Dec
10

7 smart questions any MSL manager should ask oneself

servant-leadership-mountain2-e1278812858393MSL management may be tough due to lack of tangible metrics to do good planning and acknowledgement. Besides widespred absence of KPIs in Medical Affairs may lead to diffculty in distinguishing MSL contribution from business activties. At the same time directive management will obviously reduce MSL motivation and engagement and lead to customer dissatisfaction. Probably right management is the clue? Despite 7 questions below might look quite generic, they seem to capture most relevent attributes of good MSL management.

1. What can I do to lead with asking better questions?
MSLs are usually not those who expect detailed guidelines what to do, instead they often have their own vision on what work has to be done. Right questions will encourage MSL attentiveness and shared perspectives. Leading with questions makes you a better listener. The act of questioning reinforces the idea that everyone is important and that we create success by serving one another. When you’re making genuine inquiries into a conflict, it fosters a spirit of neutrality. Asking allows others to engage in independent and creative thought. It promotes accountability when your team members are held responsible for their decisions. And your team members will be more engaged in the outcome if they have a hand in decision-making.
2. How can I encourage constructive conflicts in my team?
Encouraging constructive conflict in an environment where people are free to raise tough issues, to provide raw feedback to their leaders and team members is essential. Without open and constructive conflict scientific innovation fails, decision making stumbles and creative solutions become rare. Fear of losing control on MSLs may prevent manager from letting go the group dynamics which in fact is quite natural for high educated experts who are autonomous in decision making. You need to embrace opinion diversity in the team that leads to new challenging perspectives with the goal of finding innovative solutions.
3. What do I need to start leading outside of my responsibility area?
Collaborative leadership is about building trust based cross-functional relationships between Medical Affairs, Marketing, Sales, Compliance, Pharmacovigilance, etc. This requires a shift in thinking about who’s your team. Instead of seeing your team as consisting only of your direct reporting MSLs or Medical Advisors you must learn to embrace the horizontal team consisting of your peers. Your peers, those leading and working in other organizations, is your team. Leading a horizontal team requires influence and strong relationships.
4. What do I need to do to become showing leader rather than telling manager?
Regardless of how managers tell employees to behave, they’ll actually do whatever management shows them is the most advantageous way to behave. Make sure that you can serve the best example for your team in KOL management, crossfunctional collaboration and compliant decision making. Try not to stuck in pure management, otherwise you risk to loose any opportunity to lead with your own example and will inevitably end up with a team of MSLs willing to sacrifice real achievement in order to look good.
5. What can I do to to support my employees to stay open to learning and to keep getting better all the time?
As a leader you are committed to ensure conditions for the team members to learn and develop. Obviously we learn substantially more from failure than success. So embrace failure of your team. Besides MSLs will take more chances when they are unafraid to fail. Most of MSL practices as elaboration of customer congruent sientific projects or Investigator Initiated Trials requre many attempts to get tailored for the true needs and finally be percieved as successful. Thus try focus MSL team on a future that they can impact, not a past that they cannot change anyway.
6. What can I do to make sure my employees are consistently acknowledged and appreciated for what they do?
The top motivating factor of employees is appreciation for a job well done. Often managers are too busy to motivate their employees and give appreciation for a good job. It doesn’t cost you anything to sit down with an MSL team member who is doing a great job and communicate face to face how much you appreciate his or her efforts. Or send consistent e-mails to MSLs who have done an exceptional job on certain projects, ensuring that you copy other team members who should know about these efforts. Try to be specific, timely and public if possible.
7. Based on my experience what is the best way to improve MSL team performance and motivation without additional expenses?
Effective and timely feedback is a critical component of a successful performance management program and should be used in conjunction with setting performance goals. If effective feedback is given to MSLs on their progress towards their goals, their performance will improve. People need to know in a timely manner how they’re doing, what’s working, and what’s not. In case of motivation improvement see question 6 where I mention appreciation for good job as a main motivation factor. And yet of course this is not the ready answer to the question 7, only my thoughts.

Dr. Alexander Tolmachev,

Senior Manager for Medical and Regulatory Projects, Takeda

Nov
26

Considerations on Off-Label Issues at Prelaunch

220px-Sumner_LionPrelaunch is a critical time for MSLs to work with brand teams and build key opinion leader relationships for future interactions once an indication is approved. Quite often business executives thinking that MSLs have complete regulatory freedom to “promote” off-label may expect them to start proactively disseminating the upcoming opportunities to use the product. It may happen that MSLs might even get instructions from Business to use published articles with successful clinical data or product summaries from other countries where the product has been registered already in order to confirm efficacy or safety of a non-registered indication. This is the way business may see “market preparation”. MSLs are commonly coached to be good partners for sales teams and when measuring MSL performance managers often utilize an internal partner feedback survey. This may produce a risk for MSLs to turn «order takers» for Sales and eventually «off-label reps». The initial reason is that many managers believe that FDA regulations somehow grant MSLs special rights to proactively disseminate off-label information.

1. The rule is simple – nobody can promote off-label – not Sales, MSLs, Clinical Trial Managers, R&D directors, nor physicians who speak on behalf of pharmaceutical companies.

2. Any discussion initiated by company employees about off-label use including pure scientific data or published clinical cases is illegal. In case you only mentioning the non-registered indication without application to your product, anyway a compliance organization may ask you why you are doing this if you have no intention to sell.

3. Only if an off label discussion is initiated by a physician’s query (an unsolicited request) Medical Affairs people may communicate off-label data in the frames of the request. And of course the query must be truly initiated by a physician.

4. A situation when an MSL leads a professional to a discussion when she/he will eventually ask about off label uses is not a directly initiated discussion, but is a solicitation that is prohibited. Besides trying to promote your product in non-registered indications will never bring success to the team in current global regulatory environment.

So if not proactively disseminating off-label data, then what is the role of MSL at Prelaunch phase? – Business may ask. The mission of MSLs at laucnh is building relationships with thought leaders and listening carefully to physician needs for a particular disease area, learning where current treatments are insufficient and what physicians would like to see in a new product. This input becomes extremely valuable later as the company creates product messages and the scientific platform for publications. Therefore an important piece of job to be done by Medical Affairs is building clear perception of MSL role within internal stakeholders with special focus on off-label communication rules.

By Dr. Alexander Tolmachev

Nov
08

MSL Society Heralds Second Successful Global Gathering of MSLs, Medical Affairs Executives

The MSL Society is celebrating the success of its second successful global event of the year, the Paris 2013 Conference.  Held at the Hyatt Regency Paris Etoile, the action-packed conference brought together medical science liaisons and medical affairs professionals from nearly every corner of the globe and multiple life science industries, including pharmaceuticals, biotechnology, medical devices and diagnostics, and clinical research organizations.

The event opened in customary MSL Society fashion, with a networking reception for the conference participants to get to know each other in a comfortable setting on the evening of October 28.  During the following two days of intense content-sharing, participants heard a range of experienced speakers deliver critical information on a broad-ranging set of topics that impact the daily professional lives of MSLs and the departments and companies they serve.  Topics discussed included the Evolving Role of the MSL, Building a Medical Affairs Department, MSL Training, and Building an MSL Team Structure in a Therapeutic Area.

Speakers at the event included several leading lights in the global medical affairs community, including Elizabeth Kupferer of Sequenom (USA), Martin Obladen of Bayer Healthcare (Germany), Jennifer Williams of Bard Medical (USA), Ayse Olmez of Bayer Healthcare (Turkey), Elena Chukraeva of Janssen (Russia), Belinda Gist of Genzyme (USA), Yavuz Silay of Labiopharma (USA), Elly Grimaldi of GRS (USA), Maria Mabunay of Mundipharma (Singapore), and Gregory Fiore of the Medicines Company (USA).

For Williams, one of the featured speakers at the event, the timing is right for the MSL Society to serve its members and help them attain the maximum benefits the global medical affairs community has to offer.  “There is no better time to engage in the development and leadership of the MSL,” Williams stated.  “The MSL Society has successfully launched this type of needed engagement around the globe, and success is certain through peer review and meetings such as the professional meeting in Paris.”

Kupferer concurred with Williams’ assessment. “The conference in Paris provided an invaluable networking and collaboration experience, the kind of experience that genuinely fosters the expansion and maturation of the MSL role throughout the world,” Kupferer explained.  “Given the diverse experiential and professional backgrounds of MSLs, from health care provider to bench researcher, these types of events are integral to the advancement of the MSL profession.  Indeed, all attendeesundefinedfrom tenured MSLs and directors to those wishing to enter into the MSL role for the first timeundefinedcan benefit from attending.”

Belinda Gist of Genzyme praised the MSL Society for an event that already surpasses similar conferences staged in the healthcare space with regard to the level of interactivity among speakers, panelists, sponsors, and attendees:  “The Paris MSL Society conference was fantastic.  It was the single-most interactive event I have attended.  I thoroughly enjoyed the exchange with my peers and their willingness to share stories, successes, and challenges. I see the MSL Society as a key driver in shaping the future of the MSL profession, and I am tremendously excited to be a part of it.”  

The MSL Society extends its gratitude to the following sponsors and media partners who powered the organization’s second conference with both financial and strategic resource commitments:  Thought Leader Select, Global Prairie, Barrington James, FiercePharma, Elsevier, PM360, and inScience Training,

According to MSL Society Chairman Samuel Dyer, the event reflected the best expression twin values of networking and education for the MSL community:  “The MSL Society’s Paris conference was a great success and a rare opportunity for attendees to engage with a diverse group of speakers representing MSL leadership from the U.S., Europe, Turkey, Russia and Asia.  It is very exciting to see the global MSL community come together to support the MSL Society while discussing important issues facing the MSL role such as MSL certification, on-board training, and MSL metrics. It was also a lot of fun to socialize with friends and establish new relationships during the evening networking events held overlooking the Eiffel Tower and the Louvre.”

Stay tuned to this space for announcements regarding 2014 MSL Society events.

Oct
21

What is the Future of Medical Affairs?

By Dr. Alexander Tolmachev

According to McKinsey & Company report, back in 2007 medical leaders from across the pharmaceutical industry assembled to develop a common understanding of a ten-year vision for Medical Affairs. With five years now past, it is hardly surprising that significant change has occurred in the world in which the pharmaceutical industry operates, especially given the remarkable economic environment and the continued acceleration of technological change. While many of the trends predicted in 2007 will continue, the pace of change is expected to increase even more as we approach 2020. The report states that three new, stronger forces will emerge that will greatly alter the healthcare landscape:

1. The definition of value will be much broader and will expand as the types of healthcare stakeholders who demand a demonstration of value increase. At the same time, there will be an increased focus on evidence and higher hurdles for proving product value.

2. Interactions between pharmaceutical companies and various medical stakeholders will continue to evolve with the emergence of new decision makers and with greater public scrutiny of these relationships. The role of patients will also fundamentally change with the rise of consumerism in healthcare.

3. The proliferation of data and demands for transparency we see today will accelerate as we head towards 2020. The number and types of users of medical data and information will continue to expand rapidly.

Given the significant changes in the healthcare landscape, this is an appropriate time to reassess and redefine the vision for Medical Affairs developed five years ago. Over the past 12 months, McKinsey & Company worked with Medical Affairs executives across the industry to produce this updated 2020 Vision for Medical Affairs. If achieved, the four aspirations below would enable the Medical Affairs function to create significantly greater value for their companies, industry and society:

1. Enhance patient access to best use of optimal medical treatment by clearly demonstrating value to practitioners and payors throughout the lifecycle of each product.
2. Embrace patient-centric healthcare by engaging and partnering with a broader range of healthcare stakeholders to more fully understand the different needs of patients and to be able to provide tangible value to patients.
3. Facilitate coordination and integration of different medical data and types of knowledgein the company and achieve external recognition for providing credible and unbiased medical information.
4. Acquire and develop the talent to cultivate and build a strong, multi-faceted Medical Affairs organization that encompasses the new set of competencies required to navigate the future healthcare landscape across the globe.

Much work will be required to realize this vision to create value for individual companies and the industry overall. At the heart of this effort, improved patient care and outcomes must be the central motivation of the Medical Affairs leaders. To do that effectively, Medical Affairs must become an equal to the R&D and commercial functions in advocating the patient-centric view. Deep patient insights have to come from engagements with emerging medical stakeholders and mining of new data, such as real-world evidence. Medical Affairs will also need to build new capabilities to leverage these insights.

Reference
1. Pharma Medical Affairs 2020 and beyond – McKinsey & Company Report. www.mckinsey.com