to meet with even more regulatory restrictions. “In my opinion, regulators are trying to define the MSL’s job today and I don’t think that is a good thing, because they are defining how the interaction should occur based on inaccurate assumptions and perceptions in the marketplace," he says. “Through restrictions and regulations, the effectiveness of sales representatives is marginalized and this is beginning to happen to MSLs. Interactions between MSLs and thought leaders are going to start to become very guarded and restricted." One of the downfalls of a more specialized MSL field is the loss of flexibility, Dr. Winter-Sperry says. The generalist MSL is able to move between therapeutic areas and he or she is very good with dealing with high-level scientific information. As MSLs become more device- and diagnostic-oriented, their ability to move from one role to another will be reduced, because the specialties will become too diverse. “In other words, a MSL with 10 years pharma experience will not be hired by a company that is seeking someone with device experience," she says. F PharmaVOICE welcomes comments about this article. E-mail us at [email protected]. “Specialization is the future for MSLs — period." Dr. Erin Albert Pharm LLC “I expect the need for MSL ­specialization to grow." Dr. Doug Young Bristol-Myers Squibb “Executives have become distracted from the true question, which is “what is the value of our MSL team?“ Dr. Jane Chin The MSL Institute “MSLs may have to become generalists to survive in the future environment." Dr. Anton Ehrhardt Millennium: The Takeda Oncology Company “MSLs are now part of the ­fabric of commercializing a product or therapeutic agent." Dr. Robin Winter-Sperry Scientific Advantage and MSL Advantage “The effectiveness of sales reps has been marginalized by ­promotional ­regulations, and this is ­beginning to happen to MSLs." Rob Nauman BioPharma Advisors Neil H. Gray is Managing Partner of Healthcare Trends & Strategies LLC, a ­consultancy focused on improving medical science liaison performance, problem solving, and value generation. For more ­information, e-mail [email protected]. “The biggest challenge facing MSLs continues to be their ability not only to ­maintain their proficiency in scientific ­intelligence, but to be equally facile in business and emotional ­intelligence with an emphasis on problem ­solving and value generation. Many MSLs today were predominantly hired for their strength in science and sadly that has led to a surplus of talkers not doers. More than ever before, today’s life-sciences companies need work horses, not show ponies." Joy Morrell is Senior VP and Managing Director of The Therapeutics Institute, which provides dedicated teams of medical science liaisons and clinical ­educators to create and expand market ­opportunities and achieve business objectives for pharmaceutical and biotech clients. For more information, visit inventivhealth.com. “There is little doubt that the MSL role will ­continue to be the cornerstone of brand ­success but this is not without challenges in ­demonstrating the value of this investment. MSL teams will be scrutinized more carefully due to budget ­constraints and the need to streamline services become part of the normal business analysis in pharmaceutical industry. The ­ability to define the value of the MSL teams will be essential to ­sustaining their role. Quantitative and qualitative tools will determine the ­difference whether companies maintain MSL teams as the ­marketplace evolves over the next 10 years." John Pelkowski is Senior Director Client Engagement, Medical Affairs at AstraZeneca, a global pharma ­company. For more information, visit astrazeneca.com. “One of the challenges — connectivity — is being overcome with new technology, which is empowering smaller pharmaceutical teams, such as medical affairs, with better tools. AstraZeneca’s medical affairs team recently ­transitioned to the cloud with a new CRM ­system, proving a very down-to-earth strategy. We needed richer reporting, planning, and ­management functionality plus the ability to easily collaborate with other AZ teams, ­partners, and outside resources. While it took eight months to select Veeva System’s CRM suite, it took less than three months to ­implement the system to all 200-plus medical scientific liaisons at AstraZeneca US. It is remarkable how ­smoothly everything went, especially since this was the first time we implemented a true ­ multi-tenant ­system in the cloud. Even more ­impressive is that we implemented Veeva CRM on time and under budget despite expanding the scope of the project along the way. We had an ROI using Veeva CRM of 29%, saving 30% annually. We deployed this new application to our medical science liaisons that delivered far greater functionality and flexibility." Bryan Vaughan is ­Managing Member of ­Trinetpharma, an equitable talent sourcing company that provides both ­permanent and contract solutions for the placement of MSLs. For more ­information, visit trinetpharma.com. “In the next five to 10 years, we will see a very specialized internal MSL structure, ­containing three to four types of MSLs within each ­organization, and that industry ­guidelines will change in the future. Currently, the average interaction between a sales rep and a physician is close to two minutes, while the average ­interaction between a MSL and a physician is close to 45 minutes. Sales ­representatives ­numbers are decreasing while MSL numbers continue to rise. As this occurs, how will MSL maintain their core values? Expanding the KOL target audience Critical to supporting the relationship building between MSLs and their customers is using the advice obtained from KOLs and letting the KOLs know that the advice is being used. According to Anton Ehrhardt, Ph.D., senior medical director at Millennium: The Takeda Oncology Company, many KOLs have experienced advisory board interactions that just allow company representatives to dump data on them, be asked relatively mundane questions, and then have their advice go nowhere. Dr. Ehrhardt suggests a different tactic. “One program I’m aware of tasked the MSL team with developing and executing advisory boards," he says. “In that program, headquarters’ personnel who participated in the advisory board were not asked to chair or run the meeting, and it was obvious that the MSLs were running the program and moderating the discussions." The same program documented both the advice provided and subsequently that the advice was used in the decision-making process at the company. “In addition to the MSL control of the advisory board, the other novelty is that the advisors subsequently received written updates on what was captured at the meeting, what decisions were made using the advice, and what future plans were being affected by that advice," he says. “Those documents were delivered by the MSLs, and they were provided on a semi-annual basis for, in one instance, a period of years. Again, the perception of partnership created by this was attributed to the MSL." The ultimate MSLs will not only call on the traditional thought leaders, but also others in and around a particular therapeutic area, says Erin Albert, Pharm.D., president and CEO of Pharm LLC. The best MSLs also call on researchers in areas outside of their traditional therapeutic areas in the event that the drug is later approved for an additional indication outside of the original studies. “This technique is what leads to truly innovative uses for future therapeutics," she says. “In fact, the savvy MSL is already calling on clinical pharmacists who are supporting their patients with medication therapy management (MTM) services." According to Dr. Albert, the therapeutic areas of diabetes, asthma, and hyperlipidemia are three great examples where the MSL could have a huge positive impact on sharing data with clinical pharmacists because they must stay abreast of new clinical data and translate the information back to patients on multiple medications. “With the NY Times writing articles about companies paying patients to be more adherent with medication, I think the MSL could assist clinical pharmacists with better ways to have patients achieve adherence other than simply paying them to take their medications," she says. Studies rfom Cutting Edge Information (CEI) show that most MSLs working with established products are not recruiting new thought leaders as much as they have in the past, but instead are focusing on nurturing the existing base of KOLs. According to Yanis Saradjian, director of consulting at CEI, most companies have their MSLs in touch with KOLs no more than twice per month. “We had a few discussions with MSL managers and they are saying that more and more there is a shift in the focus from existing KOLs to new KOLs," he says. “In the future those old KOLs will not be there, and managers are increasingly realizing that catering to the same eroding KOL base will jeopardize long-term product success." Mr. Saradjian says there is an increasing need in today’s environment to identify and grow relationships with the new generation of thought leaders. Ultimate is Unique to Each ­Company While all these tools are helpful in developing a better MSL, the first step is to determine what the company defines as “ultimate," says Jane Chin, Ph.D., founder of MSL Institute. “The ultimate MSL performance is specifically relevant to each organization and may or may not translate wholly to another biopharmaceutical organization," she says. “After all, companies don’t become leaders in their therapeutic market by doing what other companies are doing; they do what is right for their business identity, and conduct themselves in the right way in the market." And while there are many ways for improving relationships, the bottom line is to provide physicians with information they find valuable in their role in advancing healthcare. “We are tempted to look for new ways to build relationships because the old ways are too hard, take us out of our comfort zone, force us to admit we don’t know everything, or require too much discipline to sustain," Dr. Chin says. “But the ultimate MSL needs to provide value and keep providing value, even when physicians’ needs change." The challenges of MSL ­Performance Measurement Soft skills and hard metrics don’t correspond well, making measuring the performance of MSLs a difficult task. Successfully measuring the performance of MSLs has been problematic since Day One, our experts say. The challenge is developing a system that matches management’s need for metrics with the qualitative nature of what MSLs do. According to Mr. Saradjian, measurement has always created some tension among upper management, but now with fewer sales reps in the field, the focus on the MSL function is increasing. “With salesforces being trimmed down, the MSL function is becoming the rising field force," he says. In Cutting Edge Information’s latest medical affairs study, The New MSL Profile, executives all pointed to a wide disconnect between upper management and the MSL function. Managers struggle with understanding what happens in the field and how to qualify those actions so they can be measured and translated into an ROI figure. Management is more comfortable correlating activities with metrics they can understand, such as the amount of times MSLs meet with KOLs, for instance. But trying to put a value on MSL and KOL relationships is like measuring a friendship, Mr. Saradjian says. “A person might have a friend he or she speaks to just once a year, and the interaction may be as if that year never passed and is very rewarding," he says. “Then there may be friends one sees every day who might not be as valued. How can this be measured?" To meet these challenges, companies are establishing softer metrics as new ways to measure MSL performance, Mr. Saradjian says. “When they meet with MSL managers to talk about the performance of their work, they are able to talk about their interactions and the quality of them," he says. “So each MSL is building stories around each KOL by recording all interactions throughout the year, and that builds the value. The MSL manager can then take that information and package it to qualify the value of the MSLs to upper management." Developing Metrics and Measurement guidelines PharmaVOICE polled MSL thought leaders to discuss how the industry can best cope with this difficult task of measuring MSL performance. According to Robin Winter-Sperry, M.D., president and CEO, Scientific Advantage, all companies can come up with some basic core competencies to measure, but the markers of success and the performance metrics really need to reflect the value of the company and the functional role the team plays within a particular company. While MSLs at different companies may perform similar basic activities, the weighting of those activities will be modified according to what resources are available and what functional need they are serving in the company and what the lifecycle stage or therapeutic agent they are dealing with. “People get so stuck on how to measure MSL performance," Dr. Winter-Sperry says. “The bottom line is that performance metrics don’t come in a one-size-fits all model." “This has and always will be the $64 million question for the MSL leader," Dr. Albert says. “Unfortunately, in the past five years more emphasis has been put on reach and frequency models." Dr. Albert cautions against this model, as it may fail to demonstrate the true success of a MSL. “At the end of the day, the quality of an interaction will always be the gold standard and trump quantity, reach, and frequency models," she says. “As both a law student and coach for healthcare and life-sciences professionals, I describe a high-quality MSL as Justice Stewart did in describing pornography in Jacobellis v. Ohio: ‘I know it when I see it.’" Most companies will admit that their metrics can be better, and they are making the best of what they can measure, Dr. Chin says. Companies could do a better job managing a MSL team in general if they gave thought to what they are looking to achieve and if they even need a MSL team. Dr. Chin says the first three questions a company should ask before hiring a MSL are: One, do we really need a MSL team? Two, how educated are our internal stakeholders about the challenges and rewards of owning a MSL function? And, three, is our medical director prepared to lead a MSL function?" Getting the truthful answers to these questions will require the company to do the research and the leadership development up front before installing the MSL function. “These are not easy tasks, and companies can be too eager to hire a MSL they do not need or want," Dr. Chin says. Performance measurement relates to these questions as metric concerns often stem from doubts of upper management that the role is necessary in the first place. “Most of the metrics problems I have witnessed are predicated by how the companies would have answered those hard questions," Dr. Chin says. “A company needs to set parameters that guide the process for which executives formulate metrics that work for its departments, not what everyone else is doing." There is no perfect solution for measuring MSL performance, according to Doug Young, Ph.D., VP, global medical affairs, Bristol-Myers Squibb. However, developing qualitative assessments is key. “While productivity can be assessed by quantitative measures, such as the number of physician interactions, the number of MSL presentations, the number of clinical trials supported, the number of speakers trained, these quantitative measures can only provide a sense of what MSLs are doing, but they don’t tell anything about the quality of their work," he says. “For this, a company needs to use qualitative assessments such as feedback from managers, colleagues, and even HCPs." Measuring MSL performance and relating that to value has been a challenge for years, but today the gap seems wider than ever, Dr. Ehrhardt says. He also believes that the subjective ways of qualifying MSL value through customer surveys or KOL participation in speaker programs for example, put today’s MSLs in jeopardy of not receiving an adequate performance review. “It seems that the stronger the firewall between the MSL function and sales, the softer the metrics have become," he says. “This may be reasonable from a compliance standpoint, but it makes the MSL’s value to the company hard to quantify, and this puts MSLs at risk." By characterizing the MSL function purely in terms of relationship management with KOLs, the quality of MSLs and the value they bring are dependent on the whims of customers. Dr. Ehrhardt says techniques for measuring this have involved customer surveys, access metrics, and even using selected spontaneous statements from customer that are brought to the attention of management. Companies have used point scales (ratings from 1-10), and assessment characterizations (from “very poor" to “outstanding") to capture their customer’s view of MSL value, he says. Another area of measurement activity has been advocacy or KOL development. “This is a complex topic, and I think it has been oversimplified by those of us in management for that very reason," Dr. Ehrhardt says. He explains that a given KOL’s speaking or writing activities in support of a company or product are, of course, of high interest to the company. Those activities, and the KOL’s enthusias to take part in them, are influenced by a myriad of factors, very few of which are within the control of a MSL, and yet management ties MSL compensation to the KOL’s activities and attitudes regardless. He gives a more concrete example: if MSLs are rated on how often their KOLs speak about the company’s product and how aligned those presentations are to the product messages then the MSL’s performance evaluation goes up when the company uses the KOL more often in its speakers bureau. “In one case, both the frequency and enthusiasm of that KOL’s advocacy decreased immediately after the product received a new black-box warning to its label," he says. “And the MSL’s performance rating decreased as a result." This type of approach forces MSLs to take credit for positive changes that they may or may not have been involved with, and correspondingly, to disavow any responsibility for negative changes, he concludes. For more successful measurement in the future, Dr. Ehrhardt recommends a better matching process between the role the company envisions the MSL having and the role the MSL has and then aligning performance metrics that match to both. For more successful measurement in the future, Dr. Ehrhardt recommends a better matching process between the role the company envisions MSLs having and MSL themselves, and then aligning performance metrics that match to both. F Pre- and Postlaunch Activities One metric that MSL managers are always interested in tracking and comparing with peers is the percentage of time MSLs spend in the field. While these data are broken down by therapeutic area, company size, and number of products supported, the average is close to 70%. The information below shows the five most time consuming tasks in pre- and postlaunch mode. The KOL identification tasks accounts for a third of an MSLs time in pre-launch mode, but drops to an average 15% in post-launch, refocusing their time to educating KOLs. This provides a better profile of what MSLs are doing and the differences in activities performed at different stages of a product lifecycle for instance. PreLaunch Identifying and building KOL relationships 35% Delivering presentations/speeches 14% Assisting clinical trial investigators 13% Developing scientific collateral 12% Coordinating/facilitating IIT processes 10% PostLaunch Educating thought leaders and HCPs 26% Identifying and building new KOL relationships 15% Supporting field sales forces 13% Coordinating new IITs 10% Participating in managed-care activities 10% Source: Cutting Edge Information. For more information, visit cuttingedge.com. Company-Adopted MSL Metrics • Some organizations are relying on organic measurement, which provides a qualitative solution to a qualitative problem. • Other companies construct systems of milestones to track the progress of thought leader relationships. • One company incorporates a set of steps into its MSL training program for new hires. Within a 90-day training program, the company assesses MSLs’ command of relationship-building steps and goals at 30 days, 60 days, and upon completing their training. • Another company’s MSL team established a formal set of guidelines that tracks relationship-building progression in levels. At the first level, MSLs and KOLs get to know each other. KOLs move to the second level when they have started to show interest in the company’s activities, such as participating in clinical trials and writing articles. • Another company is developing what it calls “stories" for each KOL that the MSL is nurturing. Every time an MSL has an exchange or interaction with a KOL, he or she records it in an Excel spreadsheet and puts it in his or her own records. Source: Cutting Edge Information. For more information, visit cuttingedge.com. Company-Adopted MSL Metrics • Some organizations are relying on organic measurement, which provides a qualitative solution to a qualitative problem. • Other companies construct systems of milestones to track the progress of thought leader relationships. • One company incorporates a set of steps into its MSL training program for new hires. Within a 90-day training program, the company assesses MSLs’ command of relationship-building steps and goals at 30 days, 60 days, and upon completing their training. • Another company’s MSL team established a formal set of guidelines that tracks relationship-building progression in levels. At the first level, MSLs and KOLs get to know each other. KOLs move to the second level when they have started to show interest in the company’s activities, such as participating in clinical trials and writing articles. • Another company is developing what it calls “stories" for each KOL that the MSL is nurturing. Every time an MSL has an exchange or interaction with a KOL, he or she records it in an Excel spreadsheet and puts it in his or her own records. Source: Cutting Edge Information. For more information, visit cuttingedge.com. ritical to supporting the relationship building between MSLs and their customers is using the advice obtained from KOLs and letting the KOLs know that the advice is being used. According to Anton Ehrhardt, Ph.D., senior medical director at Millennium: The Takeda Oncology Company, many KOLs have experienced advisory board interactions that just allow company representatives to dump data on them, be asked relatively mundane questions, and then have their advice go nowhere. Dr. Ehrhardt suggests a different tactic. “One program I’m aware of tasked the MSL team with developing and executing advisory boards," he says. “In that program, headquarters’ personnel who participated in the advisory board were not asked to chair or run the meeting, and it was obvious that the MSLs were running the program and moderating the discussions." The same program documented both the advice provided and subsequently that the advice was used in the decision-making process at the company. “In addition to the MSL control of the advisory board, the other novelty is that the advisors subsequently received written updates on what was captured at the meeting, what decisions were made using the advice, and what future plans were being affected by that advice," he says. “Those documents were delivered by the MSLs, and they were provided on a semi-annual basis for, in one instance, a period of years. Again, the perception of partnership created by this was attributed to the MSL." The ultimate MSLs will not only call on the traditional thought leaders, but also others in and around a particular therapeutic area, says Erin Albert, Pharm.D., president and CEO of Pharm LLC. The best MSLs also call on researchers in areas outside of their traditional therapeutic areas in the event that the drug is later approved for an additional indication outside of the original studies. “This technique is what leads to truly innovative uses for future therapeutics," she says. “In fact, the savvy MSL is already calling on clinical pharmacists who are supporting their patients with medication therapy management (MTM) services." According to Dr. Albert, the therapeutic areas of diabetes, asthma, and hyperlipidemia are three great examples where the MSL could have a huge positive impact on sharing data with clinical pharmacists because they must stay abreast of new clinical data and translate the information back to patients on multiple medications. “With the NY Times writing articles about companies paying patients to be more adherent with medication, I think the MSL could assist clinical pharmacists with better ways to have patients chieve adherence other than simply paying them to take their medications," she says. Studies rfom Cutting Edge Information (CEI) show that most MSLs working with established products are not recruiting new thought leaders as much as they have in the past, but instead are focusing on nurturing the existing base of KOLs. According to Yanis Saradjian, director of consulting at CEI, most companies have their MSLs in touch with KOLs no more than twice per month. “We had a few discussions with MSL managers and they are saying that more and more there is a shift in the focus from existing KOLs to new KOLs," he says. “In the future those old KOLs will not be there, and managers are increasingly realizing that catering to the same eroding KOL base will jeopardize long-term product success." Mr. Saradjian says there is an increasing need in today’s environment to identify and grow relationships with the new generation of thought leaders. Ultimate is Unique to Each ­Company While all these tools are helpful in developing a better MSL, the first step is to determine what the company defines as “ultimate," says Jane Chin, Ph.D., founder of MSL Institute. “The ultimate MSL performance is specifically relevant to each organization and may or may not translate wholly to another biopharmaceutical organization," she says. “After all, companies don’t become leaders in their therapeutic market by doing what other companies are doing; they do what is right for their business identity, and conduct themselves in the right way in the market." And while there are many ways for improving relationships, the bottom line is to provide physicians with information they find valuable in their role in advancing healthcare. “We are tempted to look for new ways to build relationships because the old ways are too hard, take us out of our comfort zone, force us to admit we don’t know everything, or require too much discipline to sustain," Dr. Chin says. “But the ultimate MSL needs to provide value and keep providing value, even when physicians’ needs change." The challenges of MSL ­Performance Measurement Soft skills and hard metrics don’t correspond well, making measuring the performance of MSLs a difficult task. Successfully measuring the performance of MSLs has been problematic since Day One, our experts say. The challenge is developing a system that matches management’s need for metrics with the qualitative nature of what MSLs do. According to Mr. Saradjian, measurement has always created some tension among upper management, but now with fewer sales reps in the field, the focus on the MSL function is increasing. “With salesforces being trimmed down, the MSL function is becoming the rising field force," he says. In Cutting Edge Information’s latest medical affairs study, The New MSL Profile, executives all pointed to a wide disconnect between upper management and the MSL function. Managers struggle with understanding what happens in the field and how to qualify those actions so they can be measured and translated into an ROI figure. Management is more comfortable correlating activities with metrics they can understand, such as the amount of times MSLs meet with KOLs, for instance. But trying to put a value on MSL and KOL relationships is like measuring a friendship, Mr. Saradjian says. “A person might have a friend he or she speaks to just once a year, and the interaction may be as if that year never passed and is very rewarding," he says. “Then there may be friends one sees every day who might not be as valued. How can this be measured?" To meet these challenges, companies are establishing softer metrics as new ways to measure MSL performance, Mr. Saradjian says. “When they meet with MSL managers to talk about the performance of their work, they are able to talk about their interactions and the quality of them," he says. “So each MSL is building stories around each KOL by recording all interactions throughout the year, and that builds the value. The MSL manager can then take that information and package it to qualify the value of the MSLs to upper management." Developing Metrics and Measurement guidelines PharmaVOICE polled MSL thought leaders to discuss how the industry can best cope with this difficult task of measuring MSL performance. According to Robin Winter-Sperry, M.D., president and CEO, Scientific Advantage, all companies can come up with some basic core competencies to measure, but the markers of success and the performance metrics really need to reflect the value of the company and the functional role the team plays within a particular company. While MSLs at different companies may perform similar basic activities, the weighting of those activities will be modified according to what resources are available and what functional need they are serving in the company and what the lifecycle stage or therapeutic agent they are dealing with. “People get so stuck on how to measure MSL performance," Dr. Winter-Sperry says. “The bottom line is that performance metrics don’t come in a one-size-fits all model." “This has and always will be the $64 million question for the MSL leader," Dr. Albert says. “Unfortunately, in the past five years more emphasis has been put on reach and frequency models." Dr. Albert cautions against this model, as it may fail to demonstrate the true success of a MSL. “At the end of the day, the quality of an interaction will always be the gold standard and trump quantity, reach, and frequency models," she says. “As both a law student and coach for healthcare and life-sciences professionals, I describe a high-quality MSL as Justice Stewart did in describing pornography in Jacobellis v. Ohio: ‘I know it when I see it.’" Most companies will admit that their metrics can be better, and they are making the best of what they can measure, Dr. Chin says. Companies could do a better job managing a MSL team in general if they gave thought to what they are looking to achieve and if they even need a MSL team. Dr. Chin says the first three questions a company should ask before hiring a MSL are: One, do we really need a MSL team? Two, how educated are our internal stakeholders about the challenges and rewards of owning a MSL function? And, three, is our medical director prepared to lead a MSL function?" Getting the truthful answers to these questions will require the company to do the research and the leadership development up front before installing the MSL function. “These are not easy tasks, and companies can be too eager to hire a MSL they do not need or want," Dr. Chin says. Performance measurement relates to these questions as metric concerns often stem from doubts of upper management that the role is necessary in the first place. “Most of the metrics problems I have witnessed are predicated by how the companies would have answered those hard questions," Dr. Chin says. “A company needs to set parameters that guide the process for which executives formulate metrics that work for its departments, not what everyone else is doing." There is no perfect solution for measuring MSL performance, according to Doug Young, Ph.D., VP, global medical affairs, Bristol-Myers Squibb. However, developing qualitative assessments is key. “While productivity can be assessed by quantitative measures, such as the number of physician interactions, the number of MSL presentations, the number of clinical trials supported, the number of speakers trained, these quantitative measures can only provide a sense of what MSLs are doing, but they don’t tell anything about the quality of their work," he says. “For this, a company needs to use qualitative assessments such as feedback from managers, colleagues, and even HCPs." Measuring MSL performance and relating that to value has been a challenge for years, but today the gap seems wider than ever, Dr. Ehrhardt says. He also believes that the subjective ways of qualifying MSL value through customer surveys or KOL participation in speaker programs for example, put today’s MSLs in jeopardy of not receiving an adequate performance review. “It seems that the stronger the firewall between the MSL function and sales, the softer the metrics have become," he says. “This may be reasonable from a compliance standpoint, but it makes the MSL’s value to the company hard to quantify, and this puts MSLs at risk." By characterizing the MSL function purely in terms of relationship management with KOLs, the quality of MSLs and the value they bring are dependent on the whims of customers. Dr. Ehrhardt says techniques for measuring this have involved customer surveys, access metrics, and even using selected spontaneous statements from customer that are brought to the attention of management. Companies have used point scales (ratings from 1-10), and assessment characterizations (from “very poor" to “outstanding") to capture their customer’s view of MSL value, he says. Another area of measurement activity has been advocacy or KOL development. “This is a complex topic, and I think it has been oversimplified by those of us in management for that very reason," Dr. Ehrhardt says. He explains that a given KOL’s speaking or writing activities in support of a company or product are, of course, of high interest to the company. Those activities, and the KOL’s enthusias to take part in them, are influenced by a myriad of factors, very few of which are within the control of a MSL, and yet management ties MSL compensation to the KOL’s activities and attitudes regardless. He gives a more concrete example: if MSLs are rated on how often their KOLs speak about the company’s product and how aligned those presentations are to the product messages then the MSL’s performance evaluation goes up when the company uses the KOL more often in its speakers bureau. “In one case, both the frequency and enthusiasm of that KOL’s advocacy decreased immediately after the product received a new black-box warning to its label," he says. “And the MSL’s performance rating decreased as a result." This type of approach forces MSLs to take credit for positive changes that they may or may not have been involved with, and correspondingly, to disavow any responsibility for negative changes, he concludes. For more successful measurement in the future, Dr. Ehrhardt recommends a better matching process between the role the company envisions the MSL having and the role the MSL has and then aligning performance metrics that match to both. For more successful measurement in the future, Dr. Ehrhardt recommends a better matching process between the role the company envisions MSLs having and MSL themselves, and then aligning performance metrics that match to both. F

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